19 CSR — Department of Health and Senior Services

Division 10 Office of the Director

Chapter 1 Organization

19 CSR 10-1.010 General Organization of the Department of Health {#sec-19-csr-10-1.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-1.010}

PURPOSE: As required by section 536.023, RSMo (1986), this rule describes the organization of the department and where the public may obtain information about the department.

(1) The Department of Health was created and established, effective September 28, 1985, by the 83rd General Assembly by Senate Bill 25 under the authority of Article IV,

Section 12, of the Constitution. The department is charged with the responsibility for supervising and managing public health functions and programs transferred to the department by type I transfer including but not limited to, responsibilities and functions set forth in chapters 189, 190, 191, 192, 193, 195, 196, 197, 199 and 201, RSMo. The State Cancer Center and Cancer Commission,

chapter 200, RSMo were transferred to the Department of Health by type III transfer.

Such transfers are defined in section 1 of the Omnibus State Reorganization Act of 1974,

Appendix B, RSMo (1986).

(2) The department director, appointed by the governor by and with the advice and consent of the senate, is the chief executive officer of the department. The State Board of Health, appointed by the governor and with the advice and consent of the senate, advises the department on the promulgation of rules and formulation of the budget. The director appoints the management staff including the deputy director, principal assistants, legal counsel and division directors. The deputy director, who acts for the director in his/her absence, has major delegated responsibility for the management of internal affairs and supervision of the division directors. The offices of fiscal management, personnel and training, public information and health promotion report to the director and deputy director. In addition to the directorís office, the department is organized into four (4) divisions.

(3) The Division of Environmental Health and Epidemiology Services is responsible for environmental epidemiology which includes the investigation and prevention of diseases related to the environment or workplace; community sanitation which includes food, drug and cosmetic protection and general sanitation and radiological health which includes surveillance of radiation-producing devices, materials and sources. The division administers programs for the prevention and control of communicable and sexually-transmitted diseases, tuberculosis, nosocomial infections, cancer and zoonoses. The division is responsible for promoting the enforcement of the state school immunization law and implementation of other immunization programs. The state public health laboratory is assigned to this division. It supports public health programs by providing testing services in the fields of chemistry, environmental bacteriology, microbiology, serology, virology and metabolic diseases.

(4) The Division of Local Health and Institutional Services is responsible for the supervision of the departmentís district offices which provide direct public health services through programs such as the crippled childrenís service, communicable disease control and environmental health. The divisionís central and district offices provide nursing and other professional program consultation and assistance to city and county public health units which deliver the departmentís health services to the public through contractual agreements. This division works closely with the other divisions in the implementation of programs at the district and local levels. Other statewide responsibilities include promoting primary care services, staffing the medical student loan program, physician recruitment and placement, rural and urban health initiative programs and technical consultation to communities in developing health services. The Missouri Re-habilitation Center in Mt. Vernon is assigned to this division. It was formerly the State Chest Hospital which cared for patients with lung diseases and the facility expanded its services to include long-term care of persons needing rehabilitation care when it became the rehabilitation center on September 28, 1985. The center provides rehabilitation services for respiratory, cardiac, head injury, stroke, spinal cord injury and other long-term physical impairments.

(5) The Division of Health Resources includes the State Center for Health Statistics which is responsible for the collection and analysis of health-related information to promote a better understanding of health problems and needs in Missouri, as well as spotlighting improvements and progress achieved in the general health status of Missourians.

Data generated by the center aid in the planning, development and evaluation of programs and services of the Department of Health as well as health-related activities of other agencies and institutions. The center is also responsible for the registration of all births and deaths in Missouri, issuing copies of birth and death certificates and maintaining records of marriages and marriage dissolutions. The division administers statewide programs of licensing and certification of hospitals, home health agencies, independent laboratories and other health care facilities; implements the Missouri Ambulance Licensure Law (chapter 190, RSMo), including inspection and licensure of ambulances and testing and licensure of all ambulance attendants in the state; and administers programs for the registration and surveillance of firms and individuals who manufacture, distribute, prescribe, dispense or handle controlled substances. The division also includes the State Health Planning and Development Agency (SHPDA) which administers the Certificate of Need program and works with the Missouri Health Coordinating Council in developing the state health plan.

(6) The Division of Personal Health Services is responsible for administering maternal and child health services including prenatal care; family planning; high-risk infant follow-up; prevention of mental retardation; child health conferences; early periodic screening, diagnosis and treatment (EPSDT); Special Supplemental Foods for Women, Infants and Children (WIC); and Missouri Crippled Childrenís Service. The division is also responsible for dental health programs including promotion of fluoridation of public water supplies, provision of dental treatment to selected groups such as handicapped children, and dissemination of dental health information. The division administers programs for the prevention and control of chronic diseases including diabetes, hypertension, hemophilia, sickle cell anemia, genetic diseases, cystic fibrosis and arthritis.

(7) The State Cancer Commission is appointed by the governor with the advice and consent of the senate. The director of the Department of Health serves on the commission as an ex officio member. The State Cancer Commission serves as the board of directors of the State Cancer Center and appoints the director for the center, who is responsible for its operation.

(8) The public may obtain information or make submissions or requests to the director of the Department of Health, P.O. Box 570, Jefferson City, MO 65102, (314) 751-4330.

MATTBLUNT(1/29/03)

Chapter 1óOrganization19 CSR 10-1

Readopted: Filed Oct. 3, 1986, effective Dec. 26, 1986. *Original authority: 192.005, RSMo 1985 and 536.023, RSMo 1975, amended 1976.

4CODE OF STATE REGULATIONS

(1/29/03) MATTBLUNT 19 CSR 10-1óDEPARTMENT OF HEALTH AND SENIOR SERVICES

History

AUTHORITY: sections 192.005.2. and 536.023, RSMo 1986. This rule was previously filed as 13 CSR 50-1.010. Original rule filed Sept. 27, 1976, effective Jan. 13, 1977.

Chapter 2 Civil Rights Compliance

19 CSR 10-2.010 Civil Rights Compliance Requirements {#sec-19-csr-10-2.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-2.010}

PURPOSE: This rule specifies civil rights compliance requirements for all health service providers and contractors who provide services for the Department of Health and for all hospitals and public health clinics that receive federal financial assistance or reimbursements for services provided.

(1) The following definitions shall be used in the interpretation and enforcement of this

rule:

(A) Applicant is any individual who applies for services from a covered recipient agency;

(B) Assurance is a contractual agreement in which a covered recipient agency legally agrees to administer programs and services in accordance with this rule;

(C) Civil rights requirements are the requirements of Title VI of the Civil Rights Act of 1964 (42 USC 2000dó2000d.6), Section 504 of the Rehabilitation Act of 1973 (P.L. 93-516), the Age Discrimination Act of 1975, Title II and Title III of the American Disabilities Act of 1990 and this rule;

(D) Complainant is any person or group of persons who allege discrimination on the

basis of race, color, national origin, age, sex or disability in the delivery of health care services by a covered recipient agency;

(E) Complaint is a verbal or written allegation of discrimination which indicates that a health care service is provided in a manner that results in disparity of services to persons or groups of persons because of race, color, national origin, age, sex or disability;

(F) Compliance review is a review of a covered recipient agency conducted by the Department of Health and Senior Services (DHSS) to determine compliance with the requirements of this rule;

(G) Covered recipient agency is any facility operated primarily to provide health care services as a nonprofit or for-profit institution which receives federal reimbursements for the services provided; and (H) Federal assistance is any United States government funding, reimbursement, property or aid which is given to a covered recipient agency to provide health care services or program benefits to clients or patients.

(2) The DHSS shall strive to assure that all public health care services and benefits are made available and provided to all eligible individuals without regard to race, color, national origin, age, sex or disability status.

(3) To eliminate duplication of civil rights compliance efforts, the DHSS and the Department of Social Services (DSS) shall follow a cooperative agreement negotiated by the two (2) departments designating the responsibilities and relationships of each agency in carrying out Title XIX (Medicaid) programs.

(4) Contractors who provide goods to DHSS are not subject to this rule.

(5) In all contracts for services, the DHSS shall include clauses regarding civil rights.

(A) A covered recipient agency shall comply with the civil rights requirements defined in subsection (1)(C) of this rule. A covered recipient agency will affirm compliance at the time of contract signing.

(B) A covered recipient agency which is a government entity and is receiving federal funds through DHSS shall have and maintain a personnel merit system.

(C) A covered recipient agency which employs fifteen (15) or more persons shall designate an employee to coordinate civil rights efforts.

(D) A covered recipient agency which receives or contract(s) with DHSS and employs fifty (50) or more persons shall implement an affirmative action program that complies with the civil rights requirements.

(E) Each covered recipient agency shall implement a public notification system which encourages participation and informs all potential participants, particularly minorities, of the availability of its programs.

(F) Each covered recipient agency shall print in easily read type on all public program communications this statement: Eligibility criteria for acceptance and participation in this program are administered on a nondiscriminatory basis regardless of race, color, national origin, age, sex or disability.

(G) Each covered recipient agency shall maintain a system for collecting racial/ethnic participation data. This data shall include the number of recipients of services and shall be acceptable to DHSS.

(H) Each covered recipient agency shall display DHSS-approved nondiscrimination posters and policy statements in all facility areas frequented by employees, applicants and recipients of services.

(I) Each covered recipient agency shall display notices of the availability of complaint procedures and have appropriate guidelines in place for referring civil rights complaints and complainants to the DHSS for review and resolution. The DHSS shall notify the appropriate federal agency of the receipt of a complaint if that notification is required.

(J) Each covered recipient agency shall make reasonable accommodations for handicapped applicants and recipients of services including, but not limited to, provision of appropriate auxiliary aids to persons with impaired sensory or speaking skills, parking and access to the facility for the disabled, and removal of barriers to accessibility if the removal is readily achievable.

(K) If the covered recipient agency uses any funds from DHSS and contracts in a subcontract, the contractor shall require the subcontractor to comply with subsections (5)(A)ñ(L) of this rule.

(L) The DHSS shall have the right to enforce all applicable clauses in subsections (5)(A)ñ(K) of this rule by appropriate and reasonable procedures including, but not limited to, requests, reports, site visits and inspection of relevant documentation of the contractor.

(6) Periodically the DHSS shall assess the compliance level of covered recipient agencies by conducting a desk audit or on-site review on randomly selected agencies. An on-site civil rights compliance review shall be performed by the DHSS when there is evidence of substantial noncompliance as shown by a desk audit or a complaint investigation.

(7) If the contractor fails to comply with the terms of the civil rights assurance in the contract, DHSS shall terminate the contract.

Prior to termination of a contract, DHSS shall give fifteen (15) daysí notice to the contractor specifying the reasons why the department believes the contractor is not in compliance and shall provide the contractor an opportunity to show compliance with the contract. The contractor may request a conference with DHSS during this period. The request shall be in writing to the director of the DHSS.

MATTBLUNT(9/30/02)

Chapter 2óCivil Rights Compliance19 CSR 10-2

History

AUTHORITY: Governorís Executive Order 87-6 and section 536.023.3., RSMo 2000. Original rule filed Sept. 8, 1992, effective April 8, 1993. Amended: Filed April 15, 2002, effective Oct. 30, 2002. Original authority: Executive Order 87-6, RSMo 1987 and 536.023.3., RSMo 1975, amended 1976, 1997.

Chapter 3 General and Family Physician Loan and Training Programs

19 CSR 10-3.020 Funding of the Programs to Increase General and Family Physician SERVICES Training Programs {#sec-19-csr-10-3.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-3.020}

19 CSR 10-3.010 Loan Program for Medical Students medical student loan program authorized by section 191.505, RSMo 1986. {#sec-19-csr-10-3.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-3.010}

Editor’s Note: The forms mentioned in this rule follow 19 CSR 10- 6.010.

(1) The Missouri Department of Health may appoint a committee(s) to interview applicants and to make recommendations concerning the administration of the program.

(2) To qualify for a student loan, the applicant must have no conflicting service obligation that would prevent the state from benefiting from his/her professional services after graduation. To qualify as a student from a rural area, the applicant should have lived most of his/her life in a rural area; in particular cases, the Missouri Department of Health may determine that a student who is a resident of a rural area at the time of application qualifies even though s/he has not lived most of his/her life in a rural area. When there are more applicants than available loans, financial need may be considered in selecting loan recipients.

(3) Using data provided by the statistical section of the Missouri Department of Health, each year the Missouri Department of Health will designate areas of defined need. A community or section of an urban area will be designated as an area of defined need if the area has a population to primary-carephysician ratio of at least three thousand five hundred to one (3500:1); or if the area has a population to primary-carephysician ratio of less than three thousand five hundred to one (3500:1); but greater than two thousand five hundred to one (2500:1) and has an unusually high need for primary health care services or is underserved by specialized hospital care. An area of defined need must be a community or city of six thousand (6,000) or more population—plus the surrounding area up to a radius of approximately fifteen (15) miles—that serves generally as the central community of that area for a variety of services; or an urban or metropolitan neighborhood—generally located within the central city(ies) of a Standard Metropolitan Statistical Area—that has limited interaction with contiguous areas, a minimum population of approximately twenty thousand (20,000) and consisting of census tracts whenever possible. Any other area with unusual circumstances—such as impending retirement or failing health of physicians in the area or refusal of physicians to accept certain types of patients such as persons eligible for Medicaid or Medicare—can be evaluated on a case-by-case

basis for designation as an area of defined need.

(A) For the purpose of area determination, primary-care physicians are those fully licensed and currently registered by the State Board of Registration for the Healing Arts who report general or family practice, internal medicine, pediatrics or obstetrics and gynecology as their primary specialities.

Primary-care physicians in part-time practice due to partial retirement, disability or nonpatient care activities will be counted on a full-time equivalent basis according to the number of hours reported in patient care a week compared to forty (40) hours. Physicians engaged solely in administration, research and teaching and those in training as interns and residents will not be included in counting an area’s primarycare physicians.

(B) An area will be considered to have an unusually high need for primary-care medical services if more than twenty percent (20%) of the population is fifty-five (55) years of age or over, or if more than twenty percent (20%) of the population or households is below the poverty level.

(C) An area will be considered underserved by specialized hospital care if the largest hospital in the area is approximately thirty (30) miles or more from a comparable or larger facility; or if the central community in the area is approximately fifteen (15) miles or more from a hospital having more than four thousand (4,000) discharges a year or more than four hundred (400) deliveries annually.

(4) Loan applications should be sent to the Missouri Department of Health, Division of Injury Prevention, Head Injury Rehabilitation and Local Health Services, P.O. Box 570, Jefferson City, MO 65102. Except for the first academic year that the program is in effect, completed applications must be received prior to April 1 for loans to be made for the next academic year. Except for the first academic year that the program is in effect, applicants must be notified by letter on or before July 1, indicating that a loan will or will not be made available if funds are appropriated for the particular fiscal year.

(5) The form for the loan contract will be approved by the office of the attorney general. Loan recipients must sign new contracts for each year’s loan they receive.

(6) Each loan recipient must notify the Department of Health of any change in his/her address or educational enrollment eligibility status. The full amount of the principal and accumulated interest on the loan will be due immediately for repayment when the loan recipient loses educational enrollment eligibility status. A loan recipient loses educational enrollment eligibility status when s/he is no longer a medical student in good standing, quits school or takes a leave of absence which has not been approved by the Department of Health or fails to notify the department of changes in his/her address.

(7) If the loan recipient does not qualify for deferral of payment of the loan and interest as set forth in section 191.505, RSMo (1986), the entire loan and interest must be repaid within one (1) year. Loan recipients who do not qualify for this deferral include, but are not limited to:

(A) Recipients who are in an internship or residency program for any specialty other than primary care;

(B) Recipients who are in an internship or residency training status extending beyond the limit of three (3) years; and (C) Recipients who enter a practice in an area not defined as rural or as an area of defined need as designated by the Department of Health.

(8) Repayment of Loans.

(A) Interest will accrue from the date the check is issued.

(B) Once a loan recipient has started a practice in a rural area or in an area of defined need, the loan and interest will continue to be forgiven even if the defined need designation of the area is withdrawn.

(C) The Department of Health may grant an extension, not to exceed forty-eight (48) consecutive months, for repayment of a loan if the director of the Department of Health decides that circumstances explained in a written request from the loan recipient warrant an extension.

(D) Forgiveness and cash repayment periods are limited to forty-eight (48) consecutive months. Forgiveness and cash repayment periods are calculated beginning the first day of the calendar year following completion of internship or residency training. Forgiveness of the loan and the accrued interest may be authorized for monthly periods of less than one (1) year. No repayment period shall extend beyond the forty-eight (48)month time period.

(E) A portion of the loan and accrued interest may be forgiven for primary care physician services provided on a full-time

basis in an area of defined need or a rural area. Forgiveness shall be calculated in increments of no less than one (1) month.

The physician shall provide services qualifying for forgiveness for a minimum of fifteen (15) days during a calendar month for forgiveness credit to apply. Partial year forgiveness periods may be authorized by the director of the Department of Health.

(F) When, during the forty-eight (48)-month repayment period, a physician in noncompliant cash repayment status desires to return to a forgiveness status, s/he shall submit to the director of the Department of Health a written request stating the conditions that caused the original breach of contract, reasons for desiring to return to a forgiveness status and a detailed primary care practice plan. The director may request any additional information needed to evaluate the situation. Failure to provide complete information shall nullify the reconsideration. The director may reinstate a physician’s forgiveness status for the time remaining in the repayment period. The recipient shall continue to make cash restitution for the interval of noncompliance. Failure to comply with the cash repayment schedule shall result in the loss of the reinstated forgiveness status. The cash repayment shall be completed by the end of the forty-eight (48)-month repayment period and failure to comply shall result in legal action against the physician or his/her estate.

(G) Interest accrued during the deferral period by a loan recipient who is pursuing an internship or residency in primary care shall be forgiven on the same basis as the original loan and interest.

rule filed May 14, 1979, effective Aug. 11, 1979. Amended: Filed Nov. 14, 1988, effective Jan. 27, 1989. Amended: Filed Nov. 2, 1990, effective April 29, 1991. Changed to 19 CSR 10-3.010 July 30, 1998. ** *Original authority: 191.505, RSMo 1978, amended 1988. **Pursuant to Executive Order 21-07, 19 CSR 10-3.010, subsection (8)(A) and section 191.530, RSMo was suspended from March 25, 2020 through August 31, 2021.

History

AUTHORITY: section 191.505, RSMo Supp. 1989. This rule was previously filed as 13 CSR 50-170.010 and 19 CSR 50-1.010. Original

19 CSR 10-3.020 Funding of the Programs to Increase General and Family Physician Training Opportunities {#sec-19-csr-10-3.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-3.020}

PURPOSE: This rule establishes criteria for funding family physician training opportunities authorized by section 191.585, RSMo (1986).

(1) Applications may be submitted to the Department of Health from an approved family practice residency program or an approved general rotating internship program for funds for the operation and administration of a new or existing family practice residency program or a general rotating internship program. Funds shall be used for the support of faculty, interns, residents and other employees; for supplies, equipment and incidental expenses as may be needed for the program; and for construction and renovation of new family practice offices utilized in approved programs. Applications also may be submitted to the Department of Health by an approved family practice residency program or an approved general rotating internship program or by a hospital to request funds for planning of a family practice residency program or a general rotating internship program.

(2) Applicants may obtain application forms and instructions from the director of the Missouri Department of Health. The deadline for submission of the completed applications will be at the discretion of the director of the Department of Health annually.

(3) Approval of any application will be based on an analysis of these factors—the potential effectiveness of the proposed project in carrying out activities authorized in section 191.585, RSMo (1987); the extent of responsiveness to the project requirements, guidelines and application requirements; the administrative and management capability of the applicant to carry out the proposed project in a cost-effective manner; and the qualifications of the proposed staff and faculty of the unit.

(4) Funds may be awarded for all or specific portions of activities or programs included in an application.

(5) One (1) year following receipt of each grant award the recipient organization shall provide the Missouri Department of Health a written narrative status evaluation of the program for which the grant was received. Interim reports may be required by the Missouri Department of Health in those instances where the applicant requests consideration for additional grants for continuation of the same program. Interim reports and access to fiscal and performance information necessary to evaluate the grantee’s performance shall be available to the Missouri Department of Health to insure that the grantee has expended the funds granted for the purposes stated in the grant application.

History

AUTHORITY: section 191.580, RSMo 1986. This rule was previously filed as 13 CSR 50-171.010 and 19 CSR 50-1.020. Original rule filed June 27, 1980, effective Oct. 11, 1980. Amended: Filed April 8, 1988, effective June 27, 1988. Changed to 19 CSR 10-3.020 July 30, 1998. Original authority: 191.580, RSMo 1979, amended 1987

19 CSR 10-3.030 Health Professional Student Loan Repayment Program Health Professional Student Loan Repayment Program that will reduce the burden of educational debt among selected health professionals in return for providing professional clinical services in areas of defined need. {#sec-19-csr-10-3.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-3.030}

(1) The following definitions shall be used in interpretation and enforcement of this rule:

(A) Approved practice site means the practice location for which the department agreed to provide support;

(B) Area of defined need means a geographic area or population designated by the Missouri Department of Health and Senior Services as experiencing a shortage of accessible primary and preventive health care services;

(C) Department means the Missouri Department of Health (D) Director means the director of the Missouri Department (E) Health care professional means a general dentist or primary care physician as defined in 191.600, RSMo;

(F) Hospital means a facility licensed in the state of Missouri pursuant to Chapter 197, RSMo;

(G) Licensing board means the Board of Registration for the Healing Arts and the Missouri State Dental Board within the Missouri Department of Economic Development;

(H) Primary care means the services provided by a general dentist or a physician engaged in general or family practice, internal medicine, pediatrics, or obstetrics and gynecology as his/her primary specialty;

(I) Qualifying loans means government and commercial loans for actual costs paid for tuition and educational costs and associated living expenses for the health professional;

(J) Sliding scale fee means a fee structure that provides adjustment to charges for all individuals under two hundred percent (200%) of the federal poverty limit, based upon family income and size.

(2) The department may contract with selected health care professionals to repay in total or in part, qualifying loans in exchange for an agreement to provide primary health care services to populations in need within the state.

(3) Applicants must submit a written request that contains all of the following information and documentation presented in the order they are listed in subsections (3)(A)–(J). Applications for participation that do not comply with these requirements will not be considered. Each request shall contain:

(A) A written request from the applicant for participation in the program;

(B) A detailed written description of the proposed practice site, including the facility in which the applicant will be working and the health care services currently provided at that site;

(D) For physicians, a letter from the medical director of all hospitals at which the physician has or will have privileges delineating the status of the privileges. This should include when the privileges began or will begin, how they may have changed over time and an explanation for any changes;

(E) A written statement from the applicant’s malpractice insurance carrier setting forth any claims that have been made against the applicant and the disposition of those claims;

(F) A written statement from the local public health agency, whose jurisdiction includes the applicant’s proposed practice site, that the applicant’s services are required by and are in the interest of the community;

(G) A copy of the applicant’s employment contract for the proposed practice site for a period of no less than two (2) years;

(H) Documentation of agreement to provide care to the populations in the area of defined need, including:

Acceptance as a provider by the Missouri Medicaid agency; and 2. A copy of the sliding scale fee;

(I) Documentation of qualifying loans for which repayment is requested; and (J) A signed release of information document to allow the department to obtain current information on qualifying loans from the appropriate institutions.

(4) Selection for participation in the Health Professional Student Loan Repayment Program will be prioritized utilizing the following criteria:

(A) The degree of need for health professional services (areas with a lack of access for the entire population will be given priority over those areas without access for specific populations);

(B) Recruitment of health professionals into an area will be given priority over retention of existing providers;

(C) Those employed by an organization with a history of service to the underserved may be given priority over other employment types including self-employed applicants; and (D) Those approved practice sites participating with the department in the financing of the loan repayments.

(5) Participation in the Health Professional Student Loan Repayment Program shall consist of payments to individual health professionals under a written contract.

(A) The contract period shall be, at a minimum, two (2) years in length.

(B) Contract amounts shall not exceed the maximum amounts allowed under the National Health Service Corps Loan Repayment Program, 42 U.S.C. section 2541-1, P.L. 106-213.

(D) Prepayment of the contract amount may be made to facilitate placement in areas of need within the state.

(E) The department may approve contract extensions up to three (3) additional years beyond the original contract, not to exceed five (5) years in total.

(6) Participants shall supply the following to the department by July 1 of each year:

(A) Participant’s name;

(B) Address of the participant’s approved practice site(s);

Gender;
Race/ethnicity;
Age distributions; and 4. Payor source (Medicaid, Medicare, commercial insurance or sliding scale fee);

(D) Letter from the applicable licensing board stating that the participant is licensed in good standing in Missouri; and (E) Documentation of remaining educational debt.

(7) If an individual violates the written contract the state shall be entitled to recover from the individual an amount equal to the sum of:

(A) The total of the amounts prepaid by the state on behalf of the individual and the interest on those amounts which would be payable if at the time the amounts were paid they were loans bearing interest at the maximum prevailing rate as determined by the Treasurer of the United States;

(B) An amount equal to any damages incurred by the department as a result of the breach;

History

AUTHORITY: section 191.607, RSMo Supp. 2001. This rule was previously filed as 19 CSR 50-1.030. Original rule filed Nov. 14, 1988, effective April 28, 1989. Changed to 19 CSR 10-3.030 July 30, 1998. Rescinded and readopted: Filed April 15, 2002, effective Oct. 30, 2002. Original authority: 191.607, RSMo 1988, amended 2001.

19 CSR 10-3.040 Rural Primary Care Physician Grant Program Rural Primary Care Physician Grant Program. {#sec-19-csr-10-3.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-3.040}

(1) For the purposes of this regulation, the following definitions shall be used in interpretation and enforcement of this rule:

(A) Awardee means a primary care physician who applied to and was selected by the department to participate in the Rural Primary Care Physician Program;

(B) Department means the Missouri Department of Health (C) Director means the director of the Missouri Department (D) Health Professional Shortage Area (HPSA) is defined as a geographic area, population group, or facility designated by the United States Department of Health and Human Services’ Health Resources and Services Administration (HRSA) with a shortage of primary care, dental health, or mental health providers and services;

(E) Missouri rural county is defined as a county, in the state of Missouri, with a population of less than thirty-five thousand (35,000) inhabitants;

(F) Primary Care HPSA is defined as the shortage designation in primary care physicians and includes all the primary care specialties in which a primary care physician could be licensed, to determine the primary care HPSA score;

(G) Primary Care HPSA score ranges from one (1) to twentyfive (25) and demonstrates the shortage level of providers providing primary care services in the HPSA; the higher the score, the greater the need;

(H) Primary care physician is defined as a physician licensed and registered pursuant to Chapter 334, RSMo, and engaged in general or family practice, internal medicine, pediatrics, or obstetrics and gynecology (OB/GYN) as his/her primary specialty;

(I) Primary care specialty is defined as general medicine, family medicine, internal medicine, pediatrics, or OB/GYN as his/her specialty; and (J) Sliding Fee Scale or Schedule is defined as fees for services that are adjusted depending on an individual’s income; a payment model providers can use to care for patients who cannot afford care otherwise.

(2) Primary care physicians wanting to be considered for an award under the Rural Primary Care Physician Grant Program must— (A) Begin providing primary care services after July 1, 2022, in a Missouri rural county, in which the applicant has not previously practiced;

(B) Reside in the same Missouri rural county in which services will be provided;

(C) Not have previously received an award of funds under the rural primary care physician grant program; and (D) Submit an application package to the department in accordance with this rule.

(3) Bids will be accepted February 1 through March 15 each year.

(4) Applicants must apply by responding to the Rural Primary Care Physicians Grant Program Invitation for Bid posted annually on February 1 at https://missouribuys.mo.gov/. Applicants shall follow all applicant instructions regarding format and contents of the application, as described in the Invitation for Bid.

(5) In addition to other information required, as described in the Invitation for Bid, applicants must include the following information in their response to the Invitation for Bid:

(A) Demographical information— 1. Applicant’s full name;

Primary care specialty, including identifying Doctor of Allopathic Medicine or Doctor of Osteopathic Medicine, as a General, Family Medicine, Internal Medicine, Pediatric, or OB/ GYN;
National Provider Number (NPI);
Medicaid Provider Number;
Medicare Provider Number;
Employment title;
Home address;
Home and work email addresses;
Employer name;
Proposed practicing site location, name, address, and county;
Contact phone numbers, including personal, home, and work; and 12. The following information which is used for reporting purposes only and does not affect the determination of awards and will not be used for consideration of eligibility:

A. Substance use disorder services provided (yes/no); and B. Telehealth services provided (yes/no);

(B) A detailed written description of the proposed practice site, including the facility in which the applicant will be working and the health care services currently provided at that site;

(C) If the applicant will utilize the grant funds to relocate or open a solo or private practice in a rural county, identify the expected location and employment title;

(D) In the event that the applicant is not currently employed or practicing in the rural county, the applicant shall identify the intended rural county and employment information, including practice location, anticipated employment title, and start date projected to begin practice;

(E) Official notification from the Missouri Board of Registration for the Healing Arts that the applicant is licensed in good standing;

(F) Copy of the applicant’s Missouri professional license;

(G) Proof of malpractice insurance and a written statement from the applicant’s malpractice insurance carrier setting forth any claims that have been made against the applicant and the disposition of those claims;

(H) A copy of the applicant’s job description where services will be provided;

(I) A copy of the applicant’s executed employment contract for the proposed practice site for a period of no less than two (2) years with the ability to renew up to at least five (5) years or, if self-employed, an attestation agreeing to practice for at least five (5) years in the proposed practice site;

(J) Proof that the location where the physician will practice medicine is in a designated HPSA. The applicant shall provide a print out of HPSA designations for the service area from http://hpsafind.hrsa.gov/HPSASearch.aspx. If no Missouri HPSA designations exist for the physician’s service area, the applicant shall contact the department to identify other documentation of services to underserved patients; and (K) Any sliding scale or schedule utilized by the practice site.

(6) In addition to other factors as described in the Invitation for Bid, the Primary Care HPSA will be utilized, for the purposes of this Rural Primary Care Physician Grant Program, to determine the primary care needs in the Missouri rural counties. The department will use the following criteria to prioritize selection for participation in the Rural Physician Grant Program:

(A) Each primary care specialty will be analyzed in each of the applicants’ practice site locations to determine the highest need of each specialty within the primary care designation in each of the applicants’ practicing rural counties.

The department will determine the ratio of each primary care specialty to the population to determine the most needed type of primary care specialty in the specific rural county.

The department will use the HRSA data to determine if a county has sufficient number of general medicine, family medicine, internal medicine, pediatrics, or OB/GYN physicians in the specific county in which the applicants specify in their applications. This will allow the department to choose the type of primary care specialty most needed in that specific HPSA area.

A. Priority will be given to an applicant whose practicing county has no physicians of their primary care specialty with the highest HPSA score.

B. If there are multiple applicants with no physicians of their primary care specialty in their practicing county and the county HPSA scores are equal, the department shall prioritize based on the highest county population.

If there are multiple applicants with one (1) or more physicians of their primary care specialty in their practicing county, priority will be given to the applicant with the highest HPSA score.

A. If there are multiple applicants with one (1) or more physicians of their primary care specialty in their practicing county and the county HPSA scores are equal, the department shall prioritize based on the highest county population.

B. Priority will be given to the applicant with the lowest ratio of the primary care specialty to the highest population in that county.

In the event that all applicants are equally demonstrating the same need in their practicing county, for their specialty and the population being served including HPSA score, the department will conduct a formal drawing by writing each tie applicant’s name on a piece of paper and will select at random one (1) of the tied applicant’s name for the award. The department will have witnesses present for the formal drawing.

(7) The department may, subject to appropriated funds, contract with awardee(s), to provide grant award(s) of up to two hundred thousand dollars ($200,000). The awardee(s) shall agree to reside and practice as a primary care physician in a Missouri rural county for a continuous five- (5-) year period and shall provide primary health care services to underserved populations in a Missouri HPSA.

(8) Participation in the Rural Physician Grant Program shall consist of payments directly to an awardee, under a written contract, in the form of direct deposit. Payment will be deposited in the awardee’s bank account upon the department’s final approval of the written contract.

(9) As described in the Invitation for Bid, the contract shall include information regarding the following:

(A) Awardee physician’s information;

(B) Contract terms, including the length of contract and required deliverables;

(D) Breach and penalties; and (E) Extension.

(10) The contract shall detail that the awardee earns forgiveness on their grant award through a service obligation and the dates of said service obligation shall be prominently shown on the contract.

(11) If the awardee violates the written contract and is in breach of any of the requirements outlined in the Invitation for Bid, the department shall be entitled to recover from the awardee damages as outlined in the Invitation for Bid.

History

AUTHORITY: section 192.006, RSMo 2016. Original rule filed Aug. 1, 2023, effective Feb. 29, 2024. Original authority: 192.006, RSMo 1993, amended 1995.

19 CSR 10-3.050 Graduate Medical Education Grant Program Graduate Medical Education Grant Program. {#sec-19-csr-10-3.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-3.050}

(1) The following definitions shall be used in the interpretation and enforcement of this rule:

(A) “Academic year” is the time period between July 1 to June 30 of the following year;

(B) “Agreement period” or “grant agreement period” is the thirty-seven (37) months, regardless of the length of residency, reflecting the three- (3-) consecutive-year period of performance, during which first-year residents funded by this program start their residency plus a one (1) month period before residents begin during which funding is received;

(C) “Applicant” is an eligible entity applying for a Graduate Medical Education (GME) Program’s Notice of Grant Opportunity (NGO) that meets the specific eligibility requirements set forth in this rule;

(D) “Commitment” or “commitment period” or “grant commitment period” is the duration during which the grantee is expected to fulfill the obligations and deliverables specified in the GME NGO and this rule correlating with the signed grant agreement. This includes the grant agreement period, plus the remaining years for the funded first-year residents to finish their residency, plus two (2) additional months to submit the final report.

For residencies of three (3) years duration, this period is five (5) years and three (3) months.
For residencies of four (4) years duration, this period is six (6) years and three (3) months;

(E) “Department” is the Missouri Department of Health and Senior Services;

(F) “Designated institutional official” is the representative from the sponsoring institution who collaborates with their internal graduate medical education committee to ensure the sponsoring institution’s and its program’s substantial compliance with the applicable Accreditation Council for Graduate Medical Education (ACGME) institutional, common, and specialty-specific program requirements;

(G) “Eligible entity” is an entity that operates a physician medical residency program in Missouri and is accredited by the ACGME;

(H) “General primary care and psychiatry” includes family medicine, general internal medicine, general pediatrics, internal medicine-pediatrics, general obstetrics and gynecology (Ob/Gyn), and general psychiatry;

(I) “Graduate medical education” is the required training after graduating from medical school in order for a physician to be eligible for full licensure and board certification. This training includes medical residencies which can last three to four (3-4) years, depending on the specialty;

(J) “Graduate Medical Education Grant Program” or “Grant Program” or “GME Grant Program” is the program established within the department to administer the Medical Residency Grant Program Fund, established by section 191.592, RSMo, to support additional medical residency position in existing Missouri medical residency programs;

(K) “Grant agreement” is the written instrument that sets forth the terms and conditions of participation in the Graduate Medical Education Grant Program, including all written and executed amendments thereto, between the department and a grantee;

(L) “Grantee” is an applicant whose application to the Graduate Medical Education Program was selected for funding by the department according to the eligibility and selection criteria described in this rule and who has a grant agreement signed by both parties;

(M) “Health Professional Shortage Area” or “HPSA” is a geographic area, population group, or health care facility that has been designated by the Health Resources and Services Administration (HRSA) as having a shortage of healthcare professionals. There are three (3) categories of HPSAs: primary care, dental health, and mental health. Primary care and mental health are the only relevant HPSAs for the purposes of this rule. HPSA data is available at https://data.hrsa.gov/tools/ shortage-area/hpsa-find;

(N) “Match” is the National Resident Matching Program.

This is the process by which residency programs rank their preferred candidates, residency applicants rank their preferred programs, and a one-to-one (1-to-1) match is generated;

(O) “Medical residency program” or “residency program” are those in the general primary care and psychiatry specialties for the purposes of this rule;

(P) “Residency positions” or “positions” or “residency slots” or “slots” refers to the number of residents in a specific medical residency program. This number requires approval from ACGME. These terms are often specified in reference to either the entire multiyear residency program or to a particular postgraduate year (PGY).

“Expanded slots” or “awarded slots” or “assigned slots” refer to the additional slots added through the grant program as described in this rule;

(Q) “Resident” is a physician in an accredited graduate medical education program;

(R) “Rural” refers to those counties in Missouri that have less than one hundred fifty (150) people per square mile and do not contain any part of a central city in a Metropolitan Statistical Area; and (S) “Sponsoring institution” is the organization that assumes the financial and academic responsibility for a residency program of GME. The sponsoring institution has the primary

purpose of providing educational programs and/or health care services.

(2) The following acronyms shall be used in the interpretation and enforcement of this rule:

(A) ACGME—Accreditation Council for Graduate Medical Education. This is the accreditation agency for all medical residencies in the United States;

(B) AHEC—Area Health Education Center;

(D) FQHC—Federally Qualified Health Centers;

(E) GME—Graduate Medical Education;

(F) HPSA—Health Professional Shortage Area;

(G) NGO—Notice of Grant Opportunity;

(H) NPI—National Provider Identification Number;

(I) NRMP—National Resident Matching Program;

(J) PGY—Post-Graduate Year. This refers to the annual level of training during a multi-year residency program. PGY-1 refers to the first-year class of residents, PGY-2 refers to the second-year class of residents, etc.; and (K) SOAP—Supplemental Offer and Acceptance Program. This is the process by which the residency applicants and residency programs without a match scramble to find mutually agreeable placements. This was once referred to as “The Scramble.”

(3) Communication.

(A) All inquiries during the application process and after selections are made shall be directed to the primary point of contact as noted in the NGO and grant agreement.

(B) Applicants are required to maintain and provide to the department, upon application, a current and valid email address for electronic communication with the department.

(4) Grant Award Parameters.

(A) Available Funding and Grant Award Amounts.

The GME Grant Program is subject to appropriations to the department to provide grant awards to support increased residency slots. The maximum number of residency-position awards is contingent upon the amount of the appropriation available.
The grant cannot supplant existing funds for existing residency positions. The grant funds are only for newly added accredited residency positions to support new residents through the completion of their multiyear residencies.
The maximum grant award per resident per training year shall be specified in the NGO and is subject to appropriations.

The department may increase the award amount if funds are not completely allocated.

Funding is awarded for the number of approved residency slots for three (3) years of consecutive incoming firstyear residents to finish the entirety of their residency training.
A sponsoring institution may request awards for multiple qualified residency position in one (1) or more eligible specialties, but each residency program corresponding to each of those different specialties shall submit their own application.
Eligible specialties will be specified in the NGO and are subject to appropriation in that the department may not have appropriation authority in certain years to award grant funds for residency programs in all general primary care and psychiatry specialties.

(B) Timing of Grant Agreement Period, Grant Commitment Period, and Payment.

The Grant Agreement Period is three (3) years and one (1) month for all grantees, regardless of the length of the residency training. Three (3) consecutive years of incoming first-year resident would be funded in an amount corresponding to the entire duration of their multiyear training, subject to appropriations.
The duration of the Grant Commitment Period includes the sum of— A. The Grant Agreement Period (three (3) years and one (1) month); and B. The remaining years needed for the residents who matriculated under this funding to finish their residency; and C. An additional two (2) months at the end for final reporting.
The department shall provide funding to grantees annually in June, prior to the start of the incoming first-year class, in an amount corresponding to the entire duration of the multiyear training for the expanded slots filled by those firstyear residents.

A. This payment will occur for three (3) consecutive years, to cover three (3) consecutive incoming classes of first year residents into the approved number of expanded residency slots. The award amount will be disbursed up front, upon selection of the awardees and execution of the contracts, for the total amount for all three (3) or four (4) years, up to the maximum allowable amount per resident for all three (3) or four (4) years. Payment is subject to— (I) Appropriations; and (II) Grant agreement expectations and deliverables met satisfactorily, at the sole judgment of the department.

Allowable costs, in order of priority, include— A. Direct graduate medical education costs, including— (I) Resident salary;

(II) Resident fringe benefits;

(III) Resident malpractice insurance, licenses, and other required fees; and (IV) Salaries and benefits for faculty and program staff directly attributable to resident education;

B. Indirect costs of graduate medical education necessary to meet the standards of the ACGME.

Unallowable costs include— A. Capital improvements;

B. Consultant fees;

C. Sub-contracts;

D. Planning activities;

E. Supplanting or replacing existing funds from other sources, including local, state, or federal resources, for the same purpose; and F. Alcohol.

Costs not specifically mentioned in the original budget submission shall be submitted to the department for prior approval before being expended.

(D) Sustainability of the Expanded Residency Slots.

Future sustainability of the expanded residency slots is the responsibility of the medical residency program and/or sponsoring institution.
Subject to appropriations and timely receipt of all grant agreement deliverables, current grantees will be able to submit a new application any year to request additional residency slots beyond the initial number of expanded residency slots.

(E) Cost Sharing. Applicants must agree to provide additional funds or in-kind resources as needed beyond the annual GME Grant Program award to supplement the newly created residency positions according to the requirements of ACGME accreditation.

(5) Eligibility and Selection.

(A) An eligible applicant is a Missouri ACGME-accredited— 1. GME program which intends to increase and fill ACGMEapproved medical residency positions during the grant commitment period; or 2. Sponsoring institution (hospital, medical school, or consortium) that sponsors and maintains primary organizational and financial responsibility for a Missouri GME program which intends to increase and fill ACGME-approved medical residency positions during the grant commitment period.

(B) Mandatory Award Selection Criteria.

Applicant shall be an established ACGME-accredited residency program, located in the state of Missouri, requesting funding to increase the number of residents in their program.
Only those residency program specialties appropriated funding, as specified in the NGO, shall be considered.
Number of residency slots.

A. Residency programs need to demonstrate that they are currently utilizing one hundred percent (100%) of their maximal allocated federal Medicare GME funding for current residency slots.

B. Residency programs need to demonstrate that they have ACGME accreditation for the additional residency slots they are requesting or have a pending request before the ACGME for a complement increase. The department may specify time periods within the NGO for when such requests must have been submitted to the ACGME and when proof of approval of such requests must be submitted to the department to verify eligibility.

Residency programs must demonstrate the ability to cover the remaining required costs to fund additional residency slots required to supplement the grant award amount.
Application for this grant opportunity includes the satisfactory completion and submission of all requested components.
One hundred percent (100%) of the registered slots for the residency program were filled during the most recent match cycle through both the National Resident Match Program and any additional placement of residents via the Supplemental Offer and Acceptance Program.
The residency program is required to have been in existence for at least five (5) years.

(C) Award Selection Criteria – Prioritization. The following criteria for award selection will be applied only if there are applications for more slots than funding available.

Ranking of applicants. Selection priority will be given according to a point-based scoring system, adding up to one hundred (100) maximum points, as detailed in Exhibit 1 below.
Tiebreakers. If there are any scores tied for available slots, priority will be given in this order:

A. If there are two (2) or more OB/Gyn programs tied, priority will be given to the program(s) whose faculty also train family medicine residents in obstetrics;

B. If there are two (2) or more family medicine programs tied, priority will be given to the program(s) with the highest number of vaginal birth deliveries per resident before graduation;

C. If any other programs are tied, priority will be given to the program(s) whose location of the majority of their resident training during residency is rural;

D. If programs are still tied, then priority will be given to the program(s) whose location of the majority of their resident training during the entire duration of residency has the highest HPSA score; and E. After this algorithm, if there is still a tie between programs, a lottery will be used to determine preference.

Slot assignments.

A. Each awarded slot provides grant funding to cover the duration of the residency for one (1) resident, for three (3) consecutive years of incoming first-year residents, subject to annual appropriations and the program meeting grant requirements.

B. The process of assigning awarded slots is as follows:

(I) Once the residency program applicants are ranked by the selection criteria above, the expanded residency slots will be assigned in awards up to three (3) slots for each applicant, as funding allows;

(II) The highest ranked applicant is eligible for the first three (3) slots;

(III) If the applicant requested only one (1) or two (2) slots, then the applicant will be awarded the number of slots requested;

(IV) If the applicant requested four (4) or more slots, then the applicant will be awarded only three (3) slots, unless there are remaining slots available after all eligible applicants have been reviewed;

(V) The process continues with the next applicant with the next highest score, receiving the next three (3) slots, or fewer if the applicant requested fewer, until all slots are assigned; and (VI) In the event that there are remaining slots to fund, the applicants who requested more than three (3) slots will be considered for those remaining slots. The scores rendered from the processes described in paragraphs (5)(C)1. and (5)(C)2. above will be utilized to rank the remaining applicants, and each applicant will receive all of their remaining slots requested, in order of highest ranking score, until available funding is depleted.

Exhibit 1 (D) Selection Process.

Application screening. The department will screen the applications to determine if they were submitted before or by the deadline specified in the timeline and if they adhere to the other grant program mandatory requirements. If there are more applicants meeting these requirements than funding available, then the selection prioritization criteria detailed above will be utilized.
Selection of applicants for awards.

A. The department shall evaluate applications which must demonstrate that the applicant will use grant funding to increase the number or accredited residency positions.

B. Priority will be applied to GME programs as described above.

C. The department shall select applications to be funded according to the criteria listed above.

D. Applicants must indicate how they intend to provide matching funds or in-kind resources to supplement funding as needed to fully support the additional residency slots in line with ACGME accreditation standards.

(6) Timeline. The department may set deadlines for application submission; verification of award components, including but not limited to ACGME accreditation; and agreement execution.

These deadlines shall be noted in the NGO.

(7) Application.

(A) Applicant. For the purposes of this regulation, the applicant refers to the eligible residency program or the institution sponsoring a specific residency program. If one (1) institution is applying for expanded slots in multiple residency programs, then that institution will need to submit a separate application for each residency program.

(B) Submission Instructions. Applicants shall only submit their applications electronically via the online platform as provided and designated by the department.

The applicant is solely responsible for ensuring that the applicant’s entire online application is completed by the deadline specified in the NGO. Applicant shall retain proof of timely submission.
The applicant may contact the department to verify receipt of their application. Confirmation of receiving the Ranking of applicants— SELECTION PRIORITY will be given according to a point-based score, adding up to 100 maximum points, as follows:

Residency Program Attributes— (Note: These are used to rank program applicants; these are not prerequisites. If applicant does not meet the criteria for a category below it will result in zero points for that category.)

Points (max 100) 1Average percentage of training time over the full course of residency that includes clinical work in rural counties— -At least 50% (for family medicine, internal medicine, pediatrics) or at least 30% (for OB/Gyn and psychiatry) -Between 25-49% (for family medicine, internal medicine, pediatrics) or between 15-29% (for OB/Gyn and psychiatry) 2The HPSA score corresponding to the location where the majority of residency training takes place— -15 and above -Between 7-14 -Between 1 and 6 (For family medicine, internal medicine, pediatrics, and OB/Gyn – use primary care HPSA scores. For psychiatry residency applications – use the mental health HPSA scores.) 25, or 3Includes outpatient clinic training in a rural health clinic, federally qualified health center, AHEC, or outpatient family practice clinic in a rural county— -For a weekly continuity clinic throughout the entire duration of residency training program -For a weekly continuity clinic for at least one year, or at least 12 weeks of full-time outpatient clinic in one of these settings 4Current medical residents with ties to Missouri— -At least 50% graduated from high school in Missouri -At least 50% went to college or other graduate school in Missouri -At least 50% went to medical school in Missouri 5, and 5, and 5Data from the previous 5 years of graduates of the residency program indicate that as of the current calendar year— -State: ○At least 75% practice medicine within the state of Missouri, or ○At least 67% practice medicine within the state of Missouri -Setting: ○At least 70% practice medicine in a rural setting ○50-74% practice medicine in a rural setting ○30-49% practice medicine in a rural setting 10, or application is not an indication of a complete application or eligibility.

(C) Application Format and Components. Every application shall include the following components and the applicant shall provide documentation providing evidence for the requested items as outlined below:

Certification of the application information.

A. The application must be certified and submitted by an individual who is legally authorized to submit the application on behalf of the applicant.

B. Each medical residency application requires its own certification, even if a sponsoring organization has multiple medical residency programs applying for the grant;

General applicant information— A. Name of sponsoring institution;

B. Sponsoring institution contact information, including the name, email, and phone number of the contact person responding to department correspondence;

C. Medical residency program for which funding is being requested;

D. List additional medical residency programs by the same sponsoring organization for which funding is separately being requested; and E. Letter of approval from current Chief Executive Officer or designated institutional official;

Medical residency program information. The following must be completed for each separate medical residency program for which funding is being requested and include all evidentiary documentation:

A. Medical residency general information— (I) Name of eligible residency program;

(II) Program specialty and length;

(III) Location— (a) Program main location address;

(b) Program main mailing address; and (c) County: List the county of the main program training location, and identify any additional teaching sites located in other counties for routine resident clinical training, if applicable. Identify the percentage of training time occurring at each site;

(IV) Current accreditation dates according to the ACGME;

(V) Start date for first-year residents starting in the next three (3) calendar years;

(VI) Medical residency program director contact information;

(VII) Questions only for Ob/Gyn applicants— (a) Do your residency program faculty also take time to train family medicine residents in OB?; and (b) If yes, to what extent? Please describe the volume of this training; and (VIII) Questions only for family medicine applicants— (a) Does your program require and ensure forty (40) vaginal deliveries for all residents to graduate?; and (b) If no, or if you wish to comment further, please provide data on your vaginal delivery rates for your residents prior to graduation;

B. Medical residency position data— (I) Number of new first-year positions requested via this GME Grant Program; and (II) Number of positions. Provide the following information for each post-graduate year (PGY) of your program and any comments you wish to provide:

(a) Number of first-year residency slots posted in the match for the past three (3) to four (4) years, pertaining to each of these current classes of residents;

(b) Number of current filled positions as of July 1 in the previous academic year;

(d) Number of positions currently funded by Medicare GME. Provide verification from Medicare/CMS;

(e) Number of positions approved by the ACGME prior to March of the application year. Provide verification from ACGME. If ACGME accreditation for number of slots is not disaggregated by PGY level, then provide the total number of approved positions for the entire program; and (f) Number of positions currently approved by the ACGME, if different than above. Provide verification from ACGME. If ACGME accreditation for number of slots is not disaggregated by PGY level, then provide the total number of approved positions for the entire program;

C. Residency Program Attributes—Clinical training.

(I) Indicate the average percentage clinical training time for the entire residency program in the following locations. Provide the name, location, timing, and nature of the training exposure at these sites. Distinguish what is a blockrotation and/or what serves as a continuity clinic that meets approximately weekly and for how many months or years in duration:

(a) Rural county;

(b) Rural Health Clinic;

(d) Outpatient community-based clinic in a rural setting;

(e) Area Health Education Center (AHEC); and (f) Health Center Program Look-Alikes.

(II) Provide documentation of the highest HPSA score associated with any of the routine training sites for your residency.

(a) For primary care residencies, use the primary care HPSA score.

(b) For psychiatry residencies, use the mental health HPSA score;

D. Current resident data. Provide each of the following for current post-graduate years (PGY1, PGY2, PGY3, and PGY4 if applicable):

(I) Number and percentage of current residents who graduated from high school in Missouri;

(II) Number and percentage of current residents who went to college (or other non-medical school or graduate school) in Missouri; and (III) Number and percentage of current residents who attended medical school in Missouri;

E. Residency graduate outcomes. Provide each of the following for residents who graduated during the current calendar year and the previous four (4) calendar years:

(I) Total number of residents who graduated;

(II) Number of graduates who currently practice in the same field as their residency training;

(III) Number of graduates who currently practice in Missouri;

(IV) Number of graduates who are currently practicing in a rural setting; and (V) Number of graduates who are currently practicing in an underserved urban setting;

F. Budget.

(I) Each applicant shall include a detailed budget and budget narrative documenting utilization of grant funds for each year of the commitment period.

(a) The applicant shall develop a line-item budget for allowable costs for each year of the commitment period.

The budget must indicate how applicants intend to provide out-of-pocket funds or in-kind resources to supplement the funding as needed to support the added residency slots in a manner consistent with ACGME standards.

(II) The budget narrative shall include— (a) Justification and calculations for each line item by year;

(b) Fringe benefits and malpractice insurance calculated separately as a percentage of salary;

(d) If providing stipends or honoraria for faculty, explain individual activities covered;

(e) For faculty travel, include the purpose;

(f) Information about other funding sources supporting the resident, including amounts per year and covered costs;

(g) Brief discussion about how the new residency positions will be sustained after the grant ends; and (h) Address potential strategies to engage local and regional health systems, community-based organizations, employers, and other GME stakeholders in developing new physicians and approaches for encouraging new physicians to practice in underserved areas.

(III) The budget shall demonstrate how the funds will be utilized, including amounts spent for each allowable grant fund expenditure over the grant commitment period.

(IV) Reports will be required each year detailing expenditures for which grant funds were used. Refunds for unallowable or unspent funds will be required; and G. Financial viability. Provide a financial statement for the previous fiscal year for the existing medical residency program for which funding is being requested. Include a summary overview of amounts and sources of income and amounts and categories of expenses related to operation of the program; and 4. Documentation of eligible residency programs. Applications must include the following documentation for each program, in order to verify eligibility and to indicate that the residency program is not using grant funding to supplant any existing funding:

A. ACGME—

(I) ACGME program identification number;

(II) ACGME sponsoring institution identification number;

(III) Documentation of current program’s ACGME accreditation. Provide each program’s and institution’s most recent accreditation letter from the ACGME, listing current accreditation status, any citations or areas of concern, or quality improvement assignments or activities;

(IV) Provide evidence from ACGME of accreditation for the exact number of allowed residency positions in the residency program; itemize this by post-graduate year or, if not available, then by the total program;

(V) If applicable, provide evidence of applicant’s request to and approval from ACGME for an increase in the number of residency positions, also itemized by PGY or, if not available, by the total program. If the complement request has not yet been approved, provide evidence of the applicant’s submission for a complement on or prior to the deadline specified in the NGO. Complement increase approval letters must be submitted to the department by the date specified in the NGO for the program to be eligible for the GME grant program; and (VI) If the request and approval are for a temporary increase, provide a plan, including a timetable, for obtaining accreditor approval for a permanent increase in the number of program positions;

B. Match results from the past three (3) years. Provide verification for each of the following for Match Day of the current calendar year and the two (2) previous calendar years:

(I) Number of PGY1 slots submitted for NRMP;

(II) Number of PGY1 slots matched via NRMP;

(III) Number of unmatched PGY1 slots filled via SOAP;

(IV) Number of PGY1 slots filled outside of NRMC/SOAP; and (V) Number of unfilled PGY1 slots after NRMP and SOAP; and C. Medicare GME funding. Provide documented verification from Medicare/CMS of the maximal number of positions eligible for Medicare GME and the costs. Submit the most recent year of complete cost report data, including the following Medicare Cost Report Workbooks:

(I) Worksheet S-2—Part I: Hospital and Hospital Health Care Complex Identification Data;

(II) Worksheet S-2—Part II: Hospital and Hospital Health Care Complex Reimbursement Questionnaire;

(III) Worksheet A—Reclassification and Adjustment of Trial Balance of Expenses;

(IV) Worksheet B—Part I: Cost Allocation—General Service Costs;

(V) Worksheet E—Part A: Calculation of Reimbursement Settlement—Inpatient PPS;

(VI) Worksheet E-4: Direct Graduate Medical Education (GME) & ESRD Outpatient Direct Medical Education Costs; and (VII) Worksheet L: Calculation of Capital Payment.

(8) Distribution of Grant Funds.

(A) Verification of Filled Positions.

To qualify for distribution of awarded funds, the grantee must submit verification to the department annually that they have filled the new residency positions by the date(s) specified in the NGO.
If a grantee fails to verify to the department that they filled the awarded residency positions, then the grantee shall forfeit the award for any unverified positions.
If a grantee verifies to the department that they filled an awarded residency position, but the resident resigns, is terminated, or otherwise fails to remain qualified prior to completion of the program, the grantee will not forfeit that slot in subsequent years of the agreement period.

(B) Funds Distribution.

Payments. Grantees must follow any instructions specified in the NGO for registering as a vendor with the State of Missouri prior to any payments becoming due.
Retraction or reduction of payments. The department is not bound by any award estimates in the NGO. After making a finding that a grantee has failed to perform or failed to conform to grant conditions, the department may retract the grant amount for the grantee. This retraction shall be prorated in relation to the earliest date for which there is evidence that the grantee failed to perform or conform to grant conditions as specified in the NGO. If that date is the start of the grant commitment period, then the entire grant award shall be retracted. If funds have been disbursed, the grantee shall issue reimbursement to the department.
Grantees shall return any unexpended balance of the award at the end of the grant commitment period to the (4/30/24) John R. Ashcroft 4. Return of prorated funds.

A. If the grantee is awarded funding for a residency position, but fails to fill the residency position, the grantee is required to return the funds awarded for that slot for that academic year.

B. If the grantee is awarded funding for a residency position and fills the residency position for any portion of the academic year, the grantee will not be required to return the funds awarded for that slot for the academic year or for the following academic year if the following academic year is the third year of a three- (3-) year residency program or the fourth year of a four- (4-) year residency program.

(9) Reporting Requirements.

(A) Grantee shall submit reports to the department by the deadlines set and in the format specified in the NGO or as communicated to the grantee by the department.

(B) Annual Program Report. Grantees shall submit an annual report to the department. The report will include but not be limited to— 1. Current residents— A. Number of total residents in the program, by postgraduate year;

B. Number of resident slots funded by the GME Grant Program, by post-graduate year;

C. Were there any residents in the class(es) funded by the GME Grant Program who left the program as of the date of the report? If yes, enumerate and explain;

D. Registry of all current residents of all years in training, organized by post-graduate year, including— (I) Resident name;

(II) Post-graduate year;

(III) NPI;

(IV) Physician license number;

(V) Resident age;

(VI) Resident gender;

(VII) Resident race;

(VIII) Resident trainee;

(IX) Attended high school in Missouri (yes/no);

(X) Attended college or any other non-medical school graduate training in Missouri (yes/no);

(XI) Graduated from a Missouri medical school (yes/ no); and (XII) Passed Step 3 exam (yes/no);

E. Curriculum/training over the entire course of residency, including— (I) Training site name;

(II) Training site street address;

(III) Training site city;

(IV) Training site state;

(V) Training site zip code;

(VI) Training site percent training time;

(VII) Rural county (yes/no);

(VIII) Training site type (FQHC, Health Center Program Look-Alike, rural health center, AHEC, outpatient communitybased clinic in a rural setting, hospital); and (IX) HPSA score (if psychiatry residency program, use mental health HPSA score; other residency programs, use primary care HPSA score); and F. Residency graduate outcomes during calendar year of report and four (4) previous calendar years— (I) Total number or residents who graduated;

(II) Number of graduates who currently practice in the same field as their residency training;

(III) Number of graduates who currently practice in Missouri;

(IV) Number of graduates who are currently practicing in a rural setting; and (V) Number of graduates who are currently practicing in an underserved urban setting.

Annual financial report. Grantees shall submit financial reports to the department annually or when otherwise requested by the department. This report shall detail the— A. Amount received from this funding opportunity;

B. Actual expenditures for the grant duration by purpose and amount;

C. Remaining projected expenditures;

D. Unexpended balance of the GME Grant Program funds as of the date specified by the department;

E. Amount owed back to the department, if applicable;

F. Total cost for the additionally funded residence positions;

G. Grantee’s out-of-pocket expense; and H. Total amount of funding from all sources.

Each financial report shall include a statement of certification by the program director or authorized representative of the sponsoring institution.

(D) Final Program Report. A final program report will be due by August 31 in the last year of the grant commitment period. This report will include similar content to the annual reports, but with outcome information limited to those residents funded by the GME Grant Program, including where the residents have or will be establishing practice, whether located in an underserved area, whether they remained in the prioritized specialty previously reported. This will also include a final financial report containing the same information as the annual financial report.

(E) Delinquent Reports. Medical residency programs with any required reports deemed to be delinquent may be ineligible for funding for the remainder of the grant agreement period or for participation in future funding cycles or expansion of this grant program.

(10) Additional Contractual Requirements. In order to receive funding under this grant program, grantees shall agree to abide by all contract terms and conditions as set forth in the grant agreement.

Original rule filed Sept. 1, 2023, effective Feb. 29, 2024. *Original authority: 191.592, RSMo 2023.

History

AUTHORITY: section 191.592, RSMo Supp. 2023. Emergency rule filed Sept. 1, 2023, effective Sept. 18, 2023, expired March 15, 2024.

19 CSR 10-3.060 Health Professional Loan Repayment Program Health Professional Loan Repayment Program (HPLRP) that will reduce the burden of educational debt among selected health care, mental health, and public health professionals in return for providing health care, mental health, and public health services in areas of defined need. {#sec-19-csr-10-3.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-3.060}

(1) Definitions. The following definitions shall be used in the interpretation and enforcement of this rule:

(A) Area of defined need means a geographic area, population, or field of work designated by the Missouri Department of Health and Senior Services as experiencing a shortage of health care, mental health, or public health care services;

(B) Awardee means a health care, mental health, or public health professional who applied to and was selected by the department to participate in the Health Professional Loan Repayment Program (HPLRP);

(C) Breach of written contract means failing to begin or complete service obligation, failing to submit employment verification surveys to the department annually, upon the request of the department, or within thirty (30) days of any change in employment, or failing to submit verification that awarded funds were applied to educational debt prior to the service obligation end date;

(D) Default means failure to repay any amount awarded as a loan, by the department directly to the individual who entered into the contract, which has not yet been forgiven;

(E) Department means the Missouri Department of Health (F) Director means the Director of the Missouri Department (G) Forgiveness means fulfilling a service obligation through full-time qualifying employment consistent with the terms and conditions in the executed contract for a period no less than twenty-four (24) months as defined in the contract;

(H) Greatest need in the best interests of the public is defined by considering a number of factors related to the access to health care, mental health, and public health services and the professional shortages associated with the type of services provided, to determine the areas of most needed services and areas in Missouri with the greatest need, related to increasing access to health care, mental health, or public health services.

Factors to be considered are subject to availability and may include but are not limited to census data, designated HPSAs, workforce analysis, and data presented to the director prior to selection of eligible health professional and practitioner types;

(I) Health Professional Shortage Area (HPSA) means a geographic area, population group, or facility designated by the United States Department of Health and Human Services’ Health Resources and Services Administration (HRSA) with a shortage of primary care, dental health, or mental health providers and services;

(J) Health Professional Shortage Area score is a numerical representation of the shortage level of providers providing services in the HPSA; the higher the score, the greater the need.

The score ranges from one (1) to twenty-five (25) for primary care and mental health, and from one (1) to twenty-six (26) for dental health;

(K) Health care professional means a licensed provider of health care or dental health treatment and services who has graduated with an associate degree or higher associated with a health care profession. This includes but is not limited to advanced practice registered nurse, assistant physician, dental hygienist, dentist, physician, physician assistant, registered dietitian, registered nurse, physical therapist, occupational therapist, or respiratory therapist;

(L) Mental health professional means a licensed mental health practitioner or licensed social and human services provider who offers services for the purpose of improving an individual’s mental health or to treat mental disorders and who has graduated with an associate degree or higher associated with a mental health or health care profession. This includes but is not limited to applied behavior analyst, licensed clinical social worker, licensed professional counselor, psychiatric advanced practice registered nurse, psychiatric assistant physician, psychiatric nurse, psychiatric physician assistant, psychiatric social worker, psychiatrist, or psychologist;

(M) Proof of use of funds means documentation provided by the awardee to provide proof that the total funding awarded was utilized to pay on the qualifying educational debt submitted in the awardee’s application;

(N) Public health professional, for the purpose of this

regulation, means professionals working to analyze, develop, and implement programs that protect the health of individuals, families, and communities with a bachelor’s degree or higher. This includes but is not limited to epidemiologist, health educator, public health administrator, public health laboratorian, public health program specialist, public health service coordinator, public health nurse, public school counselor, public school nurse, or social services professional;

(O) Qualifying educational debt means government and commercial loans for actual costs paid for tuition and educational costs for the applicant to obtain a degree relevant to the applicant’s qualifying employment; and (P) Qualifying employment means employment in a health care, mental health, or public health field for a minimum of forty (40) hours per week in an area of need as defined by the (2) The department may contract with selected health care, mental health, and public health professionals to repay, in total or in part, qualifying educational debt in exchange for a two- (2-) year service obligation in an area of defined need, per award.

(3) Eligibility. Annually, the director will determine the professional and practitioner types eligible to receive HPLRP loans from the department.

(A) The director will consult with the Department of Higher Education and Workforce Development, Office of Workforce Development, and Department of Mental Health or their successor agencies.

(B) The director will have the sole discretion to make the determination using evidence identifying the greatest needs in the interest of the public. The determination is not subject to appeal.

Health Care Professions.

A. Cardiologist;

B. Physical Therapist;

C. Occupational Therapist; and D. Respiratory Therapist.

Mental Health Professions that treat substance use and opioid use disorders.

A. Licensed and provisional professional counselor;

B. Licensed behavior analyst;

C. Licensed assistant behavior analyst; and D. Licensed and provisional licensed psychologist.

Public Health Professions— (4/30/24) John R. Ashcroft A. Public Health Nurse.

(D) All applicants must meet the following criteria:

Missouri licensed, if applicable to profession;
A United States citizen, or authorized to work in the United States;
A Missouri resident;
Qualifying employment in a Missouri area of defined need as determined by the department;
Have obtained an associate degree or higher; and 6. Have qualifying educational debt.

(4) Application Process. Applications will be accepted September 1 through November 1 each year. Applications will be accepted via electronic submission to DHSS.LoanRepayment@ health.mo.gov or mail to PO Box 570, Jefferson City, MO 65102.

It is the responsibility of the applicant to verify that an application has been received timely by the department. Applications and verification instructions can be found on the HPLRP webpage at https://health.mo.gov/living/families/primarycare/ hplrp/index.php.

(A) Applicants must submit an application that contains all of the following information and documentation presented in the order they are listed in subsection (4)(A). Applications that do not include the required documentation will not be considered. Each application request shall contain— 1. Completed and signed application;

Current job description, title, name, and location of employment;
Proof of Missouri professional license, if applicable;
Proof of qualifying educational debt;
Proof of U.S. citizenship, or authorization to work in the United States;
Proof of Missouri residency; and 7. Copy of the applicant’s federal tax return for most recent tax year.

(5) Selection Process. The department will allocate one-third (1/3) of the appropriated funding for each of the health professional categories: one-third (1/3) for health care loan repayment awards, one-third (1/3) for mental health loan repayment awards, and one-third (1/3) for public health loan repayment awards. In the event that allocated funding from any of the health professional categories is not awarded, the funds not awarded may be split equally between the other health professional categories, if they have unfunded qualifying applicants. Funding received through donation, gift, grant award, or any means other than general revenue will be utilized for awards as specified by the donor or grantor per appropriation authority. The department intends to fully allocate all funding in any given year provided that sufficient qualifying applications are received.

(A) Selection of health care professionals will be prioritized using the following criteria:

The greatest degree of need for health professional services, utilizing a workforce shortage analysis by qualifying health professional type to population ratios and HPSA scoring if available;
Applicant’s financial need based on the applicant’s applicant’s federal poverty level (FPL) percentage. To calculate the FPL percentage, the applicant’s income is divided by the federal poverty guideline for their household size, as determined annually by the federal Department of Health and Human Services (HHS), and multiplied by one hundred (100); and 3. If the number of applicants exceeds the amount of (B) Selection of mental health professionals will be prioritized by using the following criteria:
Mental health professionals working in a state or local health department, public school, or a state-owned and/or operated health facility will be given priority;
The greatest degree of need for mental health professional services, utilizing a workforce shortage analysis by qualifying health professional type to population ratios and HPSA scoring if available;
Applicant’s financial need based on the applicant’s applicant’s FPL percentage. To calculate the FPL percentage, the applicant’s income is divided by the federal poverty guideline for their household size, as determined annually by the federal Department of Health and Human Services (HHS), and multiplied by one hundred (100); and 4. If the number of applicants exceeds the amount of (C) Selection of public health professionals will be prioritized by using the following criteria:
Public health professionals working in a state or local health department or public school;
The greatest degree of need for public health professional services, utilizing a workforce shortage analysis by qualifying health professional type to population ratios and HPSA scoring if available;
Applicant’s financial need based on the applicant’s applicant’s FPL percentage. To calculate the FPL percentage, the applicant’s income is divided by the federal poverty guideline for their household size, as determined annually by the federal Department of Health and Human Services (HHS), and multiplied by one hundred (100); and 4. If the number of applicants exceeds the amount of (6) Awards. The department will award selected applicants as follows:

(A) Licensed health and mental health practitioners with a doctorate degree will be awarded up to sixty-five thousand dollars ($65,000), not to exceed their qualifying educational debt;

(B) Licensed health or mental health provider with a bachelor’s or master’s degree will be awarded up to thirtyfive thousand dollars ($35,000), not to exceed their qualifying educational debt;

(C) Public health professional with a bachelor’s degree or higher will be awarded up to twenty thousand dollars ($20,000), not to exceed their qualifying educational debt; and (D) Licensed health or mental health provider with an associate’s degree will be awarded up to ten thousand dollars ($10,000), not to exceed their qualifying educational debt.

(7) Service Obligation. Participation in the Health Professional Loan Repayment Program shall consist of loan award payments made directly to an awardee under written contract, in the form of direct deposit.

(A) The contract shall include the following sections:

Awardee’s information;
Employer information;
Contract terms;
Verification, waiver, and deferral;
Breach and penalties;
Modifications/extension;
Execution; and 8. The applicant’s notarized signature.

(B) The contract period shall be, at a minimum, two (2) years in length.

(C) The contract shall bind the awardee to provisions of the program, including the financial consequences associated with a breach of contract.

(D) The contract shall detail that the awardee earns forgiveness on their grant award through a service obligation and the dates of said service obligation shall be prominently shown on the contract.

(E) The awardee shall respond to all department correspondence, including but not limited to written in email and letter and telephone communication sent to their last known contact information. If the applicant’s contact information changes, it is the applicant’s responsibility to notify the department within thirty (30) days of change.

(F) The contract shall include that the awardee must submit the completed and signed contract to the department by mail to PO Box 570, Jefferson City, MO 65102.

(8) The awardee shall earn forgiveness of their service obligation by engaging in qualifying employment as approved by the department. No forgiveness will be granted until proof of use of funds is provided. Repayment through forgiveness shall begin no later than the specific date identified on their executed contract.

(A) Forgiveness may be granted upon completion of the two- (2-) year service obligation, as approved and determined by the (B) A waiver of the service obligation may be granted in extreme circumstances, as determined by the department.

In the event that the awardee is unable to complete the service obligation due to serious debilitating illness or other compelling personal circumstances, the department may waive the remaining service obligation left on the contract.

The department can waive, in whole or in part, an awardee’s service or payment obligation in cases where enforcement of the obligation would be impossible or an extreme medical or financial hardship and unconscionable. The department may also choose to defer the service obligation in its sole discretion, for up to one (1) year, if the awardee’s compliance with the obligation is temporarily impossible or an extreme medical or financial hardship, in lieu of permanently waiving the service obligation.

(9) The awardee shall provide to the department, annually or upon request by the department, a completed employment Health Professional Loan Repayment Employment Verification Form detailing the awardee’s employment status and dates of service. This form must also be submitted to the department if there are any changes in employment, or at the request of the department. The Health Professional Loan Repayment Employment Verification Form, published 2023, is incorporated by reference in this rule as published by the department and available on the department’s webpage at https:// health.mo.gov/living/families/primarycare/loanrepayment/ pdf/ev-form-hplrp.pdf. This rule does not incorporate any subsequent amendments or additions. A copy of this form may be requested by contacting the department via email at DHSS.

LoanRepayment@health.mo.gov.

(10) If an awardee under contract violates the written contract and is in breach of any of the requirements outlined in the contract and/or this rule, the state shall be entitled to recover from the awardee an amount equal to the sum of— (A) The total amount of the loan awarded by the department or, if the department had already awarded partial forgiveness or waiver at the time of the breach, the amount of the loan not yet forgiven;

(B) The interest on the amounts owed will accrue at the maximum prevailing rate as determined by the Treasurer of the United States on the date awarded to awardee. Interest begins accruing on award date;

(C) An amount equal to any damages incurred by the department as a result of the breach; and (D) Any legal fees or associated costs incurred by the department or the state of Missouri in the collection of damages.

(11) An awardee who is in breach of contract must pay the total amount owed within twenty-four (24) months from the payment date specified on the cash repayment letter sent by the department to the last known address or email address of the awardee. The cash repayment letter is deemed to have been received by awardee within five (5) calendar days of the date of mailing.

Original rule filed Oct. 13, 2023, effective May 30, 2024. *Original authority: 191.430, RSMo 2023.

History

AUTHORITY: section 191.430, RSMo Supp. 2023. Emergency rule filed Oct. 13, 2023, effective Oct. 27, 2023, expired April 23, 2024.

Chapter 4 Coordinated Health Care Services

19 CSR 10-4.010 Primary Care Resource Initiative for Missouri (PRIMO) Program {#sec-19-csr-10-4.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-4.010}

PURPOSE: This rule implements a system of incentives to develop coordinated health care services available and accessible to all persons under Primary Care Resource Initiative for Missouri (PRIMO).

(1) The following definitions shall be used in the interpretation and enforcement of this rule:

(A) Approved family practice residency program means a graduate medical education program designed to train family or general practice physicians and approved by the Accreditation Council for Graduate Medical Education for allopatric residencies or by the American Osteopathic Association for osteopathic residencies;

(B) Approved primary care residency program means a graduate medical education program designed to train family practice, general practice, general pediatric or general internal medicine physicians and approved by the Accreditation Council for Graduate Medical Education for allopatric residencies or by the American Osteopathic Association for osteopathic residencies;

(C) Area of defined need means a geographic area or population designated by the Missouri Department of Health and Senior Services as experiencing a shortage of accessible primary and preventive health care providers and adverse health outcomes;

(D) Department means the Missouri Department of Health (E) Director means the Director of the Missouri Department of Health and Senior Services;

(F) Forgivable loan means the financial assistance provided by the Department of Health and Senior Services for professional education that may be forgiven, fully or partially, in return for qualifying employment;

(G) Forgiveness means the monetary reduction of a recipient’s PRIMO debt in exchange for qualifying employment in a defined area of need;

(H) Eligible student means a Missouri resident accepted or enrolled in a participating institution in a formal course of instruction leading to:

A bachelor of science degree leading to certification as a primary care advanced practice nurse, a doctor of dentistry or a doctor of allopatric or osteopathic medicine;
A master of science degree in nursing leading to a primary care advanced practice nursing degree;
A degree as a doctor of allopatric or osteopathic medicine;
A degree as a doctor of dentistry;
A degree leading to licensure as a registered dental hygienist; or 6. Based on documented need assessments utilizing a scientifically proven methodology, all other health profession students will be considered for funding pending resource availability;

(I) Participating institution means an institution in Missouri, which grants degrees as a doctor of allopatric or osteopathic medicine; as a doctor of dentistry; as a master of science in nursing leading to certification as a primary care advanced practice nurse; as a bachelor of science in a field leading to acceptance into a school of allopatric or osteopathic medicine, school of dentistry or a master of science in nursing program; leading to licensure as a registered dental hygienist; or an institution, which offers an approved primary care residency program;

(J) Advanced practice nurse means a nurse who has received a graduate degree from a participating accredited college or university with a concentration in advanced practice nursing and who has received from the Missouri State Board of Nursing a “Document of Recognition” authorizing the nurse to practice as a certified nurse practitioner or a certified clinical specialist.

Nursing specialties are limited to family, adult, women’s health, gerontology and pediatric nurse practitioner;

(K) Primary health care provider means a generalist physician, advanced practice nurse, dentist or dental hygienist specializing in the provision of primary and preventive health care services;

(L) Qualified employment means employment at a minimum of thirty (30) hours per week in this state providing primary health care services in an area of defined need;

(M) Resident means an individual who has lived in this state for any purpose, other than attending an educational institution located within this state, for one (1) or more years before submitting an application for financial assistance from the department;

(N) Rural area means a town or community within this state, which is not an urbanized area. An urbanized area is defined as a central city(ies) and its contiguous, closely settled territory with a combined population of at least fifty thousand (50,000);

(O) Primary health care services are defined as the actual, hands-on provision of primary and preventive health care services by a licensed physician specializing in family practice, general practice, general internal medicine or general pediatrics, or by an advanced practice nurse specialist certified in family, women’s health, pediatric, gerontology, or adult health or a licensed general dentist or dental hygienist.

(2) The department in cooperation with appropriate public and nonprofit agencies, institutions and organizations, shall develop and implement a statewide, integrated primary and preventive health care delivery system including the education, recruitment and retention of health care professionals, extending from high school student identification and support systems to placement of professionals in areas of defined need.

(A) The department may contract with appropriate public and/or nonprofit agencies, institutions and organizations to develop and implement a statewide recruitment, education and support system for high school and undergraduate college students to enter into primary and preventive health care professional education.

The system shall assure appropriate and academically sound pre-college academic preparation.
The system shall provide experiential, hands-on learning opportunities.
The system shall emphasize recruitment of minority students and students from areas of defined need or rural areas.

(B) The department may provide financial assistance to eligible students and resident physicians.

Eligible students and resident physicians may apply for financial assistance from the Primary Care Resource Initiative for Missouri (PRIMO) Program, upon acceptance for admission into an approved Missouri institution or residency program.
To qualify for assistance the applicant shall have no other conflicting service obligation, with the exception of the National Guard or military reserves.
Recipients must apply for funding annually.
In return for an obligation to provide primary health care services in an area of defined need upon completion of their training eligible students may receive forgivable loans as follows:

A. Full-time undergraduate and dental hygienist students may receive five thousand dollars ($5,000) per academic year not to exceed four (4) loans;

B. Full-time graduate nursing students may receive five thousand dollars ($5,000) per academic year not to exceed two (2) loans;

C. Part-time undergraduate and dental hygienist students may receive three thousand dollars ($3,000) per academic year not to exceed six (6) loans;

D. Part-time graduate nursing students may receive three thousand dollars ($3,000) per academic year not to exceed four (4) loans;

E. Graduate nursing students engaged in a clinical experience with a preceptor may receive one (1) five thousand dollar ($5,000) loan.

In return for an obligation to provide primary health care services in an area of defined need upon completion of their training eligible students at schools of allopatric and osteopathic medicine and dentistry may receive forgivable loans as follows:

A. Students enrolled in a six (6)-year program may receive ten thousand dollars ($10,000) per academic year for year one (1) and year two (2) of the program;

B. Students enrolled in a six (6)-year program may receive from twenty thousand dollars ($20,000) to twentyfive thousand dollars ($25,000) based upon the participating institution’s tuition, for academic years three (3) through six (6), not to exceed four (4) loans;

C. Students enrolled in a four (4)-year program may receive from twenty thousand dollars ($20,000) to twentyfive thousand dollars ($25,000) based upon the participating institution’s tuition, not to exceed four (4) loans.

Selected primary care resident physicians may receive ten thousand dollars ($10,000) per year in forgivable loans, not to exceed three (3) loans.
Interest at the rate of nine and one-half percent (9 1/2%) per year from the date of check issuance shall be charged on all PRIMO loans.
The department may grant a deferral of repayment of principal and interest when deferral is in the best interests of the state and the PRIMO program.
Interest accrued during a deferral period by a PRIMO scholar shall be forgiven on the same basis as the original principal and interest.
Forgiveness of interest and principal for financial assistance recipients engaged in qualified employment shall occur at the rate of twenty percent (20%) per calendar year of the total financial assistance provided through the PRIMO program. If a recipient receives assistance for less than five (5) years, forgiveness shall occur on a year-for-year basis.
Forgiveness and cash repayment periods shall begin no later than six (6) months following the completion of training.
Recipients found to be in default of their contracts shall be allowed a cash repayment period of up to sixty (60) months.

The repayment period shall begin the first day of the calendar month following the month the recipient is found to be out of compliance.

Preference for financial assistance shall be given to:

A. Students previously participating in the PRIMO or PRIMO approved programs;

B. Minority students and students from areas of defined need or rural areas;

C. Students with an interest in providing primary health care services in areas of defined need.

(C) The department may provide support to participating institutions to facilitate development of programs to increase the number of primary health care professionals and clinical training sites in areas of defined need.

(D) The department may facilitate the development of community-based, comprehensive primary health care delivery systems throughout the state.

The department may contract with organizations to develop community-based, comprehensive primary health care delivery systems.
Participation will be prioritized according to community health care needs, extent of community support and a documented community strategic intervention plan.
Participants will be reviewed annually and may be approved for continued funding, not to exceed five (5) consecutive years, based on:

A. Availability of state funds;

B. Participant’s documented accomplishments and adherence to project activities; and C. Annual detailed record to the department of the expenditure of PRIMO funds.

(3) PRIMO program participants shall file with the department the following completed forms:

(A) All applicants for financial assistance shall file form MO 580-1968 (4-99);

(B) Applicants approved for financial assistance shall file the contract form MO 580-1966 (3-96).

rule filed Feb. 23, 1995, effective March 5, 1995, expired July 2, 1995.

Original rule filed Nov. 1, 1994, effective June 30, 1995. Changed to 19 CSR 10-4.010, July 30, 1998. Rescinded and readopted: Filed Feb. 15, 2002, effective Aug. 30, 2002. ** *Original authority: 191.411, RSMo 1993 amended 2001. **Pursuant to Executive Order 21-07, 19 CSR 10-4.010, paragraph (2)(B)7. was suspended from March 25, 2020 through August 31, 2021.

History

AUTHORITY: section 191.411, RSMo Supp. 2001. This rule was previously filed as 19 CSR 50-4.010. Emergency rule filed Nov. 1, 1994, effective Nov. 11, 1994, expired March 10, 1995. Emergency

19 CSR 10-4.020 J-1 Visa Waiver Program {#sec-19-csr-10-4.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-4.020}

PURPOSE: This rule outlines the Department of Health and Senior Services’ J-1 visa waiver recommendation process in accordance with section 214(l) of the Immigration and Nationality Act.

(1) The following definitions shall be used in the interpretation of this rule:

(A) Department means the Missouri Department of Health (B) Director means the director of the Missouri Department of Health and Senior Services;

(C) Health Professional Shortage Area (HPSA) means a geographic area, population group, or facility designated by the United States Department of Health and Human Services, Health Resources and Services Administration with a shortage of primary care, dental, or mental health providers and services;

(D) Primary Care Specialty means a physician practicing Family Medicine, General Internal Medicine, General Pediatrics, General Obstetrics and Gynecology, or General Psychiatry; and (E) Primary Care Physician means a physician practicing in one (1) of the Primary Care Specialties in (1)(D).

(2) A waiver request must come from a Missouri health care facility on behalf of a J-1 Visa physician. All of the required information and documentation, as required by the United States Department of State, J-1 Visa Waiver Program, must be submitted with the documents presented in the order as prescribed in subsections (2)(A)-(M). Waiver requests that do not comply with these requirements will not be considered.

The required documents include:

(A) A completed DS-3035 Form, J-1 Visa Waiver Recommendation Application;

(B) An employment contract between the physician and the health care facility employing the physician named in the waiver application that includes the following:

The name and address of the health care facility;
A statement that the physician agrees to begin employment with the employer within ninety (90) days of receiving the waiver;
A statement that indicates the physician’s specialty;
The specific geographical area or areas where the physician will practice medicine;
A statement by the physician that he or she agrees to meet the requirements set forth in the Immigration and Nationality Action, Section 214(l);
An employment period of at least three (3) years in a designated HPSA; and 7. A full-time schedule of at least forty (40) hours per week in direct patient care in the HPSA;

(C) Proof that the location where the physician will practice medicine is in a designated HPSA. The applicant shall provide a print out of HPSAs from http://hpsafind.hrsa.gov/HPSASearch.

aspx. If no Missouri HPSA designations exist for the facility’s service area, the applicant shall contact the department to identify other documentation of services to underserved patients;

(D) Copies of all DS-2019s/IAP-66s/1-94s, Certificate of Eligibility for Exchange Visitor (J-1) Status for all programs;

(E) A copy of the physician’s curriculum vitae, and passport pages;

(F) A copy of Missouri Licensure, or proof of application and paid fee, from the Missouri Board of Healing Arts;

(G) A copy of the statement of no objection from the physician’s country of nationality or last residence, if the physician is contractually obligated to return to the home country;

(H) A Notice of Entry of Appearance as Attorney on the Department of Homeland Security (DHS) Form G-28, if an attorney represents the facility or physician;

(I) A statement of reason from the applicant regarding the applicant’s reason for not wishing to fulfill the two (2) year county residence to which the International Medical Graduates (IMG) agreed at the time of acceptance of exchange visitor status;

(J) A letter from the applicant’s employer to the department indicating their intent to hire the physician;

(K) A signed statement from the physician agreeing to the contractual requirements set forth in section 214(l) of the Immigration and Nationality Act;

(L) The third party barcode page; and (M) The waiver division barcode age.

(3) Application packages will be accepted between October 1 and October 31 of the current year. Applications will be accepted via regular mail or electronic submission through the J-1 Visa Waiver Program webpage at https://health.mo.gov/living/ families/primarycare/j1visa/index.php. All applications are considered submitted on the day received by the department and must be received by October 31. It is the responsibility of the applicant to verify that an application has been received timely by the department. Each application package received by the department will be reviewed for completeness. An original copy of the required documents should be included in the application package. For purposes of this regulation, an electronic submission is considered an original copy of the application package. Complete applications are those which include all required documentation, as listed in subsections (2)

(A)-(M). Complete applications will be forwarded for approval by the director or his/her designee in the priority as outlined in sections (4)-(6). Upon approval, the department will send the request to the appropriate federal authorities.

(4) The department’s J-1 Visa Waiver Program will give priority to those physicians in one (1) of the following primary care specialties: Family Medicine, General Pediatrics, General Obstetrics and Gynecology, General Internal Medicine, or General Psychiatry. Primary Care Physician applications that meet all applicable requirements will always receive an available selection regardless of the location or HPSA score of the application. If the department receives more than thirty (30) completed application packages between October 1 and October 31, application packages will be prioritized in the following order:

(A) Primary Care Physicians will be prioritized before other specialties;

(B) In the event that more than thirty (30) Primary Care Physician applications are received, all applications will be recommended based on the highest HPSA score of the location of the health care facility employing the physician. In the event of a tie for the last remaining slot, a lottery will determine the selection.

(5) In addition to the eligible physicians set forth in section (4), waivers may be recommended for other specialties and subspecialties.

(A) Physicians trained in other specialties may be considered for recommendation for a J-1 Visa Waiver based on the following criteria:

Vacant recommendation slots must be available; and 2. The specialty physician’s application must comply with all other requirements of the J-1 Visa Program.

(B) The number of specialty recommendations in any given program year will be determined by the number of available recommendation slots after all application packages for primary care physicians as outlined in section (4) are reviewed.

If more application packages are received for specialists than the department has recommendations available, priority will be determined as follows:

The department divided the state of Missouri into three (3) regions for distribution purposes under this regulation. The specialist slots will be divided evenly among the regions. Region A consists of counties of Warren, St. Charles, Franklin, Jefferson, St. Louis, and St. Louis City. Region C consists of counties of Jackson, Lafayette, Cass, Johnson, Bates, Henry, Benton, Vernon, St. Clair, Hickory, Barton, Cedar, Polk, Dallas, Laclede, Dade, Greene, Webster, Wright, Texas, Jasper, Lawrence, Newton, McDonald, Christian, Barry, Stone, Taney, Ozark, Howell, and Douglas. Region B consists of all of the remaining Missouri counties not included in region A and C;
The first four (4) remaining vacant slots for specialists will be identified as reserved slots;
Any remaining vacant slots after excluding the reserved slots, will be divided evenly into three (3) with each region receiving the same number of vacant slots. If the remaining vacant slots cannot be evenly divided into three (3), then the remainder slots will be identified as a reserved slot;
The vacant slots for each region may receive waiver recommendations from the department prioritized by highest HPSA score of the location of the health care facility employing the physician;
If any health care facility or institution within a specific region would receive more than fifty percent (50%) of the specialty slots assigned to that region, then the number of slots over fifty percent (50%) will be reviewed by the department director to ensure appropriate distribution of specialists based on the needs of each region. The department director shall have the authority to award one (1) or more recommendations to the next highest HPSA score of the location of the health care facility employing the physician, excluding the institution that received more than fifty percent (50%) of the slots. If such distribution shall be in the best interest of the state or region;
The remaining reserved slots will be distributed, irrespective of region, to the applicants with the highest remaining HPSA scores of the location of the health care facility employing the physicians; and 7. In the event that there are fewer remaining slots than qualified applicants, or a tie for the last remaining slot, and with all of those applicants having equal status in priority, the remaining slots will be recommended by lottery.

(6) If the department recommends less than thirty (30) physicians for J-1 Visa Waivers for application packages received between October 1 and October 31 of the current year, application packages will continue to be accepted, reviewed for completeness, and recommended in the order of the date they are received for any specialty until all available slots are filled.

(A) In the event that there are fewer remaining waivers than applicants, and with all of those applicants having equal status in priority, remaining waiver(s) will be recommended by lottery.

(7) It is the responsibility of the physician and the employer to meet Missouri’s licensing and credentialing requirements as delineated by the Missouri Board of Healing Arts.

(8) A physician with a Missouri J-1 Visa Waiver must provide employment verification within thirty (30) days from a request by the department. The department will make employment verification requests at least once per calendar year.

(9) A physician who is practicing under a J-1 Visa in another state who wishes to practice in a HPSA in Missouri and obtain a J-1 Visa Waiver may do so only under the following conditions:

(A) The physician must complete the J-1 Visa Waiver Application process in Missouri and obtain a Missouri medical license prior to commencing practice;

(B) The physician should make no plans for the transfer or to move personal possessions until the department has approved the request. The physician retains sole responsibility for notifying the employer of the intent to transfer, and payment of any financial penalty caused by a breach of contract, as determined by the employer; and (C) All other J-1 Visa Waiver requirements remain in effect.

(10) A physician with a J-1 Visa Waiver who is practicing in Missouri and who wishes to transfer to another HPSA in Missouri may do so under the following conditions:

(A) At least sixty (60) days in advance of the proposed change, the physician must notify the department of the new practice site address, telephone number, site director, and the effective date of the proposed change;

(B) The reason for the transfer must be explained in the written notice;

(D) The physician should make no plans for the transfer or moving of personal possessions until the department has issued written approval of the transfer. The physician retains sole responsibility for notifying the employer of the intent to transfer and payment of any financial penalty caused by a breach of contract, as determined by the original employer.

(11) The department is not responsible for exceptions to or interpretations of these policies which have occurred without the written approval of the director of the department or his/ her designee.

(12) The department is not responsible for any practice arrangements or contractual obligations entered into by the physician prior to approval of a J-1 Visa Waiver request.

Filed Dec. 16, 2002, effective May 30, 2003. Emergency rescission and rule filed Sept. 17, 2019, effective Oct. 1, 2019, expired March 27, 2020. Rescinded and readopted: Filed Sept. 17, 2019, effective April 30, 2020. Amended: Filed April 1, 2020, effective Sept. 30, 2020.

Amended: Filed March 15, 2021, effective Oct. 30, 2021. *Original authority: 191.411, RSMo 1993, amended 2001, 2007.

History

AUTHORITY: section 191.411, RSMo 2016. This rule was previously filed as 19 CSR 50-4.020. Emergency rule filed April 17, 1995, effective April 27, 1995, expired Aug. 24, 1995. Original rule filed April 17, 1995, effective Oct. 30, 1995. Changed to 19 CSR 10-4.020 July 30, 1998. Emergency amendment filed Sept. 19, 2000, effective Sept. 29, 2000, expired March 27, 2001. Amended: Filed Sept. 19, 2000, effective Feb. 28, 2001. Emergency amendment filed Dec. 16, 2002, effective Dec. 26, 2002, expired June 23, 2003. Amended:

19 CSR 10-4.030 National Interest Waiver Program {#sec-19-csr-10-4.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-4.030}

PURPOSE: This rule establishes the procedure for requesting an attestation from the Department of Health that an alien physician’s work in an area or areas of the United States that have been designated as having a shortage of health care providers by the Secretary of Health and Human Services is in the public interest for the purpose of applying for a National Interest Waiver from the Immigration and Naturalization Service.

(1) The following definitions shall be used in interpretation and enforcement of this rule:

(A) Department means the Missouri Department of Health;

(B) Director means the director of the Missouri Department of Health;

(D) Physician means an individual licensed and registered pursuant to Chapter 334, RSMo;

(E) Hospital means a facility licensed in the state of Missouri pursuant to Chapter 197, RSMo;

(F) Health Professional Shortage Area (HPSA) means an area or facility designated by the Secretary of Health and Human Services as having inadequate health care providers; and (G) Approved practice site means the practice location for which the department has issued the attestation of public interest.

(2) The department may provide attestations in support of a National Interest Waiver request for waiver to the job offer requirement that applies to alien second preference employment-based immigrant visa petitions.

(A) The request must contain all of the following information and documentation and must be submitted in a single package with the documents presented in the order they are listed in paragraphs (2)(A)1.–9. Waiver requests which do not comply with these requirements will not be considered. Each request shall contain:

A written request from the physician that the department provide a letter that the physician’s work in such an area, areas or facility is in the public interest;
A detailed written description of the service area, facility or population in which the physician will be working, including documentation of its designation as a Health Professional Shortage Area and the services currently being provided;
A letter from the board stating that the physician is licensed in good standing in Missouri;
A letter from the medical director of all hospitals at which the physician has privileges delineating the status of the privileges that were granted, when the privileges began and how the privileges may have changed over time along with an explanation for any changes;
A written statement from the physician’s malpractice insurance carrier stating the claims made against the physician and the disposition of those claims;
A written statement from the city council or county commission, whose jurisdiction includes the physician’s practice site, that the physician’s services are required by and are in the interest of the community;
A written statement from the local public health agency, whose jurisdiction includes the physician’s practice site, that the physician’s services are required by and are in the interest of the community;
A copy of the physician’s employment contract for the practice site for a period of no less than five (5) years; and 9. A written statement as to how the denial of the waiver will affect the provision of medical services in that community.

(3) No attestation shall be granted to any physician who fails to provide any of the information in paragraphs (2)(A)1.–9.

(4) No attestation shall be granted to any physician who does not have privileges at any hospital in Missouri.

(5) A physician must work at the approved practice site for a minimum of five (5) years. If the physician fails to comply with this section, the department shall report the physician to the Immigration and Naturalization Service and other agencies as necessary.

(6) A physician with a National Interest Waiver from Missouri, who wishes to transfer to another qualifying practice site in Missouri, may do so under the following circumstances:

(A) The physician must notify the department at least sixty (60) days prior to the proposed change. The notice must contain, at minimum the following:

All the information and documentation required in subsection (1)(A) of this rule; and 2. A detailed explanation as to the reason for the change;

(B) The physician retains sole responsibility for financial liabilities caused by the change in approved practice site.

(7) Physicians for whom the department provides public attestations shall supply the following to the department by February 1 of each year:

(A) Name;

(B) Address of the physician’s present practice site(s);

Gender;
Age distributions; and 3. Payor source (Medicaid, Medicare, commercial insurance or self-pay);

(D) Letters of continued support from the medical director of all hospitals at which said physician has privileges;

(E) Letters of continued support from the local public health agency; and (F) Letter from the board stating that the physician is licensed in good standing in Missouri.

Original rule filed March 27, 2001, effective Sept. 30, 2001. *Original authority: 191.411, RSMo 1993.

History

AUTHORITY: section 191.411, RSMo 2000. Emergency rule filed March 27, 2001, effective April 9, 2001, expired Jan. 17, 2002.

19 CSR 10-4.040 Definition of a Public Health Setting {#sec-19-csr-10-4.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-4.040}

PURPOSE: The purpose of this rule is to implement section 332.311, RSMo as amended by HB567 of the 91st General Assembly and define the public health settings in which a dental hygienist may practice without the supervision of a dentist.

(1) For the purposes of section 332.311, RSMo only, the term “public health setting” shall be defined as a location where dental services authorized by section 332.311, RSMo are performed so long as the delivery of services are sponsored by a governmental health entity which includes:

(A) Department of Health and Senior Services;

(B) A county health department;

(D) A combined city/county health department; or (E) A nonprofit community health center qualified as exempt from federal taxation under section 501(c)(3) of the Internal Revenue Code including a community health center that receives funding authorized by sections 329, 330, and 340 of the United States Public Health Services Act.

History

AUTHORITY: section 332.311.2, RSMo Supp. 2001. Emergency rule filed March 15, 2002, effective March 25, 2002, expired Sept. 20, 2002. Original rule filed March 15, 2002, effective Aug. 30, 2002. Original authority: 332.311, RSMo 1969, amended 1997, 2001.

19 CSR 10-4.050 Healthy Communities Incentive Program {#sec-19-csr-10-4.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-4.050}

PURPOSE: This rule establishes the requirements and the process for participation of a health professional in the Healthy Communities Incentive Program.

(1) The following definitions shall be used in interpretation and enforcement of this rule:

(A) Approved practice site means the practice location for which the department agreed to provide support;

(D) Department means the Missouri Department of Health (E) Director means the director of the Missouri Department of Health and Senior Services;

(F) Hospital means a facility licensed in the state of Missouri pursuant to Chapter 197, RSMo;

(G) Licensing board means the Board of Registration for the Healing Arts and the Missouri State Dental Board within the Missouri Department of Economic Development;

(H) Physician means an individual licensed and registered pursuant to Chapter 334, RSMo;

(I) Sliding scale fee means a fee structure that provides adjustment to charges for all individuals under two hundred percent (200%) of the federal poverty limit, based upon family income and size.

(2) The department may contract with selected primary care physicians and general dentists to provide health care services to populations in need within the state.

(3) Applicants must submit a written request that contains all of the following information and documentation presented in the order they are listed in subsections (3)(A)–(H). Applications for participation that do not comply with these requirements will not be considered. Each request shall contain:

(A) A written request from the applicant for participation in the program;

(B) A detailed written description of the proposed practice site, including the facility in which the applicant will be working and the health care services currently provided at that site;

(E) A written statement from the applicant’s malpractice insurance carrier setting forth any claims that have been made against the applicant and the disposition of those claims;

(G) A copy of the applicant’s employment contract for the proposed practice site for a period of no less than four (4) years;

(H) Documentation of agreement to provide care to the populations in the area of defined need, including:

Acceptance as a provider by the Missouri Medicaid agency; and 2. A copy of the sliding scale fee.

(4) Selection for participation in the Healthy Communities Incentive Program will be prioritized utilizing the following criteria:

(A) The degree of need for health professional services (areas with a lack of access for the entire population will be given priority over those areas without access for specific populations);

(B) Recruitment of health professionals into an area will be given priority over retention of existing providers;

(5) Participation in the Healthy Communities Incentive Program shall consist of payments to individual health professionals under a written contract.

(A) The contract period shall be, at a minimum, four (4) years in length;

(B) Contract amount shall be one hundred thousand dollars ($100,000) for each four (4)-year period;

(C) Payment for the contract shall be due the final quarter of the last year of the contract period; and (D) Pre-payment of the contract amount may be made to facilitate placement in areas of defined need within the state.

(6) Participants shall supply the following to the department by July 1 of each year:

(A) Participant’s name;

(B) Address of the contracted practice site(s);

Gender;
Age distributions; and 3. Payor source (Medicaid, Medicare, Commercial Insurance or Sliding Scale Fee);

(D) Letters of continued support from the Local Public Health Agency; and (E) Letter from the applicable licensing board stating that the participant is licensed in good standing in Missouri.

(7) If an individual violates the written contract the state shall be entitled to recover from the individual an amount equal to the sum of:

(A) The total of the amounts prepaid by the state on behalf of the individual;

(B) The interest on the amounts which would be payable if at the time the amounts were paid they were loans bearing interest at the maximum prevailing rate as determined by the Treasurer of the United States; and (C) Any legal fees or associated costs incurred by the department or the state of Missouri in the collection of damages.

History

AUTHORITY: section 191.411, RSMo Supp. 2001. Original rule filed Feb. 15, 2002, effective Aug. 30, 2002. Original authority: 191.411, RSMo 1993, amended 2001.

19 CSR 10-4.060 Substance Use Disorder Grant Program {#sec-19-csr-10-4.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-4.060}

PURPOSE: This rule establishes guidelines for implementing the Substance Use Disorder (SUD) Grant Program that will increase access to evidence-based low-barrier drug addiction treatment, support overdose prevention education, and support job placement, housing, and counseling for those with substance use disorders.

(1) For the purposes of this regulation, the following definitions shall be used in the interpretation and enforcement of this

rule:

(A) “Applicant” is an agency or not-for-profit organization applying for a grant through the Substance Use Disorder (SUD)

Grant Program that meets the eligibility requirements set forth in this rule and the notice of grant opportunity (NGO);

(B) “Department” is the Missouri Department of Health and Senior Services (DHSS);

(C) “Disparate population” is a group of people who experience preventable differences in health outcomes that are worse than the general population. These differences, called health disparities, can be caused by a variety of factors, including race or ethnicity, gender, sexual orientation, age, disability or mental health status, income, geographic location, and language;

(D) “Evidence-based” is in accordance with ethical, current, peer-reviewed, systematically derived, research-based evidence about the most effective methods of preventing and reducing SUD;

(E) “Grant agreement” is the written instrument between the department and grantee that sets forth the terms and conditions of participation in the SUD Grant Program, including all written and executed amendments;

(F) “Grant agreement period” is the time frame of the grant agreement defined by the NGO;

(G) “Grantee” is an agency or organization that has a grant agreement signed by the department;

(H) “Notice of grant opportunity (NGO)” is the document that outlines the details, requirements, and processes for applying for grants from the SUD grant program;

(I) “Physical presence” refers to an office or staff member located in Missouri. Grantees are allowed to conduct grant activities from another state but must maintain agency representation by having an office or staff present in Missouri;

(J) “Substance Use Disorder Grant Program” or “SUD Grant Program” is the program established within the department to administer the SUD Grant Program funds; and (K) “Substance use disorder (SUD)” is a treatable mental disorder that affects a person’s brain and behavior, leading to their inability to control their use of substances like legal or illegal drugs, alcohol, or medications.

(2) SUD Grant Program.

(A) The SUD Grant Program is a state-authorized program funded by the Missouri Veterans, Health, and Community Reinvestment Fund, which consists of taxes and fees from retail sales of non-medical marijuana sold to consumers at licensed marijuana facilities within Missouri.

(B) The purpose of the SUD Grant Program is to provide grants to government or community-based agencies and notfor-profit organizations to increase access to evidence-based low-barrier drug addiction treatment, prioritizing medically proven treatment and overdose prevention and reversal methods and public or private treatment options with an emphasis on reintegrating recipients into their local communities, to support overdose prevention education, and to support job placement, housing, and counseling for people with SUD. The department may offer one (1) or more NGOs each addressing a specific strategy related to the program purpose each fiscal year.

(C) Funding amount. The department shall determine the amount of funding allocated for each grant based on the nature and scope of the project(s) needed and funding available to the department by appropriation.

(D) Number of awards. The maximum number of awards is contingent upon the amount of the SUD Grant Program appropriations for each state fiscal year and the length of the grant agreement period (e.g., 1 to 3 years).

(E) The SUD Grant Program shall distribute available funding through grant awards in at least one (1) of the following areas:

To develop new or improve, enhance, or increase evidence-based SUD recovery support services;
To develop new or improve, enhance, or increase evidence-based SUD prevention services and interventions; or 3. To develop new or improve, enhance, or increase quality evidence-based SUD treatment services.

(3) Application.

(A) Eligible applicants.

Eligible applicants shall be a community-based, nonprofit organization, or local or state government that engages in at least one (1) of the following activities:

A. Implements projects related to SUD prevention, treatment, or recovery support; or B. Provides services related to SUD prevention, treatment, or recovery support.

Eligible applicants shall have or establish a physical presence in the state of Missouri. Eligible applicants shall submit a completed application in response to the NGO with a budget that does not exceed the allotted amount for each budget year of the grant agreement.
Eligible applicants must be registered as a vendor with the state of Missouri through the current procurement system.
The department may reject applications submitted by organizations or individuals that have a contractual, corporate, organizational, or business responsibility to promote or assist in promoting the use or sale of alcohol or tobacco products.

(B) Solicitation.

The department will solicit applications for grants by preparing one (1) or more NGOs.

A. Applicants shall have a minimum of thirty (30) days from the date of posting to respond to the NGO(s) posted on the DHSS website.

The specific NGO(s) shall contain the guidelines for providing evidence-based recovery, prevention, or treatment projects addressing SUD in Missouri.
If grantees seek federal funds to support their project, they may use their SUD Grant Program grant award as a local match if required by federal notice of funding opportunities.

A. Grantees are required to notify the department of any instance where SUD Grant Program funds are used as a match before applying for the federal grant and after receiving the federal grant.

(D) Applicant requirements.

Applicants shall follow all application instructions provided in the NGO regarding the format and content of the application.

A. The applicant is solely responsible for ensuring that the applicant’s entire application is completed by the deadline specified in the NGO.

B. The applicant shall retain proof of timely submission.

C. The department will not contact applicants in the case of incomplete applications or untimely submissions.

(E) Submission.

Initial grants.

A. Applicants shall submit an application for an initial grant via the mechanism set forth in the NGO.

B. Applicants shall submit an application for a grant by the date set forth in the NGO.

(4) Evaluation and Selection.

(A) Evaluation for initial grants.

Preliminary screening.

A. The department will screen submitted applications to determine if they were submitted by the deadline specified in the NGO and are complete pursuant to these regulations and the NGO.

B. The department will exclude from the selection process any application that is missing information, does not meet the NGO requirements, or is received after the deadline.

Evaluation criteria.

A. The department will evaluate grant applications that meet preliminary screening criteria based on the criteria of these regulations and specified information in the NGO.

(I) The criteria shall include the following:

(a) The applicant’s organizational, budget management and administration, programmatic, and collaboration experience and capacity to implement the proposed project;

(b) The applicant’s understanding of and ability to communicate and meet the needs of the specified disparate population;

(c) The applicant’s project purpose, goal(s), objectives, use of evidence-based services and interventions, specific measurable improvement on the specified population, and timeline;

(d) The applicant’s current or planned partnerships and collaborations with stakeholders that may contribute to the proposed project;

(e) An evaluation plan for the proposed project;

(f) The extent to which the applicant’s proposed budget is clear and justified; and (g) Any other criteria the department deems relevant, as specified in the NGO.

(B) Ranking of applicants.

The department will weigh the importance of each evaluation criterion using a point-based scoring system. The criteria weighing shall be provided in the NGO.
Using the evaluation criteria, the department will evaluate each application against each applicable criterion and assign points signifying the degree to which the application meets each criterion up to the maximum number of points specified in the NGO.
Each application will receive a score based on the total points assigned to the application.
The department shall numerically rank each application using their score for each NGO.
Rejection. The department may reject any application that fails to meet the content specifications set in this rule and specified NGO.

A. Rejection of an application for failure to meet the content specifications is not subject to appeal.

(C) Timeline. The department will set deadlines in the NGO for application submissions, verification of award selection, agreement execution, and project implementation.

(D) Award notification. The department will notify all applicants by the deadline stated in the NGO regarding grant award decisions. Selected applicants must submit the signed grant agreement by the deadline specified in the NGO. The department reserves the right to select the next highest-ranking applicant if the selected applicant does not meet the deadline.

(E) Grant agreement period. The maximum grant agreement period is three (3) years (thirty-six (36) months). The amount of funding shall correspond to the NGO and type of project proposed.

The grant agreement period shall commence upon the execution of the grant agreement, which requires the signature of the department to be considered executed.
Awardees shall complete project implementation within the timeline identified within the NGO.

(F) Grant agreement. The department shall make all grant awards through a grant agreement between the department and each applicant selected to receive a grant.

(5) Restrictions.

(A) Costs not specifically included in the original budget submission shall be submitted to the department for prior approval before being expended.

(B) Grantees shall maintain fiscal records and provide information to the department as required within the NGO and the grant agreement for purposes of project and fiscal monitoring and audits and, at the request of the department, shall appear before the department to respond to any questions about the use of grant monies.

(C) The department may terminate any grant if the grantee does not meet the basic performance requirements specified by the grant agreement.

(D) If any prohibited activities are conducted, the department may terminate the grant and recover funds previously paid to the grantee. Additionally, awardees may not be considered for future grant awards.

(6) Distribution of Grant Funds.

(A) Payments. Participation in the SUD Grant Program will consist of payments directly to an awardee as a vendor with the state of Missouri, pursuant to a grant agreement.

(B) Retraction or reduction of payments. The department is not bound by any award estimates in the NGO. After making a finding that a grantee has failed to perform or failed to conform to grant agreement conditions or regulation requirements, the department may retract the grant amount of the awarded grantee. If funds have been disbursed, the grantee shall issue reimbursement to the department within thirty (30) days of notification of the retraction or reduction.

(C) Grantees shall return any unexpended balance of the award to the department at the end of the grant agreement period unless the awardee and the department sign an amended grant agreement.

(7) Reporting Requirements.

(A) Grantees shall submit reports to the department by the deadlines and in the format specified in the NGO and grant agreement or as otherwise communicated to the grantee in writing by the department.

Grantees who do not comply with this requirement may have to return part or all of their award and may not be considered for additional grant awards.

(B) Delinquent reports. Grantees with any required reports deemed to be delinquent may be placed on a performance plan and may be ineligible for participation in future grant opportunities or subsequent payment of funds until the report is submitted.

(8) Recipient Meetings.

(A) Grantees shall meet with the department as set forth in the NGO and grant agreement or as otherwise communicated to the grantee in writing by the department.

(9) Additional Grant Agreement Requirements. To receive funding under the SUD Grant Program, grantees must abide by all grant agreement terms and conditions.

History

AUTHORITY: Article XIV, section 2.6(2), and section 192.006, RSMo 2016. Original rule filed Dec. 27, 2024, effective July 30, 2025. Original authority: 192.006, RSMo 1993, amended 1995.

Chapter 5 Procedures for the Collection and Submission of Data to Monitor Health Maintenance Organizations

19 CSR 10-5.010 Monitoring Health Maintenance Organizations Definitions {#sec-19-csr-10-5.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-5.010}

PURPOSE: This rule establishes the procedures for health maintenance organizations to collect and submit data to the Department of Health pursuant to section 192.068, RSMo.

(1) The following definitions shall be used in the interpretation and enforcement of this

rule:

(A) Department means Missouri Department of Health and Senior Services;

(B) Director means the director of the Missouri Department of Health and Senior Services;

(C) Health care plan means any separately licensed entity subject to the provisions of sections 354.400 to 354.636, RSMo which had enrollees in the plan for at least six (6) months of the year for which data are to be reported and for at least six (6) months of the following year;

(D) NCQA means the National Committee on Quality Assurance; and (E) HEDISÆ means the current Health Plan Employer Data and Information Set.

(2) Starting in 1998, health care plans shall submit annually to the department, member satisfaction survey dataó (A) The member satisfaction survey shall be conducted according to HEDISÆ technical specifications, including survey instrument, sample size, sampling method, collection protocols and CAHPSÆ component of the HEDISÆ compliance audit;

(B) The commercial and Medicaid member satisfaction data shall be submitted to the department in electronic form, through a certified survey vendor, and meet the specifications of Table A. Table A is included herein.

(C) In 1998 the data shall be submitted by September 1. In subsequent years a final member-level data file and a CAHPSÆ component audit verification letter shall be submitted by June 15 or the date required by NCQA if other than June 15. If the required submission date falls on a weekend or a federally recognized holiday, the due date will be the first working day following the weekend or federal holiday. The data year (reporting period) for the CAPHSÆ submission shall be the calendar year (CY) immediately preceding the JUne 15 submission date; and (D) Medicare health care plans shall participate in a member satisfaction survey conducted by the Centers for Medicare and Medicaid Services. The department will obtain the data from the Centers for Medicare and Medicaid Services.

(3) Starting in 1998, health care plans shall provide annually to the department, audited quality indicator dataó (A) Quality indicator data shall be in accordance to all HEDISÆ specifications;

(B) All health care plans shall submit to the department documentation from a NCQA licensed organization that the quality indicator data submitted to the department have been audited through a partial or complete compliance audit according to HEDISÆ specifications;

(C) Each licensed health care plan shall submit separate quality indicator data files for their commercial, Medicaid and Medicare enrollees. Health care plans that contract with the Division of Medical Services to provide coverage in more than one Medicaid region, shall submit separate quality indicator data for the enrollees in each region. The quality indicator data shall be submitted to the department in electronic form and conform to the specifications listed in Table B. Table B is included herein.

(D) In 1998 the data shall be submitted by September 1. In subsequent years a final data file shall be submitted by June 15 or the date file required by NCQA if other than June 15.

If the required submission date falls on a weekend or a federally recognized holiday, the due date will be the first working day following the weekend or federal holiday. The data year (reporting period) for the HEDISÆ (Table B) submission shall be the calendar year (CY) immediately preceding the June 15 submission date.

(4) In 1998 access to care data shall be submitted by September 1. In subsequent years the data shall be submitted by June 15. If the required submission date falls on a weekend or a federally recognized holiday, the due date will be the first working day following the weekend or federal holiday. The data year (reporting period) for Table D (access to care) submission shall be the calendar year (CY) immediately preceding the June 15 submission date. Access to care data shall include the data elements and conform to the specifications listed in Table D. Table D is included herein.

(5) A health care plan demonstrates continual or substantial failure to comply with the provisions of this rule when the health care plan has been notified by the department that it fails to comply with the provisions of section 192.068, RSMo and this rule and the health care planó (A) Fails to provide required data;

(B) Fails to submit data that meet the data standards detailed in this rule; or (C) Fails to submit data within the time frames established in this rule.

4CODE OF STATE REGULATIONS

Table A Member Satisfaction Survey Data File Specifications File Content Commercial : Member satisfaction survey data for commercial plans shall be based on the version of the NCQA-required Consumer Assessment of Health Plans Study (CAHPS)

Questionnaire, applicable for the reporting year. The data reported to the Department shall include the member level and a CAHPS component audit verification letter from the commercial adult core set of questions, plus any NCQA-mandated or -recommended items for the adult segment of the questionnaire. The data shall also include any HEDIS measures specified in Table B, for a given product line and reporting year, that are collected via the CAHPS survey tool.

Medicaid : Member satisfaction survey data for MC+ plans shall be based on the version of the NCQA-required Consumer Assessment of Health Plans Study (CAHPS) Questionnaire, applicable for the reporting year. The data reported to the Department shall include the member level and a CAHPS component audit verification letter from the child core survey (Medicaid version) plus any additional questions required by the Division of Medical Services for the reporting year. The data shall also include any HEDIS measures specified in Table B, for a given product line and reporting year, that are collected via the CAHPS survey tool.

File format and media The member level and a CAHPS component audit verification letter and their respective record layouts shall be submitted electronically, using the data submission tools (DST) specified by the Department. Other file specifications shall conform to those required by NCQA for submission of the CAHPS Questionnaire results by the certified vendors.

File consistency Plans that elect to submit separate files for sub-groups of their enrollment population must consistently do so for all data submission categories required by this rule.

Table B Quality Indicator Data Specifications Data reported for each of the indicators listed below shall conform to the NCQA HEDIS Data Submission Tool and all other HEDIS technical specifications for indicator descriptions and calculations.

An ìXî in the table below indicates data are to be reported for this quality indicator if the health care plan offers this product line to Missouri residents. NCQA rotates certain measures every year. Rotated measurers shall be reported in accordance with current HEDISÆ technical specifications for reporting rotated measures. Measures followed by an asterisk (*) shall be reported every year regardless of NCQAís rotation strategy.

Applicable to:

Indicator Commercial Medicaid Medicare Childhood Immunization Status* X X Adolescent Immunization Status* X X Adolescent Well-Care Visits X X Use of Appropriate Medications for People with Asthma X X Chlamydia Screening for Women X X Breast Cancer Screening X X Cervical Cancer Screening X X Beta Blocker Treatment After Heart Attack X X Controlling High Blood Pressure X X Cholesterol Management After Acute Cardiovascular Event X X Comprehensive Diabetes Care X X Antidepressant Medication Management X X Flu Shots for Older Adults (CAHPSÆ) X Advising Smokers to Quit (CAHPS) X X Annual Dental Visit X ______________________________________________________________________________________ File Content As applicable for each of the quality indicators listed above, except for those collected via the CAHPS questionnaire, the plans shall report the following elements from the NCQA HEDIS Data Submission Tool:

Data collection methodology (Administrative or Hybrid).
Eligible member population (i.e., members who meet all denominator criteria).
Minimum required sample size (MRSS) or other sample size.
Number of original sample records excluded because of valid data errors.
Number of records excluded because of contraindications identified through administrative data.
Number of records excluded because of contraindications identified through medical record review.
Additional records added from the auxiliary list.
Denominator.
Numerator events by administrative data.
Numerator events by medical record.
Reported rate.
Lower 95% confidence interval.
Upper 95% confidence interval.

All data elements above shall conform to the HEDIS technical specifications, as outlined in the NCQApublished technical manuals.

6CODE OF STATE REGULATIONS

File Specifications Responses to the survey items in Table D must be submitted electronically, in a data file format specified by the Department.

Table D must be completed for each managed care product line (Commercial, Medicaid, or Medicare) offered by each licensed health care plan. Responses should be based on activity or status during the reporting period, within each product line (payer). Survey questions in Table D shall apply, except where otherwise noted, only to fully insured (ERISA exempt) enrollments.

Table B Quality Indicator Data Specifications (continued)

File format and media The quality indicator data shall be submitted electronically, in a data file format to be specified by the Department. All other data specifications shall conform to those required by NCQA for submission of the audited quality indicator data.

File Consistency Plans that elect to submit separate files for sub-groups of their enrollment population must consistently do so for all data submission categories required by this rule. Health care plans that contract with the Division of Medical Services to provide coverage in more than one Medicaid region, shall submit separate quality indicator data for the enrollees in each region.

I. HEALTH PLAN INFORMATION

Instructions : Submit one set of Table D information, Parts I and II, for each product line (i.e. type of payor) offered by your organization. 1.) Product Line (CHECK ONE): ( ) Commercial ( ) Medicare ( ) Medicaid 2.) Missouri Department of Insurance Licensed Plan Name: ___________________________________ Dba (if applicable): ______________________ 3.) Extended NAIC Identification Number (7-digit): __ __ __ __ __ __ __ 4.) Name as marketed to your members (for Consumerís Guide display purposes): ____________________________________________________________________________ 5.) List the following for each of your products within this product line:

Marketed ------------Phone Numbers------------a.) Product Name b.) HMO/POS c.) Customer Service d.) RN Hotline ___________________ _________ ______________ ___________ ___________________ _________ ______________ ___________ 6.) Through what organization was your mana ged care organization accredited as of the last day of the reporting period?

Accrediting organization: ( ) NCQA ( ) URAC ( ) JCAHO ( ) None Level of Accreditation: _________ _________ _________ 7.) Managed Care Organization Contact Person for Table D Information: a.) Name: _______________________________ b.) Title: __________________________ c.) Phone: _______________ d.) Fax: ________________ e.) E-mail: __________________ 8CODE OF STATE REGULATIONS II. HEALTH PLAN SERVICES 1.) Please indicate for each of the following high risk conditions/diseases, if your managed care plan (A) has screening mechanisms, (B) distributes educational material for all plan enrollees, (C) provides specific educational materials to persons-at-risk, (D) provides case management, and (E) provides disease management. (CHECK ALL THAT APPLY.

SEE NOTE BELOW.)

(A)(B)(C)(D)(E)

High RiskScreeningEducation forEducation forCaseDisease Conditions/Diseases MechanismsAll Plan Enrollees Persons-at-RiskManagementManagement Asthma( NA )( )( NA )( )( )

Stroke/Cardiovascular Disease( NA )( )( NA )( )( )

Breast Cancer( )( )( )( )( )

Cervical Cancer( )( )( )( )( )

Ovarian Cancer( NA )( )( NA )( )( )

Colorectal Cancer( NA )( )( NA )( )( )

Sickle Cell Disorders( NA )( )( NA )( )( )

Congestive Heart Failure (CHF) ( NA )( )( NA )( )( )

Chronic Obstructive Pulmonary Disease (COPD)( NA )( )( NA )( )( )

Diabetes( NA )( )( NA )( )( )

Depression( NA )( )( NA )( )( )

HIV( NA )( )( NA )( )( )

High Risk Pregnancy( NA )( )( NA )( )( )

Obesity( NA )( )( NA )( )( )

Lead Poisoning( NA )( )( NA )( )( )

Chlamydia: Females( NA )( )( NA )( )( )

High Blood Pressure( NA )( )( NA )( )( )

Alcohol/Substance Abuse:

Adolescents( NA )( )( NA )( )( )

Pregnant Women( NA )( )( NA )( )( )

Tobacco Use( NA )( )( NA )( )( )

Other__________________ (PLEASE SPECIFY)( )( )( )( )( )

Note: Screening Mechanisms is a protocol by which the Managed Care Organization identifies through administrative data, members at risk for certain diseases or conditions, utilizing clinical guidelines, and then formally conveys to the network PCPs or personal physician to proactively screen these at-risk patients in their daily practice.

Education strategies for plan enrollees may include but are not limited to newsletters, periodicals, direct mailings and similar types of media campaigns.

Case management is a protocol where case managers work with providers and physicians to coordinate the medical care that patients with complex or chronic illnesses need to receive. Case managers help members obtain services and medical equipment as ordered by their physicians.

Disease management is a strategy where nurses and other health professionals help members learn to self-manage their chronic condition effectively through disease-specific education, general health promotion and reinforcement of the treatment plan designed by each memberís physician.

10CODE OF STATE REGULATIONS

12CODE OF STATE REGULATIONS

14CODE OF STATE REGULATIONS

Original rule filed Jan. 16, 1998, effective Aug. 30, 1998. Amended: Filed Oct. 30, 1998, effective May 30, 1999. Amended:

Filed Dec. 20, 1999, effective May 30, 2000.

Amended: Filed Sept. 15, 2000, effective April 30, 2001. Amended: Filed Oct. 2, 2001, effective March 30, 2002. Amended: Filed Oct. 2, 2002, effective April 30, 2003.

Amended: Filed Sept. 12, 2003, effective March 30, 2004. *Original authority: 192.068, RSMo 1997.

History

AUTHORITY: section 192.068, RSMo 2000. Emergency rule filed Jan. 16, 1998, effective Jan. 26, 1998, terminated April 15, 1998.

Chapter 6 Professional and Practical Nursing Student Loans

19 CSR 10-6.010 Nurse Loan and Nurse Loan Repayment Programs {#sec-19-csr-10-6.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-6.010}

PURPOSE: This rule establishes the requirements for implementing the professional and practical nursing student loan and loan repayment programs.

(1) The following definitions shall be used in the interpretation and enforcement of this

rule:

(A) Academic year for a practical nursing program means a calendar year. Academic year for a professional nursing program means the period of time from the beginning of the fall semester to the final day of the spring semester and may include a summer session;

(B) Advisory panel means the advisory group of nurses appointed by the director of the Missouri Department of Health to advise the department regarding the rules, funding and guidelines for implementing and administration of the nurse loan and nurse loan repayment programs;

(C) Application contract means the form provided by the Missouri Department of Health for the purpose of applying for a nurse loan;

(D) Area of defined need means a geographic area or a type of practice specialization designated by the Missouri Department of Health as experiencing nursing shortages and published annually by rule;

(E) Board means the State Board of Nursing;

(F) Department means the Missouri Department of Health;

(G) Director means the director of the Missouri Department of Health;

(H) Educational loan means the financial assistance provided by the department under the authority of the nurse loan program; or commercial loans made by banks, credit unions, savings and loan associations, insurance companies, schools and other financial institutions for nurse education purposes; or loans made by federal, state, county or city agencies authorized by law to make loans for nurse education purposes;

(I) Eligible applicant for the nurse loan repayment program means a current Missouri licensed professional nurse who has attained either an associate degree, a diploma, a bachelor of science degree or a graduate degree in nursing from an accredited institution; or a student nurse in the final full year as a fulltime student in a school of nursing leading to a bachelor of science degree or a graduate nursing program leading to a master’s degree in nursing;

(J) Eligible student means a resident who has made application to be a full-time student in a formal course of instruction leading to an associate degree, a diploma, a bachelor of science degree, or a master of science degree in nursing, or leading to the completion of educational requirements for a licensed practical nurse;

(K) Participating school means an institution within Missouri which is approved by the board for participation in the nurse loan program;

(L) Practical nurse means a person licensed under the provisions of sections 335.011—335.096, RSMo 1986 to engage in the practice of practical nursing;

(M) Professional nurse means a nurse licensed under the provisions of sections 335.011—335.096, RSMo 1986 to engage in the practice of professional nursing;

(N) Qualified applicant for the nurse loan program means a student matriculating in a participating school;

(O) Qualified employment means employment on a full- or part-time basis in Missouri in a position requiring a licensed practical nurse or registered professional nurse in any public or nonprofit agency, institution or organization in an area of defined need;

(P) Reasonable educational costs means tuition, books, fees, supplies, equipment and materials required by the program of the school in which the financial aid recipient was or is enrolled to obtain a professional diploma or degree or practical nurse certification;

(Q) Reasonable living expenses means the cost of room, board, transportation and miscellaneous costs based on individual program costs as published annually by the department;

(R) Repayment application means the form provided by the department for the purpose of applying for participation in the nurse loan repayment program; and (S) Repayment contract means the form signed by a professional nurse loan repayment applicant and the director of the department or an authorized agent in which the applicant agrees to accept responsibility for repayment of educational loans through qualified employment or by cash.

(2) Members of the advisory panel shall serve for three (3) years from the date of appointment by the director and may be reappointed for consecutive three (3)-year terms. Resignations from the panel may be accepted by the director at any time. Appointments to fill vacated panel positions shall be for three (3) years. Nonattendance by a panel member at two (2) consecutive scheduled panel meetings shall constitute a resignation from the panel unless a written explanation of the absences with a written request to continue service on the panel is received by the director within thirty (30) days after the second absence of a panel member from a scheduled panel meeting. Nonattendance at more than four (4) scheduled panel meetings in any two (2) consecutive years may constitute, at the discretion of the director, a resignation from the panel.

(3) Recipients of professional and practical nurse loans shall verify to the department their enrollment, their program eligibility, their academic standing following the completion of each semester and summer session, and their expected program completion date.

(A) Interest on funds loaned by the nurse loan program shall accrue at a rate of nine and one-half percent (9 1/2%) per year from the issue date of the department check.

(B) When a recipient of financial assistance ceases his/her study prior to the successful completion of the course of instruction required for graduation from a participating school, repayment of the principal and interest shall begin within ninety (90) days after the date the recipient ceases to be an eligible student, in accordance with the repayment contract. The department shall be notified by the loan recipient within thirty (30) days of the date the recipient ceases to be an eligible student. Payment shall be completed no more than twelve (12) months from that date.

(C) The department may grant a limited deferral of repayment of the principal and interest on the basis of hardship such as critical illness of the participant or an immediate family member, or death in the immediate family, or severe handicapping condition of the participant when the hardship has been adequately documented such as attending physician statement, death certificate or Social Security disability determination.

(D) The department may grant a limited deferral of the repayment of the principal and interest when the deferral would best serve the interest of the state and the nurse loan program.

(E) The status of each deferral may be reviewed as often as necessary by the department but shall be reviewed annually to insure compliance with the intent of the deferral.

(F) Interest accrued during a deferral period by a financial assistance recipient shall be forgiven on the same basis as the original loan and interest.

(G) Forgiveness of interest and principal for a financial assistance recipient engaged in qualified employment on a less than full-time

basis may be prorated. Partial year forgiveness of the loan and accrued interest for employment in an area of defined need may be authorized by the director.

(H) Once a financial assistance recipient has started to practice in an area of defined need, the principal and interest shall continue to be forgiven even if the designation of the area of defined need changes. If the recipient terminates that employment, reemployment in an area of defined need shall be required to reestablish forgiveness status.

(I) Recipients found to be in default of their contracts shall be allowed a repayment period up to twenty-four (24) months. The repayment period begins on the date the recipient is out of compliance.

(4) To qualify for a nurse student loan, the applicant shall have no conflicting service obligation that would prevent the state from benefitting from the applicant’s services after graduation, with the exception of service in the National Guard or military reserve.

(5) Application contracts shall be completed, signed by the applicant and received by the department at least eight (8) weeks prior to the beginning of classes.

(A) Application contracts shall be accompanied by proof of Missouri residency, such as a copy of the Missouri individual income tax return for the previous year of the applicant or of the applicant’s parents or legal guardian, or current Missouri driver’s license.

(B) Loan recipients shall apply annually.

(C) Completed application contracts on file in the department shall be prioritized for funding based on each applicant’s financial need, willingness to serve in an area of defined need, and the total amount estimated to be needed by the applicant to complete the applicant’s program.

(D) Application contract forms for the nurse loan program shall be made available through the financial aid offices of the participating schools and the department for distribution to eligible students.

(E) Upon approval for funding, the application contract shall be signed by the department director or an authorized agent and shall become the agreement of the applicant to accept responsibility for repayment either by cash or by service in an area of defined need.

(F) A copy of an applicant’s financial aid award notice from the participating school and of the applicant’s notice of acceptance by the participating school shall be on file in the department prior to funding by the nurse loan program.

(6) Selection criteria for the nurse loan repayment program are willingness to serve in an area of defined need, professional references and appropriate work history.

(7) Repayment applications for the nurse loan repayment program shall be made on forms available through the department.

(A) To qualify for a nurse loan repayment the applicant shall have no conflicting service obligation that would prevent the state from benefitting from the applicant’s professional services with the exception of service in the National Guard or military reserve.

(B) Repayment applications shall be completed, signed by the applicant and accompanied by proof of professional licensure.

(8) Subject to availability of federal, state or community funds for the nurse loan repayment program, the department shall enter into a minimum two (2)-year contract with each individual qualifying for repayment of educational loans. No loan repayment shall be made for any professional practice performed prior to the effective date of the health professional’s nurse loan repayment contract.

(A) Participants shall practice in an approved area of defined need.

(B) Final approval of a nurse loan repayment contract is contingent upon approval by the director and a signed service agreement from an approved site, agreed upon by the site authority and the applicant.

(9) Participants who default on their written repayment contracts shall be subject to monetary repayment of the contracted amount and interest. Cash repayment periods may be authorized up to a maximum of twenty-four (24) consecutive months.

(A) The department may grant a deferral of payment of the loan repayment amount and interest at the discretion of the director on the

basis of hardship such as critical illness of participant or an immediate family member, or death in the immediate family, or severe handicapping condition of the participant when that hardship has been adequately documented such as statement of the attending physician, death certificate or Social Security disability determination.

(B) The status of each deferral may be reviewed as often as necessary by the department but shall be reviewed annually to insure compliance with the intent of the deferral.

(C) Once a loan repayment participant has begun qualified employment, loan repayment shall continue, even if the designation of the area of defined need of qualified employment changes as long as the loan repayment participant does not terminate employment.

(D) If circumstances beyond the control of a loan repayment participant result in the termination of qualified employment, deferral status may be granted for a period up to ninety (90) days to allow the participant to gain employment in an area of defined need.

Original rule filed Feb. 4, 1991, effective July 8, 1991. Changed to 19 CSR 10-5.010 July 30, 1998. Changed to 19 CSR 10-6.010 August 30, 1998. ** *Original authority 1963, amended 1988, 1990. **Pursuant to Executive Order 21-07, 19 CSR 10-6.010, subsection (3)(A) and section 335.233, RSMo was suspended from March 25, 2020 through August 31, 2021.

(9/30/21) JOHN R. ASHCROFT

History

AUTHORITY: section 173.030(3) and (6), RSMo Supp. 1990. This rule previously filed as 19 CSR 50-2.010 and 19 CSR 10-5.010.

Chapter 10 Vital Records

19 CSR 10-10.010 Birth {#sec-19-csr-10-10.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.010}

PURPOSE: This rule concerns recording of births for babies born in wedlock and out of wedlock.

(1) If the mother was married either at the time of conception or birth, the name of the husband shall be entered on the certificate as the father of the child unless paternity has been determined otherwise by a court of competent jurisdiction, in which case the name of the father, as determined by the court, shall be entered.

(2) If the mother was not married either at the time of conception or birth, the name of the father shall not be entered on the certificate of birth without the written consent of the mother and the person to be named as the father unless a determination of paternity has been made by a court of competent jurisdiction, in which case the name of the father, as determined by the court, shall be entered.

Original rule filed July 16, 1965, effective July 26, 1965. Changed to 19 CSR 10-10.010 July 30, 1998. Amended: Filed March 12, 1999, effective Sept. 30, 1999. *Original authority: 193.035, RSMo 1984, amended 1993, 1995.

History

AUTHORITY: section 193.035, RSMo Supp. 1998. This rule was previously filed as 13 CSR 50-150.010 and 19 CSR 30-10.010.

19 CSR 10-10.020 Vital Records Issuance {#sec-19-csr-10-10.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.020}

PURPOSE: This rule authorizes local registrars to issue certifications of birth and death records of events occurring in the state of Missouri.

(1) Who May Issue. Computer-generated certifications of birth and death records may be issued by the local registrar once the record has been registered with the Bureau of Vital Records.

Permission to issue certifications grants validity and legality to the certifications when not in conflict with the laws of this state.

(2) Confidentiality. The state registrar and local registrars shall request the signature, relationship to the person named on the record, the reason for the record of each applicant for a birth or death certification, and shall require identification of the applicant or when a copy is requested by mail, a notarized statement shall be required. If the applicant is under the age of eighteen (18) years old, the signature of a parent or legal guardian shall be substituted. An exception to this rule shall be made when a governmental agency is obtaining information for protection of the public interest. The signature, title of the agent, name of agency, and employee identification shall be required.

(3) Responsibility of Applicant. The burden of proper and adequate identification of a record in the files of the Bureau of Vital Records shall rest upon the applicant for the record. In a contested case, the burden of proof that an individual is authorized under Chapter 193, RSMo, to obtain a copy of all or any part of a vital record shall rest upon the applicant for the record.

The state registrar or local registrars at all times may request additional information to support the demand of an applicant whose request for a copy appears not to be in accordance with the law.

History

AUTHORITY: section 193.035, RSMo 2016. This rule was previously filed as 13 CSR 50-150.020 and 19 CSR 30-10.020. Original rule filed March 6, 1951, effective March 16, 1951. Changed to 19 CSR 10-10.020 July 30, 1998. Amended: Filed March 12, 1999, effective Sept. 30, 1999. Amended: Filed Jan. 11, 2023, effective July 30, 2023. Original authority: 193.035, RSMo 1984, amended 1993, 1995.

19 CSR 10-10.030 Filing a Delayed Birth Certificate {#sec-19-csr-10-10.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.030}

PURPOSE: This rule establishes procedures for registering a birth certificate for an individual when a birth certificate is not registered within the prescribed time period and establishes the delayed birth certificate form to be registered with the Department of Health and Senior Services for each birth occurring in this state.

PUBLISHER’S NOTE: The secretary of state has determined that publication of the entire text of the material that is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here.

(1) No delayed certificate of live birth shall be registered for a deceased individual.

(2) All delayed certificates of live birth shall be processed and registered only at the State Bureau of Vital Records.

(3) For an individual born in Missouri for whom no prior birth certificate is on file with the Bureau of Vital Records that can be reasonably presumed to belong to the individual, the following procedures shall be used to apply for a delayed certificate of live birth:

(A) Before an individual’s twelfth birthday, the registration of live birth shall be on a certificate of live birth form as described in 19 CSR 10-10.040. The basic procedure shall be as nearly as practicable the same as for registering a current certificate of live birth. Out of hospital or institution births may require proof of pregnancy and proof of presence in Missouri prior to registration; or (B) After an individual’s twelfth’s birthday, the registrant or registrant’s parent(s) shall complete the Application/Certificate to Record Birth After Twelfth Birthday in accordance with the instructions contained in the application. The Application/ Certificate to Record Birth After Twelfth Birthday as published on March 2024 by Missouri Department of Health and Senior Services is incorporated by reference in this rule and may be obtained at Missouri Department of Health and Senior Services, Bureau of Vital Records, 930 Wildwood Drive, Jefferson City, MO 65109 or www.health.mo.gov. This rule does not incorporate any subsequent amendments or additions.

(4) If a delayed certificate of live birth is rejected under the provisions of section 193.105, RSMo, registrant may file a petition, as prescribed in section 193.115, RSMo, with a court of competent jurisdiction for an order establishing a record of the full name, date and place of birth, and the parentage of the individual whose birth is to be registered. Registrant(s) shall complete form CV310 Petition for Establishing Record of Birth After 12th Birthday as published on July 2024 by the State Judicial Review Committee, which is incorporated by reference in this rule and may be obtained at www.courts.mo.gov. This

rule does not incorporate any subsequent amendments or additions.

(5) A court order shall be required to amend a delayed certificate of birth once the certificate of live birth has been established.

Changed to 19 CSR 10-10.030 July 30, 1998. Amended: Filed March 12, 1999, effective Sept. 30, 1999. Amended: Filed Oct. 4, 2024, effective April 30, 2025. *Original authority: 193.035, RSMo 1984, amended 1993, 1995; 193.105, RSMo 1984; and 193.115, RSMo 1984, amended 2005.

History

AUTHORITY: sections 193.035, 193.105, and 193.115, RSMo 2016. This rule was previously filed as 13 CSR 50-150.030 and 19 CSR 30-10.020. Original rule filed Sept. 6, 1955, effective Sept. 16, 1955.

19 CSR 10-10.040 Filing a Certificate of Live Birth {#sec-19-csr-10-10.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.040}

PURPOSE: This rule prescribes a time for the recording of births and clarifies the procedure, including births not attended by a licensed physician or midwife.

(1) Any physician, midwife or other legally authorized person in attendance at a birth must file a birth certificate within seven (7) days after the date of birth.

(2) If the birth was not attended, one (1) of the parents must file a birth certificate within seven (7) days after the date of birth.

(3) The birth certificate shall include the following items: registration district number; registrar’s number; child’s name, date of birth, time of birth, sex; city, town or location of birth; county of birth; place of birth; if residence (home) birth, was it planned that way; facility name; certifier signature, date signed, certifier’s name and title; attendant’s name and title, attendant’s Missouri license number, attendant’s mailing address; registrar’s signature, date signed by registrar; mother’s name, maiden surname, date of birth, birthplace, residence— state, county, city, town or location, street and number; inside city limits—yes or no; years living at present address; mother’s mailing address; father’s name, date of birth; birthplace; signature of parent or other informant, relation to child; permission given to provide Social Security Administrative (SSA) with the necessary birth information to issue Social Security number—yes or no; mother of Hispanic origin—no or yes—specify; father of Hispanic origin—no or yes—specify; race of mother; race of father; education—mother; education— father; mother participated during pregnancy (check all that apply); live births now living; live births now dead; date of last live birth; other terminations; date of last termination; mother married to father—yes or no; date last normal menses began; month pregnancy prenatal care began; number of prenatal visits; birth weight; crown heel length; clinical estimate of gestation; plurality; if not single birth—specify; other risk factors for this pregnancy—tobacco use during pregnancy, alcohol use during pregnancy; mother’s height; mother’s weight before pregnancy; weight gained during pregnancy; apgar score; mother transferred from another facility or physician’s office prior to delivery—yes or no; infant transferred—yes or no; mother’s blood tested for syphilis; prophylactic drug used in baby’s eyes; medical risk factors for this pregnancy; obstetric procedures; complications of labor, delivery, or both; method of delivery; abnormal conditions of the newborn; and congenital anomalies of child.

(4) A live birth certificate shall be filed for any child showing any evidence of life such as breathing, action of heart or movement of voluntary muscles, after the child is entirely outside of the mother, even if the cord is uncut and the placenta is still attached.

History

AUTHORITY: section 193.085, RSMo 1986. This rule was previously filed as 13 CSR 50-150.040 and 19 CSR 30-10.040. Original rule filed March 13, 1958, effective March 23, 1958. Amended: Filed Nov. 4, 1977, effective Feb. 11, 1978. Rescinded and readopted: Filed Sept. 12, 1988, effective Jan. 1, 1989. Changed to 19 CSR 10-10.040 July 30, 1998. Original authority: 193.085, RSMo 1984, amended 1997.

19 CSR 10-10.050 Death Certificate Form {#sec-19-csr-10-10.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.050}

PURPOSE: This rule establishes the content of the death certificate for each death in this state to be filed with the Department of Health.

(1) The death certificate shall include the following items: registration district number; registrar’s number; decedent’s name, sex, date of death, Social Security number, age (under 1 year—months and days—under 1 day—hours, minutes), date of birth, birthplace, was decedent ever in United States armed forces—yes, no or unknown; place of death—hospital (specify inpatient, emergency room (ER)/outpatient or dead on arrival (DOA)) or other (specify nursing home, residence or other); facility name; city, town or location of death; county of death; marital status; surviving spouse’s name; decedent’s usual occupation; kind of business or industry; residence—state, county, city town or location—zip code, street and number, inside city limits, years at present address; was decedent of Hispanic origin—no or yes—specify; race; decedent’s education; father’s name, mother’s name; informant’s name, mailing address; burial, cremation or other (specify); date of disposition; place of disposition; location; signature of funeral service licensee or person acting as such; name and address of facility; funeral establishment license number; immediate cause and underlying causes of death and approximate interval between onset and death; other significant conditions contributing to death; if deceased was female 10–49, was she pregnant in the last 90 days—yes, no or unknown; was autopsy performed—yes or no; were autopsy findings available prior to completion of cause of death—yes or no; manner of death; date of injury; time of injury; injury at work—yes, no or unknown; describe how injury occurred; check whether certifying physician or medical examiner/coroner; signature and title of certifier; date signed; time of death; name and address of certifier, Missouri license number; case referred to medical examiner/coroner—yes or no; name of attending physician if other than certifier; registrar’s signature; and date received by local registrar.

History

AUTHORITY: section 193.145, RSMo 2000. This rule was previously filed as 13 CSR 50-150.050 and 19 CSR 30-10.050. Original rule filed Nov. 4, 1977, effective Feb. 11, 1978. Rescinded and readopted: Filed Sept. 12, 1988, effective Jan. 1, 1989. Changed to 19 CSR 10-10.050 July 30, 1998. Amended: Filed Oct. 2, 2002, effective March 30, 2003. Original authority: 193.145, RSMo 1984, amended 1989, 1997.

19 CSR 10-10.060 Report of Fetal Death {#sec-19-csr-10-10.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.060}

PURPOSE: This rule establishes the content of the report of fetal death to be filed with the Department of Health for each fetal death in this state.

(1) The report of fetal death shall include the following items: registration district number; registrar’s number; fetus name; city, town or location of delivery; county of delivery; date of delivery; sex of fetus; place of delivery; if residence (home) delivery, was it planned that way—yes or no; facility name; mother’s name, maiden surname, date of birth, residence (state, county, city, town or location), zip code, street and number, inside city limits—yes or no, years living at present address; father’s name, date of birth; immediate and underlying cause of death and specify if cause is fetal or maternal; other significant conditions; fetus died before labor, during labor or delivery or unknown (specify); attendant’s name and title, Missouri license number; name and title of person completing report; burial, cremation, other (specify); cemetery or crematory, location (city or town, state); date; name and address of facility; informant; registrar’s signature; date received by local registrar; mother of Hispanic origin—no or yes; father of Hispanic origin— no or yes; mother’s race; father’s race; mother’s education; father’s education; mother participated during pregnancy (check all that apply); live births—now living; live births—now dead; date of last live birth; other terminations, date of last other termination; was mother married to father—yes or no; date last normal menses began (month, day, year); month pregnancy prenatal care began (specify); prenatal visits (total number); birth weight; crown heel length; clinical estimate of gestation (weeks); plurality (specify); if not single birth—born first, second, third, etc. (specify); mother transferred from another facility or physician’s office prior to delivery—yes or no and if yes enter name of facility; medical risk factors for this pregnancy (check all that apply); other risk factors for this pregnancy (complete all items); obstetric procedures (check all that apply); complications of labor or delivery or both (check all that apply); method of delivery (check all that apply); congenital anomalies of child (check all that apply).

History

AUTHORITY: section 193.165, RSMo 1986. This rule was previously filed as 13 CSR 50-150.060 and 19 CSR 30-10.060. Original rule filed Nov. 4, 1977, effective Feb. 11, 1978. Rescinded and readopted: Filed Sept. 12, 1988, effective Jan. 1, 1989. Changed to 19 CSR 10-10.060 July 30, 1998. Original authority: 193.165, RSMo 1984.

19 CSR 10-10.070 Certificate of Dissolution of Marriage {#sec-19-csr-10-10.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.070}

PURPOSE: This rule establishes the content of the certificate of dissolution of marriage for dissolutions granted by any court in this state to be filed with the Department of Health.

(1) The certificate of dissolution of marriage shall include the following items: case number; husband’s name, residence (city, town or location), state, zip code, county, date of birth, birthplace; wife’s name, maiden surname, residence (city, town or location), state, zip code, county, date of birth, birthplace, place of marriage (city, town or location), county, state or foreign country; date of this marriage; date couple last resided in same household; number of children under eighteen (18) in this household as of the date the couple last resided in same household; petitioner (check appropriate box); name of petitioner’s attorney; address of attorney; date of dissolution (month, day, year); type of decree (check appropriate box); date recorded; number of children under eighteen (18) whose physical custody was awarded to (designate in appropriate spaces); child support was awarded to (check appropriate box); county of decree; title of court; signature of certifying official; title of certifying official; number of this marriage—husband; number of this marriage—wife; husband—if previously married, last marriage ended by (check box) and date; wife—if previously married, last marriage ended by (check box) and date; husband’s race; wife’s race; husband’s education; wife’s education.

History

AUTHORITY: section 193.205, RSMo 1986. This rule was previously filed as 19 CSR 30-10.070. Original rule filed Sept. 12, 1988, effective Jan. 1, 1989. Changed to 19 CSR 10-10.070 July 30, 1998. Original authority: 193.205, RSMo 1984, amended 1996.

19 CSR 10-10.080 Report of Marriage {#sec-19-csr-10-10.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.080}

PURPOSE: This rule establishes the content of the report of marriage for each marriage performed in this state to be filed with the Department of Health.

(1) The report of marriage shall include the following items: license number; groom’s name, age last birthday, date of birth, birthplace, residence (city, town or location), state, zip code, county, number of this marriage if previously married, last marriage ended by (check appropriate box), date ended, race, education; bride’s name, maiden surname, age last birthday, date of birth, birthplace, residence (city, town or location), state, zip code, county, number of this marriage if previously married, last marriage ended by (check appropriate box) and date ended, race, education; groom’s signature; bride’s signature; month, day, year and time subscribed to and sworn to; county of recording; date and time license issued; name of recorder of deeds; signature and title of official; date ceremony performed; where married—city, town or location; where married—county; name of parent or legal guardian of groom (if minor), relationship to applicant, address of parent or legal guardian of groom, state, zip code, signature of parent or legal guardian; name of parent or legal guardian of bride (if minor), relationship to applicant, address of parent or legal guardian of bride, state, zip code, signature of parent or legal guardian; month, day and year subscribed to and sworn to; signature and title of official.

History

AUTHORITY: section 193.185, RSMo 1986. This rule was previously filed as 19 CSR 30-10.070. Original rule filed Sept. 12, 1988, effective Jan. 1, 1989. Changed to 19 CSR 10-10.080 July 30, 1998. Original authority: 193.185, RSMo 1984.

19 CSR 10-10.090 Access to Vital Records {#sec-19-csr-10-10.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.090}

PURPOSE: This rule protects the integrity of vital records and the personal privacy of the registrants and determines who is entitled to receive copies or information from vital records.

(1) The state registrar of vital records or the custodian of permanent local vital records shall not permit anyone to disclose information contained in vital records, or to copy or issue a copy of all or part of any vital records except as authorized in this rule.

(A) As authorized by section 193.255.1, RSMo 1986, the registrant, a member of his/her immediate family, his/her guardian or one (1) of their respective official representatives shall be considered to have a direct and tangible interest and may be issued a certified copy of a vital record. Others may demonstrate a direct and tangible interest when information is needed for determination or protection of personal or property rights.

Applicants requesting records shall furnish adequate identifying information contained on the record to insure the correct record is being released.
The term immediate family shall include those family members and in-laws in the direct line of descent up to, but not including, cousins. Immediate family members are eligible to receive copies of birth certificates.
All family members, genealogists representing a family member and professionally recognized genealogists are eligible to receive copies of death certificates.
The term official representative shall include an attorney, physician, funeral director or other authorized agent acting in behalf of the registrant or his/her family. An other authorized agent shall produce a signed statement by the registrant or a member of his/her family authorizing the release of a record.

A funeral director may act as the official representative of a family to obtain copies of death certificates only.

A guardian may receive a copy of the birth certificate of a child who is under his/her care and custody by showing guardianship papers.
Foster parents may receive a copy of a birth certificate of a child who is under their care and custody upon furnishing a copy of their custody papers.
A stepparent may receive a copy of a certificate of a legitimate birth by stating relationship.
An alleged father of a child may not receive a copy of that child’s birth records unless he is shown as the father on that record.
Whenever it shall be deemed necessary to establish an applicant’s right to information from a vital record, the state registrar or local custodian also may require identification of the applicant or a notarized sworn statement.

(B) As authorized by section 193.245(3), RSMo (1986), the state registrar of vital records may authorize the disclosure of information contained in vital records for legitimate research purposes.

The term legitimate means conforming to or in accordance with generally accepted standards or principles governing research.
The term research means a systematic study designed to develop or contribute to generalizable knowledge. The term generalizable means to emphasize the general character rather than specific details of, to formulate general principles or inferences from particulars.
No data shall be furnished from records for research purposes until the state registrar of vital records has received and approved a formal request for the research project. The request shall be approved only if adequate assurances are provided to assure that the research is legitimate and to protect the confidentiality of the records requested. These assurances include, but are not limited to:

A. Security measures shall limit access to the records to members of the research staff;

B. Any release of records to other agencies shall be only with prior approval from the state registrar;

C. Individuals shall not be identified in published data;

D. Upon completion of a study, the records shall be destroyed or adequate security provided to prevent access or disclosure; and E. A registrant or his/her family members or acquaintances shall not be contacted without written permission from the state registrar.

(C) To comply with sections 192.067 and 610.021(14), RSMo Cum. Supp. 1989, nothing in this rule shall be construed to permit disclosure of information contained in the confidential Information for Medical and Health Use Only section of a vital record unless specifically authorized by the state registrar of vital records or by a court of competent jurisdiction.

(D) As authorized by section 193.255.4, RSMo 1986, the state registrar or the local custodian may furnish—when deemed in the public interest and not for purposes of commercial solicitation or private gain—copies of records or data from records to public agencies administering health, welfare, safety, law enforcement, education or public assistance programs, and to private agencies approved by the state registrar. Subject to the limitations of this rule, confidential verification of the facts contained in a vital record may be furnished by the state registrar of vital records or the custodian of permanent local vital records to any federal, state, county or municipal government agency. These confidential verifications shall be on forms prescribed and furnished by the state or local registrar of vital records or on forms furnished by the requesting agency and acceptable to the state or local registrar; or the state registrar or the custodian of permanent local vital records may authorize the verification in other ways when it shall prove in the best interests of the office of the state or local registrar.

(E) Representatives of heir-tracing companies establishing personal or property rights and reporters for newspapers, radio, television or other news media when investigating news stories are allowed access to vital records subject to restrictions outlined in section 193.245, RSMo 1986. These representatives and reporters shall provide proper identification and state in writing the proposed use of the requested record.

To protect the integrity of the birth records and to enforce the provisions of sections 193.125 and 193.245(1), RSMo 1986, nothing in this rule shall be construed as authorization to permit reporters physical inspection of the original or permanent birth certificates or the birth indexes of the state or local registrar. Access shall be limited to searches conducted and copies made by the vital records staff. A fee as authorized by law shall be levied.
To protect the integrity of the death records, physical inspection of the original or permanent death certificates are prohibited. Access to death indexes shall be permitted under supervised conditions during normal working hours on regular work days. Authorization for physical access and inspection of death record indexes shall be approved by the vital records office in advance to insure availability of proper supervision and minimization of office disruption. The state or local registrar shall determine work area location and quantity of indexes made available at any one (1) time. Searches of death indexes conducted by reporters and representatives of heirtracing companies do not require a fee. Copies of death records shall be made by vital records staff upon request of reporters or heir-tracing representatives. Copy fees as required by law will be levied. Cause of death information shall be released to the news media or heir-tracing companies only if the information is needed for their research and not for personal information.

(F) A listing of persons who are born or who die on a particular date may be disclosed upon request, but no information from the record other than the name and the date of the birth or death shall be disclosed. A fee may be charged to recapture the expense of generating these listings.

(G) When the state registrar of vital records or the custodian of permanent local vital records finds evidence that a certificate was registered or application or request was made through misrepresentation or fraud, s/he shall have authority to withhold the issuance of a copy of the certificate until a court determination of the facts has been made.

(H) Nothing in this rule shall be construed as authorization to permit access to or inspection of the vital records or indexes in the vital records offices by any person other than the state or local custodian or his/her employees unless otherwise authorized in this rule.

1988, effective Jan. 27, 1989. Amended: Filed June 14, 1989, effective Sept. 11, 1989. Amended: Filed June 4, 1990, effective Dec. 31, 1990. Changed to 19 CSR 10-10.090 July 30, 1998. *Original authority: 192.067, RSMo 1988; 193.145, RSMo 1984, amended 1989; 193.255, RSMo 1984; 193.155, RSMo 1984 and 610.021, RSMo 1987.

History

AUTHORITY: sections 192.067, 193.145, 193.255.1, 193.255.4 and 610.021(5), RSMo Supp. 1989 and 193.155, RSMo 1986. This rule was previously filed as 19 CSR 30-10.090. Original rule filed Nov.

19 CSR 10-10.100 Authorization for Cremation {#sec-19-csr-10-10.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.100}

PURPOSE: This rule establishes procedures required prior to cremation of a dead human body.

(1) If the cause of death can be established within seventy-two (72) hours after death, a completed death certificate certifying the cause of death as determined by the medical examiner/ coroner or physician shall be delivered or mailed to the local registrar of the county where the death occurred before a body is cremated.

(2) If a completed death certificate cannot be filed because the cause of death has not been determined, the medical examiner/coroner or physician certifying the cause of death shall give the funeral director notice of the reason for the delay.

A body shall not be cremated until written authorization by the medical examiner/coroner or physician is received by the funeral director. This authorization shall be a signed statement which identifies the deceased and authorizes final disposition by cremation.

(3) Management of a crematory shall require from an authorized funeral home representative presenting a body for cremation a signed statement which identifies the deceased and which states that— (A) A completed death certificate has been filed with the local registrar where the death occurred; or (B) The funeral director has received a written authorization to cremate the body from the medical examiner/coroner or physician who will be certifying the cause of death.

History

AUTHORITY: sections 193.145 and 193.175, RSMo 1986. This rule was previously filed as 19 CSR 30-10.100. Original rule filed July 15, 1991, effective Jan. 13, 1992. Changed to 19 CSR 10-10.100 July 30, 1998. Original authority: 193.145, RSMo 1984, amended 1989 and 193.175, RSMo 1984.

19 CSR 10-10.110 Amending or Correcting Vital Records {#sec-19-csr-10-10.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.110}

PURPOSE: This rule identifies when an affidavit is appropriate to amend or correct a vital record and when a court order is required.

(1) A request for correction(s) of a certificate shall be made to the Bureau of Vital Records. The request shall identify the certificate to be corrected by stating whether it is a birth, death, or fetal death record; the name and sex of the registered person; the date of the event; which items are omitted or in error; and the correct information for the items. The Bureau of Vital Records shall make available a correction affidavit to the applicant with instructions regarding who should sign and what documentary proof is required to support the correction requested. The correction affidavit process shall only be utilized to restore an item to its intended original value.

(A) To correct an item(s) on a certificate, documentary evidence necessary to preserve the integrity of the certificate shall be required. Depending on the number of items to be corrected, more than one (1) document may be required.

Corrections, other than those that are court ordered, require a notarized affidavit or electronic submission in the Missouri Electronic Vital Records System by an approved professionally licensed or certified data provider or a person in charge of a licensed institution or such person’s designated representative.

Documentary evidence which supports the alleged facts shall be a filed document which shows, as a minimum, the correct full name and correct age or date of birth and, when possible, shall have been filed at least five (5) years prior to the date of application for the amendment. A filed document is defined as a record which is permanently maintained by an agency, organization, or business and is accessible for verification at a later date.

(B) The burden of submitting proof is on the applicant.

The state registrar shall determine whether the document submitted satisfactorily supports the correction requested.

When the applicant cannot submit proper documentation, the applicant shall be notified of the deficiencies and given appeal rights to a court of competent jurisdiction.

(2) Major deficiencies on individual vital records shall be corrected or amended by court order. The Bureau of Vital Records shall be furnished with a certified copy of an order from a court of competent jurisdiction indicating the desired change(s). The order shall identify the record(s) as presently filed and indicate the items to be corrected or amended.

(A) Major deficiencies specifically requiring a court order are those that— 1. Change year of birth on a birth record;

Change any birth, death, or fetal death record created or previously amended or corrected by court order, adoption, or legitimation;
Change an item previously amended or corrected by affidavit, except when the cause or manner of death on a death record is being corrected from pending investigation;
Change on a birth record the registrant’s first name, middle name, last name, or suffix when different from the mother’s birth certificate worksheet used to originally register the birth certificate (not including if first and middle names not yet chosen);
Completely change the mother’s name on a birth record.

The mother’s first, middle, and maiden name can be corrected by a notarized affidavit from the hospital’s medical records department if the hospital prepared the original record in error.

If the error was not made by the hospital, then one (1) of the recorded parents or the registrant, if of legal age, shall furnish a notarized affidavit requesting correction and a certified copy of the mother’s birth record or a certified copy of the parent’s marriage certificate from the recorder of deeds’ office or a certified statement of marriage;

Completely change, on the birth record, the name of the natural parent or add the name of a parent when deceased;
Change, on the birth record, the surname of the registrant, last name of the mother, or the last name of the father by changing three (3) or more letters, or by changing one (1) or two (2) letters which results in a different pronunciation of the last name;
Change, on the death record, the last name of the deceased by changing three (3) or more letters or by changing one (1) or two (2) letters which results in a different pronunciation of the last name;
Change both the sex and registrant’s name when the name appears to be that typically used for the opposite sex;
Change a written signature (new signature will be typed); or 11. Delete father’s name on a birth record. To delete the father’s name from a birth certificate, the court order shall find that he is not the natural father and then direct the Bureau of Vital Records to delete his name from the birth record. If the court also finds the natural father and the mother have been legally married, the birth certificate can be legitimated by the same court order. The order shall give the date and place of marriage. The order also shall give the natural father’s full name, date of birth, state of birth, race, Social Security number, and the natural mother’s date of birth and Social Security number to establish a new birth certificate by legitimation. If the child’s name is to be changed, the order also shall indicate the name change.

(3) The original certificate/office working copy of the birth, death, or fetal death shall have the amendment or correction entered on its face by interlineation with a line drawn through the incorrect entry or, if possible, by electronic deletion of the incorrect entry and replacement with the updated item. The item name and/or number and date amended or corrected and a summary description of the method and, if applicable, evidence submitted in support of the change shall be endorsed on or made part of the record.

(4) Depending on the item(s) to be amended or corrected, those qualified to make application to change a record are the informant, midwife, physician, coroner, medical examiner, and personnel from institutions, clinics, and funeral homes who were responsible for filing the certificate.

(A) To correct a death certificate by affidavit, application may be made by the informant or the funeral director or a person acting for the funeral director, upon written authorization, on the following items: decedent’s first name, decedent’s middle name, decedent’s sex, decedent’s date of death (affidavit of funeral home representative or certifier only), decedent’s Social Security number, decedent’s age, decedent’s month of birth, decedent’s day of birth, was decedent ever in United States armed forces?, place of death, marital status, surviving spouse’s name (see paragraph (2)(A)8. of this rule), decedent’s usual occupation and kind of business or industry, decedent’s residence, decedent’s origin and race, decedent’s education, father’s first name, father’s middle name, mother’s first name, mother’s middle name. Informant’s name, informant’s mailing address, disposition information, name and address of funeral home, and funeral establishment license number can be corrected only by affidavit of funeral home representative.

The medical information can be corrected only by the medical certifier, coroner, or medical examiner who certified the cause of death.

An affidavit and supporting documentation is required to correct the spelling of a last name(s) except as provided in paragraph (2)(A)8. of this rule. Age, date of birth, and last names of mother, father, and surviving spouse require an affidavit and one (1) document other than an insurance policy which gives the correct information.
To correct all other items on a death certificate through the correction process, documentary evidence considered necessary to preserve the integrity of the certificate shall be required.

(B) To correct a fetal death certificate, application may be made by informant, coroner, medical examiner, or personnel from the hospital, clinic, or funeral home who prepared the 1. Except for medical information, the correction process is the same as for a birth or death certificate.

The medical information can be corrected only by the medical certifier, coroner, medical examiner, or personnel of the institution responsible for filing the certificate. Cause of death information can be corrected only by the medical certifier, coroner, or medical examiner.
To correct all other items on a fetal death certificate, documentary evidence considered necessary to preserve the integrity of the certificate shall be required.

(C) To correct a birth certificate, application may be made by one (1) of the parents, the legal guardian, the registrant, if of legal age, or the individual or individual representing the institution responsible for the filing of the certificate. An affidavit and any required supporting document shall be filed according to the requirements of the following chart:

Items Corrected or Inserted Affidavit of Registrant or Parent if <18 yrs.

Affidavit of Hospital or Attendant Supporting Documentation Other If an item on this chart is marked with an “X,” an affidavit and/or document is required as indicated.

When both affidavit columns are marked with an “X,” an affidavit will be accepted by either 1) registrant or parent if <18 yrs. or 2) hospital or attendant (only one affidavit is required).

CHILD’S NAME

First, Middle X X X See paragraph (2)(A)4.

Last X X X See paragraphs (2)(A)4. and (2)(A)7. of this rule.

Suffix X X X See paragraph (2)(A)4.

No Name X X X Document must show mother’s name prior to first marriage (maiden) or father’s name on record.

CHILD’S DATE OF BIRTH

Day, Month X X X Year X See paragraph (2)(A)1. of this rule.

CHILD’S TIME OF BIRTH

X X CHILD’S SEX

X X X See paragraph (2)(A)9. court ordered. Court order if 1)sex changed by surgical procedure or 2) see paragraph (2)(A)9. of this

rule.

MOTHER’S NAME

First, Middle X X X See paragraph (2)(A)5.

Last (Legal) X X X See paragraph (2)(A)7.

Prior to First Marriage (Maiden)

X X X See paragraph (2)(A)5.

MOTHER’S AGE/

DATE OF BIRTH

MOTHER’S RACE

MOTHER’S STATE OF

BIRTH

Items Corrected or Inserted Affidavit of Registrant or Parent if <18 yrs.

Affidavit of Hospital or Attendant Supporting Documentation Other FATHER’S NAME First, Middle X X X Last X X X See paragraphs (2)(A)6. and (2)(A)7. of this rule.

FATHER’S AGE/

DATE OF BIRTH

FATHER’S RACE

FATHER’S STATE OF

BIRTH

NOTE: 1.The medical information can be changed only by the medical certifier or personnel of the institution responsible for filing the certificate. 2.To correct other items on a birth certificate, documentary evidence shall be required as is considered necessary to preserve the integrity of the certificate. 3.Original documents for amending or correcting certificates are not required unless otherwise specified; copies of most documents are acceptable as supplemental proof.

History

AUTHORITY: sections 193.035 and 193.215, RSMo 2016. This rule was previously filed as 19 CSR 30-10.110. Original rule filed Jan. 24, 1992, effective June 25, 1992. Changed to 19 CSR 10-10.110, July 30, 1998. Amended: Filed March 15, 2023, effective Sept. 30, 2023. Original authority: 193.035, RSMo 1984, amended 1993, 1995, and 193.215, RSMo 1984, amended 1994, 1997, 1998, 2014.

19 CSR 10-10.120 New Certificate Through Legitimation {#sec-19-csr-10-10.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.120}

PURPOSE: This rule defines the documentation required to legitimate a birth record.

(1) If the mother marries the natural father after the birth of their child, a new birth certificate can be created by the mother furnishing certified copies of her marriage license or marriage certification to the natural father. If the mother previously was married, certified copies of other marriage licenses or marriage certification also shall be furnished. Notarized affidavits shall be signed by the mother and father.

(A) If the father is deceased, a notarized affidavit is required from one (1) of the alleged father’s parents or his brother or sister stating that s/he believes him to be the father of the child based on an oral or written statement of the man. A certified copy of the father’s death certificate also is required.

(B) If the mother is deceased, an affidavit is required from one (1) of the mother’s parents or her brother or sister stating that s/he believes the man to be the father of the child based on an oral or written statement of the man. A certified copy of the mother’s death certificate also is required.

(2) A court-ordered legitimation shall be obtained when the requirements of section (1) of this rule cannot be met. The court shall find that the natural parents are or were legally married and state the date and place of marriage. The order also shall give the natural father’s full name, date of birth, state of birth, race and Social Security number, and the natural mother’s date of birth and Social Security number in order to establish a new birth certificate by legitimation. If the child’s surname is to be changed to the father’s surname, the order also shall indicate this change.

History

AUTHORITY: section 193.135, RSMo 1986. This rule was previously filed as 19 CSR 30-10.120. Original rule filed Jan. 24, 1992, effective June 25, 1992. Changed to 19 CSR 10-10.120 July 30, 1998. Original authority: 193.135, RSMo 1984.

19 CSR 10-10.130 Missouri Adoptee Rights {#sec-19-csr-10-10.130 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.130}

PURPOSE: This rule provides the process for an adoptee, an adoptee’s attorney, and the birth parents of an adoptee to receive a copy of the adoptee’s original birth certificate, the process for a birth parent and the adoptee to state his or her contact preference regarding whether and how the adoptee/birth parent can contact him or her, the process for completion of a medical history form by a birth parent, and the process for lineal descendants of a deceased adoptee to receive a copy of the adoptee’s original birth PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this

(1) For purposes of this rule only, unless the context clearly indicates otherwise, the following terms mean:

(A) “Adoptee,” an adopted person who was born in Missouri and is at least eighteen (18) years of age;

(B) “Adoptee Contact Preference Form,” a form used by an adoptee to indicate his or her preference about contact with the birth parent(s);

(C) “Applicant,” the person completing application for a form or certificate as specified in this rule and may be the adoptee, adoptee’s attorney, birth parent, or lineal descendant of a deceased adoptee;

(D) “Attorney,” a currently-licensed member of the Missouri Bar or bar of another state of the United States;

(E) “Birth parent,” the parent(s) identified on the adoptee’s original birth certificate;

(F) “Birth Parent Contact Preference Form,” a form used by a birth parent to indicate his or her preference about contact with the adoptee;

(G) “Birth Parent Medical History Form,” a form used by a birth parent to provide his or her medical history information to the adoptee;

(H) “Department,” the Missouri Department of Health and Senior Services;

(I) “Identifying information,” the name, date of birth, place of birth, and last known address of the biological parent;

(J) “Intermediary,” the person or agency identified by the birth parent or adoptee to act as a means of contact between the birth parent and adoptee;

(K) “Lineal descendant,” a person who is in direct line to an ancestor, such as child, grandchild, great-grandchild, and so on, either by blood or legal adoption. This does not include a step-child or collateral descendant. Collateral descendants are those from the line of a brother, sister, aunt, or uncle;

(L) “Original birth certificate,” the adoptee’s registered birth certificate sealed upon court order at the time of adoption;

(M) “Redact,” to obscure or remove identifying information.

(2) Birth Parent Contact Preference Form. A birth parent may state his or her preference for contact with the adoptee by completing a Cover Sheet for Birth Parent Contact Preference Form and a Birth Parent Contact Preference Form as published August 2018 which are incorporated by reference in this rule and may be obtained at www.health.mo.gov or by calling (573) 751-6387. This rule does not incorporate any subsequent amendments or additions. Completed forms may be delivered in person to the department at 930 Wildwood Drive, Jefferson City, Missouri, or by mail to the Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102.

(A) A birth parent shall provide to the department adequate information as requested on the Cover Sheet for Birth Parent Contact Preference Form so that the department can identify the correct sealed file in which to place the form. A birth parent shall also pay a non-refundable fee for processing the form and searching for the original birth record in an amount equal to the fee for a certified copy of a birth certificate. If the upon the information provided by the birth parent on the Cover Sheet for Birth Parent Contact Preference Form, the department shall return the Cover Sheet for Birth Parent Contact Preference Form and the Birth Parent Contact Preference Form to the birth (B) A birth parent may change his or her contact preference by completing a new Cover Sheet for Birth Parent Contact Preference Form and Birth Parent Contact Preference Form. A birth parent shall also pay a non-refundable fee for processing the form and searching for the original birth record in an amount equal to the fee for a certified copy of a birth certificate. The forms and fee shall be mailed or delivered to the department at the address listed in section (2) above. If the upon the information provided by the birth parent on the Cover Sheet for Birth Parent Contact Preference Form, the department shall return the Cover Sheet for Birth Parent Contact Preference Form and the Birth Parent Contact Preference Form to the birth (C) A birth parent may request that an adoptee contact him or her only through an intermediary, rather than be contacted directly by the adoptee, as indicated by the birth parent on the Birth Parent Contact Preference Form. In this case, the birth parent shall write the name and contact information of the intermediary on the Birth Parent Contact Preference Form.

(D) If a birth parent has filed a Birth Parent Contact Preference Form with the department, the department shall provide a copy of the form to the adoptee, adoptee’s attorney, or lineal descendant applicant.

(E) If a birth parent has filed more than one (1) Birth Parent Contact Preference Form, the department shall issue a copy of only the most recently dated Birth Parent Contact Preference Form to the adoptee, adoptee’s attorney, or lineal descendant (F) The Birth Parent Contact Preference Form issued to the adoptee, adoptee’s attorney, or lineal descendant shall not include the Cover Sheet for Birth Parent Contact Preference (G) The department shall not issue a copy of the original birth certificate to the adoptee, adoptee’s attorney, birth parent, or lineal descendant applicant when— 1. The applicant does not meet the requirements of section 193.128, RSMo, and this rule; or 2. Both birth parents have filed a Birth Parent Contact Preference Form indicating that they prefer not to be contacted or prefer contact through an intermediary.

(H) The department shall issue a non-certified, unredacted copy of the original birth certificate stamped “For genealogical purposes only-not to be used for establishing identity” upon request to a qualified adoptee, adoptee’s attorney, birth parent, or lineal descendant applicant when— 1. The original birth certificate lists two (2) parents and neither birth parent has filed a Birth Parent Contact Preference Form;

The original birth certificate lists two (2) parents and both have filed a Birth Parent Contact Preference Form indicating he/she prefers to be contacted;
The original birth certificate lists two (2) parents and indicating that he/she prefers to be contacted and the other parent has not filed a Birth Parent Contact Preference Form;
The original birth certificate only lists one (1) parent and that parent has filed a Birth Parent Contact Preference Form indicating that he/she prefers to be contacted; or 5. The original birth certificate only lists one (1) parent and that parent has not filed a Birth Parent Contact Preference (I) The department shall issue a non-certified copy of the original birth certificate stamped “For genealogical purposes only-not to be used for establishing identity” to the adoptee, adoptee’s attorney, birth parent, or lineal descendant applicant with the identifying information redacted for the birth parent who indicated they prefer not to be contacted or preferred to be contacted by an intermediary when— 1. The original birth certificate only lists one (1) parent and that parent has filed a Birth Parent Contact Preference Form contact by an intermediary;
The original birth certificate lists two (2) parents and contact through an intermediary and the other parent has not filed a Birth Parent Contact Preference Form; or 3. The original birth certificate lists two (2) parents and contact through an intermediary and the other parent has filed a Birth Parent Contact Preference Form indicating that he/she prefers to be contacted.

(3) Birth Parent Medical History Form. A birth parent may provide or update his or her medical history by completing a Cover Sheet for Birth Parent Medical History Form and a Birth Parent Medical History Form as published August 2018 which are incorporated by reference in this rule and may be obtained at www.health.mo.gov or by calling (573) 751-6387.

This rule does not incorporate any subsequent amendments or additions. Completed forms may be delivered in person to the (A) A birth parent shall furnish to the department adequate information as requested on the Cover Sheet for Birth Parent Medical History Form so that the department can identify the correct sealed file in which to place the Birth Parent Medical

History Form. If the department is unable to identify the correct sealed file based upon the information provided on the Cover Sheet for Birth Parent Medical History Form, the department shall return the Cover Sheet for Birth Parent Medical History Form and the Birth Parent Medical History Form to the birth (B) A birth parent may change or update the Birth Parent Medical History Form by completing a new Cover Sheet for Birth Parent Medical History Form and Birth Parent Medical

History Form and delivering or mailing the forms to the department at the address listed in section (3) above.

(C) A birth parent shall provide information regarding only him or herself, and his or her blood relatives, such as mother, father, sisters, brothers, grandparents, and other biological children on the Birth Parent Medical History Form.

(D) If a birth parent has filed more than one (1) Birth Parent Medical History Form, the department shall release to the applicant a copy of only the most recently dated form.

(E) The department shall not use the information on the Cover Sheet for Birth Parent Medical History Form or Birth Parent Medical History Form for statistical or any other purposes and shall not disclose the information to anyone other than the adoptee, adoptee’s attorney, or lineal descendant applicant.

(F) The copy of the Birth Parent Medical History Form issued to the adoptee, adoptee’s attorney, or lineal descendant shall not include the Cover Sheet for Birth Parent Medical History (4) Adoptee Contact Preference Form. An adoptee may state his or her preference for contact with the birth parent(s) by completing a Cover Sheet for Adoptee Contact Preference Form and an Adoptee Contact Preference Form as published August 2018 which are incorporated by reference in this rule and may be obtained at www.health.mo.gov or by calling (573) 751-6387.

This rule does not incorporate any subsequent amendments or additions. Completed forms may be delivered in person to the (A) An adoptee shall provide to the department adequate information as requested on the Cover Sheet for Adoptee Contact Preference Form so that the department can identify the correct sealed file in which to place the form. An adoptee shall also pay a non-refundable fee for processing the form and searching for the original birth record in an amount equal to the fee for a certified copy of a birth certificate. If the upon the information provided by the adoptee on the Cover Sheet for Adoptee Contact Preference Form, the department shall return the Cover Sheet for Adoptee Contact Preference Form and the Adoptee Contact Preference Form to the adoptee.

(B) An adoptee may change his or her contact preference by completing a new Cover Sheet for Adoptee Contact Preference Form and Adoptee Contact Preference Form. An adoptee shall also pay a non-refundable fee for processing the form and searching for the original birth record in an amount equal to the fee for a certified copy of a birth certificate. The forms and fee shall be mailed or delivered to the department at the address listed in section (4) above. If the department is unable to identify the correct sealed file based upon the information provided by the adoptee on the Cover Sheet for Adoptee Contact Preference Form, the department shall return the Cover Sheet for Adoptee Contact Preference Form and the Adoptee Contact Preference Form to the adoptee.

(C) An adoptee may request that a birth parent contact him or her only through an intermediary, rather than be contacted directly by the birth parent, as indicated by the adoptee on the Adoptee Contact Preference Form. In this case, the adoptee shall write the name and contact information of the intermediary on the Adoptee Contact Preference Form.

(D) If an adoptee has filed an Adoptee Contact Preference Form with the department, the department shall provide a copy of the form to the birth parent and lineal descendant (E) If an adoptee has filed more than one (1) Adoptee Contact Preference Form, the department shall issue a copy of only the most recently dated Adoptee Contact Preference Form to the birth parent or lineal descendant applicant.

(F) The Adoptee Contact Preference Form issued to the birth parent and lineal descendant applicant shall not include the Cover Sheet for Adoptee Contact Preference Form.

(5) Adoptee, Adoptee’s Attorney, and Birth Parent Request for Original Birth Certificate. An adoptee, adoptee’s attorney, or birth parent may request a copy of the adoptee’s original birth certificate by completing an Application for Non-Certified Copy of an Original Birth Certificate by Adoptee, Adoptee’s Attorney, or Birth Parent form which is incorporated by reference in this

rule as published August 2018 and may be obtained at www. health.mo.gov or by calling (573) 751-6387. This rule does not incorporate any subsequent amendments or additions. The application shall include a non-refundable fee in an amount equal to the fee for a certified copy of a birth certificate.

Completed forms and fees may be delivered in person to the (A) If the adoptee’s attorney submits the Application for Non-Certified Copy of an Original Birth Certificate by Adoptee, Adoptee’s Attorney, or Birth Parent form, the attorney shall provide the department with a statement signed by the adoptee or other documentation establishing the attorney’s

(B) The applicant shall furnish to the department adequate information as requested on the Application for Non-Certified Copy of an Original Birth Certificate Adoptee, Adoptee’s Attorney, or Birth Parent form so that the department can identify the correct sealed file containing the original birth (C) The department shall issue copies of the original birth certificate to the adoptee, adoptee’s attorney, or birth parent(s) as provided in subsections (2)(G)-(I) of this rule. If the department cannot locate the original birth certificate, the department shall issue to the applicant a written statement that no record was found.

(D) The copy of the original birth certificate issued to the adoptee, adoptee’s attorney, or birth parent applicant shall be stamped “For genealogical purposes only—not to be used for establishing identity.”

(E) If the adoptee’s birth parent(s) have provided a Birth Parent Contact Preference Form or Birth Parent Medical History Form to the department, the department shall provide a copy to the adoptee, adoptee’s attorney, or lineal descendant (6) Lineal Descendant Request for Original Birth Certificate.

Lineal descendants of a deceased adoptee may request a copy of the adoptee’s original birth certificate by completing an Application for Non-Certified Copy of an Original Birth Certificate by Lineal Descendant form which is incorporated by reference in this rule as published August 2018 and may be obtained at www.health.mo.gov or by calling (573) 751-6387.

This rule does not incorporate any subsequent amendments or additions. The application shall include a non-refundable fee in an amount equal to the fee for a certified copy of a birth certificate. Completed forms and fees may be delivered in person to the department at 930 Wildwood Drive, Jefferson City, Missouri, or by mail to the Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102.

(A) The applicant shall furnish to the department adequate information as requested on the Application for Non-Certified Copy of an Original Birth Certificate by Lineal Descendant form so that the department can identify the correct sealed file containing the original birth certificate.

(B) The department shall not issue a copy of the original birth certificate to the applicant when— 1. The applicant cannot provide a certified death certificate of the adoptee; or 2. The applicant cannot provide documentation that confirms the applicant is a lineal descendant of the adoptee.

(C) The department shall issue copies of the original birth certificate to the lineal descendant as provided in subsections (2)(G)–(I) of this rule. If the department cannot locate the original birth certificate, the department shall issue to the applicant a written statement that no record was found.

(D) The copy of the original birth certificate issued to the applicant shall be stamped “For genealogical purposes only— not to be used for establishing identity.”

(E) If the adoptee’s birth parent(s) have provided a Birth Parent Contact Preference Form or Birth Parent Medical History Form to the department, or the adoptee has provided an Adoptee Contact Preference Form to the department, the department shall provide a copy of the form(s) to the lineal descendant applicant.

(7) Applicants, birth parents, or others shall not send to the department items other than the forms prescribed by this

regulation (e.g., letters, papers, photos, mementos, etc). Any such items sent to the department shall be discarded.

(8) The department shall not issue copies of vital records, including birth, death, marriage, or divorce records, for the birth parents to an adoptee, adoptee’s attorney, or lineal descendant of the adoptee.

(9) The department shall not release any information pertaining to the adoptee other than the original birth certificate or Adoptee Contact Preference form, if completed, to the birth (10) The department shall not amend the adoptee’s original birth certificate as defined in this rule.

(11) When the state registrar of vital records finds evidence that an application was made through misrepresentation or fraud, he or she shall have authority to withhold issuance of a certificate until a court determination of facts has been made.

Amended: Filed Sept. 10, 2018, effective March 30, 2019. *Original authority: 193.035, RSMo 1984, amended 1993, 1995; 193.045, RSMo 1984; and 193.128, RSMo 2016, amended 2018.

History

authority to act on behalf of the adoptee.
AUTHORITY: sections 193.035 and 193.045, RSMo 2016, and section 193.128, RSMo Supp. 2018. Emergency rule filed Aug. 29, 2016, effective Sept. 8, 2016, expired March 6, 2017. Original rule filed Aug. 29, 2016, effective Feb. 28, 2017. Emergency amendment filed Sept. 10, 2018, effective Sept. 20, 2018, expired March 18, 2019.

Chapter 15 Abortions

19 CSR 10-15.050 Complication Plans for Certain Drug- and Chemically-Induced Abortions (3/31/23) John R. Ashcroft DIVISIONo10 OFFICE OF THE 19 CSR 10-15 DEPARTMENT OF HEALTH DIRECTOR AND SENIOR SERVICES SENIOR SERVICES {#sec-19-csr-10-15.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.050}

19 CSR 10-15.010 Abortion Report {#sec-19-csr-10-15.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.010}

PURPOSE: Under section 188.055, RSMo, the Department of Health and Senior Services is responsible for providing abortion forms to abortion facilities, hospitals, and physicians. This rule establishes the content of the report of induced termination of pregnancy to be filed with the department for statistical purposes for each abortion performed or induced as required by section 188.052, RSMo.

PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here.

(1) The abortion report will include the following items: name of abortion facility or hospital; the city, town, or location of the abortion facility or hospital; county where the abortion facility or hospital is located; patient identification number; age of patient; marital status of patient; date of abortion; residence of patient (state, county, city or town, inside city limits (yes or no), and zip code); patient’s race; patient’s ethnicity; patient’s education; previous pregnancy history; number of live births now living; number of live births now dead; number of spontaneous terminations and number of induced terminations; procedure used to complete abortion; type of termination procedure used (check only one (1)); date last normal menses began; clinical estimate of gestation; method of estimating gestational age; biparietal diameter measurement (if gestation age greater than or equal to eighteen (18) weeks by date of last normal menses or clinical estimate); name and signature of attending physician; physician’s Missouri license number; name of person completing report; fetus viable (yes or no); certifications of the physician who performed or induced the abortion; physician certification they have no knowledge that the woman sought the abortion solely because of a prenatal diagnosis, test, or screening indicating Down Syndrome or of the potential of Down Syndrome in the unborn child (yes or no); physician certification they have no knowledge that the woman sought the abortion solely because of the sex or race of the unborn child (yes or no); physician certification that the abortion was due to a “medical emergency,” a condition which, based on reasonable medical judgment, so complicates the medical condition of the pregnant woman as to necessitate the immediate abortion of her pregnancy to avert the death of the pregnant woman or for which a delay will create serious risk of substantial and irreversible physical impairment of a major bodily function of the pregnant woman (yes or no); 1)

Has the patient ever served on active duty in the Armed Forces of the United States and separated from such service under conditions other than dishonorable (yes or no); and 2) If the patient has answered question (1) in the affirmative, would the patient like to receive information and assistance regarding the agency’s veteran services (yes or no). The information shall be reported on the Abortion Report, which is incorporated by reference in this rule as published October 2022 and may be obtained at www.health.mo.gov or by calling (573) 751-6387.

Within forty-five (45) days from the date of abortion, submit this form to: Department of Health and Senior Services, Attention:

Bureau of Vital Records, PO Box 570, Jefferson City, MO 65102.

This rule does not incorporate any subsequent amendments or additions.

(2) The abortion report shall be signed by the attending physician and submitted to the Department of Health and Senior Services, Bureau of Vital Records, PO Box 570, Jefferson City, MO 65102-0570, within forty-five (45) days of the abortion.

section 188.052, RSMo Supp. 2022*. This rule was previously filed as 13 CSR 50-151.010 and 19 CSR 30-15.010. Original rule filed Sept. 30, 1980, effective Jan. 12. 1981. Changed to 19 CSR 10-15.010, July 30, 1998. Amended: Filed Oct. 24, 2017, effective April 30, 2018.

Amended: Filed Sept. 27, 2022, effective April 30, 2023. *Original authority: 188.052, RSMo 1979, amended 2019; 188.055, RSMo 1974, amended 1979; and 192.006, RSMo 1993, amended 1995.

History

AUTHORITY: sections 188.055 and 192.006, RSMo 2016, and

19 CSR 10-15.020 Complication Report for Post-Abortion Care {#sec-19-csr-10-15.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.020}

PURPOSE: Under section 188.055, RSMo, the Department of Health and Senior Services is responsible for providing abortion forms to abortion facilities, hospitals, and physicians. This rule establishes the content of the complication report for any post-abortion care to be filed with the department for statistical purposes.

(1) The complication report for post-abortion care shall contain the following items on a form provided by the department: patient identification number; patient’s date of birth; residence of patient state, county, city; date of abortion; name and address of abortion facility or hospital; type or abortion performed; name and address of facility reporting complication; was patient previously seen at another facility for post-abortion care (yes or no); if yes, name and address of other facility that treated patient; complications (check all that apply: incomplete abortion, hemorrhage, endometritis, parametritis, pyrexia, abscess-pelvic, uterine perforation, failed medical abortion, failed surgical abortion, immediately recognized, failed surgical abortion, with delayed recognition, retained products, cervical lacerations, diagnosable psychiatric condition, other-describe); result of complication (check all that apply: hysterectomy, death of woman, transfusion, otherdescribe); was patient hospitalized (yes or no); if yes, name and address of hospital; name and signature of physician providing post-abortion care; and date of the post-abortion care. The information shall be reported on the Complication Report for Post-Abortion Care which is incorporated by reference in this

rule as published February 2020 and may be obtained at www. health.mo.gov or by calling (573) 751-6387. This rule does not incorporate any subsequent amendments or additions.

(2) The physician providing post-abortion care shall submit the

19 CSR 10-15 DEPARTMENT OF HEALTH DIVISION 10—OFFICE OF THE {#sec-19-csr-10-15 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15}

AND SENIOR SERVICES DIRECTOR

Complication Report for Post-Abortion Care to the Department of Health and Senior Services, Bureau of Vital Records, PO Box 570, Jefferson City, MO 65102-0570, within forty-five (45) days from the date of post-abortion care.

History

AUTHORITY: section 188.052, RSMo Supp. 2019, and sections 188.055 and 192.006, RSMo 2016. This rule was previously filed as

13 CSR 50-151.020 and 19 CSR 30-15.020. Original rule filed Sept. 30, 1980, effective Jan. 12, 1981. Changed to 19 CSR 10-15.020 July 30, 1998. Amended: Filed Oct. 24, 2017, effective April 30, 2018. {#sec-13-csr-50-151.020 omnilex-key=us-mo-regs-official--title-19--13 CSR 50-151.020}

Amended: Filed Feb. 25, 2020, effective Sept. 30, 2020. *Original authority: 188.052, RSMo 1979, amended 2019; 188.055, RSMo 1974, amended 1979; and 192.006, RSMo 1993, amended 1995.

19 CSR 10-15.030 Content and Filing of Tissue Report {#sec-19-csr-10-15.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.030}

PURPOSE: Under section 188.055, RSMo, the Department of Health and Senior Services is given the responsibility to provide forms relating to abortion to abortion facilities, hospitals, and physicians. This rule establishes the content of the tissue report and filing requirements for tissue reports.

(1) The department will accept local pathologists’ report forms for compliance with section 188.047, RSMo, if the reports contain the following: patient identification number, identical in labeling and format to the patient identification number assigned by the facility where the abortion took place, and reported on the report of induced termination of pregnancy; date of the procedure; name and address of the abortion facility or hospital where the procedure was performed; name and address of the pathologist who examined the tissue. All reports shall contain the findings of a gross and histopathological examination. One (1) or more sections shall be examined histopathologically. The section(s) shall be determined by the pathologist based upon his or her assessment.

(2) The pathologist shall file the tissue report with the Department of Health and Senior Services, Bureau of Vital Records, PO Box 570, Jefferson City, MO 65102-0570, within thirty (30) days after the examination of the tissue.

(3) The physician who performed or induced the abortion may, based on his or her medical judgment and prevailing standards of care, provide the results of the gross and histopathological examination to the patient.

Amended: Filed Oct. 24, 2017, effective April 30, 2018. *Original authority: 188.047, RSMo 1979, amended 2017 and 192.006, RSMo 1993, amended 1995.

History

AUTHORITY: section 188.047, RSMo Supp. 2017, and section 192.006, RSMo 2016. This rule was previously filed as 13 CSR 50- 151.030 and 19 CSR 30-15.030. Original rule filed Sept. 30, 1980, effective Jan. 12, 1981. Changed to 19 CSR 10-15.030 July 30, 1998.

(Rescinded April 30, 2018)

History

AUTHORITY: section 188.039, RSMo 1986 and Planned Parenthood Association of Kansas City v. Ashcroft, 483 F. Supp. 679 (W.D. Mo. 1980). This rule was previously filed as 13 CSR 50-151.040 and 19 CSR 30-15.040. Original rule filed Feb. 13, 1981, effective June 11, 1981. Changed to 19 CSR 10-15.040 July 30, 1998. Rescinded: Filed Oct. 24, 2017, effective April 30, 2018.

19 CSR 10-15.050 Complication Plans for Certain Drug- and Chemically-Induced Abortions by Physicians via Hospitals {#sec-19-csr-10-15.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.050}

PURPOSE: This rule establishes the standards governing complication plans required by section 188.021, RSMo, for abortions induced by physicians via hospitals. This rule also explains the process for submitting such complication plans to the Department of Health and Senior Services for approval.

(1) For purposes of this rule, the following terms mean:

(A) Abortion—The act of using or prescribing any instrument, device, drug, or any other means or substance resulting in the intentional destruction of an embryo or fetus in a woman’s uterus or the intentional termination of a pregnancy of a woman with intent other than to increase the probability of a live birth or to remove a dead or dying embryo or fetus;

(B) Hospital—As such term is defined in section 197.020, RSMo;

(C) Complication—Includes, but is not limited to, incomplete abortion, excessive hemorrhage, endometritis, parametritis, pyrexia, pelvic abscess, uterine perforation, failed abortion, retained products, cervical lacerations, or psychiatric issues;

(D) Department—The Missouri Department of Health and Senior Services;

(E) Drug—A drug or chemical used to induce an abortion for which the federal Food and Drug Administration (FDA) label includes any clinical study in which more than one percent (1%) of those administered the drug required surgical intervention after its administration;

(F) OB/GYN—

A physician who is board-certified or board-eligible by the American Osteopathic Board of Obstetrics and Gynecology, or who is in a residency approved by that board; or 2. A physician who is board-certified by the American Board of Obstetrics and Gynecology (ABOG); or who is an ABOG Registered Residency Graduate or an ABOG Active Candidate; or who is in an ABOG-approved residency;

(G) Physician—A person licensed to practice medicine pursuant to Chapter 334, RSMo.

(2) Complication plans for certain drug- and chemicallyinduced abortions.

(A) A physician shall not prescribe or administer a drug without first obtaining written approval from the department of a complication plan applicable to the physician’s prescription or administration of the drug.

(B) A physician may obtain approval of a complication plan applicable to the physician prescribing or administering drugs via a hospital. In the alternative, a hospital may obtain approval of a complication plan applicable to a physician prescribing or administering drugs via the hospital.

(C) Each hospital shall take reasonable measures to ensure that no physician prescribes or administers drugs via the hospital in the absence of a complication plan as required by these rules. Each hospital shall also take reasonable measures to ensure that physicians prescribing or administering drugs via the hospital comply with this rule.

(D) To ensure the safety of all patients, a primary objective of complication plans shall be to recognize the importance of the physician-patient relationship by providing for continuity of care and ensuring communication among the physician who induced the abortion and all subsequent health care providers (3/31/23) John R. Ashcroft DIVISIONo10 OFFICE OF THE 19 CSR 10-15 DEPARTMENT OF HEALTH DIRECTOR AND SENIOR SERVICES involved in treating the patient’s complication.

(E) Every complication plan shall provide that an OB/GYN is on-call and available twenty-four hours a day, seven days a week (24/7) to treat complications related to drugs prescribed or administered by the physician via the hospital. To ensure this required twenty-four hours a day, seven days a week (24/7) coverage, the complication plan for each physician who will prescribe or administer drugs shall include a written agreement between the physician and an OB/GYN or group of OB/GYNs to treat complications, or in the alternative, a written agreement between the hospital and an OB/GYN or group of OB/GYNs to treat complications.

(F) If the physician who will prescribe or administer drugs is an OB/GYN, that physician’s complication plan may provide that the physician treats complications, but the physician and/ or the hospital must have a written agreement with an OB/GYN or group of OB/GYNs to ensure the required twenty-four hours a day, seven days a week (24/7) coverage when the physician is unavailable to treat complications.

(G) Every complication plan shall provide that the OB/GYN with whom there is a written agreement or member of the group of OB/GYNs with which there is a written agreement, or the physician who prescribes or administers drugs if he or she is an OB/GYN, shall:

Personally treat all complications, including those requiring surgical intervention, except in any case where doing so would not be in accordance with the standard of care, or in any case where it would be in the patient’s best interest for a different physician to treat her; and 2. Assess each patient suffering a complication individually, and shall not, as a mat ter of course, refer all patients to the emergency room or other facilities or physicians unless the patient is experiencing an immediately life-threatening complication.
This regulation does not prohibit screening or triage of patients by a nurse or physician to determine whether or when it is necessary to contact the OB/GYN.

(H) Every complication plan shall provide that, in any case where it would not be in accordance with the standard of care or would not be in the patient’s best interest for the OB/GYN to personally treat the complication (e.g., surgery in a hospital is required, and it is not in the patient’s best interest to travel to a hospital where the OB/GYN has privileges), the OB/GYN shall arrange for hand-off of the patient to an appropriately-qualified physician and shall fully brief such physician regarding the patient at the time of hand-off.

(I) Every complication plan shall require that the OB/GYN treating a patient’s complication shall prepare a complication report as required by section 188.052, RSMo and ensure that it is submitted to the department.

(J) The physician shall ensure that before discharge, every patient who receives a drug also receives the phone number, in writing, for the OB/GYN or OB/GYN group providing complication coverage. The phone number given may be for the on-call service rather than the OB/GYN’s direct number.

(K) The physician or hospital shall submit complication plans to the department for approval in writing using the complication plan submission form provided by the department. The form shall require at least the following information:

The full name of each physician whose prescription or administration of drugs via the hospital will be covered by the plan;
The full name of the OB/GYN who will provide complication coverage, or if a group of OB/GYNs will provide coverage, the full legal name of the group and the full name of each OB/GYN who is part of the group; and 3. A description of how the complication plan meets each requirement in this regulation, including treating complications requiring surgical intervention.

(L) With the completed complication plan forms, the facility shall also submit:

Documents establishing that each OB/GYN who will provide complication coverage under the plan is board-eligible or board-certified by the American Board of Obstetrics and Gynecology or the American Osteopathic Board of Obstetrics and Gynecology; and 2. A copy of the executed written agreement between the physician(s) whose prescription or administration of drugs will be covered by the plan (and/or the hospital) and the OB/GYN or group of OB/GYNs that will provide the complication coverage.

The written agreement shall cite this regulation and specify that complication coverage under the written agreement shall be provided in compliance with this regulation.

(M) If any change occurs that prevents full compliance with a complication plan as approved by the department, the physician or hospital shall immediately notify the department in writing, providing details regarding the change. If the change results in the physician being unable to provide twenty-four hours a day, seven days a week (24/7) OB/GYN coverage for complications as required by this regulation, the physician shall ensure that no drugs are prescribed or administered until 1) full compliance with the plan is achieved and the physician or hospital has so notified the department in writing, or 2) a new or revised complication plan has been submitted to and approved by the department in writing.

(N) The physician shall ensure that each complication plan approved by the department and currently in use is on file at the physician’s office or hospital. The physician or hospital shall maintain copies of complication plans no longer in use for seven (7) years following the last use. The physician or hospital shall make current and past complication plans available to patients or the department for review upon request.

(3) Pursuant to section 188.021.2, RSMo, no complication plan is required where the patient is administered the drug in a medical emergency at a hospital and is then treated as an inpatient at a hospital under medical monitoring by the hospital until the abortion is completed.

History

AUTHORITY: sections 188.021 and 197.225, RSMo Supp. 2017. Emergency rule filed Oct. 24, 2017, effective Nov. 3, 2017, expired May 1, 2018. Original rule filed Oct. 24, 2017, effective April 30, 2018. Original authority: 188.021, RSMo 2013, amended 2017 and 197.225, RSMo 1975, amended 1986, 2017.

19 CSR 10-15.060 Prohibition on Expenditure of Funds {#sec-19-csr-10-15.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.060}

PURPOSE: This rule outlines how the Department of Health and Senior Services ensures that expenditures are compliant with annual General Assembly budget bills.

(1) After July 1 of each calendar year, no claims for payment shall be submitted by any provider until that provider submits the requisite form issued by the department to be used for the upcoming fiscal year. Such form shall contain the applicable provisions related to legislative authority regarding expenditure of funds, including but not limited to, definitions, restrictions, and prohibitions. Such form shall also contain a

19 CSR 10-15 DEPARTMENT OF HEALTH DIVISION 10—OFFICE OF THE {#sec-19-csr-10-15 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15}

AND SENIOR SERVICES DIRECTOR declaration to be executed by the provider, which shall state that said provider will not submit claims for payment that violate the applicable provisions related to the legislative

Original rule filed July 5, 2018, effective Feb. 28, 2019. Emergency amendment filed June 21, 2019, effective July 1, 2019, expired Feb. 27, 2020. Amended: Filed June 21, 2019, effective Jan. 30, 2020.

Emergency amendment filed May 22, 2020, effective June 8, 2020, expired Feb. 25, 2021. Amended: Filed May 22, 2020, effective Nov. 30, 2020. *Original authority: 192.006, RSMo 1993, amended 1995.

History

authority regarding expenditure of funds. This form shall be effective from the date that the department receives a provider’s executed copy until a new form is issued by the department. A copy of this form can be requested by contacting the department.
AUTHORITY: section 192.006, RSMo 2016 and House Bill 2010, 100th General Assembly, Second Regular Session. Emergency rule filed July 5, 2018, effective July 15, 2018, expired Feb. 28, 2019.

Chapter 33 Hospital and Ambulatory Surgical Center Data Disclosure

19 CSR 10-33.010 Reporting Patient Abstract Data by Hospitals, Ambulatory Surgical {#sec-19-csr-10-33.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.010}

19 CSR 10-33.020 Reporting Charges for Leading Diagnoses and Procedures by Hospitals and {#sec-19-csr-10-33.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.020}

19 CSR 10-33.040 Electronic Reporting of Patient Abstract Data by Hospitals for Public Health {#sec-19-csr-10-33.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.040}

19 CSR 10-33.050 Reporting of Healthcare-Associated Infection Rates by Hospitals, HEALTH AND SENIOR SERVICES Surgical Center Data Disclosure {#sec-19-csr-10-33.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.050}

19 CSR 10-33.010 Reporting Patient Abstract Data by Hospitals, Ambulatory Surgical Centers, and Abortion Facilities {#sec-19-csr-10-33.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.010}

PURPOSE:

This rule establishes procedures for reporting patient abstract data for inpatients and outpatients by hospitals, ambulatory surgical centers, and abortion facilities to the Department of Health and Senior Services and for the management and dissemination of this data.

rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction.

This note applies only to the reference material. The entire text of the rule is printed here.

(1) The following definitions shall be used in the interpretation of this rule:

(A) Coinvestigator means any person or organization that applies to the Department of Health and Senior Services to be a coinvestigator of an epidemiological study;

(B) Department means the Missouri Department of Health and Senior Services;

(C) Epidemiological study means research using patient abstract data to understand, promote, or safeguard the health of a defined population. No marketing study or study designed to use data on a specific provider shall be considered an epidemiological study;

(D) Inpatient encounter means an encounter which begins with the formal acceptance by a hospital or a distinct part of a hospital of a patient who is to receive physician, dentist, or allied services while receiving room, board, and continuous nursing care. It ends with the termination of the room, board, and continuous nursing services, and the formal release of an inpatient from the hospital or the transfer of the patient to a different distinct hospital unit.

All significant procedures are to be reported.

A significant procedure is one that is surgical in nature; carries a procedural risk; requires specialized training; carries an anesthetic risk such as open procedures, endoscopy procedures, catherization procedures, pain management procedures, injection procedures such as myelograms, arthrograms, etc.; or is needed for Medicare Severity Diagnosis Related Group (MS-DRG) assignment. Inpatient procedures should be coded according to the International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS);

(E) Observation services are those services furnished on a hospital’s premises, including use of a bed and periodic monitoring by a hospital’s nursing or other staff, which are reasonable and necessary to evaluate an outpatient’s condition or determine the need for a possible admission to the hospital as an inpatient. Charges for observation services usually are made on an hourly basis. Observation services usually do not exceed twenty-four (24) hours. However, there is no hourly limit on the extent to which they may be used;

(F) Outpatient encounter refers to patients seen in the emergency room and patients receiving invasive procedures on an outpatient

basis. All significant procedures are to be reported. A significant procedure is one that is surgical in nature; carries a procedural risk; requires specialized training; or carries an anesthetic risk such as open procedures, endoscopy procedures, catherization procedures, pain management procedures, injection procedures such as myelograms, arthrograms, etc. Outpatient procedures should be coded according to the Healthcare Common Procedure Coding System (HCPCS). HCPCS is divided into two (2) principal subsystems, referred to as level I and level II. Level I is comprised of Current Procedural Terminology (CPT-4), and level II is a standardized coding system used to report services not identified by CPT-4 codes; and (G) Public health authority means an agency or authority that is responsible for public health matters as part of its official mandate.

Examples of public health authorities include agencies of a state, territory, political subdivision of a state or territory, or an Indian tribe, or persons or entities acting under a grant of

(2) Data which meet the completeness, validity, and consistency criteria in subsections (2)(C) and (D) of this rule shall be submitted to the department or to an association or related organization with which the department has a binding agreement to obtain data on a quarterly basis according to the Data Reporting Schedule in Table 1, included herein. Data shall be considered to be submitted when received by the department or the association or related organization prior to the close of business on the scheduled due date.

Requests for extensions shall be submitted to the department at least ten (10) working days prior to the due date as listed in Table 1.

Extensions to the submittal schedule may be granted for a maximum of thirty (30) calendar days. The facility shall separately request each additional thirty (30) calendar day extension.

(A) Each facility shall submit to the department, or to an association or related organization with which the department has a binding agreement to obtain data, a single record for each patient discharge, according to the schedule shown in Table 1 – Data Reporting Schedule, included herein. For a patient with multiple discharges, a facility shall submit a separate data record for each individual discharge. For a patient with multiple billing claims, a facility shall consolidate the multiple billings into a single discharge data record for submission after the patient’s discharge.

(B) The patient abstract data shall include the data elements and conform to the specifications listed in the document entitled “Patient Abstract System File Specifications” dated October 24, 2017, which is incorporated by reference in this rule and is available at the Missouri Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102-0570 or on the department’s website at http://health.mo.gov/data/pdf/paslayout.pdf.

This rule does not incorporate any subsequent amendments or additions. The patient abstract data shall be submitted electronically through the department’s online system or by any other mutually agreed upon method.

The Department of Health and Senior Services, Bureau of Health Care Analysis and Data Dissemination may be contacted by mail at PO Box 570, Jefferson City, MO 65102-0570 or by telephone at (573) 751-6272.

(C) Each data element shall have an acceptable code in at least ninety-nine percent (99%) of the records. Each data element shall be missing or unknown in less than one percent (1%) of records.

(D) The following data elements shall be consistent within at least ninety-nine percent (99%) of individual records:

Date of birth, sex, diagnoses, External Cause of Morbidity (ECM) code, Present On Admission (POA) ECM code, ECM Place of Occurrence code, ECM Activity code, ECM Status code, procedure(s);
State of residence, zip code, county; and Table 1 – Data Reporting Schedule Quarter Period of Patient Encounter (Discharge Date)

Date Due st January 1 – March 31 June 1 nd April 1 – June 30 September 1 rd July 1 – September 30 December 1 th October 1 – December 31 March 1 of the following year 3. Admission date, procedure date(s), discharge date, date of birth.

(3) After the due date listed in Table 1, included herein, providers shall be allowed fifteen (15) working days from the date of notification by the department to correct identified data submission errors. Revisions of data originally filed shall contain the entire quarterly dataset.

(4) Providers may submit the required data to the department through an association or related organization with which the department has a binding agreement to obtain data.

The association or related organization shall provide to the department by January 1 of each year a list of providers for whom it will submit data. Providers selecting this option are responsible for ensuring that the data meet the quality criteria of completeness, validity, and consistency in subsections (2)(C) and (D) of this rule. Data shall be submitted to the association or related organization according to the time schedule in section (2), Table 1, included herein, of this rule. The association or related organization is responsible for ensuring that the data are provided to the department using one (1) of the submission methods specified in subsection (2)(B) of this rule and conform to the specifications listed in the document entitled “Patient Abstract System File Specifications” dated October 27, 2014, which is incorporated by reference in this rule and is available at the Missouri Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102-0570 or on the department’s website at http://health.mo.gov/data/pdf/paslayout.pdf, for all records with a discharge date of October 1, 2015 or later. This rule does not incorporate any subsequent amendments or additions. The association shall submit provider data to the department within thirty (30) days following the due date listed in section (2), Table 1, included herein, of this

rule. The association or related organization may submit a request for extension, as described in section (2) of this rule, on behalf of a facility.

(5) Providers may submit data directly to the department or through a third party acting as their agent, other than one (1) with which the department has a binding agreement.

Providers selecting this option shall be responsible for ensuring that all data specifications conform to the requirements listed in section (2) of this rule. The third party agent may submit a request for extension, as described in

section (2) of this rule, on behalf of a facility.

(6)

The department may develop and publish reports pertaining to individual hospitals, ambulatory surgical centers, and abortion facilities. The reports may include information on charges. The reports and the data they contain shall be public information and may be released on electronic media. The department shall make the reports and data available for a reasonable charge based on (7) The department shall use statistical rules to minimize random fluctuations and extreme outliers in publishing provider-specific reports on charges. The rules may vary by publication but average charges based on fewer than twenty (20) events shall not be published.

(8) The department may develop summary reports upon request which do not directly or indirectly identify patients, physicians, or providers. The reports shall be public information. The department shall make the reports available for a reasonable charge based upon (9) The department shall store the patient abstract data in password-protected directories to limit access of the data only to employees of the department who are designated to have access to the files.

(10) The department may release patient abstract data to a public health authority to assist the agency in fulfilling its public health mission. Public health authorities shall follow the same guidelines used by the department when releasing summary reports based on record-level data. Record-level data shall not be rereleased in any form by the public health

(11) The public health authority shall agree to the department’s requirements regarding the confidentiality, security, and release of data and shall agree to the review and oversight requirements imposed by the department.

(12) Any person may apply to the department to be a coinvestigator of an epidemiological study using patient abstract data. A research protocol shall be submitted which includes all of the following:

(A) A description of the proposed study;

(B) The purpose of the study;

(D) A statement indicating whether the study protocol has been reviewed and approved by an institutional review board;

(E) A description of data security procedures, including who shall have access to the data; and (F) A description of the proposed use and release of the data.

(13) The director of the department shall appoint a data release advisory committee which may be composed of representatives from the department, the Hospital Industry Data Institute (HIDI) of the Missouri Hospital Association (MHA), and other entities. The advisory committee shall review all research protocols of persons applying to be a coinvestigator of an epidemiological study using patient abstract data. The advisory committee shall make a recommendation to the department whether the coinvestigator protocol should be accepted, accepted with conditions, or rejected. The committee shall consider the following factors:

(A) The review made by the staff of the department;

(B) Whether the proposed study meets the definition of an epidemiological study;

(D) The professional expertise of the applicant to conduct the study;

(E) The appropriateness of the proposed study design;

(F) The willingness and ability of the applicant to protect the identity of any patient, physician, or provider;

(G) The data security measures and final disposition of the data proposed; and (H) Whether the proposed study is relevant to public health in Missouri.

(14) The coinvestigator shall follow the same guidelines used by the department when releasing summary reports based on recordlevel data. Record-level data released to the coinvestigator shall not be rereleased in any form by the coinvestigator without the prior (5/31/20) JOHN R. ASHCROFT authorization of the department. Authorization for subsequent release of record-level data or summary reports shall be considered only if patient, physician, or provider. The following data elements permit identification of a patient, physician, or provider, and are not to be rereleased by a coinvestigator: patient name; patient Social Security number; any datum which applies to fewer than three (3) patients, physicians, or providers; physician number; provider number; and a quantity figure if one (1) hospital, ambulatory surgical center, or abortion facility contributes more than sixty percent (60%) of the amount.

(15) The coinvestigator shall agree to the department’s requirements regarding the confidentiality, security, and release of data and shall agree to the review and oversight requirements imposed by the department.

(16) The department shall release only those patient abstract data elements to the coinvestigator which the department determines are essential to the study. The National Provider Identifier (NPI) associated with any patient abstract data shall not be released to any coinvestigator. If the research being conducted by a coinvestigator requires a physician number, the department may create a unique number which is not the NPI. The department shall not provide information which links the unique number to the name of the physician.

(17) No epidemiological study conducted with a coinvestigator shall be approved unless the department determines that— (A) The epidemiological study has public benefit sufficient to warrant the department to expend resources necessary to oversee the project with the coinvestigator;

(B) The department has sufficient resources available to oversee the project with the coinvestigator; and (C) The data release advisory committee reviewed the study and the director of the department authorized approval.

(18) Public health authorities and coinvestigators receiving data shall be informed by the department of the penalty for violating section 192.067, RSMo.

(19) Any provider which determines that it will be temporarily unable to comply with any of the provisions of sections (1) through (5) of this rule or with the provisions of a previously-submitted plan of correction shall provide the department with written notification of the expected deficiencies and a written plan of correction. This notification and plan of correction shall include the specific reasons why the provider cannot comply with the rule, an explanation of any extenuating factors which may be relevant, the means the provider will employ for correcting the expected deficiency, and the date by which each corrective measure will be completed.

(20) Any provider which is not in compliance with sections (1) through (5) of this rule shall be notified in writing by the department. The notification shall specify the section number and text of the rule in question, the deficiency, and the action which must be taken to be in compliance. The chief executive officer or designee shall have ten (10) working days following receipt of the written notification of noncompliance to provide the department with a written plan for correcting the deficiency. The plan of correction shall specify the means the provider will employ for correcting the cited deficiency and the date that each corrective measure will be completed.

(21) Upon receipt of a required plan of correction, the department shall review the plan to determine the appropriateness of the corrective action. If the plan is acceptable, the department shall notify the chief executive officer or designee in writing and indicate that implementation of the plan should proceed. If the plan is not acceptable, the department shall notify the chief executive officer or designee in writing and indicate the reasons why the plan was not accepted. A revised, acceptable plan of correction shall be provided to the department within ten (10) working days.

(22) Failure of the provider to submit an of the department.

(23) Failure of any provider to follow its wise by the director of the department.

(24) Any provider in continued and substannotified in writing and reported by the department to its appropriate licensing program within the Division of Regulation and Licensure and the Bureau of Special Health Care Needs, the MO HealthNet Division of the Department of Social Services, and other state agencies that administer a program with provider participation. The department shall notify the agencies that the provider is no longer eligible for participation in a state program or to receive any monies from the state.

(25) Any provider that has been declared to be ineligible to participate in a state program or to receive any monies from the state shall be eligible for reinstatement by correcting the deficiencies and making written application for reinstatement to the Department of Health and Senior Services. Any provider meeting notified in writing. Those agencies that received a notice pursuant to section (24) of this rule shall be notified by the Department of Health and Senior Services when the provider has come into compliance.

Emergency amendment filed March 1, 2001, effective April 1, 2001, expired Jan. 10, 2002.

Amended: Filed April 13, 2001, effective Oct. 30, 2001. Rescinded and readopted: Filed Jan. 29, 2015, effective Sept. 30, 2015.

Amended: Filed Oct. 24, 2017, effective April 30, 2018. ** 1993, 1995, 2004, 2016, 2017. **Pursuant to Executive Order 21-07, 19 CSR 10-33.010 and sections 192.067 and 192.667, RSMo was suspended from April 3, 2020 through August 31, 2021 and 19 CSR 10-33.010 and sections 192.067 and 192.667, RSMo was suspended from April 8, 2020 through August 31, 2021.

History

authority or contract with a public health
authority.
authority without the prior authorization of the department. Authorization for subsequent release of the data shall be considered only if patient, physician, or provider. The following data elements permit identification of a patient, physician, or provider, and shall not be rereleased by a public health authority: patient name; patient Social Security number; any datum which applies to fewer than three (3) patients, physicians, or providers; physician number; provider number; and a quantity figure if one (1) hospital, ambulatory surgical center, or abortion facility contributes more than sixty percent (60%) of the amount. However, the department may authorize contact with the patient, physician, or provider based upon the information supplied. The physician and provider that provided care to a patient shall be informed by the public health authority of any proposed contact with a patient.
AUTHORITY: section 192.667, RSMo Supp. 2017. Emergency rule filed Nov. 4, 1992, effective Nov. 14, 1992, expired March 13, 1993. Emergency rule filed March 4, 1993, effective March 14, 1993, expired July 11, 1993. Original rule filed Nov. 4, 1992, effective June 7, 1993. Emergency amendment filed April 1, 1993, effective April 11, 1993, Filed May 15, 1998, effective Nov. 30, 1998.

19 CSR 10-33.020 Reporting Charges for Leading Diagnoses and Procedures by Hospitals and Ambulatory Surgical Centers for reporting charges for leading diagnoses and procedures by hospitals and ambulatory surgical centers to the Department of Health. {#sec-19-csr-10-33.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.020}

(1) Hospitals and ambulatory surgical centers shall report to the Department of Health by March 1 of each year, the charges as of December 31 of the previous year for the diagnoses and procedures listed in Exhibit C of this rule, included herein.

(9/30/21) JOHN R. ASHCROFT

(2) The Department of Health may develop and publish reports pertaining to individual providers. The reports and the data they contain shall be public information and may be released on magnetic media. The Department of Health shall make the reports and data available for a reasonable charge based upon (3) The Department of Health may develop reports and release data upon request which do not directly or indirectly identify individual providers. The reports and data shall be public information and may be released on magnetic media. The Department of Health shall make the reports and data available for a reasonable charge based upon incurred costs.

(4) Any provider which determines it temporarily will be unable to comply with any

part of this rule or with the provisions of a previously submitted plan of correction can provide the Department of Health with written notification of the expected deficiencies and a written plan of correction. The notification and plan of correction shall include the

section number and text of the rule in question, specific reasons why the provider cannot comply with the rule, an explanation of any extenuating factors which may be relevant, the means the provider will employ for correcting the expected deficiency, and the date by which each corrective measure will be completed.

(5) Any provider which is not in compliance with this rule shall be notified in writing by the Department of Health. The notification shall specify the deficiency and the action which must be taken to be in compliance.

The chief executive officer or designee shall have ten (10) working days following receipt of the written notification of noncompliance to provide the Department of Health with a written plan for correcting the deficiency.

The plan of correction shall specify the means the provider will employ for correcting the cited deficiency and the date that each corrective measure will be completed.

(6) Upon receipt of a required plan of correction, the Department of Health shall review the plan to determine the appropriateness of the corrective action. If the plan is acceptable, the Department of Health shall notify the chief executive officer or designee in writing and indicate that implementation of the plan should proceed. If the plan is not acceptable, the Department of Health shall notify the chief executive officer or designee in writing and indicate the reasons why the plan was not accepted. A revised, acceptable plan of correction shall be provided to the Department of Health within ten (10) working days.

(7) Failure of the provider to submit an of the Department of Health.

(8) Failure of any provider to follow its wise by the director of the Department of Health.

(9) Any provider in continued and substantial noncompliance with this rule shall be notified by registered mail and reported by the Department of Health to its Bureau of Hospital Licensing and Certification, Bureau of Narcotics and Dangerous Drugs, Bureau of tion. The Department of Health shall notify the agencies that the provider is no longer eligible for participation in a state program.

(10) Any provider that has been declared to be ineligible for participation in a state program shall be eligible for reinstatement by correcting the deficiencies and making written application for reinstatement to the Department of Health. Any provider meeting notified by registered mail. The Department of Health shall notify state agencies that tion that the provider’s eligibility for participation in a state program has been reinstated.

EXHIBIT C

List of Diagnoses and Procedures List of Inpatient Diagnoses Cesarean section without complications or comorbidities, or both Four-day stay DRG 371 Vaginal delivery without complicating diagnoses Two-day stay DRG 373 Normal newborn Two-day stay DRG 391 List of Outpatient Procedures* Operations on the Nervous System Epidural pain block CPT-4 62278 Injection of anesthetic substance (including narcotics), diagnostic or therapeutic; lumbar or caudal epidural, single ICD-9 03.91 Injection of anesthetic into spinal canal for analgesia Carpal tunnel release CPT-4 64721 Neuroplasty or transposition, or both; median nerve at carpal tunnel ICD-9 04.43 Release of carpal tunnel Operations on the Eye Radial keratotomy (surgical correction of myopia)

CPT-4 65771 Radial keratotomy ICD-9 11.75 Radial keratotomy Cataract removal, with intraocular lens implant CPT-4 66983 Intracapsular cataract extraction with insertion of intraocular lens prosthesis (one stage procedure)

CPT-4 66984 Extracapsular cataract removal with insertion of intraocular lens prosthesis (one stage procedure), manual or mechanical technique (for example, irrigation and aspiration or phacoemulsification)

ICD-9 13.19 Other intracapsular extraction of lens, plus ICD-9 13.71 Insertion of intraocular lens prosthesis at time of cataract extraction, one (1) stage ICD-9 13.59 Other extracapsular extraction of lens, plus ICD-9 13.71 Insertion of intraocular lens prosthesis at time of cataract extraction, one (1) stage Removal of secondary cataract CPT-4 66821 Discussion of secondary membranous cataract (opacified posterior lens capsule, anterior haloid, or both); laser surgery (for example, YAG laser) (one (1) or more stages)

ICD-9 13.64 Discussion of secondary membrane (after cataract)

Secondary insertion of intraocular lens/Exchange of intraocular lens CPT-4 66985 Insertion of intraocular lens prosthesis (secondary implant), not associated with concurrent cataract removal CPT-4 66986 Exchange of intraocular lens ICD-9 13.72 Secondary insertion of intraocular lens prosthesis Operations on the Ear, Nose, Mouth and Pharynx Myringotomy, with or without tubes CPT-4 69421 Myringotomy including aspiration or eustachian tube inflation, or both, requiring general anesthesia CPT-4 69436 Tympanostomy (requiring insertion of ventilating tube), general anesthesia ICD-9 20.01 Myringotomy with insertion of tube Nasal fracture, closed reduction CPT-4 21320 Manipulative treatment, nasal bone fracture; with stabilization ICD-9 21.71 Closed reduction of nasal fracture Septoplasty CPT-4 30520 Septoplasty or submucous resection, with or without cartilage scoring, contouring or replacement with graft ICD-9 21.88 Other septoplasty Tonsillectomy without adenoidectomy CPT-4 42825 Tonsillectomy, primary or secondary; under age 12 CPT-4 42826 age 12 or over ICD-9 28.2 Tonsillectomy without adenoidectomy Tonsillectomy with adenoidectomy CPT-4 42820 Tonsillectomy and adenoidectomy; under age 12 CPT-4 42821 age 12 or over ICD-9 28.3 Tonsillectomy with adenoidectomy Operations on the Cardiovascular System Cardiac catheterization, left heart CPT-4 93510 Left heart catheterization, retrograde, from the brachial artery, axillary artery or femoral artery; percutaneous CPT-4 93511 by cutdown CPT-4 93514 Left heart catheterization by left ventricular puncture CPT-4 93524 Combined transseptal and retrograde left heart catheterization ICD-9 37.22 Left heart cardiac catheterization Varicose vein ligation and stripping CPT-4 37720 Ligation and division and complete stripping of long or short saphenous veins ICD-9 38.5 Ligation and stripping of varicose veins Endoscopic Procedures Bronchoscopy, diagnostic CPT-4 31622 Bronchoscopy; diagnostic, (flexible or rigid), with or without cell washing or brushing ICD-9 33.22 Fiber-optic bronchoscopy ICD-9 33.23 Other bronchoscopy Dilation of esophagus CPT-4 43455 Dilation of esophagus, by balloon or dilator; under fluoroscopic guidance CPT-4 43456 retrograde ICD-9 42.92 Dilation of esophagus Upper GI endoscopy, diagnostic CPT-4 43235 Upper gastrointestinal endoscopy including esophagus, stomach and either the duodenum, jejunum, or both, as appropriate; complex diagnostic ICD-9 44.13 Other endoscopy of small intestine Endoscopy of small intestine, diagnostic CPT-4 44360 Small intestinal endoscopy, enteroscopy beyond second portion of duodenum; diagnostic ICD-9 45.13 Other endoscopy of small intestine Colonoscopy, diagnostic CPT-4 45378 Colonoscopy, fiber-optic, beyond splenic flexure; diagnostic, with or without colon decompression ICD-9 45.23 Colonoscopy Sigmoidoscopy, diagnostic CPT-4 45330 Sigmoidoscopy, flexible fiber-optic; diagnostic ICD-9 45.24 Flexible sigmoidoscopy Operations on the Digestive System Cholecystectomy (gall bladder removal)

CPT-4 49310 Laparoscopy, surgical; cholecystectomy (any method)

ICD-9 51.23 Laparoscopic cholecystectomy Inguinal hernia repair CPT-4 49500 Repair inguinal hernia, under age 5 years, with or without hydrocelectomy CPT-4 49505 Repair inguinal hernia, age 5 or over ICD-9 53.00 Unilateral repair of inguinal hernia, not otherwise specified ICD-9 53.01 Repair of direct inguinal hernia ICD-9 53.02 Repair of indirect inguinal hernia Diagnostic laparoscopy CPT-4 58980 Laparoscopy, diagnostic (separate procedure)

ICD-9 54.21 Laparoscopy Cystoscopy CPT-4 52000 Cystourethroscopy (separate procedure)

ICD-9 57.32 Other cystoscopy Sterilization Vasectomy CPT-4 55250 Vasectomy, unilateral or bilateral (separate procedure), including postoperative semen examination(s)

ICD-9 63.73 Vasectomy Tubal ligation CPT-4 58982 Laparoscopy, surgical; with fulguration of oviducts (with or without transection)

CPT-4 58983 with occlusion of oviducts by device (for example, band, clip, or Falope ring)

ICD-9 66.21 Bilateral endoscopic ligation and crushing of fallopian tubes ICD-9 66.22 Bilateral endoscopic ligation and division of fallopian tubes ICD-9 66.29 Other bilateral endoscopic destruction or occlusion of fallopian tubes Gynecological Operations Conization of cervix CPT-4 57520 Conization of cervix, with or without fulguration, with or without dilation and curettage, with or without repair (any method)

ICD-9 67.2 Conization of cervix Laser destruction of cervical lesion CPT-4 57513 Cauterization of cervix; laser ablation ICD-9 67.39 Other excision or destruction of lesion or tissue of cervix Diagnostic D & C CPT-4 58120 Dilation and curettage, diagnostic therapeutic (nonobstetrical), or both ICD-9 69.09 Other dilation and curettage Operations on the Musculoskeletal System Bunionectomy CPT-4 28110 Ostectomy, partial excision, fifth metatarsal head (bunionette) (separate procedure)

CPT-4 28290 Hallux valgus (bunion) correction, with or without sesamoidectomy; simple exostectomy (Silver type procedure)

CPT-4 28292 Keller, McBride or Mayo type procedure CPT-4 28293 resection of joint with implant CPT-4 28294 with tendon transplants (Joplin type procedure)

CPT-4 28296 with metatarsal osteotomy (for example, Mitchell, Chevron, or concentric type procedures)

CPT-4 28297 Lapidus type procedure CPT-4 28298 by phalanx osteotomy CPT-4 28299 by other methods (for example, double osteotomy)

ICD-9 77.51 Bunionectomy with soft tissue correction and osteotomy of the first metatarsal ICD-9 77.52 Bunionectomy with soft tissue correction and arthrodesis ICD-9 77.53 Other bunionectomy with soft tissue correction ICD-9 77.54 Excision or correction of bunionette ICD-9 77.57 Repair of claw toe ICD-9 77.58 Other excision, fusion and repair of toes ICD-9 77.59 Other bunionectomy Hammertoe correction CPT-4 28285 Hammertoe operation; one toe (for example, interphalangeal fusion, filleting, phalangectomy)

ICD-9 77.56 Repair of hammertoe Knee arthroscopy, diagnostic CPT-4 29870 Arthroscopy, knee, diagnostic, with or without synovial biopsy (separate procedure)

ICD-9 80.26 Arthroscopy, knee ICD-9 80.36 Biopsy of joint structure, knee Knee arthroscopy, removal of cartilage CPT-4 29881 Arthroscopy, knee, surgical; with meniscectomy (medial OR lateral including any meniscal shaving)

ICD-9 80.6 Excision of semilunar cartilage of knee Ganglionectomy, hand or wrist CPT-4 25111 Excision of ganglion, wrist (dorsal or volar); primary CPT-4 26160 Excision of lesion of tendon sheath or capsule (for example, cyst, mucous cyst, or ganglion), hand or finger ICD-9 82.21 Excision of lesion of tendon sheath of hand Operations on the Integumentary System Breast biopsy, incisional CPT-4 19101 Biopsy of breast; incisional ICD-9 85.12 Open biopsy of breast Removal of breast lesion CPT-4 19120 Excision of cyst, fibroadenoma, or other benign or malignant tumor, aberrant breast tissue, duct lesion or nipple lesion (except 19140), male or female, one or more lesions ICD-9 85.21 Local excision of lesion of breast Miscellaneous Diagnostic and Therapeutic Procedures CAT scan of head, without contrast CPT-4 70450 Computerized axial tomography, head or brain; without contrast material ICD-9 87.03 Computerized axial tomography of head CAT scan of head, with and without contrast CPT-4 70470 Computerized axial tomography, head or brain; without contrast material, followed by contrast material(s) and further sections ICD-9 87.03 Computerized axial tomography of head Contrast myelogram of spine CPT-4 61055 Cisternal or lateral cervical (C1-C2) puncture; with injection of drug or other substance for diagnosis or treatment (C1-C2) or CPT-4 62284 Injection procedure for myelography or computerized axial tomography, or both, spinal (other than C1-C2 and posterior fossa), plus CPT-4 72270 Myelography, entire spinal canal, radiological supervision and interpretation ICD-9 87.21 Contrast myelogram Mammography CPT-4 76092 Screening mammography, bilateral (two view film study of each breast)

ICD-9 87.37 Other mammography (X-ray imaging of the breast, other than xerography)

CAT scan of abdomen, without contrast CPT-4 74150 Computerized axial tomography, abdomen; without contrast material ICD-9 88.01 Computerized axial tomography of abdomen CAT scan of abdomen, with and without contrast CPT-4 74170 Computerized axial tomography, abdomen; without contrast material, followed by contrast material(s) and further sections ICD-9 88.01 Computerized axial tomography of abdomen Diagnostic ultrasound, abdomen and retroperitoneum CPT-4 76700 Echography, abdominal, B-scan or real time with image documentation, or both; complete CPT-4 76770 Echography, retroperitoneal (for example, renal, aorta, nodes), B-scan or real time with image documentation, or both; complete ICD-9 88.76 Diagnostic ultrasound of abdomen and retroperitoneum Diagnostic ultrasound, gravid uterus CPT-4 76805 Echography, pregnant uterus, B-scan or real time with image documentation, or both; complete (complete fetal and maternal evaluation)

CPT-4 76810 complete (complete fetal and maternal evaluation), multiple gestation, after the first trimester ICD-9 88.78 Diagnostic ultrasound of gravid uterus Magnetic resonance imaging, brain, without contrast CPT-4 70551 Magnetic resonance (for example, proton) imaging, brain (including brain stem); without contrast material ICD-9 88.91 Magnetic resonance imaging of brain and brain stem Magnetic resonance imaging, brain, with and without contrast CPT-4 70553 Magnetic resonance (for example, proton) imaging, brain (including brain stem); without contrast material, followed by contrast material(s) and further sequences ICD-9 88.91 Magnetic resonance imaging of brain and brain stem Magnetic resonance imaging, spinal canal, without contrast CPT-4 72141 Magnetic resonance (for example, proton) imaging, spinal canal and contents, cervical; without contrast material CPT-4 72146 Magnetic resonance (for example, proton) imaging, spinal canal and contents, thoracic; without contrast material CPT-4 72148 Magnetic resonance (for example, proton) imaging, spinal canal and contents, lumbar; without contrast material ICD-9 88.93 Magnetic resonance imaging of spinal canal Magnetic resonance imaging, spinal canal, with and without contrast CPT-4 72156 Magnetic resonance (for example, proton) imaging, spinal canal and contents, without contrast material, followed by contrast material(s) and further sequences; cervical CPT-4 72157 thoracic CPT-4 72158 lumbar ICD-9 88.93 Magnetic resonance imaging of spinal canal Treadmill stress test CPT-4 93015 Cardiovascular stress test using maximal or submaximal treadmill or bicycle exercise or pharmacological stress, or both; continuous electrocardiographic monitoring, with interpretation and report ICD-9 89.41 Cardiovascular stress test using treadmill Electrocardiogram CPT-4 93000 Electrocardiogram, routine ECG with at least 12 leads; with interpretation and report ICD-9 89.52 Electrocardiogram Extracorporeal shockwave lithotripsy, kidney, ureter or bladder, or any combination of these CPT-4 50590 Lithotripsy, extracorporeal shockwave ICD-9 98.51 Extracorporeal shock wave lithotripsy (ESWL) of the kidney, ureter or bladder, or any combination of these *Charges for outpatient procedures shall include the facility’s total customary charges for a specific procedure or group of procedures defined according to ICD-9-CM or CPT-4 codes. Charges shall include fees associated with the preparation of the patient (preoperative phase), performance of the procedure (intraoperative phase) and recovery (postoperative phase): Preoperative phase includes those services and procedures that prepare the patient for the surgical procedure. It shall include, but is not limited to, charges for standard preoperative diagnostic laboratory testing, radiological services, preparatory pharmaceuticals (preoperative medications), skin preparation supplies, and the like. Intraoperative phase includes those services and procedures during the period of time of the actual surgical procedure itself (as identified by ICD-9-CM or CPT-4 code) as performed to eliminate or improve the patient’s diagnostic condition. It shall include, but is not limited to, room charges for the surgery suite, anesthesia and other intraoperative pharmaceuticals, equipment and supplies (drapes/barriers, electrocautery tips and grounding pads, specialized scalpel blades, dressing materials, casting materials and orthopedic supplies, and the like). Postoperative phase includes those services and procedures that are provided to the patient from the point at which the patient exits the surgery suite to the point at which the patient is discharged from the facility. It shall include, but is not limited to, charges for use of the recovery room, dressings, pharmaceuticals, respiratory therapy, supplies and the like. Professional fees for facility-based radiologists, pathologists, anesthesiologists and the like, if they are reported by the facility, shall be reported separately.

History

AUTHORITY: section 192.667, RSMo 2000. Emergency rule filed Nov. 4, 1992, effective Nov. 14, 1992, expired March 13, 1993. Emergency rule filed March 4, 1993, effective March 14, 1993, expired July 11, 1993. Original rule filed Nov. 4, 1992, effective June 7, 1993. Emergency amendment filed April 1, 1993, effective April 11, 1993, Filed April 13, 2001, effective Oct. 30, 2001. 1993, 1995.

19 CSR 10-33.030 Reporting Financial Data by Hospitals for reporting financial data by hospitals to the Department of Health. {#sec-19-csr-10-33.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.030}

(1) Hospitals shall report the financial data listed in Exhibit D of this rule, included herein, for the previous fiscal year to the Department of Health by April 15 of each year starting in 1993. If any data element has been submitted previously to the Division of Medical Services of the Department of Social Services, the hospital does not have to report that data to the Department of Health. The Department of Health shall notify each hospital what data elements are not available from the Division of Medical Services.

(2) Hospitals may provide the financial data directly or through an association to the Department of Health from the financial section of the annual licensing survey.

(3) The Department of Health shall develop and publish reports pertaining to individual hospitals. The reports and the data they contain shall be public information and may be released on magnetic media. The Department of Health shall make the reports and data available for a reasonable charge based upon (4) The Department of Health may develop reports and release data upon request which do not directly or indirectly identify individual hospitals. The reports and data shall be public information and may be released on magnetic media. The Department of Health shall make the reports and data available for a reasonable charge based upon incurred costs.

(5) Any provider which determines it temporarily will be unable to comply with any of the provisions of this rule or with the provisions of a previously-submitted plan of correction can provide the Department of Health with written notification of the expected deficiencies and a written plan of correction. The notification and plan of correction shall include the section number and text of the

rule in question, specific reasons why the provider cannot comply with the rule, an explanation of any extenuating factors which may be relevant, the means the provider will employ for correcting the expected deficiency and the date by which each corrective measure will be completed.

(6) Any provider which is not in compliance with this rule shall be notified in writing by the Department of Health. The notification shall specify the deficiency and the action which must be taken to be in compliance.

The plan of correction shall specify the means the provider will employ for correcting the cited deficiency and the date that each corrective measure will be completed.

(7) Upon receipt of a required plan of correction, the Department of Health shall review the plan to determine the appropriateness of the corrective action. If the plan is acceptable, the Department of Health shall notify the chief executive officer or designee in writing and indicate that implementation of the plan should proceed. If the plan is not acceptable, the Department of Health shall notify the chief executive officer or designee in writing and indicate the reasons why the plan was not accepted. A revised, acceptable plan of correction shall be provided to the Department of Health within ten (10) working days.

(8) Failure of the provider to submit an of the Department of Health.

(9) Failure of any provider to follow its wise by the director of the Department of Health.

(10) Any provider in continued and substannotified by registered mail and reported by the Department of Health to its Bureau of Hospital Licensing and Certification, Bureau of Narcotics and Dangerous Drugs, Bureau of tion. The Department of Health shall notify the agencies that the provider is no longer eligible for participation in a state program.

(11) Any provider that has been declared to be ineligible for participation in a state program shall be eligible for reinstatement by correcting the deficiencies and making written application for reinstatement to the Department of Health. Any provider meeting notified by registered mail. The Department of Health shall notify state agencies that tion that the provider’s eligibility for participation in a state program has been reinstated.

EXHIBIT D

Financial Data Elements BALANCE SHEET* 1a. Cash and cash equivalents________________________________ 1b. Net patient accounts receivable________________________________ 1c. Other current assets________________________________ 1d. Total current assets________________________________ 2a. Fixed assets at cost________________________________ 2b. Less: accumulated depreciation________________________________ 2c. Fixed assets (net) ________________________________ 3. Other assets ________________________________ 4. Total assets ________________________________ 5. Current liabilities ________________________________ 6. Long-term debt ________________________________ 7. Other long-term liabilities ________________________________ 8. Fund balance ________________________________ 9. Total liabilities and fund balance________________________________ INCOME STATEMENT** 1a. Inpatient revenue________________________________ 1b. Outpatient revenue________________________________ 1c. Total gross patient revenue________________________________ 2a. Charity care________________________________ 2b. Other allowances and deductions________________________________ 2c. Total deductions and allowances ________________________________ 3. Net patient revenue ________________________________ 4. Other revenue ________________________________ 5. Total revenue ________________________________ 6a. Payroll expenses________________________________ 6b. Employee benefits________________________________ 6c. Depreciation expense________________________________ 6d. Bad debt expense________________________________ 6e. All other operating expenses________________________________ 6f. Total operating expenses ________________________________ 7. Net income from operations ________________________________ 8a. Investment income________________________________ 8b. Contributions________________________________ 8c. Tax support and other subsidies________________________________ 8d. Miscellaneous gains and losses________________________________ 8e. Nonoperating gains and losses ________________________________ 9. Net income before extraordinary and other nonrecurring items________________________________ 10. Extraordinary gains and losses ________________________________ 11. Net income ________________________________ SUPPLEMENTAL ITEMS*** 1. If depreciation is funded, balance at end of reporting period________________________________ 2a. Medicare gross patient revenue________________________________ 2b. Medicaid gross patient revenue________________________________ 2c. Other government patient revenue________________________________ 2d. Nongovernment patient revenue________________________________ Definitions for Exhibit D Balance Sheet* 1a. Cash and cash equivalents means money on hand, and includes money in checking accounts, time deposits, temporary cash investments and uninvested funds held by investment custodians.

1b. Net patient accounts receivable means accounts receivable, net of estimated uncollectibles.

1c. Other current assets means other accounts receivable, notes receivable and may include the current portion of assets whose use is limited, prepaid expenses, inventory and short-term investments.

1d. Total current assets means the sum of lines 1a. through 1c.

2a. Fixed assets at cost means land, land improvements, buildings and improvements, leasehold improvements, equipment (fixed and movable), leased property and equipment, and construction in progress, at cost.

2b. Accumulated depreciation means depreciation and amortization.

2c. Fixed assets (net) means fixed assets at cost (line 2a.) less accumulated depreciation (line 2b.).

Other assets means all other assets, and may include deferred financing costs, unamortized bond issue costs, investment in affiliated company, deferred third-party reimbursement and other assets.
Total assets means the sum of lines 1d., 2c. and 3.
Current liabilities means those which will be discharged with current assets, and may include notes payable to banks; the current portion of long-term debt; accounts payable; advances from and amounts payable to third-party payers for estimated and final reimbursement settlements; refunds to and deposits from patients and others; deferred revenue; accrued salaries and payroll taxes; and other accruals such as pension or profit-sharing contributions, compensated absences, and income and other taxes.
Long-term debt means notes payable, mortgages payable, capital leases, bonds payable and loans/contracts payable.
Other long-term liabilities means other long-term obligations, and may include estimated malpractice costs, deferred compensation payable, deferred third-party reimbursement and accrued pension/deferred pension liability.
Fund balance means the excess of assets over liabilities (net equity). An excess of liabilities over assets is reflected as a deficit.
Total liabilities and fund balance means the sum of lines 5.–8. Must agree with total assets, line 4.

Income Statement** 1a. Inpatient revenue means full hospital charges for all hospital services to inpatients.

1b. Outpatient revenue means full hospital charges for all hospital services to outpatients.

1c. Total gross patient revenue means the sum of lines 1a. and 1b. Full hospital charges for all hospital patient services before considering any deductions for charity care or contractual allowances.

2b. Other allowances and deductions means revenue deductions incurred in treating patients other than charity patients, including Medicare, Medicaid, other insured and uninsured patients. It includes courtesy discounts given to employees and others. It does not include bad debt expense, which is to be reported as an operating expense (line 6d.).

2c. Total allowance and deductions means the sum of lines 2a. and 2b.

Net patient revenue means total gross revenue (line 2.) less total allowances and deductions (line 2c.).
Other revenue means revenue from services other than health care provided to patients and residents, and includes sales and services to nonpatients. This revenue arises from the normal day-to-day operations of the health care entity. Other revenues may include: revenue such as gifts, grants, or endowment income restricted by donors to finance charity care; revenue from educational programs; revenue from research and other gifts and grants; revenue from miscellaneous sources, such as rental of facility space, sales of medical and pharmacy supplies, fees charged for transcripts for attorneys, insurance companies and others, proceeds from the sale of cafeteria meals and guest trays, proceeds from the sale of scrap, used X-ray film, and proceeds from sales at gift shops, snack bars, newsstands, parking lots, vending machines and other service facilities operated by the health care entity.
Total revenue means the sum of lines 3. and 4.

6a. Payroll expenses means salaries and wages paid to employees of the health care entity.

6b. Employee benefits means Social Security, group insurance, retirement benefits, Workers’ Compensation, unemployment insurance and others.

6c. Depreciation expense means depreciation and amortization of property and equipment recorded for the reporting period.

6d. Bad debt expense means revenue amounts deemed uncollectible primarily because of a patient’s unwillingness to pay as determined after collection efforts based upon sound credit and collection policies. It does not include charity care, which is to be reported on line 2a.

6e. All other operating expenses means expenses for professional fees, interest, supplies, purchased services, utilities, income taxes, operating losses and any other expenses not included in the above categories.

6f. Total operating expenses means the sum of lines 6a.–6e.

Income from operations means total revenue (line 5.) less total operating expenses (line 6f.).

8a. Investment income means return on investments of general funds, except that investment income and realized gains and losses on borrowed funds held by a trustee, investment income on malpractice trust funds and investment income that is essential to the ongoing major or central operations are included in other revenue (line 4.).

8b. Contributions means contributions, donations and bequests for general operating purposes from foundations, similar groups or individuals, or any combination of these.

8c. Tax support and other subsidies means tax levies and other subsidies from governmental or community agencies received for general support of the entity.

8d. Miscellaneous gains and losses means all other gains and losses from a provider’s peripheral or incidental transactions, such as gain or loss on sale of health care entity properties; net rentals of facilities used in the operation of the entity; and term endowment funds that are available for general operating purposes upon termination of restrictions.

8e. Nonoperating gains and losses means the sum of lines 8a.–8d.

Net income before extraordinary and other nonrecurring items means the sum of net income from operations (line 7.) and nonoperating gains and losses (line 8e.).
Extraordinary gains and losses means gains or losses unusual in amount and nonrecurring in nature that do not result from normal operating activities. Events or transactions that occur frequently in the health care environment, such as large, unrestricted gifts, cannot be regarded as extraordinary, regardless of their financial effect, and are to be included in ordinary income.
Net income means the sum of lines 9. and 10.

Supplemental Items*** 1. Funded depreciation means cash resources which have been set aside and accumulated for the purpose of financing the renewal or replacement of plant assets.

2a. Medicare gross patient revenue means full hospital charges for all hospital services provided to Medicare patients.

2b. Medicaid gross patient revenue means full hospital charges for all hospital services provided to Medicaid patients.

2c. Other government patient revenue means full hospital charges for all hospital services provided to other government patients, including CHAMPUS, government retirement and Crippled Children’s Service.

2d. Nongovernment patient revenue means full hospital charges for all hospital services provided to nongovernment patients, including those with private insurance, those belonging to HMOs or PPOs, and those without insurance.

Emergency rule filed March 4, 1993, effective March 14, 1993, expired July 11, 1993.

Original rule filed Nov. 4, 1992, effective June 7, 1993. Emergency amendment filed April 1, 1993, effective April 11, 1993, Filed April 13, 2001, effective Oct. 30, 2001. 1993, 1995.

History

AUTHORITY: section 192.667, RSMo 2000. Emergency rule filed Nov. 4, 1992, effective Nov. 14, 1992, expired March 13, 1993.

19 CSR 10-33.040 Electronic Reporting of Patient Abstract Data by Hospitals for Public Health Syndromic Surveillance for secure electronic reporting of patient abstract data for inpatients and outpatients by hospitals to the Department of Health and Senior Services for the purpose of conducting epidemiologic monitoring and studies and publishing information to safeguard the health of the citizens of Missouri as authorized by sections 192.020, 192.067 and 192.667, RSMo. {#sec-19-csr-10-33.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.040}

(1) The following definitions shall be used in the interpretation of this rule in addition to the definitions found in 19 CSR 10-33.010:

(A) Batch message file means the transmission of a file containing multiple discrete standard electronic messages to the department from the hospital data system on a periodic basis less than real time.

(B) Chief complaint means the textual literal or ICD-9-CM code or both pertaining to the initial complaint a patient stated during an acute care hospital encounter.

(C) Data encryption means the electronic obfuscation of data within an electronic message using industry standard practices for encryption including, but not limited to:

Public Key Infrastructure (PKI), digital certificates/signatures, department generated symmetric keys, or by secure message transport protocols. Minimum requirements will be tripleDES 128-bit encryption.

(D) Default standard message means a standard electronic message meeting HL7 2.3.1 Admission, Discharge, and Transfer (ADT) specifications as identified in Exhibit A, included herein.

(E) Acute care hospital encounter means patients seen in the emergency room, urgent care and inpatient admissions of a hospital.

(F) Real time message means the transmission of discrete standard electronic messages to the department as they are generated by the hospital data system.

(G) Secure message transport protocol means a method of sending electronic data to the department in a way that prevents unauthorized access to the data. Possible methods include: Virtual Private Network (VPN), Secure File Transport Protocol (SFTP), secure socket layer (HTTPS/SSL), Secure SHell (SSH), encrypted files using TCP/IP, or other secure transmission protocol agreed upon by the hospital and the department.

(H) Standard electronic message means a real time message or batch message file meeting national or international standards for the electronic interchange of data. Standards include, but are not limited to, Health Level 7 (HL7), Extensible Mark-up Language (XML), Electronic Business XML (ebXML), Electronic Data Interchange (EDI), and other standards as they become available.

(I) Hospital means a hospital as defined in

section 197.020, RSMo. For the purposes of this rule only, hospital shall not include a hospital in a rural area as defined in section 191.500, RSMo; a hospital designated by the Health Resources Services Administration as a small rural hospital; a hospital licensed as a psychiatric or a rehabilitative hospital; or a hospital without an emergency room.

Following the completion of implementation of plans submitted to and approved by the department pursuant to section (4), the department may review the need to expand this definition to include hospitals in a rural area as defined in section 191.500, RSMo or hospitals designated by the Health Resources Services Administration as a small rural hospital.

(2) All hospitals shall submit to the department a minimum data set on acute care hospital encounters occurring after the date proposed by the hospital and approved by the department. This date shall be either between April 2004 and January 2007 or an earlier date agreed upon by the hospital and the department. Before April 2004, the department shall conduct a pilot study with hospitals that volunteer to participate in the pilot study. At the sole discretion of the department, the pilot study may be extended. If the pilot study is continued, the department shall inform hospitals that their planned implementation date has been postponed to a new date as determined by the department. The data shall be submitted as a default standard electronic message or other format as agreed upon by the hospital and the department, using secure message transport protocols and data encryption.

(A) The minimum dataset shall be submitted a minimum of once per day as a batch message file containing the previous day’s hospital encounters and updates.

(B) Real time messages will be default standard electronic messages. Other message formats must be approved and agreed upon by the department prior to submission of real time messages.

(3) The minimum dataset shall include: record type, hospital identifier, unique encounter identifier, type of encounter, place of service, patient medical record number, patient name, patient Social Security number, patient birth date, patient sex, patient race, patient ethnicity, residence address, city of residence, state of residence, zip code, county code, admission date, type of admission, and chief complaint. See Exhibit A and Exhibit B, included herein, for default standard electronic message specifications.

(4) Every hospital shall submit to the department by November 1, 2003 a plan that specifies how and when they will submit data to the department in compliance with section (2) of this rule. This plan may be revised by the hospital, with the approval of the department, in the event the hospital’s capacity to report electronic messages changes to support the default standard electronic message as either batch or real time messages. The hospital shall notify the department by sixty (60) days in advance of the date they plan to change the method in which they report data. This plan shall include but not be limited to:

(A) Timing of messages either real time or batch;

(B) Secure message transport protocols to be used when submitting data to the department;

(C) Proposed format of data if the hospital is not able to conform to the default standard electronic message defined in Exhibit A or Exhibit B;

(D) Proposed format code set domain values if the hospital is not able to conform to the code sets defined in Exhibit A or Exhibit B;

(E) Hospital technical contact(s) and contact information for the department to utilize in the event technical assistance or support is necessary;

(F) Expected date to begin sending messages;

(G) If a change request, the reason for change.

(5) Hospitals shall notify the department by sixty (60) days in advance if they plan to submit the required data to the department through an association or related organization with which the department has a binding agreement to obtain data. Providers selecting this option are responsible for ensuring that the data meet the data standards defined in this rule and are submitted to the association or related organization so the time schedule in section (2) of this rule is met. The association or related organization is responsible for ensuring that the data are provided to the department and conform to the specifications listed in Exhibit A of this rule, meeting the time schedule of section (2) of this rule.

(6) Hospitals may submit data directly to the department or through a third party acting as their agent, other than one with which the department has a binding agreement.

Providers selecting this option are responsible for ensuring that all data specifications conform to the requirements of this rule.

(7) The department may release patient data on hospital encounters to a public health

(8) Any hospital which determines it will be temporarily unable to comply with any of the provisions of this rule or with the provisions of a previously submitted plan or plan of correction can provide the department with written notification of the expected deficiencies and a written plan of correction. This notification and plan of correction shall include the

(9) Any hospital, which is not in compliance with these rules, shall be notified in writing by the department. The notification shall specify the deficiency and the action, which must be taken to be in compliance. The chief executive officer or designee shall have ten (10) working days following receipt of the written notification of noncompliance to provide the department with a written plan for correcting the deficiency. The plan of correction shall specify the means the provider will employ for correcting the cited deficiency and the date that each corrective measure will be completed.

(10) Upon receipt of a required plan of correction, the department shall review the plan to determine the appropriateness of the corrective action. If the plan is acceptable, the department shall notify the chief executive officer or designee in writing and indicate that implementation of the plan should proceed. If the plan is not acceptable, the department shall notify the chief executive officer or designee in writing and indicate the reasons why the plan was not accepted. A revised, acceptable plan of correction shall be provided to the department within ten (10) working days.

(11) Failure of the hospital to submit an of the department.

(12) Failure of any hospital to follow its wise by the director of the department.

(13) Any hospital in continued and substannotified by registered mail and reported by the department to its Bureau of Hospital Licensing and Certification, Bureau of Narcotics and Dangerous Drugs, Bureau of tion. The department shall notify the agencies that the provider is no longer eligible for participation in a state program.

(14) Any hospital that has been declared to be ineligible for participation in a state program shall be eligible for reinstatement by correcting the deficiencies and making written application for reinstatement to the department.

Any provider meeting the requirements for reinstatement shall be notified by registered mail. The department shall notify state agencies that administer a program with provider participation that the provider’s eligibility for participation in a state program has been reinstated.

History

authority to assist the agency in fulfilling its public health mission. This data shall not be re-released in any form by the public health
authority without the prior authorization of the department. Authorization for subsequent release of the data shall be considered only if patient, physician or provider. However, the department may authorize contact with the patient, physician or provider based upon the information supplied. The physician and provider that provided care to a patient shall be informed by the public health authority of any proposed contact with a patient.
AUTHORITY: sections 192.020, 192.067 and 192.667, RSMo 2000. Emergency rule filed June 25, 2003, effective July 6, 2003, expired Jan. 2, 2004. Original rule filed June 25, 2003, effective Dec. 30, 2003. Original authority: 192.020, RSMo 1939, amended 1945, 1951; 192.067, RSMo 1988; and 192.667, RSMo 1992, amended 1993, 1995.

19 CSR 10-33.050 Reporting of Healthcare- Associated Infection Rates by Hospitals, Ambulatory Surgical Centers, and Abortion Facilities {#sec-19-csr-10-33.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.050}

PURPOSE: This rule establishes requirements and procedures for reporting hospital, ambulatory surgical center, and abortion facility healthcare-associated infection incidence data to the Department of Health and Senior Services.

(1) The following definitions shall be used in the interpretation of this rule:

(A) Ambulatory Surgery Centers (ASCs) and Abortion Facilities (AFs) as defined in

section 197.200, RSMo;

(B) CDC means the federal Centers for Disease Control and Prevention;

(C) Catheter-associated urinary tract infections (CAUTI) as defined by the National Healthcare Safety Network (NHSN), or its successor;

(D) Central line-associated bloodstream infection (CLABSI) as defined by NHSN, or its successor, means central line-related bloodstream infection as referred to in section 192.667.12(3), RSMo;

(E) Department means the Missouri Department of Health and Senior Services;

(F) HAI means Healthcare Associated Infection;

(G) Hospitals as defined in section 197.020, RSMo, but excluding Critical Access Hospitals, Psychiatric Hospitals, Rehabilitation Hospitals, and Long Term Acute Care Hospitals, as designated by the Centers for Medicare and Medicaid Services;

(H) Intensive care unit (ICU) means coronary, medical, surgical, medical/surgical, pediatric intensive care unit (PICU), and neonatal intensive care units (NICU) as defined by NHSN;

(I) NHSN means the National Healthcare Safety Network, CDC’s widely used healthcare-associated infection tracking system;

(J) Risk index means grouping patients who have operations according to the American Society of Anesthesiologists (ASA) score, length of procedure, wound class, and other criteria as defined by the CDC for the

purpose of risk adjustment as required in section 192.667.3, RSMo;

(K) The Standardized Infection Ratio (SIR) is a summary measure used to track HAIs over time at a national, state, or facility level.

It adjusts for various facility and/or patientlevel factors that contribute to HAI risk within each facility;

(L) Surgical site infection (SSI) as defined by NHSN, or its successor; and (M) Ward means pediatric, medical, surgical, and medical/surgical hospital areas for the evaluation and treatment of patients, as defined by NHSN, or its successor.

(2) All hospitals shall confer rights, via NHSN, to the department to access data necessary to compute HAI incidence metrics on the following:

(A) CLABSIs detected in wards and ICUs;

(B) SSIs from designated types of surgeries as set forth in section (4) of this rule; and (C) CAUTIs detected in wards and ICUs, excluding NICUs.

(3) All ASCs and AFs shall submit to the department or NHSN, or its successor, data to compute HAI incidence metrics on SSIs from designated types of surgeries as set forth in section (5) of this rule.

(4) Hospitals shall report SSIs and associated denominator data to NHSN, or its successor, related to a hip prosthesis, to an abdominal hysterectomy, to a colon surgery, and to a coronary artery bypass graft with both chest and donor site incisions performed.

(5) ASCs and AFs shall report SSIs and associated denominator data by risk index related to breast surgery and herniorrhaphy.

(6) All hospitals shall annually complete the NHSN Patient Safety Component- Annual Hospital Survey and confer rights to grant the department access to these survey results.

(7) Any ASC or AF who voluntarily submits HAI data via NHSN shall annually complete the NHSN Patient Safety Component- Annual Facility Survey for ASC and confer rights to grant the department access to these survey results.

(8) Any ASCs or AFs who do not voluntarily submit to NHSN shall complete an annual survey when prompted by the department, providing, at a minimum, the number of surgical procedures as required in section (5).

(9) Based on the survey information reported in section (7), ASCs and AFs that reported performing fewer than twenty (20) surgeries per surgery type, as specified in section (5), shall be exempt from reporting the SSI information regarding the surgery.

(10) Hospitals, ASCs, and AFs who submit HAI data to NHSN or its successor, shall meet the HAI reporting requirements if— (A) All NHSN mandatory data items are submitted;

(B) All data are submitted to the NHSN within sixty (60) days of the end of the reporting month; and (C) All data are submitted to NHSN per NHSN guidelines.

(11) If an ASC or AF chooses to not submit the required data to NHSN, the ASC or AF may meet the HAI reporting requirements by submitting to the department numerator and denominator data on electronic forms provided by the department, or in a format approved by the department, for each of the infections specified in section (5) and if— (A) All mandatory data items are submitted;

(B) Policies and procedures are in place to ensure that all HAIs as required by this rule are detected and reported. Such policies and procedures shall be consistent with appropriate guidelines of CDC, or the SHEA, or the APIC; and (C) All data are submitted to the department within sixty (60) days of the end of the reporting month.

History

AUTHORITY: section 192.667, RSMo Supp. 2017. Original rule filed Feb. 1, 2005, effective July 30, 2005. Amended: Filed Oct. 24, 2017, effective April 30, 2018. 1993, 1995, 2004, 2016, 2017.

Chapter 60 Professional and Practical Loan and Training Programs

19 CSR 10-60.060 Health Professional Loan Repayment Program AND SENIOR SERVICES DIVISION 10—OFFICE OF THE DIRECTOR SERVICES and Training Programs {#sec-19-csr-10-60.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-60.060}

19 CSR 10-60.060 Health Professional Loan Repayment Program (Terminated October 6, 2023) {#sec-19-csr-10-60.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-60.060}

Emergency rule filed Sept. 28, 2023, terminated Oct. 6, 2023.

Chapter 130SN * - moved to 19 CSR 30-1

19 CSR 10-130SN * - moved to 19 CSR 30-1 {#sec-19-csr-10-130sn omnilex-key=us-mo-regs-official--title-19--19 CSR 10-130SN}

MATTBLUNT(1/29/03)

Rules of Department of Health and Senior Services Division 10óOffice of the Director SPECIAL NOTICE

Chapter 130óControlled Substances On August 1, 1986, Chapter 130 of Division 10óOffice of the Director was transferred to Division 30óDivision of Health Resources. These rules may be found at 19 CSR 30-1.

Division 15 Division of Senior and Disability Services

Chapter 1 Organization

19 CSR 15-1.010 Organization and Operation {#sec-19-csr-15-1.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-1.010}

(Rescinded February 29, 2024)

This rule originally filed as 13 CSR 15-1.010. Emergency rule filed Aug. 13, 1979, effective Oct. 1, 1979, expired Jan. 25, 1980.

Original rule filed Aug. 13, 1979, effective Dec. 13, 1979. Emergency amendment filed Oct. 15, 1980, effective Oct. 25, 1980, expired Feb. 26, 1981. Amended: Filed Nov. 10, 1980, effective Feb. 12, 1981.

Amended: Filed Oct. 7, 1981, effective Dec. 11, 1981. Amended: Filed Nov. 12, 1982, effective Feb. 11, 1983. Amended: Filed Nov. 9, 1984, effective Feb. 11, 1985. Moved to 19 CSR 15-1.010, effective Aug. 28, 2001. Rescinded: Filed Sept. 1, 2023, effective Feb. 29, 2024.

History

AUTHORITY: Executive Order 77-9 of the Governor filed Jan. 31, 1979, effective Sept. 28, 1979, Chapter 198 and sections 207.020 and 208.152, RSMo Supp. 1993, 251.070 and 536.023, RSMo 1986.

Chapter 2 Education and Program Enhancement

19 CSR 15-2.010 Alzheimer’s Pilot Project Grants {#sec-19-csr-15-2.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-2.010}

PURPOSE: This rule describes the general requirements that all applicants shall meet to receive a grant to provide pilot projects in compliance with section 660.069, RSMo (Supp. 1987).

(1) All grantee contracts solicited through competitive bid under this rule shall be done so in accordance with Chapter 34, RSMo (Supp. 1987).

(2) Public and private agencies are eligible to apply for funds available through the pilot projects program. Public and private agencies shall not receive funds to expand existing services or to duplicate services already available through the agency in their jurisdiction or locale.

(3) The grantees shall use the funds for development or delivery of program-related services and expenses, and not for administrative expenses normally considered a cost of doing business which are to be considered as a grantee match.

(4) The pilot projects shall develop appropriate services for persons having Alzheimer’s disease and related disorders as defined in subdivision 660.067(2), RSMo (Supp. 1987).

(5) The actual amount and availability of funds for the pilot projects grants will depend upon the appropriations provided by the general assembly for each fiscal year.

(6) The specific focus of the grants, the amount of the individual grants and the number of grants to be awarded through the solicitation will be determined by the Division of Aging for each year that funding is available.

(7) The Division of Aging shall publicly announce all solicitations at least thirty (30) calendar days prior to the deadline for acceptance of response. Media announcements shall be made within the appropriate area in a manner that will enable potential grantees to be notified. Public notice shall— (A) Identify the program to be funded;

(B) Specify the date by which the response shall be submitted to the Division of Aging for consideration; and (C) Advise how copies of the Request for Proposal (RFP) may be obtained.

(8) Agencies wishing to apply for the pilot projects grants shall submit an RFP response to the Division of Aging within the allotted time frames.

(9) All applications shall be reviewed and grants awarded by a committee comprised of representatives from the Division of Aging, the Department of Mental Health, the Department of Health and other organizations as determined by the Division of Aging.

(10) Grants awarded shall be limited to a duration of one (1) year and the grantee shall expend monies within that time frame.

(11) No grantee shall charge for any service to recipients of the pilot project.

(12) Grantees shall keep required records of monies spent and services provided available to the Division of Aging upon request.

(13) Grantees shall meet all applicable state and local licensure and safety requirements for the provision of those particular services.

(14) Grantees shall maintain a regular licensure, certification or registration mandated by any state or local government, body or board.

(15) Grantees shall allow only employees or volunteers holding a current license, certification or registration to perform those tasks, duties or functions for which licensure, certification or registration is required by any state or local agency, body or board.

(16) Grantees shall be in compliance with all applicable state and local fire and safety laws.

(17) The division may award extensions of existing grants without requiring submission of a new proposal. Should the grantee wish to change the existing proposal for extension, an amended contract must be executed.

(18) Grantees who have previously applied but were not awarded a grant may resubmit a proposal to subsequent RFPs.

(19) The state shall not be liable for pilot project participants.

(20) The Division of Aging reserves the right to terminate and recoup any grant monies or portions thereof awarded for nonconformance with stipulated criteria in this rule and provisions set out in the RFP.

(21) Grantees shall not discriminate against any participants in the pilot projects.

(22) The pilot project shall encourage the development of services for Alzheimer’s disease victims and/or their caregivers according to the guidelines established in subsection 660.069(1), RSMo (Supp. 1987).

MATTBLUNT(3/31/02)

History

AUTHORITY: section 660.069, RSMo Supp. 1987. This rule was previously filed as 13 CSR 15-4.310 and as 13 CSR 15-2.010. Original rule filed April 4, 1988, effective Sept. 11, 1988. Amended: Filed April 19, 1989, effective June 30, 1989. Moved to 19 CSR 15- 2.010, effective Aug. 28, 2001. Original authority: 660.069, RSMo 1987.

Chapter 3 Service Credit Program (Older Volunteer Service Bank)

19 CSR 15-3.010 Definitions as 13 CSR 15-3.010. Original rule filed Sept. 19 CSR 15-3.010, effective Aug. 28, 2001. {#sec-19-csr-15-3.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-3.010}

19 CSR 15-3.020 Sponsoring Agencies as 13 CSR 15-3.020. Original rule filed Sept. 19 CSR 15-3.020, effective Aug. 28, 2001. {#sec-19-csr-15-3.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-3.020}

19 CSR 15-3.030 Volunteers as 13 CSR 15-3.030. Original rule filed Sept. 19 CSR 15-3.030, effective Aug. 28, 2001. {#sec-19-csr-15-3.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-3.030}

19 CSR 15-3.040 Service Credits as 13 CSR 15-3.040. Original rule filed Sept. 19 CSR 15-3.040, effective Aug. 28, 2001. {#sec-19-csr-15-3.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-3.040}

19 CSR 15-3.050 Redemption of Credits as 13 CSR 15-3.050. Original rule filed Sept. 19 CSR 15-3.050, effective Aug. 28, 2001. {#sec-19-csr-15-3.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-3.050}

JOHNR. ASHCROFT(7/31/18)

Chapter 4 Older Americans Act

19 CSR 15-4.160 Review, Submission, and Approval of Area Agency on Aging Area Plans {#sec-19-csr-15-4.160 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.160}

19 CSR 15-4.175 Funding for Establishment, Maintenance, Modernization, Acquisition, {#sec-19-csr-15-4.175 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.175}

19 CSR 15-4.190 Areas Agency on Aging Development of a Comprehensive and {#sec-19-csr-15-4.190 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.190}

19 CSR 15-4.220 Area Agency on Aging Technical Assistance, Monitoring, and Evaluation HEALTH AND SENIOR SERVICES Disability Services {#sec-19-csr-15-4.220 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.220}

19 CSR 15-4.010 Definition of Terms {#sec-19-csr-15-4.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.010}

PURPOSE: This rule defines terms used in this chapter.

(1) Access services—A category of services which facilitates access to and utilization of other services. Access services may include but are not limited to transportation, outreach, case management, and information and assistance.

(2) Act—The Older Americans Act of 1965, as amended.

(3) Acquiring—Obtaining ownership of an existing facility in fee simple or by a lease of ten (10) or more years for use as a multipurpose senior center.

(4) Administration for Community Living (ACL)—An agency of the U.S. Department of Health and Human Services (HHS). ACL is structured to provide general policy coordination while retaining unique programmatic operations specific to the needs of each population it serves.

(5) Administration on Aging (AoA)—An agency within the Administration for Community Living of the U.S. Department of Health and Human Services, charged with administering provisions of the Older Americans Act of 1965, as amended, with the exception of the Senior Community Service Employment Program (SCSEP).

(6) Administrative action—Any action or decision made by an owner, employee, or agent of a long-term care (LTC) facility, or by an area agency on aging or the division, which affects the provision of services to service recipients.

(7) Adequate proportion—An amount of supportive services funds determined by the state agency to be sufficient to meet the need for a given priority service in a particular planning and service area.

(8) Adult day care—As defined in 19 CSR 30- 90.010.

(9) Adult(s) with disabilities—Any individual who has a mental or physical impairment that substantially limits one (1) or more of their major life activities, has a record of such impairment, or is regarded as having such an impairment.

(10) Advisory council—A council consisting of older adults (including minority individuals and older adults residing in rural areas) who are participants or who are eligible to participate in programs administered under the Older Americans Act, family caregivers of such individuals, representatives of older adults, service providers, representatives of the business community, local elected officials, providers of veterans’ health care (if appropriate), and the general public to advise continuously the area agency on aging on all matters relating to the development of the area plan, the administration of the plan, and operations conducted under the plan.

(11) Advocacy—The act of speaking or writing in support of older adults and/or issues concerning older adults.

(12) Aging and Disability Resource Center— An entity, network, or consortium established by a state as part of the state system of longterm care, to provide a coordinated and integrated system for older adults and adults with disabilities, and the caregivers of older adults and adults with disabilities, that provides— (A) Comprehensive information on the full range of available public and private longterm care programs, options, service providers, and resources within a community, including information on the availability of integrated long-term care services, and federal or state programs that provide long-term care services and supports through home and community-based service programs;

(B) Person-centered counseling to assist individuals in assessing their existing or anticipated long-term care needs and goals, and developing and implementing a personcentered plan for long-term care that is designed to meet the individual’s specific needs, goals, and circumstances;

(C) Access for individuals to the range of publicly-supported long-term care services and supports for which the individuals may be eligible, including home and communitybased service options, by serving as a convenient point of entry for such programs and supports; and (D) In cooperation with area agencies on aging, centers for independent living described in part C of Title VII of the Rehabilitation Act of 1973 (29 U.S.C. 796f et seq.), and other community-based entities, information and referrals regarding available home and community-based services for individuals who are at risk for residing in, or who reside in, institutional settings, so that the individuals have the choice to remain in or to return to the community.

(13) Altering or renovating—Making modifications to an existing facility which are necessary for its effective use as a multipurpose senior center, including restoration, repair, expansion, and all related physical improvements.

(14) Area Agency on Aging (AAA)—The agency designated by the division in a planning and service area to develop and administer a plan and administer available funds for a comprehensive and coordinated system of services for older adults and adults with disabilities who require similar services.

(15) Area Agency on Aging governing body—The policy-making board or oversight body which directs the actions of the AAA under local, state, and federal laws and regulations.

(16) Area plan—The document submitted by an area agency on aging to the division for approval in order to receive subgrants or contracts.

(17) Assessment—The mechanism for determining needs and eligibility for programs and (18) Assistant Secretary—The Assistant Secretary for Aging of the U.S. Department of Health and Human Services.

(19) Case management—A service which ensures that individuals with chronic or acute care needs are assessed and provided with a comprehensive and coordinated service program designed to meet those assessed needs.

(20) Caterer—A restaurant, hospital, school, or commercial organization which prepares meals under contract.

(21) CBSA (Core Based Statistical Area)— Consists of one (1) or more counties with at least one (1) urban core of at least ten thousand (10,000) in population, plus adjacent counties that are socioeconomically tied to the urban core by commuting.

(22) Collocation of services—Coordination and scheduling representatives of providers and other agencies and organizations to assure that, in addition to a center’s usual services, all available services benefiting older adults are accessible and convenient for recipients.

(23) Confidentiality—Procedures which assure the anonymity of the individual service recipient.

(24) Congregate nutrition services—The provision of nutrition services to older adults in a congregate or group setting.

(25) Contributions—Money or Supplemental Nutrition Assistance Program (SNAP) (for meals only) given voluntarily and confidentially toward the cost of a service received.

(26) Construction—The building of a new multipurpose senior center including the costs of land, acquisition, and architectural engineering fees.

(27) Continuum of care—A full range of economic, physical, psychological, and social support programs and services necessary to maintain or restore older adults to optimal functioning.

(28) Department—Missouri Department of Health and Senior Services.

(29) Disaster preparedness plan—A regional or statewide plan to organize local efforts to assist older adults and adults with disabilities in the event of a disaster situation which affects large numbers of people.

(30) Division—The Division of Senior and Disability Services within the Department of Health and Senior Services, the designated state unit on aging.

(31) Education and training services—Supportive services designed to broaden the knowledge and skills of older adults, their caregivers, advocates, and the professionals serving them to cope more effectively with their economic, health, and personal needs.

(32) Focal point—A facility established to encourage the maximum collocation and coordination of services for older adults.

(33) Greatest economic need—The need resulting from an income level at or below the poverty line.

(34) Greatest social need—The need caused by non-economic factors, including disability; language barriers; and cultural, social, or geographic isolation, including isolation caused by racial or ethnic status, which restrict the ability of an individual to perform normal daily tasks and/or threatens the capacity of the individual to live independently.

(35) Health screening services—Services in which the service recipient’s general health is reviewed, health education is provided, simple tests are provided, or referral is made if indicated.

(36) Highest Level Evidence-Based Program—A program that meets the following criteria: demonstrated through evaluation to be effective for improving the health and well-being or reducing disease, disability, and/or injury among older adults; proven effective with older adult population, using experimental or quasi-experimental design; research results published in a peer-reviewed journal; fully translated in one (1) or more community site(s); and includes developed dissemination products that are available to the public.

(37) Home-delivered nutrition services— Nutrition services delivered to eligible recipients in their homes.

(38) Indirect costs—Those costs allocated to area agency on aging grant awards based on a rate approved by the organization’s cognizant federal agency.

(39) Information and assistance—A service for older adults that— (A) Provides current information on opportunities and services available to older adults within their communities;

(B) Assesses the problems and capabilities of the older adults;

(D) Ensures that older adults receive the services needed, and are aware of the opportunities available to the older adult, by establishing follow-up procedures; and (E) Serves older adults with greatest social need, economic need, and those at risk for institutional placement.

(40) Legal assistance—Legal advice and representation provided by an attorney to older adults and adults with disabilities with economic and social needs. Legal Assistance includes to the extent feasible, counseling or other appropriate assistance by a paralegal or law student under the supervision of an attorney, and counseling or representation by a nonlawyer where permitted by law.

(41) Local government—A political subdivision of the state, whose authority is general and not limited to only one (1) function or combination of related functions.

(42) Long-Term Care (LTC) facility—As defined in section 192.2300, RSMo.

(43) Match—The equivalent cash value of third-party in-kind contributions or non-federal cash resources representing that portion of the costs of a grant-supported project or program not fully borne by the federal or state government.

(44) Monitoring—The review and evaluation of all area agency on aging activities by the division or designee, or of contractor activities by the area agency on aging.

(45) Multipurpose senior center—A community or neighborhood facility for the organization and provision of a broad spectrum of services which shall include, but not be limited to, provision of health, including mental health, social, nutritional, and educational services, and the provision of facilities for recreational activities for older adults.

(46) Net cost—The total allowable costs, less grant-related income, for the purpose of meeting match requirements.

(47) Nonprofit—An agency, institution, or organization which is owned and operated by one (1) or more corporations or associations with no part of the net earnings benefiting any private shareholder or individual.

(48) Nutrition services—Provision of congregate or home-delivered meals, or both.

(49) Older adult—A person sixty (60) years of age or older.

(50) Ombudsman—An individual assigned by the division, the area agency on aging, or the area agency on aging’s contractors to investigate and resolve complaints made by or on behalf of older adults who are residents of LTC facilities relating to administrative action which may adversely affect the health, safety, welfare, and rights of these residents.

(51) Outreach—Intervention with individuals initiated by an agency or organization for the

purpose of identifying potential clients (or their caregivers) and encouraging their use of existing services and benefits.

(52) Planning and service area (PSA)—A geographic area of the state that is designated by the division for purposes of planning, developing, delivering, monitoring, and administering services to older adults and adults with disabilities.

(53) Policy—A principle established by a government, organization, or an individual that guides decision making and actions.

(54) Preprint—The division’s instruction for development and submission of the area agency on aging plan or plan amendment.

(55) Priority services—Those service categories of access, in-home, and legal assistance.

(56) Program—Any service funded under the approved area plan.

(57) Program costs—Costs incurred by the area agency on aging in managing and delivering a service.

(58) Program evaluation—The review and determination of program effectiveness in meeting recipient needs.

(59) Program monitoring—The review and determination of progress in meeting program objectives.

(60) Protective services—Services provided by the division in response to the need for protection from harm or neglect to older adults and adults with disabilities under sections 192.2400–192.2505, RSMo.

(61) Public hearing—An open hearing which provides an opportunity for older adults, the general public, officials of general purpose, local government, and other interested parties to comment.

(62) Regional office—U.S. Department of Health and Human Services, Administration for Community Living (ACL) office located in Kansas City, Missouri.

(63) Renovating—See altering.

(64) Request for proposal (RFP)—A formal invitation to prospective contractors to submit bids for procurement of a defined set of activities, services, or goods.

(65) Request for qualifications (RFQ)—A type of RFP which is a formal invitation to prospective providers to submit information suitable for determining eligibility as a qualified provider.

(66) Rural areas—An area that encompasses all population, housing, and territory not included within an urban area as defined by the United States Census Bureau.

(67) Senior center—A facility providing nutrition services and a variety of supportive services to older adults.

(68) Service provider—Any entity which contracts with the Department of Health and Senior Services or an area agency on aging to provide services directly to older adults.

(69) Service recipient—An eligible individual who receives one (1) or more services.

(70) Staff hour—An hour of staff time spent on any activity related to the service identified.

(71) Standards—The minimum requirements to be met for the operation of programs and the delivery of services.

(72) State plan—The document containing the division’s priorities, goals, policy statements, and objectives for enabling older adults to fulfill their potential for independent functioning.

(73) Structural change—Any change to the loadbearing members of a building.

(74) Supportive services—The set of services described in Section 321a and Section 373b of the Older Americans Act.

(75) Supportive service center—A facility providing only activities and supportive services, but no nutrition services.

(76) Target population—Older adults aged sixty (60) or over, with the greatest social and economic need, including low-income minority adults and adults residing in rural areas.

(77) Technical assistance—Specific guidance and expertise provided by the division staff to the area agency on aging or by the area agency on aging staff to the service provider staff.

(78) Time/temperature control for safety food—A food that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation per the Food and Drug Adminstration (FDA).

(79) Transportation service—A vehicular service which facilitates access to other services.

(80) Third-party in-kind contributions— Property or services which benefit grant-supported projects or programs and which, under the grant or subgrant, are contributed by nonfederal third parties without charge to the grantee, the subgrantee, or a cost-type contractor.

(81) Unit of general purpose local government—See local government.

(82) Urban areas—Urbanized areas of fifty thousand (50,000) or more people; or urban clusters of at least two thousand five hundred (2,500) and less than fifty thousand (50,000) people.

(83) Volunteer—A person, other than staff or Senior Community Service Employment Program (SCSEP) enrollees, who contributes personal service.

(84) Waiver—The granting of a deviation from portions of service standards, prohibition of direct service delivery, or any other state regulation. 15-6.005 and 13 CSR 15-4.010. Original rule effective Oct. 31, 1991. Amended: Filed Nov. 14, 1991, effective March 9, 1992. Amended:

Filed Aug. 28, 2000, effective March 30, 2001. Moved to 19 CSR 15-4.010, effective Aug. 28, 2001. Amended: Filed Jan. 25,

19 CSR 15-4.020 Administration of the Older Americans Act {#sec-19-csr-15-4.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.020}

PURPOSE: This rule describes the organizational structure in the state for administration of Title III of the Older Americans Act of 1965, as amended.

(1) The Division of Senior and Disability Services, within the Department of Health and Senior Services, is the single organizational unit that is delegated all authority and responsibility to administer programs under Title III of the Older Americans Act of 1965, as amended, and in accordance with all applicable federal and state laws and regulations.

(2) The division has designated ten (10) distinct planning and service areas (PSAs) within the state with one (1) area agency on aging (AAA) in each PSA. These agencies are Senior Age Area Agency on Aging (including Dallas, Polk, Dade, Lawrence, Greene, Webster, Wright, Texas, Shannon, Oregon, Howell, Douglas, Christian, Barry, Stone, Taney, and Ozark counties); Southeast Missouri Area Agency on Aging (SEMO), d/b/a Aging Matters (including Cape Girardeau, Ste.

Genevieve, Perry, St. Francois, Iron, Madison, Reynolds, Wayne, Bollinger, Scott, Mississippi, Stoddard, Butler, Ripley, Carter, New Madrid, Pemiscot, and Dunklin counties); District III Area Agency on Aging, d/b/a Care Connection for Aging Services (including Chariton, Carroll, Saline, Lafayette, Johnson, Pettis, Henry, Benton, Bates, St. Clair, Hickory, Vernon, and Cedar counties); Young at Heart Resources (including Atchison, Daviess, Nodaway, Worth, Harrison, Mercer, Putnam, Sullivan, Grundy, Gentry, Holt, Andrew, DeKalb, Buchanan, Clinton, Caldwell, Livingston, and Linn counties); Northeast Missouri Area Agency on Aging (NEAAA) (including Adair, Schuyler, Scotland, Clark, Knox, Lewis, Macon, Shelby, Marion, Randolph, Monroe, Ralls, Pike, Lincoln, Montgomery, and Warren counties); Central Missouri Area Agency on Aging (CMAAA), d/b/a Aging Best (including Audrain, Boone, Callaway, Cooper, Howard, Miller, Moniteau, Cole, Osage, Morgan, Gasconade, Crawford, Washington, Dent, Phelps, Maries, Pulaski, Laclede, and Camden counties); Mid-America Regional Council, Department of Aging and Adult Services (including Ray, Clay, Platte, Jackson, and Cass counties); Aging Ahead (including St. Louis, St. Charles, Franklin, and Jefferson counties); St. Louis Area Agency on Aging (SLAAA) (St. Louis City); and Region X Area Agency on Aging (including Barton, Jasper, Newton, and McDonald counties).

(3) Any public or nonprofit private agency or office or agency of a unit of general purpose local government, regional planning area, or metropolitan area which is designated to function only for the purpose of serving as an area agency on aging may apply to the division to be designated as a PSA. The division will consider the following factors in making a determination:

(A) A population of one hundred thousand (100,000) or more;

(B) The numbers of adults aged sixty (60) or older, including those with the greatest economic and social need;

(D) The incidence of need for services and the resources available to administer services to meet those needs; and (E) The boundaries of units of general purpose local government, regional planning areas, existing economic development districts and areas within the state established for planning and administering human services, including the area-wide comprehensive planning and development districts or regions established pursuant to the state and local review system which replaces that of the Office of Management and Budget Circular A-95, Part IV. The division will include all portions of an economic development district within a single PSA.

(4) If the division denies an application for designation as a PSA, the applicant shall receive written notification which shall include:

(A) Explanation of the reasons for denial of the application;

(B) Provision of the opportunity for the applicant to review any pertinent documents upon which the determination was based; and (C) Notification of the right to request a formal hearing on the determination. 4.020. Original rule filed Jan. 6, 1986, effective April 30, 1986. Emergency amendment filed Jan. 5, 1989, effective Jan. 16, 1989, expired April 24, 1989. Amended: Filed Jan. 5, 1989, effective March 25, 1989. Moved to 19 CSR 15-4.020, effective Aug. 28, 2001.

19 CSR 15-4.030 Governor’s Advisory Council on Aging {#sec-19-csr-15-4.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.030}

(Rescinded August 30, 2018)

History

AUTHORITY: section 660.050, RSMo 1986. 15-6.030 and 13 CSR 15-4.030. Original rule Moved to 19 CSR 15-4.030, effective Aug. 28, 2001. Rescinded: Filed Jan. 5, 2018, effective Aug. 30, 2018.

19 CSR 15-4.040 State Plan {#sec-19-csr-15-4.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.040}

PURPOSE: This rule describes the process where the division develops the state plan.

(1) The assessment and planning process used by the division to develop a comprehensive and integrated plan for delivery of services statewide includes but is not limited to consulting with area agencies on aging, division staff, and other agencies and organizations to— (A) Assess the needs of older adults in the state;

(B) Establish statewide priorities;

(C) Review procedures with regard to the development and implementation of the state plan; and (D) Ensure that the objectives established in the state plan and the area agencies on aging’s area plans are consistent.

(2) The state plan is developed to cover a period of up to four (4) years, is reviewed by the governor and submitted to the assistant secretary. It is reviewed annually and updated as needed reflecting input and advice from older adults throughout the state and from the area agencies on aging.

(3) The state plan is available for review in the office of the director of the Division of Senior and Disability Services, or at https://health.mo.gov/seniors/state-planaging.php. 15-6.035 and 13 CSR 15-4.040. Original 1986. Emergency amendment filed Oct. 16, 1991, effective Oct. 26, 1991, expired Feb. 13, 1992. Amended: Filed Oct. 16, 1991, effective Feb. 6, 1992. Amended: Filed Aug. 19 CSR 15-4.040, effective Aug. 28, 2001.

19 CSR 15-4.050 Funding Formula and Fiscal Management {#sec-19-csr-15-4.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.050}

PURPOSE: This rule describes the division’s fiscal management responsibilities under Title III of the Older Americans Act.

(1) The division in consultation with all area agencies on aging (AAAs) shall develop and use an intrastate funding formula for the allocation of funds received under Title III of the Older Americans Act (the Act) and Title III-B funds utilized for outreach demonstration projects and the ombudsman program.

(2) The intrastate funding formula for the state of Missouri shall be established by the proportion of the population in each planning and service area (PSA) as calculated by using the following four (4) factors:

(A) All adults in each PSA sixty (60) years of age or older;

(B) All adults in each PSA sixty (60) years of age or older who are low income;

(D) All adults in each PSA who are sixty (60) years of age or older who are in the greatest social need. The basis for this factor shall be determined by the number of adults who are of the appropriate age— 1. With a physical or mental disability;

With a language barrier;
Who are geographically isolated; or 4. Who are culturally or socially isolated;

(E) Data used to compute the area agency on aging allotment percentages will be derived from the most recent decennial Census of Population and Housing, for the following categories:

Population sixty (60) years of age and over;
Population sixty (60) years of age and over, below poverty;
Population sixty (60) years of age and over, minority below poverty;
Population sixty (60) years of age and over, rural or geographically isolated; and 5. Population sixty (60) years of age and over, minority;

(F) Data from the most recent decennial Census of Population and Housing, will be used for the following categories:

Population sixty (60) years of age and over with a disability;
Population sixty (60) years of age and over with limited English.

(3) The funds allocated to each area agency on aging shall include an identical base amount to each AAA in the state and an amount allotted using the factors in section (2).

(4) The division shall use the data from the most recent decennial census in computing allotment percentages. In addition, the division shall revise allotment percentages, at least, biennially in accordance with population estimates made available through the Missouri Office of Administration.

(5) Area agencies on aging shall have available not more than ten percent (10%) of the total federal Older Americans Act Title III

Part B, Part C-1, Part C-2, and Part E funds for paying such percentage, but not more than seventy-five percent (75%) of the cost of administration of the area plan. The ten percent (10%) administration allowance shall only be taken from amounts made available to the area agencies on aging from federal Older Americans Act Title III Part B, Part C-1, Part C-2, and Part E. 15-6.195 and 13 CSR 15-4.050. Original rule 15, 1988. Emergency amendment filed June 16, 1992, effective July 1, 1992, expired Oct. 28, 1992. Amended: Filed April 1, 1992, effective Sept. 6, 1992. Emergency amendment filed April 14, 1994, effective April 24, 1994, expired Aug. 21, 1994. Emergency amendment filed April 27, 1994, effective May 13, 1994, expired Sept. 9, 1994.

Amended: Filed April 14, 1994, effective Sept. 30, 1994. Emergency amendment filed Aug. 1, 1994, effective Aug. 22, 1994, expired Dec. 19, 1994. Emergency amendment filed Aug. 1, 1994, effective Sept. 11, 1994, expired Jan. 8, 1995. Emergency amendment filed Dec. 19, 1994, effective Jan. 8, 1995, expired May 7, 1995. Emergency amendment filed April 26, 1995, effective May 9, 1995, expired Sept. 5, 1995.

Amended: Filed Dec. 20, 1994, effective June 30, 1995. Emergency amendment filed June 22, 1995, effective July 1, 1995, expired Oct. 28, 1995. Amended: Filed July 17, 1995, effective Jan. 30, 1996. Emergency amendment filed Oct. 19, 1995, effective Oct. 29, 1995, expired April 25, 1996. Amended:

Filed Dec. 28, 1995, effective June 30, 1996.

Amended: Filed Feb. 20, 1997, effective Aug. 30, 1997. Amended: Filed March 16, 1998, effective Sept. 30, 1998. Amended: Filed Feb. 11, 1999, effective Aug. 30, 1999. Amended:

Filed Feb. 2, 2000, effective Aug. 30, 2000.

Amended: Filed Jan. 16, 2001, effective July 30, 2001. Moved to 19 CSR 15-4.050, effective Aug. 28, 2001. Amended: Filed Feb. 15, 2002, effective Aug. 30, 2002. Amended:

Filed March 31, 2003, effective Sept. 30, 2003. Amended: Filed Jan. 25, 2022, effec-

19 CSR 15-4.060 State Long-Term Care Ombudsman Program {#sec-19-csr-15-4.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.060}

PURPOSE: This rule describes how the division operates the statewide Long-Term Care Ombudsman Program.

(1) The statewide Long-Term Care Ombudsman Program (LTCOP) consists of the state office, regional offices, and volunteers. The regional programs are housed in or subcontracted by the designated area agencies on aging. The LTCOP— (A) Identifies, investigates, and resolves complaints made by or on behalf of residents in long-term care (LTC) facilities relating to action, inaction, or decision of providers, or their representatives, of long-term care services, of public agencies or of social service agencies, which may adversely affect the health, safety, welfare, or rights of such residents. If regional LTCOP coordinators, staff or volunteers determine that a nursing home administrator is not willing to work with the ombudsman program to resolve complaints, the regional LTCOP coordinator, staff, or volunteer shall notify the state ombudsman in writing.

The state ombudsman, or his/her designee, may facilitate a meeting with the nursing home administrator, and the regional LTCOP coordinator, staff, and/or volunteer.

If deemed appropriate, the state ombudsman or his/her designee may notify the nursing facility’s corporate staff (if applicable) of the meeting and its results.

The regional LTCOP coordinator or staff of the LTCOP state office may contact the Section for Long-Term Care Regulation (SLTCR). The LTCOP state office staff will monitor cases where the nursing home administrator is unwilling to work with the LTCOP and monitor the involvement and/or investigation conducted by SLTCR;

(B) Monitors the development and implementation of federal, state and local laws, regulations and policies that relate to LTC facilities in the state;

(D) Trains LTCOP staff and volunteers and promotes and assists in the development of citizen organizations;

(E) Implements additional activities, as appropriate, that enhance the LTCOP and are consistent with federal and state requirements and guidelines;

(F) Develops procedures to assure that representatives of the LTCOP are given appropriate access to LTC facilities, appropriate private access to residents and appropriate access to the residents’ personal and medical records; and (G) Establishes a statewide uniform reporting system to collect and analyze complaints about conditions in LTC facilities for the purpose of identifying problems. Information developed is submitted to the division’s licensure and certification section and follow-up is coordinated to resolve significant problems.

Reports on the information gathered and analyzed through the statewide uniform reporting system are submitted to the assistant secretary as required.

History

AUTHORITY: section 192.2000, RSMo 2016, and section 192.2305, RSMo Supp. 2021. 15-6.065 and 13 CSR 15-4.060. Original 1986. Moved to 19 CSR 15-4.060, effective Aug. 28, 2001. Emergency amendment filed Sept. 12, 2003, effective Sept. 22, 2003, expired March 19, 2004. Amended: Filed Sept. 12, 2003, effective Feb. 29, 2004. 192.2305, RSMo 1991, amended 2003, 2014, 2020.

19 CSR 15-4.070 Designation of Area Agencies on Aging {#sec-19-csr-15-4.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.070}

PURPOSE: This rule describes the process used to designate an Area Agency on Aging, what types of agencies may be eligible and the criteria used by the division for designation.

(1) No more than one (1) area agency on aging will be designated within a planning and service area (PSA). If the division withdraws designation of one (1) of the existing area agencies on aging in accordance with

section 192.2000.3, RSMo, prior to designating a new area agency on aging, the division shall— (A) Consider the views of the unit(s) of general purpose government within the PSA;

(B) Determine through an on-site assessment that the potential area agency on aging has the capacity to perform all of the required functions.

(2) Any one (1) of the following types of agencies may be designated as an area agency on aging for a PSA:

(A) Any office or agency representing a unit of general purpose local government that is proposed by the chief elected official of the unit;

(B) Any office or agency proposed by the chief elected officials representing a combination of units of general purpose local government; or (C) Any other public or private nonprofit agency, except any regional or local agency of the state.

(3) Whenever a new area agency on aging is designated after the date of enactment of the Older Americans Act of 1965, as amended, the division will give the right of first refusal to a unit of general purpose local government if— (A) The unit can meet the requirements of subsection (4)(C); and (B) The boundaries of that unit and the boundaries of the area are reasonably contiguous.

(4) The division considers applicants eligible for designation as an area agency on aging that meet the following criteria:

(A) The applicant has prepared and submitted to the division a comprehensive area plan. The area plan shall be completed in accordance with the uniform plan format developed by the division;

(B) If the applicant has responsibilities beyond programs for older adults, it shall agree to create a single organizational unit with delegated authority whose principal function shall be the effective development and implementation of an area plan;

(C) The applicant has demonstrated the capacity to assess the needs of older adults and to plan, administer, monitor, and evaluate services for the entire PSA, including underrepresented groups. The applicant shall be able to work effectively with all public and private social, economic, cultural, political, and geographic elements of the PSA it seeks to serve;

(D) The applicant has documented support of local governments and any local aging councils. The applicant, if a private nonprofit agency, has documented that it is incorporated by the Missouri Secretary of State and maintains a current certificate of good standing; and (E) The applicant, if a private nonprofit agency, has documented that it has applied to the Internal Revenue Service and received the appropriate tax status designation. 15-6.045 and 13 CSR 15-4.070. Original rule Moved to 19 CSR 15-4.070, effective Aug. 28, 2001. Amended: Filed Jan. 25, 2022, effec-

19 CSR 15-4.080 Withdrawal of Designation {#sec-19-csr-15-4.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.080}

PURPOSE: This rule identifies the circumstances under which the division may withdraw designation of an area agency on aging, notify the assistant secretary of the action, and provide for continuity of services.

(1) The division may withdraw an area agency on aging’s designation if— (A) The area agency on aging does not comply with requirements of federal and state laws or rules;

(B) State or federal funds are not being expended for the purposes for which they were intended; or (C) Older adults are not receiving appropriate services within available resources.

(2) Withdrawal of designation of an area agency on aging shall not occur without consultation with the director of the area agency on aging and the area agency on aging board and an opportunity has been granted for a formal hearing and review by the governor.

(3) Should the division withdraw designation of an area agency on aging, the division will notify the assistant secretary in writing of its action, provide a plan for the continuity of services in the affected planning and service area (PSA), and designate a new area agency on aging in the PSA in a timely manner.

(4) If necessary to ensure a continuity of services in a PSA, the division, for a period of up to one hundred eighty (180) calendar days, may perform the responsibilities of the area agency on aging or assign the responsibility of the area agency on aging to another agency in the PSA. The division may request an extension of an additional one hundred eighty (180) days from the assistant secretary if the need for the extension can be demonstrated. 15-6.050 and 13 CSR 15-4.080. Original rule March 30, 2001. Moved to 19 CSR 15-4.080, * Original authority: 192.2000, RSMo 1984, amended

19 CSR 15-4.090 Appeal to the Assistant Secretary {#sec-19-csr-15-4.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.090}

PURPOSE: This rule describes the action that the division takes when an application for designation as a planning and service area has been denied and the denial has been upheld in a division hearing.

(1) Any applicant for designation as a planning and service area (PSA) whose application has been denied by the division and who has requested and received a formal hearing at the state level shall be notified in writing of the right to appeal to the assistant secretary of the Department of Health and Human Services. Written notification shall advise the applicant that a written appeal may be filed with the assistant secretary within thirty (30) calendar days of receipt of notification of the hearing decision.

(2) Upon request by the assistant secretary, the division shall submit the following information regarding an applicant who has filed an appeal:

(A) A copy of the applicant’s application for designation as a PSA;

(B) A copy of the written decision of the division; and (C) Any other relevant information the assistant secretary may require.

(3) Upon receipt of written notice of the date, time, and location, the division director or designated representative or both shall attend the assistant secretary’s hearing on the applicant’s appeal. 15-6.055 and 13 CSR 15-4.090. Original 1986. Amended: Filed Aug. 28, 2000, effective March 30, 2001. Moved to 19 CSR 15- 4.090, effective Aug. 28, 2001. Amended:

19 CSR 15-4.100 Area Agency on Aging Governing Body agency on aging to have a governing body and, unless otherwise governed by local law, ordinance, or charter, specifies its composition, responsibilities, and requirements. {#sec-19-csr-15-4.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.100}

(1) Each area agency on aging, unless otherwise structured by local law, ordinance, or charter shall have a governing body of adequate size and structure to operate efficiently and effectively.

(2) The area agency on aging governing body shall maintain the ultimate authority and responsibility for administration of the approved area plan to provide services to older adults within the designated planning and service area in accordance with all applicable federal, state, and local laws and regulations and division policies and procedures.

(3) The area agency on aging governing body shall have written bylaws, ordinances, or charter that define its membership, authority, responsibilities, and procedures for operation. Unless specified otherwise by local laws, ordinances, or charter the governing body shall comply with the requirements below:

(A) Officers of the governing body shall be elected by the full membership of the board;

(B) No officer of the governing body shall serve in the same office for more than two (2) consecutive terms;

(C) The composition, selection and purpose of standing committees shall be specified in the bylaws. Standing committees must report to the full governing board as directed by the agency’s bylaws, but at least annually;

(D) Membership in the area agency on aging governing body shall not be restricted to individuals from any specific race, creed, color, sex, religion, age, national origin, disabilities, or veteran status. Elections procedures shall conform to 19 CSR 15-4.105.

(E) All members of the area agency on aging governing body shall serve three- (3-) year staggered terms, meaning one-third (1/3) of the membership is elected in year one (1), one-third (1/3) is elected in year two (2), and one-third (1/3) is elected in year three (3), then continue in the same manner; and (F) The area agency on aging governing body shall not select, appoint, or elect as a member, or ex officio member, any individual who is an owner, board member, or employee of a service provider agency that has currently submitted a proposal to the area agency on aging to receive funding to provide services or that is currently providing services under a grant, contract, or stipend with the area agency on aging.

(4) The area agency on aging governing body shall maintain full and complete written minutes of all meetings. Upon request, these minutes shall be available for review by the division and the public.

(5) Meetings of the governing body must follow Robert’s Rules of Order and a parliamentarian shall be designated by the board.

(6) All meetings of the board shall be open to the public as required by section 610.010, RSMo, et seq. commonly referred to as the Sunshine Law.

(7) The governing body annually shall review the bylaws and update if necessary.

(8) The area agency on aging governing body, within thirty (30) days, shall notify the division of any changes it makes in its corporate status, administrative status, staff, location, or telephone number. 15-6.070 and 13 CSR 15-4.100. Original rule 15, 1988. Amended: Filed Aug. 28, 2000, 15-4.100, effective Aug. 28, 2001. Amended:

19 CSR 15-4.105 Area Agency on Aging Election Procedures for Governing Body Membership {#sec-19-csr-15-4.105 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.105}

PURPOSE: This rule establishes and describes election procedures for membership on the area agency on aging governing body.

This rule does not apply to area agency on aging board members appointed by the chief executive of a unit of local government, political subdivision, or council of government who are elected officials with the exception of

section (2).

(1) Solicitation for governing board nominees shall be publicized locally within the area from which a governing body member will be elected. Nominations may be made by filing a statement of intent at a publicized location in each area or at a publicized open meeting held in the area.

(2) Nominees must be residents of the area they represent and must sign a code of ethics as approved by the governing body.

(3) All voters must register to vote at the polling location. Any person sixty (60) years of age or older shall be eligible to vote.

(4) The area agency on aging governing body will designate a minimum of one (1) polling location per county.

(5) The time and location of the election shall be publicized in community newspapers at least seven (7) days prior to the election and posted at a minimum in all area agency on aging sponsored senior centers.

(6) Polling places shall be open for voting at least six (6) consecutive hours, with provisions for persons with special needs, including optional absentee voting. Polling locations shall not be open earlier than 6:00 a.m., nor stay open any later than 7:00 p.m.

(7) The area agency on aging will be responsible for printing the official ballots. Nominees shall be listed alphabetically.

(8) A minimum of two (2) persons designated by the area agency on aging shall be present to count votes unless a local county clerk agrees to count votes and certify the results.

(9) Results of the election will be submitted to the area agency on aging central office in a standard reporting format.

(10) All ballots and affidavits shall be kept for a minimum of twenty-two (22) months as required by 52 U.S.C. 20701 for federal elections, provided they have received final audit approval.

(11) A maximum of thirty (30) days will be allowed to contest the results of an election. 4.105. Original rule filed Feb. 17, 1988, effective June 15, 1988. Amended: Filed Aug. 19 CSR 15-4.105, effective Aug. 28, 2001.

19 CSR 15-4.110 Area Agency on Aging Advisory Council agency on aging to have an advisory council and establishes the requirements it shall meet. {#sec-19-csr-15-4.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.110}

(1) Each area agency on aging shall have an advisory council which shall develop and make public written bylaws which specify the role and functions of the advisory council, number of members, procedure for selection of members, term of membership, and the frequency of meetings.

(2) The advisory council shall meet at least quarterly.

(3) The composition of the councils shall be more than fifty percent (50%) older adults, including older adults with the greatest economic or social need, older minority adults, service recipients and also shall include representatives of older adults, local elected officials, and the general public.

(4) The advisory council shall advise the area agency on aging on developing and administering the area plan, conducting public hearings, representing the interests of older adults, and reviewing and commenting on community policies, programs, and actions affecting older adults.

(5) The area agency on aging shall provide staff and assistance to the advisory council. 192.2020, RSMo 2016.* This rule was previously filed as 13 CSR 15-6.085 and 13 CSR 15-4.110. Original rule filed Jan. 6, 1986, effective April 30, 1986. Moved to 19 CSR 15-4.110, effective Aug. 28, 2001. Amended: 192.2020, RSMo 1984, amended 1994, 2014.

19 CSR 15-4.120 Affirmative Action/Equal Employment Opportunity/Preference in Hiring agency on aging receiving federal or state funds to comply with the requirements of Affirmative Action/Equal Employment Opportunity programs and to give preference in hiring to persons aged sixty (60) or over. {#sec-19-csr-15-4.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.120}

(1) Each area agency on aging shall have an Affirmative Action/Equal Employment Opportunity program as required by 5 CFR

part 900, subpart F. The written Affirmative Action/Equal Employment Opportunity plan shall be kept on file for review and shall be updated as required.

(2) The area agency on aging, subject to established job qualification requirements or merit system requirements, shall give preference in hiring to applicants who are sixty (60) years of age or over for all full- or part-time positions. 15-6.075 and 13 CSR 15-4.120. Original rule Moved to 19 CSR 15-4.120, effective Aug.

19 CSR 15-4.130 Area Agency on Aging Staff cy on aging to have a written staffing plan, employ a full-time director, and have adequate numbers of staff. {#sec-19-csr-15-4.130 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.130}

(1) The area agency on aging shall have on file for review—an up-to-date staffing plan that includes, but is not necessarily limited to, an organizational chart; a description of the education, experience, and background qualifications required for each position (paid and volunteer); a description of the responsibility assigned to each position (paid and volunteer); and a salary schedule.

(2) The area agency on aging shall employ a full-time director to assure the effective and efficient administration of the area plan. The full-time director shall possess the education, experience, and background qualifications as determined necessary by the governing body to fulfill the requirements and functions of the director’s position.

(3) The area agency on aging shall employ sufficient staff to carry out the required functions of the area agency on aging. 15-6.080 and 13 CSR 15-4.130. Original 1986. Moved to 19 CSR 15-4.130, effective Aug. 28, 2001. Amended: Filed Jan. 25,

19 CSR 15-4.135 Area Agency on Aging Director {#sec-19-csr-15-4.135 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.135}

PURPOSE: This rule establishes and describes procedures each area agency on aging shall follow in hiring a director unless otherwise governed by merit system requirements established under local law, ordinance, or charter.

(1) The governing body will appoint a search committee for purposes of filling the vacancy.

An interim or acting director may be appointed by the board until the time a permanent director is selected.

(2) The governing body shall propose a job description and qualifications, and update as necessary. This responsibility may be delegated to the search committee.

(3) The governing body shall establish a salary range for the director of the area agency on aging which is commensurate with the duties and responsibilities of the position.

(4) The search committee shall advertise the vacancy.

(5) The search committee will screen all applications and conduct initial interviews.

(6) The search committee will recommend to the full governing body a list of at least the top three (3) finalists based on applications, interviews and reference checks. At the governing body’s discretion, re-interviews of all candidates, including the top three (3) recommended by the search committee may take place.

(7) The governing body shall review the recommendations of the search committee and make the final decision.

(8) If the desire is to promote an in-house person, the open search process may be conducted in a shorter time frame than might otherwise be required. 4.135. Original rule filed Feb. 17, 1988, effective June 15, 1988. Amended: Filed Aug. 19 CSR 15-4.135, effective Aug. 28, 2001.

19 CSR 15-4.140 Area Agency on Aging Plan ments that the area agency on aging shall meet to develop or amend and submit an area plan. {#sec-19-csr-15-4.140 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.140}

(1) The area agency on aging shall develop the area plan in accordance with all applicable federal and state regulations, the uniform plan format, and other guidelines issued by the division.

(2) The area plan shall encompass a planning period as specified by the division. However, fiscal budgets, including allotments/funds for services and planned service delivery shall be amended at least annually or as available allotments/funds change.

(3) The area plan shall be amended under the following situations:

(A) A new amended state or federal statute or regulation requires a new provision or conflicts with any existing provisions;

(B) A supreme court decision changes the interpretation of a statute or regulation;

(D) Receipt by area agency on aging staff or board members of compensation or other items of value above their salaries or the normal fringe benefits available to all staff; or (E) The area agency on aging takes any action for which prior division approval is required by state regulation, divisional policy, or preprint instructions.

(4) The area plan or plan amendments shall not be implemented until approved in writing by the division director or designee. 192.2025, RSMo 2016.* This rule was previously filed as 13 CSR 15-6.095 and 13 CSR 15-4.140. Original rule filed Jan. 6, 1986, effective April 30, 1986. Amended: Filed Feb. 17, 1988, effective June 15, 1988. Amended:

Filed Aug. 28, 2000, effective March 30, 2001. Moved to 19 CSR 15-4.140, effective Aug. 28, 2001. Amended: Filed Jan. 25, 192.2025, RSMo 1999, amended 2014.

19 CSR 15-4.150 Waivers {#sec-19-csr-15-4.150 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.150}

PURPOSE: This rule allows the area agency on aging to request a waiver from meeting specific requirements and sets forth procedures to be followed.

(1) An area agency on aging shall request a waiver if unable to comply with a specific division requirement. The request shall— (A) Be in writing;

(B) Be signed by the chairperson of the governing body and the director of the area agency on aging;

(C) State the requirement for which a waiver is requested; and (D) Include supportive documentation that explains why the requirement cannot be met, a description of the area agency on aging’s proposed alternative for meeting the requirement, and an explanation of why the proposed alternative is most applicable for the area agency on aging’s situation.

(2) Public Hearing for Waivers for Priority Services.

(A) Prior to submitting a waiver request for a priority service, the area agency on aging shall conduct, at a minimum, one (1) public hearing on the content of a proposed waiver. The hearing shall be scheduled at a convenient time and location to ensure maximum attendance by interested parties, representatives of the governing body and advisory council to the area agency on aging, public officials, and older adults.

(B) Notice of the public hearing shall be publicized through widely circulated newspapers and other public media at least twenty (20) calendar days before the date of the hearing. The notice shall be published in English and other languages as appropriate to the geographic area or to the target population to be served.

(C) In addition, notice of the public hearing shall be provided to service providers, organizations of older adults, public officials, and other public and private agencies in the planning and service area.

(D) Records of the public hearings held shall be on file at the area agency on aging office and shall be submitted to the division with the waiver request. The records shall include the following:

Documentation of public notice;
List of names of persons attending the hearing and organizations represented; and 3. Written summary of all comments received, including if and how comments were incorporated.

(3) A waiver may be approved for the life of the plan, not to exceed four (4) years.

(4) A waiver request may only be submitted with the area plan or area plan amendments. 15-6.100 and 13 CSR 15-4.150. Original rule March 30, 2001. Moved to 19 CSR 15-4.150,

19 CSR 15-4.160 Review, Submission, and Approval of Area Agency on Aging Area Plans and Plan Amendments ments for review, submission to the division, and the criteria for approval of the area agency on aging’s area plan or plan amendments. {#sec-19-csr-15-4.160 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.160}

(1) Where not covered by charter or established governmental procedures the following shall apply. The area agency on aging shall submit the area plan and any plan amendments for review and approval by the area agency on aging’s governing body. The area agency on aging shall obtain signed documentation stating that the area plan and annual updates have been approved by the governing body. The area agency on aging shall also submit the area plan and annual updates to its advisory council for review and comment prior to transmittal to the state unit on aging as required by 45 CFR 1321.57. The area agency on aging shall comply with the Missouri state and local review process.

(2) Following guidelines specified by the division in the preprint, the area agency on aging shall submit the proposed area plan or amendments to the division for approval.

(3) The division will approve, in writing, an area agency on aging’s plan or plan amendment indicating that it meets federal and state regulations and division policies and guidelines.

(4) The division will notify the area agency on aging, in writing, within fifteen (15) business days of receipt at division offices of making a determination that it finds that any provision of the area plan or any plan amendment is not approvable and that the division proposes to disapprove the area plan or amendment. Written notification shall include the following:

(A) Explanation of the reasons for the disapproval;

(B) Provision for the opportunity for the area agency on aging to review any pertinent documents upon which the determination was based; and (C) Notification of the right to request a formal hearing on the determination. 192.2025, RSMo 2016.* This rule was previously filed as 13 CSR 15-6.110 and 13 CSR 15-4.160. Original rule filed Jan. 6, 1986, effective April 30, 1986. Amended: Filed Aug. 28, 2000, effective March 30, 2001.

Moved to 19 CSR 15-4.160, effective Aug. 28, 2001. ** Amended: Filed Jan. 25, 2022, 192.2025, RSMo 1999, amended 2014. **Pursuant to Executive Order 21-07, 19 CSR 15-4.160, section (4) was suspended from April 3, 2020 through May 1, 2021.

(1) The area agency on aging shall establish a system to monitor financial expenditures of grants and contracts. In order to ensure adequate monitoring, at a minimum, the area agency on aging shall— (A) Establish written policies and procedures governing the expenditures of funds by service providers. These procedures shall provide for record maintenance by each service provider;

(B) Document, through assessment reports, that expenditures are made in accordance with the provisions of 45 CFR Part 75, this rule, as published on October 1, 2021, by the Office of the Federal Register, National Archives and Record Administration, 7G Street NW, Suite A-734, Washington, DC 20401-0001 and available at https://bookstore.gpo.gov/catalog/code-federal-regulations-cfrs-print. This rule does not incorporate any subsequent amendments or additions;

(D) Assure that service providers have recorded documentation of the amount of cash and in-kind resources provided as a match; and (E) Require adequate bonding of persons handling fiscal responsibilities.

(2) The area agency on aging shall submit written requests for transfers to the division.

(3) The area agency on aging, upon request, shall provide fiscal information to the division, from area agency on aging documentation.

(4) The area agency on aging shall provide assurances that at least the minimum amount allotted for supportive services (Title III B of the Older Americans Act) to the planning and service area will be expended for the delivery of each of the priority services as outlined in the Missouri State Plan on Aging 2020–2023, this rule, as published by Missouri Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102-0570, and available by the department at https://health.mo.gov/seniors/state-planaging.php.

This rule does not incorporate any subsequent amendments or additions.

(5) The area agency on aging annually shall specify in the area plan, as submitted or as amended, in detail, the amount of funds expended for each category of services during the fiscal year most recently concluded.

(6) Nonfederal matching requirements shall be met by the area agency on aging on the aggregate net cost of supportive and nutrition services and administration under Title III of the Older Americans Act. Further requirements are as follows:

(A) The nonfederal match shall be in the form of allowable costs of third-party in-kind contributions or funds which are from a nonfederal source and which are not used as match for any other federal program;

(B) The nonfederal match for administrative costs shall be no less than twenty-five percent (25%) of the net administrative cost;

(C) The nonfederal match for supportive and nutrition services’ net costs shall be no less than fifteen percent (15%) of the net cost;

(D) No less than twenty-five percent (25%) of the nonfederal match shall be in the form of allowable costs of state or local public agencies; and (E) Five percent (5%) of the net cost shall be met by allowable costs of the state and shall be included toward meeting the nonfederal matching requirements.

(7) The area agency on aging shall have an organization-wide audit completed by an independent certified public accountant yearly. Further requirements are as follows:

(A) Audits shall be completed and submitted to the division no later than one hundred eighty (180) calendar days after the close of the agency’s fiscal year;

(B) The area agency on aging may request, in writing, a one- (1-) month extension from the division. The request shall include the reason(s) for the extension and shall be received by the division no later than ten (10) working days before the audit due date. The division shall approve or reject a request for extension no more than five (5) working days after receipt of the written request;

(C) The criteria to be followed in auditing an area agency on aging shall be for— 1. Governmental agencies, the audit provisions in 2 CFR Part 200, which has been incorporated by reference in this rule, as published on January 1, 2021, by the Office of the Federal Register, National Archives and Record Administration, 7G Street NW, Suite A-734, Washington, DC 20401-0001 and available at https://bookstore.gpo.gov/catalog/code-federal-regulations-cfrs-print, shall apply for fiscal years beginning after December 31, 1984. This rule does not incorporate any subsequent amendments or additions;

All other agencies, the audit provisions in 2 CFR Part 200 shall apply; and (D) The audit shall be received by the division by the due date or the approved extended due date. Audits not in compliance with federal regulations will not be accepted.

(8) The area agency on aging shall not delegate authority to award or administer funds under Title III of the Older Americans Act to other agencies. The exception may be for transportation agreements with agencies which administer programs under the Rehabilitation Act of 1973 and Titles XIX and XX of the Social Security Act to meet the common need for transportation of service recipients under the separate programs.

(9) Unexpended funds and administrative allotments from Title III B, III C-1, III C-2 awarded under the Older Americans Act for which there are no legal obligations shall not exceed fifteen percent (15%) of each sub-

part’s total allotment at the end of each fiscal year.

(10) Program income shall be— (A) Earned gross income by an area agency on aging from activities, part or all of the cost of which is either borne as a direct cost by a grant or counted as a direct cost toward meeting a cost-sharing or matching requirement of a grant. It includes but is not limited to income in the form of fees-for-services performed during the grant or subgrant period, proceeds from sale of tangible personal or real property, usage or rental fees, and patent or copyright royalties. If income meets this definition, it shall be considered program income regardless of the method used to calculate the amount paid to the area agency on aging;

(B) Used to expand services for older adults in the program from which it was earned;

(C) Expended in the current fiscal year or following fiscal year; and (D) Documented as to the program under which income was earned and expended.

(11) The area agency on aging shall submit fiscal reports to the division on an accrual accounting basis. If the area agency on aging’s fiscal records show effective control and accountability, the agency may develop the reports through available documentation.

The area agency on aging may estimate outlays in instances where— (A) There is adequate documentation on which to develop a sound and reasonable estimate of outlays; and (B) The area agency on aging is unable to obtain actual data in time to meet reporting deadlines.

(12) The area agency on aging shall follow 45 CFR Part 75 Administration of Grants except where inconsistent with federal statutes, regulations, or other terms of a grant or when either the language of the provision itself or other text in the same subpart indicates the provision affects service provider agencies (subgrantees) and use of the term— (A) Recipient shall be taken as referring to area agencies on aging (subgrantees); and (B) Awarding party shall be taken as referring to the division (granting agency).

(13) The area agency on aging shall meet requirements concerning advancements, reimbursements, or interest earned on federal funds as follows:

(A) Use methods and procedures to minimize the time lapse between the transfer of funds and disbursement;

(B) Not request reimbursement for the federal share of amounts withheld from contractors to ensure satisfactory completion of work until it makes those payments;

(D) Expend interest earned on federal funds for allowable costs of the funds which earned the interest;

(E) Budget and report interest earned of federal funds, distinguishing the interest from the fund which earned the interest; and (F) Maintain documentation of compliance.

(14) The area agency on aging shall submit monthly invoices for reimbursement of expenditures to the division within twentyone (21) days after the close of each fiscal month on forms prescribed by the division.

(15) The area agency on aging shall meet the division’s reporting requirements for quarterly and final financial reports as follows:

(A) Submit quarterly financial and program reports with the appropriate invoice;

(B) Submit a final financial report to the division within ninety (90) days after the fiscal year of the grant ending;

(C) Submit financial reports on the forms prescribed by the division; and (D) Be subject to the withholding of payments for failure to comply with reporting requirements, until such time as reports are received.

(16) Any cost allocation plans and indirect costs rates shall be determined in accordance with the following guidelines:

(A) For governments, 2 CFR Part 255, this rule, as published on January 1, 2021, by the Office of the Federal Register, National Archives and Record Administration, 7G Street NW, Suite A-734, Washington, DC 20401-0001 and available at https://bookstore.gpo.gov/catalog/code-federal-regulations-cfrs-print, this rule does not incorporate any subsequent amendments or additions, including any amendments published by the United States OMB;

(B) For institutions of higher education, 2 CFR Part 220, which has been incorporated by reference in this rule, as published on January 1, 2021, by the Office of the Federal Register, National Archives and Record eral-regulations-cfrs-print and as published in the Federal Register by OMB. This rule does not incorporate any subsequent amendments or additions; and (C) For other nonprofit organizations, 2 CFR Part 230, which has been incorporated by reference in this rule, as published on January 1, 2021, by the Office of the Federal Register, National Archives and Record eral-regulations-cfrs-print. This rule does not incorporate any subsequent amendments or additions.

(17) In order to minimize a loss of funds in the event of bank insolvency, the area agency on aging shall not deposit contributions and federal grant funds in any one (1) bank in an amount that exceeds that bank’s maximum insured amount by the Federal Deposit Insurance Corporation (FDIC). The total deposits in one (1) bank, regardless of the number of separate accounts, shall not exceed the maximum amount insured by the FDIC. An acceptable alternative is to request the bank to pledge securities to the area agency on aging. These securities shall act as insurance for excessive cash balances. Documentation of compliance shall be maintained by the area agency on aging.

(18) Contributions shall be handled according to procedures as required for service providers in 19 CSR 15-7.010. 15-6.200 and 13 CSR 15-4.170. Original rule 15, 1988. Amended: Filed Aug. 28, 2000, 15-4.170, effective Aug. 28, 2001. Amended:

19 CSR 15-4.175 Funding for Establishment, Maintenance, Modernization, Acquisition, or Construction of Multipurpose Senior Centers {#sec-19-csr-15-4.175 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.175}

PURPOSE: This rule sets forth the procedures and guidance mandated in 42 U.S.C. 3030b and Administration on Aging PI-91-04 for financing the establishment, maintenance, modernization, acquisition, or construction of multipurpose senior centers with funding received from the division.

(1) The requirements of this rule apply to the use of division funding for establishment, maintenance, modernization, acquisition, or construction of multipurpose senior centers.

The requirements apply whether division funding is used to finance the cost in whole or in part.

(2) Area agencies on aging may utilize supportive services funding received from the division to finance the acquisition, establishment, maintenance, modernization, or construction of multipurpose senior centers only where an area plan or area plan update has been approved by the division, where funding has been explicitly identified and designated in the plan or plan update for the named center, and where— (A) The center is operated under an approved direct service waiver where title to the structure is held by the area agency on aging; or (B) A grant is made to a public or nonprofit private organization where title to the structure is held by the public or nonprofit organization.

(3) Area agencies on aging must notify the division in writing within thirty (30) days of any decision to acquire, establish, maintain, modernize, or construct a multipurpose senior center. The notification must include:

(A) Date the decision was approved by the agency’s board of directors;

(B) Amount approved by the board for the project;

(D) Nature of the project funded (acquisition, or construction);

(E) Name and address of grantee, where applicable;

(F) Name and address of the center; and (G) A plan to use the skills and services of older adults in paid and unpaid work, including multigenerational and older adult to work.

(4) Total cost, for the purposes of this rule, includes all costs incurred by the title holder whether financed with division funding, other area agency on aging funding, or funding from third parties. Total cost does not include the value of any third-party in-kind contributions.

(5) Funding under the area agency on aging’s grant/contract with the division, for the purposes of this rule, includes funding received from the division and funding counted toward satisfying any matching requirement for receipt of division funding.

(6) Area agencies on aging must file the following notice of record with the appropriate unit of local government when acquiring or constructing an agency-owned center:

“This is to serve as notice to all potential sellers, purchasers, transferors, and recipients of a transfer of the real property described below as to the federal government’s reversionary interests as set forth in section 312 of the Older Americans Act of 1965, as amended, 42 U.S.C. 3030b, which have arisen as a result of (grantee’s name) receipt and use of Department of Health and Human Services’ grant funds in connection with the purchase or construction of said property. The property to which this notice is applicable is (address) and identified as parcel (insert appropriate number(s)) in the books and records of (insert appropriate name of local unit of government’s recording agency). Said real property is also described as: (insert description provided in survey). Further information as to the federal government’s interest referred to above can be obtained from: (name and address of area agency on aging).”

(7) Area agencies on aging must include a requirement in all grant awards for acquisition, or construction of a multipurpose senior center that the grantee file the notice of record detailed in section (6) and deliver a copy of the filed notice to the agency.

(8) Within thirty (30) days of the filing date, area agencies on aging must deliver a copy of all filed notice of records to the division.

(9) Area agencies on aging must notify the division in writing within thirty (30) days when— (A) The area agency on aging’s board of directors approves additional funding for acquisition, establishment, maintenance, modernization, or construction of a multipurpose senior center project;

(B) The area agency on aging’s board of directors approves funding for acquisition, establishment, maintenance, modernization, or construction of a multipurpose senior center with division funding;

(D) The site ceases to be used as a multi- (E) The title holder ceases to be a public or nonprofit private organization.

(10) Area agencies on aging must maintain a perpetual inventory listing of all multipurpose senior centers acquired, established, maintained, modernized, or constructed financed with division funding.

(11) The inventory listing must include all centers whether owned by the area agency on aging or by a public or nonprofit private organization.

(12) The inventory listing must include the following information:

(A) Date the project was approved by the area agency on aging’s board of directors;

(B) Amount approved by the area agency on aging’s board of directors for the project;

(C) Percentage of total cost which will be paid from funding under the area agency on aging’s grant/contract with the division;

(D) Nature of the project funded (acquisition, or construction of multipurpose senior centers);

(E) Name and address of current title holder;

(F) Name and address of original grantee, where applicable;

(G) Name and address of the center;

(H) Date the site ceased operation as a senior center, when applicable; and (I) Date the title holder ceased to be a public or nonprofit private organization, when applicable.

(13) Area agencies on aging must update the inventory when any of the following occur:

(A) The area agency on aging’s board of directors approves new or additional funding for a public or nonprofit private organization to acquire, establish, maintain, modernize, or construct a multipurpose senior center;

(B) The area agency on aging’s board of directors approves new or additional funding to acquire, establish, maintain, modernize, or construct a multipurpose senior center;

(D) The site ceases to be used as a multi- (E) The title holder ceases to be a public or nonprofit private organization.

(14) The area agency on aging must maintain an annual inventory listing and provide a copy to the division upon request.

(15) The division shall be entitled to recover funds from an area agency on aging when a multipurpose senior center within ten (10) years after acquisition, establishment, maintenance, modernization, or construction or within twenty (20) years after completion of construction ceases to be— (A) Owned by a public or nonprofit private organization; or (B) Used for the purpose for which it was acquired, established, maintained, modernized, or constructed.

(16) The amount recoverable by the division shall be a percentage of current market value.

The percentage shall be equivalent to the percentage of funds contributed under the area agency on aging’s grant/contract with the division to the total original cost of the acquisition, establishment, maintenance, modernization, or construction of multipurpose senior centers.

(17) Area agencies on aging are encouraged to enter into legally binding agreements with the grantees permitting the area agency on aging to recover an equivalent amount of funding. The division shall be entitled to recover the full amount from the area agency on aging regardless of the area agency on aging’s ability to recover funding from a grantee.

(18) An area agency on aging may petition for waiver of recovery by submitting a written request within thirty (30) days of any event outlined in section (15). The request must detail the reason(s) the area agency on aging believes good cause exists for releasing the agency from the obligation.

(19) The division may approve or disapprove any waiver requested.

(20) Area agencies on aging must maintain the following on file:

(A) Records documenting total costs incurred by the title holder;

(B) Records documenting the amount of total costs paid with funding under the area agency on aging’s grant/contract with the division;

(D) Documents supporting market value determination at the time of any event listed in section (15); and (E) Records documenting the receipt of amounts recovered from public or nonprofit private organizations pursuant to any event listed in section (15).

(21) Area agencies on aging must maintain all material listed in section (20) applicable to a center for three (3) years after the division obtains an independent audit in conformance with federal Office of Management and Budget requirements covering the period in which— (A) The structure ceases to be owned by a public or nonprofit private organization;

(B) The structure ceases to be used as a multipurpose senior center;

(C) Ten (10) years have elapsed from the time division funding was used to acquire, establish, maintain, or modernize, the multi- (D) Twenty (20) years have elapsed from the time division funding was used to construct the multipurpose senior center. 4.175. Original rule filed Feb. 11, 1992, effective June 25, 1992. Amended: Filed Aug. 19 CSR 15-4.175, effective Aug. 28, 2001.

19 CSR 15-4.180 Area Agency on Aging Advocacy Responsibility cy on aging to carry out activities to advocate in the interest of older adults. {#sec-19-csr-15-4.180 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.180}

(1) The area agency on aging shall serve as the advocate for older adults in the planning and service area by performing at least the following activities:

(A) Monitor, evaluate and comment on all policies, programs, hearings, levies and community actions which affect older adults;

(B) Solicit comments from the public on the needs of older adults;

(D) Carry out activities in support of the department’s Long-Term Care Ombudsman Program; and (E) Coordinate planning with other agencies and organizations to promote new or expanded benefits and opportunities for older adults.

(2) The area agency on aging shall develop and implement written policies and procedures that describe how it carries out advocacy activities. 6.115 and 13 CSR 15-4.180. Original rule Moved to 19 CSR 15-4.180, effective Aug.

19 CSR 15-4.190 Area Agency on Aging Development of a Comprehensive and Coordinated Service Delivery System ments the area agency on aging shall meet to develop a comprehensive and coordinated service delivery system within the planning and service area. {#sec-19-csr-15-4.190 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.190}

(1) The area agency on aging continuously shall work toward development of a comprehensive coordinated community-based system that shall facilitate access to and utilization of all supportive and nutritional services provided by any source within the planning and service area (PSA). Components of this system may include:

(A) Services which facilitate access, such as transportation, outreach, information and assistance, and case management;

(B) Services provided in the community, such as congregate meals, continuing education, health and nutrition education, health screening, legal assistance, program development and coordination activities, advocacy, information and assistance, case management, casework, counseling and assistance (concerning taxes, financial problems, public benefits, the use of facilities and services, preretirement or second career), adult day health care, protective services, services designed for the unique needs of persons with disabilities, emergency services, disaster relief services, minor home repair, physical fitness and recreation, services to help obtain adequate housing and alteration, renovation, acquisition and construction of facilities to be used as multipurpose senior centers;

(C) Services provided in the home, such as homemaker services, personal care services, legal assistance, respite, case management, counseling, chore, visiting, shopping assistance, reading/letter-writing, telephone reassurance, home-delivered meals, and nutrition education; and (D) Services provided to residents of careproviding facilities, such as case management counseling, placement and relocation assistance, group services, legal assistance, complaint and grievance resolution and visiting.

Care-providing facilities include long-term facilities, emergency shelters and other congregate living arrangements.

(2) The area agency on aging shall assess the needs of older adults in the PSA and the effectiveness of resources in meeting identified needs.

(3) The area agency on aging shall establish effective and efficient procedures for coordination of planning and service delivery with other agencies and organizations within the PSA, including agencies that administer the following:

(A) Workforce Innovation and Opportunity Act (WIOA);

(B) Title II of the Domestic Volunteer Act of 1973;

(D) Sections 231 and 232 of the National Housing Act;

(E) The Housing Act of 1937;

(F) Section 202 of the Housing Act of 1959;

(G) Title I of the Housing and Community Development Act of 1974;

(H) Title I of the Higher Education Act of 1965 and the Adult Education and Family Literacy Act;

(I) Sections 3, 9 and 16 of the Urban Mass Transportation Act of 1964;

(J) The Public Health Service Act;

(K) The Low-Income Home Energy Assistance Act of 1981;

(L) Part A of the Energy Conservation in Existing Buildings Act of 1976;

(M) The Community Services Block Grant Act; and (N) Demographic statistics and analysis programs conducted by the United States Census Bureau.

(4) The area agency on aging may make arrangements with other local agencies and organizations for services and programs that benefit older adults, such as— (A) Children’s day care organizations so that older adults can volunteer to help provide the day care; and (B) Local educational agencies, institutions of higher education, and nonprofit private organizations.

(5) The area agency on aging shall develop and publish the methods that are used to establish priorities for services, particularly— (A) Services associated with access to other services. These services include transportation, outreach, information and assistance, and case management;

(B) In-home services. These services include homemaker, personal care, visiting and telephone reassurance, chore, respite, adult daycare, homebound shopping, home modification and repair, medication set-up, and supportive services for families of older adult victims of Alzheimer’s disease and other neurological and organic brain disorders of the Alzheimer’s type; and (C) Legal assistance.

(6) The area agency on aging shall give preference in the delivery of services to older adults with the greatest economic or social need. A description of the methods and procedures used to assure that services are provided to those with the greatest economic and social need including low-income minority shall be included in the area plan.

(7) The area agency on aging shall provide adequate and effective opportunities for older adults to express their views on policy development and program implementation.

(8) The area agency on aging shall develop and implement organized ongoing outreach activities to older adults, particularly those residing in rural areas and those with greatest economic or social need and inform them of services that are available. Area agency on aging outreach activities shall be coordinated with the outreach activities required of each service provider within the PSA.

(9) The area agency on aging shall develop a comprehensive, coordinated disaster preparedness plan which shall include service providers in the PSA.

(10) The area agency on aging shall assure that all service providers follow the applicable requirements set forth in 19 CSR 15-7, 19 CSR 15-4.245, 19 CSR 15-4.295, and 19 CSR 15-4.410.

(11) The area agency on aging shall assure that older adults residing in the PSA have reasonably convenient access to information and assistance systems.

(12) The area agency on aging shall designate focal points for comprehensive service delivery giving special consideration to multipurpose senior centers and assuring that the facility can accommodate the collocation of (13) The area agency on aging shall encourage maximum collocation and coordination of services through the community focal point by— (A) Establishing guidelines for operating schedules that are convenient for service recipients;

(B) Assuring reasonably convenient access to existing information and referral services;

(14) The area agency on aging may plan, coordinate, and provide services funded under other programs if it continues to meet its area agency on aging responsibilities. 6.120 and 13 CSR 15-4.190. Original rule March 30, 2001. Moved to 19 CSR 15-4.190,

19 CSR 15-4.200 Area Agency on Aging Subgrants or Contracts {#sec-19-csr-15-4.200 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.200}

PURPOSE: This rule sets forth requirements for the area agency on aging to follow in awarding subgrants and contracts.

(1) The area agency on aging shall follow applicable procurement standards as specified in 45 CFR Part 75, which has been incorporated by reference in this rule, as published on October 1, 2021, by the Office of the Federal Register, National Archives and Record eral-regulations-cfrs-print; and 2 CFR Part 200, which has been incorporated by reference in this rule, as published on January 1, 2021, by the Office of the Federal Register, National Archives and Record Administration, 7G Street NW, Suite A-734, Washington, DC 20401-0001 and available at eral-regulations-cfrs-print. This rule does not incorporate any subsequent amendments or additions.

(A) The area agency on aging may waive the requirement of competitive bids for the purchase of food items when special temporary market conditions exist and the food items can be purchased for at least ten percent (10%) less than the most current bid price for the same food items.

(2) The area agency on aging shall use subgrants or contracts with service providers to provide supportive services, nutrition services, and/or in-home services under all Older Americans Act (OAA) funding sources. For waiver of this requirement, the area agency on aging shall submit a written request that thoroughly documents that direct provision of service, using its own employees, is necessary— (A) To assure an adequate supply of the service;

(B) Where those services are directly related to the area agency on aging’s administrative functions; or (C) Where those services of comparable quality can be provided more economically by the area agency on aging.

(3) If an area agency on aging receives a waiver to provide a service directly, all applicable requirements for that service as set forth in 19 CSR 15-7 and 19 CSR 15-4 shall be met. 6.125 and 13 CSR 15-4.200. Original rule March 30, 2001. Moved to 19 CSR 15-4.200,

19 CSR 15-4.210 Area Agency on Aging Grievance Procedures {#sec-19-csr-15-4.210 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.210}

PURPOSE: This rule requires area agencies on aging to establish written grievance procedures.

(1) Each area agency on aging shall establish written grievance procedures that provide the opportunity to appear before the governing body to the following:

(A) Individuals who wish to resolve areas of conflict regarding delivery of services;

(B) Service provider applicants whose application to provide services is denied; and (C) Service providers whose subgrant or contract is terminated or not renewed.

(2) The written grievance procedures shall be filed with the division as an addendum to the area agency on aging’s plan and shall include, at a minimum, the following:

(A) Time limitations, as applicable, and procedures to be followed to request a grievance hearing;

(B) Procedures for conducting the grievance hearing;

(C) Opportunity to review any pertinent information relating to the issues; and (D) Criteria to be used for making a final determination that include:

Time limitations for notification of the decision from the date of grievance hearing;
Reasons for the final determination and the evidence on which it was based; and 3. Notice of the right to appeal the decision to the division to service providers who meet the following conditions:

A. Application to provide services under an area plan has been denied; or B. Subgrant or contract is terminated or not renewed for reasons other than a determination that the service provider has materially failed to comply with the terms of the subgrant or contract as provided in 45 CFR

part 75, subpart D. 6.090 and 13 CSR 15-4.210. Original rule Moved to 19 CSR 15-4.210, effective Aug. 28, 2001. Amended: Filed Jan. 25, 2022, effec-

19 CSR 15-4.220 Area Agency on Aging Technical Assistance, Monitoring, and Evaluation Responsibilities cy on aging to provide technical assistance to service providers and other organizations and to monitor and assess service provider performance. {#sec-19-csr-15-4.220 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.220}

(1) The area agency on aging shall provide technical assistance to service providers, organizations where joint program agreements are in effect, and upon request, to groups and public and private organizations that are interested in developing or expanding programs for older adults.

(2) The area agency on aging shall develop and implement an ongoing process for monitoring service providers that includes requiring periodic written financial and program reports.

(3) At least annually, the area agency on aging shall conduct a full on-site evaluation of each service provider to monitor compliance with fiscal and program standards and to provide technical assistance, if needed. The division shall have the right to require an area agency on aging to conduct more frequent onsite monitoring if there is evidence of inadequate quality or quantity of service being delivered by a service provider.

(4) The area agency on aging shall develop and implement written policies and procedures that describe how it meets its technical assistance, monitoring, and evaluation responsibilities. 6.130 and 13 CSR 15-4.220. Original rule Moved to 19 CSR 15-4.220, effective Aug. 28, 2001. ** Amended: Filed Jan. 25, 2022, **Pursuant to Executive Order 21-09, 19 CSR 15-4.220, section (3) was suspended from September 22, 2020 through December 31, 2021.

19 CSR 15-4.230 Multipurpose Senior Center ments that shall be met by an area agency on aging for the acquisition, establishment, maintenance, modernization, or construction of a multipurpose senior center. {#sec-19-csr-15-4.230 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.230}

(1) Area agencies on aging may award funds to a public or private nonprofit agency for the following purposes:

(A) Acquiring, establishing, maintaining, modernizing, or constructing of a multipurpose senior center; or (B) Paying the costs of professional and technical personnel required to operate multi-

purpose senior centers.

(2) In making multipurpose senior center awards, the area agency on aging shall give preference to facilities located in communities with the greatest numbers of older adults, including those who are low-income minorities and those with greatest economic and social need.

(3) The area agency on aging shall assure the following general requirements will be met prior to awarding funds for a multipurpose senior center:

(A) It serves a cross-section of all segments of the older adult population of its planning and service area, including those who are low-income minorities and those with greatest economic and social need; and (B) It operates a program of group activities, individual services and community service, opportunities in each of the following categories:

Access services;
Community services, including advocacy-related services;
Services for frail, vulnerable, and atrisk older adults; and 4. Nutrition services.

(4) The area agency on aging shall submit to the division, for review and prior approval, a written plan for purchase or construction of a multipurpose senior center with accompanying justification and documentation. The division shall approve the proposed plan based on the following criteria:

(A) For proposed award for construction, there is no other suitable facility available to be a community focal point for service delivery; and (B) For proposed award for purchasing or constructing a facility, only if there are no suitable facilities for leasing.

(5) The area agency on aging shall submit to the division, for review and prior approval, the plans and specifications for any proposed acquisition, establishment, maintenance, modernization, or construction of a multipurpose senior center funded with federal or state funds in order to assure that all applicable minimum construction standards shall be met, particularly the requirements of the Architectural Barriers Act of 1968, as amended.

(6) The area agency on aging shall submit to the division, for review, an assurance by a licensed architect, a certified code enforcement official, or certified general contractor that the plans and specifications for any proposed alteration or renovation comply with all applicable local or state ordinances, laws, or building codes that affect the load-bearing structures of a multipurpose senior center funded with federal or state funds, or both. In the absence of state and local codes, the area agency on aging shall assure compliance with the International Building Code 2015 Edition, which has been incorporated by reference in this rule, published by the International Code Council, 500 New Jersey Avenue NW, 6th Floor, Washington, DC 20001. To order 1-888-422-7233, ext. 33822, or visit the International Code Council website at http://shop.iccsafe.org/codes/2015-international-codes-and-references.html. This rule does not incorporate any subsequent amendments or additions.

(7) The area agency on aging shall require recipients of an award for the establishment, maintenance, modernization, or construction of a facility to be used as a multipurpose senior center to comply with the requirements of the Davis-Bacon Act and other mandatory federal labor standards.

(8) A facility acquired, established, maintained, modernized, or constructed to be used as a multipurpose senior center shall be used for that purpose for a minimum of ten (10) years from the date of acquisition, establishment, maintenance, modernization, or construction or twenty (20) years after the completion of construction.

(9) The area agency on aging shall ensure that no federal or state funds shall be used for religious instruction or worship.

(10) The area agency on aging shall ensure that no federal or state funds shall be used for the promotion of any political point of view.

(11) The area agency on aging shall assure the following:

(A) Sufficient funds shall be available to meet the nonfederal share of the award;

(B) Sufficient funds shall be available to effectively use the facility as a multipurpose senior center;

(C) In a facility that is shared with other age groups, federal or state funds shall support only— 1. That part of the facility used by older adults; or 2. A proportionate share of the costs based on the extent of use of the facility by older adults; and (D) A multipurpose senior center program must be operated in that facility in accordance with standards set forth in 19 CSR 15- 7.010 6.140 and 13 CSR 15-4.230. Original rule Amended: Filed June 3, 1991, effective Oct. 31, 1991. Amended: Filed Aug. 28, 2000, 15-4.230, effective Aug. 28, 2001. Amended:

19 CSR 15-4.240 Nutrition Service Requirements ments to be met by the area agency on aging to fund, establish, and operate nutrition services for older adults. {#sec-19-csr-15-4.240 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.240}

(1) The area agency on aging may award nutrition services funds to a service provider to provide meals and other nutrition services, including outreach and nutrition education, to eligible service recipients within the planning and service area (PSA).

(2) The area agency on aging shall assess the level of need for congregate and home-delivered meals within the PSA and maintain documentation of the method(s) used to assess level of need and how the results were used to determine levels of services to meet those needs.

(3) The area agency on aging may make awards for congregate and home-delivered nutrition services to a service provider that furnishes either or both type(s) of service(s).

The area agency on aging may award federal and state funds to a service provider that delivers only home-delivered nutrition services if congregate nutrition services are also provided through the area agency on aging.

(4) The area agency on aging shall assure that the provisions of nutrition services are contracted for in accordance with the standards set forth in 19 CSR 15-4.200.

(5) Eligibility of individuals to receive nutrition services shall be determined as follows:

(A) Any person aged sixty (60) years or over and the spouse of that person regardless of age shall be eligible to receive congregate nutrition services;

(B) Any person aged sixty (60) years or over who is homebound by reason of illness, incapacitating disability, or is otherwise isolated shall be determined eligible for homedelivered nutrition services. Occasional escorted trips from the home for medical or other necessary services will not affect the individual’s eligibility for home-delivered meals. The following conditions shall be met:

The area agency on aging shall require an assessment of the individual’s eligibility for home-delivered nutrition services prior to initiation of the service and assess the individual’s need for continued service at least annually after that. In emergency situations, home-delivered meals may be delivered for a maximum of five (5) days prior to the initial assessment of eligibility; and 2. The area agency on aging shall develop written criteria by which to determine if the spouse and/or primary caregiver who resides in the home, regardless of their age or condition of the spouse, may receive a homedelivered meal. The criteria developed shall assure that the receipt of the meal by the spouse and/or caregiver is in the best interest of the homebound older adult;

(C) Adults with disabilities under sixty (60) years of age who reside in housing facilities occupied primarily by older adults at which congregate nutrition services are provided may receive congregate nutrition services. Any person meeting these requirements also may be eligible to receive home-delivered nutrition services provided the procedures of paragraph (5)(B)2. are followed; and (D) Under the Social Services Block Grant (SSBG), adults with disabilities under sixty (60) years of age who do not reside in housing facilities occupied primarily by older adults may be eligible to receive congregate nutrition services. Any person meeting these requirements also may be eligible to receive home-delivered nutrition services under SSBG provided procedures in paragraph (5)(B)2. are followed.

(6) The area agency on aging may allow guests under sixty (60) years of age to eat a meal at a nutrition center provided that— (A) An eligible service recipient is not deprived of a meal; and (B) The full cost of the meal is paid.

(7) The area agency on aging may allow nutrition center volunteers under sixty (60) years of age to eat a meal at the nutrition center. If volunteer meals are allowed, the criteria shall allow these meals only if— (A) An eligible service recipient is not deprived of a meal;

(B) The volunteer has expended substantial direct effort in the preparation, service, delivery, cleanup of the meal, or a combination of these; and (C) The volunteer is afforded the opportunity to contribute to the cost of the meal.

(8) The area agency on aging shall request prior approval from the division for any new nutrition centers, construction of nutrition centers, renovation of nutrition centers, or relocation of existing nutrition centers.

(9) The area agency on aging shall request prior approval, in writing, from the division for any proposed termination of a nutrition center and shall not terminate any nutrition center until written approval has been received from the division.

(10) The area agency on aging shall report the occurrence or suspicion of a food-borne illness to the appropriate health authorities and the division. The area agency on aging shall cooperate with health authorities and keep the division informed of the investigation status as well as provide notice of resolution.

(11) The area agency on aging shall hire or retain the services of a qualified dietitian/nutritionist who does monitoring and provides technical assistance to service providers in the areas of food and nutrition. The dietitian/nutritionist shall meet one (1) of the following qualifications:

(A) Dietitian—A person who holds a bachelor of science degree from an accredited college or university with a major in dietetics, food and nutrition, or institutional food management and is eligible to take the registration examination offered by the American Dietetic Association;

(B) Registered Dietitian (RD)—A dietitian who has successfully completed the required examination for registration with the American Dietetic Association and maintains the status by meeting continuing education requirements;

(C) Nutritionist—A person who holds a bachelor of science degree with a major in human nutrition or a major in dietetics from an accredited college or university;

(D) Food and Nutrition Specialist—A person who holds a bachelor of science degree with a major in food and nutrition or institutional food management; or (E) Public Health Nutritionist—A person who holds a master of public health nutrition or master of science with a major in public health nutrition.

(12) The area agency on aging shall provide for technical assistance/training to nutrition service provider’s staff and volunteers that shall include, but not necessarily be limited to, meal cost and portion control, commodity/cash use, nutrition education, nutrition policies and standards, modified diets, food buying and preparation, food inventory, menu planning, kitchen design, purchase of equipment, fire and safety procedures, sanitation, first-aid, and emergency life-saving techniques.

(A) Technical assistance and training for nutrition education, modified diets and menu planning shall be provided by a dietitian/nutritionist.

(B) In all other areas, technical assistance and training may be provided by other area agency on aging staff who have been trained in the subject matter. 6.145 and 13 CSR 15-4.240. Original rule effective Oct. 31, 1991. Amended: Filed May 12, 2000, effective Nov. 30, 2000. Moved to 19 CSR 15-4.240, effective Aug. 28, 2001. ** **Pursuant to Executive Order 21-09, 19 CSR 15-4.240 was suspended from April 3, 2020 through December 31, 2021.

19 CSR 15-4.245 Nutrition Service Standards {#sec-19-csr-15-4.245 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.245}

PURPOSE: This rule establishes the minimum standards for providing nutrition services for older adults with federal or state funds.

(1) A unit of nutrition service is one (1) qualifying meal— (A) Served to a service recipient in a center for congregate nutrition services; or (B) Delivered to a homebound service recipient’s home for home-delivered nutrition (2) Nutrition service providers shall provide services and meet all requirements set forth in 19 CSR 15-7.010.

(3) Staffing and Training.

(A) There shall be an administrator who shall be responsible for the operation of the senior center and nutrition services provided by the center. The administrator, or a person designated by the administrator, shall be present in the senior center at all times the senior center is open.

(B) There shall be an adequate number of staff (paid or volunteer) who are qualified to perform assigned functions in order to implement the activities and services of the senior center.

Administrator—six (6) hours orientation plus twelve (12) hours supervised on-thejob training and an additional four (4) hours in-service training per quarter or sixteen (16) hours annually.
Cook—four (4) hours orientation plus six (6) hours supervised on-the-job training and additional two (2) hours in-service training per quarter or eight (8) hours annually.
Cook helper—two (2) hours orientation plus four (4) hours supervised on-the-job training and an additional one (1) hour in-service training per quarter or four (4) hours annually.

(4) Record Keeping. The following additional records shall be maintained by nutrition service providers:

(A) Daily record documenting persons who receive meals, both congregate and home-delivered, following a method developed by the area agency on aging and approved by the division;

(B) Meal count or reports, including total Nutrition Services Incentive Program (NSIP)-eligible meals, NSIP-eligible meals served to low-income older minority adults, meals served to adults with disabilities eighteen to fifty-nine (18–59) and meals served to ineligible guests and staff;

(5) Equipment Requirements.

(A) Whether the senior center is catered or has an on-site food preparation kitchen, adequate equipment shall be available to keep refrigerated foods at or below forty-one degrees Fahrenheit (41°F), heated foods above one hundred forty degrees Fahrenheit (140°F), and frozen foods at or below zero degrees Fahrenheit (0°F).

(B) Specific equipment required for all centers serving meals is as follows:

A home-style or commercial range;
A home-style or commercial refrigerator;
A handwashing sink;
A three- (3-) vat sink or other acceptable method for dishwashing;
A hot table if the senior center serves a total of thirty (30) meals or more per day (if the senior center serves fewer than thirty (30) meals per day, the meals can be served directly from the insulated carriers, provided meal service begins immediately after the food arrives);
A cold table or another acceptable method of keeping cold food at the proper temperature during food service; and 7. Additional equipment as needed and required by the area agency on aging.

A range with an automatic rangehood extinguishing system, preferably commercial;
Adequate number of refrigerators and freezers, preferably commercial;
A three- (3-) vat sink; and 4. Other equipment as determined by the area agency on aging (ice machine, mixer, dishwasher, and the like).

(D) Insulated carriers for delivery of the food are required for senior centers receiving bulk prepared foods.

(6) Menu Planning Requirements.

(A) If one (1) meal per day is served, it shall contain a minimum thirty-three and one-third percent (33 1/3%) of the daily Dietary Reference Intakes (DRI) as established by the Food and Nutrition Board of the National Academies of Sciences, Engineering, and Medicine. A minimum of sixty-six and two-thirds percent (66 2/3%) of the DRI shall be provided if two (2) meals are served, and one hundred percent (100%) of the DRI shall be provided if three (3) meals are served. The area agency on aging shall follow the U.S. Department of Agriculture and U.S.

Department of Health and Human Services Dietary Guidelines for Americans, 2020- 2025, 9th Edition, December 2020, which has been incorporated by reference in this

rule, as published by the United States Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201, and the United States Department of Agriculture, 1400 Independence Ave. SW, Washington, D.C. 20250. A copy is available on Dietary Guidelines for Americans website at https://www.dietaryguidelines.gov/. This

rule does not incorporate any subsequent amendments or additions.

(B) A twenty to twenty-eight (20–28) day menu cycle shall be developed to be repeated for a three- (3-) month period. Suggestions from service recipients shall be solicited regarding menu choices.

(D) Menus shall be reviewed and certified by an individual who meets the standards set forth in 19 CSR 15-4.240(12) at least annually. Copies of all certified menus shall be submitted to the area agency on aging and shall be maintained for at least three (3) years.

(E) Menu substitutions shall be made in accordance with the established procedures of the area agency on aging.

(7) Special menus shall be provided to meet the particular dietary needs arising from the health requirements, religious requirements, or cultural backgrounds of service recipients, where reasonable.

(A) Special meals provided for health requirements shall be planned, prepared, and served under the supervision/consultation of a dietitian/nutritionist. Copies of all certified menus shall be maintained on file by the area agency on aging for at least three (3) years.

(B) The persons responsible for the service of special diets shall be trained to make appropriate substitutions based on food values.

(C) Diet counseling, if provided, shall be conducted by a dietitian/nutritionist, according to the individual’s diet prescription which shall be obtained from the service recipient’s physician.

(D) A diet prescription may be obtained for persons receiving home-delivered special meals. Any prescription on file shall be kept current and shall be reviewed at least annually with the service recipient’s physician.

(E) Individuals with a strict dietary regimen shall be referred to the medical profession for management of dietary needs.

(8) Requirements for handling prepared foods are as follows:

(A) A two (2) ounce separate sample of each time/temperature control for safety food item served shall be refrigerated and kept at least seventy-two (72) hours. Sample(s) shall be available for analysis by the Department of Health and Senior Services if a food-borne illness is suspected;

(B) Time/temperature control for safety food which has been held at one hundred forty degrees Fahrenheit (140°F) or higher over four (4) hours or between forty-one degrees and one hundred forty degrees Fahrenheit (41°–140°F) for two (2) hours and any prepared food that has lost its quality shall not be served and shall be destroyed;

(C) Foods that are usually considered safe to store, such as fruits, vegetables, cake, breads, cookies, ice cream, and fruit pies, may be retained for use while quality remains acceptable;

(D) The proper equipment shall be used to maintain hot foods at or above one hundred forty degrees Fahrenheit (140°F) and cold foods at or below forty-one degrees Fahrenheit (41°F) while serving. Hot and cold food temperatures shall be checked immediately prior to service and recorded daily. Records must be kept for two (2) years at the center;

(E) When cooling, food shall be placed no more than two inches (2") deep in a container, covered and immediately placed in the refrigerator or freezer so it will cool to fortyone degrees Fahrenheit (41°F) or below as rapidly as possible. Once food is cooled to forty-one degrees Fahrenheit (41°F) or below, it may be stored in a container more than two inches (2") deep;

(F) When transporting prepared foods, the following procedures shall be used:

Hot food shall be delivered within three and one-half (3 1/2) hours following end preparation time. This limit includes the time required for packaging foods by the caterer, transporting to the centers, holding time at the center, packaging meals for homedelivered meal recipients, and transporting meals to the home; and 2. Hot foods delivered to the center shall be at a minimum temperature of one hundred forty degrees Fahrenheit (140°F) and cold foods shall be at a maximum temperature of forty-one degrees Fahrenheit (41°F). A daily record of the delivery time and temperature of the food when received shall be kept at each center. Records must be kept for three (3) years at the center;

(G) Meal service shall be scheduled so that food is available for at least thirty (30) minutes after serving begins;

(H) Appropriate serving utensils shall be used for food portion control;

(I) Appropriate food containers and utensils for service recipients who are blind or otherwise disabled shall be available for use upon request; and (J) Area agencies on aging may develop their own policies, in accordance with local public health codes, for allowing leftover foods to be removed from the center. It is recommended that centers include information about food safety in nutrition education.

(9) Food Storage Requirements for All Foods.

(A) Cleaning supplies and pesticides shall be clearly labeled and stored in separate locations from food products.

(B) Food products shall be stored at least six inches (6") above the floor.

(C) Dry food storage shall be well-ventilated, away from direct sunlight and maintained between fifty degrees Fahrenheit and seventy degrees Fahrenheit (50°F–70°F).

(D) All refrigerated foods shall be maintained at or below forty-one degrees Fahrenheit (41°F).

(E) Frozen foods shall be maintained at or below zero degree Fahrenheit (0°F).

(F) Inventory of all foods shall be depleted on a first-in/first-out basis.

(G) Adequate transportation for all foods shall be provided as required.

(H) Thermometers shall be kept in each refrigerator and freezer and temperatures shall be checked and recorded daily. Records must be kept for three (3) years at the centers.

(10) Health and Sanitation Requirements.

(A) Personnel with symptoms of communicable disease or open or infected wounds shall not be permitted to handle food.

(B) All food handlers shall use effective hair restraints. Effective restraints are devices which both cover and hold hair, such as hair nets, caps, hats, and bandannas. Hair spray is not an acceptable hair restraint.

(D) Disposables shall be discarded by a locally approved sanitary method.

(E) If a garbage disposal is not used, waste shall be kept in leak-proof containers with close-fitting lids and disposed of daily. Waste containers shall be cleaned daily.

(F) Dishes and utensils washed in water temperatures of less than one hundred fifty degrees Fahrenheit (150°F) and rinsed at less than one hundred eighty degree Fahrenheit (180°F) shall be chemically sanitized. When single-tank, stationary-rack, and door-type machine using chemicals for sanitizing are used, the wash water shall not be less than one hundred twenty degrees Fahrenheit (120°F) and rinse water not less than seventy-five degrees Fahrenheit (75°F). If the dishwashing machine uses hot water for sanitizing, the wash water shall be at least one hundred fifty degrees Fahrenheit (150°F) and the final rinse at least one hundred-eighty degrees Fahrenheit (180°F). A test kit or other device that accurately measures the parts per million concentration of the solutions shall be provided and used.

(G) All dishes and utensils shall be air dried.

(H) Disposable towels and soap shall be available at the handwashing sink in the kitchen.

(I) A handwashing sign shall be posted in the restroom.

(J) Methods of insect and rodent control shall be used on a regularly scheduled basis.

(K) A product thermometer must be available and used to check internal food temperatures required.

(11) Nutrition service providers shall— (A) Provide outreach services;

(B) Coordinate activities with the Missouri Department of Social Services, Family Support Division, to facilitate participation of eligible persons in the Supplemental Nutrition Assistance Program (SNAP) and assist service recipients in taking advantage of the benefits available to them under SNAP. All centers may be authorized to accept SNAP benefits; and (C) Comply with the requirements of the area agency on aging regarding eligibility of individuals to receive nutrition services (see 19 CSR 15-4.240(6)–(8)).

(12) Senior Centers.

(A) Senior centers shall be visible within the community and located as close as possible to the majority of older adults.

(B) Physical Plant Requirements.

Senior centers shall have a minimum of fifteen (15) square feet per service recipient to assure adequate space for programs and activities. Food preparation, office, and storage areas are not included in this minimum.
Adequate storage space shall be available as well as adequate space for hanging and storing coats, wraps, and packages.
Senior centers shall be clean and have an attractive appearance. Walls, ceilings, floors, and furniture in a center shall be of smooth, easily cleanable materials. Maintenance shall be performed daily to assure the center is clean, neat, and safe.
Adequate lavatory facilities shall be available. The number of rest rooms shall be adequate for the size of the facility and number of persons served with at least one (1) barrier-free restroom each for men and women.

(C) Each senior center shall provide— 1. Services to older adults at least five (5) days per week with sufficient hours to meet community needs;

Hot or other appropriate meals at least once a day, five (5) or more days a week;
A variety of supportive services;
An information area with a bulletin board, display rack, or other method of posting information which is easily accessible and well-lighted. Notices should be attractive, easy to read, and placed within eye level;
An easy-to-read posted monthly activities calendar in an area which is highly visible and accessible to service recipients;
A posted, attractive, easy-to-read, weekly menu in a conspicuous location in the dining room on Friday of the week prior to service.

(13) Home-delivered meals service providers shall— (A) Provide identification other than the meal container which is easily recognizable through a door or window for the person delivering the meals to the service recipient’s home, such as an identification badge;

(B) Maintain a list in priority order of homebound persons requesting meals for which units of service are not available. Priority will be based on published criteria developed by the area agency on aging;

(C) Use insulated carriers to assure that foods delivered to home-delivered meal recipients are at the proper temperature, over one hundred forty degrees Fahrenheit (140°F) for hot food and at or below fortyone degrees Fahrenheit (41°F) for cold food.

Frozen foods shall be delivered frozen.

Check and record at least quarterly the temperature of hot and cold food items at the end of delivery on each home-delivered meal route. All equipment used in transporting foods shall have smooth cleanable surfaces, be cleaned and sanitized daily, or be disposable;

(D) Deliver hot foods to the service recipient within three and one-half (3 1/2) hours following end preparation time. Record time meal preparation ended and time last meal was delivered at least quarterly for each route;

(E) Make available home-delivered meals at least once a day, five (5) or more days a week; and (F) Arrange for the availability of meals to service recipients in weather-related emergencies. 6.155 and 19 CSR 15-7.060. Original rule effective Oct. 31, 1991. Amended: Filed Nov. 14, 1991, effective March 9, 1992. Amended:

Filed May 12, 2000, effective Nov. 30, 2000.

Moved to 19 CSR 15-7.060, effective Aug. 28, 2001. ** Moved to 19 CSR 15-4.245 and amended: Filed Jan. 25, 2022, effective Aug. **Pursuant to Executive Order 21-07, 19 CSR 15-7.060 was suspended from April 3, 2020 through August 31, 2021.

19 CSR 15-4.250 Area Agency on Aging Nutrition Services Incentive Program {#sec-19-csr-15-4.250 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.250}

PURPOSE: This rule requires area agency on aging participation in the Nutrition Services Incentive Program and describes the requirements for participating in the program.

(1) The area agency on aging shall accept and distribute funds received through the Nutrition Services Incentive Program (NSIP) to nutrition service providers based on the percentage of eligible meals served within the planning and service area.

(2) The area agency on aging shall develop procedures to assure that NSIP funds are used in compliance with requirements under

Section 311 of the Older Americans Act.

These procedures shall include but are not limited to the following:

(A) All funds received from NSIP shall be spent to purchase United States agricultural food items;

(B) All purchases made with NSIP funds shall be documented by one (1) of the following methods:

If food is purchased through bid, the invoice shall show the number of units and unit cost, with a copy of the bid specification attached that contains the following statement, “The food is to be United States-produced”;
If food is purchased without bid, the following procedures shall apply:

A. Invoices for bread and fresh dairy products must show the number of units and unit cost. These products are assumed to be United States-produced;

B. When canned goods, meat products, and produce are purchased on a continuing basis from a vendor, a letter from him/her stating that all food supplied to the nutrition center is United States-produced will be adequate documentation. The letter shall be renewed annually; and C. Invoices for occasional purchases shall show the number of units, unit cost, and a statement assuring that the food was United States-produced; or 3. The contract for catered meals shall contain a clause stating the NSIP funds shall be spent for United States-produced foods only and shall inure only to the benefit of the nutrition program; and (C) The area agency on aging will monitor the nutrition service provider to assure adequate documentation is maintained for all these purchases. 6.150 and 13 CSR 15-4.250. Original rule 15, 1988. Moved to 19 CSR 15-4.250, effective Aug. 28, 2001. Amended: Filed Jan. 25,

19 CSR 15-4.260 Outreach Services {#sec-19-csr-15-4.260 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.260}

PURPOSE: This rule sets forth the requirements for outreach services and requires outreach training.

(1) Area agencies on aging shall provide outreach services to identify older adults and inform them of the availability of services.

Outreach efforts should have special emphasis on rural older adults and on those with the greatest economic or social need. With respect to nutrition services, outreach efforts should ensure that the maximum number of eligible persons have an opportunity to receive services.

(2) The area agency on aging shall provide outreach training to outreach workers which shall include but not be limited to the following:

(A) An understanding of the limits to which workers can serve persons contacted;

(B) Problems of older adults;

(D) Sensitivity to needs of minority older adults; and (E) Procedures for conducting outreach services and assessing effectiveness of outreach activities conducted. 6.175 and 13 CSR 15-4.260. Original rule Moved to 19 CSR 15-4.260, effective Aug.

19 CSR 15-4.270 Legal Assistance {#sec-19-csr-15-4.270 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.270}

PURPOSE: This rule sets forth the requirements for legal assistance and establishes criteria that legal assistance providers shall meet.

(1) The area agency on aging shall award funds to the legal assistance provider(s) that most fully meets the following requirements.

The legal assistance provider(s) shall— (A) Have staff with expertise in specific areas of law affecting older adults with economic or social needs, for example, public benefits, institutionalization, and alternatives to institutionalization;

(B) Demonstrate the capacity to provide effective administrative and judicial representation in the areas of law affecting older adults with economic or social need;

(C) Demonstrate the capacity to provide support to other advocacy efforts, for example, the long-term care ombudsman program;

(D) Demonstrate the capacity to deliver legal assistance to institutionalized, isolated and homebound older individuals effectively;

(E) Demonstrate the capacity to provide legal assistance in the principal language spoken by clients in areas where a significant number of clients do not speak English as their principal language.

(2) A legal assistance provider may not require an older adult to disclose information about income or resources as a condition for providing legal assistance under this part. A legal assistance provider may ask about the person’s financial circumstances as a part of the process of providing legal advice, counseling, and representation or for the purpose of identifying additional resources and benefits for which an older adult may be eligible.

(3) Each legal assistance provider, its attorney and employees shall comply with the following regulations when engaged in the outside practice of law:

(A) No attorney shall engage in any outside practice of law if the director of the provider has determined that the practice is inconsistent with the attorney’s full-time responsibilities;

(B) If the requirement of subsection (3)(A) engage in compensated outside practice of law when the attorney is newly employed and has a professional responsibility to close cases from a previous law practice and does so as expeditiously as possible;

(C) If the requirement of subsection (3)(A) engage in compensated outside practice of law when the attorney is acting pursuant to an appointment made under a court rule or practice of equal applicability to all attorneys in the jurisdiction and remits to the provider all compensation received; or (D) If the requirement of subsection (3)(A) engage in uncompensated outside practice of law when the attorney is acting pursuant to an appointment made under a court rule or practice of equal applicability to all attorneys in the jurisdiction or on behalf of a close friend, family member, religious community or charitable group.

(4) A provider, employee of the provider or staff attorney shall not engage in the following prohibited political activities:

(A) A provider shall not contribute or make available Older Americans Act (the Act) funds or any personnel requirement to any political party or association to the campaign of any candidate for public or party office or for use in advocating or opposing any ballot measure, initiative or referendum;

(B) No employee intentionally shall identify the Title III program or provider with any partisan or nonpartisan political activity or with the campaign of any candidate for public or party office;

(C) No employee shall use any Act funds for activities prohibited to attorneys under subsection (4)(A); nor shall an employee intentionally identify or encourage others to identify the provider with those activities;

(D) While engaged in legal assistance activities (any activity carried out during an employee’s working hours which uses resources provided under the Act, and, in fact, provides legal assistance to an eligible client), no employee and no staff attorney, at any time, shall— 1. Use official authority or influence for the purpose of interfering with or affecting the result of an election or nomination for office, whether partisan or nonpartisan;

Coerce, directly or indirectly, attempt to coerce, command or advise an employee under the Act to pay, lend or contribute anything of value to a political party or committee, organizations, agency or person for political purposes; or 3. Be a candidate for partisan elective public office; and (E) While engaged in legal assistance activities supported under the Act, no attorney shall engage in any— 1. Political activity;
Activity to provide voters with transportation to the polls or to provide similar assistance in connection with an election; or 3. Voter registration activity.

(5) No provider shall use funds received under the Act to provide legal assistance in a fee-generating case unless other adequate representation is unavailable. All providers shall establish procedures for the referral of fee-generating cases.

(A) Fee-generating case means any case or matter which, if undertaken on behalf of an eligible client by an attorney in private practice, reasonably may be expected to result in a fee for legal assistance from an award to a client, from public funds or from the opposing party.

(B) Other adequate representation is deemed to be unavailable when the provider had determined that fee referral is not possible due to any of the following:

The case has been rejected by the local lawyer-referral service or by two (2) private attorneys;
Neither the referral service nor any lawyer will consider the case without payment of a consultation fee; or 3. Emergency circumstances compel immediate action before referral can be made, but the client is advised that, if appropriate, and consistent with professional responsibility, referral will be attempted at a later time.

(C) Other adequate representation is deemed to be unavailable when— 1. Recovery of damages is not the principal object of the case and a request for damages is merely ancillary to an action for equitable or other nonpecuniary relief or inclusion of a counterclaim requesting damages is necessary for effective defense or because of applicable rules governing joinder of counterclaims;

A court appoints a provider or an employee for a provider pursuant to a statute or a court rule or practice of equal applicability to all attorneys in the jurisdiction; or 3. An eligible client is seeking benefits under Title II of the Social Security Act, 42 U.S.C. 401, Federal Old Age Act, Survivors and Disability Insurance Benefits; or Title XVI of the Social Security Act, 42 U.S.C. 1381, Supplemental Security Income for Aged, Blind, and Disabled.

(D) A provider may seek and accept a fee awarded or approved by a court or administrative body or included in a settlement if— 1. The requirements of subsections (4)(B) and (C) are met; and 2. Funds received are not used for purposes prohibited by the Act.

(E) When a case or matter subject to this

section results in a recovery of damages, other than statutory benefits, a provider may accept reimbursement from the client for outof-pocket costs and expenses incurred in connection with the case or matter, if the— 1. Requirements of subsections (4)(B) and (C) are met; and 2. Client has agreed in writing to reimburse the provider for these costs and expenses.

(6) While carrying out legal assistance activities funded under the Act, no employee shall— (A) Knowingly participate in any public demonstration, picketing, boycott or strike, except as permitted by law in connection with the employee’s own employment situation;

(B) Intentionally exhort, direct or coerce others to engage in those activities or otherwise usurp or invade the rightful authority of a client to determine what course of action to follow; and (C) Be prohibited, if an attorney, by any provision of this section from— 1. Informing and advising a client about legal alternatives to litigation or the lawful conduct of litigation; or 2. Fulfilling the professional responsibilities of an attorney to a client.

(7) No funds made available to a provider under the Act shall be used, at any time, directly or indirectly, to support activities intended to influence the issuance, amendment or revocation of any executive or administrative order or regulation of a federal, state or local agency or to undertake to influence the passage or defeat of any legislation by the Congress of the United States or by any state or local legislative body or state proposals by initiative petition, except that an employee may— (A) Respond to a request from a governmental agency or a legislative body, committee or member made to the employee or to a recipient to testify, draft or review measures or to make representation to the agency, body, committee or member on a specific matter; or (B) Engage in the activities at the request of an eligible client of a provider, to the extent the activities are necessary to the provision of legal advice and representation to a client who has sought this legal advice and representation with respect to particular legal rights and responsibilities which would be affected by particular legislation or administrative measures, but no employee shall solicit a client in violation of professional responsibilities for the purpose of making the representation possible.

(8) Providers shall adopt procedures and forms to document that the legislative and administrative activities in which they engage fall within the activities permitted in 45 CFR

section 1321.71.

(A) With respect to activities permitted under subsection (7)(A), a written request signed by an official of the governmental agency or a member of the legislative body or committee making the request which states the type of representation or assistance required and identified the executive or administrative order, regulation or legislation to be addressed;

(B) With respect to activities permitted under subsection (7)(B), a retainer agreement signed by the client(s) represented, or by an official of the client group in the case of a group client, which agreement shall specify the legislative or administrative measure on which representation is sought (appearance at a hearing, legislative drafting, etc.) and which shall include a statement of the client’s direct interest in the particular legislative or administrative measure to be addressed; and (C) Providers shall obtain the documentation required by this section prior to undertaking any of the activities permitted by sub-

section (7)(A) or (B) in the absence of a written request provided that the fact, nature and circumstances of the request are subsequently documented in writing and signed by the requesting authority.

(9) No funds made available under the Act shall be used to— (A) Maintain separate offices for the sole

purpose of engaging in legislative activity;

(B) Pay dues to any organization (other than a bar association) a substantial purpose or function of which is to take positions on matters pending before legislative or administrative bodies;

(C) Pay for transportation to legislative or administrative proceedings of persons other than employees engaged in activities permitted under this section or witnesses entering appearances in the proceedings on behalf of clients of the providers, except that those funds may be used to transport the client where necessary and appropriate. This sub-

section does not authorize payment of transportation expenses for employees not actually engaged in permitted representation activities;

(D) Pay, in whole or in part for the conduct of, or transportation to, an event if a primary

purpose of expenditure is to facilitate lobbying or any other activity which would be prohibited if conducted with funds made available under the Act;

(E) Pay for administrative or related costs associated with any activity prohibited by this

part; or (F) Assist others, through legislative liaison activities, to influence legislation in a manner that would be prohibited if undertaken with funds made available under the Act.

Legislative liaison activities include, but are not limited to, attending legislative sessions or committee hearings, gathering information regarding pending legislation and analyzing the effect of pending legislation.

(10) Notwithstanding the provisions of sub-

section (7)(A), providers shall not use funds made available under the Act for publicity or propaganda purposes designed to support or defeat proposed legislation or legislation pending before Congress or any state legislature. For purpose of this regulation, publicity or propaganda means any oral communication or any advertisement, telegram, letter,

article, newsletter or other printed or written matter or device which contains a direct suggestion or, when taken as a whole, an indirect suggestion to the public at large or to selected individuals to contact elected representatives in support of or in opposition to pending or proposed legislation.

(11) No funds made available to a provider under the Act shall be used to support the preparation, production, and dissemination of any article, newsletter, or other publication or written matter for general distribution which contains any reference to proposed or pending legislation unless— (A) The publication does not contain any publicity or propaganda prohibited by section (10);

(B) The provider has adopted a policy requiring the provider’s executive director, or his/her designee, to review each application produced by the provider prior to its dissemination for conformity to these regulations;

(C) The provider provides a copy of any such material produced by the provider to the area agency on aging within thirty (30) days after publication; and (D) These funds are used only for costs incident to the preparation, production, and dissemination of publications to providers, providers’ staff, and board members, private attorneys representing eligible clients and the area agency on aging, as opposed to the public at large.

(12) Notwithstanding the provisions of section (7), no funds made available to a provider under the Act shall be used, directly or indirectly, to pay for any personal service, advertisement, telegram, telephone communication, letter, printed or written matter or other device, intended or designed to influence any decision by a federal, state or local agency, except where legal assistance is provided by an employee of a provider to an eligible client on a particular application, claim or case, which directly involves the client’s legal rights and responsibilities or to influence any member of Congress or any other federal, state or local elected officials to favor or oppose any acts, bills, resolutions or similar legislation or any referendum, initiative, constitutional amendment or any similar procedure of Congress, any state legislature, any local council or any similar governing body, except that this subsection shall not preclude funds from being used in connection with communications made in response to any federal, state or local official upon a specific matter.

(A) The exception for communications to officials does not authorize communication with anyone other than the requesting party.

(B) No employee of the provider, directly or indirectly, shall solicit a request from any official to testify or otherwise advocate the support or defeat of legislative measures.

(13) Nothing in this section is intended to prohibit an employee from— (A) Communicating with a governmental agency for the purpose of obtaining information, clarification or interpretation of the agency’s rules, practices or policies;

(B) Informing a client about a new or proposed statute, executive order or administrative regulation consistent with the requirements of sections (10) and (11);

(C) Responding to an individual client’s request for advice only with respect to the client’s own communications to officials unless otherwise prohibited by the Older Americans Act, Title III regulations or other applicable law. This provision does not authorize publication or training of a client on lobbying techniques or the composition of a communication for the client’s use; or (D) Making direct contact with the area agency on aging for any purpose. 6.180 and 13 CSR 15-4.270. Original rule March 30, 2001. Moved to 19 CSR 15-4.270,

19 CSR 15-4.280 Ombudsman Services cy on aging to support the statewide Long- Term Care Ombudsman program and establishes criteria for funding local programs. {#sec-19-csr-15-4.280 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.280}

(1) The area agency on aging shall conduct ombudsman activities that support the division-administered Long-Term Care Ombudsman program. The area agency on aging may award funds for the provision of a Long-Term Care Ombudsman program and that award shall be based on a consideration of the degree to which the ombudsman service provider has— (A) Established measurable objectives;

(B) Identified facilities in the project area;

(C) Developed a plan for informing and serving the older residents of the identified facilities; and (D) Developed a plan for recordkeeping that includes such data as to the nature of the complaints received, efforts made to resolve complaints and procedures to maintain the confidentiality of service recipient records and files. 192.2310, RSMo 2016.* This rule was previously filed as 13 CSR 15-6.185 and 13 CSR 15-4.280. Original rule filed Jan. 6, 1986, effective April 30, 1986. Moved to 19 CSR 15-4.280, effective Aug. 28, 2001. Amended: 1988, 1992, 1993, 1994, 1995, 2001, 2014, and 192.2310, RSMo 1991, amended 2014.

19 CSR 15-4.290 Information and Assistance cy on aging to provide information and assistance services and describes the requirements for operating the program. {#sec-19-csr-15-4.290 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.290}

(1) The area agency on aging shall provide information and assistance services sufficient to ensure that all older adults within the planning and service area have reasonably convenient access to information about the services available within their geographic region.

(2) The area agency on aging shall comply with divisional standards for information and assistance services (see 19 CSR 15-4.295). 6.190 and 13 CSR 15-4.290. Original rule March 30, 2001. Moved to 19 CSR 15-4.290,

19 CSR 15-4.295 Information and Assistance Service Standards {#sec-19-csr-15-4.295 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.295}

PURPOSE: This rule sets forth minimum standards for information and assistance service providers to assure that all older adults within a planning and service area have reasonable access to services.

(1) A unit of service is one contact.

(A) A contact is an individual encounter with a client or their advocate.

(B) A contact may be a simple, one-time inquiry, or one which requires follow-up.

Contact may be by phone, in person or in writing, or by electronic means such as fax or e-mail.

(2) The service provider shall— (A) Identify target groups within the project area having the greatest need for services;

(B) Develop a plan for informing and serving the identified target group, establishing measurable objectives;

(C) Establish liaison with other information and assistance programs including services available through the Social Security Administration;

(D) Develop a plan for record keeping which includes data from the nature of requests received, the agencies to which the caller was referred and the service to which the caller was directed or referred;

(E) Maintain a file with respect to current resources and services available to the target population;

(F) Utilize staff specially trained to inform older adults or their advocates of the opportunities and services available;

(G) Develop a plan to provide services in the language spoken by the target population, if other than English; and (H) Establish a plan for the follow-up of referrals.

(3) Additional services may include advocacy, case management, public information and education.

(4) The information and assistance staff shall be composed of competent, ethical, qualified individuals, paid or volunteer, sufficient in number to carry out administrative and service responsibilities. Service responsibilities shall include:

(A) Maintaining an up-to-date resource file;

(B) Providing information to all inquirers;

(D) Conducting public information and education activities; and (E) Collecting data on inquirers and maintaining confidential, accurate and up-to-date records.

(5) Training shall be provided to all information and assistance staff, paid and volunteer, to ensure adequate delivery of information and assistance services. Training shall consist of the following components:

(A) Preservice orientations and training which should include:

The role, purpose, and function of the information and assistance service;
Skills training in the areas of interviewing techniques, attitudes, listening, communications, proper telephone usage, assessment techniques, information and assistance procedures, follow-up, data reading, maintenance of records, use of resource file; and 3. Recognizing abuse/neglect and exploitation of older adults, the requirements and limitations of sections 192.2400– 192.2505, RSMo, and procedures for reporting to the division’s hotline;

(B) On-the-job training which should consist of a program of increasing levels of involvement in handling inquiries, beginning with observation and ending with full responsibility for handling inquiries; and (C) In-service training provided on a regular basis which should include the refinement and updating of the staff’s understanding and knowledge of appropriate topics, including the operation of human service systems (legal, health, aging, welfare, governmental, education, advocacy and the like) and shall address techniques that assist staff in maintaining appropriate personal perspective.

(6) Information and assistance service staff shall maintain an accurate resource file which shall be updated periodically by— (A) Conducting a general survey of existing organization(s) and service(s) available;

(B) Making site visits to the organizations and services, as necessary.

(7) The resource file shall coin a list of public, private, and voluntary organizations that provide essential human services and opportunities to older adults. Each organization listing shall include at least:

(A) The legal name, common name, address, telephone number, hours and days of service of the organization;

(B) The service(s) provided by the organization;

(D) Application procedures required by organization (for example, birth certificate, other documents); and (E) The cost of service (the word sliding scale may be sufficient).

(8) Records shall be maintained of all transactions. Reports shall be in a manner that identification of older adults who use the service is not revealed or accessible to anyone other than staff members assisting them.

(9) In the event a referral is made which requires follow-up, a client intake form shall be started. Client intake instruments shall have the capacity to gather at least the following information:

(A) Family name, address, apartment, street, city or town, county, zip code, telephone number (business and home);

(B) Name of primary inquirer for which services are sought (if other than caller);

(D) Service needed; organization(s) to which inquirer was referred;

(E) Nature of request (information or referral, or both); and (F) Means of contact (for example letter, telephone, walk-in).

(10) If follow-up is provided, the results of the follow-up shall indicate the final disposition and notation shall be made as to whether service is— (A) Completed;

(B) Ongoing; or (C) Incomplete because of, but not limited to— 1. Insufficient availability of service;

Inquirer’s refusal to accept available service;
Inquirer’s refusal or unwillingness to contact service; or 4. Failure of inquirer to meet eligibility requirements (for example, income, residence, age, or sex of the inquirer).

(11) The service provider annually shall prepare and submit to the division reports of services and service agencies about which information given or to which referrals were made and the results of follow-up efforts with service providers and persons who sought assistance. 6.191 and 19 CSR 15-7.050. Original rule March 30, 2001. Moved to 19 CSR 15-7.050, 4.295 and amended: Filed Jan. 25, 2022, *Original authority: 192.2000 RSMo 1984, amended

19 CSR 15-4.300 Record Keeping and Confidentiality {#sec-19-csr-15-4.300 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.300}

PURPOSE: This rule establishes the length of time that the division, area agencies on aging, and service providers shall maintain records and the standards by which confidentiality of records will be maintained.

(1) The division, area agencies on aging, and service providers shall maintain all records under Title III for a minimum of three (3) years; Social Services Block Grant records shall be maintained for five (5) years.

(2) The division, area agencies on aging, and service providers shall maintain the confidentiality of records as follows:

(A) All records that identify individual recipients of alternative services shall be confidential and may be released, for administrative and program monitoring purposes only, to the following:

Designated employees of the United States Department of Health and Human Services, Administration for Community Living (ACL);
Designated employees of the Missouri Department of Health and Senior Services and the Division of Senior and Disability Services;
Designated employees of the area agency on aging or service provider; or 4. Court of competent jurisdiction, when subpoenaed;

(B) No information or records maintained by the Long-Term Care Ombudsman program may be disclosed unless the Long-Term Care Ombudsman authorizes the disclosure;

(C) Lists of names of older adults shall be used for the purpose of providing services and shall not be distributed, released, or used for any other reason;

(D) Records that contain confidential client information shall be released only for purposes of program monitoring by an authorized federal, state, or local monitoring agency, unless— 1. The service recipient or their legal representative has given informed consent prior to the release of that information;

The signed release indicates to whom the information will be given;
Indicates the specific information to be released; and 4. Specifies the inclusive dates for which the written consent is valid.

(E) Program, fiscal and statistical records that do not identify individual service recipients are not confidential and shall be made available for public inspection upon written request. 6.015 and 13 CSR 15-4.300. Original rule March 30, 2001. Moved to 19 CSR 15-4.300,

19 CSR 15-4.310 Corporate Eldercare {#sec-19-csr-15-4.310 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.310}

(Rescinded August 30, 2018)

This rule previously filed as 13 CSR 15-4.310. Original rule filed June 16, 1992, effective Jan. 15, 1993. Amended: Filed Aug. 19 CSR 15-4.310, effective Aug. 28, 2001.

Rescinded: Filed Jan. 5, 2018, effective Aug. 30, 2018.

History

AUTHORITY: section 660.050, RSMo Supp.

19 CSR 15-4.410 Transportation Service Standards {#sec-19-csr-15-4.410 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.410}

PURPOSE: This rule sets forth the minimum standards to be met by a transportation service provider receiving state or federal funds for the operation of transportation services for adults sixty years of age and over and adults with disabilities between ages eighteen and fifty-nine and applies to all transportation service delivery systems, both direct and indirect.

(1) Contracted transportation service providers and transportation service provided directly by the area agency on aging to eligible service recipients shall meet the following requirements:

(A) Have sufficient phones and personnel to handle calls regarding the service;

(B) Develop and operate an efficient system for scheduling trips to assure that the service is dependable and no passenger is left stranded;

(C) Service will be provided for the duration of a contract period or as agreed upon by the area agency on aging and service provider;

(D) Have a program manual available to all employees and volunteers detailing its operational policies, procedures, and general requirements applicable to service provision.

Program manual shall include:

Safety precautions for drivers and passengers;
Information on the procedure for denial of service, provided in sections (4)– (7);

(E) Ensure all drivers have completed orientation training prior to transporting eligible service recipients;

(F) Ensure that all drivers of any vehicle used in transportation have a valid driver’s license as required by Missouri law— 1. Class F: required to transport for pay for a transportation network company;

Class E: required to transport for pay up to fourteen (14) passengers unless working for a transportation network company; or 3. CDL: required for transporting for pay fifteen (15) or more passengers;

(G) Ensure that all vehicles used for transportation shall be in compliance with all state and federal laws, rules, and regulations including the Americans with Disabilities Act; and (H) Be in compliance with all general requirements for service providers provided in 19 CSR 15-7.010.

(2) Any driver, using personally-owned vehicles to transport service recipients shall maintain proper vehicle insurance and shall sign an agreement indicating understanding and acceptance of liability.

(3) Vehicles shall meet the following requirements:

(A) All vehicles shall be licensed and registered in accordance with Missouri law;

(B) All vehicles shall receive a vehicle safety inspection, as required by state law, and shall be clean and in good repair;

(D) All vehicles shall have for each passenger an available seat that is securely fastened to the floor of the vehicle. Cars and vans shall have a useable seat belt, and include seat belt extenders as needed, for each person being transported;

(E) All vans and buses shall be in ADA compliance in accordance with 49 CFR Part 38, Subpart B; and (F) All vehicles shall be insured in accordance with Missouri law.

(4) Drivers are authorized to deny transportation to a service recipient attempting to board the vehicle who, in the judgment of the driver— (A) Is intoxicated;

(B) Is too ill or experiencing an emergency health episode;

(C) Has a mobility limitation that prevents safe entry or exit from the vehicle even with reasonable human or mechanical assistance;

(D) Demonstrates violent or unruly behavior; or (E) Insists on transporting prohibited items.

(5) Drivers shall report incidents of denial of transportation to the transportation service provider. Written documentation of each incident shall be maintained.

(6) Without written approval of the contracting agency, the transportation service provider shall not suspend service to a passenger for more than five (5) consecutive days due to problems with the service recipient.

(7) The transportation service provider shall submit to the contracting agency a written request to suspend service indefinitely to any service recipient who, in the provider’s judgment, exhibits behavior— (A) That is contrary to these standards; or (B) Which has been and continues to be hazardous to the safety of self or others. 6.165 and 19 CSR 15-7.040. Original rule Amended: Filed Aug 28, 2000, effective March 30, 2001. Moved to 19 CSR 15-7.040, 4.410 and amended: Filed Jan. 25, 2022,

19 CSR 15-4.440 Division Formal Hearings {#sec-19-csr-15-4.440 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.440}

PURPOSE: This rule requires the division to provide the opportunity for a formal hearing, describes when a formal hearing may be requested and the procedures to be followed.

(1) The division shall provide the opportunity for a formal hearing, under the following circumstances:

(A) To an area agency when the division finds that any provision of the area plan or plan amendment is not approvable and the division proposes to disapprove the area plan or plan amendment;

(B) To an area agency on aging when the division proposes to withdraw its designation in accordance with 19 CSR 15-4.080;

(D) To any nutrition project that was receiving funds under the former Title VII of the Act on September 30, 1978, that an area agency proposes to defund except as provided in 45 CFR Part 75 and has appealed the determination through the area agency on aging grievance procedure; and (E) To any other service provider whose application to provide services is denied or whose subgrant or contract is terminated or not renewed except as provided in 45 CFR

Part 75 and has appealed the determination through the area agency on aging grievance procedure.

(2) A written request for a formal hearing shall be filed with the director within thirty (30) calendar days following receipt of notice of the adverse action to be appealed. The written request shall state clearly the actions to be reviewed and enumerate the issues to be resolved.

(A) The director shall designate a hearing officer that is an impartial decision-maker to hear all appeals. The designated hearing officer shall be the director or director’s designee.

(B) The designated hearing officer is responsible for arranging the formal hearing and, within fifteen (15) calendar days of receipt of a request for hearing, shall send written notification to all parties advising of the date, time, and location of the hearing.

(C) The hearing shall be completed one hundred twenty (120) calendar days of the date the request for hearing was received by the division.

(D) The purpose of the hearing shall be to receive factual information, both verbal and written, related to the identified issues.

(E) Letters and other written material regarding matters at issue shall be considered correspondence and shall not be considered as part of the information or the record unless formally introduced by the parties involved and admitted by the designated hearing officer.

(3) The designated hearing officer shall assure that the aggrieved party received timely written notice of the determination that is being appealed which included the following:

(A) Explanation of the reasons for the determination and the evidence on which the determination was based;

(B) Provision for the opportunity to review any pertinent evidence upon which the determination was based; and (C) Notification of the right to appeal the determination.

(4) The designated hearing officer shall assure that in the conduct of the hearing the aggrieved party shall have an opportunity to— (A) Appear in person to refute the basis for the decision;

(B) Be represented by counsel or other representative;

(5) The designated hearing officer shall conduct a fair hearing, avoid delays, and maintain order. The designated hearing officer shall have the authority to— (A) Regulate the course of the hearing;

(B) Regulate the participation and conduct of the parties and others at the hearing;

(D) Question all persons presenting information;

(E) Receive or exclude information; and (F) Rule on or limit information.

(6) The designated hearing officer shall designate a reporter for the hearing who shall maintain a record of the proceedings. The record shall consist of the verbatim (taperecorded) information, exhibits, rulings, decisions, and all other pertinent papers and requests, except for correspondence.

(7) The designated hearing officer shall issue a final written decision, within sixty (60) calendar days of the date of the hearing, which sets forth the reasons for the division’s decision and the evidence on which the decision is based.

(8) The division may terminate the formal hearing procedures at any point if the division and/or aggrieved parties negotiate a written agreement, signed by both parties, that resolves the issue(s) which led to the hearing.

(9)The division shall notify an applicant for designation as a planning and service area who receives an adverse decision from the division’s formal hearing of the right to appeal to the assistant secretary.

(10) The division shall retain the complete record for a period of at least three (3) years following the date of the hearing.

History

AUTHORITY: sections 251.070, 536.023, and 192.2000, RSMo 2016. Executive Order of the Governor filed Jan. 31, 1979, effective Oct. 1, 1979 and in compliance with 45 CFR 1321.15(b)(2). This rule previously filed as

13 CSR 15-6.025 and 19 CSR 15-6.025. {#sec-13-csr-15-6.025 omnilex-key=us-mo-regs-official--title-19--13 CSR 15-6.025}

Original rule filed Feb. 10, 1982, effective May 11, 1982. Moved to 19 CSR 15-6.025, 4.440 and amended: Filed Jan. 25, 2022, *Original authority: 251.070, RSMo 1967; 536.023, RSMo 1975, amended 1976, 1997, 2004; and 192.2000, RSMo 1984, amended 1988, 1992, 1993, 1994, 1995, 2001, 2014.

Chapter 6 Alternative Services

19 CSR 15-6.020 Division Mediation Procedures {#sec-19-csr-15-6.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-6.020}

(Rescinded August 30, 2022)

History

AUTHORITY: sections 251.070 and 536.023, RSMo 1986; Executive Order of the Governor filed Jan. 31, 1979, effective Oct. 1, 1979 and in compliance with 45 CFR 1321.15(b)(2). This rule previously filed as

13 CSR 15-6.020. Original rule filed Feb. 10, 1982, effective May 11, 1982. Moved to 19 CSR 15-6.020, effective Aug. 28, 2001. {#sec-13-csr-15-6.020. omnilex-key=us-mo-regs-official--title-19--13 CSR 15-6.020.}

Rescinded: Filed Jan. 25, 2022, effective Aug. 30, 2022.

19 CSR 15-6.025 Division Formal Hearings {#sec-19-csr-15-6.025 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-6.025}

(Moved to 19 CSR 15-4.440)

Chapter 7 Service Standards

19 CSR 15-7.050 Information and Assistance Service Standards {#sec-19-csr-15-7.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-7.050}

(Moved to 19 CSR 15-4.295) ..12 SERVICES

19 CSR 15-7.005 Definitions {#sec-19-csr-15-7.005 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-7.005}

PURPOSE: This rule defines terms used in this chapter.

(1) Area Agency on Aging—The agency designated by the division in a planning and service area to develop and administer a plan and administer available funds for a comprehensive and coordinated system of services for older adults and adults with disabilities who require similar services.

(2) Case management—A service which ensures that individuals with chronic or acute care needs are assessed and provided with a comprehensive and coordinated service program designed to meet those assessed needs.

(3) Caterer—A restaurant, hospital, school, or commercial organization which prepares meals under contract.

(4) Center—Any facility regardless of terminology used, that is, senior center, congregate nutrition center, nutrition site, supportive services center, satellite center or site, or multipurpose senior center, that is utilized to provide one (1) or more services to older adults.

(5) Congregate nutrition services—The provision of nutrition services to older adults in a congregate or group setting.

(6)

Contributions—Money or Supplemental Nutrition Assistance Program (SNAP) (for meals only) given voluntarily and confidentially toward the cost of a service received.

(7) Division—The Division of Senior and Disability Services of the Missouri Department of Health and Senior Services.

(8) Greatest economic need—The need resulting from an income level at or below the poverty line.

(9) Greatest social need—The need caused by non-economic factors, including disability; language barriers; and cultural, social, or geographic isolation, including isolation caused by racial or ethnic status, which restrict the ability of an individual to perform normal daily tasks and/or threatens the capacity of the individual to live independently.

(10) Follow-up—Recontacting the inquirer or agency/ organization to whom the referral was made to assure if contact was made or if further services are required.

(11) Frail elderly—Older adults having a physical or mental disability, including having Alzheimer’s disease or a related disorder with neurological or organic brain dysfunction, that restricts the ability of the individual to perform normal daily tasks or which threatens the capacity of the individual to live independently.

(12) Home and community based services—services offered to eligible adults in a non-institutional setting.

(13) Homebound—One who is confined to the home because of illness or incapacitating disability.

(14) Home-delivered nutrition services—Nutrition services delivered to eligible recipients in their homes.

(15) Low-income—Persons whose annual income is at or below the poverty threshold established by the Office of Management and Budget.

(16) Minority—Individuals of the following racial/ethnic compositions: American Indian/Alaskan Native; Asian/Pacific Islander; Black, not of Hispanic origin; or Hispanic.

(17)

Multipurpose senior center—A community or neighborhood facility for the organization and provision of a broad spectrum of services which shall include but not be limited to provision of health, including mental health, social, nutrition, and educational services, and the provision of facilities for recreational activities for older adults.

(18) Nutrition services—Provision of congregate or homedelivered meals, or both.

(19) Older adult—A person sixty (60) years of age or older.

(20) Outreach—Intervention with individuals initiated by an agency or organization for the purpose of identifying potential participants (or their caregivers) and encouraging their use of existing services and benefits.

(21) Participant—An eligible individual who receives one (1) or more services.

(22) Public education—Provision of information to the public where seniors gain access to area agency on aging services or the information meets a need of the elderly.

(23) Senior center—A facility providing nutrition services and a variety of supportive services to older adults.

(24) Service provider—Any agency which contracts with the Missouri Department of Health and Senior Services;

Department of Social Services, Missouri Medicaid Audit and Compliance; or an area agency on aging to provide services directly to older adults.

(25) Volunteer—A person, other than staff or Senior Community Service Employment Program (SCSEP) enrollees, who contributes personal service.

Moved to 19 CSR 15-7.005, effective Aug. 28, 2001. Amended: Filed Feb. 7, 2023, effective Aug. 30, 2023.

History

AUTHORITY: section 192.2000, RSMo 2016. Original rule filed Jan. 6, 1986, effective April 30, 1986. Amended: Filed Feb. 17, 1988, effective June 15, 1988. Amended: Filed June 3, 1991, effective Oct. 31, 1991. Amended: Filed May 12, 2000, effective Nov. 30, 2000.

19 CSR 15-7.010 General Requirements for All Service Providers {#sec-19-csr-15-7.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-7.010}

PURPOSE: This rule describes the general requirements that all service providers shall meet to receive grants or subgrants to provide services for older adults or low income adults with disabilities funded by the division or area agencies on aging.

(1) Service providers shall meet all applicable state and local licensure and safety requirements for the provision of those particular services.

(2) Service providers shall maintain any licensure, certification or registration mandated by any state or local government, body or board.

(3) Service providers shall allow only employees or volunteers holding a current license, certification or registration to perform those tasks, duties or functions for which licensure, certification or registration is required by any state or local agency, body or board.

(4) Service providers shall have an adequate number of staff (paid or volunteer) who are qualified to perform assigned functions in order to implement the activities and services.

(A) Multilingual staff shall be available when there are substantial numbers of non-English speaking participants.

(B) A written job description for each position function and responsibility and the line of supervisory authority for each position (paid and volunteer) shall be developed and maintained. Personnel qualifications shall meet job description requirements.

(C) A written performance evaluation of each paid staff member shall be done at least annually and shall be maintained in the employee’s personnel file.

(D) A training file shall be maintained that documents the type of training provided, names of staff and volunteers participating, number of hours of training provided, and date(s) training was provided. A report of each employee’s orientation and in-service training provided by the service provider and from other sources shall be placed in that employee’s personnel file.

(5) Centers shall be in compliance with all applicable state and local fire and safety laws, as well as the following requirements:

(A) If the division determines that the state or local fire safety laws, ordinances, or codes are not adequate to assure the safety of older persons or for any locality that has no governing fire and safety laws, ordinances, or codes, the provisions of the National Fire Protection Association Life Safety Code (NFPA No. 101, 1981 edition) for places of assembly shall apply;

(B) Centers shall have installed and shall maintain in operable condition an adequate number of smoke detectors and fire extinguishers of the appropriate type as determined by consultation with state or local fire authorities. All smoke detectors and fire extinguishers shall be located within the premises according to the recommendations of state or local fire authorities;

(C) Centers shall develop a written safety and evacuation plan for assuring the safety of participants, staff, and volunteers in case of fire or other hazardous situations and evacuation drills shall be conducted annually. Copies of the plan shall be on file at the center and at the area agency on aging’s office and a charted plan shall be posted conspicuously in the center.

The plan and procedures shall include but need not necessarily be limited to— 1. A written assessment of potential fire or safety hazards present on the premises and actions and procedures that are to be followed to minimize danger;

A written schedule for annual check of smoke detectors and fire extinguishers to assure that adequate pressure or battery strength is maintained for efficient operation when needed; and 3. A written training plan including frequency of comprehensive and refresher training for staff and volunteers on safety responsibilities and actions to be taken if an emergency situation occurs with documentation of training sessions provided; and (D) Fire inspections shall be conducted annually at all centers by state or local fire authorities. Documentation of the inspector’s report, recommendations, and corrections of any deficiencies shall be maintained at the area agency on aging and center offices.

(6) Service providers whose staff have direct physical contact with participants shall make emergency arrangements in consultation with relevant agencies for dealing with participant personal emergencies that include— (A) Specific personnel designated and trained to take charge in an emergency;

(B) A person, present or immediately available during all hours that the center is open, who has successfully completed a training course in first aid or emergency care that included at least:

Basic first aid;
Cardiopulmonary resuscitation (CPR);
Heimlich maneuver; and 4. Guidelines on when to attempt first aid or when to take alternative action; and (C) Written instructions posted conspicuously which include the 911 emergency telephone number, if available, or other local emergency telephone numbers, such as those of physicians, ambulances, hospital emergency rooms, and local civil defense or disaster offices if the 911 number is not available in the community.

(7) Caterers and centers in which food is prepared, served, or both, shall be maintained in a safe and sanitary manner and shall be in compliance with all applicable state, county, or city health codes. Each location at which food is prepared shall be inspected annually by state or local health authorities. Each location at which prepared food is received from another source shall be inspected annually by state or local health authorities.

Documentation of the inspector’s report, recommendations, and corrections of any deficiencies shall be kept at both the area agency on aging and center offices.

(8) Service provider staff and volunteers shall be familiar with and shall be able to recognize situations of possible abuse, neglect, exploitation, or likelihood of serious physical harm involving older adults. Instances of potential abuse, neglect, exploitation, or likelihood of serious physical harm shall be immediately reported to the division’s Adult Abuse and Neglect Hotline (1-800-392-0210) or Missouri Adult Abuse and Neglect Online Reporting System (https://health.mo.gov/safety/ abuse/).

(9) Service providers shall provide the following:

(A) Public information and education activities to ensure that older adults are informed of the services available and have maximum opportunity for participation;

(B) Coordination with other service providers in the planning and service area to assure comprehensive delivery of services and reduce duplication; and (C) A written complaint procedure through which the participant can communicate to the service provider aspects of the service which impact negatively upon them.

(10) Service providers who use volunteers shall develop a written plan for recruiting, orienting, training, supervising and terminating volunteers.

(11) Service providers shall serve older adults with the greatest economic or social need, especially low-income minority persons, older adults residing in rural areas, and frail individuals.

Service providers may use methods such as location of services and specialization in the types of services most needed by these groups to meet this requirement. Service providers shall not use a means test to deny individuals services within the target population.

(12) Service providers shall obtain the views of participants about the services they receive.

(13) Service providers shall assure that federal funds shall be used as the payer of last resort.

(14) Service providers shall implement the provisions of the Americans with Disabilities Act (ADA) of 1990 (PL 101-336), which prohibits discrimination against people with disabilities, to include— (A) Operation of programs, services, and activities in such a manner as to be readily accessible to and usable by persons with disabilities;

(B) Senior centers are considered places of public accommodation and must therefore comply with the ADA.

The responsibility to remove barriers in existing buildings is an ongoing process and area agencies on aging should use the following priorities as a guide to increase accessibility:

access to the facility; 2) access to the area in which goods and services are available; 3) access to restroom facilities; and 4) removing any remaining barriers. Area agencies on aging offering services in buildings where barrier removal is not readily achievable must develop a written implementation plan designed to achieve compliance, as well as a written policy outlining alternative methods to provide services during the interim. All renovations, alterations, or new construction must ensure compliance with ADA requirements by using the ADA Standards for Accessible Design published in Appendix A to the Department of Justice Title III regulations, 28 CFR part 36, which is incorporated by reference in this rule, as published on July 1, 2021, by the Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408, and available at https:\bookstore.gpo.gov. This rule does not incorporate any subsequent amendments or additions; and (C) Reasonable accommodation shall be made in policies, practices, and procedures to allow participation of persons with disabilities. To the greatest extent possible, services should be provided in an integrated setting; however, when barriers cannot be removed, alternative methods of providing the services, programs, and activities must be offered.

(15) Procedures for handling contributions shall be developed and implemented that include the following:

(A) Each participant shall be provided with an opportunity to voluntarily contribute to the cost of the service;

(B) The privacy of each participant with respect to his/her contribution shall be protected;

(C) Establish and implement a system of internal control that ensures all contributions received are fully and accurately recorded, deposited, accounted for, and reported to the area agency on aging.

Collecting contributions in a locked box at senior centers.
Using two (2) persons when accessing contributions or to count receipts.
Keeping receipts in a secure area or locked box until deposited.
Recording all contributions on the date of receipt.
Taking precautions to prevent theft of cash receipts.
Reporting contribution receipts to the area agency on aging at least monthly.
Avoiding an accumulation of a large balance of income on hand;

(D) All contributions shall be used to expand the service for which the contribution was made. Nutrition services contributions shall be used to increase the number of meals served, to facilitate access to meals and to provide supportive services directly related to nutrition services;

(E) A suggested contribution schedule may be developed for each service provided. In developing a contribution schedule, the provider shall consider the income ranges of elderly persons in the community, the provider’s other source of income and the actual cost of the service. The contribution schedule should be revised periodically as needed; and (F) A provider shall not deny any elderly person a service because the elderly person will not or cannot contribute to the cost of the service. An eligible participant shall not be charged for participating in any service or activity.

(16) Administrative policies and procedures shall be followed which include— (A) A current Affirmative Action/Equal Employment Opportunity Plan and Program as required by the Civil Rights Act of 1964 and the Equal Employment Opportunity Act of 1972;

(B) Record keeping and confidentiality as cited in 19 CSR 15- 4.300;

(D) Bonding for all volunteers, staff or governing body members who have fiscal responsibilities, to protect against loss of federal and state funds or agency income;

(E) Insurance coverage which includes— 1. Workers’ Compensation—statutory amount as prescribed by the laws of Missouri;

Comprehensive general liability covering employees, volunteers and participants;
Product liability as applicable to the service provided;
Automobile liability for service provider vehicles and, for volunteers using their own vehicles, at least a procedure for verifying that the volunteer maintains adequate insurance and understands his/her liability;

(F) Written policies that specify which holidays and special event days may be observed by curtailing delivery of services and procedures for publicizing these dates and assuring that participants are informed;

(G) Written policies and procedures to be followed when service delivery must be interrupted due to emergency situations including— 1. Definition of types of emergencies (weather, natural disaster, health, pandemic, and the like);

Specifications of the person/position responsible for making the decision to interrupt scheduled service delivery;
Identification of procedures to be followed for notifying participants; and (H) Written policies and procedures to be followed when it is necessary to terminate or deny services to an individual participant that include— 1. Justification for termination or denial;
Referral to other needed services; and 3. Follow-up for return to service, when appropriate.

(17) Any facility altered, renovated, acquired by purchase or lease, or constructed using federal or state funds may not be used for religious instruction or as a place of worship, as follows:

(A) Federal and state funds shall not be used to renovate, alter or construct a building that is also intended to be used, or is used, as a place of worship even though the building may serve as a multipurpose senior center;

(B) Service providers shall have a written agreement with sectarian organizations housing alternative services programs which includes the provision that all equipment purchased with federal funds remain the property of the area agency on aging, as per 45 CFR part 75, which is incorporated by reference in this rule, as published on October 1, 2021, by the Office of the Federal Register, National Archives and Records Administration, Washington, DC 20408, and available at https:\bookstore.gpo.gov. This rule does not incorporate any subsequent amendments or additions;

(C) Each individual participant shall have a free choice of whether or not they wish to participate in prayer and no staff (paid or volunteer for that day) shall initiate, lead, organize, or encourage a prayer or moment of silence; and (D) Service providers shall ensure that no federal or state funds shall be used for religious instruction or worship.

(18) Any facility altered, renovated, acquired by purchase or lease, or constructed using federal or state funds may not be used for political campaigning on behalf of any candidate for local, state, or national office unless— (A) The political discussion is a planned, scheduled activity;

(B) All candidates for a particular office are personally present or afforded the opportunity to be present; and (C) All candidates are afforded the opportunity to present their views through a series of discussions, scheduled at intervals, but given equal time.

Amended: Filed Aug. 28, 2000, effective March 30, 2001. Moved to 19 CSR 15-7.010, effective Aug. 28, 2001. Amended: Filed Feb. 7, 2023, effective Aug. 30, 2023.

History

AUTHORITY: section 192.2000, RSMo 2016. This rule was previously filed as 13 CSR 15-6.135. Original rule filed Jan. 6, 1986, effective April 30, 1986. Amended: Filed Feb. 17, 1988, effective June 15, 1988. Amended: Filed June 3, 1991, effective Oct. 31, 1991.

19 CSR 15-7.021 In-Home Service Standards {#sec-19-csr-15-7.021 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-7.021}

PURPOSE: This rule sets forth standards to be met by any agency which contracts with the Missouri Department of Social Services, Missouri Medicaid Audit and Compliance Unit for provision of inhome services authorized by the Missouri Department of Health and Senior Services, Division of Senior and Disability Services.

(1) The Department of Health and Senior Services (also referred to as the department), Division of Senior and Disability Services’ (also referred to as the division) payment to the provider is made on behalf of an eligible participant as an act of indirect or third-party reimbursement and is not made as a payment for the purchase of a service. Only those services authorized by the division shall be reimbursable to the provider.

(2) The in-home service provider shall deliver services in compliance with the standards set forth in this rule and 13 CSR 70-91.010, 13 CSR 65-2.020, and 13 CSR 70-3.030.

(3) Failure of the in-home service provider to comply with the terms of the contract and these standards may constitute a breach of contract.

(4) In accordance with the protective service mandate (Chapter 192, RSMo), the division may take immediate action to protect participants from providers who are found to be out of compliance with the requirements of this rule and of any other

rule applicable to the in-home services program, when such noncompliance is determined by the division to create a risk of injury or harm to participants.

(A) Evidence of such risk may include— 1. Unreliable, inadequate, falsified, or fraudulent documentation of service delivery or training;

Failure to deliver services in a reliable and dependable manner;
Use of in-home service workers who do not meet the minimum employment requirements or training standards of this rule;
Failure to comply with the requirements for background screening of employees (sections 192.2490 and 192.2495, RSMo); or 5. Discontinuing services outside the provisions specified in section (16) of this rule without the knowledge and consent of the participant for a period of one (1) week or three (3) consecutive scheduled service delivery dates, whichever is shorter.

(B) Immediate action may include but is not limited to— 1. Removing the provider from any list of providers and, for participants who request the unsafe and noncomplaint provider, informing the participants of the determination of noncompliance after which any informed choice will be honored by the division; or 2. Informing current participants served by the provider of the provider’s noncompliance and that the division has determined the provider unable to deliver safe care. Such participants will be allowed to choose a different provider from the list maintained by the division which will then be immediately authorized to provide service to them.

(5) The Missouri Medicaid Audit and Compliance Unit (MMAC) will not consider any proposal for an in-home services contract and subsequent enrollment as a Medicaid personal care provider under 13 CSR 70-91.010(3) unless the proposal is fully completed, properly attested to or affirmed by a person with the expressed authority to sign the proposal, and contains all required attachments.

(A) The proposal shall be made in the exact legal name of the applicant for a contract. The attachments to the proposal shall include but are not limited to the following information/ copies:

Federal tax identification number;
Most recent corporate annual registration report filed with the Missouri secretary of state (if applicable);
Certificate of Good Standing issued by the Missouri secretary of state (if applicable);
Fictitious name registration filed with the Missouri secretary of state (if applicable);
Corporation by-laws, if the applicant is a corporation;
Operating agreement and management agreement, if applicable, if the provider is a limited liability company; and 7. Certificate of Insurance evidencing the coverage described in subsection (18)(E) of this rule, naming the division as a certificate holder.

(B) Upon receipt of a proposal, MMAC will conduct whatever investigation, at MMAC’s discretion, is necessary to determine the applicant’s eligibility for a contract. The decision determining eligibility for a contract may include but is not limited to the conduct of the provider and principals of the provider during any prior contractual periods.

(C) Prior to the issuance of an initial contract, a site visit will be conducted for in-home service providers entering the program.

(6) Respite care services are maintenance and supervisory services provided to a participant in the individual’s residence to provide temporary relief to the caregiver(s) that normally provides the care.

(A) Respite care services shall include, at a minimum, the following activities:

Supervision—The respite care worker will provide personal oversight of the participant for the duration of the service period. Personal oversight includes making a reasonable effort to assure the safety of the participant and to assist the participant in meeting his/her own essential human needs. Sleeping is permitted when the participant is asleep, provided there is no indication that the condition of the participant would pose a risk if the participant awoke while the respite care worker was sleeping. The worker must be in close proximity to the participant during a sleeping period;
Companionship—The worker will provide companionship during the participant’s waking hours and attempt to make the participant as comfortable as possible;
Direct client assistance—The worker will provide direct participant assistance as needed to meet needs usually provided by the regular caregiver.

(B) Basic respite care services are provided to participants with nonskilled needs.

(C) Advanced respite care services are maintenance and supervisory services provided to a participant with nonskilled needs that require specialized training.

Participants appropriate for this service include persons with special needs, requiring a higher level of personal oversight as determined by the division.

(7) Homemaker services are general household activities provided by a trained homemaker when the participant is unable to manage the home and care for him/herself or others in the home or when the individual (other than the participant) who is regularly responsible for these activities is temporarily absent. Homemaker services shall include, at a minimum, the following activities:

(A) Plan and prepare meals, including special diet menus and perform cleanup after meals;

(B) Wash dishes, pots, pans, and utensils;

(D) Clean bathroom fixtures;

(E) Make beds and change sheets;

(F) Sweep, vacuum, and scrub floors;

(G) Tidy and dust the home;

(H) Launder clothes and linens;

(I) Iron and mend clothes;

(J) Wash inside windows and clean blinds that are within reach without climbing;

(K) Bag trash inside the home and put it out for pick up;

(L) Shop for essential items (for example, groceries, cleaning supplies, etc.);

(M) Perform essential errands (for example, pick up medication, post mail, etc.);

(N) Read and write essential correspondence for participants who are blind, illiterate, or have physical disabilities; and (O) Instruct the participant in ways to become self-sufficient in performing household tasks.

(8) Chore services are short-term, intermittent tasks necessary to maintain a clean, safe, sanitary, and habitable home environment and determined by the division to be critical in maintaining the participant’s health and safety. Chore services shall be provided only when the participant or other household member is incapable of performing or financially providing for them, and when no other relative, caregiver, landlord, community or volunteer agency, or third-party payer is capable of or responsible for providing such tasks. Chore services include the following activities:

(A) Wash walls and woodwork;

(B) Clean closets, basements, and attics;

(D) Air mattresses and bedding;

(E) Spray for insects within the home with over-the-counter supplies; and (F) Provide rodent control within the home (for example, setting traps and putting out over-the-counter supplies).

(9) The range of homemaker, chore, and respite activities the in-home worker provides is mutually determined by the provider agency and the participant.

(10) Basic personal care services are maintenance services provided to a participant in the individual’s residence to assist with the activities of daily living. Regulations for personal care are filed at 13 CSR 70-91.010.

(11) Advanced personal care services are maintenance services provided to a participant in the individual’s home to assist with activities of daily living when this assistance requires devices and procedures related to altered body functions. Regulations for advanced personal care are filed at 13 CSR 70-91.010.

(12) Authorized nurse visits are skilled nursing services of a maintenance or preventive nature provided to participants with stable chronic conditions. They are provided at the participant’s residence and prior-authorized by the division.

These services are not intended primarily as treatment for an acute health condition. Authorized nurse visit services may be provided by a licensed practical nurse (LPN) or a graduate nurse (GN) under the direction of a registered nurse (RN). Regulations for authorized nurse visits are filed at 13 CSR 70-91.010.

(13) The in-home service provider shall not perform and shall not be reimbursed for the following activities:

(A) Providing therapeutic/health-related activities that should be performed by a registered nurse, licensed practical nurse, graduate nurse, or home health aide under Titles XVIII or XIX home health programs;

(B) Providing transportation services;

(D) Performing household services not essential to the participant’s needs; and (E) Providing friendly visiting.

(14) Prior to approval by MMAC for an in-home services contract and subsequent enrollment as a Medicaid personal care provider under 13 CSR 70-91.010(3), in addition to the contract, all providers must— (A) Designate to MMAC the manager who will be responsible for the provider’s day-to-day operation. This manager shall be a policymaker and direct the provider’s recordkeeping, service delivery verification, hiring and firing practices, and staff training;

(B) Ensure that the designated manager successfully completes (or has completed) a MMAC provider certification course offered (quarterly or as needed) at no charge;

(C)

Be responsible for maintaining documentation of attendance and requiring attendance by new managers within six (6) months of hire; and (D) Ensure the designated managers annually attend MMACsponsored training designed to update managers.

(15) Participants shall be accepted for care on the basis of a reasonable expectation that the participant’s maintenance care needs can be met adequately by the agency in the participant’s place of residence. Services shall follow a stateapproved care plan developed in collaboration with and signed by the participant.

(A) The care plan shall consist of an identification of the services and tasks to be provided, frequency of services, and the maximum number of units of service per month.

(B) A new in-home assessment and care plan may be completed by the division as needed to redetermine the need for in-home services or to adjust the monthly amount of authorized units. The service provider must always have an active care plan. Only the division, not the service provider, may increase the overall maximum number of units for which the individual is eligible per month.

(C) The participant will be informed of the option of services available to him/her in accordance with the assessment findings.

(16) To ensure safety and welfare of participants, the following policies and procedures shall be followed when discontinuing in-home services:

(A) Services for a participant shall be immediately discontinued by a provider upon receipt of information that the participant’s case is closed by the division;

(B) When the provider learns of circumstances that may require closing the case (for example, death, entry into a nursing home, participant no longer needs services, etc.), the provider shall immediately notify the division in writing and request that the participant’s service be discontinued;

(C) When the participant, family member, or other person living in the household threatens or abuses provider personnel, the provider shall immediately notify the division in writing, including information regarding the threat(s) or abusive acts.

The division and provider shall mutually determine appropriate intervention and the feasibility of continuing services. The division shall discontinue the participant’s services, and may refer the participant to other programs that could meet the participant’s needs, when the division has determined that it is no longer appropriate for any in-home services provider to continue to provide services to the participant due to threats to or abuse of provider or division personnel; or (D) When a participant is noncompliant with the agreedupon care plan or the provider is unable to continue to meet the needs of a participant still in need of assistance, the provider shall contact the division and participant (including the caregiver or family when appropriate). The provider shall give written notice of discharge to the participant or participant’s family and the division at least twenty-one (21) days prior to the date of discharge. During this twenty-one- (21-) day period, the division shall make appropriate arrangements with the participant for transfer to another agency, or arrange for care in another care setting. The provider must continue to provide care in accordance with the care plan for these twenty-one (21) days or until alternate arrangements can be made by the division, whichever comes first.

(17) Unless otherwise specified below, a unit of in-home service is fifteen (15) minutes of direct service provided to the participant in the participant’s home by a trained in-home service worker, including time spent on entry of electronic visit verification. No units are reimbursed except as authorized by the division.

(A) Time spent for travel, lunch, breaks, or administrative activities, such as completing other reports or paperwork, shall not be included.

(B) For monthly invoicing purposes, partial units of a particular service provided in the course of the month may be accumulated over the billing cycle; partial units shall not be accumulated or carried over to the next month’s billing cycle.

(D) The invoice submitted to the Missouri Department of Social Services, MO HealthNet Division, for in-home service shall not exceed actual delivered units of services.

(18) The in-home service provider shall meet, at a minimum, the following administrative requirements:

(A) Employ and train the staff necessary to provide the required services and make staff available to serve in all sections of the provider’s designated service area;

(B) Monitor a current copy of the department’s Employee Disqualification List to ensure that no current or prospective employee’s name appears on the list and discharge any such employee once it is discovered by the provider that the employee is on the Employee Disqualification List;

(C) Have the capability to provide service outside of regular business hours, on weekends, and on holidays as authorized by the division;

(D) Protect the department and its employees, agents, or representatives from any and all liability, loss, damage, cost, and expense which may accrue or be sustained by the department, its officers, agents, or employees as a result of claims, demands, costs, suits, or judgments against it arising from the loss, injury, destruction, or damage, either to person or property, sustained in connection with the performance of the in-home service;

(E) Maintain a commercial general liability insurance policy in full force and effect that covers all places of business and any and all participants, customers, employees, and volunteers.

Such policy shall be an occurrence policy and shall provide coverage for no less than one (1) million dollars per event and three (3) million dollars aggregate and shall include coverage for negligent acts and omissions of the provider’s employees and volunteers in the provision of services to participants in such participants’ homes. Such policy shall name the MMAC as a certificate holder. Providers shall also maintain a professional liability insurance policy in full force and effect that covers all places of business and any and all participants, customers, employees, and volunteers. Such policy shall provide coverage for no less than one (1) million dollars per event and three (3) million dollars aggregate and shall include coverage for negligent acts and omissions of the provider’s employees and/or volunteers in the provision of professional services to participants in such participants’ homes. Such policy shall name MMAC as a certificate holder. The policies shall be coordinated to ensure coverage for all negligent acts and omissions in the provision of the in-home services described in this rule and in 13 CSR 70-91.010, by the provider’s employees and volunteers. Additionally, providers shall maintain an employee dishonesty bond covering employees and volunteers who are connected with the delivery and performance of inhome services in the participant’s home;

(F) Furnish adequate identification (ID) to employees of the provider. This ID shall be carried by the employee in a way that the participant can see the name of the agency with whom the aide is employed. A permanent ID including the provider’s name and employee’s name and title shall be considered adequate ID. At the time of employment, an ID shall be issued which will meet the ID requirement. The provider shall require the return of the ID from each employee upon termination of employment;

(G) Ensure that no in-home services worker is a member of the immediate family of the participant being served by that worker. An immediate family member is defined as a spouse; parent; sibling; child by blood, adoption, or marriage (stepchild); grandparent; or grandchild;

(H) Notify MMAC of any changes of ownership, managing employees, office location, telephone number(s), email address, or administrative or corporate status;

(I) Have and enforce a written code of ethics which is distributed to all employees and participants. The code of ethics shall allow use of the bathroom facilities and, with the participant’s consent, allow the worker to eat the lunch provided by the worker, in the participant’s home. The code of ethics shall be reviewed with the participant, caregiver, or family when appropriate, and include, at a minimum, the following prohibitions:

Use of participant’s car;
Consumption of participant’s food or drink (except water);
Use of participant’s telephone for personal calls;
Discussion of own or other’s personal problems, religious or political beliefs with the participant;
Acceptance of gifts or tips;
Bringing other persons to the participant’s home;
Consumption of alcoholic beverages, or use of medicine or drugs for any purpose, other than medical, in the participant’s home or prior to service delivery;
Smoking in participant’s home;
Solicitation or acceptance of money or goods for personal gain from the participant;
Breach of the participant’s privacy and confidentiality of information and records;
Purchase of any item from the participant even at fair market value;
Assuming control of the financial or personal affairs, or both, of the participant or of his/her estate including power of attorney, conservatorship, or guardianship;
Taking anything from the participant’s home; and 14. Committing any act of abuse, neglect, or exploitation;

(J) Ensure prompt initiation of authorized services to new participants. The provider shall deliver the in-home service within ten (10) calendar days of receipt of the service authorization from the division or on the beginning date specified by the authorization, whichever is later, and on a regular basis after that in accordance with the care plan. The date of receipt must be recorded on each service authorization by the provider. Verbal authorization shall be effective upon acceptance by the provider and services must begin as agreed.

If service is not initiated within the required time period, detailed written justification must be sent to the division with a copy maintained in the participant’s file;

(K) Recommend, verbally or in writing, changes to the authorized care plan any time the participant has an ongoing need for service activities which may require more or fewer units than the amount specified in the care plan;

(L) Keep documentation of undelivered services, including the reason for this failure to deliver authorized units;

(M) Be aware that in-home services provided shall not be reimbursed unless authorized by the division;

(N) Ensure that all subcontractors comply with all standards required by section (2) of this rule;

(O) Shall give a written statement of the participant’s rights and review the statement with each participant and primary caregiver, when appropriate, at the time service is initiated. The statement of participant rights must contain at a minimum, the right to— 1. Be treated with respect and dignity;

Have all personal and medical information kept confidential;
Have direction over the services provided, to the degree possible, within the care plan authorized;
Know the provider’s established grievance procedure and how to make a complaint about the service and receive cooperation to reach a resolution, without fear of retribution;
Receive service without regard to race, creed, color, age, sex, or national origin; and 6. Receive a copy of the provider’s code of ethics under which services are provided;

(P) Have a system through which participants may present grievances concerning the operation of the in-home service program and/or delivery of care;

(Q) Report all instances of potential abuse, neglect, exploitation of a participant, or any combination of these, to the division’s Adult Abuse, Neglect, and Exploitation Hotline (1-800-392-0210), including all instances which may involve an employee of the provider agency;

(R) Copayment, as determined by the division, shall be collected monthly from non-Medicaid participants. Liability levels for copayment are based on a sliding fee schedule as determined by the division. The money collected as copayment replaces the amount withheld from reimbursement by the automated payment system. Prompt and reasonable attempts to collect from the participant or the participant’s guardian or estate shall be made by the provider. Failure of participants to submit the required copayment, when determined to be a condition of participation, shall be reported to the division.

Failure of participants to comply with copayment requirements may result in termination of services. Unsuccessful attempts to collect from the estate of a deceased participant are to be referred to the home and community services deputy director of the division;

(S) Implement a contribution system which accounts for contributions received from participants for in-home services.

Non-Medicaid participants shall be informed of their right to voluntarily contribute when they are admitted for services.

Services shall not be denied to any participant based on failure to make a contribution. Only the division may authorize expenditure of contributed funds, which shall be used for the sole purpose of providing in-home services. Reports of contributions by county shall be made to each home and community services regional manager including the balance on hand, contributions received, contributions used for division-authorized services, and ending balance. The provider shall submit to the regional manager a contributor report at the end of any month in which contributions are received and/or expended. Upon termination or lapse of a provider’s contract, the remaining balance of all contribution funds held by the provider shall be reported to the division and will be withheld from the provider’s final reimbursement;

(T) Understand that both program and fiscal monitoring of the in-home service program shall be conducted by MMAC or its designee.

Monitoring visits may be announced or unannounced.
MMAC shall disclose the findings of the visit to the provider.
Upon request by the division, the provider shall submit a written plan for correcting areas found to be out of compliance;

(U) Designate trainer(s) to perform the sessions required as

part of the basic training. The designated trainer(s) may be the RN, LPN, supervisor, or an experienced aide who has been employed by a provider agency at least six (6) months. A list of designated trainers must be available for monitoring;

(V) Providers must establish, enforce, and implement a policy whereby all contents of the personnel files of its employees are made available to department employees or representatives when requested as part of an official investigation of abuse, neglect, financial exploitation, misappropriation of participant’s funds or property, or falsification of documentation which verifies service delivery;

(W) Have established policies to promote the safety of its employees. The provider shall make available to its employees information about and access to public information sources to determine whether a participant, family member, or other person living in the household may pose a potential danger to its employees. Public information includes but is not limited to the Missouri State Highway Patrol’s Sex Offender Registry and the Missouri State Courts Automated Case Management System.

If an employee has a reasonable belief that a participant, family member, or other person living in the household poses a potential danger to the employee, the provider shall document all necessary steps taken to protect the employee, which may include but is not limited to— 1. Obtaining a signed agreement from the participant, family member, or other person living in the household not to engage in inappropriate activity involving the provider’s employees;

Seeking approval from the division to send two (2) provider employees for service delivery;
Requiring that a third party approved by the provider, the division, and the participant or participant’s designee be present on-site while the employee is on the premises;

(X) The provider shall not harass, dismiss, or retaliate against an employee because the employee declines to provide services to a participant based on the employee’s reasonable belief that such participant, family member, or other person living in the household poses a danger to the employee; and (Y) The provider shall notify employees and implement established safety procedures upon receipt of information from the division or any other reliable source that a participant, family member, or other person living in the household may pose a potential danger to provider employees.

(19) In-home service providers shall meet, at a minimum, the following personnel requirements:

(A) The in-home provider shall employ an RN or designate an RN as a consultant who meets each of the following qualifications:

Currently licensed in Missouri;
Have at least one (1) year of experience with direct care of the elderly or individuals with disabilities or medically complex conditions; and 3. Meet the RN supervisory requirements for personal care and advanced personal care in accordance with 13 CSR 70-91.010;

(B) An administrative supervisor shall be designated by the provider to supervise the day-to-day delivery of in-home service and shall be at least twenty-one (21) years of age and meet at least one (1) of the following requirements:

Be a registered nurse who is currently licensed in Missouri; or 2. Possess a baccalaureate degree; or 3. Be a licensed practical nurse who is currently licensed in Missouri with at least one (1) year of experience with direct care to the elderly or individuals with disabilities or medically complex conditions; or 4. Have at least two (2) years of experience with direct care to the elderly or individuals with disabilities or medically complex conditions;

Be at least eighteen (18) years of age;
Be able to read, write, and follow directions; and 3. Shall not be an immediate family member of the participant. Immediate family member is defined as spouse; parent; sibling; child by blood, adoption, or marriage (stepchild); grandparent; or grandchild;

(D) All advanced personal care aides and advanced respite care workers employed by the provider shall be— 1. A licensed practical nurse; or 2. Certified nurse assistant; or 3. A competency-evaluated home health aide having completed both written and demonstration portions of the test required by the Missouri Department of Health and Senior Services and 42 CFR 484.80, which is incorporated by reference in this rule, as published on October 1, 2021, by the Office the Federal Register, National Archives and Records Administration, Washington, DC 20408, and available at https:\bookstore.gpo.gov. This rule does not incorporate any subsequent amendments or additions; or 4. Documented to have successfully completed personal care aide training;

(E) All individuals employed to deliver authorized nurse visits shall be currently licensed to practice as a registered nurse, licensed practical nurse, or a graduate nurse in Missouri; and (F) The provider shall ensure that all employees are registered with the Family Care Safety Registry (FCSR) pursuant to the requirements of sections 210.900 to 210.936 and section 192.2495.7, RSMo.

(20) The RN required by (19)(A) of this rule will be primarily responsible for ensuring that policies and procedures of the in-home service provider meet the clinical standards for proper care of participants, training of staff, and general clinical integrity of the in-home service provider. Such responsibilities shall include, at a minimum, the following functions:

(A) Monitor or provide oversight to staff that supervise inhome workers in the direct provision of services to assure that services are being delivered in accordance with the care plan;

(B) Direct or oversee staff responsible for in-home worker orientation and in-service training required herein; assure all training requirements are met; and ensure that in-home workers are trained to competently perform all basic and advanced service tasks as specified in this rule;

(C) Provide oversight to the process and documents used by the staff who conduct annual supervisory visits and have in place a system that ensures that completed evaluations are reviewed by the nurse when appropriate;

(D) Assure that appropriate recommendations or reports are forwarded to the division including requests to increase, reduce, or discontinue services; changes in the participant’s condition; noncompliance with care plan; nondelivery of authorized services; or the need for increased division involvement;

(E) Establish, implement, and enforce a policy governing communicable diseases that prohibits provider staff contact with participants when the employee has a communicable condition including colds or flu;

(F) Assure compliance with reporting requirements governing communicable diseases, including hepatitis and tuberculosis, as set by the Missouri Department of Health and Senior Services (19 CSR 20-20.020); and (G) Monitor or provide oversight of nurse tasks or functions delegated to and performed by the LPN or GN.

(21) The administrative supervisor’s responsibilities shall include, at a minimum, the following functions:

(A) Monitoring the provision of services by the in-home services worker to assure that services are being delivered in accordance with the care plan. This shall be primarily in the form of an at least monthly review, and comparison of the worker’s record of provided services with the care plan. Documentation, including the reason, must be kept on authorized services/units not delivered;

(B) Evaluating, in writing, each in-home service aide’s performance at least annually. The evaluation shall be based in part on at least one (1) on-site visit. This annual site visit can be completed during a general health evaluation (GHE) or a reassessment. The evaluation will include, in addition to the aide’s performance, the adequacy of the care plan, including review of the care plan with the participant. The written report of the evaluation shall contain documentation of the visit, including the participant’s name and address, the date and time of the visit, the aide’s name, and the supervisor’s observations and notes from the visit. The evaluation shall be signed and dated by the supervisor who prepared it and by the aide. If the required evaluation is not performed or not documented, the aide’s qualifications to provide the services may be presumed inadequate and all payments made for services by that aide may be recouped;

(C) Communicating with the division and provider RN regarding changes in any participant’s condition, changes in scope or frequency of service delivery, and recommending changes in the number of units of service per month including documentation of that communication; and (D) Assure that all individuals who may not be considered employees but work for the provider in any capacity involving direct care of participants have a signed agreement detailing the employment arrangement, including all rights and responsibilities. Such agreement would apply to all individuals hired through contract or other employment arrangement.

(22) The in-home service provider shall have a written plan for providing training for new aides, respite care workers, and homemakers which shall include, at a minimum, the following requirements:

(A) Twelve (12) hours of orientation training for in-home service workers, including at least two (2) hours orientation to the provider agency and the agency’s protocols for handling emergencies, within thirty (30) days of employment.

A minimum of six (6) hours of training will be provided prior to the first day of participant contact.
New employee orientation curricula shall include an overview of Alzheimer’s disease and related dementias and methods of communicating with persons with dementia pursuant to the requirements of section 192.2000.7, RSMo.
Four (4) hours of required orientation training may be waived for aides and homemakers with adequate documentation in the employee’s records that they have received similar training during the previous twelve (12) months.
All hours of orientation training (with the exception of the statutorily required dementia training and two (2) hours provider agency orientation) may be waived with adequate documentation, placed in the aide’s personnel record, that the aide is a licensed practical nurse, registered nurse, or certified nurse assistant. The documentation shall include the employee’s license or certification number which must be current and in good standing at the time the training was waived;

(B) Five (5) hours of in-service training annually are required after the first twelve (12) months of employment. The provider may waive the required annual five (5) hours of in-service training and require only two (2) hours of refresher training annually, when the personal care aide has been employed for three (3) years and has completed fifteen (15) hours of in-service training. In-service training curricula shall include updates on Alzheimer’s disease and related dementia; and (C) Prior to the delivery of service, the personal care aide shall receive a copy of the care plan for the participant and be provided with information about the participant in order to appropriately deliver services to meet the needs of the participant.

(23) The in-home service provider shall have written documentation of all basic and in-service training provided which includes, at a minimum— (A) A report of each employee’s training in that employee’s personnel record. The report shall document the dates of all classroom or on-the-job training, trainer’s name, topics, number of hours and location, the date of the first participant contact, and shall include the aide’s signature;

(B) If a provider waives the in-service training, the employee’s training record shall contain documentation sufficient to support the waiver. In-service training shall not be waived, unless the employee’s record contains documentation that the employee has received Alzheimer’s disease and related dementias training.

(C) The provider agency shall maintain an established training curriculum that contains— 1. A list of all trainings used to fulfill training requirements;

A copy of all agendas outlining the content of the different trainings.

(24) The in-home service provider shall maintain, at a minimum, the following records in a central location for five (5) years.

Records must be provided to the department staff or designees upon request, and must be maintained in a manner that will ensure they are readily available for monitoring or inspection.

Records include— (A) Individual participant case or clinical records including records of service provision. These are confidential and shall be protected from damage, theft, and unauthorized inspection and shall include, at a minimum, the following:

The care plan for the authorization for services from the division which documents authorization for all units of service provided;
Verification of services delivered through electronic visit verification (EVV) pursuant to 13 CSR 70-3.320;
Documentation explaining discrepancies between authorized and delivered services including a description of corrective action taken, when applicable;
All clinical notes concerning the participant;
Documentation of all correspondence and contacts with the participant’s physician or other care providers; and 6. Any other pertinent documentation regarding the participant.

(B) Individual personnel record for each employee which is a confidential record and shall be protected from damage, theft, and unauthorized inspection and shall include, at a minimum, the following:

Employment application containing the employee’s signature and documentation sufficient to verify that the employee meets age, education, and work experience requirements. The record shall document employment and termination dates;
Documentation concerning all training and certification received;
Documentation supporting any waiver of employment or training requirements;
Annual performance evaluation which includes observations from one (1) on-site visit;
A signed statement documenting that the employee received and reviewed a copy of the participant’s rights, the code of ethics, and the service provider’s policy regarding confidentiality of participant information, and that all were explained prior to service delivery;
A signed statement verifying that the supervisor received and reviewed a copy of the in-home service standards;
Statement identifying the employee’s position, including whether the employee performs administrative duties for the provider or delivers services to clients;
A signed statement verifying the employee is not a participant if the employee will be delivering direct care to participants;
Returned permanent ID for a terminated employee or documentation of why it is not available; and 10. Verification of the current Missouri certified nurse assistant, licensed practical nurse, graduate nurse, or registered nurse license including, at least, the license or certificate number; and (C) Documentation of each Employee Disqualification List (EDL) and criminal background screening sufficient to show the identity of the person who was screened, the dates the screening was requested and completed, and the outcome of the screening. Providers that use the Family Care Safety Registry (FCSR) to conduct EDL and criminal background screenings shall maintain documentation of each FCSR screening sufficient to show the identity of the person who was screened, the dates the screening was requested and completed, and the outcome of the screening.

Filed Sept. 14, 2001, effective April 30, 2002. Amended: Filed June 1, 2006, effective Dec. 30, 2006. ** Amended: Filed Feb. 7, 2023, effective Aug. 30, 2023. **Pursuant to Executive Order 21-07, 19 CSR 15-7.021, subsections (16)(B) and (16)(D) was suspended from April 30, 2020 through May 1, 2021, and subsection (24)(B) was suspended from April 3, 2020 through August 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 15-7.021, section (1), paragraphs (4)(A)3. and (6)(C)2., section (12), subsections (13)(B), (14)(D), (18)(B), (18)(H), paragraphs (19)(A)2. and (19)(B)4., subparagraphs (19)(C)2.A.-C., paragraph (19)(D)4., subsection (21)(C), and section (22) was suspended from April 30, 2020 through December 31, 2021.

History

AUTHORITY: section 192.2000, RSMo 2016. This rule previously filed as 13 CSR 15-7.021. Original rule filed Sept. 1, 1994, effective April 30, 1995. Amended: Filed Dec. 15, 1997, effective July 30, 1998. Moved to 19 CSR 15-7.021, effective Aug. 28, 2001. Amended:

19 CSR 15-7.040 Transportation Service Standards {#sec-19-csr-15-7.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-7.040}

(Moved to 19 CSR 15-4.410)

19 CSR 15-7.050 Information and Assistance Service Standards {#sec-19-csr-15-7.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-7.050}

(Moved to 19 CSR 15-4.295)

19 CSR 15-7.060 Nutrition Service Standards {#sec-19-csr-15-7.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-7.060}

(Moved to 19 CSR 15-4.245)

Chapter 8 Consumer-Directed Services

19 CSR 15-8.100 Definitions {#sec-19-csr-15-8.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-8.100}

PURPOSE: This rule defines terms used in establishing procedures for the provision of consumer-directed services under the Department of Health and Senior Services to eligible consumers through eligible vendors, subject to legislative appropriations.

(1) As used in this rule and other rules established for consumerdirected services (CDS), except as otherwise required for the context, the following terms shall have the meanings ascribed:

(A) Adjusted gross income. The amount reported to the Internal Revenue Service (IRS) as adjusted gross income on the previous calendar year’s income tax return for the consumer and the consumer’s spouse;

(B) Assets. Any tangible, real, or personal property as would be reported to the Department of Social Services (DSS), Family Support Division (FSD) for the purpose of determining eligibility for Medicaid;

(C) Consumer. A physically disabled person determined by the Department of Health and Senior Services (DHSS) to be eligible to receive consumer-directed services (CDS). Consumer does not include any individual with a legal limitation of his or her ability to make decisions, including the appointment of a guardian or conservator, or who has an effective power of attorney that authorizes another person to act as the agent or on behalf of the individual for any of the duties required by the CDS program;

(D) Consumer-directed. The hiring, training, supervising, and directing of the personal care attendant (attendant) by the physically disabled person;

(E) Consumer-directed services (CDS). All services that are required or may be provided as part of the CDS program;

(F) Disability-related medical expenses. Any medical expense, as defined and approved by the IRS, that is directly related to the consumer’s disability;

(G) Health care coverage. Any insurance policy that provides personal care assistance benefits;

(H) Income. Any income as would be reported to DSS/FSD for the purpose of determining eligibility for Medicaid;

(I) Live independently. To reside and perform routine tasks of daily living and activities of daily living and activities in the community in a noninstitutional or unsupervised residential setting;

(J) Non-Medicaid eligible (NME). Has been found by DSS/FSD not to be eligible to participate under guidelines established by the Medicaid state plan;

(K) Non-Medicaid eligible (NME) program. Financial assistance for CDS through eligible vendors for individuals who are NME consumers;

(L) Personal care assistance (PCA) services. Those routine tasks provided to meet the unmet needs required by a physically disabled person to enable him or her to live independently;

(M) Personal care attendant (attendant). A person, other than the consumer’s spouse, who performs PCA services for a physically disabled person;

(N) Physically disabled. Loss of, or loss of use of, all or part of the neurological, muscular or skeletal functions of the body to the extent that person requires the assistance of another person to accomplish routine tasks;

(O) Routine tasks. Routine tasks and instrumental activities of daily living include, but are not limited to, the following:

Bowel and bladder elimination;
Dressing and undressing;
Moving into and out of bed;
Preparation and consumption of food and drink;
Bathing and grooming;
Shopping/transportation;
Maintenance and use of prostheses, aids, equipment and other similar devices; and/or 8. Ambulation, housekeeping, or other functions of daily living based on an independent living philosophy as specified in state law and regulation;

(P) Undue hardship. The result of a significantly difficult circumstance experienced by the disabled consumer that creates a situation of burden, risk or harm to the consumer.

Undue hardship includes, but is not limited to, the following:

Loss of consumer’s income;
Overall disintegration of the family;
Abuse and neglect;
Misuse of child labor; and/or 5. Presence of physical contraindication(s);

(Q) Unit of service. One unit equals fifteen (15) minutes;

(R) Unmet needs. Routine tasks and activities of daily living which cannot be reasonably met by members of the consumer’s household or other current support systems without causing undue hardship; and (S) Vendor. Any person, firm or corporation having a written agreement with DHSS to provide services, including monitoring and oversight of the attendant, orientation and training of the consumer, and fiscal conduit services necessary for delivery of CDS to physically disabled persons.

Amended: Filed Sept. 12, 2003, effective April 30, 2004. Moved to 19 CSR 15-8.100, effective Aug. 29, 2005. Emergency amendment filed Dec. 15, 2005, effective Dec. 25, 2005, expired June 23, 2006.

Amended: Filed Dec. 15, 2005, effective July 30, 2006. *Original authority: 208.900, RSMo 2005; 208.927, RSMo 2005; and 208.930, RSMo 2005.

History

AUTHORITY: sections 208.900, 208.927 and 208.930, RSMo Supp. 2005. This rule originally filed as 5 CSR 90-7.010. Original rule filed Jan. 10, 1985, effective May 13, 1985. Amended: Filed Aug. 1, 1988, effective Nov. 25, 1988. Emergency amendment filed Aug. 31, 1992, effective Sept. 10, 1992, expired Jan. 9, 1993. Amended: Filed Aug. 31, 1992, effective April 8, 1993. Amended: Filed May 31, 1994, effective Dec. 30, 1994. Amended: Filed Oct. 31, 1996, effective June 30, 1997. Amended: Filed June 28, 2001, effective Jan. 30, 2002.

19 CSR 15-8.200 Eligibility {#sec-19-csr-15-8.200 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-8.200}

PURPOSE: This rule establishes the criteria and procedures for determining an applicant eligible to receive consumer-directed services and describes consumer’s responsibilities for consumerdirected services.

(A) All consumers must meet the following general criteria for eligibility under the CDS program:

Be at least eighteen (18) years of age;
Able to direct their own care (consumer-directed);
Capable of living independently with CDS;
Physically disabled;
Require at least a nursing facility level of care under regulations established by DHSS;
Unmet needs must be safely met at a cost that shall not exceed the average monthly Medicaid cost of nursing facility care as determined by the Department of Social Services (DSS);
Document proof of Medicaid eligibility under Title XIX of the Social Security Act pursuant to federal and state laws and regulations; and 8. Participate in an assessment and/or evaluation conducted by DHSS to assign point values pursuant to federal and state laws and regulations.

(2) Individuals eligible for Medicaid under Title XIX of the Social Security Act who do not meet the above criteria for the CDS program shall be referred to other programs or agencies, as appropriate, to determine eligibility for personal care services pursuant to federal and state laws and regulations.

(3) Any assessments and/or evaluations shall be conducted by DHSS or its designee, utilizing the approved interactive assessment tool.

(4) The CDS plan of care is based on the assessment and/ or evaluation performed by DHSS and determines the appropriateness and adequacy of services and ensures that services furnished are consistent with the nature and severity of the individual’s disability.

(A) The initial assessment and/or evaluation shall be conducted in the consumer’s home or place of residence and include, but not be limited to, the following:

The functions of daily living;
The frequency and duration of the routine tasks or activity(ies) required to live independently; and 3. A description of met and/or unmet needs.

(B) The CDS plan of care shall include, but not be limited to, the following:

The maximum number of units of personal care assistance (PCA) to be provided based on the consumer’s unmet needs;
The description and frequency of services to be provided as documented on the assessment and/or evaluation;
The starting date for PCA services;
The date for reassessment or reevaluation of CDS services;
Documentation of the consumer’s choice of vendor; and 6. Consent signatures by the consumer and DHSS.

(D) If a consumer is receiving services or transferring from another service provider or agency, DHSS is responsible for collaborating and coordinating services through the plan of care.

(5) The individual shall be notified of DHSS’s decision regarding eligibility for CDS within ten (10) days of the date of the decision.

(6) CDS are consumer-directed and the consumer shall be responsible, at a minimum, for the following:

(A) Selection, hiring, training, and supervision of the consumer’s personal care attendant (attendant);

(B) Expectation of the use of Electronic Visit Verification (EVV) in compliance with 13 CSR 70-3.320;

(C) Ensuring that units submitted for reimbursement do not exceed the amounts authorized by the CDS plan of care and/or those eligible for reimbursement through Medicaid;

(D) Promptly notifying DHSS and/or the vendor within ten (10) days of any changes in circumstances affecting the CDS plan of care and/or changes in the consumer’s place of residence;

(E) Prompt notification to the vendor regarding any problems resulting from the quality of services rendered by the attendant. Any problems not resolved with assistance from the vendor shall be reported to DHSS;

(F) Allowing the vendor to comply with its quality assurance supervision process, which shall include but not be limited to annual face-to-face home visits and monthly case management activities; and (G) Report to DHSS significant changes in consumer’s health and ability to self-direct care by contacting the vendor and/or DHSS.

(7) The needs of the consumer shall be reassessed and/or reevaluated at least annually by DHSS, and the amount of assistance authorized by DHSS shall be maintained, adjusted, or eliminated accordingly.

(8) A consumer’s CDS may be discontinued or denied by DHSS in certain circumstances including but not limited to the following:

(A) DHSS and/or the vendor learns of circumstances that require the denial or closure of a consumer’s case, including but not limited to, death, admission to a long-term care facility, consumer no longer needing services, and/or the inability of the consumer to self-direct his or her services;

(B) The consumer has falsified records, committed fraud, or provided DHSS with false information about his or her condition(s), functional capacity, or level of care during the assessment that resulted in an authorization of services not needed;

Noncompliance requires persistent actions by the consumer or his or her family/representative which negate the services provided in the plan of care;

(D) The consumer or a member of the consumer’s household threatens and/or abuses the attendant and/or vendor to the point where the staff’s welfare is in jeopardy;

(E) The consumer’s needs exceed available plan of care hours; and/or (F) The attendant is not providing services as set forth in the CDS plan of care and attempts to remedy the situation have been unsuccessful.

(9) DHSS shall notify the consumer/applicant in writing regarding denial, reduction, or termination of CDS services.

(10) The consumer may request a hearing under the rules promulgated by DHSS. DHSS shall not suspend, reduce or terminate services provided to a consumer during this time period, unless the consumer requests in writing that services be suspended, reduced or terminated.

rule filed June 28, 2001, effective Jan. 30, 2002. Amended: Filed Sept. 12, 2003, effective April 30, 2004. Moved to 19 CSR 15-8.200, effective Aug. 29, 2005. Emergency amendment filed Dec. 15, 2005, effective Dec. 25, 2005, expired June 23, 2006. Amended: Filed Dec. 15, 2005, effective July 30, 2006. ** Amended: Filed Sept. 1, 2023, effective Feb. 29, 2024. *Original authority: 208.903, RSMo 2005; 208.906, RSMo 2005; 208.909, RSMo 2005; 208.921, RSMo 2005; 208.924, RSMo 2005; 208.927, RSMo 2005; and 208.935, RSMo 2020. **Pursuant to Executive Order 21-09, 19 CSR 15-8.200 was suspended from April 3, 2020 through December 31, 2021.

History

AUTHORITY: sections 208.903, 208.906, 208.921, and 208.927, RSMo 2016, and sections 208.909, 208.924, and 208.935, RSMo Supp. 2023. This rule originally filed as 5 CSR 90-7.100. Original

19 CSR 15-8.300 Eligibility for Non-Medicaid Eligible Program {#sec-19-csr-15-8.300 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-8.300}

PURPOSE: This rule incorporates changes to the non-Medicaid eligible consumer-directed services program required by Senate Bill 74/49, 93rd General Assembly, First Regular Session (2005), to establish the criteria and procedures for determining eligibility for consumer-directed services through the non-Medicaid eligible program.

(1) Subject to legislative appropriations, the Department of Health and Senior Services (DHSS) shall provide financial assistance for consumer-directed services (CDS) through eligible vendors, pursuant to applicable state law and regulation, to each person determined eligible to participate in the non- Medicaid eligible (NME) program. All consumers must meet the CDS requirements found in state law and regulations, except for proof of Medicaid eligibility under Title XIX of the Social Security Act. In addition, consumers must meet the following criteria for eligibility under the NME program:

(A) Participation in the NME program through the Department of Elementary and Secondary Education, Division of Vocational Rehabilitation, on June 30, 2005, and make application to DHSS;

(B) Demonstrate financial need and eligibility pursuant to the applicable rules and regulations;

(C) Provide proof of having been found by the Department of Social Services (DSS) ineligible to participate in the Medicaid state plan; and (D) Does not have access to employer-sponsored or other health care coverage that includes personal care assistance, or the costs of such coverage exceed on a monthly basis one hundred thirty-three percent (133%) of the monthly average premium required in the state’s current Missouri Consolidated Health Care Plan (MCHCP).

(2) Financial need and eligibility are based upon the adjusted gross income (AGI) of the applicant and the applicant’s spouse and the assets of the applicant and/or the applicant’s spouse.

(A) In order to demonstrate a financial need, an applicant and the applicant’s spouse must have an AGI, less disabilityrelated medical expenses as approved by DHSS, that is equal to or less than three hundred percent (300%) of the federal poverty level.

AGI is calculated on an annual basis by calendar year, using the AGI as reported to the Internal Revenue Service, less any disability-related medical expenses paid during the same year.
Disability-related medical expenses must be documented and proof of payment is required.

(B) Applicant and/or the applicant’s spouse shall not have assets in excess of two hundred fifty thousand dollars ($250,000).

Any assets of the applicant and/or the applicant’s spouse transferred within twelve (12) months of the date of application shall be included in the calculation of assets.

(3) Consumers shall pay a monthly premium to DHSS.

(A) The premium shall be equal to the statewide average premium required for the MCHCP, but shall not exceed five percent (5%) of the consumer’s and the consumer’s spouse’s AGI for the previous calendar year.

(B) Nonpayment of the required premium shall result in denial or termination of services, unless the person demonstrates good cause for such nonpayment by providing documentation of income and expenses that substantiates the inability to pay the premium.

Any consumer who is denied services for nonpayment of the premium shall not receive services until past due and current premiums are paid.
Any consumer who does not make any payments for past due premiums for sixty (60) consecutive days shall have their enrollment in the program terminated.
Any consumer who is terminated due to non-payment of premiums shall not be re-enrolled unless all past due and current premiums are paid prior to re-enrollment.
Nonpayment shall include payment with a returned, refused, or dishonored instrument.

(4) Continued participation in the NME program shall require that eligibility be reevaluated on an annual basis, pursuant to applicable state law and regulation.

(A) The amount of financial assistance shall be adjusted or eliminated based on the outcome of the reevaluation and shall be recorded in the consumer’s plan of care.

(B) Consumers must respond and provide requested documentation within ten (10) days of DHSS’ notice of reevaluation of eligibility.

(C) Failure by the consumer to provide requested documentation within ten (10) days will result in DHSS sending the consumer a notification letter that he or she has ten (10) days to file an appeal or services will be terminated.

(5) Applicants or consumers whose services are denied, reduced, or terminated have the right to request a hearing under the applicable rules of DHSS.

Original rule filed Dec. 15, 2005, effective July 30, 2006. *Original authority: 209.930, RSMo 2005.

History

AUTHORITY: section 208.930, RSMo Supp. 2005. Emergency rule filed Dec. 15, 2005, effective Dec. 25, 2005, expired June 23, 2006.

19 CSR 15-8.400 Vendors {#sec-19-csr-15-8.400 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-8.400}

PURPOSE: This rule establishes the criteria, procedures, and responsibilities for entities eligible to be vendors of consumerdirector services administered by the Department of Health and Senior Services.

(1) All vendors of the consumer-directed services (CDS) program shall— (A) Have a philosophy that promotes the consumer’s ability to live independently in the most integrated setting. This philosophy includes the following independent living services:

Advocacy;
Independent living skills training;
Peer counseling; and 4. Information and referral;

(B) Have a valid written agreement with the Missouri Medicaid and Compliance (MMAC);

(D) Designate to MMAC the manager who will be responsible for the vendor’s day-to-day operation. This manager shall be a policy maker and supervise the vendor’s record keeping, service delivery verification, training, and orientation of consumers in skills needed to recruit, employ, instruct, supervise, and maintain the services of attendants; and (E) Implement a quality assurance and supervision process that ensures program compliance and accuracy of records, including but not limited to— 1. CDS managers shall be required to successfully complete (or have completed) the CDS certified manager orientation and test offered (quarterly or as needed) by MMAC at no charge.

Completion of the test for all new managers is required within six (6) months of hire;

CDS managers shall annually attend MMAC-sponsored training update CDS meeting; and 3. CDS vendors and managers shall maintain documentation of attendance for all training, testing, and meetings.

(2) Vendors shall have a written pandemic preparedness policy to be followed when service delivery must be interrupted due to a pandemic. Vendors shall distribute this policy to all consumers annually. Vendors shall train all consumers on this policy at least annually. Consumers shall train attendants on this policy at least annually.

(3) Vendors shall perform, directly or by contract, payroll and fringe benefit accounting functions for consumers, including but not limited to— (A) Collecting Electronic Visit Verification (EVV) records and verifying accuracy;

(B) Transmitting individual payments to the personal care attendant (attendant) on behalf of the consumer; and (C) Ensuring all payroll, employment, and other taxes are paid timely.

The vendor shall be liable to the consumer for any garnishment action occurring as a result of the vendor’s failure to timely pay payroll, employment, or other taxes on behalf of the consumer.
The vendor shall notify the consumer of any communications or correspondence from any federal, state, or local tax
The vendor may be subject to a one thousand dollar ($1,000) penalty per occurrence of the vendor’s failure to timely pay payroll, employment, or other taxes on behalf of the consumer.

(4) Vendors shall, directly or by contract, file claims for Medicaid reimbursement.

(5) In addition to the above requirements, vendors shall be responsible, directly or by contract, for the following:

(A) Maintaining a list of eligible attendants— 1. Ensuring that each attendant is registered, screened, and employable pursuant to the Family Care Safety Registry (FCSR) and the Employee Disqualification List (EDL) maintained by Department of Health and Senior Services (DHSS) and applicable state laws and regulations prior to beginning service delivery;

Notifying the attendant of his or her responsibility to comply with applicable state laws and regulations regarding reports of abuse or neglect;
Attendants must meet the following qualifications:

A. Be at least eighteen (18) years of age;

B. Be able to meet the physical and mental demands required to perform specific tasks required by a particular consumer;

C. Agree to maintain confidentiality;

D. Be emotionally mature and dependable;

E. Be able to handle emergency type situations;

F. Be a person other than the consumer’s spouse or guardian;

G. Not be a consumer; and H. Have not been involved in Medicaid fraud previously; and 4. The attendant is an employee of the consumer only for the time period subsidized with CDS funds, but is never the employee of the vendor, DHSS, or the state of Missouri;

(B) Training and orientation of consumers in the skills needed to recruit, employ, instruct, supervise, and maintain the services of attendants including but not limited to— 1. Assisting consumers in the general orientation of attendants as requested by the consumer. To the fullest extent possible, this shall take place in the presence of the attendant;

Federal and state requirements regarding the mandatory use of EVV;
Identification of issues that would be considered fraud of the program;
Allowable and non-allowable tasks;
Notifying consumers that falsification of any attendant visit verification records shall be considered fraud and shall be reported to MMAC;
Rights and responsibilities of the attendant;
Identification of abuse, neglect, and/or exploitation; and 8. The attendant shall report to DHSS and/or the vendor if he or she witnesses significant deterioration of the health of the consumer or if he or she has a belief that the consumer is no longer capable of self-directed care. Failure of the attendant to report this information should be reported by the vendor to DHSS.

(D) Public information, outreach, and education activities to ensure that persons with disabilities are informed of the services available and have maximum opportunity for participation;

(E) Maintaining confidentiality of consumer records, including eligibility information from DHSS, pursuant to applicable federal and state laws and regulations;

(F) The vendor shall perform ongoing monitoring of the provision of services in the plan of care and shall assess the quality of care being delivered. Such monitoring shall include— 1. At least one (1) annual face-to-face visit as outlined in

section 208.918, RSMo. Face-to-face is defined as an interaction that occurs in person and does not include interactions that occur through telecommunication or electronic technologies.

Face-to-face visits shall be completed within three hundred sixty-five (365) days from original authorized care plan, and annually thereafter. Documentation of each face-to-face visit must contain at a minimum, the name of the monitoring individual, those present at the time of the visit, service delivery evaluation summary, the quality of care being delivered, and date and time of the visit. All documentation must be maintained in the consumer’s case file and shall be available to send to DHSS upon request. The vendor shall report to DHSS if services are not being provided to the consumer as authorized in the plan of care, which may result in suspension of services to the consumer;

Monthly case management activities which must be completed by phone, videoconference, or in-person with the consumer;
Other monitoring may include electronic monitoring, telephone checks, written case notes, or other departmentapproved methods. The ongoing monitoring shall not preclude the vendor's responsibility of ongoing diligence of case management activity oversight;

(G) Ensuring the consumer has an emergency and/or backup plan;

(H) Ensuring that the consumer’s case file contains, at a minimum, the following:

Employer Identification Number and Missouri Tax ID;
Written plan of care and service authorization that document the type of services and quantity of units to be provided;
Documentation of use of EVV in accordance with 13 CSR 70-3.320;
Copies of all correspondence with DHSS, the consumer’s physician, other service providers, and other administrative agencies;
Documentation of training provided to the consumer in the skills needed to understand and perform the essential functions of an employer;
Documentation of the consumer’s emergency and/or backup plans;
Signed documentation that the consumer has been informed of their rights concerning hearings and consumer responsibilities.

A. Such forms must comply with Medicaid and/or DHSS’ requirements; and 8. Any pertinent documentation regarding the consumer;

(I) Demonstrating positive impact on consumer outcomes regarding the provision of CDS through the submission of quarterly service reports and an annual service report to MMAC;

(J) Operating programs, services, and/or activities in such a manner as to be readily accessible to and usable by persons with disabilities;

(K) Providing information necessary to conduct state and/or federal audits, as requested by MMAC;

(L) Complying with Title VI of the Civil Rights Act of 1964,

Section 504 of the Rehabilitation Act of 1973, Title IX of the Education Amendments of 1972, and the Age Discrimination Act of 1975;

(M) Complying with applicable statutes and regulations regarding reports of abuse or neglect; and (N) Complying with applicable statutes and regulations regarding reports of misappropriation of a consumer’s property or funds or the falsification of documents verifying CDS delivery.

(6) Vendors shall refer the following situations upon discovery to DHSS for investigation:

(A) Circumstances that may require closure or termination of services, including but not limited to— 1. Death;

Admission into a long-term care facility;
The consumer no longer needing services;
The inability of the consumer to self-direct and/or significant changes which would result in the need of a change in the authorized care plan for the consumer; and/or 5. An inability to continue to meet the maintenance needs of the consumer because the plan of care hours needed to ensure the health and safety of the consumer exceed availability;

(B) Upon a finding that such circumstances exist, DHSS may close or terminate services.

(7) Vendors, after notice to DHSS— (A) May suspend services to consumers in the following circumstances:

The inability of the consumer to self-direct;
Falsification of records, falsification of condition, or fraud;
Persistent actions by the consumer of noncompliance with the plan of care;
The consumer or a member of the consumer’s household threatens or abuses the attendant and/or vendor; and/or 5. The attendant is not providing services as set forth in the plan of care and attempts to remedy the situation have been unsuccessful; and (B) Shall provide written notice to DHSS and the consumer listing specific reasons for requesting closure or termination.

All supporting documentation shall be maintained in the consumer’s case file. DHSS shall investigate the circumstances reported by the vendor and assist the consumer in accessing appropriate care. Upon a finding that such circumstances exist, DHSS may close or terminate services.

(8) Vendors shall comply, either directly or by contract, with the following fiscal requirements:

(A) No state or federal funds shall be authorized or expended to pay for CDS if the primary benefit of such services is to the household unit, or is a task that members of the consumer’s household may reasonably be expected to share or do for one another, unless such service is above and beyond typical activities household members may reasonably provide for another household member without a disability;

(B) No state or federal funds shall be authorized or expended to pay for CDS provided by an attendant who is listed on any of the background check lists in the Family Care Safety Registry, pursuant to applicable state laws and regulations, unless a good cause waiver is first obtained from DHSS in accordance with applicable state laws and regulations;

(C) No state or federal funds shall be authorized or expended to pay for personal care assistance services if any direct employee of the CDS vendor conducts the face-to-face home visit of a consumer for whom such employee is also the attendant, unless such person provides services solely on a temporary basis on no more than three (3) days in a thirty- (30-) day period. The certified manager shall maintain records and provide to MMAC upon request.

(D) The general assembly shall set the statewide reimbursement rate to be paid for CDS;

(E) The total monthly payment for CDS made on behalf of a consumer shall not exceed one hundred percent (100%) of the average statewide monthly cost for care in a nursing facility as defined in applicable state laws and regulations;

(F) Assure that federal funds shall not be used to replace funds from nonfederal sources and that the vendor shall continue or initiate efforts to obtain support from private sources or other public organizations;

(G) Be responsible for repayment of any federal or state funds that are deferred and/or ultimately disallowed;

(H) CDS Quarterly Financial and Service Reports shall be submitted to MMAC thirty (30) days after the end of each calendar quarter;

(I) Maintain CDS financial records separately from any other financial records and make all consumer and CDS financial records, documents, reports, and data available to MMAC upon request; and (J) Submit an annual audit or review by a properly licensed independent practitioner (certified public accountant licensed in the state of Missouri) pursuant to applicable federal and state laws and regulations, including any audit parameters as established by DHSS.

Audit requirements for vendors— A. An annual financial statement audit is required if the vendor’s annual gross revenue is two hundred thousand dollars ($200,000) or more.

B. An annual financial statement audit or annual financial statement review is required if the vendor’s annual gross revenue is less than two hundred thousand dollars ($200,000).

The audit report must be submitted to MMAC within one hundred fifty (150) days after the end of the vendor’s fiscal year.

(9) MMAC may withhold funding if the vendor does not submit required documentation pursuant to this rule.

(10) The vendor shall maintain, at a minimum, all case files and records of its activities pursuant to applicable state laws and regulations in a central location for six (6) years. Records must be provided to DHSS or its designee upon request and must be maintained in a manner that will ensure they are readily available for monitoring or inspection. Such records shall include but not be limited to records verifying the delivery of services.

(11) MMAC or its designee shall conduct on-site visits, which may be announced or unannounced, for the purpose of program and/or fiscal monitoring of the vendor. The vendor shall provide proof of maintaining a business location that shall comply with any and all applicable city, county, state, and federal requirements upon request of MMAC. The vendor’s principal place of business shall have staff on the premises with access to records during business hours as prescribed by the vendor’s written agreement with MMAC.

(12) MMAC may invoke sanctions, upon written notice to the vendor, when it has cause to do so, including but not limited to the following:

(A) Elimination of one (1) or more counties from the vendor’s authorized service commitment area and the subsequent transfer of consumers served in those counties to other vendors;

(B) Prospective cessation, temporarily or permanently, of new consumer service authorizations to the vendor, either for specific counties or for all counties served by the vendor;

(C) Demand that the vendor make certain assurances, including but not limited to audits or financial assurances to satisfy MMAC; and/or (D) Any remedies calculated to correct or prevent further impairment of the delivery of service by the vendor or the attendant that is substandard, delivered in a substandard manner, or delivered but not documented according to the requirements of this rule.

(13) MMAC may take immediate action to protect consumers from vendors who are found to be out of compliance with this

rule and/or any other statute and/or rule applicable to the CDS program, when such noncompliance creates a risk of injury or harm to the consumer.

(14) MMAC may suspend or terminate the written agreement of any vendor found to be out of compliance with the written agreement and with the provisions of this rule and/or the requirements of applicable state laws and regulations.

Amended: Filed Sept. 12, 2003, effective April 30, 2004. Moved to 19 CSR 15-8.400, effective Aug. 29, 2005. Emergency rescission and

rule filed Dec. 15, 2005, effective Dec. 25, 2005, expired June 23, 2006, Rescinded and readopted: Filed Dec. 15, 2005, effective July 30, 2006. ** Amended: Filed Sept. 1, 2023, effective Feb. 29, 2024. *Original authority: 208.900, RSMo 2005; 208.903, RSMo 2005; 208.906, RSMo 2005; 208.909, RSMo 2005; 208.912, RSMo 2005; 208.915, RSMo 2005; 208.918, RSMo 2005; 208.921, RSMo 2005; 208.927, RSMo 2005; and 208.930, RSMo 2005. **Pursuant to Executive Order 21-07, 19 CSR 15-8.400, subsection (7)(J) was suspended from May 18, 2020 through August 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 15-8.400, paragraph (4)(A)1., subsections (4)(B), (6)(B), and (7)(B), and section 208.918.1(2) was suspended from April 30, 2020 through December 31, 2021.

History

authority of any overdue or unpaid tax obligation, as well as any notice of an impending garnishment.
AUTHORITY: sections 208.900, 208.903, 208.906, 208.912, 208.915, 208.921, and 208.927, RSMo 2016, and sections 208.909, 208.918, and 208.930, RSMo Supp. 2023. This rule originally filed as 5 CSR 90-7.200. Original rule filed June 28, 2001, effective Jan. 30, 2002.

19 CSR 15-8.500 Hearing Rights {#sec-19-csr-15-8.500 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-8.500}

PURPOSE: This rule establishes procedures by which an applicant or consumer dissatisfied with a determination made regarding the provision of services by the Department of Health and Senior Services (DHSS) can request a hearing.

(1) When an applicant or consumer is determined ineligible for consumer-directed services (CDS) or when a dispute arises concerning the provision of CDS, after preparation of the CDS plan (plan of care), or termination of CDS, the applicant or consumer may request, in writing, a hearing with the Department of Social Services (DSS).

(2) An applicant or consumer may request a hearing by contacting Department of Health and Senior Services (DHSS) in writing within ninety (90) days of denial of eligibility, denial of financial assistance, the determination of financial assistance, discontinuation, suspension or reduction of CDS.

(3) If the consumer appeals in writing within ten (10) days of the mailing of the notice regarding denial, suspension, reduction or termination of CDS, DHSS will not suspend, reduce, or terminate services provided to a consumer under an existing plan of care pending a decision from a hearing, unless the consumer requests in writing that services be suspended, reduced or terminated.

(A) The consumer shall be responsible for repayment of any federal or state funds expended for services while the appeal is pending, when if DHSS’ decision is upheld and the state requests repayment of such funds.

Filed Dec. 15, 2005, effective July 30, 2006. *Original authority: 208.921, RSMo 2005; 208.927, RSMo 2005; and 208.930, RSMo 2005.

History

AUTHORITY: sections 208.921, 208.927 and 208.930, RSMo Supp. 2005. This rule originally filed as 5 CSR 90-7.300. Original rule filed June 28, 2001, effective Jan. 30, 2002. Moved to 19 CSR 15- 8.500, effective Aug. 29, 2005. Emergency amendment filed Dec. 15, 2005, effective Dec. 25, 2005, Expired June 23, 2006. Amended:

19 CSR 15-8.510 Informal Review {#sec-19-csr-15-8.510 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-8.510}

(Rescinded: July 30, 2006)

This rule originally filed as 5 CSR 90-7.310. Original rule filed June 28, 2001, effective Jan. 30, 2002. Moved to 19 CSR 15-8.510, effective Aug. 29, 2005. Emergency rescission filed Dec. 15, 2005, effective Dec. 25, 2005, expired June 23, 2006. Rescinded: Filed Dec. 15, 2005, effective July 30, 2006.

History

AUTHORITY: sections 161.092, 178.671 and 178.673, RSMo 2000.

19 CSR 15-8.520 Hearings {#sec-19-csr-15-8.520 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-8.520}

(Rescinded: July 30, 2006)

Original rule filed June 28, 2001, effective Jan. 30, 2002. Amended:

Filed Sept. 12, 2003, effective April 30, 2004. Moved to 19 CSR 15- 8.520, effective Aug. 29, 2005. Emergency rescission filed Dec. 15, 2005, effective Dec. 25, 2005, expired June 23, 2006. Rescinded:

Filed Dec. 15, 2005, effective July 30, 2006.

History

AUTHORITY: sections 161.092, RSMo Supp. 2003 and 178.671 and 178.673, RSMo 2000. This rule originally filed as 5 CSR 90-7.320.

Chapter 9 Electronic Visit Verification

19 CSR 15-9.100 Definitions {#sec-19-csr-15-9.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-9.100}

(Rescinded January 30, 2021)

Filed July 31, 2020, effective Jan. 30, 2021.

History

AUTHORITY: sections 208.909 and 660.023, RSMo Supp. 2013. Original rule filed Sept. 1, 2015, effective Feb. 29, 2016. Rescinded:

19 CSR 15-9.200 Electronic Visit Verification {#sec-19-csr-15-9.200 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-9.200}

(Rescinded January 30, 2021)

Filed July 31, 2020, effective Jan. 30, 2021.

History

AUTHORITY: sections 208.909 and 660.023, RSMo Supp. 2013. Original rule filed Sept. 1, 2015, effective Feb. 29, 2016. Rescinded:

Division 20 Division of Community and Public Health

Chapter 1 Food Protection

19 CSR 20-1.060 Licensing of Beverage Manufacturers and Distributors and the Collection HEALTH AND SENIOR SERVICES Public Health {#sec-19-csr-20-1.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.060}

19 CSR 20-1.010 Sanitation of Food Service Establishments {#sec-19-csr-20-1.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.010}

(Rescinded October 30, 1999) and 196.045, RSMo 1986. This rule was previously filed as 13 CSR 50-61.010. Original

rule filed Oct. 21, 1948, effective Oct. 31, 1948. Amended: Filed March 22, 1954, effective April 1, 1954. Amended: Filed March 24, 1958, effective April 3, 1958.

Amended: Filed Jan. 23, 1963, effective Feb. 2, 1963. Rescinded and readopted: Filed Sept. 1, 1981, effective Dec. 11, 1981.

Amended: Filed July 18, 1989, effective Sept. 28, 1989. Rescinded: Filed April 7, 1999, effective Oct. 30, 1999.

19 CSR 20-1.020 Sanitation of Retail Food Stores {#sec-19-csr-20-1.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.020}

(Rescinded October 30, 1999) and 196.045, RSMo 1986. Original rule filed Feb. 4, 1986, effective April 25, 1986.

Amended: Filed July 18, 1989, effective Sept. 28, 1989. Rescinded: Filed April 7, 1999, effective Oct. 30, 1999.

19 CSR 20-1.025 Missouri Food Code {#sec-19-csr-20-1.025 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.025}

PURPOSE: This rule establishes up-to-date sanitation standards for food establishments designated in Chapter 196, RSMo.

al. The entire text of the rule is printed here.

(1) Food establishments shall comply with the sanitation standards and processes contained in the Department of Health and Senior Services Missouri Food Code manual. The manual is incorporated by reference in this

rule as published June 3, 2013, by the Department of Health and Senior Services and is available on the web at www.health.mo.gov or by contacting the department at PO Box 570, Jefferson City, MO 65102-0570, (573) 751-6095. This rule does not incorporate any subsequent amendments or additions.

Supp. 2012.* Original rule filed April 26, 1999, effective Oct. 30, 1999. Amended:

Filed March 1, 2005, effective Sept. 30, 2005. Rescinded and readopted: Filed March 11, 2013, effective Sept. 30, 2013. *Original authority 192.006, RSMo 1993, amended 1995; 192.020, RSMo 1939, amended 1945, 1951, 2004; 196.190, RSMo 1939; 196.195, RSMo 1939; 196.210, RSMo 1939; 196.220, RSMo 1939; 196.225, RSMo 1939, amended 1977; 196.230, RSMo 1939; 196.235, RSMo 1939; 196.240, RSMo 1939; 196.245, RSMo 1939; 196.250, RSMo 1939; and 196.265, RSMo 1939.

19 CSR 20-1.030 Frozen Dessert License {#sec-19-csr-20-1.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.030}

PURPOSE: This rule defines and establishes sanitation and production standards for frozen desserts as they relate to public health. entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive.

This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no This note applies only to the reference material. The entire text of the rule is printed here.

(1) Applicability. This rule applies to food establishments, food processing plants, and brokers manufacturing and/or distributing frozen dessert products.

(2) Definitions. The following definitions shall apply in the interpretation and application of this rule and shall have the meaning stated below:

(A) “Administrative authority” shall mean the department, local public health agency (LPHA), and/or U.S. Food and Drug Administration that has authority to govern food establishments and/or food processing plants;

(B) “Broker” shall mean any person operating a food processing plant located outside of Missouri that manufacturers and/or distributes frozen dessert products into Missouri;

(D) “Food establishment” shall be defined as specified in 19 CSR 20-1.025;

(E) “Food processing plant” shall be defined as specified in 19 CSR 20-1.025;

(F) “Frozen dessert” shall mean ice cream, ice cream mix, ice milk, sherbet, frozen malt, ice milk mix, mellorine, edible fat frozen dessert, or ices that meet the definition of a potentially hazardous food as defined in 19 CSR 20-1.025; and (G) “Person” shall mean an individual, partnership, corporation, organization, and association.

(3) Responsibilities. The person shall— (A) Allow the administrative authority access to the premises during normal hours of operation for the purposes of conducting health and sanitation inspections;

(B) Allow the administrative authority to collect water, food, and environmental samples as needed;

(C) In the event of a suspected communicable disease outbreak, implement health and sanitation control measures as required by the department and/or Local Public Health Agency (LPHA); and (D) In the event food products are deemed adulterated or misbranded, implement health and sanitation control measures as required by the department.

(4) General Criteria.

(A) Food establishments shall— 1. Be in compliance with sanitation requirements specified in 19 CSR 20-1.025 or local food ordinance; and 2. Clean and maintain frozen dessert equipment in accordance with manufacturer’s specifications.

(B) Food processing plants shall— 1. Be in compliance with sanitation requirements specified in 19 CSR 20-1.040;

Be in compliance with labeling requirements specified in 19 CSR 20-1.045.

(C) Brokers shall— 1. Be in compliance with equivalent local sanitation requirements; and/or 2. Be in compliance with sanitation requirements specified in 21 CFR Part 117;

Be in compliance with labeling requirements specified in 21 CFR Part 101.

(5) Application Requirements for Initial Frozen Dessert License.

(A) Prior to the issuance of a license, an applicant shall complete and submit an application packet to the department. The department may require additional information when deemed necessary to assure compliance with the requirements of this rule. The application packet shall include:

A completed Application for Frozen Dessert License (10-21). The Application for Frozen Dessert License is incorporated by reference into and made part of this rule as published by the Missouri Department of Health and Senior Services, 930 Wildwood Drive, Jefferson City, MO 65109, website: https://health.mo.gov/safety/foodsafety/indust ryfoods/manufacturedfoods/frozendessert.php and can be requested by e-mailing Info@health.mo.gov. This rule does not incorporate any subsequent amendments or additions;
A nonrefundable licensing fee as specified in section 196.866, RSMo;
Certificate of No Tax Due as required in section 144.083, RSMo; and 4. A copy of the most current sanitation inspection report from the administrative

(B) Private homes, hospitals, churches, or fraternal organization manufacturing frozen dessert products for their own use or food establishments serving and/or selling ice cream or frozen dessert products received in its final frozen form from a licensed manufacturer shall not be required to obtain a frozen dessert license.

(6) Procedure for Issuance or Denial of Frozen Dessert License.

(A) The applicant shall be notified in writing or electronic mail (email), by the department, when the application is approved, incomplete, or denied.

If the application is approved, the notice shall specify the application is approved and a frozen dessert license shall be issued.
If the application is incomplete, the notice shall specify the necessary information or documentation required to complete the application.

A. The applicant shall submit the requested information and/or documentation to the department within thirty (30) calendar days from the issuance date of the notice.

B. Failure to submit the requested information within the thirty (30) calendar days may result in the department denying the application.

If the application is denied, the notice shall specify the reason(s) for the denial.

(B) The applicant shall be denied a frozen dessert license for any one (1) or any combination of the following:

Failure to submit a complete application;
False or misleading statement(s) on the application; or 3. Failure to comply with the applicable requirements specified in sections (3) and (4) of this rule.

(C) If the applicant is aggrieved by a determination to deny licensure, the applicant may appeal the department’s decision to the Administrative Hearing Commission as provided by section 621.045, RSMo.

(7) License Renewal.

(A) A frozen dessert license shall be valid for one (1) year.

(B) Prior to the issuance of a renewal license, within sixty (60) calendar days but no later than thirty (30) calendar days prior to the expiration of the current license, a licensee shall complete and submit an application packet to the department. The department may require additional information when deemed necessary to assure compliance with the requirements of this rule. The application packet shall include: 1.

A completed Application for Frozen Dessert License (10-21). The Application for Frozen Dessert License is incorporated by reference into and made part of this rule as published by the Missouri Department of Health and Senior Services, 930 Wildwood Drive, Jefferson City, MO 65109, website: https://health.mo.gov/safety/foodsafety/indust ryfoods/manufacturedfoods/frozendessert.php and can be requested by e-mailing Info@health.mo.gov. This rule does not incorporate any subsequent amendments or additions;

A nonrefundable licensing fee as specified in section 196.866, RSMo;
Certificate of No Tax Due as required in section 144.083, RSMo; and 4. A copy of the most current sanitation inspection report from the administrative

Filed May 2, 1986, effective July 26, 1986.

Amended: Filed June 2, 2021, effective Jan. 30, 2022. *Original authority: 196.872, RSMo 1980, amended 1993, 1995.

History

authority.
authority.
AUTHORITY: section 196.872, RSMo 2016. This rule was previously filed as 13 CSR 50- 63.010. Original rule filed June 27, 1980, effective Oct. 11, 1980. Amended: Filed June 27, 1983, effective Nov. 11, 1983. Amended:

19 CSR 20-1.040 Good Manufacturing Practices {#sec-19-csr-20-1.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.040}

PURPOSE: This rule establishes sanitation standards of public health significance for manufactured foods.

al. The entire text of the rule is printed here.

(1) Applicability. The requirements of this rule apply to buildings or facilities, or parts thereof, used for, or in connection with, the manufacturing, packaging, processing, or holding of human food.

(2) Standards. Manufacturers, distributors, and warehouses shall operate in accordance with 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, revised as of September 17, 2015, hereby incorporated by reference and made a part of this rule as published by the U.S. Government Publishing Office, 732 North Capitol Street NW, Washington, DC 20401-0001, (202) 512-1800, http://bookstore.gpo.gov. This rule does not incorporate any subsequent amendments or additions.

Original rule entitled Missouri Division of Health E 1.20 was filed Nov. 17, 1949, effective Nov. 27, 1949. Rescinded and readopted:

Filed March 11, 2013, effective Sept. 30, 2013. Emergency amendment filed Oct. 13, 2017, effective Oct. 23, 2017, expired April 20, 2018. Amended: Filed Oct. 13, 2017, effective April 30, 2018. 192.020, RSMo 1939, amended 1945, 1951, 2004, 2016; and 196.045, RSMo 1943, amended 1993,

History

AUTHORITY: sections 192.006, 192.020, and 196.045, RSMo 2016. This rule was previously filed as 13 CSR 50-70.010.

19 CSR 20-1.042 Acidified Foods {#sec-19-csr-20-1.042 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.042}

PURPOSE: This rule establishes standards to assure the facilities, methods, practices, and controls used to manufacture, process, and package acidified foods are safe and conducted under sanitary conditions.

al. The entire text of the rule is printed here.

(1) Applicability. The requirements of this

rule apply to any person engaged in or connected with manufacturing, processing, and/or packaging of acidified foods.

(2) Standards. Any person engaged in the manufacturing, processing, and/or packaging of acidified foods shall operate in accordance with 21 CFR Part 114 Acidified Foods, revised as of April 1, 2012, hereby incorporated by reference and made a part of this

rule as published by the U.S. Government Printing Office, 732 North Capitol Street NW, Washington, DC 20401-0001, (202) 512-1800, http://bookstore.gpo.gov. This

rule does not incorporate any subsequent amendments or additions.

Supp. 2012.* Original rule filed March 11, *Original authority: 192.006, RSMo 1993, amended 1995;

19 CSR 20-1.045 Food Labeling {#sec-19-csr-20-1.045 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.045}

PURPOSE: This rule establishes food labeling standards for manufactured foods.

al. The entire text of the rule is printed here.

(1) Applicability. The requirements of this

rule apply to buildings or facilities or parts labeling of human food.

(2) Standards. Manufacturers, distributors, and warehouses shall label human food in accordance with 21 CFR Part 101 Food Labeling, revised as of April 1, 2012, hereby incorporated by reference and made a part of this rule as published by the U.S. Government Printing Office, 732 North Capitol Street NW, Washington, DC 20401-0001, (202) 512-1800, http://bookstore.gpo.gov.

This rule does not incorporate any subsequent amendments or additions.

Supp. 2012.* Original rule filed March 11,

19 CSR 20-1.050 Sanitation Standards for the Manufacture of Soft Drinks and Beverages {#sec-19-csr-20-1.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.050}

PURPOSE: This rule defines and establishes sanitation standards for nonintoxicating beverage and soft drink manufacturers. entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive.

Therefore, the material which is so incorporated is on file with the agency who filed this

rule, and with the Office of the Secretary of State. Any interested person may view this material at either agency’s headquarters or the same will be made available at the Office of the Secretary of State at a cost not to exceed actual cost of copy reproduction. The entire text of the rule is printed here. This note refers only to the incorporated by reference material.

(1) The following definitions shall apply in the interpretation and the enforcement of this

rule:

(A) Bottling means filling, capping, packaging and enclosing in bottles or other containers, including metal cans and premixed tanks;

(B) Flavor manufacturing plant means a building in which soft drink flavors are prepared, manufactured and packaged, including any separate room used for the accommodation of workers;

(C) Franchisee means a person authorized or given contractual permission to bottle, offer for sale or distribute a soft drink in a specified territory for a company or franchiser who owns the trademark or name and formula for the soft drink;

(D) Governing jurisdiction means standards, codes or ordinances as administered by local, state or federal agencies;

(E) Nonintoxicating beverage plant means a building in which soft drinks are produced including any separate room used in the preparation or storage of soft drink flavors and including any separate room used for the accommodation of production employees;

(F) Nonnutritive sweeteners means saccharin salt, aspartame and other such nonsugar sweetening ingredients as may be approved by the federal Food and Drug Administration (FDA) and recognized by of the Department of Health;

(G) Person means any individual, firm, corporation or other legal entity;

(H) Sodium means the amount of this element expressed in terms of milligrams (mg) per eight (8) fluid ounces.

Sodium-free means less than five milligrams (5 mg) of sodium per eight (8) fluid ounces.
Very low sodium means thirty-five milligrams (35 mg) or less of sodium per eight (8) fluid ounces.
Low sodium means one hundred forty milligrams (140 mg) or less of sodium per eight (8) fluid ounces;

(I) Soft drink shall be held to mean and include all beverages of every kind manufactured or sold in the state which shall be understood to include those containing less than one-half (1/2) of one percent (1%) of or no alcohol, including carbonated beverages, still drinks, seltzer water, artificial or natural mineral waters and all other waters used and sold for beverage purposes. Among other products, this rule shall be interpreted to include carbonated beverages, soda, soda water, fruitade, any nonalcoholic flavored still beverages, artificial or natural mineral waters, bottled table waters, artificial waters whether carbonated or not, seltzer and club soda, and beverages that are manufactured or created by the use of parts of or natural fruit juices and the use of artificial flavoring and water such as orange juice, lemon drink, reconstituted orange juice or other similar names. These rules do not apply to whole or concentrated beverages such as concentrated grape juice, unfermented grape juice, orange juice, lemon juice, grapefruit juice, pineapple juice and apple juice or cider, provided that the same is the juice extracted from the natural fruit and that it is in its natural state and properly labeled. This rule does, however, cover all reconstituted products which are bottled from the concentrates referred to in this subsection;

(J) Soft drink flavors mean any type of soda water flavor or beverage base, syrup extracts, concentrate, powder or other compound prepared for use as a flavoring for soft drinks; and (K) Sweetening ingredient means cane sugar or beet sugar, in liquid or crystal form, dextrose, corn sugar syrup in liquid or direct form, honey or any syrup from any sugar or any combination of these sugars;

(2) Beverage Labeling. Beverages shall be labeled in compliance with sections 196.010, 196.015, 196.075, 196.120 and 196.415, RSMo (1986).

(A) Labels or advertising pertaining to sodium content shall have the serving size and sodium content declared on the label and shall be in conformance with section (1) of this rule.

(B) Supplemental printed information and graphics may appear on the label but shall not imply properties of the product or preparation methods which are not factual.

If a public water system is used as the source of water for the bottled water, the container shall be labeled to clearly inform the consumer of the source of the water. If the bottler further processes, conditions or treats the water from the public water system, the additional treatments may also be included on the label;
A bottled water with or without natural or added carbonation may be prepared with added flavors, extracts, essences or fruit juice concentrates derived from a spice or fruit and comprising less than one percent (1%) by weight of the final product. The final product shall contain no sweeteners or additives— including nonnutritive sweeteners— other than any of the following flavors, extracts, essences or fruit juice concentrates and carbon dioxide and shall be designated on labels and in advertising as follows:

A. The common or usual name of the characterizing flavor shall accompany the designation of the bottled water-product type;

B. The product may be designated as natural only if it meets the requirements of the designation as defined in subparagraph (2)(C)3.E. of this rule and naturally derived flavors, extracts or essences are used;

C. Products labeled as one (1) type or one (1) source of bottled water shall not be blended with water that is not bottled water or that is of another bottled water type; and D. Water which meets the definition of more than one (1) type of water as defined in paragraph (2)(C)3. of this rule may be labeled with either the applicable description or a combination of applicable descriptions;

If a manufacturer or distributor provides information on the label or in advertising stating or implying it is the product of a specific water type—for example, spring water—or treated in a specific manner—for example, purified water—the type or treatment shall be on the label in an easily readable format. A label or advertising implying a specific water type or specific treatment shall conform to the following criteria:

A. Artesian well water means water from a well tapping an aquifer in which the water level will stand above the bottom of the confining bed of the aquifer, and in which the hydraulic pressure of the water in the aquifer is greater than the force of gravity. Artesian well water shall not be altered by the addition or deletion of minerals or by blending it with water from a nonartesian well water source, except that artesian well water shall be treated with a disinfection process and may be filtered to reduce the concentration of any naturally occurring substance which exceeds the bottled water standards set forth in sections (6)–(8) of this rule;

B. Fluoridated water means water containing naturally occurring or added fluoride. The label shall specify whether fluoride is naturally occurring or is added. Any water which meets the designation of fluoridated water shall contain at least eight-tenths of a milligram per liter (0.8 mg/l) fluoride and shall otherwise comply with standards established by the United States FDA in 21 CFR 103.35(d)(2)(1991);

C. Mineral water means water containing more than five hundred milligrams per liter (500 mg/l) of total dissolved solids and originating entirely from an underground source, which may be a well, artesian well or spring. Mineral water may be derived from a natural orifice or from a bore hole adjacent to the natural orifice. If it is derived from a bore hole adjacent to the natural orifice, the water shall be from the same underground stratum and be of the same quality and composition as the water derived from the natural orifice without external force. Mineral water may not be altered by the addition or deletion of minerals or by blending it with water from a nonmineral water source, except that mineral water may be filtered and shall be treated with a disinfection process approved by the Department of Health and shall be treated to reduce the concentration of any naturally occurring substance which exceeds the bot tled water standards set forth in sections (6)–(8) of this rule. Exemption from the requirement for a disinfection process of the mineral water may be granted on an individual basis and only if the bottler can demonstrate continuing compliance with the standards of the European Economic Community Directive 80/777/EEC for Natural Mineral Water, July 15, 1980. Mineral water may be collected and transported by pipes, tunnels, trucks or similar devices. Any water which meets the criteria of this paragraph may also be labeled natural mineral water.

(I) Mineral water which contains carbon dioxide as it emerges from the source and is bottled directly with its entrapped gas, or from which the gas is mechanically separated and later reintroduced into the water at the time of bottling shall be labeled naturally carbonated or naturally sparkling.

(II) Mineral water which contains carbon dioxide other than that naturally occurring in the source product shall be labeled with the words carbonation added or carbon dioxide added, whether the carbonation is obtained from a natural or manufactured source;

D. Mineralized water means water which meets the requirements of mineral water in subparagraph (2)(C)3.C. of this rule, except that the water also contains added minerals;

E. Natural water means spring, artesian well or well water which is unmodified by mineral addition or deletion, except natural water may be filtered and shall be treated with a disinfection process and treated to reduce the concentration of any substance which exceeds standards set forth in sections (6)–(8) of this rule;

F. Purified water means water produced by distillation, deionization, ion exchange treatment or reverse osmosis and that meets the definition of purified water in the United States Pharmacopeia: Purified water is water obtained by distillation, exchange, reverse osmosis or other suitable exchange. It is prepared from water complying with the regulations of the United States Environmental Protection Agency (U.S.

EPA) with respect to drinking water. It contains no added substance. Purified water which is vaporized and then condensed may be labeled distilled water;

G. Sparkling, carbonated or carbonation added means water which contains carbon dioxide. Naturally sparkling water means water with a carbon dioxide content from the same source as the water;

H. Spring water means water which issues by natural forces out of the earth at a particular place. Spring water may be derived from the natural orifice or from a bore hole adjacent to the natural orifice. If it is derived from the natural orifice by external force or from a bore hole adjacent to the natural orifice, the water shall be from the same underground stratum and be of the same quality and composition as the water derived from the natural orifice without external force.

Spring water may not be altered by the addition or deletion of minerals or by blending it with water from a nonspring source. Spring water shall be treated with a disinfection process and may be filtered. Spring water may be collected and transported by pipes, tunnels, trucks or similar devices; and I. Well water means water from a hole bored or drilled into the ground which taps the water of an aquifer. Well water shall be treated with a disinfection process and may be filtered. Well water may not be altered by the addition or deletion of minerals or by blending it with water from a nonwell water source.

(3) License Application and Expiration. Any person desiring to manufacture or distribute soft drinks or beverages as defined by the statute shall apply to the Department of Health for a license for each production facility and each warehouse operated by the applicant. The application shall be made on a form prescribed by the department for that purpose. Each license shall expire on the last day of June following the day of issuance. A license is not transferable and no refunds will be made. If the business is sold, the new owner shall obtain a new license.

(4) Sanitary Requirements. Every building, room, basement or cellar occupied or used for the preparation for sale, holding for sale, manufacturing, packing, storage, sale or distribution of soft drinks or beverages shall be properly lighted, drained, plumbed and ventilated and conducted with due regard for the purity and wholesomeness of the products produced there and the strict regard to the influence of the conditions upon the health of the operatives, employees, clerks or other persons employed there.

(A) The following rules regarding the building and premises used within Missouri for the manufacture and distribution of soft drinks and beverages shall be observed:

Location and use of building. The building or portion of the building shall be used for no other purpose and shall be so located as to be protected from objectionable surroundings;
Plant layout. Bottling plants shall be located in buildings so constructed that the bottling operation and syrup preparation are located in a separate room. This relates specifically to operations such as bottle washing and filling, compounding and mixing of syrups, warehousing and loading. This requirement, except for the syrup room, does not apply to existing bottling plants which have been located continuously in the same building prior to the promulgation of this

rule. In all cases of major structural changes to existing production facility or construction of a new production facility all separation requirements are to be achieved. The Department of Health will assist and recommend suggestions prior to the start of construction;

Floors. The floors of all rooms used for manufacturing operations shall be of a construction as to be impervious, easily cleaned, smooth and shall be kept sanitary and in good repair;
Walls and ceilings. Walls and ceilings in the syrup and bottling room shall be of hard, sound materials with smooth, easily cleaned surfaces and maintained clean.

Surfaces that require painting shall be frequently painted with light colored paint;

Light. All processing areas shall have shielded fixtures with adequate footcandle lighting. All other areas shall be adequately lighted;
Ventilation. All room areas utilized for manufacture, bottling and container cleaning shall be provided with the necessary air movement to prevent excessive condensation on the ceiling and on filling equipment, which could contaminate the beverage or its ingredients. When overhead drip due to condensation is exposing cleaned containers on conveyor lines to possible contamination, shields shall be provided over the conveyor lines;
Screening and vermin control.

Screens or other suitable equipment must be provided and used for the purpose of excluding insects from the processing area. All necessary vermin and rodent control measures must be taken;

Syrup room. All nonintoxicating beverage plants shall be equipped with a room known as a syrup room in which syrup, flavors, extracts and other liquid beverage ingredients or concentrates are measured, mixed or prepared. This room shall be separately enclosed and substantially constructed of easily cleanable material. It shall be well-ventilated and lighted, shall be provided with adequate facilities for washing and sanitizing equipment and shall have hot and cold running water easily accessible to all parts. It shall be protected against rodents, vermin, insects and dust and so constructed as to be easily cleaned;
Water and sewer connections. Water supply (if private) must meet construction requirements as found in 19 CSR 20-3.010 of the rules of the Department of Health and be of a sanitary quality. Running water under pressure from an approved source shall be easily accessible to all parts of the plant and adequate provisions for quickly carrying off and disposing of waste water shall be provided. If more than one (1) source of water is available in a plant, no cross connections shall be permitted between the two (2) sources. Sewage and other wastes must be disposed of in a manner approved by the Department of Natural Resources;
Toilet and washrooms. Every nonintoxicating beverage plant shall be provided with toilet facilities complying with plumbing codes of the governing jurisdiction. Toilet rooms should not open directly into any room used as a processing area. The doors of all toilet rooms shall be self-closing. Toilet rooms shall be kept in a clean condition, in good repair and well-ventilated. A sign directing employees to wash their hands before returning to work shall be posted in all toilet rooms used by employees;
Lavatory facilities. Adequate and convenient handwashing facilities shall be provided, including hot and cold running water, soap and approved sanitary towels.

The use of a common towel is prohibited. No employee shall resume work after using the toilet room without first washing his/her hands; and 12. Clothing storage. Suitable places for changes of garments and proper care of same are required.

(B) The following rules regarding the machinery and equipment used within Missouri for the manufacture and distribution of soft drinks and beverages shall be 1. Equipment. Every plant manufacturing soft drinks, soft drink flavors and beverages shall be equipped with easily cleaned, suitable mechanical-washing apparatus and with approved machines for carbonating, filling and closing so that they may be readily accessible for cleaning and sanitizing;

Conveyors, palletizers and cases.

These items shall be maintained free from accumulating dust, dirt, mud and other foreign materials;

Syrup making equipment. All vats, covers, jars, mixing and storage tanks, pipe lines, filters and other apparatus employed in the preparation of syrups shall be of sanitary construction and lined when necessary with materials resistant to the action of syrup ingredients;
Water clarification equipment.

Electrical or chemical coagulation devices and filters employed for clarification of water shall be of types acceptable to the Department of Health, shall not be operated beyond their rated capacity and shall be maintained in a clean, wholesome and sanitary condition at all times; and 5. Miscellaneous equipment. Every plant shall be adequately provided with thermometers and methods for ascertaining the strength of the washer solution employed in bottle washing. All piping, vats, covers, tanks and other equipment or utensils shall be of easily cleanable construction and shall be kept in good repair. No containers shall be used for mixing or storing syrup or soft drink flavors unless they are of glass, stainless steel, good grade plastic, porcelain lined or block-tin lined; or made of or lined with, or both, some other suitable impervious, noncorrosive material. Utensils or equipment which are cadmium plated or zinc plated or in which cadmium, zinc or lead is a part of the metal are prohibited for the delivery of finished syrup or beverage. Only solder of a low lead content should be used for jointing.

(C) The following rules regarding the manufacturing methods and operations of soft drink and beverage plants which manufacture beverage products in Missouri shall be 1. Cleaning facilities. Adequate facilities must be provided for the proper cleaning of all containers, utensils and equipment used in the manufacturing and processing of soft drinks;

Cleaning. All pipe lines, apparatus and containers employed in the manufacturing process shall be cleaned and washed after each day’s use. Sanitization shall be done as necessary to maintain at all times a sanitary system. Steam, hot water, chlorine or other equally efficient agents approved by the Department of Health are permissible for sanitization;
Sanitation of bottles. All closable containers in which soft drink flavors and beverages are sold or dispensed shall be washed or rinsed immediately before filling and shall be free of pathogenic bacteria. No containers intended by the manufacturer to be nonreturnable shall be refilled with beverages. Hand bottle washing, except as a preliminary before mechanical washing, shall be prohibited.

A. All reusable glass containers used in the manufacture or bottling of soft drinks and beverages, before being filled, shall be sanitized during the washing cycle in a hot caustic solution of a temperature of not less than one hundred forty degrees Fahrenheit (140°F) that shall contain not less than four percent (4%) caustic or alkali, sodium hydrate or other residual materials acquired from the sanitizing procedure. Noncaustic cleansers may be used for reusable glass containers as described in subparagraph (4)(C)3.C. of this rule if the bottler can demonstrate to the Department of Health that the process is sufficient to clean and sanitize the glass.

B. All premix and postmix containers, before being filled, shall be sanitized in a hot caustic solution at a temperature of not less than one hundred eighty degrees Fahrenheit (180°F) that shall contain not less than three percent (3%) caustic or alkali expressed in terms of sodium hydrate for a washing cycle of not less than one (1) minute and then thoroughly rinsed in clean water until free of alkali, sodium hydrate or other residual materials acquired from the sanitizing procedure.

C. Polycarbonate and other plastic containers designed and intended for reuse shall be sanitized with noncaustic cleansers in the following manner:

(I) Only noncaustic cleansers labeled for use for polycarbonate or plastic returnable containers shall be used. Specific washing conditions directed by the manufacturer shall be followed;

(II) Washing shall be performed for at least one (1) minute if using high-velocity jets or for three (3) minutes if using soakertype wash;

(III) A sanitizing rinse shall follow the washing of the container. The sanitizing rinse shall use either water at an inside bottle temperature not less than one hundred seventy degrees Fahrenheit (170° F) for not less than fifteen (15) seconds; or shall use a sanitizing solution. The sanitizing solution shall contain not less than one hundred parts per million (100 ppm) nor more than two hundred parts per million (200 ppm) chlorine water solution at seventy-five degrees Fahrenheit (75°F) for not less than thirty (30) seconds. Other sanitizing agents may be allowed upon approval of the Department of Health;

(IV) A final rinse with product water or operations water shall be used to remove all traces of sanitizer; and (V) Manufacturers currently using caustics for sanitizing plastic containers as of July 1, 1992, the effective date of this rule may continue to use this method of sanitizing bottles as described for glass containers in subparagraph (4)(C)3.A. New installations of bottle washing equipment shall use the noncaustic cleanser method as described in this

section.

D. A record of key operating parameters of the container washer shall be maintained. The record shall include wash temperature, concentration of caustic or cleanser, concentration of sanitizer when using noncaustic cleansers, lack of carry-over of caustic or cleanser in containers, and maintenance on washers. Records shall be kept on file at least two (2) years for regulatory inspection.

Preparation of syrup. Syrups shall be prepared in a clean manner and every precaution shall be taken against contamination or absorption of deleterious substances during the process, preparation and subsequent storage. All vats, tanks and other equipment must be provided with suitable covers so as to protect the syrup and other ingredients used in the manufacturing of soft drinks from contamination. Covers shall be in place on all vats which contain ingredients;
Filling and closing. Manual filling crowning, closing or both shall be prohibited.

Containers shall be filled and closed with automatic machinery and neither the operator nor his/her clothes shall come in contact with any portion of the bottle, can or machinery which might result in contamination of the product. This shall not apply to premix or postmix tanks for which mechanical closing equipment is not available. If and when mechanical closing apparatus becomes available, manual closing shall be prohibited after a period of five (5) years;

Storage of closures. Crowns, can covers or any other closures shall be stored in dustproof containers;
Storage of sweetening ingredient.

Sweetening ingredients shall be stored in a clean sanitary manner and protected from insects, rodents, dust and other contamination;

Storage of finished goods. The finished product shall be stored in a manner as not to interfere with the sanitation of the processing area;
Refuse and rubbish. All waste, broken bottles and other such refuse shall be promptly and properly disposed of and all garbage and trash shall be kept in suitable clean, covered receptacles in a manner as not to become a nuisance;
Storage and handling of utensils and equipment. After bactericidal treatment, utensils shall be stored in a clean, dry place protected from insects, dust or other contamination and utensils shall be handled in a manner as to prevent contamination; and 11. Miscellaneous. The surroundings of all plants shall be kept clean and free from litter or rubbish. None of the operations shall be conducted in any room used for domestic purposes. Clothing and hands shall be kept clean. Soiled linens, aprons and coats shall be kept in covered containers for this purpose.

Animals such as dogs, cats or birds, etc. are not permitted in the plant.

(D) The following rules regarding personnel employed in the manufacture and distribution of soft drinks and beverages must be 1. Appearance and sanitary habits. All employees engaged in the mixing of syrups, filling of containers or in any other capacity which brings them in contact with the ingredients or containers of soft drinks, soft drink flavors or beverages shall be clean, have a neat appearance and wear clean clothes as determined by the licensee. Spitting or the use of tobacco in any form in the syrup room or bottling rooms is prohibited; and 2. Health. It is the employer’s responsibility to assure him/herself that no employee has a contagious or infectious disease while engaged in handling, production, preparation, manufacture, packing, storage, sale or distribution of soft drinks, soft drink flavors or beverages.

(E) All bulk water sources and facilities shall be approved and maintained for sanitary quality at all times.

Bulk water shall be from approved sources.

A. All sources of water within the state intended for bulk water that is obtained from community public water supplies, noncommunity public water supplies or both shall comply with the laws and rules administered by the Public Drinking Water Program, Department of Natural Resources, governing public water supplies.

B. All sources of water within the state intended for bulk water that is obtained from springs or private wells shall be approved by the Department of Health. The Department of Health shall request a preliminary review by the Division of Geology and Land Survey, Department of Natural Resources of the geology and potential sources of contamination of springs and their recharge areas, such as sinkholes or chemical pipelines. The review, at the option of the Division of Geology and Land Survey, may include site evaluation, dye tracing, flow movement or other criteria to assist in determining characteristics of the spring. The spring orifice shall be protected from avoidable contamination, such as keeping livestock out. Because each spring and surrounding area may be unique, plans for protection from avoidable contamination shall be presented for review and approval by the Department of Health.

C. All privately owned wells within the state intended for bulk water shall be in compliance with the laws and rules administered by the Division of Geology and Land Survey, Department of Natural Resources, governing wells.

D. Sources of water which may be classified as surface or ground water under the influence of surface water shall be provided with filtration or disinfection methods capable of controlling pathogenic organisms or both.

E. All sources of water outside the state intended for bulk water, after treatment if needed, shall be in compliance with the appropriate regulatory authority for that jurisdiction and shall meet the requirements for microbiological, chemical and radiological standards set forth in sections (6)–(8) of this rule. Documentation of compliance with the appropriate regulatory authority shall be provided to the Department of Health.

Bulk water sources shall meet requirements for microbiological, chemical and radiological standards set forth in sections (6)–(8) of this rule.
All water storage facilities shall be maintained clean and sanitary at all times and shall meet the requirements set forth in section (4) of this rule.
Tank trucks, loading and unloading facilities, and other equipment used to transport bulk water shall be constructed of materials that do not import toxic substances, tastes, odor or color to the water, and shall be maintained clean and sanitary at all times.

Tanks previously used to transport toxic materials, petroleum products or other deleterious substance shall not be used to haul drinking water.

Bulk transport and transfer procedures, at a minimum, shall meet the following requirements:

A. The tank shall be sanitized monthly and at any time contamination is suspected or any substance other than water has been introduced or transported in the tank. The tank interior shall be cleaned, flushed with potable water, sanitized with a chemical sanitizer equivalent in bactericidal action of either a two (2)-minute exposure of fifty parts per million (50 ppm) of available chlorine at fifty-seven degrees Fahrenheit (57° F) when used as a circulating solution or an exposure of one hundred parts per million (100 ppm) available chlorine at fifty-seven degrees Fahrenheit (57° F) when used as a spray or fog. The tank cover shall not be opened after sanitizing;

B. Tanks also used for the transport of dairy products must have the interior of the tank inspected with an ultraviolet lamp by the hauler each time water is to be transported.

Tanks shall be rejected for use when odors or contaminants are found. The dome cover shall be closed immediately after inspection;

C. All hoses, connections and fittings shall be sanitized with a chemical solution equivalent in bactericidal action of a one (1) minute exposure of fifty parts per million (50 ppm) chlorine water solution by brushing solution on all exposed parts;

D. A minimum chlorine residual of one-half parts per million (0.5 ppm) shall be maintained in the water being hauled;

E. Tank trucks or tank trailers may be filled through the fitting on the inner-dome cover when the tailpipe cannot be used;

F. Water quality in the tank, after twenty to thirty (20–30) gallons have been delivered into the tank, shall be checked as follows:

(I) Stop filling;

(II) Have discharge valve opened;

(III) Inspect water as it discharges.

If water has unpleasant odor or looks dirty, it shall be rejected for use; and (IV) When these checks indicate satisfactory water quality, proceed to fill the tank; and G. The dome cover and tank discharge valve cover shall be closed and sealed after filling to volume desired;

H. When a fill connection is used, it shall be constructed in a manner to prevent contamination and shall be capped at all times when not in use; and I. Records, at a minimum, shall meet the following requirements:

(I) Records shall be maintained and include the number of gallons delivered daily and cleansing and sanitizing methods used for tank truck and tank trailer interiors, riser, connections and hoses;

(II) Records shall include date, time and location of delivery, concentration of chlorine residual and time of contact when applicable; and (III) The records shall be maintained for two (2) years and be available upon written or oral request by the Department of Health.

(5) Approval of License. When the analysis of samples shows the beverages to be unadulterated and free from ingredients injurious to health and sanitation conditions are satisfied as described in subsections (5)(A) and (B) of this rule, the manufacturer, upon payment of license fee, will be issued a license authorizing the applicant to manufacture a nonintoxicating beverage or a soft drink. A license will be renewed annually upon the same terms and conditions as required for the original license. Licenses are not transferable and no refunds shall be made. If the business is sold, the new owner shall obtain a new license to operate.

(A) The buildings and equipment to be used by beverage manufacturers located in Missouri are found by the Department of Health to be in a sanitary condition as described in section (4) of this rule.

(B) Out-of-state manufacturers shall provide a copy of a current license or permit from the regulatory authority of the state or country of origin to manufacture the beverage; a copy of a current inspection report indicating the manufacturer is approved for a license or permit by the regulatory authority of the state or country of origin and that application for a license or permit has been made and issuance of a license or permit is pending; or other documentation acceptable by the Department of Health may be provided when a license or permit is not yet available.

If a license or permit is not required by the regulatory authority of the state or country of origin, the manufacturer shall provide the Department of Health a copy of a current inspection report indicating the manufacturer is in compliance with the standards of the regulatory authority. If no regulatory authority exists for the inspection of the manufacturer, the manufacturer shall provide either a copy of the most current inspection report from an independent third party acceptable to the Department of Health which indicates the manufacturer complies with the standards of the state or country of origin or a signed affidavit that the beverages were manufactured under sanitary conditions, are unadulterated and do not contain ingredients injurious to health.

(6) Bacteria, Yeast and Mold Standards. All product-contact surfaces of nonreturnable containers shall be exposed to an adequate clean water rinse. Each size and flavor of beverage shall be sampled at least annually.

The following bacteria, yeast and mold standards shall be used to determine the sanitary status of all containers and their contents:

(A) No carbonated beverages, including carbonated natural and mineral waters, shall be sold, offered for sale or held in possession for sale in the state which contains a total bacterial count above one hundred (100) bacteria per milliliter as determined by the pour plate method using plate count agar, incubated at thirty-two degrees Centigrade (32° C) for seventy-two (72) hours; or a most probable number of coliforms which exceeds a count of two (2) per one hundred (100) milliliters as determined by the multiple-tube ferrmentation test method or which indicates the presence of coliforms as determined by the membrane filter method; or the yeast or mold count or a combination of yeast and mold count which exceeds ten (10) per milliliter;

(B) No still beverage including nondairy fluid products used as a beverage, excluding bottled water, shall be sold, offered for sale or held in possession for sale in the state which contains a bacterial count in excess of one thousand (1,000) bacteria per milliliter; or a most probable number of coliforms which exceeds a count of two (2) per one hundred (100) milliliters as determined by the multiple-tube fermentation test method or which indicates the presence of coliforms as determined by the membrane filter method; or the yeast or mold count or a combination of yeast or mold count which exceeds ten (10) per milliliter;

(C) No still, flat or uncarbonated bottled water shall be sold, offered for sale or held in possession for sale in the state: which contains a total bacterial count above twenty thousand (20,000) bacteria per milliliter as determined by the pour plate method using R2A agar, incubated at twenty-eight degrees Centigrade (28° C) for five (5) days or which contains a most probable number of coliforms which exceeds a count of two (2) per one hundred (100) milliliters as determined by the multiple-tube fermentation test method or which indicates the presence of coliforms as determined by the membrane filter method, presence-absence coliform method, minimal medium ONPG-MUG (MMO- MUG) method or any other analytical method approved by the U.S. EPA for the determination of coliform in drinking water; or which indicates the presence of Pseudomonas aeruginosa; or which contains a yeast or mold count or a combination of yeast or mold count which exceeds ten (10) per milliliter; and (D) Total bacteria counts by the rinse method shall not exceed two hundred fifty (250) bacteria per bottle for sanitized empty bottles. Sanitized equipment or premix containers should not exceed an estimated count of one hundred (100) bacteria per swabbed area of eight (8) square inches.

(7) Chemical Quality Standards for Source Water for Bottled Water. Source water for bottled water shall meet standards of chemical quality as established by the United States FDA in 21 CFR 103.35 (1991) Standards of Quality for Bottled Water, except— (A) Samples for all chemical parameters shall be analyzed at least every three (3) years;

(B) The total dissolved solids limitation and other standards for which the U.S. EPA has not established a primary drinking water standard shall not apply to mineral water; and (C) The level of lead shall not exceed fifteen thousandths milligrams per liter (0.015 mg/l).

(8) Radiological Quality Standards for Source Water for Bottled Water. Source water for bottled water shall meet the standards of radiological quality as established by the United States FDA in 21 CFR 103.35 (1991)

Standards of Quality for Bottled Water.

Samples shall be analyzed at least every four (4) years. Instate sources of water may be exempted from these standards if they are located in areas unlikely to yield water excessive of the United States FDA standards.

Sources will be exempted on an individual

basis by the Department of Health after consultation with the Department of Natural Resources.

(9) Routine Sampling of Beverages Including Bottled Waters. Manufacturers or their distributors shall send samples for microbiological quality standards either to the Department of Health laboratory or to an approved laboratory, as described in paragraph (9)(C)3. of this rule, with results of required analyses recorded and routinely forwarded to the Department of Health. Samples of source water or finished water for bottled water for chemical and radiological quality standards shall be sent to an approved laboratory, as described in paragraph (9)(C)3. of this rule, with results of required analyses recorded and routinely forwarded to the Department of Health.

(A) Beverages shall be sampled at the minimum frequency and analyzed for the parameters described in sections (6)–(8) of this

rule.

(B) Samples for any parameter not specified in sections (6)–(8) of this rule shall be collected and analyzed as may be required by the Department of Health.

Source water samples for bulk water, bottled water or both shall be taken from each approved source;
Product samples shall be taken from a batch or segment of a continuous production run for each type of beverage produced in a day’s production. The representative sample shall consist of a primary container of the beverage;
All beverage manufacturers and source water suppliers for bulk water, water bottled or both within Missouri shall submit microbiological samples either to the Department of Health laboratory or to a laboratory meeting one (1) of the following criteria; and all chemical and radiological samples shall be sent to a laboratory meeting one (1) of the following criteria:

A. A laboratory certified by the Department of Health for analyses required for beverages, bulk water or source water;

B. A laboratory operated or approved the governmental regulatory agency having

EPA or other appropriate federal agency, provided the laboratory tests and procedures are acceptable to the Department of Health; and 4. If a laboratory other than a Department of Health laboratory is used, each manufacturer or distributor must submit proof of certification approval or acceptance by an appropriate governmental agency concerning the ability to perform the designated analyses. and 196.440, RSMo 1986.* This rule was previously filed as 13 CSR 50-74.010.

Original rule entitled Missouri Department of Health E 7.19 filed on Sept. 28, 1967, effective Nov. 27, 1967. Amended: Filed April 11, 1975, effective June 12, 1975. Amended:

Filed Nov. 26, 1980, effective April 11, 1981.

Amended: Filed Nov. 26, 1991, effective July 1, 1992. *Original authority: 192.005, RSMo 1985, amended 1993, 2011; 192.020, RSMo 1939, amended 1945, 1951, 2004; and 196.440, RSMo 1943.

History

authority for beverage regulation or drinking water regulation or both in that state, province or country, provided their laboratory tests and procedures are acceptable to the Department of Health; or C. A laboratory operated by or approved by the United States FDA, the U.S.

19 CSR 20-1.060 Licensing of Beverage Manufacturers and Distributors and the Collection of Inspection Fees {#sec-19-csr-20-1.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.060}

(Rescinded October 30, 2005)

This rule was previously filed as 13 CSR 50- 75.010. Original rule filed Nov. 1, 1961, effective Jan. 1, 1962. Amended: Filed June 2, 1982, effective Sept. 11, 1982. Rescinded:

Filed April 15, 2005, effective Oct. 30, 2005.

History

AUTHORITY: section 196.440, RSMo 1986.

19 CSR 20-1.070 Monitoring Animals for Presence of Diseases and Toxic Substances Emergency rule filed March 19, 1986, effective March 29, 1986, expired July 12, 1986. {#sec-19-csr-20-1.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.070}

19 CSR 20-1.100 Seafood Hazard Analysis and Critical Control Points (HACCP) {#sec-19-csr-20-1.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.100}

PURPOSE: This rule establishes standards to determine whether the facilities, methods, practices, and controls used to process fish and fishery products are safe and that those products have been processed under sanitary conditions.

al. The entire text of the rule is printed here.

(1) Applicability. The requirements of this

rule apply to buildings or facilities, or parts processing of fish and fishery products.

(2) Standards. Any person engaged in commercial, custom, or institutional processing of fish or fishery products shall operate in accordance with 21 CFR Part 123 Fish and Fishery Products, revised as of April 1, 2012, hereby incorporated by reference and made a part of this rule as published by the U.S. Government Printing Office, 732 North Capitol Street NW, Washington, DC 20401-0001, (202) 512- 1800, http://bookstore.gpo.gov. This rule does not incorporate any subsequent amendments or additions.

Supp. 2012.* Original rule filed March 11, 196.045, RSMo 1943, amended 1993, 1995.

19 CSR 20-1.200 Juice Hazard Analysis and Critical Control Points (HACCP) {#sec-19-csr-20-1.200 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.200}

PURPOSE: This rule establishes sanitation and Hazard Analysis and Critical Control Points (HACCP) standards for the processing of fruit and vegetable juices.

al. The entire text of the rule is printed here.

(1) Applicability. The requirements of this

rule apply to buildings or facilities, or parts processing of fruit and vegetable juices.

(2) Standards. Manufacturers of any juice sold as such or used as an ingredient in beverages shall operate in accordance with 21 CFR Part 120 Hazard Analysis and Critical Control Point (HACCP) Systems, revised as of April 1, 2012, hereby incorporated by reference and made a part of this rule as published by the U.S. Government Printing Office, 732 North Capitol Street NW, Washington, DC 20401-0001, (202) 512- 1800, http://bookstore.gpo.gov. This rule does not incorporate any subsequent amendments or additions.

History

AUTHORITY: sections 192.006, 196.045, and 196.050, RSMo 2000, and section 192.020, RSMo Supp. 2012. Original rule filed March 11, 2013, effective Sept. 30, 2013. Original authority: 192.006, RSMo 1993, amended 1995; 192.020, RSMo 1939, amended 1945, 1951, 2004; 1995; and 196.050, RSMo 1943.

Chapter 2 Protection of Drugs and Cosmetics

19 CSR 20-2.010 Inspection of the Manufacture and Sale of Drugs and Devices {#sec-19-csr-20-2.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-2.010}

19 CSR 20-2.020 Inspection of the Manufacture and Sale of Cosmetics HEALTH AND SENIOR SERVICES Public Health and Cosmetics {#sec-19-csr-20-2.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-2.020}

19 CSR 20-2.010 Inspection of the Manufacture and Sale of Drugs and Devices {#sec-19-csr-20-2.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-2.010}

(Rescinded October 30, 2005)

This rule previously filed as 13 CSR 50- 71.010. Original rule filed Nov. 17, 1949, effective Nov. 27, 1949. Rescinded: Filed April 15, 2005, effective Oct. 30, 2005.

History

AUTHORITY: section 196.045, RSMo 1986.

19 CSR 20-2.020 Inspection of the Manufacture and Sale of Cosmetics {#sec-19-csr-20-2.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-2.020}

(Rescinded October 30, 2020)

This rule previously filed as 13 CSR 50- 72.010. Original rule entitled Missouri Division of Health E 1.20 was filed on Nov. 17, 1949, effective Nov. 27, 1949. Rescinded:

Filed April 23, 2020, effective Oct. 30, 2020.

History

AUTHORITY: section 196.045, RSMo 1986.

19 CSR 20-2.030 The Return and Resale of Drugs and Medicines {#sec-19-csr-20-2.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-2.030}

(Rescinded October 30, 2005)

Filed April 15, 2005, effective Oct. 30, 2005.

History

AUTHORITY: sections 192.020 and 196.045, RSMo 1986. This rule previously filed as 13 CSR 50-73.010. Original rule filed Nov. 21, 1958, effective Jan. 20, 1959. Rescinded:

Chapter 3 General Sanitation

19 CSR 20-3.010 The Construction of Water Supply Wells {#sec-19-csr-20-3.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-3.010}

(Rescinded October 25, 1987)

Filed Sept. 1, 1981, effective Dec. 11, 1981.

Rescinded and readopted: Filed March 21, 1984, effective Sept. 14, 1984. Rescinded:

Filed July 30, 1987, effective Oct. 25, 1987.

History

Authority: sections 191.420 and 192.020, RSMo 1978. Original rule filed April 30, 1974, effective June 29, 1974. Amended:

19 CSR 20-3.015 The Operation of On-site Sewage Treatment and Disposal Systems {#sec-19-csr-20-3.015 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-3.015}

PURPOSE: This rule implements the provisions of sections 701.025–701.039, RSMo (1986) relating to the regulation of certain sewage disposal systems.

(1) The following definitions shall apply in the interpretation and the enforcement of this

rule:

(A) Aquifer means water-bearing formation (soil or rock horizon) that transmits water in sufficient quantities to supply a well;

(B) Department means the Missouri Department of Health;

(D) Domestic sewage means wastewater originating primarily from the sanitary conveniences of residences, commercial buildings, factories and institutions, including any wastewater that may have infiltrated the sewer;

(E) Engineer means an individual registered as a professional engineer in the state of Missouri;

(F) Hauled sewage means accumulated solids and liquids from septic and holding tanks, private aerobic treatment plants, dosing chambers, distribution boxes and various forms of toilets and privies;

(G) Human wastes means undigested food and byproducts of metabolism which are passed out of the human body;

(H) Innovative system means a sewage system of new design, construction and/or operation that could be utilized in place of a conventional system;

(I) Normal business hours means an eight (8)-hour interval beginning at 8:00 a.m. and ending at 5:00 p.m.;

(J) On-site sewage disposal system means any sewage handling or treatment facility receiving domestic sewage and retaining that sewage on the property(ies) upon which it was generated;

(K) On-site sewage disposal contractor means any person engaged in the business of maintaining, serving or cleaning on-site sewage disposal systems or the hauling or disposal of wastes removed from sewage disposal systems;

(L) Person means any individual, group of individuals, association, trust, partnership, corporation, person doing business under an assumed name, the state of Missouri or any department of the state of Missouri or any political subdivision of this state;

(M) Property owner means the person in whose name legal title to the real estate is recorded;

(N) Treatment facilities means any method, process or equipment which removes, reduces or renders less obnoxious water contaminants released from any source;

(O) Wastes means either human waste or domestic sewage, or both.

(2) The requirements of this rule pertain to on-site sewage disposal contractors and to any owner or operator of an on-site sewage disposal system with a daily flow of one thousand five hundred (1,500) gallons or less of domestic sewage where people live, work or assemble with the exception of lots of three (3) acres or more which are excluded if the entire on-site sewage disposal system is more than ten feet (10') from the property line and if no effluent enters an adjoining property or contaminates a water supply as determined by dye tracing.

(3) All on-site sewage disposal systems having a maximum daily flow of one thousand five hundred (1,500) gallons or less shall be operated in a manner that will not cause nuisances, health hazards or contamination of surface waters or groundwater. These operations shall comply with the following:

(A) On-site sewage disposal systems shall be designed and operated so that no effluent leaves the property of the owner. These systems must comply with 10 CSR 20-7.015 of the Missouri Clean Water Commission— 1. When a discharge does occur from any facility other than a single-family residence, a National Pollution Discharge Elimination System (NPDES) permit shall be secured to comply with 10 CSR 20-6.010 of the Missouri Clean Water Commission;

Subsurface discharges shall receive adequate soil treatment to prevent contamination of aquifers; and 3. On-site sewage disposal systems shall be operated so that the treated effluence does not pool on the surface creating insect-breeding habitat, odors or other nuisances; and (B) The owner or operator shall have all hauled sewage properly disposed of either by transporting the sludge to a municipal sewage treatment plant (STP) capable of receiving the sludge or by arranging for removal by a person or company in the business of cleaning septic tanks and properly disposing of the removed sewage.

(4) All on-site sewage disposal systems being repaired by construction replacement or parts replacement shall have such repairs designed and built in compliance with 10 CSR 20- 8.020 of the Missouri Clean Water Commission unless an innovative system proposed by an engineer is used. The trial or experimental use of an innovative system for on-site sewage disposal shall be allowed if approved by the department after consultation with the staff of the Missouri Clean Water Commission and shall be subject to conditions that the department may set.

(5) All on-site sewage disposal systems shall be operated in accordance with the manufacturer’s specifications, the design engineer’s operating and maintenance guide or a nationally recognized standard for the systems operation and maintenance recognized by the department.

(6) All owners and operators of on-site sewage disposal systems shall permit department staff and staff of the Missouri Department of Natural Resources to inject dyes or other tracers into their on-site sewage disposal systems during normal business hours for the purpose of tracing the discharge. All owners and operators shall cooperate in attempts to recover dyes injected into on-site sewage disposal systems by allowing samples of their drinking water to be collected for analysis.

(7) The department shall investigate any written or verbal complaint received concerning an on-site sewage disposal system. These investigations shall be made during the normal business hours and all results and findings shall be in writing. Copies of the report shall be filed with the owner, the complainant and the department. When a complaint is received within a political subdivision that maintains its own ordinances establishing standards to control on-site sewage disposal systems that are equal to or more stringent than those standards established in this rule, the complaint shall be transferred to the political subdivision. If a properly documented inspection and action report is received from the political subdivision within thirty (30) days, no additional action will be taken by the department. If the report is not received, the department shall proceed with the investiga- (8) When it is determined by the department that an emergency exists—conditions that constitute an immediate health hazard or threat of an immediate health hazard—which requires immediate action to protect the health and welfare of the public, the department shall seek a temporary restraining order and injunction. This action shall be taken upon the request of the director of the department by the prosecuting attorney of the county in which the violation occurred. When the conditions that caused the emergency are corrected and the health of the public is no longer threatened, the department shall request that the temporary restraining order or injunction be dissolved.

(9) All owners or operators of on-site sewage disposal systems who are found to be in violation of this rule or Chapter 701, RSMo (1986) shall be subject to a violation notice from the director. The written notice shall— (A) Include a statement of the reasons for the issuance of the notice;

(B) Allow reasonable time as determined by the director for the performance of any act it requires;

(C) Be served upon the owner, operator or contractor, as the case may require, provided that the notice or order shall be deemed to have been properly served upon the owner, operator or contractor when a copy of the notice or order has been sent by registered or certified mail to his/her last known address as furnished to the director, or when s/he has been served such notice by any other method authorized by the laws of this state; and (D) Contain an outline of remedial action which is required to effect compliance with sections 701.025–701.039, RSMo (1986) and this rule.

(10) The prosecuting attorney of the county in which any case of noncompliance or violation of sections 701.025–701.039, RSMo (1986) or of this rule occurs shall institute, upon request of the department, appropriate proceedings for correction of the noncompliance or violation involved.

(11) Action under sections 701.025–701.039, RSMo (1986) does not preempt any private rights of action which exist.

rule filed Nov. 25, 1986, effective Feb. 28, 1987. *Original authority: 192.005, RSMo 1985, amended 1993.

History

AUTHORITY: sections 192.005.2. and 701.025–701.039, RSMo 1986. Original

19 CSR 20-3.020 Sanitation of Public Bathing Places {#sec-19-csr-20-3.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-3.020}

PURPOSE: This rule provides public bathing places standards which will assure sanitary conditions and water quality that is satisfactory for bathing purposes.

(1) The following definitions shall apply in the interpretation and the enforcement of this

rule:

(A) Public bathing places shall include any place open to the public for swimming or recreative bathing whether or not a fee is charged for use and shall be classified as natural lakes, artificial lake impoundments, ponds, rivers, streams; outdoor pools which are partly artificial and partly natural in character; and pools outdoor or indoor which are entirely of artificial construction;

(B) Owner shall mean the state, county, city, town, village, corporation, firm, company, institution, person(s) owning, controlling or operating any public bathing place; and (C) Department of Health shall mean the Missouri Department of Health.

(2) Preliminary Report Required. Before detailed plans and specifications for new construction or improvements are prepared, the owner or his/her authorized agent shall submit to the Department of Health a preliminary report concerning the construction or improvements to be made, together with the preliminary plans and reports as have been made, whereupon the Department of Health will outline the requirements as regards further investigations, analytical data, information required and general design of proposed works, conformity with which will meet approval.

(3) Submission of Plans for New Public Bathing Facilities. Every owner or his/her authorized agent, before installing or entering into a contract for installing public bathing facilities, shall submit in duplicate to and receive the written approval of the Department of Health for complete plans and specifications fully describing the bathing places and thereafter the plans and specifications shall be substantially adhered to unless deviations are submitted to and receive the written approval of the Department of Health.

(4) Submission of Plans for Alteration to Public Bathing Places. Every owner or his/her authorized agent, before making or entering into contract for making alterations or changes in or additions to any existing public bathing place shall submit to and receive the written approval of the Department of Health for complete plans and specifications fully describing such alterations, changes or additions; and thereafter, plans and specifications must be substantially adhered to unless deviations are submitted to and receive the written approval of the Department of Health.

(5) Procedure for Submission of Plans. All reports, plans and specifications shall be submitted at least thirty (30) days prior to the date upon which action by the Department of Health is desired. The documents submitted for formal approval shall include: engineering report; general layout; detailed plans; specifications; summary of design data; and revisions to approved plans.

(A) The preliminary plans must be submitted with the engineer’s report for review prior to the preparation of detailed plans and specifications. No approval for construction can be issued until final, complete, detailed plans and specifications have been submitted to the Department of Health and found to be satisfactory. The Department of Health will issue the general requirements concerning submission of plans, necessary data and design criteria which will meet the approval of the Department of Health.

(6) Final Approval. Every owner before accepting or placing in operation new public bathing-place facilities, or additions to, or changes or alterations in any existing facility shall receive written final approval of the Department of Health stating that the completed work substantially adheres to the approved plans and specifications.

(7) Operation of Public Bathing Facilities. No public bathing place shall be provided or rendered available to the public for swimming or recreational purposes where water quality and other sanitation conditions which may affect the health of users are unsatisfactory and are not approved by the Department of Health. All public bathing facilities shall be maintained in an efficient operating condition in order to insure satisfactory functioning of the facilities. Every owner will be required to (4/30/09) ROBIN CARNAHAN operate the bathing facilities so as obtain the highest possible degree of efficiency at all times. A competent person, familiar with the principles and operation of the various bathing place equipment and facilities shall be in charge of each facility. Chemicals used in connection with sanitation shall be on hand at all times in sufficient quantity of high grade material to insure against ineffective operation due to delays in securing these materials. The owner shall make suitable analyses and maintain records of operation as required by the Department of Health and shall submit copies of these records upon request to the Department of Health.

(8) Water. The water in the public bathing place and that supplied to it shall at all times have a sanitary quality satisfactory to the Department of Health. The Department of Health will establish the standards of quality as are deemed necessary.

(9) If, after investigation, the Department of Health finds that any public bathing place is in any way a menace to health on account of defective design, inadequacy, incompetent supervision or inefficient operation, or if the water quality is unsatisfactory for bathing purposes, alterations and additions in the design or the construction of the equipment, or such changes in the operation of the facilities as are necessary to produce satisfactory results, shall be made in accordance with recommendations of, and within the time limits set by the Department of Health. Failure to properly maintain a public bathing place in a sanitary condition shall be sufficient reason to close it as a public health menace.

Original authority: 192.020, RSMo 1939, amended 1945, 1951.

History

AUTHORITY: section 192.020, RSMo 1986. This rule previously filed as 13 CSR 50- 82.010. Original rule filed Dec. 21, 1955, effective Dec. 31, 1955.

19 CSR 20-3.030 Sanitation of Preparation Rooms in Funeral Establishments {#sec-19-csr-20-3.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-3.030}

(Rescinded August 27, 1987)

Filed June 2, 1987, effective Aug. 27, 1987.

History

AUTHORITY: sections 192.005.2 and 333.131, RSMo 1969. Original rule filed Oct. 28, 1965, effective Nov. 7, 1965. Rescinded:

19 CSR 20-3.040 Environmental Health Standards for the Control of Communicable Diseases {#sec-19-csr-20-3.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-3.040}

(Rescinded October 30, 2020)

This rule previously filed as 13 CSR 50- 83.010. Original rule filed May 12, 1949, effective May 22, 1949. Rescinded: Filed April 23, 2020, effective Oct. 30, 2020.

History

AUTHORITY: section 192.020, RSMo 1986.

19 CSR 20-3.050 Sanitation and Safety Standards for Lodging Establishments {#sec-19-csr-20-3.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-3.050}

PURPOSE: This rule establishes sanitation and safety standards pertaining to life safety, fire safety, electrical wiring, fuel-burning appliances, plumbing and swimming pools/spas for lodging establishments. more than the actual cost of reproduction.

rial. The entire text of the rule is printed (1) General.

(A) Definitions.

“Administrative authority” shall mean local or state health department representative or local codes administrator/fire marshal, state fire marshal or his/her representative.
“Air break” shall mean a piping arrangement in which a drain from a fixture, appliance or device discharges indirectly into another fixture, receptacle or interception at a point below the flood level rim. The connection does not provide an unobstructed vertical distance and is not solidly connected but precludes the possibility of backflow to a potable water source.
“Air gap” shall mean the unobstructed vertical distance through the free atmosphere between the lowest opening from any pipe or outlet supplying fixture, or other device, and the flood level rim of the receptacle. The vertical physical separation shall be at least two (2) times the inside diameter of the water inlet pipe above the flood rim level but shall not be less than one inch (1").
“Approved” shall mean acceptable to the administrative authority having jurisdic- 5. “Bed and breakfast” shall mean an existing building(s) with no more than three (3) occupiable stories, with at least five (5) but no more than ten (10) guest rooms. The building shall have interior corridors and be provided with a kitchen; breakfast shall be provided to guests and the owner must live in or adjacent to the building.
“Dead-end corridor” shall mean a corridor, aisle or passageway arranged without an exit access in two (2) directions.
“Equivalent code” shall mean any code that is accepted by state regulatory authorities and the industry that contains the same definition or standard as the code referenced in this rule, including but not limited to, fire alarm systems, wireless smoke detectors and supervised sprinkler systems.
“Existing lodging establishment” shall mean a building, component or feature that is operating as a licensed lodging establishment or has a current inspection conducted by or for the Missouri Department of Health and Senior Services (DHSS) and is in the process of obtaining a lodging license as of the effective date of this rule.
“Exit” shall mean the portion of a means of egress that is separated from all other spaces of the building or structure by construction or equipment required to provide a protected way of travel to the exit discharge. Exits include exterior exit doors, exit passageways, horizontal exits, separated exit stairs and separated exit ramps.
“Exit access” shall mean the portion of a means of egress that leads to an exit.
“Exit discharge” shall mean the portion of a means of egress between the termination of an exit and a public way.
“Fire alarm system” is as described in the National Fire Protection Association 72, National Fire Alarm Code 2002 Edition, which is incorporated by reference in this

rule or equivalent code. Any interested person may view this material at the agency’s headquarters or may purchase a copy from the National Fire Protection Association, 11 Tracy Drive, Avon, MA 02322. This rule does not incorporate any subsequent amendments or additions.

“Fire barrier” shall mean a structural element, either vertical or horizontal, such as a wall or floor assembly, that is designed and constructed with a specified fire resistance rating to limit the spread of fire and restrict the movement of smoke. Such barriers may have protected openings.
“Fire resistance rating” shall mean the length of time, in minutes or hours, that materials or structural elements can withstand fire exposure.
“Flame resistant material” shall mean the property of material or its structural elements that prevents or retards the passage of excessive heat, hot gases or flames under conditions in which they are used.
“Furnace” shall mean a heating device with forced air ductwork.
“Group of buildings” as referenced in the lodging establishment definition, shall mean any building, structure, facility, place, bed and breakfast, or places of business, including but not limited to, multiple, individual or multi-unit cabins and guest rooms that are not attached to the main building but receive the same services/amenities as those guest rooms within the main building.
“Guest room” shall mean any room or unit where sleeping accommodations are regularly furnished to the public.
“Hardwired” shall mean wired directly and permanently into the building’s main electrical wiring system and/or a wireless system as described in the National Fire Protection Association 72, National Fire Alarm Code 2002 Edition or equivalent code.
“Hazardous areas” shall mean areas of structures or buildings posing a degree of hazard greater than normal to the general occupancy of a building or structure, such as areas used for the storage or use of combustibles or flammable, toxic, noxious or corrosive materials, or heat-producing appliances.
“Historic building” shall mean a building that is listed individually in the National Register of Historic Places or is located in a registered historic district and certified by the Secretary of the Interior as contributing to the historic significance of the district.
“Lodging establishment” shall include any building, group of buildings, structure, facility, place, or places of business where five (5) or more guest rooms are provided, which is owned, maintained, or operated by any person and which is kept, used, maintained, advertised or held out to the public for hire which can be construed to be a hotel, motel, motor hotel, apartment hotel, tourist court, resort, cabins, tourist home, bunkhouse, dormitory, or other similar place by whatever name called, and includes all such accommodations operated for hire as lodging establishments for either transient guests, permanent guests, or for both transient and permanent guests. This definition shall not apply to dormitories and other living or sleeping facilities owned or maintained by public or private schools, colleges, universities, or churches unless made available to the general public and not used exclusively for students and faculty, school-sponsored events, baseball camps, conferences, dance camps, equitation camps, football camps, learned professional society meetings, music camps, retreats, seminars, soccer camps, swimming camps, track camps, youth leadership conferences, or church-sponsored events.
“Major renovation” shall mean a physical change to a lodging establishment or portion thereof, including the replacement or upgrading of major systems, which extends the useful life. Examples include, but are not limited to, demolition of the interior or exterior of a building or portion thereof, including the removal and subsequent replacement of electrical, plumbing, heating, ventilating and air conditioning systems, fixed equipment and interior walls and partitions (whether fixed or moveable). Replacement of broken, dated or worn equipment/items, including but not limited to, individual air conditioning units, bathroom tile, shower stalls that do not require any additional or new plumbing, electrical, etc. shall not be considered a major renovation.
“Means of egress” shall mean a continuous and unobstructed way of travel from any point in a building or structure to a public way. A means of egress consists of three (3) distinct parts, the exit access, the exit and the exit discharge.
“New lodging establishment” shall mean a building, component or feature that begins operation as a lodging establishment after the effective date of this rule or an existing lodging establishment that has ceased operation for a time period of eighteen (18) months or more and reopens as a lodging establishment after the effective date of this 26. “Occupiable story” shall mean a story available to guests.
“Potable water” shall mean water which is safe for human consumption in that it is free from impurities in amounts sufficient to cause disease or harmful physiological effects and, for the purpose of this rule, must be approved by the Department of Natural Resources (DNR) or the DHSS prior to serving to the general public.
“Potentially hazardous food” shall mean those foods that are referenced in 19 CSR 20-1.025 Sanitation of Food Establishments.
“Prepackaged” shall mean bottled, canned, cartoned, securely bagged or securely wrapped, whether packaged in a food establishment or a food processing plant. It does not include a wrapper, carryout box or other nondurable container used to containerize food with the purpose of facilitating food protection during service and receipt of the food by the consumer.
“Primary means of egress” shall consist of, but is not limited to, an enclosed interior stair, an exterior stair, horizontal exit, door, stairway, or ramp providing a means of unobstructed travel without traversing any corridor or space exposed to an unprotected vertical opening. The primary means of escape shall lead outside of the dwelling unit at street or ground level.

Stairways serving as part of the primary means of egress shall be enclosed with fire barriers (vertical), such as wall or partition assemblies with a fire resistance rating of not less than thirty (30) minutes. Such enclosures shall be continuous from floor to floor.

Openings shall be protected as appropriate for the fire resistance rating of the barrier.

“Private water supply” shall mean a piped water supply having less than fifteen (15) service connections or serving less than twenty-five (25) people at least sixty (60) days out of the year.
“Public water supply” shall mean a piped water supply having fifteen (15) or more service connections or serving twentyfive (25) or more people at least sixty (60) days out of the year. It may be a community water system, transient noncommunity water system or nontransient noncommunity water system.
“Public way” shall mean an area such as a street or sidewalk that is open to the outside and is used by the public for moving from one (1) location to another.
“Remote exit or means of egress” shall mean when two (2) exits or two (2) exit access doors are required.
“Secondary means of egress” shall consist of, but is not limited to, a door, outside window, stairway, passage, fire escape or hall providing a way of unobstructed travel to the outside of the dwelling at street or ground level; a passage through an adjacent nonlockable space to any approved means of escape; an outside window or door operable from the inside without the use of tools, keys, or special effort and providing a clear opening of not less than twenty inches (20") in width, twenty-four inches (24") in height, and 5.7 square feet in area. The bottom of the opening shall not be more than forty-four inches (44") above the floor. Such means of escape shall be acceptable if the window is within twenty feet (20') of grade or opens onto an exterior balcony and is directly accessible to fire department rescue apparatus as approved by the local fire inspector or State Fire Marshal’s office.
“Self-closing” shall mean to be equipped with an approved device that will ensure closing after having been opened.
“Sleeping room” shall mean the part of the guest room where people sleep.
“Smoke proof enclosure” shall mean a stair enclosure designed to limit the movement of combustion products, produced by a fire occurring in any part of the building, into such enclosure.
“Spa” shall mean a pool designed for recreational and/or therapeutic use and not drained, cleaned and refilled for each individual. It may include, but is not limited to, hydrojet circulation, hot water, cold water, mineral baths, air induction systems or any combination thereof.
“Story” shall mean the portion of a building located between the upper surface of a floor and the upper surface of the floor or roof next above.
“Supervised sprinkler system” is as described in the National Fire Protection Association 13, Standard for the Installation of Sprinkler Systems 2002 Edition and the National Fire Protection Association 13R, Standard for the Installation of Sprinkler Systems in Residential Occupancies up to and Including Four Stories in Height 2002 Edition, which are incorporated by reference in this rule or equivalent code. Any interested person may view this material at the agency’s headquarters or may purchase a copy from the National Fire Protection Association, 11 Tracy Drive, Avon, MA 02322. This rule does not incorporate any subsequent amendments or additions.
“Wet location” shall mean a location subject to saturation with water or other liquids, including but not limited to, bathtubs, sinks and/or shower stalls.

(2) Requirements for Obtaining a Lodging License (Existing, New and Renovated).

Lodging establishments shall be responsible for providing any and all documentation related to inspections and evaluations required in this rule, including but not limited to, fire extinguishers, fire alarm systems, sprinkler systems and smoke detectors.

(A) Existing lodging establishments shall:

Comply with Missouri laws and the DHSS rules and regulations regarding lodging establishments;
Comply with Missouri laws and the DNR rules and regulations regarding, but not limited to, sewage treatment, drinking water and backflow;
Comply with Missouri laws and the Department of Public Safety (DPS) rules and regulations regarding pressure vessels;
Be operated and maintained in compliance with any and all applicable ordinances and regulations; and 5. If listed as a historical building, the owner must notify the DHSS. Upon notification, the DHSS will collaborate with the DNR, State Historical Preservation Office, to determine requirements for licensing.

(B) New lodging establishments shall:

Comply with Missouri laws and the DHSS rules and regulations regarding lodging establishments;
Comply with Missouri laws and the DNR rules and regulations regarding, but not limited to, sewage treatment, drinking water and backflow;
Comply with Missouri laws and the DPS rules and regulations regarding pressure vessels;
If built within a jurisdiction with applicable local ordinance(s), be erected, operated and maintained in compliance with those ordinances and regulations, or if not built within a jurisdiction with applicable local ordinance(s), be erected, operated and maintained in accordance with the 2002 Edition of a national code(s) regarding life safety, structural, electrical, plumbing, mechanical and architectural elements of the establishment, unless otherwise specifically stated in this rule;
If listed as a historical building, the owner must notify the DHSS. Upon notification, the DHSS will collaborate with the DNR, State Historical Preservation Office, to determine requirements for licensing; and 6. Present an occupancy permit issued by the regulating authority, or if not located within a jurisdiction that issues occupancy permits, certify to the DHSS that the establishment has been designed and erected in accordance with the 2002 Edition of a national code(s) regarding life safety, structural, electrical, plumbing, mechanical and architectural elements of the establishment.

Certification to these facts will be accepted by a professional engineer, architect or the general contractor responsible for the construction of the establishment being licensed.

Present an occupancy permit issued by the regulating authority, or if not located within a jurisdiction that issues occupancy permits, certify to the DHSS that the addition has been designed and erected in accordance with the 2002 Edition of a national code(s) regarding life safety, structural, electrical, plumbing, mechanical and architectural elements of the establishment. Certification to these facts will be accepted by a professional engineer, architect or the general contractor responsible for the construction of the establishment being licensed.

(3) Requirements for Operating a Lodging Establishment.

(A) Drinking Water Supply. Water supplies that serve lodging establishments shall provide safe drinking water. Bacteriological, chemical and radiological contaminants shall be within levels acceptable to the administrative authority. Supplies deemed unsafe by the DHSS or DNR shall not be used as a potable water supply.

Treatment equipment for community, noncommunity public and private water supplies.

A. New or existing treatment equipment necessary to provide a safe drinking water supply shall be installed, maintained and operated according to manufacturer’s specifications and the DHSS requirements as defined in (3)(A)1.–7. or the DNR requirements.

B. Existing chlorinators and chlorinators required to be installed to provide safe drinking water, after the effective date of this

rule, shall be a positive feed liquid chlorinator with thirty (30)-minute retention time based on pump capacity and must maintain a residual no less than 0.5 and no greater than four (4) parts per million (ppm) free available chlorine.

C. Equipment, approved by the administrative authority, shall be available to test the treatment system.

Community and noncommunity public water supplies:

A. Shall be in compliance with Missouri laws and the DNR rules and regula- B. Noncommunity water supplies shall have a valid DNR permit to dispense water. A current copy of the DNR permit to dispense water must be available for review by the administrative authority.

Private water supplies:

A. Shall be regulated under the jurisdiction of the DHSS and constructed and located according to 10 CSR 23-3.010–10 CSR 23-3.110 Missouri Well Construction Code with the following aboveground construction components verified by inspection:

(I) Well casing shall extend a minimum of twelve inches (12") above grade; and (II) The top of the well casing shall be free of openings that may allow the entry of contaminants;

B. Potentially influenced by surface water or shallow groundwater (i.e. springs, bored and dug wells) shall be equipped with a treatment system that includes:

(I) Microfiltration using a filter with a one (1) micron absolute or smaller pore size; and (II) A chlorinator as defined in (3)(A)1.B.

Routine testing for transient noncommunity public and private water supplies.

A. Transient noncommunity public water and private water supplies shall be in compliance with all applicable testing mandated by the DHSS or DNR.

(I) During each inspection, but no less than annually, a bacteriological water sample shall be collected by the administrative authority and analyzed for the presence of coliform bacteria; and (II) A nitrate sample shall be collected when deemed necessary by the administrative authority and at least annually when a chlorinator is present. Wells exceeding nitrate levels of ten (10) ppm shall not be used for drinking water; a permanent alternative water supply must be provided.

B. Water supplies with chlorinators installed, after the effective date of this rule, (I) Have a nitrate analysis conducted prior to installing a chlorinator;

(II) Provide two (2) consecutive bacteriological sampling results, collected by the administrative authority a minimum of five (5) days apart, that are absent for total coliform and/or E. coli; and (III) Provide monthly bacteriological sampling results for twelve (12) months.

(a) If results are satisfactory for twelve (12) consecutive months, the administrative authority shall determine future sampling frequencies.

(b) If bacteriological sampling results continue to indicate the presence of total coliform, the well may be deemed unsafe by the DHSS.

(c) If two (2) water samples collected by the administrative authority within a twelve (12)-month period separated by at least thirty (30) days are E. coli positive, the well shall be deemed unsafe by the DHSS, unless immediate corrective actions can be taken to provide safe drinking water. These corrective actions must be approved by the DHSS.

C. Private water supplies not meeting satisfactory bacteriological water results shall be placed under a Boil Water Order or Boil Water Notice/Advisory. Private water supplies not meeting satisfactory chemical or radiological water results shall be placed under a Limit Use Order.

During a Boil Water Order (including precautionary Boil Water Notice/Advisories) or a Limit Use Order issued on a public and/or private water supply, the operator shall comply with the following intermediate process(es) until permanent corrections have been made to the water supply:

A. Notify guests, verbally and again by written notice prominently placed in each rented guest room, that the plumbed water is not potable and only potable water should be used for drinking and/or brushing of teeth.

Additional restrictions for water use may be required by the DHSS;

B. Discard ice that may have been made from or exposed to contaminated water; and C. Obtain a temporary, alternate supply of potable water using one of the following practices:

(I) Individual containers of commercially bottled water shall be placed in each rented guest room and additional bottled water shall be available upon request by guests;

(II) Bulk water containers acceptable to the DHSS and which are filled from a source acceptable to the DHSS or DNR may be used. Such water shall be treated with an appropriate concentration of residual disinfectant to effectively counteract potential contamination that may be introduced between the filling of the container(s) and the dispensing of the water. This water shall be transported and handled in a safe and sanitary manner, which prevents contamination; or (III) Other methods approved by the DHSS or DNR.

D. Community and noncommunity public water supplies shall comply with all mandated requirements issued by the DNR, local water district or utilities.

For a Boil Water Order to be lifted on private water supplies, the operator shall comply with one (1) of the following permanent corrections:

A. Provide a chlorinator and comply with (3)(A)1.B. and (3)(A)4.B.(II);

B. Provide an alternate connection to an adjacent plumbing source of water acceptable to the DHSS and/or DNR, which is protected from contamination and capable of supplying a sufficient quantity of water; or C. Other permanent disinfection process(es) or permanent corrective measure(s) as authorized by the DHSS.

For a Limit Use Order to be lifted for public and/or private water supplies, the operator shall comply with one (1) of the following permanent corrections:

A. Provide an alternate connection to an adjacent plumbing source of water acceptable to the DHSS and/or DNR, which is protected from contamination and capable of supplying a sufficient quantity of water; or B. Other permanent corrective measures that provide a safe water supply, as approved by the DHSS.

(B) Wastewater Handling. Sewage and Wastewater Treatment and Disposal Systems.

On-site sewage treatment and disposal systems which generate three thousand (3,000) gallons or less of wastewater per day and are maintained in a subsurface treatment and disposal system shall be regulated by the DHSS.

A. Any on-site wastewater treatment system installed after January 1, 1996 shall be constructed according to 19 CSR 20-3.060 Minimum Construction Standards for On- Site Sewage Disposal Systems or applicable local ordinance.

B. On-site wastewater treatment systems shall be operated and maintained to preclude surfacing or discharging effluent, production of odors or the creation of a habitat for insect breeding, contamination of surface water or groundwater or creation of a nuisance or health hazard.

C. Malfunctioning systems shall be renovated according to 19 CSR 20-3.060 Minimum Construction Standards for On- Site Sewage Disposal Systems or applicable local ordinance.

Wastewater treatment and disposal systems which generate more than three thousand (3,000) gallons of wastewater per day or are connected into waste stabilization ponds, or other alternative systems which discharge shall be regulated by the DNR.

A. Any wastewater treatment system installed after February 2002 shall have a National Pollutant Discharge Elimination System (NPDES) Permit, a General Permit or Exemption Letter issued by the DNR.

B. Wastewater treatment systems shall be operated and maintained to preclude the production of odors or creation of a habitat for insect breeding, growth of tall weeds or trees on or in a lagoon or its berm, or creation of a nuisance or health hazard.

(C) Sanitation/Housekeeping. Lodging establishments shall be kept in a clean and sanitary condition, in good repair, and shall be maintained and operated with strict regard to the health and safety of the patrons. The following items shall be held in compliance:

Walls, floors and ceilings of guest rooms shall be kept clean and in good repair.

Furnishings, including draperies, beds, appliances, furniture and lamps, shall be kept clean and in good repair;

Clean and proper housekeeping shall be employed in guest rooms and related facilities;

A. A room in use shall be cleaned at least each time a different guest rents the room. If the same guest continuously occupies a room, the room shall be cleaned at least weekly.

B. Clean towels and washcloths shall be provided in the guest room each day that guest room is occupied by a different guest.

C. Clean bed linens shall be provided in the guest room each day that guest room is occupied by a different guest. If the same guest continuously occupies a room, bed linens shall be changed at least weekly.

Bedspreads shall be clean and maintained in good repair.

D. Mattresses and boxsprings shall be clean and in good repair. The sleeping surfaces of a mattress in use shall be completely covered by a sheet. Excessively damaged or soiled mattresses and/or boxsprings shall be replaced.

E. Single-service drinking glasses and/or utensils, if provided in guest rooms, shall be prepackaged.

F. Insects, rodents, and other pests shall be controlled to minimize their presence on the premises by routinely inspecting the premises for evidence of pests, eliminating harborage conditions and using methods, if pests are found, such as trapping devices or other means of pest control. If rodenticides and/or pesticides are used and/or stored on the premises, they shall be stored away from areas containing food and not accessible to guests.

G. Ice provided for guests and patrons’ use shall be from a commercial source or made from a potable water supply approved by the DHSS or DNR. The ice shall be protected from contamination, which shall include the following:

(I) Ice machines, dispensers or chests shall be sheltered from the weather, kept in good repair and the ice compartment shall be kept clean and free of mold, rust, debris, foreign objects or other contaminants.

Existing establishments operating before February 2002 may continue to use existing chest type ice machines and dispensers. All establishments that replace or add a new selfservice ice machine for guest use shall only provide dispensing type self-service ice machines;

(II) Ice machines and ice trays within guest refrigerators shall be kept clean and sanitary. Ice shall be removed from the ice bin and ice trays each time a different guest rents the room;

(III) An approved scoop with a handle that is seamless and without cracks shall be provided for each bin-type ice machine or chest. The scoop may be stored in a holster in the ice compartment, in a smooth nonabsorbent holder outside the ice machine or chest, or in another manner acceptable to the administrative authority; and (IV) Individual ice buckets or containers, if provided, shall be kept clean, in good repair, and constructed of a smooth, non-absorbent, food-grade material.

(a) If a food-grade single service liner is provided, the individual ice buckets/containers shall be washed, rinsed and sanitized as needed. Reuse of the food-grade single service liner is forbidden.

(b) If a food-grade single service liner is not provided, the individual ice buckets/containers shall be washed, rinsed and sanitized at least each time a different guest rents the room.

H. Ice buckets/containers and reusable glasses and utensils, if provided, shall not be located within the room housing the toilet unless approved by the administrative authority.

I. Ice buckets/containers, reusable glasses and utensils, if provided, shall be washed, rinsed and sanitized using one (1) of the following practices. Exception: Guest rooms provided with kitchenettes— (I) A sink with at least three (3) compartments shall be provided for manually washing, rinsing, and sanitizing the reusable items. Sink compartments shall be large enough to accommodate immersion of the largest piece of equipment and utensil;

(II) A mechanical dishwasher that meets the requirements for washing, rinsing and sanitizing as outlined in 19 CSR 20- 1.025 Sanitation of Food Establishments; or (III) Other methods approved by the administrative authority.

J. The guest rooms, buildings and premises shall be kept neat and free of refuse and debris.

(I) Garbage and refuse shall be stored in a covered durable, leak-proof and vermin-proof non-absorbent container. If there is evidence of vermin or a creation of a nuisance or health hazard, outdoor trash containers shall be stored on a smooth, hard surface such as concrete or machine-laid asphalt that is sloped to drain, or other methods approved by the administrative authority.

(II) Garbage and refuse shall be disposed of on a routine basis.

(III) Plant growth or other items in close proximity to the lodging establishment and its attendant facilities shall be maintained so as not to create a nuisance through harborage (cover) for pests such as rodents, vermin, reptiles and other small animals.

(IV) Items creating harborage for insects or vermin, or creating a health or safety hazard, shall be removed;

Lodging establishments that store, prepare, package, serve, vend or otherwise provide food(s), other than prepackaged nonpotentially hazardous food, for human consumption directly or indirectly to a consumer, where consumption is on or off the premises and regardless of whether there is a charge for the food, shall be considered a food establishment and shall be regulated according to

19 CSR 20-1.025 Sanitation of Food Establishments or applicable local ordinance; {#sec-19-csr-20-1.025 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-1.025}

Lodging establishments that offer only commercially prepared, individuallyportioned prepackaged foods that are nonpotentially hazardous and/or whole-uncut fresh fruits and vegetables and/or only prepare coffee for guest use shall not be considered a food establishment, and shall comply with the following requirements:

A. Food shall be of sound condition, free from spoilage, filth or other contamination and shall be safe for human consumption;

B. Condiments served shall be provided in individual packages;

C. Single service articles shall be stored, handled and dispensed in a manner that prevents contamination of surfaces, which may come into contact with food or with the mouth of the user;

D. Food serving areas and food contact surfaces shall be smooth, free of breaks, open seams, cracks, chips and similar imperfections;

E. Food shall be stored and presented in such a way as to be protected from crosscontamination; and F. Employees shall observe good hygienic practices during all working periods of food service. Employees shall wash their hands prior to beginning work, during work, and as often as necessary to keep them clean, and after using the toilet, smoking, eating and drinking; and 5. Coffeemakers and coffeepots used by the lodging establishment for preparing coffee to the guests or provided in guest rooms, shall not be located within the room housing the toilet unless approved by the administrative authority and shall be washed, rinsed and sanitized using one (1) of the following methods and/or equipment:

A. A sink with at least three (3) compartments shall be provided for manually washing, rinsing, and sanitizing the coffeemakers and coffeepots. Sink compartments shall be large enough to accommodate immersion of the largest piece of equipment and utensil;

B. A mechanical dishwasher that meets the requirements for washing, rinsing and sanitizing as outlined in 19 CSR 20- 1.025 Sanitation of Food Establishments;

C. A clean-in-place method shall be designed so that cleaning and sanitizing solutions circulate throughout the fixed system and contact all interior food contact surfaces; the system shall be self-draining or capable of being completely drained of cleaning and sanitizing solutions, and the cleaning and sanitizing solutions used are intended for food contact surfaces; or D. Other methods approved by the administrative authority.

(D) Life Safety. The lodging establishment shall be constructed, operated and maintained with strict regard to health and safety.

Operation and maintenance requirements are as follows:

A. Combustibles, whether solid, liquid or gaseous, shall be properly used and stored so that they do not present a hazard to health or life safety;

B. Toxic, corrosive, oxidizing or other hazardous materials shall be properly used, stored, and disposed of in such a manner that they do not present a hazard to health or life safety;

C. All guards placed on the sides of open face stairs shall be attached to the stair in a sturdy manner and maintained in good repair. All railings for balconies shall be attached to the balcony in a sturdy manner and maintained in good repair;

D. There shall be no storage on stairs or landings;

E. Stairways, walks, ramps and porches shall be kept free of ice and snow;

F. If the administrative authority suspects that defects are present with regard to the integrity of the structure or electrical system of the lodging establishment, that authority may require the owner to retain the services of a professional engineer to certify the lodging establishment for building safety;

G. Buildings must be adequately maintained to assure safe and sanitary condi- H. All repairs, additions and maintenance must be conducted in a manner that produces safe and sanitary conditions; and I. Facilities using fuel-fired equipment or appliances that pose a potential carbon monoxide risk, including facilities with attached parking garages or wood burning fireplaces, shall install a carbon monoxide detector(s). Carbon monoxide detectors shall be installed according to manufacturer’s specifications and should not be placed within five feet (5') of gas-fueled appliances or near cooking or bathing areas. Exception: carbon monoxide detectors installed prior to the effective date of this rule.

(I) Carbon monoxide detectors shall not be required to be installed in the attached parking garage area.

(II) Carbon monoxide detectors shall be required in rooms adjoining or sharing a common ventilation system with the attached parking garage.

(III) Carbon monoxide detectors shall be in good working condition. If the battery-operated detector is routinely not operational, the owner shall install a detector that is hardwired with battery backup.

(IV) By September 2010, all carbon monoxide detectors shall be hardwired with battery backup. All additional carbon monoxide detectors shall be maintained and in good working condition.

(V) Carbon monoxide detectors shall be tested at least monthly or as needed to ensure they are operating properly and batteries shall be changed as needed.

Electrical. Installation and maintenance of electrical components shall be in compliance with local codes when applicable.

In the absence of local codes, the following requirements shall be met:

A. New lodging establishments having electrical outlets installed within five feet (5') of wet locations or outdoors are required to be fitted with ground-fault circuit interrupters. Existing lodging establishments undergoing a major renovation or rewiring shall be required to install ground-fault circuit interrupters in electrical outlets located within five feet (5') of wet locations or outdoors;

B. Electrical switches, outlets and junction boxes must be covered and properly protected from physical damage at all times;

C. All appliances must be grounded to design specifications;

D. Wire splices shall be located in covered junction boxes at all times;

E. Bare or frayed wiring is prohibited;

F. Three (3)-prong receptacles must be properly grounded at all times.

Nongrounded three (3)-prong receptacles in existing lodging establishments shall be replaced with two (2)-prong receptacles or properly grounded;

G. Public hallways, stairways, landings, and foyers shall be sufficiently illuminated at all times to prevent tripping or other injuries to persons;

H. Exit signs shall be provided when guest room doors open to an interior corridor and where guest room doors open to the outside but not directly at grade level;

I. Exit signs shall be maintained in a clean and legible condition and shall be illuminated at all times that the building is occupied. For new construction, supplemental directions signs, when necessary, shall be installed indicating the direction and way of egress;

J. All emergency lighting shall be maintained in good working condition.

(I) Emergency lighting shall be provided when guest room doors open to an interior corridor and where guest room doors open to the outside but not directly at grade level;

K. Temporary wiring and flexible cords shall not be used in place of fixed wiring.

(I) Use of extension cords longer than six feet (6') shall be prohibited unless provided with over-current protection or rated with properly sized wire. No more than two (2) extension cords per room may be used;

L. Wattage of light bulbs shall not exceed the wattage rating of corresponding light fixtures;

M. Empty light sockets are prohibited;

N. Circuit boxes shall be protected from physical damage and maintained in good condition. Storage of items that obstruct the vision of or access to circuit boxes is prohibited; and O. Access to electrical panels shall be unobstructed; fuses and circuits must be labeled for identification.

(E) Fire Safety.

Operation and maintenance requirements for existing and new lodging establishments.

A. All facilities shall comply with all local building codes, fire codes and ordinances.

B. Housekeeping practices that ensure fire safety shall be maintained daily.

C. No fresh-cut Christmas trees shall be used unless they are treated with a flame resistant material. Documentation of the treatment shall be on file at the facility.

D. No door in any means of egress shall be locked against egress when the building is occupied.

(I) Delayed egress locks shall be permitted in buildings provided with a fire alarm system and/or an approved supervised automatic sprinkler system. No more than one (1) such device may be located in any one (1) egress path, and the door lock must unlock upon loss of power to the building, upon actuation of the fire alarm system, or upon actuation of the approved supervised automatic sprinkler system in the building.

E. Every bathroom door shall be designed to allow opening from the outside during an emergency when locked.

F. Doors serving a single dwelling unit shall be permitted to be provided with a lock, however, a key operation shall be allowed, providing that the key cannot be removed when the door is locked from the side from which egress is made.

G. Textile materials having a napped, tufted, looped, woven, nonwoven or similar surface shall not be applied to walls or ceilings unless they are treated with a flame resistant material. Documentation of the treatment shall be on file at the facility.

H. Foam plastic materials or other highly flammable or toxic material shall not be used as an interior wall, ceiling or floor finish unless approved by the administrative I. Hangings or draperies shall not be placed over exit doors or located to conceal or obscure any exit.

J. Mirrors shall not be placed on exit doors or adjacent to any exit that may confuse the direction of exit.

K. Portable fire extinguishers (5 pound, 2A-10BC) shall be required for the protection of all guests and located in the hallways, mechanical room(s), laundry area(s) and all other hazardous areas.

(I) The maximum travel distance to a fire extinguisher from a guest room door that opens into an interior corridor or a guest room door that opens to the outside but not directly at grade level shall be no greater than seventy-five feet (75') and accessible to the guest.

(II) All fire extinguishers shall be maintained in a fully charged and operable condition and inspected annually by a fire extinguisher company, fire department representative or other entity approved by the administrative authority.

(III) Fire extinguishers having a gross weight not exceeding forty (40) pounds shall be installed so that the top of the extinguisher is not more than five feet (5') above the floor. Extinguishers having a gross weight more than forty (40) pounds shall be installed so that the top of the extinguisher is not more than three and one-half feet (3 1/2') above the floor. In no case shall the clearance between the bottom of the extinguisher and the floor be less then four inches (4").

L. There shall be no louvers or other air passages penetrating the wall except properly installed heating and utility installations.

M. Guest room doors shall be provided with room latches or other mechanisms suitable for keeping the doors closed.

N. Guest room doors shall be selfclosing or provided with a closing device that closes the door automatically upon detection of smoke. Door-closing devices shall not be required in buildings protected throughout by an approved, automatic sprinkler system or when the guest room door opens directly to the outside of the dwelling unit at or to grade level.

O. Smoke detectors shall be installed in all sleeping rooms, cooking areas/kitchens, hallways, laundry rooms, mechanical rooms, hazardous areas and where specifically stated within this rule. Heat sensing devices may be installed in cooking areas in lieu of a smoke detector(s).

(I) Smoke detectors and heat sensing devices shall be maintained in good operating condition.

(II) If a wireless system is used, the system shall be designed, installed and maintained in accordance with the National Fire Protection Association 72, National Fire Alarm Code 2002 Edition or equivalent code.

(III) Smoke detectors shall be tested at least monthly or as needed to ensure they are operating properly and batteries shall be changed as needed.

(IV) All hardwired-interconnected smoke detectors shall be tested and approved annually by a sprinkler company, fire alarm company, fire department representative or other entity approved by the administrative (V) The administrative authority may require the installation of additional smoke detectors at any time.

P. All fire alarm systems and sprinkler systems shall be tested and approved annually by a fire alarm company, sprinkler company, fire department representative or other entity approved by the administrative Q. Individual fire sprinklers plumbed into a potable water line over gas water heaters and/or furnaces shall not be required to be tested and approved annually unless required by local ordinance.

R. An evacuation route diagram reflecting the actual floor or exterior doors that lead outside of the dwelling unit at street or ground level arrangement, exit locations, and room identification shall be posted in a location and manner acceptable to the administrative authority in every guest room or immediately adjacent to every guest room door. Guest room doors leading directly to the outside of the dwelling unit at grade level are not required to post an evacuation route diagram.

S. A copy of an emergency evacuation plan and employee instruction guide shall be kept on file that is accessible by all staff. All staff shall be able to demonstrate knowledge of the emergency evacuation plan.

T. Fire safety information shall be available so that guests may make an informed decision as to evacuate to the outside, evacuate to an area of refuge, remain in place, or employ any combination of the three (3) options.

Existing lodging establishments shall also meet the following requirements:

A. All facilities that use stairs as a component in the means of egress shall comply with the following:

(I) All open face stairs shall have guards placed on the sides. Guards shall be placed so that a four inch (4") diameter sphere cannot pass through them;

(II) Handrails for stairs shall not be less than thirty-four inches (34") and not more than thirty-eight inches (38") above the surface of the tread, measured vertically to the top of the rail from the leading edge of the tread;

(III) Railings for balconies shall not be less than forty-two inches (42") in height.

Guards shall be placed so that a four inch (4") diameter sphere shall not pass through them; and (IV) Existing handrails, railings and guards for stairs may continue to be used subject to approval of the administrative B. All facilities that use ramps as a component in the means of egress shall comply with the following:

(I) Ramps shall have a minimum width of forty-four inches (44") in all facilities;

(II) Ramps shall have a slip resistant surface;

(III) Ramps that are greater than six inches (6") in height shall have handrails and guards placed on each side. The handrails and guards shall comply with the stair requirements in (3)(E)2.A.(I)–(IV); and (IV) Existing ramps may continue to be used subject to approval of the administrative authority;

C. Floors that separate stories in a building shall be maintained as a smoke barrier to provide a basic degree of compartmentation;

D. Openings through floors, such as hoistways for elevators, shaftways used for light, ventilation or building services; or expansion joints and seismic joints used to allow structural movements shall be enclosed with fire barriers (vertical), such as wall or partition assemblies whose fire resistance rating is not less than thirty (30) minutes. Such enclosures shall be continuous from floor to floor. Openings shall be protected as appropriate for the fire resistance rating of the barrier;

E. Service openings such as laundry chutes, dumbwaiters and inclined and vertical conveyors shall be provided with closing devices and must be kept closed when not in active use. Outlet doors for trash or laundry chutes shall open only to a separate room designed exclusively for that purpose. This room shall be provided with a one (1)-hour fire rated door that is self-closing. Existing installations may continue to be used upon approval of the administrative authority.

(I) Service openings provided with closing devices shall be self-closing, with a positive-latching frame and door assembly of one (1)-hour fire rating.

(II) Vertical conveyors and chutes shall be separately enclosed by walls or partitions. Service openings shall not open to an exit. Existing installations may continue to be used upon approval of the administrative F. All guest rooms shall have a means of egress to the outside of the building at or to grade level;

G. Egress routes that have been approved prior to February 2002 shall not be altered without prior approval by the administrative authority;

H. Dead-end corridors or hallways shall not exceed fifty feet (50');

I. No door or path of travel in a means of escape shall be less than twentyeight inches (28") wide. Bathroom doors shall not be less than twenty-four inches (24") wide;

J. All guest rooms opening into an interior corridor(s) shall be separated by walls and twenty (20)-minute fire protection-rated doors, forty-four millimeters (44 mm) (one and three-fourths inch (1 3/4")) solid-bonded wood-core doors, steel-clad (tin-clad) wood doors, solid-core steel doors with positive latch and closer, or as approved by the administrative authority;

K. Existing transoms shall be permitted but must be permanently fixed in the closed position;

L. Smoke detectors and heat sensing devices should be installed on the ceiling, preferably in the center, but no less than four inches (4") from the wall of the sleeping area or on a sleeping room wall between four and twelve inches (4"–12") from the ceiling or as otherwise approved by the administrative M. If a battery-operated detector is routinely not operational, the owner shall install a detector that is hardwired with a battery backup;

N. By September 2010, all smoke detectors and heat sensing devices shall be hardwired with battery backup; and O. Existing fire alarm systems and sprinkler systems shall be maintained in good working order.

New lodging establishments shall meet these additional requirements. In addition to the required certification that the establishment has been designed and erected in accordance with the 2002 Edition of a national code(s), the DHSS has outlined minimum requirements for the maintenance of fire safety components and the installation of smoke detectors, fire alarm systems, sprinkler systems, and fire extinguishment to provide adequate life safety protection to ensure the safety of the occupants.

A. Lodging establishments meeting the definition of a bed and breakfast may have two (2) secondary means of egress that are independent and remote from one another in lieu of a primary means of egress.

B. Smoke detectors and/or heat sensing devices shall be installed on the ceiling, preferably in the center, but no less than four inches (4") from the wall of the sleeping area or on a sleeping room wall between four and twelve inches (4"–12") from the ceiling.

(I) All smoke detectors and/or heat sensing devices shall be hardwired with battery backup.

C. A fire alarm system shall be installed and maintained in accordance with the National Fire Protection Association 72, National Fire Alarm Code 2002 Edition or equivalent code and maintained in good working order. Exception 1: Single story buildings with guest room doors that open directly to the outside at grade level.

Exception 2: Buildings with no more than three (3) occupiable stories and with no more than four (4) guest rooms per building with guest room doors that lead directly outside at or to grade level.

(I) When a fire alarm system is required, all smoke detectors and/or heat sensing devices shall be interconnected, except those located in sleeping rooms.

D. All buildings shall be protected throughout by an approved, supervised automatic sprinkler system in accordance with the National Fire Protection Association 13, Standard for the Installation of Sprinkler Systems 2002 Edition or the National Fire Protection Association 13R Standard for the Installation of Sprinkler Systems in Residential Occupancies up to and Including Four Stories in Height 2002 Edition or equivalent code.

(I) Bed and breakfasts and buildings with no more than three (3) occupiable stories, where all guest rooms have a door that opens directly to the outside at or to grade level or to an exterior exit access are not required to be protected throughout by an approved, supervised automatic sprinkler system.

(F) Swimming Pools/Spas. Design, maintenance and operation of swimming pools, spas, and other bathing facilities shall be in accordance with the following requirements:

New swimming pools and swimming pools undergoing a major renovation, such as installing a diving board or slide, shall be designed by a professional engineer and certified by a professional engineer, architect or other qualified professional approved by the administrative authority. The design must comply with a national swimming pool code;
Requirements regarding the general safety of swimming pools are as follows:

A. Swimming pools shall be protected by a fence, wall, building or other enclosure that is at least four feet (4') in height.

The enclosure shall be made of a durable material. Artificial barriers shall be constructed so as to afford no external handholds, footholds, or opening large enough to pass a four inch (4") diameter sphere through. Existing installations may continue to be used upon approval of the administrative authority;

B. Gates shall be equipped with a self-closing and positive self-latching closure mechanism. The latch shall be installed as high as possible, but no greater than four feet (4'), to preclude access of a toddler;

C. Doors leading into an indoor pool area shall be installed with self-closing and positive self-latching closure mechanism(s).

The closure mechanism shall be installed as high as possible, but no lower than four feet (4') in height. Other means of precluding the access of a toddler into the indoor pool area must be approved by the administrative D. All natural barriers, hedges, swimming pool covers, or other protective devices must be approved by the administrative E. Depth of water shall be plainly marked with four inch (4")-high numbers, of a contrasting color to the pool background color, at or above the water surface on the vertical pool wall and on the edge of the deck, at maximum and minimum points of break between the deep and shallow portions, and at intermediate increments of depth, spaced at not more than twenty-five feet (25') intervals measured peripherally.

(I) Markings shall be on both sides and ends of the swimming pool.

(II) Where depth markings cannot be placed on the vertical walls above the water level, other means shall be used so that the markings will be plainly visible to persons in the swimming pool;

F. Lifesaving equipment, consisting of both a throwable device and a reaching device, shall be provided for all swimming pools. Swimming pools over two thousand (2,000) square feet and up to four thousand (4,000) square feet of water surface area shall have two (2) throwable and reaching devices.

Approval by the administrative authority shall be required for swimming pools in excess of four thousand (4,000) square feet of water surface area.

(I) A throwable device shall be a U.S. Coast Guard approved device, fitted with a one-quarter inch (1/4")-diameter line with a length of 1.5 times the maximum width of the swimming pool or fifty feet (50'), whichever is less and a reaching device shall be a life pole or shepherd’s crook type of pole, having blunted ends with a minimum length of twelve feet (12') or as approved by the administrative authority. This equipment (a) Be mounted in conspicuous places, distributed around the pool deck;

(b) Be kept in good repair and ready condition; and (c) Be kept in an established location and shall be used only for its intended purpose;

G. Whenever the swimming pool area is less than two thousand (2,000) square feet of water surface area and is opened for use and no lifeguard service is provided, warning signs shall be placed in plain view of the entrances and inside the pool area which state “WARNING—NO LIFEGUARD ON DUTY” with plainly legible letters;

H. Swimming pools having two thousand (2,000) square feet of water surface area or greater shall have a certified lifeguard present at all times the pool is available for use.

In swimming pools with two thousand (2,000) square feet of water surface area or more, one (1) additional certified lifeguard shall be provided for each additional two thousand (2,000) square feet of water surface area;

I. A first aid kit must be readily available to lodging employees for pool use at all times. The first aid kit shall be stored in an easily accessible location (such as the front office);

J. No glass containers shall be used in the swimming pool area;

K. The swimming pool and pool deck shall be kept clean of sediment, floating debris, visible dirt and algae; free of cracks, peeling paint and tripping hazards. Pools shall be refinished when the pool surface cannot be maintained in a safe and sanitary condition;

L. Rooms that house a gaseous chlorine introduction system shall be located on the opposite side of the pool from the direction of the prevailing winds and must provide the following features:

(I) A respiratory protective device suitable to provide protection during exposure to chlorine gas. This device shall be housed in a convenient location outside the chlorine room, which is quickly and readily accessible;

(II) An airtight duct at a maximum of eight inches (8") above the floor that terminates at a safe point of discharge to the outside away from the pool deck;

(III) A ventilating fan, capable of one (1) air change per minute and operated from a switch located outside the chlorine room door in conjunction with the airtight duct;

(IV) A louvered air intake near the ceiling;

(V) Adequate lighting with the light switch located outside the chlorine room, adjacent to the chlorine room door; and (VI) A plastic bottle of ammonia for leak detection; automatic chlorine detectors are recommended;

M. Chlorine and chlorinating equipment shall be housed in a separate room.

This room shall have no openings to other interior openings; and N. Chlorine-feeding devices shall be designed to automatically terminate gas feed when the water supply flow is interrupted.

The release of chlorine gas shall be terminated when the recirculation pump is shut off;

Requirements regarding the water quality of swimming pools and spas are as follows:

A. Swimming pools and spas shall be designed and maintained to provide for continuous disinfection of the water with a chemical or process which is an effective disinfectant and which imparts an easily measurable, active residual;

B. The disinfecting materials and methods shall not be dangerous to public health, create objectionable physiological effects, or impart toxic properties to the water;

C. An easily adjustable, automatic disinfection feeder shall be provided for the continuous application of disinfectant to the pool and/or spa water. The concentration of disinfectant in the pool and/or spa water must be maintained at the following levels:

(I) When chlorine is the disinfectant, a free chlorine residual of at least one

part per million (1.0 ppm) shall be maintained throughout the pool. When bromine is the disinfectant, a minimum residual between three and five (3–5) ppm shall be maintained throughout the spa; and (II) Other disinfecting materials or methods are subject to approval of the administrative authority and may only be used when it has been demonstrated that they provide a satisfactory residual which is easily measured and operated according to the manufacturer’s specifications;

D. An appropriate test kit shall be provided and capable of properly measuring disinfectant and pH residual;

E. The pH of the swimming pool and spa water shall be maintained at a level between 7.2 and 7.8; and F. Swimming pool water shall have sufficient clarity that the main drain cover is readily visible at the deepest point of the pool when viewed from the side of the pool;

Requirements regarding the maintenance and operation of swimming pools and spas are as follows:

A. A boundary line between the shallow and deep water shall be marked at the point where the swimming pool slope begins, or at the five foot (5') depth, by a line of contrasting color on the floor and walls of the pool, and by a safety rope and floats equipped with float keepers;

B. Steps, ladders or stairs shall be provided at the shallow end (less than five feet (5') and steps or ladders shall be provided in the deep end (greater than five feet (5').

If the pool is over thirty feet (30') wide, such steps, ladders or stairs shall be installed on each side.

(I) Pool steps, ladders, and stairs shall be easily cleanable, corrosion-resistant and equipped with non-slip treads.

(II) All ladders shall be designed so as to provide a handhold. Where steps or ladders are provided, there shall be a handrail at the top of each side thereof extending over the coping of the edge of the deck. When stairs are provided, there shall be a handrail provided.

(III) Pool steps, ladders, stairs and handrails shall be maintained in good repair at all times;

C. Daily operating records shall be maintained and be available upon request.

The residual concentration of the disinfectant used in the pool and/or spa, pH, water temperature and the date and time the information was collected shall be recorded;

D. Indoor pool areas and chemical storage rooms shall be vented directly to the exterior or vented to a room that is vented directly to the exterior;

E. Any chemical applied in swimming pools and/or spas shall be used, handled, stored and labeled in accordance with the manufacturer’s specifications;

F. Main drain grates shall be whole and openings shall not be over one-half inch (1/2") wide. Main drain grates shall be in good repair, firmly affixed at all times and designed and maintained to prevent user entrapment;

G. All pool and spa equipment shall be kept clean and in good repair at all times;

H. Diving boards and slides shall be maintained in good repair at all times;

I. A cleaning system shall be provided to remove dirt from the bottom of the pool;

J. Surface skimmers, strainer baskets and perimeter overflow systems shall be kept clean and in good repair;

K. Water shall be maintained at the overflow level; and L. Discharged pool water shall conform to the DNR regulations;

Requirements regarding the lighting and electrical systems for swimming pools and spas are as follows:

A. Artificial lighting shall be provided at swimming pools used at night or which do not have adequate natural lighting so that all portions of the pool, including the bottom, are readily seen without glare;

B. All lighting shall be maintained in good repair at all times;

C. All receptacles on the property shall be located at least ten feet (10') from the inside walls of a pool. One (1) receptacle to provide power for a recirculating pump motor on permanently installed swimming pools shall be permitted not less than five feet (5') from the inside walls of the pool provided the receptacle is single, of the locking and grounding types and protected by a groundfault circuit interrupter;

D. All receptacles located within twenty feet (20') of the inside walls of a pool shall be protected by a ground-fault circuit interrupter;

E. Switching devices on the property shall be located at least five feet (5') from the inside walls of a pool unless separated from the pool by a solid fence, wall or other permanent barrier; and F. Swimming pool areas over which utility-owned, operated and maintained supply lines, service drops, electrical lines and communication lines (i.e., telephone, cable TV) pass shall be approved in writing by the utility company;

The recirculation system serving the swimming pool and/or spa shall operate continuously or in accordance with manufacturer’s specifications/recommendations or other engineering criteria;
Spas shall meet the additional following requirements: Exemption—a spa used under direct supervision of qualified medical personnel is excluded:

A. The maximum water depth shall be four feet (4') measured from the water line. The maximum depth of any seat or sitting bench shall be two feet (2') measured from the water line;

B. Water temperature controls shall be provided to prevent water temperatures from exceeding one hundred four degrees Fahrenheit (104°F). The controls shall be accessible only to the swimming pool operator;

C. Outlets shall be designed so that each pumping system prevents user entrap- D. The agitation system shall be separate from the water treatment recirculation system. The agitation system shall be connected to a timer; and E. A legible sign visible from the spa shall be provided. The sign shall contain wording to the effect of:

(I) Caution. Any person having an acute or chronic disease such that use of this spa might adversely affect their health should consult a physician before using this spa;

(II) Do not use the spa alone or without supervision;

(III) Do not use the spa longer than ten (10) minutes;

(IV) Children shall be accompanied by an adult; and (V) Additional precautionary information may be added as deemed necessary by the lodging establishment or manufacturer.

(G) Plumbing/Mechanical. Installation and maintenance of plumbing supply lines and equipment shall be in compliance with local codes when applicable. In the absence of local codes the following requirements shall be met:

General requirements are as follows:

A. Hot and cold running water shall be available at all times;

B. Restrooms shall be provided with adequate ventilation to prevent excessive condensation, mold or algae growth or odors.

New lodging establishments shall provide mechanical ventilation;

C. Adequate venting of the drainage system shall be provided and vents shall extend above the roof;

D. All fixtures shall be adequately and properly trapped;

E. Openings for the passage of plumbing shall be vermin proof; and F. No fitting, connection, device or method of installation shall obstruct or retard the flow of water, wastes, sewage or air in the drainage or venting system;

Certification of Inspection by the Missouri Division of Fire Safety shall be required for the following water heaters, boilers and pressure vessels. Evidence of inspection and approval shall be posted on the premises, as well as on file with the State Fire Marshal’s Office, Division of Fire Safety;

A. Water heaters with heat input greater than two hundred thousand British thermal units per hour (200,000 Btu/hr) or fifty-seven and six-tenths kilowatts (57.6 kW) if electric;

B. All boilers; and C. Hot water storage tanks greater than one hundred twenty (120) gallon capacity, and water temperatures exceeding two hundred ten degrees Fahrenheit (210°F), and heat input greater than two hundred thousand (200,000) Btu/hr or fifty-seven and six-tenths (57.6) kW if electric;

Water heaters and pressure vessels not required to be inspected and approved by the Missouri Division of Fire Safety:

A. Shall be rated for a minimum working pressure of one hundred twenty-five pounds per square inch (125 psi). The maximum pressure allowed shall be permanently marked on all water heating units and holding tanks; and B. A separate valve or switch shall be provided to shut the fuel supply off to water heating units;

Safety devices to prevent the excessive buildup of heat and/or pressure in the vessel must be provided on water heaters and other pressure vessels.

A. Temperature and pressure (T&P) relief valves are required on or adjacent to hot water holding tanks but cannot be separated from the tank by a check valve or shutoff valve.

B. Temperature and pressure (T&P) relief valves are required on water heaters and must be installed so that the sensing element extends into the tank and monitors the temperatures in the top six inches (6") of the tank.

(I) Relief valves shall bear imprints, plates or tags to indicate the specifications of the valve.

(II) Btu rating of the temperature component of the T&P relief valve must be equal to or greater than the input Btu of the vessel it serves.

(III) Pressure rating of the pressure component of the T&P relief valve must be equal to or less than the pressure rating of the vessel it serves.

C. Relief valve discharge pipes shall be made of rigid pipe approved for water distribution with a temperature rating of two hundred ten degrees Fahrenheit (210°F) or other materials approved by the manufacturer to be used for this purpose and— (I) Be the same diameter, or larger, as the relief valve outlet;

(II) Be installed so as to drain by gravity flow and shall have no more than one (1) elbow or be installed according to manufacturer’s specifications;

(III) Valves shall not be connected to the relief valve discharge pipe; and (IV) Shall not discharge so as to be a hazard or a potential cause of damage;

All backflow devices used must meet

10 CSR 60-11.010 Prevention of Backflow or local codes. Potable water supplies shall be protected from sources of potential contamination. {#sec-10-csr-60-11.010 omnilex-key=us-mo-regs-official--title-19--10 CSR 60-11.010}

A. The following shall be protected by reduced pressure principle backflow prevention assembly: boiler units, fire sprinkler systems with chemical additives, lawn sprinklers with facilities for injection of pesticides, herbicides or other chemicals and pumped or repressurized cooling or heating systems.

B. The following shall be protected by a double-check valve assembly: facility wide fire sprinklers not using chemical additives and lawn sprinklers without facilities for injection of pesticides, herbicides or other chemicals.

C. The following shall be protected by vacuum breakers: threaded faucets, flush valves and shower spray hoses. Commercial dishwashers and commercial laundry machines shall be protected by either a vacuum breaker or an air gap.

D. The following shall be protected by air gaps: relief valve discharge pipes from water heaters and water holding tanks, makeup waterlines for cooling towers, potable water inlets to all plumbing fixtures, water softeners, condensation waterlines and discharge lines from commercial laundry machines. Swimming pool feed lines shall be protected by either an air gap or doublecheck valve assembly.

E. The following shall be protected by air breaks: ice containers and ice machines.

F. Fire sprinklers plumbed into a potable water line over gas water heaters and/or furnaces shall not be required to install a backflow device unless required by local ordinance;

Liquid propane (LP) gas systems shall be tested for leaks on a yearly basis.

(H) Heating, Venting and Air Conditioning (HVAC) Equipment. Air conditioning, heating, ventilating ductwork and related equipment shall be installed using acceptable procedures in a safe manner and be in good operating condition.

Unvented fuel-fired heaters, fireplaces or other appliances and portable electrical space heaters shall be prohibited from use in all areas of the lodging establishment unless approved in writing by the manufacturer for commercial use.
Existing unvented fireplace installations may continue to be used, upon approval of the administrative authority, if the following conditions are met:

A. The appliance and installation meet the National Fire Protection Association 54 ANSI 223.1-2002, 2002 Edition National Fuel Gas Code requirements for residential use;

B. The local gas company conducts an inspection to assure the appliance and installation meet the National Fire Protection Association 54 ANSI 223.1-2002, 2002 Edition National Fuel Gas Code requirements for residential use;

C. A carbon monoxide detector is installed in accordance with (3)(D)1.I.(III)– (V); and D. The unvented fireplace is not the primary source of heat.

Gas and electric heating equipment shall be equipped with thermostatic controls.
Gas water heaters, gas furnaces and other gas appliances shall be properly vented to the outside, and the flue pipe shall be constructed of galvanized pipe or material recommended by the manufacturer. All galvanized pipe shall be secured by screws at every joint in the pipe.
Joints in gas supply pipes shall be located outside the furnace cabinet housing.
Gas shutoff valves shall be located next to all gas appliances, gas furnaces and gas water heaters.
Rooms containing gas water heaters and/or gas furnaces shall have an automatic sprinkler head installed off the domestic water system with a hardwired smoke detector located directly outside the room or shall be protected throughout by an approved, supervised automatic sprinkler system or designed in a manner to be fire resistant.

A. The sprinkler head should be rated for one hundred sixty-five degrees Fahrenheit (165°F) or appropriately rated for the specific location and installed according to manufacturer’s specifications or approved by the administrative authority. Existing installations may continue to be used upon approval of the administrative authority.

B. The sprinkler head should be installed in a manner so the water spray will encompass the gas water heater and/or furnace.

C. Pipes tying into the domestic water line shall be one-half inch (1/2") or threefourths inch (3/4") copper pipe or chlorinated polyvinyl chloride (CPVC) pipe. Existing installations may continue to be used upon approval of the administrative authority.

D. CPVC pipe must meet National Fire Protection Association 13 Standard for the Installation of Sprinkler Systems 2002 Edition and National Fire Protection Association 13R Standard for the Installation of Sprinkler Systems in Residential Occupancies up to and Including Four Stories in Height 2002 Edition.

E. A smoke detector is not required to be located directly outside the room if the door to the gas water heater and/or furnace room opens directly to the outside.

F. A smoke detector is not required to be located directly outside the room if another smoke detector is already located within ten feet (10') of the door.

G. A fire resistant room shall consist of walls and ceilings designed to be fire resistant for a minimum of one (1) hour, with a one (1)-hour fire rated door and doorjamb.

All openings into this room shall be designed with one (1)-hour fire rated materials.

If a gas furnace or gas water heater is located inside a garage, it shall be at least eighteen inches (18") above the finished floor and enclosed inside a fire resistant room.
Furnaces shall be equipped with an electrical fused switch to protect the unit from electrical overloading and to disconnect the electrical supply.
Furnace rooms and rooms containing gas water heaters or any other fuel-fired appliance shall be provided with vents or other approved means to supply adequate combustion air for the units.

A. Except as specified in (3)(H)10.D. below, there shall be two (2) combustion air vent openings in each room containing gas or fuel-fired appliances.

(I) One (1) shall be located at the lower level and the other at the upper level.

(II) One (1) combustion air vent opening shall be permitted if the vent opening extends directly to the outside of the structure. This opening shall be one (1) square inch per three thousand (3,000) Btu input of the total gas appliances located in the room.

B. The vent size openings for the combustion air shall be:

(I) Measured at one (1) square inch per one thousand (1,000) Btu input if the combustion air is drawn from inside the structure;

(II) Measured at one (1) square inch per four thousand (4,000) Btu input if the air is drawn from outside the structure.

C. Other means of venting furnace rooms and rooms containing gas water heaters or any other fuel-fired appliance may be subject to approval from the administrative

(I) The sum of the required volume shall be calculated for all the gas appliances located within the space.

(II) Rooms communicating directly with the space in which the appliances are installed through openings not furnished with doors, and through combustion air openings sized and located appropriately shall be considered a part of the required volume.

Gas appliances shall have a clearance around them of one inch (1") from the sides and back and six inches (6") from the front of the unit or be installed to manufacturer’s specifications.

rule was previously filed as 13 CSR 50- 66.010. Original rule filed as Missouri Division of Health E 9.01 on Sept. 4, 1957, effective Sept. 14, 1957. Rescinded and readopted: Filed June 28, 2001, effective Feb. 28, 2002. Rescinded and readopted: Filed May 2, 2005, effective Oct. 30, 2005. *Original authority 192.006, RSMo 1993, amended 1995, 315.005–315.065, please see Revised Statutes of Missouri and Revised Statutes of Missouri Supp. 2004.

History

authority; and D. Furnace rooms and/or rooms containing gas or fuel burning appliances having a volume of fifty (50) cubic feet per one thousand (1,000) Btu/hour shall not be required to have additional venting.
AUTHORITY: sections 192.006 and 315.005– 315.065, RSMo 2000 and Supp. 2004. This

19 CSR 20-3.060 Minimum Construction Standards for On-Site Sewage Disposal Systems {#sec-19-csr-20-3.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-3.060}

PURPOSE: This rule establishes minimum construction standards for on-site sewage disposal systems. In accordance with the authority granted in section 701.040, RSMo, this

rule establishes the minimum standards and criteria for the design, location, installation and repair of individual on-site sewage disposal systems to promote the public health and general welfare and to protect the surface and ground waters of the state.

Therefore, the material which is so incorporated is on file with the agency who filed this

(1) General.

(A) Definitions. Definitions as set forth in

Chapter 701, RSMo, On-Site Sewage Disposal Law shall apply to those terms when used in this rule unless the context clearly requires otherwise or as noted in this subsection. For the purposes of these standards, certain terms or words used here shall be interpreted as follows. The word shall is mandatory and the words should and may are permissive. All distances, unless otherwise specified, shall be measured horizontally:

Administrative authority—The governing body which may include, but is not limited to, county health departments, planning and zoning commissions, county building departments, county public works department, sewer districts, municipalities and the Missouri Department of Health which has, as authorized by statute, charter or other form of enabling authority, adopted these standards for individual on-site sewage disposal sys- 2. Aeration unit—Any sewage tank which utilizes the principle of oxidation in the decomposition of sewage by the introduction of air into the sewage;
Alluvium—Soil parent material which was transported and deposited in a running water setting;
Alternative—An individual sewage disposal system employing methods and devices as presented in section (6) of this

rule;

Approved—Considered acceptable by the administrative authority;
Baffle—A device installed in a septic tank for proper operation of the tank and to provide maximum retention of solids. This includes vented sanitary tees and submerged pipes in addition to those devices normally called baffles;
Bedrock—That layer of geologic material which is consolidated;
Bedroom—Any room within a dwelling that might reasonably be used as a sleeping room. The number of bedrooms in a residence as given by an appraiser will be used in determining volumes in the sizing of on-site sewage disposal systems;
Black water—Liquid-carried waste from a dwelling or other establishment, which contains organic wastes, including excreta or other body wastes, blood or other body fluids, and garbage;
Building sewer—That part of the drainage system which extends from the end of the building drain and conveys its discharge to an on-site sewage disposal system;
Capacity—The liquid volume of a sewage tank using inside dimensions below the outlet;
Color—The moist color of the soil based on the Munsell soil color system;
Distribution pipes—Perforated rigid pipes that are used to distribute sewage tank effluent in a soil treatment system;
Dosing chamber (or pump pit or wet well)—A tank or separate compartment following the sewage tank which serves as a reservoir for the dosing device;
Dosing device—A pump, siphon or other device that discharges sewage tank effluent from the dosing chamber to the soil treatment system;
Dwelling—Any building or place used or intended to be used by human occupants as a residential unit(s);
Effluent—The liquid discharge of a septic tank or other sewage treatment device;
Gravelless system—An absorption system recognized by the administrative

A. Large diameter, eight inch (8") and ten inch (10") corrugated, perforated plastic pipe, wrapped in a sheath of spunbonded filter wrap;

B. Chamber system; and C. Drip irrigation;

Gray water—Liquid waste, specifically excluding toilet, hazardous, culinary and oily wastes, from a dwelling or other establishment which is produced by bathing, laundry or discharges from floor drains;
Grease trap—A device designed and installed so as to separate and retain oils and fats from normal wastes while permitting normal sewage or wastes to discharge into the drainage system by gravity;
Ground absorption sewage treatment and disposal system—A system that utilizes the soil for the subsurface disposal of partially treated or treated sewage effluent. The following are examples:

A. Chamber system—A system that uses an open bottom structure which forms an underground chamber over the soil's infiltrative surface. The wastewater is discharged into the chamber through a central weir, trough or splash plate and is allowed to flow over the infiltrative surface in any direction;

B. Conventional soil absorption system—A system that distributes effluent by gravity flow from the septic or other treatment tank and applies effluent to the soil through the use of a seepage trench or bed;

C. Dosing soil absorption system—A system that distributes effluent by a pump or automatic siphon to elevate or distribute effluent to the soil through the use of a seepage trench or bed;

D. Drip soil absorption system—An experimental system that distributes effluent through drip lines in a grid pattern (also known as trickle irrigation); and E. Pressure distribution system—A soil absorption system that distributes effluent by a pump and smaller diameter distribution piping with small diameter perforations to distribute effluent;

Hazardous waste—Any waste or combination of wastes, as determined by the Hazardous Waste Commission by rules, which, because of its quantity, concentration, or physical, chemical or infectious characteristics, may cause or significantly contribute to an increase in mortality or an increase in serious irreversible, or incapacitating reversible, illness, or pose a present or potential threat to the health of humans or the environment;
High ground water—Zones of soil saturation which include: perched water tables, shallow regional groundwater tables or aquifers, or zones that are seasonally, periodically or permanently saturated;
High-water level—The highest known flood water elevation of any lake, stream, pond or flowage or the regional flood elevation established by a state or federal agency;
Holding tank—A watertight tank for temporary storage of sewage until it can be transported to a point of approved treatment and disposal;
Horizon—A layer of soil, approximately parallel to the surface, that has distinct characteristics relative to adjacent layers;
Individual sewage disposal system— A sewage disposal system, or part of a system, serving a dwelling(s) or other establishment(s), which utilizes subsurface soil treatment and disposal;
Intermittent sand filters—Intermittent sand filters are beds of granular materials twenty-four to thirty-six inches (24–36") thick underlain by graded gravel and collecting pipe. Waste water is applied intermittently to the surface of the bed through distribution pipes or troughs and the bed is underdrained to collect and discharge the final effluent. Uniform distribution is normally obtained by dosing so as to flood the entire surface of the bed. Filters may be designed to provide free access (open filters) or may be buried in the ground (buried filters or subsurface sand filters);
Matrix color—The dominant color of a soil material;
Mottling—Spots or splotches of color interspersed in the dominant (or matrix color) of a soil material. Mottles may be of a wide variety of colors;
Mound system—A system where the soil treatment area is built above the ground to overcome limits imposed by proximity to water table or bedrock or by rapidly or slowly permeable soils;
Non-ground absorption sewage disposal system—A facility for waste treatment designed not to discharge to the soil, land surface, or surface waters, including, but not limited to, incinerating toilets, mechanical toilets, composting toilets and recycling sys- 33. Other establishment—Any public or private structure other than a dwelling which generates sewage;
Pan—A soil horizon compacted, hard or very high in clay content. These horizons are usually very slowly permeable.

Common pans in Missouri are claypans and fragipans;

Perched water table—A saturated zone above and separated from the water table by a horizon which is unsaturated;
Percolation rate—The time rate of drop of a water surface in a test hole as specified in subsection (2)(C) of this rule and expressed in minutes per inch;
Permeability—The ease with which liquids and gases move within the soil or rock;
Plastic limit—A soil moisture content below which the soil may be manipulated for purposes of installing a soil treatment system and above which manipulation will cause compaction, puddling and smearing, as determined by the administrative authority.

This is not to be confused with plastic limit as used or defined in the Unified Soil Classification System;

Privy—An outhouse or structure used for receiving human excrement in a container or vault beneath the structure;
Registered geologist—A person who meets the requirements of Chapter 256, RSMo;
Restrictive horizon—A soil horizon that is capable of perching groundwater or sewage effluent and that is brittle and strongly compacted or strongly cemented with iron, aluminum, silica, organic matter or other compounds. Restrictive horizons may occur as fragipans, iron pans or organic pans and are recognized by their resistance in excavation or in use of a soil auger;
Rock fragments—The percentage by volume of rock fragments in a soil that are greater than two millimeters (2 mm) in diameter or retained on a No. 10 sieve which may include, but is not restricted to, chert, sandstone, shale, limestone or dolomite;
Sanitarian—A person registered either as a sanitarian or environmental health professional by the National Environmental Health Association or the Missouri Board of Certification for Environmental Health Professionals or employed as a sanitarian or environmental health professional by the administrative authority;
Seepage bed—An excavated area larger than three feet (3') in width which contains a bedding of aggregate and has more than one (1) distribution line;
Seepage trench—An area excavated one to three feet (1–3') in width which contains a bedding of aggregate and a single distribution line;
Septage—Those solids and liquids removed during periodic maintenance of a septic or aeration unit tank or those solids and liquids removed from a holding tank;
Septic tank—Any watertight, covered receptacle designed and constructed to receive the discharge of sewage from a building sewer, separate solids from liquid, digest organic matter, store liquids through a period of detention and allow the clarified liquids to discharge to a soil treatment system;
Setback—A separation distance measured horizontally;
Severe geological limitations—Sitespecific geologic conditions which are indicative of rapid recharge of an aquifer and likely groundwater contamination. Locations with significant groundwater contamination potential should be investigated by a registered geologist to determine if the site has severe geological limitations. Standardized criteria for determination of severe geological limitations are available in the form Assessment of Individual On-Site Waste Disposal Geological Limitations from the Department of Natural Resources, Division of Geology and Land Survey;
Sewage—Any water-carried domestic waste, exclusive of footings and roof drainage. Domestic waste includes, but is not limited to, liquid waste produced by bathing, laundry, culinary operations, liquid wastes from toilets and floor drains and specifically excludes animal waste and commercial process water. Also known as wastewater;
Sewage flow—Flow as determined by measurement of actual water use or, if actual measurements are unavailable, as estimated by the best available data provided by Table 2A in subsection (1)(E) of this rule;
Sewage tank—A watertight tank used in the treatment of sewage which includes, but is not limited to, septic tanks and aeration units;
Sewage tank effluent—That liquid which flows from a septic tank or aeration unit under normal operation;
Significant groundwater contamination potential—Any condition which would cause or indicate rapid recharge of an aquifer.

This includes, but is not limited to, the following conditions or parameters: a water sample from an on-site well which exceeds drinking water standards with respect to fecal coliform; a hydrologic connection is established between the on-site waste disposal system and any well; a disposal field to be placed in Class V soils or soils with a percolation rate less than ten minutes per inch (10 min./in.); a disposal field within one hundred feet (100') of the topographic drainage of a sinkhole; or a sewage tank with fifty feet (50') of the topographic drainage of a sinkhole;

Sinkhole—A land surface depression that is hydraulically connected with a subterranean passage developed by a solution or collapse into the underlying bedrock, or both;
Site—The area bounded by the dimensions required for the proper location of the soil treatment system;
Slope—The ratio of vertical rise or fall to horizontal distance;
Soil—The naturally occurring, unconsolidated mineral or organic material of the land surface developed from rock or other parent material and consisting of sand, silt and clay-sized particles and variable amount of organic materials;
Soil characteristics, limiting—Those soil characteristics which preclude the installation of a standard system, including, but not limited to, evidence of water table or bedrock closer than three feet (3') to the ground surface and percolation rates slower than one hundred twenty minutes per inch (120 min./in.);
Soil saturation—The condition that occurs when all the pores in a soil are filled with water;
Soil scientist—An individual who has a minimum of fifteen (15) semester credit hours of soils course work including a minimum of three (3) hours in the area of soil morphology and interpretations, and has a minimum of two (2) years of field experience;
Soil textural classification—Soil particle sizes or textures specified in this rule refer to the soil textural classification in the Soil Survey Manual Handbook No. 18, United States Department of Agriculture, 1993;
Soil treatment area—That area of trench or bed bottom which is in direct contact with the trench rock of the soil treatment system;
Soil treatment system—A system where sewage tank effluent is treated and disposed of below ground surface by filtration and percolation through the soil. It includes those systems commonly known as seepage bed, trench, drainfield, disposal field and includes mound and low pressure pipe sys- 65. Standard system—An individual sewage disposal system employing a building sewer, sewage tank and the soil treatment system commonly known as seepage bed or trenches, drainfield or leachfield;
Toilet waste—Fecal matter, urine, toilet paper and any water used for flushing;
Trench rock—Clean rock, washed creek gravel or similar insoluble, durable and decay-resistant material free from dust, sand, silt or clay. The size shall range from one inch to two and one-half inches (1"–2 1/2").

If limestone, dolomite or other crushed white rock is used, it shall be washed and be a minimum size of one and one-half inches (1 1/2");

Valve box—Any device which can stop sewage tank effluent from flowing to a portion of the soil treatment area. This includes, but is not limited to, caps or plugs on distribution or drop box outlets, divider boards, butterfly valves, gate valves or other mechanisms;
Very slowly permeable—Soils, bedrock and soil horizon or layer having a vertical permeability less than one inch (1") in twenty-four (24) hours;
Wastewater—same as sewage as defined in paragraph (1)(A)50. of this rule;
Wastewater stabilization pond—A sealed earthen basin which uses the natural unaided biological processes to stabilize wastewater (also known as a sewage lagoon);
Water table—The highest elevation in the soil or rock where all voids are filled with water, as evidenced by presence of water or soil mottling or other information. This includes perched water tables or perched zones of saturation; and 73. Watertight—Constructed so that no water can get in or out below the level of the outlet.

(B) Applicability. For this rule, on-site wastewater treatment and disposal system means all equipment and devices necessary for proper conduction, collection, storage, treatment and disposal of wastewater from a dwelling or other facility producing sewage of three thousand gallons (3000 gals.) or less per day. Included within the scope of this rule are building sewers, septic tanks, subsurface absorption systems, mound systems, intermittent sand filters, gravelless systems, aeration unit wastewater treatment systems and single family wastewater stabilization ponds. Commercial or industrial facilities and developers of subdivisions must first contact the Department of Natural Resources concerning compliance with the Missouri Clean Water Law and Regulations before applying for any approvals or permits under this rule.

The design, construction, operation and maintenance of sewage treatment and disposal systems, whether septic tank systems, privies or alternative systems, shall be the responsibility of the designer, owner, developer, installer or user of the system.
Actions of representatives of the administrative authority engaged in the evaluation and determination of measures required to effect compliance with the provisions of this rule shall in no way be taken as a guarantee or warranty that sewage treatment and disposal systems approved and permitted will function in a satisfactory manner for any given period of time. Due to the development of clogging mats, which adversely impact the life expectancy of normally functioning ground absorption sewage treatment and disposal systems and variables influencing system function which are beyond the scope of this rule, no guarantee or warranty is implied or given that a sewage treatment and disposal system will function in a satisfactory manner for any specific period of time.
Prior to the issuance of a permit to install or effect major repair of an on-site sewage disposal system as regulated by

Chapter 701, RSMo, plans and specifications shall be required for review. Approval by the administrative authority shall be required for— A. Plans for absorption field showing (I) Field locations with slope(s) indicated or with contour lines based on field measurement. If field areas are essentially flat or of uniform grade, spot elevations will be required for alternate systems;

(II) Field layout, length, spacing, connection, pipe sizes and cleanout details, invert elevations of flow distribution devices and laterals, valves and appurtenances;

(III) Trench plan and profile drawings and flow distribution device details;

(IV) Location and design of associated surface and ground water drainage sys- (V) Name, address and telephone number of the person(s) drafting the plans;

(VI) Any other information required by the administrative authority; and B. Alternative systems whether or not specifically described in this rule.

The entire sanitary sewage system shall be on property owned or controlled by the person owning or controlling the system.

Necessary easements shall be obtained permitting the use and unlimited access for inspection and maintenance of all portions of the system to which the owner and operator do not hold undisputed title. Easements shall remain valid as long as the system is required and shall be recorded with the county recorder of deeds.

(D) Minimum Set-Back Distances. All onsite wastewater treatment and disposal systems shall be located in accordance with the distances shown in Table 1.

(E) Sewage Flow Rates. Table 2A or 2B shall be used to determine the minimum design daily flow of sewage required in calculating the design volume of sanitary sewage systems to serve selected types of establishments. The minimum design volume of sewage from any establishment shall be one hundred gallons (100 gals.) per day. Design of sewage treatment and disposal systems for establishments not identified in this rule shall be determined using available flow data, water-using fixtures, occupancy or operation patterns and other measured data.

Volume determination. In determining the volume of sewage from single family dwellings, the minimum flow rate shall be one hundred twenty gallons (120 gals.) per day per bedroom. The minimum volume of sewage from each single family dwelling shall be two hundred forty gallons (240 gals.) per day. When the occupancy of a single family dwelling exceeds two (2) persons per bedroom, the volume of sewage shall be determined by the maximum occupancy at a rate of sixty gallons (60 gals.) per person per day.
Other establishments. For establishments or housing developments other than a single family residence, either Table 2A shall be used to estimate the sewage flow rate or actual measured flow rate for existing systems may be used. Values for estimated sewage flow for establishments having food service operations shall be increased by a factor of one and one-half (1.5) to compensate for the high organic strength. Grease traps shall be required at food service facilities, meat markets and other places of business where the accumulation of grease or oils can cause premature failure of a soil absorption system.

The following design criteria shall be met:

A. The grease trap shall conform to Plumbing & Drainage Institute Standard PDI- G101 or equivalent;

B. The grease trap shall be plumbed to receive all wastes associated with food handling and no toilet wastes;

C. The grease trap liquid capacity shall be sufficient to provide for at least five gallons (5 gals.) of storage per meal served per day, at least two-thirds (2/3) of the required septic tank liquid capacity, or a capacity as determined in accordance with LC = D × GL × ST × HR/2 × LF where LC = grease trap liquid capacity (gallons)

D = number of seats in dining area GL = gallons of wastewater per meal (1.5 single-service; 2.5 fullservice)

ST = storage capacity factor = 2.5 HR = number of hours open LF = loading factor (1.25 interstate highway = 1.0 other highways and recreational areas = 0.8 secondary roads);

D. Two (2) or more chambers must be provided, with total length-to-width ratio at least two to one (2:1). Chamber opening and outlet sanitary tee must extend down at least fifty percent (50%) of the liquid depth;

E. Access manholes, with a minimum diameter of twenty-four inches (24”), shall be provided over each chamber and sanitary tee.

The access manholes shall extend at least to finished grade and be designed and maintained to prevent surface water infiltration.

The manholes shall also have readily removable covers to facilitate inspection and grease removal; and F. Where it has been demonstrated that specially designed grease interceptors will provide improved performance, the grease trap liquid capacity may be reduced by up to fifty percent (50%).

Population to be served. Unless satisfactory justification can be given for using lower per-unit occupancies, the figures in Table 2B shall be used in determining the population for which to design the sewage works.
Reduction in sewage flow. Reductions in design sewage flow rates may be allowed by the administrative authority on a case-bycase basis depending upon water conservation plans. Sewage flow rates may be reduced up to forty percent (40%) for gray water systems where the toilet wastes are discharged to a holding tank and disposed of off-site or where waterless toilets are utilized.

(2) Site Evaluation.

(A) All proposed sites for on-site sewage treatment and disposal systems shall be evaluated for the following:

Either percolation tests or soil conditions, properties and permeability as determined by a soil morphology examination; a profile pit shall be required for all new installations in order to conduct soil morphology examination;
Slope;
The existence of lowlands, local surface depressions, rock outcrops and sinkholes;
All required setback distances as required in subsection (1)(D) of this rule;
Surface water flooding probability and depth to water table;
Location of easements and underground utilities;
Amount of available area for the installation of the system and an area for replacement;
Location of homesite or dwelling as well as management of surface runoff water from those buildings;
Any other cultural feature, such as roads, streets and the like in the surrounding areas which influences surface and subterrainal flow of water on or near the proposed site; and 10. Any significant groundwater contamination potential.

(B) Preliminary Soils Information. During a site evaluation reference may be made of county soil survey reports which are available from the United States Department of Agriculture (USDA) Natural Resources Conservation Service (NRCS) for a majority of the counties in Missouri. NRCS soil survey reports should not be used as sole final determination for a specific site, but only as a guide to which soils are expected in a given area.

Soil permeability and soil percolation are two (2) different soil features with no direct correlation.

Soil permeability is that quality that enables soil to transmit water or air. It can be measured quantitatively in terms of rate of flow of water through a unit cross section of saturated soil in unit time under specified temperature and hydraulic conditions.
Soil percolation rate is based on a standard method which includes a twentyfour (24)-hour presoak in a six to eight inch (6–8") diameter hole to the depth of the proposed absorption field. After the presoak, water is poured into the hole to a level of eight inches (8") above the bottom. The drop in water level is then measured at thirty (30)minute intervals until a stabilized rate is obtained. Results are recorded as minutes per inch (min./in.) for the water level to drop.

(D) Procedures for Percolation Tests and Profile Holes. Two (2) types of site evaluations are acceptable. Each type depends upon the technical expertise of the individual conducting the evaluations. When percolation tests are slower than sixty minutes per inch (60 min./in.), the design must be drafted and signed by a registered engineer unless site suitability and system sizing has been determined by soil evaluation in accordance with

section (7) of this rule. This would apply to all systems except for lagoons or other systems that do not use the soil for treatment.

When percolation tests are slower than one hundred and twenty minutes per inch (120 min./in.), on-site sewage disposal systems shall not be permitted, except for lagoons or other systems designed in accordance with sections (6) and (7) of this rule. The administrative authority will determine which method(s) is to be used. The types of site evaluations are described as follows:

Percolation tests only. This type of site evaluation is where site suitability and sizing of the soil absorption system is made by percolation tests and there is no other evaluation of soil characteristics. This type of site evaluation can be used only for siting and sizing standard systems in areas which are not classified as having significant groundwater contamination potential. When using this type of evaluation, only percolation rates between ten minutes and sixty minutes per inch (10–60 min./in.) will be acceptable.

Percolation tests shall be conducted by an engineer, sanitarian, registered geologist, soil scientist or a person who has been trained and certified by the Department of Health in accordance with section 701.040(2), RSMo.

These tests shall be performed in accordance with the following procedure:

A. A minimum of four (4) percolation test holes are required with three (3) of the holes around the periphery within the proposed soil absorption site and one (1) in the middle of the proposed soil absorption site;

B. Each test hole shall be six to eight inches (6–8") in diameter, have vertical side walls and be bored or dug to a depth of the bottom of the proposed soil absorption system;

C. The bottom and sides of the hole shall be carefully scratched to remove any smearing and to provide a natural soil surface into which water may penetrate. All loose material shall be removed from the bottom of the test hole and two inches (2") of one-fourth to three-fourths inch (1/4–3/4") washed gravel shall be added to protect the bottom from scouring;

D. The hole shall be carefully filled with clear water to a minimum of twelve inches (12") over the soil bottom of the test hole and maintained for no less than four (4) hours. The hole shall then be allowed to swell for at least twenty-four (24) hours. In sandy soils, the saturation and swelling procedure shall not be required and the test may proceed if one (1) filling of the hole has seeped away in less than ten (10) minutes;

E. In sandy soils, the water depth shall be adjusted to eight inches (8") over the soil bottom of the test hole. From a fixed reference point, the drop in water level shall be measured in inches to the nearest one-eighth inch (1/8") at approximately ten (10)-minute intervals. A measurement can also be made by determining the time it takes for the water level to drop one inch (1") from an eight-inch (8") reference point. If eight inches (8") of water seeps away in less than ten (10) minutes, a shorter interval between measurements shall be used but in no case shall the water depth exceed eight inches (8"). The test shall continue until three (3) consecutive percolation rate measurements vary by a range of no more than ten percent (10%);

F. In other soils, the water depth shall be adjusted to eight inches (8") over the soil at the bottom of the test hole. From a fixed reference point, the drop in water level shall be measured in inches to the nearest oneeighth inch (1/8") at approximately thirty (30)-minute intervals, refilling between measurements to maintain an eight-inch (8") starting head. The test shall continue until three (3) consecutive percolation rate measurements vary by a range of no more than ten percent (10%). The percolation rate can also be made by observing the time it takes the water level to drop one inch (1") from an eight-inch (8") reference point if a constant water depth of at least eight inches (8") has been maintained for at least four (4) hours prior to the measurement;

G. Percolation rate shall be calculated as follows:

(I) The time interval shall be divided by the drop in water level to obtain the percolation rate in minutes per inch;

(II) The slowest percolation rate of the four (4) tests shall be used to determine the final soil treatment system design. Where the slowest percolation rate varies by more than twenty minutes per inch (20 min./in.) from the other tests, a detailed soils morphology evaluation must be conducted to justify a design based upon the average percolation rate; and (III) For reporting the percolation rate, worksheets showing all calculations and measurements shall be submitted; and H. Depth to bedrock or other restrictive layer shall be determined in areas where it is known that bedrock may exist at depths less than ten feet (10'); and 2. Soil morphology. This evaluation shall be conducted by a soil scientist unless an engineer, registered geologist or sanitarian has had special training and field experience to determine the required soil characteristics.

This type of evaluation is recommended for sites that are classified as having significant groundwater contamination potential, severe geological limitations or severe limitations relating to restrictive layers. Section (7) of this rule contains criteria for this type of site evaluation. Since this type of soil analysis pertains to the factors that relate directly to permeability, no percolation test is required, however the administrative authority may retain the option of requiring percolation tests for additional information in determining site suitability.

(3) Building Sewers. Building sewers used to conduct wastewater from a building to an onsite wastewater treatment and disposal system shall be constructed of material meeting the minimum requirements of American Society for Testing and Materials (ASTM) Standards and listed by that agency for such use.

Suitable materials meeting ASTM standards include: Acrylonitrile, butadiene styrene (ABS), cast iron pipe, concrete pipe, copper or copper-alloy tubing, polyvinyl chloride (PVC) or vitrified clay pipe. Although listed by ASTM, asbestos cement pipe will not be accepted due to potential health hazards to installers. Building sewer specifications are as follows:

(A) Size. Building sewers shall not be less than four inches (4") in diameter;

(B) Slope. Building sewers shall be laid to the following minimum slope:

Four-inch (4") sewer—twelve inches (12") per one hundred feet (100'); and 2. Six-inch (6") sewer—eight inches (8") per one hundred feet (100');

(C) Cleanouts. A cleanout shall be provided at least every one hundred feet (100') and at every change in direction or slope if the change exceeds forty-five degrees (45°). A cleanout should be provided between house and tank; and (D) Connection to Sewage Tank. The pipe going into and out of the sewage tank shall be schedule 40 PVC or cast iron and shall extend a minimum of two feet (2') beyond the hole of excavation for the sewage tank.

(4) Sewage Tanks.

(A) General. All liquid waste and washwater with the following exceptions shall discharge into the sewage tank. Roof, garage, footing, surface water, drainage, cooling water discharges and hazardous wastes shall be excluded from the sewage tank. Backwash from water softeners and swimming pool filtration systems may be excluded from the sewage tank. In such event of excluding swimming pool filter backwash, the Department of Natural Resources shall be contacted for applicability of a discharge permit. All sewage tank effluent shall be discharged to a soil absorption system that is designed to retain the effluent upon the property from which it originated. All tanks regardless of material or method of construction shall— 1. Be watertight and designed and constructed to withstand all lateral earth pressures under saturated soil conditions with the tank empty;

Be designed and constructed to withstand a minimum of two feet (2') of saturated earth cover above the tank top; and 3. Not be subject to excessive corrosion or decay. Metal sewage tanks shall not be used unless specifically allowed by the administrative authority on a case-by-case

basis. The tank shall be thoroughly coated inside and out with a bituminous or other suitable coating. Any damage to the bituminous coating shall be repaired by recoating.

Additionally, plastic sanitary tees shall be used for the inlet and outlet for the sewage tank. The administrative authority shall use Table 3 regarding minimum gauge thickness for metal sewage tanks.

(B) Septic Tanks. Septic tanks, regardless of material or method of construction, shall conform to the following criteria:

The liquid depth of any septic tank or its compartment shall be not less than thirtysix inches (36"). A liquid depth greater than six and one-half feet (6 1/2') shall not be considered in determining tank capacity;
No tank or compartment shall have an inside horizontal dimension less than twentyfour inches (24");
Inlet and outlet connections of the tank shall be protected by baffles or sanitary tees as defined in paragraph (4)(B)6. of this

rule;

The space in the tank between the liquid surface and the top of the inlet and outlet baffles shall not be less than twenty percent (20%) of the total required capacity, except that in horizontal cylindrical tanks, this space shall be not less than fifteen percent (15%) of the total required liquid capacity;
Inlet and outlet baffles shall be constructed of acid-resistant concrete, acid-resistant fiberglass or plastic;
Sanitary tees shall be affixed to the inlet or outlet pipes with a permanent waterproof adhesive. Baffles shall be integrally cast with the tank, affixed with a permanent waterproof adhesive or with stainless steel connectors top and bottom;
The inlet baffle shall extend at least six inches (6") but no more than twenty percent (20%) of the total liquid depth below the liquid surface and at least one inch (1") above the crown of the inlet sewer;
The outlet baffle and the baffles between compartments shall extend below the liquid surface a distance equal to forty percent (40%) of the liquid depth, except that the penetration of the indicated baffles or sanitary tees for horizontal cylindrical tanks shall be thirty-five percent (35%) of the total liquid depth. They also shall extend above the liquid surface as required in paragraph (4)(B)4. of this rule. In no case shall they extend less than six inches (6") above the liquid surface;
There shall be at least one inch (1") between the underside of the top of the tank and the highest point of the inlet and outlet devices;
The inlet shall be not less than three inches (3") above the outlet;
The inlet and outlet shall be located opposite each other along the axis of maximum dimension. The horizontal distance between the nearest points of the inlet and outlet devices shall be at least four feet (4');
Sanitary tees shall be at least four inches (4") in diameter. Inlet baffles shall be no less than six inches (6") or no more than twelve inches (12") measured from the end of the inlet pipe to the nearest point on the baffle. Outlet baffles shall be six inches (6") measured from beginning of the outlet pipe to the nearest point on the baffle;
Access to the septic tank shall be as follows:

A. Manholes. Access shall be provided over both the inlet and outlet devices and to each tank compartment by means of either a removable cover or a manhole. Where the top of the tank is located more than eighteen inches (18") below the finished grade, manholes and inspection holes shall extend to approximately eight inches (8") below the finished grade. The extension can be made using riser of approved material and fitted with tight covers of heavy metal or concrete.

Proper attention must be given to the accident hazard involved when manholes are extended close to the ground surface. Manhole risers are not required when the top of the tank is within eighteen inches (18") of final grade.

All manhole openings must be provided with a substantial, fitted, water-tight cover of concrete, cast iron or other approved material.

All manhole covers which terminate below grade shall be covered with at least six inches (6") of earth. Manhole covers which terminate above grade shall have either an effective locking device or otherwise be adequately sealed in a manner to prevent accidental access; and B. A six-inch (6") inspection port shall be provided over the inlet and outlet baffles of each tank and terminate at or above grade. An inspection port shall not be used as a pumpout access. A manhole cover at or above grade may also serve in place of inspection ports;

Compartmentation of single tanks shall be in accordance with the following:

A. Septic tanks larger than fifteen hundred gallons (1500 gals.) and fabricated as a single unit shall be divided into two (2) or more compartments;

B. When a septic tank is divided into two (2) compartments, not less than one- half (1/2), nor more than two-thirds (2/3), of the total volume shall be in the first compart- C. When a septic tank is divided into three (3) or more compartments, one-half (1/2) of the total volume shall be in the first compartment and the other half equally divided in the other compartments;

D. Connections between compartments shall be baffled so as to obtain effective retention of scum and sludge. The submergence of the inlet and outlet baffles of each compartment shall be as specified in paragraphs (4)(B)7. and 8. of this rule;

E. Adequate venting shall be provided between compartments by baffles or by an opening of at least fifty (50) square inches near the top of the compartment wall; and F. Adequate access to each compartment shall be provided by one (1) or more manholes with a minimum opening twenty inches (20") square or in diameter and located within six feet (6') of all walls of the tank;

The use of multiple tanks shall conform with the following:

A. Where more than one (1) tank is used to obtain the required liquid volume, the tanks shall be connected in series;

B. Each tank shall comply with all other provisions of this section;

C. No more than three (3) tanks in series can be used to obtain the required liquid volume; and D. The first tank shall be no smaller than any subsequent tanks in series;

The liquid capacity of a septic tank serving a dwelling shall be based upon the number of bedrooms contemplated in the dwelling served and shall be at least as large as the capacities given in Table 4.

Table 4—Dwelling Septic Tank Capacity* Number ofMinimum Liquid BedroomsCapacity (gallons) 1–31000 41250 51500 *These figures provide for use of garbage grinders, automatic clothes washers and other household appliances. Garbage grinders are not recommended due to the introduction of fats and other high organic loads.

A. For six (6) or more bedrooms, the septic tank shall be sized on the basis similar to an establishment. See paragraph (4)(B)17. of this rule.

B. No tank shall be designed to retain less than two (2) days’, forty-eight (48) hours’ flow; and 17. Individual residences with more than five (5) bedrooms, multiple-family residences, individual septic tank systems serving two (2) or more residences or any place of business or public assembly where the design sewage flow is greater than one thousand gallons per day (1000 gpd), the liquid capacity of the septic tank shall be designed in accordance with the following:

V = 1.5Q + 500 where V = the liquid capacity of the sep tic tank and Q = the design daily sewage flow.

The minimum liquid capacity of a septic tank serving two (2) or more residences shall be fifteen hundred gallons (1500 gals.).

The sewage tank shall be placed so that it is accessible for the removal of liquids and accumulated solids;
The sewage tank shall be placed on firm and settled soil capable of bearing the weight of the tank and its contents; and 3. The sewage tanks shall be set back as specified in subsection (1)(D) of this rule.

(D) Solids Removal. The owner of any septic tank or his/her agent shall regularly inspect and arrange for the removal and sanitary disposal of septage from the tank whenever the top of the sludge layer is less than twelve inches (12") below the bottom of the outlet baffle or whenever the bottom of the scum layer is less than three inches (3") above the bottom of the outlet baffle. Yearly inspections of septic tanks are recommended and tanks shall be pumped whenever the bottom of the scum layer is within three inches (3") of the bottom of the outlet device or the sludge level is within eight inches (8") of the bottom of the outlet device.

(E) Aeration Units. An aeration unit wastewater treatment plant utilizes the principle of oxidation in the decomposition of sewage by the introduction of air into the sewage. An aeration unit may be used as the primary treatment unit instead of a septic tank except where special local conditions may limit their use. All aeration unit type treatment systems shall comply with the general requirements for sewage tanks set forth in subsection (4)(A) of this rule and with the 1. Limitations. Special conditions where aeration units should not be used may include, but not be limited to, the following:

A. Where intermittent use (interruptions allowing more than five (5) days without continuous flow) will adversely affect the functioning of the plant; and B. Where local ordinances restrict their use;

General. The aeration unit shall be located where it is readily accessible for inspection and maintenance. Set-back distances for aeration units shall be in accordance with subsection (1)(D) of this rule;
Design. All aeration units shall comply with National Sanitation Foundation Standard No. 40 or as required by the administrative authority. In addition, all aeration unit treatment plants shall comply with the requirements stipulated in this section. The aeration unit shall have a minimum treatment capacity of one hundred twenty gallons per bedroom per day (120 gals./pbd) or five hundred gallons (500 gals.), whichever is greater;
Effluent disposal. Effluent from an aeration unit shall be discharged into a soil absorption system or other final treatment system in accordance with section (6) of this

rule. No reductions in the area of soil absorption systems or other final treatment systems shall be permitted because of the use of an aeration unit instead of a septic tank; and 5. Operation and maintenance. Where aeration units are used in institutional or administrative arrangements to control their use, operation and maintenance are recommended. Aeration units should be inspected at least one (1) time each year and pumped when mixed liquor solids concentrations result in excessive clarifier loading.

(5) Absorption Systems. The common design of absorption systems is the use of absorption trenches, each separate from the other and each containing a distribution pipe. This type system should be used whenever practical.

Other types of absorption systems may be used as alternatives where the site conditions meet the specific design requirements of the alternative systems. Installation shall not be made while the soil is wet or moist. This is to prevent smearing and destroying the structure of the soil. All absorption systems should have curtain drains, terraces or use of other flow diversion methods to minimize surface or ground water from loading the absorption field.

(A) Absorption Trenches. The absorption trench gives additional treatment to the sewage from the treatment tank. Regardless of its appearance of clarity or transparency, the outflow or effluent from a sewage tank is a dangerous source of contamination. The satisfactory operation of the sewage disposal system is largely dependent upon the proper site selection, design and construction of the absorption trench.

Absorption trenches should not be constructed in soils having a percolation rate slower than sixty minutes per inch (60 min./in.) and in no case shall absorption trenches be constructed in soils with percolation rates slower than one hundred twenty minutes per inch (120 min./in.) or where rapid percolation may result in contamination of water-bearing formations or surface waters.
The absorption trench shall be located on the property to maximize the vertical separation distance from the bottom of the absorption trench to the seasonal high groundwater level, as determined by the presence of mottling, bedrock or other limiting layer. The vertical separation between the bottom of the absorption trench and limiting layer or seasonal high water table shall be no less than one foot (1') for standard systems.

Greater vertical separation may be required where water-bearing formations are in danger of contamination.

Absorption trenches shall not be constructed in unstabilized fill or ground which has become severely compacted due to construction equipment.
The minimum area in any absorption trench system shall be in accordance with Table 5. Absorption trenches in these highly permeable soils shall have a minimum vertical separation of four feet (4') between the absorption trench bottom and seasonal high groundwater table or bedrock. Cherty clays may have percolation rates between zero (0) and sixty (60) minutes per inch. Cherty clay soils located in areas of severe geological limitations shall have less than fifty percent (50%) rock fragments and a vertical separation distance of four feet (4') or more between the absorption trench bottom and bedrock. Unlined absorption trenches shall not be installed in cherty clays when the field evaluation indicated the presence of large voids. Regardless of the percolation rate, absorption trenches installed in areas of severe geological limitations with cherty clays should be designed for a maximum loading rate of forty-five hundredths gallons per square foot (0.45 gals/sq. ft.) or a minimum of two hundred sixty-five square feet per bedroom (265 sq. ft./bedroom).

Table 5 Minimum Absorption Area Absorption Percolation LoadingLoading RateAreaRate (sq. Ft./(gal./sq.

(min./in.)bedroom)ft.)* £101501.0 11-302000.8 31-452650.45 46-603000.4 61-120 Æ**6000.2 * Gallons of sewage tank effluent per day per square foot of trench bottom. ** Soils with percolation rates of one to ten minutes per inch (1 10 min./in.) or less shall either be evaluated for severe geological limitations by a registered geologist or a soil morphology examination shall be required. *** Note: When percolation rate is greater than forty-five minutes per inch (45 min./in.), backfill above infiltration barrier shall be sand, loamy sand or sandy loam when available. Two to four inches (2 4”) of loamy soil shall be used to cap the sandy backfill. This is to keep rainwater from entering the system. Æ Must be designed and approved by a Missouri registered engineer.

Each absorption trench system shall have a minimum of two (2) trenches with no one (1) trench longer than one hundred feet (100') unless approved by the administrative
Absorption trenches shall be at least eighteen inches (18") wide and no more than thirty-six inches (36") wide. Thirty-six inch (36") wide trenches should not be utilized in soils with percolation rates slower than fortyfive minutes per inch (45 min./in.). The bottom of standard absorption trenches shall be at least eighteen inches (18") and no more than thirty inches (30") below the finished grade except as approved by the administrative authority.
The pipe used between the sewage tank and the absorption system shall be a minimum of four-inch (4") inside diameter equivalent to the pipe used for the building sewer as set forth in section (3) of this rule.

The pipe shall have a minimum fall of not less than one-eighth inch (1/8") per foot. All joints shall be of watertight construction.

Gravity-fed absorption field distribution lines should be at least four inches (4") in diameter. Perforated distribution line shall have holes at least one-half inch (1/2") and no more than three-fourths inch (3/4") in diameter.

A. Pipe used for distribution lines shall meet the appropriate ASTM standard or those of an equivalent testing laboratory.

Fittings used in the absorption field shall be compatible with the materials used in the distribution lines.

B. When four-inch (4") or six-inch (6") diameter corrugated plastic tubing is used for distribution lines, it shall be certified as complying with applicable ASTM standards. The corrugated tubing shall have either two (2) or three (3) rows of holes, each hole between one-half inch (1/2") and threefourths inch (3/4") in diameter and spaced longitudinally approximately four inches (4") on centers. Coiled tubing shall not be used.

The absorption trenches shall be constructed as level as possible, but in no case shall the fall in a single trench bottom exceed one-fourth inch (1/4") in ten feet (10'). The ends of distribution lines should be capped or plugged, or when they are at equal elevations, they shall be connected.
Rock used in soil absorption systems shall be clean gravel or crushed stone, and graded or sized between one and one-half and three inches (1 1/2 3") with no more than ten percent (10%) material to pass through a onehalf inch (1/2") screen. The rock shall be placed a minimum of twelve inches (12") deep with at least six inches (6") below the pipe and two inches (2") over the pipe and distributed uniformly across the trench bottom and over the pipe. Limestone and dolomite shall be avoided when possible.

Before placing soil backfill over the trenches, the gravel shall be covered with one (1) of the A. Unfaced, rolled, three and onehalf inch (3 1/2") thick fiberglass insulation;

B. Untreated building paper;

C. Synthetic drainage fabric; or D. Other material approved by the administrative authority laid as to separate the gravel from the backfill.

Complex slope patterns and slopes dissected by gullies shall not be considered for installation of absorption trenches.

Uniform slopes under fifteen percent (15%) shall be considered suitable slope for installation of absorption trenches. When slopes are less than two percent (2%), provisions shall be made to insure adequate surface drainage.

When slopes are greater than four percent (4%), the absorption trenches shall follow the contour of the ground. Uniform slopes between fifteen percent (15%) and thirty percent (30%) should not be used for installation of absorption trenches unless the soils are three feet (3') or more below the trench bottom. Slopes within this range may require installation of interceptor drains upslope from the soil absorption system to remove all excess water that might be moving laterally through the soil during wet periods. Usable areas larger than minimum are ordinarily required in this slope range. Slopes greater than thirty percent (30%) shall not be utilized for installation of absorption trenches unless the following requirements can be met and approval is obtained from the administrative

A. The slope can be terraced or otherwise graded or the absorption trenches can be located in naturally occurring soil so as to maintain a minimum ten foot (10') horizontal distance from the absorption trench and the top edge of the fill embankment;

B. The soil is permeable and no restrictive layers or water tables occur at a depth within two feet (2') of the trench bottom;

C. Surface water runoff is diverted around the absorption trench field so that there will be no scouring or erosion of the soil over the field or to allow surface runoff onto the field;

D. If necessary, groundwater flow from heavy rainfall is intercepted and diverted to prevent that water from running into or saturating the soil absorption system; and E. There is sufficient ground area available to install the absorption trench system with these modifications.

Effluent distribution devices, including distribution boxes, flow dividers and flow diversion devices, shall be of sound construction, watertight, not subject to excessive corrosion and of adequate design as approved by the administrative authority. Effluent distribution devices shall be separated from the sewage tank by a minimum of two feet (2') of undisturbed or compacted soil and shall be placed level on a solid foundation of soil, gravel or concrete to prevent differential settlement of the device. Distribution boxes provided with flow equalizers are recommended.

A. Each distribution line shall connect individually to the distribution box and shall be watertight.

B. The pipe connecting the distribution box to the distribution line shall be of a watertight construction laid on undisturbed earth.

C. No more than four (4) distribution lines should be connected to a distribution box receiving gravity flow unless the ground surface elevation of the lowest trench is above the flow line elevation of the distribution box.

Stepdowns or drop boxes may be used where topography prohibits the placement of absorption trenches on level grade.

Serial distribution systems should be limited to a separation of at least three feet (3') between the bottom of the absorption trenches and the limiting condition such as slow permeability or zone of seasonal saturation as evidenced by mottling. Whenever the design sewage flow rate requires more than seven hundred and fifty lineal feet (750 lin. ft.) of distribution line in a stepdown or drop-box type system, the absorption field shall be divided into two (2) or more equal portions.

Stepdowns shall be constructed of two feet (2') of undisturbed soil and constructed to a height level with the top of the upper distribution line. The inlet to a trench should be placed either in the center or as far as practical from the outlet (overflow) from the same trench. Drop boxes shall be constructed so that the inlet supply pipe is one inch (1") above the invert of the outlet supply pipe which is connected to the next lower drop box. The top of the trench outlet laterals, which allow effluent to move to the distribution lines, shall be two inches (2") below the invert of the outlet supply line. It is recommended that drop boxes be designed to close off the trench outlets to provide for periods of resting when the absorption trench becomes saturated.

Dosing is recommended for all systems except serial distribution systems and shall be provided when the design sewage flow requires more than five hundred lineal feet (500 lin. ft.) of distribution line. When the design sewage flow requires more than one thousand lineal feet (1000 lin. ft.) of distribution line, the absorption field shall be divided into two (2) equal portions and each half dosed alternatively, not more than four (4) times per day. Dosing may be accomplished by the use of a pump. Each side of the system shall be dosed not more than four (4) times per day. The volume of each dose shall be the greater of the daily sewage volume divided by the daily dosing frequency, or an amount equal to approximately three-fourths (3/4) of the internal volume of the distribution lines being dosed (approximately onehalf gallon per lineal foot (1/2 gal./lin. ft.) of four-inch (4") pipe). Whenever dosed distribution box systems are utilized, the separation distance between the absorption trench bottom and limiting condition should be at least two feet (2').
Gravelless subsurface absorption systems may be used as an alternative to conventional four-inch (4") pipe placed in gravel filled trenches, however they cannot be used in areas where conventional systems would not be allowed due to poor permeability, high groundwater or insufficient depth to bedrock.

Design approval for these systems may be required from the administrative authority prior to installation and all manufacturing specifications and installation procedures shall be closely adhered to. Gravelless trench systems using fabric wrapped tubing shall not be used, however, where wastes contain high amounts of grease and oil, such as in restaurants.

A. The eight (8)-, ten (10)-, and twelve (12)-inch (inner diameter) corrugated polyethylene tubing used in gravelless systems shall meet the requirements of ASTM F667, Standard Specification for Large Diameter Corrugated Polyethylene Tubing.

For purpose of calculation, the eight-inch (8") pipe may be considered equal to eighteen inches (18") in width of a standard absorption trench. The ten-inch (10") pipe may be considered equal to twenty-five inches (25") in width of a standard absorption trench.

B. Two (2) rows of perforations shall be provided located one hundred twenty degrees (120°) apart along the bottom half of the tubing, each sixty degrees (60°) from the bottom centerline. The tubing shall be marked with a visible top location indicator one hundred twenty degrees (120°) away from each row of holes. Perforations shall be cleanly cut and uniformly spaced along the length of the tubing and should be staggered so that there is only one (1) hole in each corrugation. The tubing shall be marked with a visible top location indicator. All gravelless drainfield pipe shall be encased at the point of manufacture with a filter wrap of spun-bonded nylon, spun-bonded polypropylene or other substantially equivalent material approved by the administrative authority.

C. Rigid corrugated tubing shall be covered with filter wrap at the factory and each joint shall be immediately encased in a protective wrap that will prevent ultraviolet light penetration which shall continue to encase the large diameter pipe and wrap until just prior to installation in the trench. Filter wrap encasing the tubing shall not be exposed to sunlight (ultraviolet radiation) for extended periods. Rocks and large soil clumps shall be removed from backfill material prior to being used. Clayey soils (soil group IV) shall not be used for backfill. The near end of the large diameter pipe shall have an offset adapter (small end opening at top) suitable for receiving the pipe from the septic tank or distribution device and making a mechanical joint in the trench.

D. The trench for the gravelless system shall be dug with a level bottom. On sloping ground, the trench should follow the contour of the ground to maintain a level trench bottom and to ensure a minimum backfill of six inches (6"). It is recommended that the minimum trench width for the gravelless system be eighteen inches (18") in friable soils to ensure proper backfill around the bottom half of the pipe. In cohesive soils, the minimum width of excavation should be twenty-four inches (24"). In clay soils, it is recommended that the trench be backfilled with sandy material, sandy loam, loam, clay loam, silt loam or silty clay loam. The gravelless system may be installed at a trench bottom depth of eighteen inches (18") minimum to thirty inches (30") maximum, but a more shallow trench bottom depth of eighteen to twenty-four inches (18–24") is recommended. To promote equal effluent and suspended solids distribution, the slope of the drain pipe should be from zero to one-half inch per one hundred feet (0–1/2 in./100 ft.).

E. A gravelless chamber may be installed based on bottom absorption area utilizing a reduction of up to twenty-five percent (25%) in the size of a standard gravel absorption area based upon a soil morphology evaluation indicating the feasibility of a reduction. However, as described in Table 6, the maximum loading rate provided for any particular soil group must not be exceeded when sizing for the thirty-four inch (34") chamber.

For this purpose, the fifteen inch (15") chamber may be considered equal to twenty-four inches (24") in width of a standard absorption trench. The twenty-two inch (22") chamber may be considered equal to twenty-eight inches (28") in width of a standard absorption trench. The thirty-four inch (34") chamber may be considered equal to forty-two inches (42") in width of a standard absorption trench.

F. Installation of the chamber system shall be in accordance with this rule except:

(I) The installation shall be made in accordance with the manufacturer's specifications;

(II) The side walls of trenches placed in Group IVa soils shall be raked to open pores which were damaged or sealed during excavation; and (III) Chambers utilizing maximum sidewall absorption features shall be installed per the manufacturer's recommendations to maximize the use of upper soil horizons; and G. A reduction of up to twenty-five percent (25%) in the size of the absorption field may be allowed based upon a soil morphology evaluation indicating the feasibility of a reduction. However, as described in Table 6, the maximum loading rate provided for any particular soil group must not be exceeded.

Table—6 Loading Rate for Chamber Systems* Soil GroupRange for Chambers (gpd/sq. ft)

I1.0–1.2

II0.7–0.8

III0.5–0.6

IVa0.3–0.4 IVbUnsuitable V**0.4–0.6 * Note: All application rates are for area of trench bottoms only. ** Note: No reduction is allowed for chamber systems in Group V soils.

Dosing/alternating systems are encouraged, especially in slowly permeable soil conditions.
The administrative authority may permit the use of a bed system on sites where the minimum soil permeability is a percolation rate of forty-five minutes per inch (45 min./in.) and essentially meeting the other requirements of this section, and only on lots which are limited by topography, space or other site planning considerations. In such cases the number of square feet of bottom area needed shall be increased by fifty percent (50%) over what would be required for a trench system. Distribution lines shall be at least eighteen inches (18") from the side of the bed and shall have lines on three-foot (3') centers and care must be taken to divert surface water away from the bed. When the design volume of sewage exceeds six hundred gallons (600 gals.) per day, adequate space shall be provided to accommodate a trench system for the absorption field. There shall be no less than a two-foot (2') separation between the bed bottom and the limiting layer or seasonal high water table.

(B) Possible modifications to standard absorption systems which may be utilized to overcome selected soil and site limitations and must be approved by the administrative

Shallow placement of absorption trenches shall be utilized where insufficient depth to seasonally high or perched water table or where insufficient soil thickness prevents the placement of conventional distribution lines in accordance with this section.

Shallow trenches shall be designed and constructed to provide a minimum of two feet (2') of natural soil separation between the trench bottom and the uppermost elevation of the seasonally high or perched water table and rock. Shallow trenches may be constructed by placing the top of the gravel at original ground level and covering the absorption field with loamy soil, (sandy loam, loam, clay loam, silt loam or silty clay loam) to a depth of eight to twelve inches (8–12") at the center. The cover over the absorption field shall extend at least five feet (5') beyond the edge of any trench and have a turf grass cover established immediately after construction. If an area is to be filled and the trenches constructed in the fill with the bottom of the trenches in at least six inches (6") of natural soil, the following procedures must be followed:

A. The fill material should be of a sandy texture with a maximum clay content of twenty percent (20%). The fill material should not be hauled or worked wet. The area to be filled must be protected from traffic and small brush and trees removed prior to place- B. The soil surface must be loosened with a cultivator or garden plow. This work must be done when the soil is dry;

C. The fill is moved onto the site without driving on the loosened soil. The fill material is then tilled into the natural soil to create a gradual boundary between the two (2). The remaining fill is then added in layers until the desired height is obtained with each layer being tilled into the preceding layer; and D. The site is then shaped to shed water and fill all low spots before the absorption system is installed. After installation of the absorption system, the site must have a turf grass cover established as soon as possible;

Alternating dual field absorption systems may be utilized where soils are limited by high clogging potentials, percolation rates slower than sixty minutes per inch (60 min./in.) or high shrink/swell potential soils and where the potential for malfunction and need for immediate repair is required.

Alternating dual field absorption systems shall be designed with two (2) complete absorption fields, each sized a minimum of seventy-five percent (75%) of the total area required for a single field and separated by an effluent flow diversion valve. The diversion valve shall be constructed to resist five hundred pounds (500 lbs.) crushing strength, structurally sound and shall be resistant to corrosion. A valve placed below ground level shall be constructed so that it may be operated from the ground surface; and 3. Sand-lined trenches may be used in areas where the soil has greater than fifty percent (50%) rock fragments and there are severe geological limitations. For a maximum loading rate of forty-five hundredths gallons per day per square foot (.45 gpd/sq. ft.) or a minimum of two hundred sixty-five square feet per bedroom (265 sq. ft./bedroom), the sand is not required to meet the requirements for intermittent sand filters. The material must be natural or manufactured sand and have no more than fifteen percent (15%) clay content. Manufactured sand shall be chat, fines manufactured from igneous rocks or chert gravel or manufactured from crushed glass. Crushed limestone is not acceptable.

For higher loading rates, the sand must meet the requirements for an intermittent sand filter.

A. In standard four-inch (4") pipe and gravel trenches, the depth of liner material must be twelve inches (12") below the gravel and at least six inches (6") on the sides of the gravel up to the top of the gravel. To place sand on the sides of the trenches, the trench walls must be excavated on a slope instead of vertically. The side slopes should be two horizontal to one vertical (2:1) and in no case steeper than one horizontal to one vertical (1:1).

B. In gravelless pipe systems the minimum thickness of liner material is six inches (6") around the pipe.

C. The effluent to sand-lined systems in areas of potential groundwater contamination should be equally distributed as much as practically possible. Serial and drop-box systems shall not be used. As a minimum, a distribution box shall be used to evenly distribute the effluent to the trenches. Dosing is recommended in order to more positively assure even distribution.

D. The sand-lined trenches may be used, with the approval of the administrative

(6) Alternative Systems.

(A) General. The intent of this section is to provide minimum standards for the design, location, installation, use and maintenance of alternative sewage disposal systems in areas of limiting soil characteristics, where a standard system cannot be installed or a standard system is not the most suitable treatment.

Where these systems are employed, they shall comply with all local codes and ordinances and should be subject to timely inspections to assure adherence to specifications. These systems, except for wastewater stabilization ponds, shall be designed and stamped by a licensed engineer. All absorption systems should have curtain drains, terraces or use of other flow diversion methods to minimize surface or ground water from loading the absorption field.

(B) Adoption and Use. Where this rule is administered by an administrative authority, those administrative authorities may adopt this section in whole or in part as part of a local code or ordinance. Further, nothing in this rule or section shall require any administrative authority to allow the installation of any system in this section.

(C) Low Pressure Pipe (LPP) System. A low pressure, two- to four-foot (2–4') pressure head, pipe system may be utilized where soil and site conditions prohibit the installation of a conventional or modified septic tank system due to the presence of shallow soil conditions, seasonally high water table conditions and slow soil permeability. The administrative authority may permit the use of a LPP system where there are cherty clay soils, severe geological limitations or both. The separation distance in these areas of concern for groundwater between the trench bottoms and bedrock shall be at least four feet (4') or more. The administrative authority may require that the hydraulic design of LPP systems be designed by an engineer. The administrative authority may also require the LPP trenches to be sand-lined if the soils have severely diminished treatment capability due to excessive rock content. The amount of rock fragments shall be less than fifty percent (50%) and in no case more than seventy percent (70%), unless the trenches are lined with sand.

The LPP shall consist of the following basic components:

A. A network of one- to two-inch (1– 2") diameter perforated PVC, one hundred sixty pounds per square inch (160 lbs./sq. in.) pipe or equivalent placed in natural soil at shallow depths, generally no more than twelve inches (12"), in narrow trenches not less than eight inches (8") in width and spaced not less than five feet (5') on center.

Trenches shall include at least five inches (5") of pea gravel, if available; or if necessary, no less than three-quarter inch (3/4") crushed stone below the pipe and two inches (2") above the pipe; and four inches (4") of soil cover. The holes in the perforated pipe should be spaced from two feet (2') to no more than eight feet (8'). The minimum hole size is five thirty-seconds inch (5/32");

B. A properly designed, two (2)-compartment septic tank or other approved pretreatment system and a pumping or dosing tank. The pumping or dosing tank shall be a minimum of five hundred gallons (500 gals.) or have the capacity to store one (1) day's flow above the pump on level, whichever is greater. The tank shall be provided with a filter or screen capable of preventing the passage of suspended solids to the soil absorption system;

C. A submersible sewage effluent pump (not a sump pump) with appropriate on/off controls for controlled dosing and a high water alarm or other approved pressure dosing and distribution system; and D. A watertight supply manifold pipe for conveying effluent from the pump to the low pressure network.

The soil and site criteria for low pressure pipe systems shall meet the following minimum requirements:

A. LPP absorption fields shall not be installed on slopes in excess of ten percent (10%). LPP absorption fields may be installed on slopes greater than ten percent (10%), but require special design procedures to assure proper distribution of effluent over the absorption field;

B. There shall be at least twenty-four inches (24") of separation between the naturally occurring soil surface and bedrock, water-impeding formation, seasonally high water table or evidence of chroma 2 mottles.

This twenty-four-inch (24") depth shall consist of permeable soils with percolation rates less than or equal to sixty minutes per inch (60 min./in.) or be classified as SUITABLE or PROVISIONALLY SUITABLE in accordance with section (7) of this rule. The bottom of percolation test holes must be dug or bored to the bottom of the proposed trenches.

The bottom of the proposed trenches must be located a minimum of one foot (1') above rock, water-impeding formation, seasonally high water table or where there is evidence of chroma 2 mottles. In areas where there are severe geological limitations and the soils have a high chert content, the bottom of the proposed trenches shall be at least four feet (4') above bedrock unless an evaluation by a registered geologist determines that the separation distance may be reduced;

C. Components of the LPP shall not be located in depressions or areas subject to frequent flooding. Surface water, perched ground water and other subsurface lateral water movement shall be intercepted or diverted away from all components of the LPP. Final shape of the LPP distribution field shall be such that rainwater or runoff is shed;

D. Location of the septic tank, pumping or dosing chamber and LPP absorption field is subject to the same horizontal setbacks specified in subsection (1)(D) of this

rule. Horizontal setback distances in Table 1 shall be measured in the LPP absorption field from a margin of two and one-half feet (2 1/2') beyond the lateral and manifold pipes;

E. An area that is at least equal in size to the LPP distribution field area plus a two and one-half foot (2 1/2') margin beyond the lateral and manifold pipes and which meets all other site and soil criteria shall be set aside for a replacement field; and F. There shall be no soil disturbance to an approved site for an LPP system except the minimum required for installation.

The following application rates shall be used in determining the maximum application rate for low pressure pipe systems:

A. In calculating the number of square feet for the absorption field (not square footage of trench bottom), the design sewage flow shall be divided by the application rate from Table 7. The lateral lines shall have a minimum spacing of five feet (5') on centers within the areas calculated for the absorption field area; and Table 7—Loading Rates Loading Rates PercolationAbsorption Loading RateAreaRate* (sq. ft./ (min. in.)bedroom) (gal./sq. ft.) £10**2000.6 11–303000.4 31–454000.3 46–606000.2 * Gallons of sewage tank effluent per day per square foot of total area. ** In areas where there are severe geological limitations and the soils consist of very gravelly soils of thirty-five or greater percent (³35%) gravels by volume, the loading rate of two-tenths gallons per day per square foot (0.2 gpd/sq. ft.) should be used even when the percolation rate would indicate a higher loading.

B. The systems shall be designed so that the discharge from any one (1) lateral line does not vary more than ten percent (10%) from the other laterals. All laterals shall have an envelope of trench rock surrounding the pipe. The trench rock shall be placed to a minimum depth of four inches (4") below the pipe and two inches (2") above the pipe.

Design of the LPP shall comply with accepted practices and be specifically approved by the administrative authority. The system shall be designed and bear the seal of a Missouri registered engineer.

(D) Wastewater Stabilization Ponds (Lagoon). A waste stabilization pond can provide satisfactory sewage disposal in rural areas where soils are not suited for absorption systems. Single residence wastewater stabilization ponds are not generally suitable in subdivisions with lots less than three (3) acres in size. No more than one (1) single family residence will be allowed on one (1) stabilization pond.

The following minimum separation distances may be modified as necessary to accommodate site requirements or local codes:

A. The pond shall be located a minimum of seventy-five feet (75') from property lines as measured from the adjoining pond shoreline. However, this distance must be increased where necessary to be sure that all effluent is disposed upon the property from which it originated;

B. The pond shall be located a minimum of two hundred feet (200') from the nearest existing residence and a minimum of one hundred feet (100') from the residence that it serves;

C. The pond shall be located at least one hundred feet (100') from a potable water supply or pump suction line; and D. The pond shall be located at least fifty feet (50') from a stream, water course, lake or impoundment.

Ponds may be utilized when there are no significant limitations related to groundwater from their use and the soils have been demonstrated to be very slowly permeable such as percolation rates slower than one hundred twenty minutes per inch (120 min./in.). There shall be either a minimum separation distance between the pond bottom and creviced bedrock of three feet (3') or installation of a clay liner with a minimum thickness of one foot (1') or a synthetic liner, either of which must be acceptable to the administrative authority. Percolation losses from the pond shall not exceed one-eighth inch (1/8") per day to prevent groundwater contamination or nuisance conditions. Site modifications may be accomplished to provide these soil requirements. In areas of severe geological limitations, restrictive layers such as fragipans shall be a minimum of twelve inches (12") thick and shall not be breached during construction.
Steeply sloping areas should be avoided.
Selection of the pond site should consider a clear sweep of the surrounding area by prevailing winds. Heavy timber should be removed for a distance of fifty feet (50') from the water's edge to enhance wind action and prevent shading.
The administrative authority may require that a properly sized and constructed septic tank or aeration unit precede the pond.

If irrigation of the effluent is required to maintain the wastewater on the property from which it originated, a septic tank or aeration unit should precede the pond. The use of a septic tank or aeration unit should not be used as a basis for reduction of the set-back distances as set forth in subparagraphs (6)(D)1.A.–D. of this rule.

The pond shall be designed on the

basis of four hundred forty square feet (440 sq. ft.) of water surface area per bedroom at the three-foot (3') operating level. This square footage may be reduced by a maximum of twenty percent (20%) if a septic tank, aeration unit or other pretreatment device precedes the pond. The minimum water surface area at the three-foot (3') level shall be nine hundred square feet (900 sq. ft.).

A single cell is generally acceptable for single residence pond systems. If multiple cells are used for further polishing or storing of the effluent, the secondary cell should be one-half (1/2) the size of the primary cell.
The minimum embankment top width shall be four feet (4'). The embankment slopes shall not be steeper than three to one (3:1) on the inner and outer slopes. Inner embankment slopes shall not be flatter than four to one (4:1). Outer embankment slopes shall be sufficient to prevent the entrance of surface water into the pond. Freeboard shall be at least eighteen inches (18") and preferably twenty-four inches (24"). Additional freeboard may be provided.
To minimize erosion and facilitate weed control, embankments shall be seeded with a locally hardy grass from the outside toe to one foot (1') above the water line.

Alfalfa or similar long-rooted crops which might interfere with the structure of the embankment shall not be used. Rip rap may be necessary under unusual conditions to provide protection of embankments from erosion.

The influent line shall be of a sound, durable material of watertight construction of SDR 35 or greater. The line shall have a minimum diameter of four inches (4") and be laid on a firm foundation at a minimum grade of one-eighth inch (1/8") per foot from the point of entry into the pond. The influent line shall discharge as far as practical from the possible outlet side of the pond. A cleanout or manhole should be provided in the influent line near the pond embankment. From this point the line shall either be laid to the inner toe of the embankment and then on the bottom of the pond to the terminus point or the line shall be supported and secured every five feet (5'). A concrete splash pad three feet (3') square should be placed under the terminus of the pipe. The elevation of the cleanout or manhole bottom should be a minimum of six inches (6") above the high water level in the pond.
The pond shall be shaped so there are no narrow or elongated portions. Round, square or rectangular cells are considered most desirable. Rectangular cells shall have a length not exceeding three (3) times the width. No islands, peninsulas or coves shall be permitted. Embankments should be rounded at corners to minimize accumulation of floating materials.
The floor of the pond shall be stripped of vegetation and leveled to the proper elevation. Organic material removed from the pond area shall not be used in embankment construction. The wetted area of the pond must be sealed to prevent excessive exfiltration. Seals consisting of soils must be adequately compacted by the construction equipment.
Embankments shall be constructed of impervious materials and compacted sufficiently to form a stable structure with very little settlement.
Any effluent should be withdrawn from six inches (6") below the water surface.

This can be accomplished by placing a tee on the inlet end of the pipe or by placing the outlet pipe eight to ten inches (8–10") lower on the inlet end than the outlet end of the pipe.

The pond area shall be enclosed with a fence conforming to the following conditions:

A. The fence shall be at least four feet (4') in height;

B. The fence shall be welded, woven or chain link material with no smaller than fourteen gauge (14 ga.) wire. Cattle or hog panels can be substituted with a tee post being used for a line post;

C. Fence posts shall be pressure-treated wood, galvanized and/or painted steel.

Fence posts shall be driven, tamped or set in concrete. Line posts should be at least eighteen inches (18") deep and shall be spaced no more than ten feet (10') apart. Corner posts should be at least twenty-four inches (24") deep and shall be properly braced;

D. The fence shall be of sound construction with no gaps or openings along the bottom;

E. The fence shall be no closer than the center of the berm to the water's edge at the three-foot (3') deep operating level. Fence set-backs should not exceed thirty feet (30') from the water's edge;

F. A properly hinged four foot (4') high gate or comparable materials shall be installed and provided with an effective latching device. The gate should be thirty-six to forty-eight inches (36–48") in width to accommodate maintenance and mowing equipment; and G. The fence must be completed prior to occupancy of the dwelling.

Effluent from a pond must be disposed of on the property from which it originated. This may be accomplished by locating the outlet as far as practical from the property line and out of any natural drainage ditches or swales. The minimum distance from the outlet to a property line shall be one hundred feet (100'). Another method is to construct a terraced swale with a minimum length of one hundred fifty feet (150'). If these methods are unsuccessful, or whenever there is less than twelve inches (12") of permeable soil over a restrictive layer, controlled surface irrigation must be used. To utilize controlled surface irrigation, the pond must be capable of operating up to five feet (5') deep with one foot (1') of freeboard or have a second cell for storage. The administrative authority shall approve the method of effluent disposal.
It may be necessary to introduce water into the pond to facilitate start-up of the biological processes, however, there shall be no permanent connection of any roof drain, footing drain or any source of rainwater to the wastewater stabilization pond.
Odor problems caused by spring turnover of water, temporary overloading, ice cover, atmospheric conditions or anaerobic conditions may be controlled by broadcasting sodium or ammonium nitrate over the surface of the pond. In general, the amount of sodium or ammonium nitrate should not exceed two pounds (2 lbs.) per day until the odor dissipates.

(E) Elevated Sand Mounds. Elevated sand mounds may be considered whenever site conditions preclude the use of absorption trenches. The construction of a mound shall be initiated only after a site evaluation has been made and landscaping, dwelling placement, effect on surface drainage and general topography have been considered. Due to the nature of this alternative system, actual selection of mound location, size of mound and construction techniques must be carefully considered and the criteria established in this

rule implicitly followed. A set-back distance of fifty feet (50') from the downslope property line is recommended.

Elevated sand mounds shall not be utilized on soils where the high groundwater level as evidenced by mottling, bedrock or other strata having a percolation rate slower than one hundred twenty minutes per inch (120 min./in.) occurs within twenty-four inches (24") of natural grade. Up to four feet (4') of soil thickness over bedrock may be required in areas where there is a significant potential for groundwater contamination.

Mounds shall be constructed only upon undisturbed naturally occurring soils.

Elevated sand mounds are subject to the setback distances required in subsection (1)(D) of this rule.
The fill material from the natural soil plowed surface to the top of the rock-filled bed shall be sand, loamy sand or sandy loam.

Loading rates on the sand fill shall not exceed the values in Table 8.

Table 8—Recommended Loading Rates for Soil Textures Suited to Use as Fill in a Mound System Texture Loading Rate (gal./sq. ft./day)

Medium to coarse sand1.2 Fine sand1.0 Loamy sand0.8 Sandy loam0.6 Note: Rock fragments larger than one-sixteenth inch (1/16") shall not exceed fifteen percent (15%) by volume of the material used for sandy fill.

There shall be a minimum of one foot (1') of fill material and two feet (2') of naturally occurring soils between the bottom of the trench rock and the highest elevation of the limiting conditions as defined in paragraph (6)(E)1. of this rule.
Whenever possible, mounds should be located on flat areas or crests of slopes.

Mounds should not be located on natural slopes of more than six percent (6%) if the percolation rate is slower than sixty minutes per inch (60 min./in.) to a depth of at least twenty-four inches (24") below the sand layer. Mounds may be located on slopes up to a maximum of twelve percent (12%) if the soil percolation rate is faster than sixty minutes per inch (60 min./in.) to a depth of twenty-four inches (24") below the sand layer.

In no case shall the width of the trench rock in a single bed exceed ten feet (10').
The required bottom area of the trenches or bed and the effective basal area of the mound shall be based on one hundred twenty gallons per bedroom per day (120 gals./pbd). The basal area of the mound shall have the minimum area as shown in Table 9.

Table 9—Loading Rate Loading Rate Percolation Rate of Basal Area (min./in.)(gpd/sq. ft.) 1–301.2 31–450.75 46–600.5 61–1200.25 8. The area of sand fill shall extend beyond the basal area and the sides shaped to a three to one (3:1) or four to one (4:1) slope.

The sand fill shall be covered with six inches (6") of fine textured soil and a final cap of six inches (6") of good topsoil applied. Also the mound shall be seeded with a hardy grass to establish a turf grass cover as soon as possible. No shrubs shall be planted on the top of the mound. Shrubs may be placed at the foot and side slopes of the mound.

The land area fifty feet (50') down slope of the elevated sand mound is the effluent dispersal area and the soil in this area may not be removed or disturbed.
Dosing shall be required for all elevated sand mounds. The mound shall be dosed not more than two (2) times per day.

The size of the dosing pump shall be selected to maintain a minimum pressure of one pound per square inch (1 psi), two and threetenths feet (2.3') of head, at the end of each distribution line.

A. Perforation holes and hole spacing shall be determined to insure equal distribution of the effluent throughout the bed or trenches.

B. The perforated pipe laterals shall be connected to a two-inch (2") diameter manifold pipe with the ends capped. The laterals shall be spaced no farther than forty inches (40") on center and no farther than twenty inches (20") from the edge of the trench rock. The perforated pipe laterals shall be installed level with the perforations downward. There shall be a minimum of nine inches (9") of trench rock below the laterals and two inches (2") above the laterals. The material used to cover the trench rock shall be untreated building paper, six inches (6") of compacted straw and three and one-half inch (3 1/2") unbacked fiberglass insulation or a geotextile.

C. The manifold pipe shall be connected to the supply pipe from the pump. The manifold shall be sloped toward the supply pipe from the pump. Antibackflow valves are prohibited in the pump discharge line. The pump discharge line shall be graded to permit gravity flow to the absorption area or back to the dosing tank. Proper air relief and antisiphon devices shall be installed in the piping to prevent siphoning of effluent from the dosing tank or from the mound.

Prior to preparing the area selected for the mound, aboveground vegetation must be closely cut and removed from the ground surface. Prior to plowing, the dosing pump discharge line shall be installed from the pump chamber to the point of connection with the distribution manifold. The area shall then be plowed to a depth of seven to eight inches (7–8") parallel to the land contour with the plow throwing the soil upslope to provide a proper interface between the fill and natural soils. A rubber-tired tractor may be used for plowing but in no case shall a rubber-tired tractor be used after the surface preparation is completed. Tree stumps should be cut flush with the surface and the roots should not be pulled. The soil shall be plowed only when the moisture content of a fragment eight inches (8") below the surface is below the plastic limit.
Mound construction shall proceed immediately after surface preparation is completed.

A. A minimum of twelve inches (12") of sand fill shall be placed where the trench rock is to be located. A crawler tractor with a blade shall be used to move the sand into place. At least six inches (6") of sand shall be kept beneath equipment to minimize compaction of the plowed layer. The sand layer upon which the trench rock is to be placed shall be level.

B. After hand leveling of the trench rock, the distribution system shall be placed and the pipes covered with two inches (2") of rock. After installation of the distribution system, the entire mound is to be covered with topsoil native to the area. The entire mound shall be crowned by providing twelve inches (12") of topsoil on the side slopes with a minimum of eighteen inches (18") over the center of the mound. The entire mound shall then have a turf grass cover established to assure stability of the installation.

C. The area surrounding the elevated sand mound shall be graded to provide diversion of surface runoff waters.

(F) Holding Tanks. The use of holding tanks is generally discouraged and their interim use should be limited to situations where construction of satisfactory sewage treatment and disposal systems will occur within one (1) year. Use of a holding tank must be specifically approved by the administrative

A holding tank shall be constructed of the materials and by the same procedures as those specified for watertight septic tanks.
A cleanout pipe of at least six inches (6") diameter shall extend to the ground surface and be provided with seals to prevent odor and exclude insects and vermin. A manhole of at least twenty inches (20") least dimension shall extend through the cover to a point within twelve inches (12") but no closer than six inches (6") below finished grade.

The manhole cover shall be covered with at least six inches (6") of earth.

The tank shall be protected against flotation under high water table conditions.

This shall be achieved by weight of the tank, earth anchors or shallow bury depths.

For a residence, the size shall be one thousand gallons (1000 gals.) or four hundred gallons (400 gals.) times the number of bedrooms, whichever is greater. For permanent structures, other than residences, the capacity shall be based on measured flow rates or estimated flow rates. The tank capacity shall be at least five (5) times the daily flow rate.
Holding tanks shall be located as follows:

A. In an area readily accessible to the pump truck under all weather conditions;

B. As specified for septic tanks in Table 1 set forth in subsection (1)(D) of this

rule; and C. Where accidental spillage during pumpage will not create a nuisance.

A contract for disposal and treatment of the sewage wastes shall be maintained by the owner with a pumper, municipality, agency or firm which possesses a current and valid permit issued by the Department of Natural Resources for such activity.
Holding tanks shall be monitored to minimize the chance of accidental sewage overflows. Techniques such as visual observation, warning lights or bells, or regularly scheduled pumping shall be used. For commercial establishments, a positive warning system shall be installed which allows twenty-five percent (25%) reserve capacity after actuation.
Holding tanks used in conjunction with permanent black water/gray water systems must conform to the requirements of this section except that the minimum size tank is one thousand gallons (1000 gals.). In these situations, the holding tank is to receive toilet wastes only.

(G) Sand Filters. Septic tanks or aeration units and sand filters may be used along with soil absorption systems in soils with percolation rates between sixty and one hundred twenty minutes per inch (60–120 min./in.).

These systems must be specifically approved by the administrative authority.

The septic tank and aeration units must be in accordance with section (4) of this

rule. Setback distances as shown in Table 1 and as specified in subsection (1)(D) of this

rule shall apply except that the minimum distance to the downslope property line should be fifty feet (50').

The following shall apply to gravity flow sand filter systems:

A. All piping in a sand filter shall be four inch (4") polyvinyl chloride (PVC).

Perforated pipe should be used for distribution and collection lines;

B. All sand filters shall be dosed at two (2) times per day. Dosing shall provide uniform distribution of wastewater throughout the filter cross-section and allow time for reaeration of the pore spaces to occur. Dosing may be accomplished by either pumps or siphons;

C. Effluent from filter underdrains must be collected and disposed of properly.

Effluent shall not discharge off the owner's property;

D. Buried sand filters shall be in conformance with Table 10 of this rule. One (1) collector line shall be provided for every six feet (6') of bed width, with a minimum of two (2) collector lines per bed. The collector lines shall have a minimum grade of one percent (1%).

(I) Distribution lines shall be level and spaced a maximum of three feet (3') apart. Each distribution line must be vented (downstream end) or connected to a common vent. Vents should extend at least twelve inches (12") above the ground surface with the outlet screened or capped (perforated).

(II) Septic tank effluent shall be applied to the filter through a distribution box. Buried filters shall be dosed with a pump or siphon. The dosing volume shall be sufficient to fill the pore spaces in the gravel to a depth of four inches (4"). For single bed filters receiving septic tank effluent, the hydraulic loading rate shall not exceed one gallon per day per square foot (1 gpd/sq. ft.) with a maximum organic loading of one and three-fourths pounds (1 3/4 lbs.) of biological oxygen demand (BOD) per day per one thousand square feet (1000 sq. ft.) of surface area. Total surface area shall not be less than two hundred square feet (200 sq. ft.); and E. Open sand filters are similar to buried filters with the exception that no soil backfill or gravel is used on the top of the sand and the filter must be enclosed within concrete walls or other substantially equivalent material. Open sand filters shall be in conformance with Table 10.

(I) Distribution of wastewater shall be applied by pipes directly over the sand surface at the center of the bed or at the four corners. Splash plates beneath points of discharge must be used to prevent erosion of the sand. Curbs around the splash plates or large stones placed around the periphery of the plate will help prevent scouring. All exposed pipes shall slope to drain.

(II) Filter walls shall be concrete, masonry, compacted clay, high density polyethylene plastic with a minimum thickness of thirty (30) mil, or other material acceptable to the administrative authority; and extend six inches (6") above the sand and six inches (6") above the adjacent ground level.

(III) Dosing shall flood the bed to a depth of two inches (2") with a hydraulic loading of two to five gallons per day per square foot (2–5 gpd/sq. ft.) (septic tank effluent). Maximum organic loading is five and thirteen-hundredths pounds (5.13 lbs.) of BOD per day per one thousand square feet (1000 sq. ft.) of surface area.

(IV) The filter may be covered to provide protection against severe weather, prevent growth of weeds and to keep children and animals out of the filter. Such cover may include six inches (6") of clean one to two inch (1–2") gravel, if so designed by an engineer as part of the system. In such event, a vent for the system would not be required if so determined by the engineer.

The following shall apply to pressure dosed sand filter systems:

A. Conventional pressure dosed sand filters use an intermittent filter with two feet (2') or more of medium sand designed to filter and biologically treat sewage tank effluent from a pressure distribution system at an application rate not to exceed one and twenty-five hundredths gallons per square foot (1.25 gals./sq. ft.) sand surface area per day, applied at a dose not to exceed one-half gallon (1/2 gal.) per orifice per dose. These sand filters may be buried or open.

B. Recirculating pressure dosed sand filters use a recirculating filter with two feet (2') or more of medium filter media designed to filter and biologically treat sewage tank effluent from a pressure distribution system at an application rate not to exceed five gallons per square foot (5 gals./sq. ft.) filter surface per day, applied at a dose not to exceed two gallons (2 gals.) per orifice per dose.

These sand filters shall be uncovered and open to the surface.

C. Minimum filter area for these filters shall be as follows:

(I) Conventional pressure dosed sand filters for single family residences shall be a minimum of three hundred and sixty square feet (360 sq. ft.) in surface area with a design sewage flow not to exceed six hundred gallons (600 gals.). If sand filter design flows exceed an average of four hundred and fifty gallons per day (450 gpd), the minimum sand surface will be based on one and twenty-five hundredths gallons per day per square foot (1.25 gpd/sq. ft.); and (II) Pressure dosed sand filters for commercial facilities shall be sized on the

basis of projected daily sewage flow. If the waste strength is proposed to be greater than residential strength waste, pretreatment shall be required which will reduce the biological oxygen demand to levels not to exceed three hundred (300), total suspended solids to levels not to exceed one hundred-fifty (150), and oil and grease to levels not to exceed twentyfive (25). The minimum sand surface will be based on two to five gallons per day per square foot (2–5 gpd/sq. ft.).

D. Design criteria shall include the (I) Sewage tanks shall be in accordance with section (4) of this rule. Set-back distances as shown in Table 1 of subsection (1)(D) and as specified in subsection (1)(E) of this rule shall apply, unless a variance has been allowed by the administrative authority.

Tanks shall be watertight and tested in the field. The test shall be performed by filling the tank two inches (2") above the riser inlet.

At the end of the first twenty-four (24)-hour period, the tank water level should be refilled. After another twenty-four (24)-hour period, no more than one inch (1”) of water should have dropped from the original reading. All sewage and pump tanks will be supplied with vandal-proof access risers to grade over the pump units. Risers should have a waterproof epoxy seal between the tank and riser;

(II) Pumping systems for a pressure dosed sand filter system should provide pumping apparatus that is capable of filtering gross solids larger than one-eighth inch (1/8") and draw from the clear zone near the outlet side of the sewage tank. This zone is described as the layer of effluent between the sludge and scum layers of the sewage tank.

Pumps should be able to deliver adequate head pressure to control orifice plugging.

Pumps should be made of a corrosive resistant material such as Type 316 stainless steel, suitable plastic, or 85-5-5-5 bronze. Screens should have at least ten square feet (10 sq. ft.) of surface area, with one-eighth inch (1/8") openings;

(III) Operation controls should be on a timer dose that distributes the average daily flow over an eighteen (18)-hour period.

Recirculating filters will be set to recirculate five (5) times the average daily flow over a twenty-four (24)-hour period. Systems should be designed with a high water alarm and light signal. Control panels should be located on an exterior location. Control operations should be located in an area available for maintenance;

(IV) Intermittent filter media shall be a mixture of sand or durable inert particles with one hundred percent (100%) passing the three-eighths inch (3/8") sieve; ninety to one hundred percent (90–100%) passing the No. 4 sieve; sixty-two to one hundred percent (62–100%) passing the No. 10 sieve; fortyfive to eighty-two percent (45–82%) passing the No. 16 sieve; twenty-five to fifty-five percent (25–55%) passing the No. 30 sieve; ten percent (10%) or less passing the No. 60 sieve; four percent (4%) or less passing the No. 100 sieve; or sand meeting the ASTM-C 33 concrete sand specification minus four percent (4%) or less passing the No. 100 sieve. All drainage rock should be a river washed, hardened and weathered rock. The treatment media will be two inches (2") deep and of a coarse media with an effective size of one and one-half to three millimeters (1 1/2–3 mm) and a uniformity coefficient of less than two (2). Limestone or dolomite is not acceptable for drainage rock;

(V) Recirculating filter media shall be a mixture of sand or durable inert particles with one hundred percent (100%) passing the three-eighths inch (3/8") sieve; seventy-nine to one hundred percent (79–100%) passing the No. 4 sieve; eight to ninety-two percent (8–92%) passing the No. 8 sieve; zero to fifteen percent (0–15%) passing the No. 30 sieve; zero to one percent (0–1%) passing the No. 50 sieve. All drainage rock should be a river washed, hardened and weathered rock.

The treatment media will be two inches (2") deep and of a coarse media with an effective size of one and one-half to three millimeters (1–1/2 3 mm) and a uniformity coefficient of less than two (2). Limestone or dolomite is not acceptable for drainage rock; and (VI) Container designs may be concrete containers consisting of watertight walls and floors to prevent groundwater from infiltrating or effluent from exfiltrating from the filter. All penetrations through the walls shall be watertight. Containers may also consist of a thirty (30) mil polyvinyl chloride liner covering the sand filter bottom and side wall areas. Polyvinyl chloride liners should be supplied with repair kits and boots for passage through the liner wall. The bottom area of the liner should be bedded in two inches (2") of leveling sand. The liner should be constructed to form a waterproof membrane between the trench bottom and trench walls.

The polyvinyl liner should incorporate all seams to be a chemically or heat bonded waterproof seam.

E. The filter design criteria shall include the following:

(I) The interior base of the filter container shall be level or constructed at a grade of one percent (1%) or less to the underdrain pipe elevation;

(II) The underdrain piping shall consist of a pipe with one-fourth inch (1/4") grooves cut every four inches (4") along the pipe length to a depth of one-half (1/2) of the pipe diameter. The bottom of the filter container shall be covered with a minimum of six inches (6") of drain media. The underdrain pipe shall be enveloped in an amount and depth of drainage rock to prevent migration of the underdrain media into the pipe perfora- (III) A minimum of twenty-four inches (24") of approved filter media shall be installed over the underdrain media. The media shall be damp at the time of installation to insure compaction of the media. The top surface of the media shall be level;

(IV) There shall be a minimum of three inches (3") of clean drain media below the distribution laterals, and sufficient media above the laterals equal to or covering the orifice shields and/or pipe;

(V) Distribution laterals shall be evenly spaced on minimum, thirty-inch (30") centers. Orifices shall be placed such that there is one (1) orifice or more on average per six square feet (6 sq. ft.) of sand surface.

Orifice holes shall be one-eighth inch (1/8") in diameter. The diameter of the piping manifold and lateral shall be no less than one-half inch (1/2"). The ends of the distribution laterals should be constructed with a means to perform flushing of the piping, collectively or individually, through the operation of a flushing valve. The flushed effluent may be discharged to the sand filter;

(VI) The top of the intermittent media in which the pressure distribution system is installed shall be covered with a breathable nylon or polypropylene spun filter fabric rated at eighty-five hundredths ounce per square yard (0.85 oz./sq. yd.) to eliminate soil intrusion into the filter media.

Recirculating filters shall be open-topped;

(VII) The top of the intermittent sand filter area shall be backfilled with a soil cover, free of rocks, vegetation, wood waste, etc. The soil cover shall have a textural class of loamy sand. The soil cover shall have a minimum depth of six inches (6") and a maximum depth of twelve inches (12").

Intermittent sand filters designs may delete soil cover and incorporate three to six inches (3–6") of a quality cypress or cedar mulch over the entire filter area;

(VIII) Where the effluent from a sand filter is to be discharged via a pump, the pump and related apparatus shall be housed in a vandal resistant vault designed to withstand the stresses placed upon it and not allow the migration of drain media, sand or underdrain media to its interior. The vault shall have a durable, affixed floor. The vault shall provide watertight access to the finished grade with a diameter equal to that of a gravity discharge sand filter. The depth of the underdrain and the operational level of the pump cycle and alarm shall not allow effluent to come within two inches (2”) of the bottom of the sand filter media. The pump off level shall be no lower than the invert of the perforations of the underdrain piping. The internal sand filter pump shall be electrically linked to the sand filter dosing apparatus in such a manner as to prevent effluent from entering the sand filter in event the internal sand filter pump fails; and (IX) Other sand filters which vary in design from those described in this rule may be authorized by the administrative

F. Effluent from these sand filters may discharge to the ground surface, provided the effluent is maintained on the owner’s property and the following separation distances are maintained:

(I) The discharge shall be a minimum of one hundred feet (100') from private water supply wells; one hundred-fifty feet (150') from unplugged abandoned wells or wells with less than eighty feet (80') of casing; and three hundred feet (300') from public water supply wells;

(II) The discharge shall be a minimum of one hundred feet (100') from springs; five hundred feet (500') from the edge of surficial sink holes; fifty feet (50') from a classified stream; and twenty-five feet (25') from a stream or open ditch; and (III) The discharge shall be a minimum of seventy-five feet (75') from property lines.

G. If effluent can not meet the minimum separation distances as described in subparagraph (6)(G)2.F., then the effluent must be disposed of into a soil absorption system. The required footage of the soil absorption system may be reduced by up to onethird (1/3) of that required for a conventional soil absorption system. Shallow bury designs should be utilized whenever possible to achieve the best absorption rates.

(H) Drip Soil Absorption. Drip soil absorption also known as trickle irrigation may be approved by the administrative

Drip lines shall be placed two feet (2') apart in a parallel arrangement. Emitters shall be placed in the drip lines every two feet (2') so there will be a two-foot by two-foot (2'×2') grid pattern. Other configurations and spacings of the drip line and emitters may be used; however, each emitter will be considered to cover four square feet (4 sq. ft.) of absorption area.
The application rate shall not exceed the values as shown in Table 7 for low pressure pipe systems in subparagraph (6)(C)3.A. of this rule.
Drip soil absorption systems may be allowed at sites where the soil is classified as being in group IVb. A minimum separation distance of twelve inches (12") shall be maintained between the drip lines and emitters and a high ground water table or other limiting condition. The maximum application rate for IVb soils shall be from five-hundredths to one-tenth gallons per day per square foot (0.05 0.10 gpd/sq. ft.) of absorption field (I) Wetlands. Constructed wetlands provide secondary levels of treatment, which means that some form of pretreatment (septic tank, aeration tank, lagoon, etc.) must be used prior to the wetland, as wetlands cannot withstand large influxes of suspended solids.

The pretreatment used must be capable of removing a large portion of these solids.

Effluent from wetlands must be contained on the owner’s property with the same set-back distances as required for lagoons in Table 1, located in subsection (1)(D) of this rule.

Free water surface wetlands are shallow beds or channels with a depth less than twenty-four inches (24") and filled with emergent aquatic plants. This type of wetland shall not be allowed.
Submerged flow wetlands are similar to free water surface wetlands except that the channels are filled with shallow depths of rock, gravel or sand. The depth of the porous media is usually less than eighteen inches (18”). The porous media supports the root systems of the emergent aquatic vegetation.

The water level is to be maintained below the top of the porous media so that there is no open water surface.

The surface area of wetlands shall be determined by using the following equation: s = [Q(inC — InC e )]/(k T × f × d) where: A s = wetland surface area, sq. ft.

Q = daily flow rate to wetland, cu.ft./day([gallons/day]÷7.5);

C = influent BOD5 concentration, mg/L;

C e = effluent BOD5 concentration, mg/L; k T = temperature dependent rate constant, per day; d = water depth in wetland, ft; and f = void fraction of rock media, decimal.

After a surface area has been determined, a cross-sectional area shall be calculated against hydraulic loading by using the following equation:

= Q/(K

× S) where:A = cross-sectional area (hydraulic loading), sq. ft.;

K = hydraulic conductivity of rock media, ft./day*; and S = slope of wetland bottom, decimal * A value of eight hundred feet per day (800 ft./day) may be used for the hydraulic conductivity for rock of one inch (1") diameter. ** Values for slope should range between twenty-five hundredths and one percent (0.25 –1%).

After the hydraulic loading has been determined, an organic loading shall be calculated using the following equation:

= OGL/0.05 where:A = cross-sectional area (organic loading), sq. ft.; and OGL = organic loading, lbs BOD5/day.

The larger of the two (2) calculations, the hydraulic loading or the organic loading, shall be used to determine the wetland dimensions. Wetlands should not be long and narrow.
The width of the wetland shall be calculated by dividing the larger cross-sectional area by the water depth. The calculated width should not be less than one-third (1/3) of the length (a length: width ratio of three to one (3:1)). Should it be necessary to construct a wetland with a ratio greater than three to one (3:1), step-loading along the length of the wetland shall be considered.
The configuration of a wetland for an individual home can be a one (1) cell or two (2) cells in series, depending upon the soil properties at the site. Larger systems may consist of multiple cells in parallel or series in order to provide more management options.

A. Single cells may be used where there will be no percolation of water through the bottom of the wetland. Water movement properties of the soil at the wetland construction site must be determined either by use of properly performed percolation tests or a thorough soil profile analysis performed by a qualified person meeting the criteria of 19 CSR 20-3.080.

B. For soils with percolation rates of sixty minutes per inch (60 min./in.) or less and where geological limitations are not severe, a two (2)-cell wetland may be used.

The first cell shall be lined, allowing no percolation. The second cell may be unlined and filled with sand (not rock) to promote some percolation from the bottom of the wetland.

The second cell shall not be larger than the first cell.

Crushed limestone or other rock with sharp edges shall not be used for a porous media as this type of rock will compact with time. Rock with rounded edges, such as creek gravel, shall be used. Rock must be thoroughly washed to remove fines which may cause plugging. Rock substrate size should be one inch (1") diameter, while rock to be used around inlet and outlet pipes may be two to four inches (2–4") diameter to reduce potential clogging. A three to four inch (3–4") layer of washed pea gravel may be used on top of the one inch (1") substrate for decorative purposes.
All piping shall be SDR 35 sewer pipe, Schedule 40 polyvinyl chloride (PVC)

DWV pipe, or material of equivalent or stronger construction. Piping shall be a four inch (4”) diameter.

Influent shall be distributed and effluent collected by header pipes running the width of the wetland. Perforated sewer pipe can be used for the headers. For unperforated pipe, a one and one-half inch (1 1/2”) hole shall be drilled every twelve inches (12”) along the header. Headers shall be placed at the bottom of the wetland on a bed of rock and covered with two to four inch (2–4”)

rock. A cleanout shall be placed before the influent header.

A. If effluent from the septic tank flows to the wetland by gravity and there are parallel cells in the wetland, a distribution box shall be placed ahead of the wetland so that flow can be controlled to individual cells.

B. If effluent is pumped, the pumping rate shall not exceed twenty-five gallons per minute (25 gpm) and no more than one-third (1/3) of the daily design flow shall be pumped at one (1) time.

Water level in a wetland shall be controllable. The range of control shall be from two inches (2") above the surface of the rock to complete draining of the wetland.

Maximum water level in the wetland shall be a minimum of twelve inches (12") below the outlet of the septic tank so that water does not back up into the septic tank.

A. To conveniently check the water level relative to the gravel surface, a four inch (4") diameter perforated pipe may be placed in the bottom of the wetland, through the channel embankment, and then elbowed up to the elevation of the top of the channel.

B. Water level control may be obtained by use of swivel standpipes or collapsible tubing.

Surface water shall be kept out of the wetland. This may be accomplished by diverting runoff away from the wetland or constructing an earthen berm around the wetland. Berms shall be a minimum of six inches (6") above the surface of the porous media.
Emergent plants shall be selected by the ability of the plants to: root and grow in the wastewater-rock environment, treat wastewater to acceptable levels, produce biomass in amounts that can be controlled and aesthetics. Reference may be made to Tables 11 and 12 in selecting desired plants.

(J) Privy. A privy will be allowed only under limited conditions and will not be recognized as a method of sewage disposal for a continuously occupied dwelling, business or other structure. A privy will only be considered for remote area not served by a piped water source. Example of these areas may be rural cemetery, a rural church with a small congregation and where hand-washing facilities are available, or a river access point provided by the Department of Conservation.

Plans and construction of a privy will need to meet the approval of the administrative 1. The privy shall be use to receive only human excreta and toilet paper. The privy shall not be used as a depository for other wastes.

A pit shall be provided for the privy.

The sides of the pit shall be curbed to prevent cave-in. If the pit has an earth bottom, the bottom shall be at least three feet (3') above saturated soil conditions. If this separation distance cannot be achieved in the location of the privy, then the pit shall be liquid tight.

The pit shall be periodically pumped out by someone who services septic tank systems. At no time shall the pit contents be allowed to accumulate to within one foot (1') of the pit top. The pit contents shall then be transported and disposed into a community sewer system that is in compliance with

Chapter 644, RSMo.

Both the pit and the privy shall be vented, Inspect-proof openings shall be placed in the walls, below the seat. A vent shall extend from the underside of the seat board through the roof or up to a horizontal vent open to the sides of the toilet. This vent must be flush with the underside of the seat board and shall not extend down into the pit.

All vent openings to the outside shall be properly screened to keep out insects. The top of the privy shall have a screened opening on each side. It is preferable the opening be all the way around the top of the privy in order to allow to allow air to pass through and to carry away any odors which may seep into the upper part of the structure. If a crescent-shaped opening is cut into the door or wall of the privy, it shall also be screened.

The inside of the privy shall be of durable, smooth, nonabsorbent material. If wood is used, the inside of the structure shall be coated with a polyurethane-type coating so as to minimize the penetration of liquids and odors into the wood.
A tight-fitting door, preferably with a self-closing feature, such as a door spring, shall be used.
A privy shall be set back from surface waters, buildings, property lines and water supply wells the same distance as required for soil treatment areas. This information may be found in subsection (1)(D), Table 1 of this 8. The privy shall be of sufficient capacity for the facility it serves, but shall have at least fifty cubic feet (50 cu. ft.) of capacity.
Abandoned pits shall have the contents removed, transported and disposed into a community sewer system that is in compliance with Chapter 644, RSMo. This activity shall be performed by someone who services septic tank systems. The pit shall then be filled with clean earth and slightly mounded to allow for settling.

(K) Other Systems. Where unusual conditions exist, special systems of treatment and disposal, other than those specifically mentioned in this rule, may be employed provided— 1. Reasonable assurance of performance of the system is presented to the administrative authority;

The engineering design of the system is first approved by the administrative authority;
Adequate substantiating data indicate that the effluent will not contaminate any drinking water supply, groundwater used for drinking water or any surface water;
Treatment and disposal of the wastes will not deteriorate the public health and general welfare;
Discharge of effluent, if any, shall be within set-back distances as described in Table 1, located in subsection (1)(D) of this

rule; and 6. These systems comply with all applicable requirements of this rule, with all local codes and ordinances, and all applicable requirements of sections 701.025–701.055 and Chapter 644, RSMo.

(L) Variances. Variances may be considered and granted by the administrative

Setbacks as specified in Table 1, located in subsection (1)(D) of this rule.
Minimum distance between the infiltrative surface and restrictive feature or bedrock.
Minimum areas for infiltrative surfaces as shown in Table 5 (see (5)(A)4.), Table 6 (see (5)(A)16.C.), Table 7 (see (6)(C)3.A.), Table 8 (see (6)(E)3.), Table 9 (see (6)(E)7.) and Tables 13 and 14 (see (7)(M)) of this rule.
A written application for a variance shall be provided to the administrative

A. An explicit description explaining why the requirements of this rule cannot be complied with, including a description of specific sections of this rule for which a variance is being requested;

B. A design of the proposed system.

The design shall show that as much soil absorption as is practically possible will be installed;

C. The existing and maximum occupancy pattern and the existing water usage records, if any;

D. Potential impact, if any, on neighboring property owners and the names and mailing addresses of these property owners;

E. Adequate substantiating data to indicate that the effluent will not contaminate any drinking water supply, groundwater used for drinking water or any surface water.

These systems shall comply with all applicable requirements of these standards except where variances have been granted.
No variance will be granted for any system that would result in noncompliance with Chapter 644, RSMo Missouri Clean Water law and subsequent rules. On-site sewage disposal systems with a discharge, other than a system serving a single family residence lot, must be referred to the Department of Natural Resources and comply with Chapter 644, RSMo, Missouri Clean Water Law and subsequent rules.
If effluent can not meet the minimum separation distances as described in Table 1 of subsection (1)(D), then the effluent must be disposed of into a soil absorption system.

Set-back distances for lagoons will be considered applicable to alternative systems. The required footage of the soil absorption system following alternative systems may be reduced by up to one-third (1/3) of that required for a conventional soil absorption system. Shallow bury designs should be utilized whenever possible to achieve the best absorption rates.

All adjacent and/or affected property owners shall be notified in writing by the administrative authority whenever consideration for granting a variance is likely to result in effluent crossing property lines. The party requesting the variance shall be responsible for supplying the names and addresses of all adjacent and/or affected property owners to the administrative authority. Adjacent and/or affected property owners shall be allowed thirty (30) days from the date of the written notification to contact the administrative
In cases of complaint abatement, where effluent cannot be maintained on the owner’s property, within the required setback distances and presents a nuisance or threat to public health or surface or ground water quality, the administrative authority may require a holding tank be placed at the optimum location within the sewage system, in order to abate the complaint. The owner shall be responsible for assuring the holding tank is pumped as needed, with the contents being disposed of in a Department of Natural Resources permitted facility.

(7) Detailed Soils Evaluation.

(A) General. The intent of this section is to provide minimum standards for site evalua tions based upon evaluation of the soil characteristics, namely texture, color, structure, drainage and depth. Criteria are also given for sizing standard systems and some alternative systems.

(B) Adoption and Use. Where this rule is administered by an administrative authority, those administrative authorities may adopt this section, in whole or in part, as part of a local code or ordinance. Nothing in this rule or section shall require any administrative

Topography and landscape position;
Soil characteristics (morphology) which includes texture, structure, porosity, consistence, color and other physical, mineral and biological properties of various horizons, and the thickness and arrangement of the horizons in the soil profile;
Soil drainage, which includes both external (surface) and internal (soil);
Soil depth;
Restrictive horizons; and 6. Available space.

(D) Site evaluations shall be made in accordance with subsections (7)(E)–(M) of this rule. Based on this evaluation, each of the factors listed in subsection (7)(C) of this

rule shall be classified as suitable, provisionally suitable or unsuitable.

(E) Topography and Landscape Position.

Uniform slopes under fifteen percent (15%) shall be considered suitable with respect to topography. When slopes are less than two percent (2%), provisions shall be made to insure adequate surface drainage. When slopes are greater than four percent (4%), the absorption lines shall follow the contour of the ground.

Uniform slopes between fifteen percent (15%) and thirty percent (30%) shall be considered provisionally suitable with respect to topography, if the soils are thirty-six inches (36") or more thick. Slopes within this range may require installation of interceptor drains upslope from the soil absorption system to remove all excess water that might be moving laterally through the soil during wet period. Usable areas larger than minimum are ordinarily required in this slope range.
Slopes greater than thirty percent (30%) shall be considered unsuitable except when a thorough study of the soil characteristics indicates that a soil absorption system will function satisfactorily and sufficient ground area is available to properly install such a system. Slopes greater than thirty percent (30%) may be classified as provisionally suitable when all of the following conditions are met:

A. The slope can be terraced or otherwise graded or the absorption lines located in naturally occurring soil to maintain a minimum ten-foot (10') horizontal distance from the absorption trench and the top edge of the fill embankment;

B. The soil characteristics can be classified as suitable or provisionally suitable to a depth of at least one foot (1') below the bottom of the absorption trench;

C. Surface water runoff is diverted around the absorption field so that there will be no scouring or erosion of the soil over the field;

D. If necessary, groundwater flow is intercepted and diverted to prevent the water from running into or saturating the soil absorption system; and E. There is sufficient ground area available to install the septic tank system with these modifications.

Complex slope patterns and slopes dissected by gullies and ravines shall be considered unsuitable to topography.
Areas subject to frequent flooding shall be considered unsuitable to landscape positions.
Depressions shall be considered unsuitable with respect to landscape positions except when the site complies essentially with the requirements of this section and is specifically approved by the administrative authority.
If directed by the administrative

(F) Soil Characteristics (Morphology).

Soil borings or pits shall be taken at the site to be used for soil absorption systems. These borings shall be taken to a depth of fortyeight inches (48") or as required to determine the soil characteristics. Soil borings or pits and core samples shall be evaluated and a determination made on the suitability of the soil to treat and absorb septic tank effluent.

The important soil characteristics which shall be reviewed by the administrative authority are as follows:

The relative amounts of the different sizes of mineral particles in a soil are referred to as soil texture. All mineral soils are composed of sand, two to five hundredths millimeters (2–.05 mm) in size; silt, which includes intermediate-sized particles that cannot be seen with the naked eye but feel like flour when pressed between the fingers, five hundredths to two thousandths millimeter (0.05–0.002 mm) in size; or clay, which is extremely small in size and is the mineral particle that gives cohesion to a soil, less than two thousandths millimeters (0.002 mm) in size or a combination of these. The texture of the different horizons of soils may be classified into five (5) general groups and shall be used for determining the application rates shown in Tables 6 and 7 of this rule.

A. Soil Group I. Sandy texture soils contain more than seventy percent (70%) sand-sized particles in the soil mass. These soils do not have enough clay to be cohesive.

Sandy soils have favorable sewage application rates, but may have a low filtering capacity leading to malfunction due to contamination of groundwater. The sandy group includes the sand and loamy sand soil textural classes and shall generally be considered suitable in texture.

(I) Sand. Sand has a gritty feel, does not stain the fingers and does not form a ribbon or ball when wet or moist.

(II) Loamy sand. Loamy sand has a gritty feel, stains the fingers (silt and clay), forms a weak ball and cannot be handled without breaking.

B. Soil group II. Coarse loamy texture soils contain more than thirty percent (30%) sand-sized particles and fewer than twenty percent (20%) clay-sized particles in the soil mass. They exhibit slight or no stickiness.

The coarse loamy group includes sandy loam and loam soil textural classes and shall generally be considered suitable in texture.

(I) Sandy loam. Sandy loam feels gritty and forms a ball that can be picked up with the fingers and handled with care without breaking.

(II) Loam. Loam may feel slightly gritty but does not show a fingerprint and forms only short ribbons ranging from twenty-five hundredths to fifty hundredths inch (.25–.50") in length. Loam will form a ball that can be handled without breaking.

C. Soil group III. These fine loamy texture soils contain fewer than forty percent (40%) clay-sized particles and not more than thirty percent (30%) sand-sized particles in a soil mass. Also this group is limited to less than thirty-five percent (35%) clay when the clay minerals exhibit high shrink/swell characteristic and exhibit slight to moderate stickiness. The fine loamy group includes sandy clay loam, silt loam, clay loam and silty clay loam textural classes and shall generally be considered provisionally suitable in texture.

(I) Silt loam. Silt loam feels floury when moist and will show a fingerprint but will not ribbon and forms only a weak ball.

(II) Silt. Silt has a floury feel when moist and sticky when wet but will not ribbon and forms a ball that will tolerate some handling.

(III) Sandy clay loam. Sandy clay loam feels gritty but contains enough clay to form a firm ball and may ribbon to form seventy-five hundredths to one-inch (.75–1") pieces.

(IV) Silty clay loam. Silty clay loam is sticky when moist and will ribbon from one to two inches (1–2"). Rubbing silty clay loam with the thumbnail produces a moderate sheen. Silty clay loam produces a distinct fingerprint.

(V) Clay loam. Clay loam is sticky when moist. Clay loam forms a thin ribbon of one to two inches (1– 2") in length and produces a slight sheen when rubbed with the thumbnail. Clay loam produces a non-distinct fingerprint.

D. Soil group IV. These clayey texture soils contain forty percent (40%) or more clay-sized particles and include sandy clay, silty clay and clay. This group may also include clay loam and silty clay loam when the clay fraction is greater than thirty-five percent (35%) and of a high shrink/swell nature. There are two (2) major types of clays nonexpandable and expandable. The nonexpandable clays, when wet, are slightly sticky to sticky; when moist, are friable to firm; and when dry, they are slightly hard to hard. The nonexpandable clays (Group IVa) shall generally be considered provisionally suitable in texture. The expandable clays, when wet, are very sticky and very plastic and when moist, these clays are very firm to extremely firm and when dry, are very hard to extremely hard. The expandable clays (Group IVb) shall be considered unsuitable in texture.

(I) Sandy clay. Sandy clay is plastic, gritty and sticky when moist and forms a firm ball and produces a thin ribbon to over two inches (2") in length.

(II) Silty clay. Silty clay is both plastic and sticky when moist and lacks any gritty feeling. Silty clay forms a firm ball and readily ribbons to over two inches (2") in length.

(III) Clay. Clay is both sticky and plastic when moist, produces a thin ribbon over two inches (2") in length, produces a high sheen when rubbed with the thumbnail and forms a strong ball resistant to breaking.

E. Soil group V. This soil group may be of any texture, however, the most predominant are cherty and very cherty clays, silt loams and silty clay loams. The amount of rock fragments in these soils is of a concern in areas of residual soils overlying highly permeable bedrock where groundwater could become contaminated. In general, soils with less than fifty percent (50%) rock fragments will be considered suitable. In general, soils with greater than fifty percent (50%) rock fragments over highly permeable bedrock will be considered unsuitable. Soils with greater than fifty percent (50%) rock fragments will be considered provisionally suitable if geological limitations are not severe.

F. The soil texture shall be estimated by field testing; and 2. Soil consistency. Soil consistency is comprised of the attributes of soil material, typically clay, that are expressed by the degree and kind of cohesion and adhesion or by the resistance to deformation or rupture.

A. Soil consistency when wet shall be considered as follows:

(I) Stickiness. Stickiness is the quality of adhesion to other objects. For field evaluation of stickiness, wet soil material is pressed between thumb and finger and its adherence noted. Degrees of stickiness are described as follows:

(a) Slightly sticky. After pressure, soil material adheres to both thumb and finger but comes off one or the other cleanly.

It is not appreciably stretched when the digits are separated;

(b) Sticky. After pressure, soil material adheres to both thumb and finger and tends to stretch somewhat and pull apart rather than pulling free from either digit; and (c) Very sticky. After pressure, soil material adheres to both thumb and finger and is decidedly stretched when they are separated; and (II) Plasticity. Plasticity is the ability to change shape continuously under the influence of an applied stress and to retain the impressed shape on removal of the stress. For field determination of plasticity, the soil material shall be rolled between the thumb and finger to observe whether or not a wire or thin rod of soil can be formed. Degree of resistance to deformation at or slightly above field capacity is as follows:

(a) Slightly plastic. Wire formable but soil mass easily deformable;

(b) Plastic. Wire formable and moderate pressure required for deformation of the soil mass; and (c) Very plastic. Wire formable and much pressure required for deformation of the soil mass.

B. Soil consistency when moist.

Consistence when moist is determined at a moisture content approximately midway between air dry and field capacity. At this moisture content, most soil materials exhibit a form of consistency—characterized by tendency to break into smaller masses rather than into powder; some deformation prior to rupture; absence of brittleness; and ability of the material after disturbance to cohere again when pressed together. To evaluate this consistency, a mass that appears slightly moist shall be selected and attempt made to crush in the hand.

(I) Friable. Soil material crushes easily under gentle to moderate pressure between thumb and finger, and coheres when pressed together.

(II) Firm. Soil material crushes under moderate pressure between thumb and finger but resistance is distinctly noticeable.

(III) Very firm. Soil material crushes under strong pressure; barely crushable between thumb and finger.

(IV) Extremely firm. Soil material crushes only under very strong pressure; cannot be crushed between thumb and finger and must be broken apart bit by bit.

C. Soil consistency when dry. The consistency of soil materials when dry is characterized by rigidity, brittleness, maximum resistance to pressure, more or less tendency to crush to a powder or to fragments with rather sharp edges, and inability of crushed material to cohere again when pressed together. For evaluation, the air-dry mass shall be selected and broken in the hand.

(I) Slightly hard. Weakly resistant to pressure, easily broken between thumb and finger.

(II) Hard. Moderately resistant to pressure; can be broken in the hands without difficulty but is barely breakable between thumb and finger.

(III) Very hard. Very resistant to pressure; can be broken in the hands only with difficulty; not breakable between thumb and finger.

(IV) Extremely hard. Extremely resistant to pressure; cannot be broken in the hands.

Soil structure. In many soils, the sand, silt and clay particles tend to cling or stick to one another to form a ped or a clump of soil. This is known as soil structure. Soil structure may have a significant effect on the movement of effluent through a soil.

Structure is usually not important in soil groups I and II, and these types of soils shall generally be considered suitable as to structure. The three (3) kinds of soil structure that are most significant in movement of sewage effluent through groups III and IV soils are block-like, platy and the absence of soil structure or massive conditions. These kinds of soil structure are described as follows:

A. Block-like soil structure. In groups III and IV soils, if the soil exhibits many peds of angular and subangular peds, then the soils have block-like structure. The sewage effluent may move between the cracks of these types of peds. Block-like structure in groups III and IV soils is frequently destroyed by mechanical excavating equipment manipulating the soil when it is too wet. Trenches for absorption lines being placed in groups III and IV soils with block-like structure should only be dug when the soils are moist or dry. Blocklike soil structure in groups III and IV soils shall be considered provisionally suitable;

B. Platy soil structure. If groups III and IV soils fall out into plate-like sheets, then the soil would have platy structure.

Water or effluent movement through these soils would be extremely slow, and the structure shall be considered unsuitable; and C. Absence of soil structure. Some groups II, III and IV soils are massive and exhibit no structural aggregates. In these kinds of soils, water or effluent movement would be negligible. This structure shall be considered unsuitable.

(G) Soil Drainage. Soils with seasonally high water tables are of major concern in evaluating sites for sewage effluent disposal.

These are the soil areas that give good sewage absorption rates during dry seasons of the year but force sewage effluent to the surface during the wetter seasons.

The depth of the seasonal high water table can commonly be recognized by those examining soil profiles. The criterion for recognition of high water tables is that of soil color. Subsurface horizons that are in colors of reds, yellows and browns generally indicate good soil aeration and drainage throughout the year. Subsurface horizons that are in colors of gray, olive or bluish colors indicate poor aeration and poor soil drainage. These dull or grayish colors may occur as a solid mass of soil or may be in mottles of localized spots. The volume of grayish color is indicative of the length of time that free water stands in that soil profile. There are soils that have light-colored mottles which are relic from the light-colored rock from which the soils have weathered. These soils would not have high water tables, so one must distinguish between a true soil composed of sand, silts and clays, or the rock material that may still exist in the soil profile. Similarly, there are also some soils with surface or subsurface eluvial horizons with light colors which can be unrelated to drainage conditions.
Any soil profile that has the grayish colors of chroma 2 or less (Munsell color chart) indicative of high water tables, or is either subject to periodic high water, within twenty-four inches (24") of the surface, or is less than twelve inches (12") between the proposed trench bottom and the high water table, shall be considered unsuitable as to drainage. Soils where the seasonally high water table is less than forty-eight inches (48") and more than twenty-four inches (24") below the naturally occurring surface shall be considered provisionally suitable for soil drainage, provided there remains at least twelve inches (12") of soil between the proposed trench bottom and the seasonally high water table. Soils where the seasonally high water table is greater than forty-eight inches (48") below the naturally occurring surface shall be considered suitable for soil drainage.

Drainage systems installed for groundwater lowering shall be maintained so that a minimum separation of one foot (1') occurs between the absorption trench bottom and the seasonally high water table. For extensive drainage systems, such as groundwater lowering in subdivisions, easements shall be recorded and shall have adequate width for reasonable egress and ingress for maintenance.

(H) Soil Thickness. The thickness of soils to rock which are classified as suitable or provisionally suitable in texture and structure shall be at least forty-eight inches (48") when conventional soil absorption systems at conventional depths are to be utilized. Soil thickness greater than forty-eight inches (48") shall be considered as suitable as to soil thickness. Soil thickness less than forty-eight inches (48") and greater than thirty-six inches (36") shall be considered provisionally suitable. Where special design and installation modifications can be made to provide at least two feet (2') of naturally occurring soil below the bottom of the absorption trench, these soils may be reclassified as provisionally suitable in thickness.

(I) Restrictive Horizons. Restrictive horizons in soils are recognized by their apparent resistance in excavation or in the use of a soil auger. Restrictive horizons may occur as fragipans or claypans. The fragipan is a layer that owes its hardness mainly to extreme density or compactness as opposed to high clay content or cementation. The layer is typically dense and brittle. Although fragments are friable when removed, when in place the material is so dense that water moves through it very slowly. Unlike fragipans, the claypan is a compact, slowly permeable layer in the subsoil having a much higher clay content than the overlying material. A sharply defined boundary exists between the claypan and the overlying material. Claypans are typically hard when dry and plastic and sticky when wet.

Restrictive horizons that are greater than six inches (6") thick severely restrict the movement of water and sewage effluent and do not adequately respond to groundwater lowering drainage systems. Where these horizons are less than six inches (6") thick, they do not severely restrict the movement of water and sewage effluent, but rather indicate the presence of a seasonally high water table and may be modified after special investiga- 2. Soils in which restrictive horizons are six inches (6") or more in thickness and at depths greater than forty-eight inches (48") below the ground surface shall be considered suitable as to depth to restrictive horizons.

Restrictive horizons six inches (6") or more in thickness and at depths between forty-eight inches and twenty-four inches (48–24") shall be considered provisionally suitable as to depth to restrictive horizons. Restrictive horizons six inches (6") or more in thickness encountered at depths less than twenty-four inches (24") below the ground surface shall be considered unsuitable as to depth to restrictive horizons.

(J) Other Applicable Factors. The site evaluation should include consideration of any other applicable factors involving environmental principles including:

The potential environmental hazard of possible failures of soil absorption systems involving large quantities of sewage, which would dictate larger separation distances than the minimums specified in subsection (1)(D) of this rule; and 2. The potential environmental and health hazard of possible massive failures of soil absorption systems proposed to serve large numbers of residences, as in residential subdivisions or mobile home parks.

(K) Determination of Overall Site Suitability. All of the criteria in subsections (7)(E)–(J) of this rule shall be determined to be suitable, provisionally suitable or unsuitable as indicated. If all criteria are classified the same, that classification shall prevail.

Where there is a variation in classification of the several criteria, the following shall be used in making the overall site classification.

The lowest of the uncorrectable characteristics will determine the overall site classification. The administrative authority shall make this determination— 1. If the topography is classified as unsuitable, it may be reclassified provisionally suitable under the conditions outlined in subsection (7)(E) of this rule;

If the soil texture is classified as unsuitable, the overall classification will be unsuitable regardless of the other criteria unless the provisions of subsection (6)(K) of this rule are met;
If the soil structure is classified as unsuitable, the overall classification will be unsuitable regardless of the other criteria unless the provisions of subsection (6)(K) of this rule are met;
When soil thickness is classified as unsuitable, it may be reclassified as provisionally suitable under the conditions outlined in subsection (7)(H) of this rule;
When the restrictive horizon is classified unsuitable, it may be reclassified as provisionally suitable under the conditions outlined in subsection (6)(K) of this rule; and 6. When drainage (groundwater level) is unsuitable, it may be reclassified as provisionally suitable under the conditions outlined in subsection (7)(G) of this rule.

(L) Site Classification. Sites classified as suitable may be utilized for a ground absorption sewage treatment and disposal system consistent with this rule. A suitable classification generally indicates soil and site conditions favorable for the operation of a ground tem or have slight limitations that are readily overcome by proper design and installation.

Sites classified as provisionally suitable may be utilized for a ground absorption sewage treatment and disposal system consistent with this rule but with moderate limitations. Sites classified provisionally suitable require some modifications and careful planning, design and installation for a ground tem to function satisfactorily.
Sites originally classified as unsuitable may be used for soil absorption disposal systems, provided engineering, hydrogeologic and soil studies indicate to the administrative

(M) Design Criteria. Tables 13 and 14 shall be used when determining application rates for the appropriate sewage disposal system design.

Table 13 shall be used when determining the application rate for septic tank systems of conventional design when using the site evaluation criteria in this rule.
The construction of any conventional or LPP system must meet the other applicable requirements as set forth in section (6) of this rule. Soils for LPP systems must be classified as suitable or provisionally suitable to a depth of two feet (2') from the original ground surface. Table 14 shall be used when determining the application rate when using the site evaluation criteria in this rule.

History

authority as an acceptable method of subsurface disposal of sewage without the required use of gravel. The following are examples:
authority on a case-by-case basis. The absorption trenches shall be located not less than three (3) times the trench width on centers with a minimum spacing of five feet (5') on centers.
authority:
authority include the following:
authority, where the percentage of rock fragments is less than seventy percent (70%) for at least four feet (4') below the trench bottom. For sand-lined trenches to function properly, the permeability of the natural material should be similar to the permeability of the liner material. Sand-lined trenches must not be used over fragipans or other restrictive layers which have potential to perch water tables and could cause saturation of the liner material.
authority on a case-by-case basis which may require stipulations in a signed agreement regarding the use and the length of time for use of the holding tank.
authority if they can be demonstrated to produce a comparable effluent quality.
authority in accordance with section (6) of this rule. Due to the various pretreatment methods and appurtenances and lack of extensive experience, drip soil absorption systems must be viewed as experimental, and back-up design for another system shall be approved in case of failure of the drip soil absorption system.
authority concerning repair to on-site sewage disposal systems existing prior to January 1, 1996 with site limitations or for property platted prior to January 1, 1996 with site limitations. Where variances have been allowed from the standards, the administrative authority may require that a higher level of pretreatment than that of a septic tank be provided. At the discretion of the administrative
authority and with relative assurance for protection of the public health and preservation of the quality of surface and ground waters, variances may be allowed for the following:
authority and shall provide the following:
authority to express comments concerning the consideration of granting a variance.
authority to allow an installation based upon the criteria contained in this section. The administrative authority may require percolation tests in addition to evaluation of soil characteristics. Whenever percolation tests and these criteria are used, the size of the proposed system or suitability of a site should be based upon which criteria produce the most conservative system. This type evaluation should be conducted by a professional soil scientist, engineer, sanitarian or registered geologist with special training in determining soil morphological characteristics in the field.
authority, the surface area on or around a ground absorption system sewage treatment and disposal system shall be landscaped to provide adequate drainage. The interception of perched or lateral groundwater movement shall be provided where necessary to prevent soil saturation on or around the ground tem.
authority that a suitable septic tank system or a suitable alternate system can reasonably be expected to function satisfactorily. These sites may be reclassified as provisionally suitable upon submission to the administrative authority and meeting the department's requirements in subsection (6)(K) of this rule.
AUTHORITY: sections 701.040(1) and 701.043.1., RSMo 1994. Emergency rule filed April 17, 1995, terminated April 26, 1995. Original rule filed April 17, 1995, effective Dec. 30, 1995. Original authority: 701.040 and 701.043, RSMo 1994.

19 CSR 20-3.070 Requirements for On-Site Wastewater Treatment System Inspectors/Evaluators {#sec-19-csr-20-3.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-3.070}

PURPOSE: This rule establishes criteria for inclusion on the lists of those individuals licensed to inspect or evaluate on-site wastewater treatment systems for the purposes of real estate transactions. more than the actual cost of reproduction.

rial. The entire text of the rule is printed (1) Applicability. The requirements and procedures included in this rule apply to individuals qualified to perform inspections and/or evaluations of existing on-site wastewater treatment systems upon a request from a lending institution, a prospective purchaser, the owner of the property, a real estate agent, or a real estate broker.

(2) Definitions.

(A) “Administrative authority” shall mean the department or local public health agencies, planning and zoning commissions, county building departments, county public works departments, sewer districts, and/or municipalities that have authority to govern on-site wastewater treatment systems.

(B) “Department” shall mean the Missouri Department of Health and Senior Services.

(C) “Lending institution” shall mean a bank, savings and loan association, credit union, consumer credit lender, mortgage banker, or any other association or institution, which makes real estate loans.

(D) “Licensed individual” shall mean any person, including staff of local administrative authorities, licensed by the department, to inspect or evaluate an existing on-site wastewater treatment system for the purposes of a real estate transaction.

(E) “On-site wastewater treatment system (OWTS)” shall mean any system handling, or treatment facility receiving, domestic sewage which discharges three thousand (3,000) gallons per day or less into a subsurface soil absorption system or a single-family residence lagoon.

(F) “Property owner” shall mean the person with the legal right to possession of real estate.

(G) “Requesting party” shall mean a lending institution, a prospective purchaser, the property owner, a real estate agent, or a real estate broker who requests an inspection or evaluation of an OWTS serving a property that is the subject of a real estate transaction.

(3) An individual must be licensed with the department to inspect or evaluate an existing OWTS upon the request from a lending institution, which is providing either a government loan or conventional loan, or from another requesting party in connection with a real estate transaction. If the inspection or evaluation determines that the OWTS does not meet department standards, any new construction, major modification, or major repair must be conducted according to the standards set forth in sections 701.025 through 701.059, RSMo, and any rules promulgated thereunder or applicable local OWTS ordinance.

(4) As deemed necessary by the department, an inspection or evaluation of an OWTS will include a microbiological test and other examination(s) of the private water supply intended for potable use serving the same property as the OWTS. In addition, the inspection or evaluation will include an inspection of any visible portion of the water supply construction, from the source to the storage vessel, and may include review of the well drilling reports.

(5) If it is necessary to enter any adjoining property in the course of an inspection or evaluation to properly make a determination regarding the OWTS inspection/evaluation, a licensed individual shall notify the owner of the adjoining property and obtain permission before entry is made.

(6) An individual must be licensed with the department to perform inspections and evaluations of existing OWTS for the purposes of a real estate transaction. To be licensed with the department, an individual shall:

(A) Complete a basic installer training (70%) or higher;

(B) Complete a licensed inspector training (70%) or higher; and (C) Complete the department’s licensing process described in section (7) of this rule.

(7) Department’s Licensing Process.

(A) The license shall be issued to only one (1) individual person and not to a company, firm, association, or other group. The license is not transferable.

(B) To obtain a license from the department, an individual must submit a completed application packet to the department for approval. Completed application packets (C) The application packet shall include 1. The completed application form, Mo Form #1 (6-08), Application for Licensure, is incorporated by reference in this rule and is available on the Internet at 2. Documentation of the successful completion of both the basic installers training course and licensed inspector training course; and 3. A check or money order made processing fee of ninety dollars ($90). The processing fee may be waived for the staff of a local administrative authority that has enacted local ordinances, which include requirements for inspections of existing OWTS that are at least equal to department standards.

(8) Department’s Renewal Licensing Process.

An individual’s license with the department shall expire thirty-six (36) months from the month of issuance unless the license has been revoked or surrendered.

(A) To renew their license with the department, an individual must submit a renewal application packet to the department for approval. Completed application packets (B) The renewal application packet shall include:

The completed application form, Mo Form #2 (6-08), Application for Licensure Renewal, is incorporated by reference in this

rule and is available on the Internet at 2. A check or money order made processing fee of ninety dollars ($90). The processing fee may be waived for the staff of a local administrative authority that has enacted local ordinances, which include requirements for inspections of existing OWTS that are at least equal to department standards; and 3. Documentation of the applicant’s successful completion, within the previous thirty-six (36) months of the following minimum continuing education:

A. For individuals who are renewing their license for the first time, at least twenty (20) hours of department-approved continuing education units of which at least eight (8) continuing education units shall meet select department criteria; or B. For individuals who are renewing their license for the second or subsequent time, at least twelve (12) hours of department-approved continuing education units of which at least eight (8) continuing education units shall meet select department criteria.

(C) Individuals submitting a renewal application more than fifteen (15) calendar days after the previous license expires shall pay a late charge of ten dollars ($10) in addition to the ninety-dollar ($90) processing fee.

(D) License renewal applications will not be accepted if received by the department the previous license expires. Individuals submitting license renewal applications more than forty-five (45) calendar days after the expiration of their license will be required to complete the initial licensing process, including any department training requirements for an initial license.

(9) A fifteen-dollar ($15) processing fee will be assessed for duplicate and/or replacement license identification cards.

(10) Standards of Practice for Licensed Individuals.

(A) A licensed individual shall:

Possess a current license with the department before conducting any inspection or evaluation of an OWTS;
Inspect or evaluate only those OWTS for which requests have been made for the purposes of real estate transactions.

Investigations of complaints or alleged violations of Chapter 701, RSMo, may only be made by the department or a local administrative authority;

As part of an OWTS inspection or evaluation, collect a water sample from a private water supply for microbiological testing and inspect any visible portion of the water supply construction, from the source to the storage vessel;
Record their license number on all bids, proposals, contracts, invoices, inspection reports, evaluation reports, and other correspondence with the requesting party or the department;
Apply department standards for all inspections and evaluations of OWTS using the correct procedures and forms to complete the inspection or the evaluation. Combining inspection and evaluation procedures or forms is not acceptable;
Document inspections and evaluations accurately in writing on departmentapproved forms;
Clearly state any defect(s), if the OWTS is found to be malfunctioning or otherwise not meeting department standards;
Retain one (1) copy of the completed documentation of the inspection or evaluation for at least three (3) years and submit a copy to the department, the local administrative
Submit completed inspection/evaluation reports to the department within thirty (30) calendar days of completion, including water sample results if applicable; and 10. Notify the property owner that he/she is not obligated to contract for repair or re-inspection services with the initial licensed individual if the OWTS has been found to be malfunctioning or otherwise not meeting department standards. However, this paragraph does not preclude the licensed individual from offering these services to the owner.

(11) The department may audit the work of a licensed individual at any time to determine whether the standards of practice, as defined by this rule, are being met. Failure to adhere to department standards may be cause for placement on probation, suspension, or revocation of the license, or for mandatory successful completion of a training course and/or testing as described in section (6) of this rule.

The audit may be an unannounced visit to the property inspected or evaluated, or a visit during an inspection or evaluation with or without prior appointment with the licensed individual.

(12) A licensed individual may have his/her license placed on probation, suspended, or revoked if the individual:

(A) Fails an audit or refuses to participate in an audit;

(B) Fails to submit reports, submits false reports, or allows another individual to use his/her license;

(C) Is convicted of a violation of any provisions of sections 701.025 through 701.059, RSMo, or any rules promulgated under these statutes;

(D) Has pled guilty or has been found other crime relating to activities of inspecting, evaluating, installing, repairing, or otherwise associated with an OWTS;

(E) Directs or allows an unlicensed individual to conduct any part of an inspection or evaluation of an OWTS; or (F) Fails to comply with the standards of practice established in this rule.

(13) The suspension or revocation of an individual’s license shall be served in writing by certified mail or personal service to the affected individual or his/her representative.

The decision of the department may be appealed to the Administrative Hearing Commission as provided in Chapters 536 and 621, RSMo.

(14) Any individual whose license has been revoked may not reapply for a license for at least one (1) year from date of revocation, must complete the department’s training requirements for licensure described in section (6) of this rule, and complete the department’s licensing process as described in section (7) of this rule.

(15) An individual may be permanently barred from reapplying for a license if the individual:

(A) Has pled guilty or has been found other crime relating to activities associated with an OWTS; or (B) Has his/her license revoked a second time within five (5) years.

(16) No person without a valid license may conduct any part of an inspection or evaluation of an OWTS, whether on his/her own or under supervision of a person with a valid license. Persons conducting inspections or evaluations without the required license, or representing themselves as licensed, are considered in violation of section 701.053, RSMo, which is a class A misdemeanor.

rule filed April 17, 1995, effective Dec. 30, 1995. Rescinded and readopted: Filed Oct. 22, 2008, effective May 30, 2009. *Original authority: 701.033, RSMo 1986, amended 1993, 1994, 1995, 2004; 701.046, RSMo 1994; and 701.051, RSMo 1994, amended 1997.

History

authority, if applicable, the requesting party, and the property owner;
AUTHORITY: section 701.033, RSMo Supp. 2008 and sections 701.046 and 701.051, RSMo 2000. Emergency rule filed April 17, 1995, terminated April 26, 1995. Original

19 CSR 20-3.080 Requirements for Percolation Testers, On-Site Soils Evaluators and Registered On-Site Wastewater Treatment System Installers {#sec-19-csr-20-3.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-3.080}

PURPOSE: This rule establishes the criteria for inclusion on the lists of those individuals qualified to perform percolation tests and/or soils morphology evaluations in determining soil properties for on-site wastewater treatment systems and for inclusion on the registered on- site wastewater system installers list in accordance with sections 701.025 through 701.059, RSMo. rated by reference as a portion of the rule more than the actual cost of the reproduction.

rial. The entire text of the rule is printed (1) Applicability. The requirements and procedures included in this rule apply to individuals qualified to perform percolation tests and/or soil morphology evaluations and installers who are seeking inclusion on the department’s on-site wastewater treatment systems professionals registry.

(2) Definitions.

(B) “Advanced on-site wastewater treatment system (OWTS) installer” shall mean an individual registered by the department to install advanced OWTS as listed by the department.

(C) “Basic on-site wastewater treatment system (OWTS) installer” shall mean an individual registered by the department to install basic OWTS as listed by the department.

(D) “Department” shall mean the Missouri Department of Health and Senior Services.

(E) “Installer” shall mean any individual, other than a homeowner, who installs a system for their own personal use, who alters, extends, repairs, or constructs an OWTS, including but not limited to, excavating or earthmoving work connected with the construction of an OWTS on behalf of, or under contract with, the property owner.

(F) “Licensed professional engineer” shall mean any person authorized pursuant to the provisions of Chapter 327, RSMo, to practice as a professional engineer in Missouri, as the practice of engineering is defined in section 327.181, RSMo.

(G) “On-site soil evaluator” shall mean individuals including soil scientists, licensed professional engineers, and registered geologists meeting the requirements of this rule.

(H) “On-site wastewater treatment system (OWTS)” shall mean any system handling, or treatment facility receiving, domestic sewage which discharges three thousand (3,000) gallons per day or less into a subsurface soil absorption system or a single-family residence lagoon.

(I) “Registered geologist” shall mean any person authorized pursuant to the provisions of Chapter 256, RSMo, to practice as a registered geologist in Missouri, as defined in

section 256.453(10), RSMo.

(J) “Soil morphology evaluation” shall mean the method of testing or evaluating absorption qualities of the soil by physical examination of the soil’s color, mottling, texture, structure, topography, and hill-slope position.

(K) “Soil scientist” shall mean a person that has successfully completed at least fifteen (15) semester credit hours of soils science course work, including at least three (3) hours of course work in soil morphology and interpretations.

(3) An individual must be registered with the department to conduct any part of a percolation test or soil morphology evaluation in which results are intended for use in the design or installation of an OWTS according to the standards set forth in sections 701.025 through 701.059, RSMo, and 19 CSR 20- 3.060.

(A) Percolation Tests. To register with the department to conduct percolation tests, an individual shall:

Successfully complete a training department, which shall include, at a minimum, course work, field work, a written examination, and a practical examination; or 2. Meet the definition of an on-site soil evaluator, licensed professional engineer, or registered geologist; and 3. Complete the department’s registra- (B) Soil Morphology Evaluations. To register with the department to perform soils morphology evaluations, an individual shall:
Meet the definition of a soil scientist with at least fifteen (15) semester credit hours of soils science course work, including at least three (3) hours of course work in soil morphology and interpretations; or 2. Meet the definition of a licensed professional engineer or registered geologist with at least ten (10) semester credit hours of soils science course work, including at least three (3) hours of course work in soil morphology and interpretations; and 3. Complete a written and field test conducted by or approved by the department with a score of seventy percent (70%) or higher on all sections of each examination; and 4. Complete the department’s registra- (4) An individual must be registered with the department, with the exception of a homeowner meeting the requirements of section 701.055, RSMo, to install an OWTS. Only installers registered as advanced OWTS installers shall install systems listed by the department as advanced OWTS.

(A) Basic OWTS Installer. To register with the department as a basic OWTS installer, an individual shall:

Complete a basic installer training (70%) or higher; and 2. Complete the department’s registra- (B) Advanced OWTS Installer. To register with the department as an advanced OWTS installer, an individual shall:
Possess a basic OWTS installer’s registration in good standing;
Complete an advanced OWTS installer training course conducted by or approved by the department with a score of seventy percent (70%) or higher; and 3. Complete the department’s registra- (5) Department’s Registration Process.

(A) To register with the department, an individual must submit a completed application packet to the department for approval.

Completed application packets shall be mailed to the Missouri Department of Health and Senior Services, Attention: Fee Receipts, PO Box 570, Jefferson City, MO 65102- 0570.

(B) The application packet shall include 1. The completed application form, Mo Form #1 (6-08), Application for Registration, which is incorporated by reference in this

rule and is available on the Internet at 2. For on-site soil evaluators, mail an original transcript from the college or university attended directly from the registrar to the Missouri Department of Health and Senior Services, Attention: Bureau of Environmental

Regulation and Licensure, PO Box 570, Jefferson City, MO 65102-0570. If requested, provide course descriptions from the college or university attended to verify the nature of the course work;

For percolation testers and on-site soil evaluators, provide proof of licensure as a professional engineer or certificate of registration by the Board of Geologist Registration indicating the registrant is in good standing, if applicable; and 4. A check or money order made processing fee of ninety dollars ($90).

(6) Department’s Temporary and Probationary Registration Process.

(A) Upon completion of the department’s registration process described in section (5) of this rule, the department may issue a one (1)-time temporary basic OWTS installer registration, valid for no more than one hundred eighty (180) calendar days for work in a specific county or counties. The temporary basic OWTS registration will be converted to a basic OWTS installer registration upon completion of a training course conducted by or approved by the department. Failure to complete the training or the department’s registration process will result in termination of the individual’s temporary basic OWTS installer registration.

(B) The department may issue a probationary basic OWTS installer registration for work in a specific county or counties. This registration will be valid for a specific period of time, as determined by the department, and will be dependent on the registered individual meeting and maintaining specific requirements as established by the department and completing the department’s registration process as described in section (5) of this rule.

(7) Department’s Renewal Registration Process. An individual’s registration with the department shall expire thirty-six (36) months from its effective date unless the registration has been revoked or surrendered.

(A) To renew his or her registration with the department, an individual must submit a renewal application packet to the department for approval. Completed application packets (B) The renewal application packet shall include:

The completed application form, Mo Form #2A (6-08), Application for Registration Renewal, which is incorporated by reference in this rule and is available on the Internet at www.dhss.mo.gov/Onsite or by contacting the department at PO Box 570, Jefferson City, MO 65102-0570, (573) 751- 6095. This rule does not incorporate any subsequent amendments or additions;
A check or money order made processing fee of ninety dollars ($90); and 3. Documentation of the applicant’s successful completion, within the previous thirty-six (36) months, of the following minimum continuing education:

A. For on-site soil evaluators, percolation testers, and basic and advanced OWTS installers who are renewing their registration for the first time, at least twenty (20) hours of department-approved continuing education units of which at least eight (8) continuing education units shall meet select department criteria;

B. For on-site soil evaluators and advanced OWTS installers who are renewing their registration for the second or subsequent time, at least twelve (12) hours of department-approved continuing education units of which at least eight (8) continuing education units shall meet select department criteria related to their OWTS profession; or C. For basic OWTS installers and percolation testers who are renewing their registration for the second or subsequent time, at least eight (8) hours of department-approved continuing education units.

(C) Individuals submitting a renewal application more than fifteen (15) calendar days after the previous registration expires shall pay a late charge of ten dollars ($10) in addition to the ninety dollar ($90) registrationprocessing fee.

(D) Registration renewal applications will not be accepted if received by the department the previous registration expires. Individuals submitting registration renewal applications expiration of their registration will be required to complete the initial registration process, including any department training requirements for an initial registration.

(8) A fifteen-dollar ($15) processing fee will be assessed for duplicate and/or replacement registration identification cards.

(9) Standards of Practice for Percolation Testers, On-Site Soil Evaluators, and OWTS Installers.

(A) A percolation tester or on-site soil evaluator shall:

Possess a current registration with the department before performing any activities related to a percolation test or soil morphology evaluation;
Record their registration number on all bids, proposals, contracts, invoices, percolation test reports, soil morphology evaluation reports, and other correspondence with the property owner or administrative authority;
Provide true and accurate information on any application, percolation test report, soil morphology evaluation report, and any other OWTS documentation;
Maintain a current address and phone number with the department and submit any address or phone number changes to the department in writing within thirty (30) calendar days of the change taking place;
Conduct percolation tests in accordance with section (2) of 19 CSR 20-3.060;
Conduct site/soil morphology evaluations in accordance with the standards detailed in sections (2) and (7) of 19 CSR 20- 3.060. Specifically, the on-site soil evaluator A. Evaluate the nine (9) items listed in paragraphs (2)(A)2. through 10. of 19 CSR 20-3.060;

B. Evaluate and classify six (6) site factors listed in subsection (7)(C) of 19 CSR 20-3.060, as suitable, provisionally suitable, or unsuitable according to subsections (7)(E) through (L) of 19 CSR 20-3.060;

C. Include a diagram showing location and extent of the area(s) evaluated;

D. Make recommendations regarding the use and effectiveness of water lowering systems when there is evidence of a high water table; and E. Based on subsection (7)(M) and Tables 13 and 14 of 19 CSR 20-3.060, for horizons that are not classified as unsuitable, assign a conventional soil loading rate for each horizon and assign an alternative soil loading rate for each horizon to a depth of at least twelve inches (12") below the likely depth of an alternative system.

(B) A registered basic OWTS installer or a registered advanced OWTS installer shall:

Possess a current basic OWTS installer registration or advanced OWTS installer registration with the department before beginning construction of any OWTS;
Record their registration number on all bids, proposals, contracts, invoices, permit application construction drawings, and other correspondence with the property owner or administrative authority;
Provide true and accurate information on any application and any other OWTS documentation;
Notify the administrative authority if their involvement as the registered installer with the permit application and OWTS changes;
Begin the construction of an OWTS only after obtaining approval from the administrative authority, unless approval is not required;
Construct the OWTS meeting the construction standards and permit criteria required by sections 701.025 through 701.059, RSMo, and any rule adopted thereunder or the more stringent requirements of the administrative authority, if applicable;
Construct the OWTS that has been authorized by the administrative authority for the specific location identified in the application;
Be present at the construction site during construction and supervise all construction activities;
Provide required notice and an opportunity for inspection prior to completion of the OWTS installation as required by the administrative authority;
Submit complete and accurate “certification without on-site inspection form,” when requested;
Not create or increase a health or safety hazard, nuisance condition, or surface water or groundwater contamination when constructing, repairing, modifying, or troubleshooting an OWTS; and 12. Maintain a current address and phone number with the department and submit any address or phone number changes to the department in writing within thirty (30) calendar days of the change taking place.

(10) The department may audit the work of a percolation tester, on-site soil evaluator, registered basic OWTS installer, or registered advanced OWTS installer at any time to determine whether the standards of practice, as defined by this rule, are being met. Failure to adhere to department standards may be cause for placement on probation, suspension, or revocation of the registration, or for mandatory successful completion of a training course and/or testing as described in sections (3) and (4) of this rule. The audit may be an unannounced visit to the property on which the percolation test, soil morphology examination, or OWTS installation was conducted, which may include an independent soil percolation test or soil morphology examination, or a visit within the period of a soil percolation test, soil morphology examination, or OWTS installation with or without prior appointment with the registered individual.

(11) A percolation tester, on-site soil evaluator, registered basic OWTS installer, or registered advanced OWTS installer may have their registration placed on probation, suspended, or revoked if the individual:

(A) Fails to maintain any professional license necessary for registration as a percolation tester or on-site soil evaluator;

(B) Fails an audit or refuses to participate in an audit;

(D) Is convicted of a violation of any provisions of sections 701.025 through 701.059, RSMo, or any rules promulgated under these statutes;

(E) Has pled guilty or has been found other crime relating to activities of percolation testing, soil morphology evaluations, installing, repairing, inspecting, or otherwise associated with an OWTS;

(F) Directs or allows an unregistered individual to conduct a percolation test or soil morphology examination;

(G) Directs or allows an unregistered individual to install an OWTS without direct supervision; or (H) Fails to comply with the standards of practice established by this rule.

(12) The suspension or revocation of a percolation tester’s, on-site soil evaluator’s, or OWTS installer’s registration shall be served in writing by certified mail or personal service to the affected individual or his/her representative. The decision of the department may be appealed to the Administrative Hearing Commission as provided in Chapters 536 and 621, RSMo.

(13) Any individual whose registration has been revoked may not reapply for registration for at least one (1) year from date of revocation, and must complete the department’s training requirements for registration described in sections (3) and (4) of this rule and complete the department’s registration process as described in section (5) of this (14) An individual may be permanently barred from reapplying for registration if the individual:

(A) Has pled guilty or has been found other crime relating to activities associated with an OWTS; or (B) Has his/her registration revoked a second time within five (5) years.

(15) No person without a valid registration may conduct any part of a percolation test or soil morphology evaluation for an OWTS, whether on their own or under supervision of a person with a valid registration. Persons conducting percolation tests or soil morphology evaluations without the required registration, or representing themselves as registered, are considered in violation of section 701.053, RSMo, which is a class A misdemeanor.

(16) No person as defined in section 701.025, RSMo, may authorize, permit, or knowingly allow a percolation test or soil morphology evaluation for an OWTS by an unregistered individual or the installation of an OWTS by an unregistered individual other than the homeowner.

Emergency amendment filed Sept. 2, 2004, effective Sept. 12, 2004, expired March 10, 2005. Rescinded and readopted: Filed Sept. 2, 2004, effective Feb. 28, 2005. Amended:

Filed Oct. 22, 2008, effective May 30, 2009. *Original authority: 701.033, RSMo 1986, amended 1993, 1994, 1995, 2004 and 701.040, RSMo 1994.

History

AUTHORITY: section 701.033, RSMo Supp. 2008 and section 701.040, RSMo 2000. Emergency rule filed April 17, 1995, terminated April 26, 1995. Original rule filed April 17, 1995, effective Dec. 30, 1995.

Chapter 8 Lead Program

19 CSR 20-8.010 Accreditation of Lead Training Program {#sec-19-csr-20-8.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-8.010}

19 CSR 20-8.020 Licensing of Lead Inspectors, Lead Abatement Workers and Lead SENIOR SERVICES AND PUBLIC HEALTH SERVICES Health {#sec-19-csr-20-8.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-8.020}

19 CSR 20-8.010 Accreditation of Lead Training Program {#sec-19-csr-20-8.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-8.010}

(Rescinded February 29, 2000)

Emergency rule filed March 1, 1995, effective March 12, 1995, expired July 9, 1995. Original rule filed Nov. 2, 1994, effective June 30, 1995. Emergency rescission filed Aug. 19, 1999, effective Aug. 30, 1999, expired Feb. 25, 2000. Rescinded: Filed Aug. 19, 1999, effective Feb. 29, 2000.

History

AUTHORITY: section 701.314, RSMo 1994. Emergency rule filed Nov. 2, 1994, effective Nov. 12, 1994, expired March 11, 1995.

19 CSR 20-8.020 Licensing of Lead Inspectors, Lead Abatement Workers and Lead Abatement Supervisors/ Contractors {#sec-19-csr-20-8.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-8.020}

(Rescinded February 29, 2000)

Emergency rule filed March 1, 1995, effective March 11, 1995, expired July 9, 1995. Original rule filed Nov. 2, 1994, effective June 30, 1995. Emergency rescission filed Aug. 19, 1999, effective Aug. 30, 1999, expired Feb. 25, 2000. Rescinded: Filed Aug. 19, 1999, effective Feb. 29, 2000.

History

AUTHORITY: section 701.314, RSMo 1994. Emergency rule filed Nov. 2, 1994, effective Nov. 12, 1994, expired March 11, 1995.

19 CSR 20-8.030 Lead Poisoning Assessment, Testing, and Reporting {#sec-19-csr-20-8.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-8.030}

PURPOSE: This rule establishes criteria for the screening and follow-up activities of children less than seventy-two (72) months of age for lead poisoning in Missouri.

(1) Applicability. This rule applies to health care professionals, local public health agencies (LPHAs), and others who perform blood lead specimen collections and lead case management.

(2) Definitions. The following definitions shall apply in the interpretation and application of this rule and shall have the meaning stated below:

(A) “Blood lead testing” shall mean the collection of a capillary or venous blood specimen for analysis of lead in an individual’s bloodstream;

(B) “Capillary blood specimen” shall mean a procedure of lancing the skin and placing an approved lead collection device at the edge of the blood droplet to collect a sample of blood for analysis;

(C) “Chelation” shall mean a treatment in which heavy metals are removed from the bloodstream by means of a medication that binds with metal ions;

(D) “Confirmatory blood lead test” shall mean a blood lead test performed by venous blood specimen;

(E) “Department” shall mean the Missouri Department of Health and Senior Services;

(F) “Elevated blood lead (EBL)” shall mean a blood lead level equal to or greater than three and five-tenths micrograms per deciliter (≥3.5 mcg/dL);

(G) “Follow-up testing” shall mean a blood lead test performed by venous blood specimen to— 1. Confirm an elevated capillary blood specimen result; and/or 2. Monitor patient treatment progression;

(H) “Health care professional” shall mean medical providers, including but not limited to physicians, nurses, pharmacists, and laboratory technicians;

(I) “Lead case manager” shall mean a licensed registered nurse, licensed medical or clinical social worker, or health educator who is supervised by a licensed medical professional and performs services for children with EBLs. The lead case manager is an agent of the— 1. Health plan for children with an EBL enrolled in MO HealthNet or Medicaid; or 2. Local Public Health Agency for children with an EBL enrolled in Fee for Service Medicaid, a private insurance company, or who are uninsured;

(J) “Lead poisoning” shall mean a condition resulting from an EBL;

(K) “Primary care provider (PCP)” shall mean the health care professional who provides medical care services and/or serves as the contact for coordinating health care services associated with a lead poisoning case;

(L) “Treatment” shall mean the medical and/or health actions and intervention procedures to be followed as the result of an identified case of lead poisoning for the purposes of lowering and maintaining the child’s blood lead level below the blood lead reference value; and (M) “Venous blood specimen” shall mean a procedure of puncturing a vein using a needle and an approved lead collection device to collect a sample of blood for analysis.

(3) Clinical Lead Education and Assessment.

(A) The primary care provider shall perform a lead risk screening, at least annually for children ages six (6) months up to seventy-two (72) months.

(B) The lead risk screening shall be conducted with the child’s parent/guardian and include— 1. Educational information regarding potential lead sources and routes of exposure;

Educational information regarding medical and behavioral effects associated with lead exposure;
Completing/updating the Healthy Children and Youth (HCY) Lead Risk Assessment Guide (2023), incorporated by reference as published by the Missouri Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102-0570, and available by the department at https://health.mo.gov/ living/environment/lead/pdf/HCYLeadRiskAssessmentGuide.

pdf. This rule does not incorporate any subsequent amendments or additions;

Assessing the child’s developmental status as it relates to potential lead exposure;
Assessing the child’s nutritional status; and 6. The primary care provider shall offer testing to all children under age four (4) years annually.

(4) A child’s blood lead level shall be tested with the consent of (3/31/25) Denny Hoskins AND PUBLIC HEALTH SENIOR SERVICES a parent or guardian when— (A) The child receives Medicaid benefits and— 1. Is twelve (12) months of age;

Is twenty-four (24) months of age; or 3. Has not previously tested;

(B) The child has prior blood lead testing results that necessitate follow-up testing as laid out in section 701.342.4, RSMo, and subsection (6)(C) below;

(D) A “yes” or “unknown” response is documented on the HCY Lead Risk Assessment Guide;

(E) There is a child under seventy-two (72) months of age residing in a household or has recently resided in a household of another lead-poisoned child in which the department is notified of a case of lead poisoning of; or (F) The child’s parent/guardian requests blood lead testing.

(5) Documentation of Blood Lead Testing or Refusal of Blood Lead Testing.

(A) For blood lead testing, the health care professional shall document in the child’s medical record— 1. The lead risk screening for children ages six (6) months up to seventy-two (72) months, at least annually;

That testing was offered annually for all children under the age of four (4) years;
Indicate capillary and/or venous blood specimen;
Collection dates; and 5. Blood lead level results.

(B) Refusal of blood lead testing.

Only the parent/guardian of the child may refuse the blood lead test.
The refusal shall be in writing, signed by the parent/ guardian, and documented in the child’s medical record.

(6) Capillary Screening and Venous Blood Lead Testing.

(A) An initial capillary or venous blood specimen shall be collected in accordance with section (4) of this rule.

(B) A confirmatory blood lead specimen shall be collected when a capillary blood specimen result indicates an EBL.

(C) Blood lead testing shall be in accordance with the Missouri Guidelines for the Assessment and Management of Childhood Lead Exposure (2024), incorporated by reference as published by the Missouri Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102-0570, and available at https://health.mo.gov/living/environment/ lead/pdf/recommended-actions-guide.pdf. This rule does not incorporate any subsequent amendments or additions.

(7) Blood Lead Specimen Collection and Laboratory Analysis.

(A) Blood lead specimens shall be obtained using federal Clinical Laboratory Improvement Act (CLIA) certified collection devices and protocols unless specifically waived by CLIA.

(B) Laboratories shall be CLIA certified to analyze venous blood specimens.

(C) Health care professionals shall follow the certified laboratory’s criteria and protocols for collecting and submitting blood lead specimens.

(8) Reporting of Blood Lead Testing Results.

(A) Health care professionals performing blood lead analysis shall report to the department in accordance with 19 CSR 20- 20.020.

(9) Medical Case Management Coordination of Childhood EBL Cases. For a child with an EBL, the— (A) Primary care provider (PCP) shall— 1. Refer to Missouri Guidelines for the Assessment and Management of Childhood Lead Exposure;

Provide the parent/guardian with lead poisoning prevention education;
Collaborate with LPHA lead case managers or MO HealthNet lead case managers, environmental lead risk assessor assigned to the case, and Woman, Infants, and Children (WIC) staff as appropriate;
If chelation therapy is initiated, coordinate with the— A. Lead risk assessor for a lead-safe discharge plan in accordance with the Missouri Guidelines for the Assessment and Management of Childhood Lead Exposure; and B. LPHA lead case manager or MO HealthNet lead case manager for a health care discharge plan;
Provide the parent/guardian with education regarding the need for appropriate nutrition, hygiene, specific cleaning techniques, and safe methods for the removal or reduction of lead exposures;
Provide clinical evaluation for complications of lead ingestion/poisoning;
Facilitate and coordinate medical treatment services; and 8. Refer child for specialty services, including but not limited to WIC, First Steps, Head Start, and Missouri’s Parent Education Program, as appropriate;

(B) Lead case managers shall— 1. Refer to Missouri Guidelines for the Assessment and Management of Childhood Lead Exposure;

Coordinate efforts with the PCP in addressing, scheduling, and documenting the dates and results of lead interventions as they relate to assessments and results of the child’s iron status, nutrition, development, behavior, cognitive, physical, and social needs; and 3. Provide home or telehealth visits to complete health questionnaires and provide nutritional and developmental assessments when a child has a blood lead level equal to or greater than ten micrograms per deciliter (≥10 mcg/dL); and (C) Environmental lead risk assessors shall— 1. Refer to Missouri Guidelines for the Assessment and Management of Childhood Lead Exposure; and 2. Conduct an environmental risk assessment in accordance with 19 CSR 30-70.620 when a child has a confirmed EBL equal to or greater than ten micrograms per deciliter (≥10 mcg/dL).

(10) Reporting Requirements of EBL Case Management Activities.

(A) The PCP providing case management for a child with an EBL shall provide information regarding each case to the department, LPHA, MO HealthNet lead case manager, and the licensed lead risk assessor as appropriate.

(B) The LPHA and/or MO HealthNet lead case manager shall document EBL case management information into the Missouri Department of Health and Senior Services electronic reporting system.

Name of agency performing case management;
Child’s full legal name;
Child’s date of birth;
Child’s residential address including zip code;
Contact information of parent/guardian;

SENIOR SERVICES AND PUBLIC HEALTH

Contact information of health care professional;
Contact information of lead risk assessor;
Description of coordination of services;
Date(s) of blood lead testing;
Laboratory blood lead test results, including initial and follow-up testing;
Date of diagnosis;
When chelation therapy is initiated, type of chelation medication, duration and method of administration, date of hospital admission and discharge information/instructions;
Interventions taken, including but not limited to parent/guardian education, nutritional supplementation, iron sufficiency testing and treatment, referrals for specialty services, and other associated testing such as abdominal x-rays and evaluations performed including results;
If applicable, date of transition of care due to change of address or insurance coverage; and 16. Date of and reason for closure of case management.

History

AUTHORITY: section 701.346, RSMo 2016. Original rule filed Feb. 3, 2003, effective July 30, 2003. Rescinded and readopted: Filed Sept. 24, 2024, effective April 30, 2025. Original authority: 701.346, RSMo 2001.

Chapter 9 Toxic Substances

19 CSR 20-9.010 Public Access to Information on Toxic Substances {#sec-19-csr-20-9.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-9.010}

(Rescinded August 24, 1989)

MATTBLUNT(1/29/03)

Chapter 9óToxic Substances19 CSR 20-9

History

AUTHORITY: sections 292.600ñ292.620, RSMo 1986. Original rule filed July 3, 1986, effective Sept. 30, 1986. Rescinded: Filed May 31, 1989, effective Aug. 24, 1989.

Chapter 10 Protection Against Ionizing Radiation

19 CSR 20-10.010 Definitions Relating to Ionizing Radiation {#sec-19-csr-20-10.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.010}

PURPOSE: This rule defines technical terms which are used throughout this chapter.

Therefore, the material which is so incorporated is on file with the agency who filed this

(1) Absorbed dose of any ionizing radiation is the energy imparted to matter by ionizing particles per unit mass of irradiated material at the place of interest. The unit of absorbed dose is the rad.

(2) Aluminum equivalent is the thickness of aluminum affording the same attenuation, under specified conditions, as the material in question.

(3) Controlled area is an area in which the occupational exposure of personnel to radiation or to radioactive material is under the supervision of an individual in charge of radiation protection. (This means that a controlled area is one that requires control of access, occupancy and working conditions for radiation protection purposes.)

(4) Dead-man switch is a switch so constructed that a circuit-closing contact can only be maintained by continuous pressure by the operator.

(5) Department is the Missouri Department of Health.

(6) Dose, unless otherwise indicated, as used in these rules, means rem dose.

(7) Effective half-life (T), in days, is— T=(T ) × (T )

(T ) + (T ) where T = biological half-life in days; and where T = physical half-life in days.

(8) Excessive radiation dose is a dose of radiation in excess of the maximum permissible dose (19 CSR 20-10.040).

(9) Individual is any human being.

(10) Installation is a place containing one (1) or more sources of radiation.

(11) Lead equivalent is the thickness of lead affording the same attenuation, under specified conditions, as the material in question.

(12) Maximum permissible accumulated dose (MPAD) is the dose of radiation which, if accumulated during the lifetime of the individual, is not expected to cause observable bodily injury.

(13) Maximum permissible dose (MPD) is the maximum rem dose that the body of an individual or specific parts of the body shall be permitted to receive in a stated period of time.

(14) Person is any individual, partnership, association, corporation, firm, trust, estate, public or private institution, group, agency, political subdivision of this state and any legal successor, representative, agent or agency of them.

(15) Personnel monitoring is the determination of the radiation dose received by an individual during the specified period.

(16) Protective barrier is a barrier of attenuating materials used to reduce radiation exposure.

(17) Qualified expert is an individual fitted by training and experience to perform dependable radiation surveys, to oversee radiation monitoring and to estimate the degree of radiation hazard. If the ability of a qualified expert is questioned, the department shall be the judge of his/her qualifications, in regard to which it may consider the testimony of other persons whom it deems expert.

(18) Rad is the unit of absorbed dose and is equal to one hundred (100) ergs per gram. It is a measure of the energy imparted to matter by ionizing particles per unit mass of irradiated material at the place of interest.

(19) Radiation is gamma rays and X-rays, alpha and beta particles, high-speed electrons, neutrons, protons, other nuclear particles and any other ionizing radiation, but not sound or radio waves or visible, infrared or ultraviolet light.

(20) Radiation hazard is any condition that might result in the exposure of individuals to excessive radiation dose.

(21) Radiation machine is any device that produces radiation when in operation.

(22) Radioactive material is any material, solid, liquid or gas, that emits radiation spontaneously.

(23) Relative biological effectiveness (RBE) is a numerical factor which is used to compare the effectiveness of absorbed dose of radiation delivered in different ways. The standard of comparison is X-ray or gamma radiation having a linear energy transfer in water of three (3) kev per micron. A list of RBE values of various kinds of radiation is given in Table 1, 19 CSR 20-10.110.

(24) Rem is equal to the absorbed dose in rads multiplied by the appropriate RBE.

(25) Roentgen is a unit of exposure dose of Xray or gamma radiation such that the associated corpuscular emission per 0.001293 gram of air produces, in air, ions carrying one (1) esu of quantity of electricity.

(26) Sealed source is a quantity of radioactive material so enclosed as to prevent the escape of any radioactive material.

(27) Source (of radiation) is a radiation machine or a quantity of radioactive materials.

(28) Survey is the evaluation of actual or potential radiation or contamination hazards by or under the supervision of a qualified expert.

(29) X-ray tube housing protective diagnostic-type is one that reduces the leakage radiation to a maximum of 0.10 roentgen in one (1) hour at a distance of one (1) meter from the tube target when the X-ray tube is operating at its maximum current and voltage.

(30) X-ray tube housing protective therapeutic-type is a tube housing so constructed that the leakage radiation at a distance of one (1) meter from the target cannot exceed the rate of one (1) roentgen per hour and at a distance ROBINCARNAHAN(1/29/03)* of five centimeters (5 cm) from any point on the surface of the housing accessible to the patient cannot exceed the rate of thirty (30) roentgens per hour when the tube is operated at its maximum current and voltage.

(31) Useful beam is that part of radiation which passes through the window, aperture, cone or collimating device of the tube housing.

(32) User is a person having administrative control over one (1) or more sources.

(33) Other scientific and technical terms not specifically defined in this rule shall be used in accordance with the definitions in recommendations of the National Committee on Radiation Protection and Measurements as published in Handbooks of the National Bureau of Standardsor the American Standard Association’s Glossary of Terms in Nuclear Science and Technology, with preference being in the order given. 90.010. Original rule filed Nov. 9, 1964,

19 CSR 20-10.020 Exemptions from Requirements of this Chapter {#sec-19-csr-20-10.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.020}

PURPOSE: This rule lists exemptions from the requirements of this chapter. It avoids unnecessary regulation and duplication of regulatory authority.

(1) The following materials, machines and conditions are exempt from the requirements of this chapter:

(A) Timepieces, instruments, novelties or devices containing self-luminous elements themselves. These timepieces, instruments, novelties or devices shall not be exempt if they are stored, used or handled in a quantity or fashion that an individual might receive a radiation dose exceeding the limits established in 19 CSR 20-10.040;

(B) Electrical equipment that produces radiation incidental to its operation for other purposes, providing the dose rate to the whole body at the point of nearest approach to this equipment when any external shielding is removed does not exceed 0.5 rem per year.

The production testing or factory servicing of this equipment shall not be exempt;

(C) Radiation machines which cannot be used in a manner as to produce radiation (for example, X-ray machines or electrical equipment in storage or transport);

(D) Radioactive material being transported across a state in conformance with regulations of any federal agency having jurisdiction over safety in interstate transport;

(E) The use of radioactive sources licensed by the United States Nuclear Regulatory Commission to installations in Missouri; and (F) Other sources of radiation that the department finds should be exempted as approved by the Committee on Radiation Control. 90.020. Original rule filed Nov. 9, 1964,

19 CSR 20-10.030 Registration of Sources of Ionizing Radiation {#sec-19-csr-20-10.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.030}

PURPOSE: This rule states the conditions under which sources of ionizing radiation must be registered with the department.

(1) The owner, user or operator of every existing not exempted source shall register the source of radiation with the department within ninety (90) days (March 9, 1965) after the effective date of this rule (December 9, 1964) and once every two (2) years after that as long as s/he continues to possess the source. Any newly acquired source shall be registered with the Department of Health within thirty (30) days after receipt. The registration shall be submitted on a form available from the department and shall describe each source, its location and use and the waste disposal practices, if any. The registration also shall give the name and address of the user(s) and the name and address of the qualified expert.

(2) The user shall notify the department in writing within thirty (30) days of any change with respect to his/her radiation sources which may substantially increase or decrease the potential for personnel exposure.

(3) All nonexempt radiation sources brought into Missouri for temporary use must be registered at least four (4) days before entry. The registration shall indicate the type and amount of the source, the scope of the use, duration of use and the exact locations of the use or storage. This requirement may be waived at the discretion of the Department of Health if the use is an unexpected occurrence of major consequence demanding immediate use and of which it would not have been possible to have knowledge four (4) days in advance.

(4) An installation registration may be issued, on application, for research institutions, teaching institutions and certain manufacturing establishments whose radiation conditions are undergoing constant change. These institutions and manufacturing establishments must maintain an active and effective radiation committee to review and approve all uses of radiation sources. A qualified expert must be retained to make hazard evaluations of all uses of all radiation sources and must be given authority to enforce recommended procedures.

(5) Registration shall not imply the department’s approval of the conditions described in the registration. 90.030. Original rule filed Nov. 9, 1964,

19 CSR 20-10.040 Maximum Permissible Exposure Limits {#sec-19-csr-20-10.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.040}

PURPOSE: This rule establishes maximum permissible exposure limits. Maximum permissible doses are established for both external and internal exposures for persons within or outside controlled areas.

(1) Except as provided in subsections (1)(A)–(C) of this rule, the maximum permissible dose (MPD) from all external sources of ionizing radiation for persons within a controlled area shall be as listed in Table I.

Table I A dose to the whole body, head and trunk, in addition to that listed in Table I, shall be permitted for a calendar year, provided that all three (3) of the following conditions are met:

4CODE OF STATE REGULATIONS

(1/29/03)* ROBINCARNAHAN

AB Maximum dose Maximum dose permitted in anypermitted in any

Part of Bodycalendar year calendar quarter Whole body, head5 rems3 rems and trunk, major portion of the bone marrow, gonads or lens of eye.

Skin of large body30 rems10 rems area.

Hands and forearms,75 rems25 rems feet and ankles (A) During any calendar quarter, the maximum dose of three (3) rems, listed in Column B of Table I, is not exceeded;

(B) The user has determined the individual’s previous accumulated occupational dose; and (C) The dose, when added to the previously accumulated occupational dose, does not exceed the maximum permissible accumulated dose (MPAD) calculated according to the formula: MPAD = (N–18) × 5 rems, where N is the individual’s age in full years.

(2) For persons within a controlled area, the radiation dose to the tissues of the body from radioactive materials within the body shall be controlled by limiting the average rates at which these materials are taken into the body.

Where this intake results from breathing contaminated air, the concentrations of the radionuclides in the air, averaged over any calendar quarter, shall not exceed the concentrations listed in Appendix I, Table 2,Column 1 of this chapter. The values in this table are for a workweek of forty (40) hours. For longer workweeks, the values must be adjusted downward accordingly. Where this intake results from the occurrence of radioactive material in drinking water and foodstuffs, the permissible concentrations shall be the same as in section (3) of this rule.

(3) For persons outside a controlled area, the MPD to the whole body due to sources within the controlled area or to radioactive materials escaping from the controlled area, shall be two (2) millirems in any one (1) hour, 0.1 rem in any seven (7) consecutive days and 0.5 rem in any year. In meeting this requirement, the user may take reasonable advantage of operational factors such as the amount of time that the radiation is present or that the area is occupied by any one (1) person.

(4) For persons outside a controlled area, the radiation dose to tissues of the body from radioactive materials within the body shall be controlled by limiting the average rates at which the materials are taken into the body.

Where this intake results from the occurrence of radioactive materials in the air, drinking water or foodstuffs, the average concentrations of the radionuclides in the air or drinking water or foodstuffs, averaged over any calendar quarter, shall not exceed the concentrations listed in Appendix I, Table 2, Columns 2 and 3 of this chapter. 90.040. Original rule filed Nov. 9, 1964,

19 CSR 20-10.050 Personnel Monitoring and Radiation Surveys {#sec-19-csr-20-10.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.050}

PURPOSE: This rule lists requirements for personnel monitoring and radiation surveys.

Conditions under which routine monitoring of individuals occupationally exposed to radiation shall not be required are also listed.

(1) The user shall provide for radiation surveys and monitoring sufficient to assure compliance with other rules of this chapter. The radiation survey and monitoring shall be performed by, or under the direction of, a qualified expert using suitable instruments and methods for measuring radiation.

(2) Until an actual radiation survey can be performed, a written statement made by a qualified expert based on his/her analysis of the situation shall be acceptable as evidence of the absence of radiation hazard in a given area.

(3) Personnel monitoring shall be required for each individual for whom there is any reasonable possibility of receiving a weekly dose of all radiation exceeding fifty (50) millirems, taking into consideration the use of protective gloves, aprons or other radiation-limiting devices.

(4) Routine monitoring of individuals occupationally exposed to radiation from radiation machines shall not be required if— (A) A qualified expert has specified the operating conditions under which there is no reasonable chance that any individual will be subjected to a dose of either more than twenty-five (25) millirems in any seven (7) consecutive days or more than three hundred twenty-five (325) millirems in any thirteen (13) consecutive weeks;

(B) The operating conditions in subsection (4)(A) of this rule are made known to all individuals who may be occupationally exposed to the radiation; and (C) The installation continues to operate only under the specified conditions.

(5) Radiation surveys of sealed sources and sealed storage areas shall be made at least semiannually to insure the integrity of the containment. The survey shall be capable of detecting the presence of 0.005 microcurie of removable contamination. If the survey reveals the presence of 0.005 microcurie or more of removable contamination, the user shall immediately withdraw the sealed source from use and shall cause it to be decontaminated and repaired, or disposed of, in accordance with procedures established by a qualified expert. 90.050. Original rule filed Nov. 9, 1964, *Original authority: 194.420, RSMo 1963.

19 CSR 20-10.060 Radiation Exposure Records and Reports {#sec-19-csr-20-10.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.060}

PURPOSE: This rule requires the user of radiation sources to keep records of personnel exposures, radiation measurements and the receipt and disposal of radioactive materials. It also states the conditions under which personnel exposures and radiation incidents must be reported.

(1) Records of all measurements required by

(2) An accurate accounting for all radioactive materials, not specifically exempted by 19 CSR 20-10.020, shall be maintained. The records shall show the amount of radioactive material received, transferred, decayed in storage and disposed of and other information as may be necessary to account for the difference between the amount of radioactive material received or produced and the amount on hand. The user shall also keep records of the release of radioactive materials to the environs sufficient to demonstrate compliance with other rules of this chapter.

The records shall be maintained and made available for inspection for at least five (5) years after final disposition of the radioactive material.

(3) Upon termination of employment of an individual, the individual or department, or both, upon request, shall be supplied with a summary statement of that individual’s radiation dose. (The estimated maximum dose shall be stated if no personnel monitoring has been carried out.) This record shall include statements of any circumstances where the dose to the employee from any source of radiation exceeded those specified in this chapter.

Employee records must be kept available for inspection by the department during the tenure of employment of an employee and for a period of five (5) years after that.

(4) When it is known or believed that an accidental dose to a person in the installation may have exceeded two (2) times the amount permitted by applicable sections of 19 CSR20- 10.040, all facts relative to the occurrence shall be reported in detail to the department within seven (7) days of the discovery of the facts, and a copy of the report shall be put in that individual’s personnel file. The cause of the overexposure shall immediately be sought out and corrected.

(5) The loss or theft of any source of radiation not exempt from these rules shall be reported immediately to the department by telephone and a written report shall be submitted within twenty-four (24) hours.

(6) At the request of any employee, each user shall advise the employee annually of the employee’s exposure to radiation as shown in records maintained by the user.

(7) Any accident involving either a public or private carrier conveying radioactive material shall be reported immediately to the Department of Health by telephone and a written report shall be submitted within twenty-four (24) hours. 90.060. Original rule filed Nov. 9, 1964,

19 CSR 20-10.070 Storage of Radioactive Materials {#sec-19-csr-20-10.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.070}

PURPOSE: This rule requires the safe storage of radioactive material.

(1) The user shall see that radioactive materials are kept in a manner that will provide reasonable assurance that, during routine access to a controlled area, no person will be exposed in excess of the limits set forth in 19 CSR 20-10.040. Provisions shall be made to minimize the hazard to emergency workers in the event of fire and in situations where earthquake, flood and windstorm potentials exist.

(2) The user shall see that vaults or rooms used for storing materials that may emit radioactive gases or airborne particulate matter are ventilated in a manner that the concentration of the gases or particulate matter in the air does not constitute a radiation hazard.

(3) When there is a reasonable possibility that chemical, radiation or other action might lead to leakage of radioactive material from a container, the user shall provide a secondary tray or catchment to the container adequate to retain the entire amount of radioactive material. 90.070. Original rule filed Nov. 9, 1964,

19 CSR 20-10.080 Control of Radioactive Contamination {#sec-19-csr-20-10.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.080}

PURPOSE: This rule limits personnel exposure by requiring the control or removal of radioactive contamination.

(1) The user shall see that all work with radioactive materials is carried out under conditions which will minimize the possibility of spread of radioactive material that could result in the exposure of any person above any limit specified in 19 CSR 20-10.040.

(2) Where the nature of work is such that a person or his/her clothing may become contaminated with radioactive material, both shall be monitored according to procedures established by a qualified expert. Personal contamination shall be removed according to procedures established by a qualified expert.

(3) Clothing or other material contaminated to a degree which could result in the exposure of any person above any limit specified in 19 CSR 20-10.040 should be retained inside the installation until it can be decontaminated or disposed of according to procedures established by a qualified expert. 90.080. Original rule filed Nov. 9, 1964,

19 CSR 20-10.090 Disposal of Radioactive Wastes {#sec-19-csr-20-10.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.090}

PURPOSE: This rule lists the conditions under which radioactive material may be released into the air or water or may be disposed of by burial in soil or discharged into a sanitary sewer.

(1) No user shall release radioactive material into the air or water in a manner which causes exposure of any person above the limits specified in 19 CSR 20-10.040. If several users are discharging radioactive wastes to the same environs, they shall cooperate in limiting the release and shall file with the Department of Health a statement of their agreed pro ratareleases.

(2) Every person who receives radioactive waste material for holding and preparation, prior to disposal, shall first obtain a permit from the Department of Health for the holding and preparation.

(3) No owner or user shall dispose of radioactive waste materials by dumping or burial in soil except at sites approved by and registered with the Department of Health.

(4) Radioactive material may be discharged into a sanitary sewer provided that the— (A) Material is readily soluble or dispersible in water;

(B) Quantity of any radioactive material released into the sewer in any one (1) day, when diluted by the average daily quantity of sewerage released into the sewer by the owner or user, will not result in average concentration exceeding the limits specified in Table 2,

Appendix I of this chapter; and (C) Gross quantity of all radioactive material so discharged does not exceed one (1) curie per year. 90.090. Original rule filed Nov. 9, 1964,

19 CSR 20-10.100 Radiation Labeling {#sec-19-csr-20-10.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.100}

PURPOSE: This rule establishes requirements for labeling radiation machines, radiation areas and containers in which radioactive materials are transferred, stored or used and to list exemptions from posting or labeling requirements.

(1) The user shall indicate the presence of radiation by posting conspicuous signs or labels which bear appropriate wording, as described in sections (5)–(10) of this rule to explain the nature of the hazard.

(2) All such radiation warning signs and labels shall bear the standard symbol for designating any radiation hazard as described in

Appendix II of this chapter.

6CODE OF STATE REGULATIONS

(3) The use of the standard symbol, signs or labels for any other purpose is expressly prohibited. The symbol, signs and labels and the lettering used with it shall be as large as practical, consistent with size of the equipment or material. The lettering shall not be superimposed on the symbol.

(4) All signs and labels required by this section shall use the conventional radiation colors (magenta or purple and yellow background) and bear a conventional radiation symbol.

(5) All radiation machines shall be clearly labeled as follows: “Caution: Radiation This Equipment Produces Radiation When Energized.” (Labels should be placed on the control panel near the switch which energizes the tube.)

(6) Each area shall be designated as a radiation area and shall be conspicuously posted with a sign(s) bearing a radiation caution symbol and the words “Caution: Radiation Area” if radiation levels exist which could subject an individual, continuously present, to five (5) millirems within any one (1) hour or could result in a dose of one hundred (100) millirems in any seven (7) consecutive days.

(7) Each radiation area where there exists a radiation level in excess of one hundred (100) milliroentgens per hour shall be conspicuously posted with a sign(s) bearing a conventional radiation caution symbol and the words “Caution: High Radiation Area.”

(A) Each high radiation area, except those containing only therapeutic units operating at sixty (60) kilovolts peak (kvp) or below or diagnostic units or both, shall be equipped with an internal control circuit which shall either cause the radiation exposure rate to be reduced to below one hundred (100) milliroentgens per hour upon entry of an individual into the area or shall energize a conspicuous visible or audible alarm signal in a manner that the individual entering and the supervisor of the activity are made aware of the entry. In the case of a temporary high radiation area (thirty (30) days or less), a control circuit is not required if a barricade, such as a fence or rope is erected and the required caution signs are posted.

(8) Any room, enclosure or operating area in which airborne radioactive materials exist in excess of the amount as stated in Table 2, Column 3, Appendix I of this chapter shall be conspicuously posted with a sign(s) bearing a conventional radiation symbol and the words “Caution: Airborne Radioactivity Area.” In the event that respiratory protection is required, the equipment prescribed shall also be conspicuously designated.

(9) Each entrance to an area or to rooms shall be conspicuously posted with a sign(s) bearing a conventional radiation symbol and the words “Caution: Radioactive Material” if the radioactive material used or stored is an amount exceeding ten (10) times the maximum exempted amount as specified in Table 1, Appendix I of this chapter.

(10) Each container in which radioactive material is transferred, stored or used shall bear a conventional symbol and the words “Caution: Radioactive Material.” Labeling shall not be required if the concentration of radioactive material does not exceed that specified in Table 2, Column 2 or 3,

Appendix I if the quantity of radioactive material does not exceed that in Table 1,

Appendix I of this chapter or for laboratory containers being used transiently. Where practical, signs required by this section should describe the quantities and kinds of radioactive materials involved.

(11) All areas that are readily accessible, but not normally occupied, and where a radiation hazard may exist on a frequent or infrequent

basis, shall be suitably restricted and posted with the accepted radiation-hazard label.

(12) All radiation-hazard labels posted shall be removed when the source of radiation is no longer present.

(13) Notwithstanding the provisions of other sections of this rule— (A) A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level twelve inches (12") from the surface of the device does not exceed five (5) milliroentgens per hour and the sealed source is properly labeled in accordance with the requirements of this rule.

(B) Rooms or other areas in hospitals are not required to be posted with caution signs because of the presence of patients containing radioactive material provided that attendant personnel are adequately instructed as to the precautions necessary to prevent the exposure of any individual to radiation or airborne radioactive materials in excess of the limits established in 19 CSR 20-10.

(C) Caution signs are not required to be posted at areas or rooms containing radioactive materials for periods of less than twentyfour (24) hours provided that these materials are constantly attended by an individual during these periods, or that there is no chance that any individual would come into the area or room not knowing a hazard exists.

(D) Radiation areas and high radiation areas which result from the operation of therapeutic X-ray machines operated at potentials of sixty (60) kvp and below or from the operation of diagnostic X-ray machines shall be exempt from the posting requirements of this

rule provided that the operator of the equipment has taken precautions to insure that no individual other than the patient shall be in the radiation area. 90.100. Original rule filed Nov. 9, 1964,

19 CSR 20-10.110 Relative Biological Effectiveness Values {#sec-19-csr-20-10.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.110}

PURPOSE: This rule lists relative biological effectiveness values which are referred to in other rules of 19 CSR 20-10.

(1) The relative biological effectiveness (RBE) values in Table I are convenient approximations to relate dose in rads to dose in rems. The value will vary greatly with the biological effect being considered, the acuteness of the exposure and many other factors.

The qualified expert should evaluate these factors for each situation and should adjust the values accordingly.

Table I—RBE Values RadiationRBE X-rays and gamma rays of all energies and electrons and beta rays above 0.03 Million electron Volts (MEV) 1.0 Fast neutrons and protons up to 10 MeV10 Alpha particles10 Heavy recoil nuclei20 90.110. Original rule filed Nov. 9, 1964,

19 CSR 20-10.120 General Requirements for Diagnostic X-ray Equipment {#sec-19-csr-20-10.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.120}

PURPOSE: This rule establishes general requirements for diagnostic X-ray equipment.

(1) The X-ray tube housing shall be of the protective diagnostic type.

(2) Total filtration shall be as follows:

(A) For fluoroscopic and radiographic equipment operating at seventy (70) kilovolts peak (kvp) and below, the total filtration permanently in the useful beam, for routine use, shall be equivalent to at least 1.5 millimeters (mm) of aluminum. This condition shall be considered fulfilled if the half value layer (HVL) of the useful beam is 1.5 mm of aluminum or greater.

(B) For fluoroscopic and radiographic equipment capable of operating above seventy (70) kvp, the total filtration permanently in the useful beam shall be equivalent to at least 2.5 mm of aluminum. This condition shall be considered fulfilled if the HVL of the useful beam is 2.5 mm of aluminum or greater.

(3) The exposure switch for routine diagnostic X-rays or routine diagnostic fluoroscopy shall be of the dead-man type or time limiting switch acceptable to the department.

(4) Diaphragms or cones shall be used for collimating the useful beam and shall provide the same degree of protection as the tube housing. 90.120. Original rule file Nov. 9, 1964, effective Dec. 9, 1964.

19 CSR 20-10.130 Special Requirements for Medical Fluoroscopic Installations requirements for medical fluoroscopic installations. {#sec-19-csr-20-10.130 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.130}

(1) All fluoroscopes shall be so constructed that the entire cross-section of the useful beam is attenuated by a primary barrier. Collimators and adjustable diaphragms or shutters shall be provided to restrict the size of the useful beam to less than the area of the barrier. For conventional fluoroscopes, this requirement is met if, when the adjustable diaphragm is open to its fullest extent, an unilluminated two centimeter (2 cm) margin is left on the fluorescent screen with the screen centered in the beam at a distance of thirty-five centimeters (35 cm) (fourteen inches (14")) from the panel or table top. The margin requirement does not apply to installations where image amplifiers are used but a protective shield shall be provided in these installations so that the useful beam does not produce a radiation hazard.

(2) Accessory shielding devices (such as cones, curtains, bucky slot covers, shielding between patient and fluoroscopist) shall be used as required to reduce the exposure dose rate to not more than fifty (50) milliroentgens per hour in the area adjacent to the machine normally occupied by the fluoroscopist and his/her assistants during fluoroscopy.

(3) The target to panel distance shall not be less than eighteen inches (18").

(4) A manually reset cumulative timing device shall be used which will either indicate elapsed time by an audible signal or turn off the apparatus when the total exposure exceeds a predetermined limit given in one (1) or a series of exposures. The device shall have a maximum range of five (5) minutes.

(5) The primary beam barrier should have a lead equivalent of at least 2.0 millimeters (mm) and shall not be less than 1.5 mm for one hundred (100) kvp, should be at least 2.4 mm and shall be not less than 1.8 mm for one hundred twenty-five (125) kvp, and should be at least 2.7 mm and shall be not less than 2.0 mm for one hundred fifty (150) kvp. For conventional fluoroscopes, this requirement may be assumed to have been met if the exposuredose rate measured at the viewing surface of the fluorescent screen does not exceed fifty (50) milliroentgens per hour with the screen in the primary beam of the fluoroscope without a patient, under normal operating condi- (6) Collimators and adjustable diaphragms or shutters to restrict the size of the useful beam shall provide a minimum of 2.0 mm lead equivalent protection for one hundred (100) kvp, 2.4 mm for one hundred twenty-five (125) kvp and 2.7 mm for one hundred fifty (150) kvp.

(7) For routine fluoroscopy, the dose rate measured at the panel or table top shall not exceed six (6) roentgens per minute.

(8) Mobile fluoroscopic equipment shall meet the requirements of sections (1)–(7) of this

rule except that— (A) In the absence of panel or table top, a cone or spacer frame hall limit the target-toskin distance to not less than twelve inches (12");

(B) It shall be impossible to operate the machine when the collimating cone or diaphragm is not in place; and (C) The maximum permissible exposuredose rate of six (6) roentgens per minute shall be measured at the minimum target-to-skin distance. 90.130. Original rule filed Nov. 9, 1964,

19 CSR 20-10.140 Special Requirements for Medical Radiographic Installations requirements for medical radiographic X-ray installations. {#sec-19-csr-20-10.140 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.140}

(1) A device shall be provided to terminate (2) The exposure switch shall be so arranged that it cannot be conveniently operated outside a shielded area. Exposure switches for spot film devices used in conjunction with fluoroscopic tables are excepted from this requirement. 90.140. Original rule filed Nov. 9, 1964,

19 CSR 20-10.150 Special Requirements for Dental Radiographic Installations requirements for dental radiographic installa- (1) The diameter of the useful beam at the cone tip should be not more than 2.75 inches and shall be not more than three inches (3") for routine intraoral radiography. {#sec-19-csr-20-10.150 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.150}

(2) A device shall be provided to terminate (3) The exposure control switch shall be provided with a cord sufficiently long so that the operator can stand at least six feet (6') from the tube housing for all exposures and well away from the useful beam.

8CODE OF STATE REGULATIONS 90.150. Original rule filed Nov. 9, 1964,

19 CSR 20-10.160 Special Requirements for Mobile Medical Radiographic Installations requirements for mobile medical radiographic installations. {#sec-19-csr-20-10.160 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.160}

(1) All mobile equipment shall be provided with cones or frames so that the minimum target-to-skin distance is at least eighteen inches (18").

(2) The exposure control switch shall be so arranged that the operator can stand at least six feet (6') from the patient and outside the primary beam for all exposures.

(3) A device shall be provided to terminate the exposure after a preset time. 90.160. Original rule filed Nov. 9, 1964,

19 CSR 20-10.170 Special Requirements for Photofluorographic Installations requirements for photofluorographic installa- (1) A collimator shall restrict the useful beam to the area of the fluorographic screen. {#sec-19-csr-20-10.170 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.170}

(2) The exposure switch shall be so arranged that it cannot be conveniently operated outside a shielded area. Exposure switches for spot film devices used in conjunction with fluoroscopic tables are exempted from this requirement.

(3) A device shall be provided to terminate (4) Output of the photofluorographic installation shall not exceed one (1) roentgen per exposure at the panel. 90.170. Original rule filed Nov. 9, 1964,

19 CSR 20-10.180 Requirements for Radiation Therapy Installations {#sec-19-csr-20-10.180 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.180}

PURPOSE: This rule establishes requirements for radiation therapy installations.

(1) The radiation source housing shall be a protective therapeutic type.

(2) Permanent diaphragms or cones shall be used for collimating the useful beam and shall afford the same degree of protection as the radiation source housing. Adjustable or removable beam-defining devices shall not transmit more than five percent (5%) of the useful beam obtained at the maximum kilovoltage and with the maximum treatment filter.

(3) The filter system shall be so arranged as to permit proper filter selection and alignment. Filters shall be secured in place to prevent them from dropping out during treatment. The filter slot shall be so constructed that the radiation escaping through it does not exceed one (1) roentgen per hour at one (1) meter.

(4) The radiation source shall be centered and mounted so that it cannot turn or slide with respect to the aperture when the source is in the on position.

(5) Means shall be provided to immobilize the radiation source during stationary radiation treatment.

(6) A timer shall be provided to terminate the exposure after a preset time.

(7) With equipment operating above sixty (60) kilovolts peak (kvp), interlocks shall be provided so that when any door to the treatment room is opened, either the machine will be shut off automatically or the radiation level within the room will be reduced to an average of not more than two (2) milliroentgens per hour and a maximum of ten (10) milliroentgens per hour at a distance of one (1) meter in any direction from the target.

After this shutoff or reduction in output, it shall be possible to restore the machine to full operation only from the control panel.

(8) The control shall be located outside of the treatment room or within a protective booth.

(9) Equipment utilizing shutters to control the useful beam shall have a shutter position indicator on the control panel.

(10) There shall be on the control panel some easily discernible device which will give positive information as to whether or not the source of the ionizing radiation is in the on position. 90.180. Original rule filed Nov. 9, 1964,

19 CSR 20-10.190 Requirements for Room Shielding {#sec-19-csr-20-10.190 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.190}

PURPOSE: This rule provides necessary information regarding requirements for room shielding for diagnostic and therapeutic installations.

(1) The requirements for room shielding shall conform to the requirements defined in the various handbooks published by the United States Department of Commerce and National Bureau of Standards. 90.190. Original rule filed Nov. 9, 1964,

19 CSR 20-10.200 Shoe-Fitting Devices {#sec-19-csr-20-10.200 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-10.200}

PURPOSE: This rule prohibits the use of radiation for the purpose of selling footwear.

(1) It shall be unlawful for any person, partnership, association or corporation to operate or maintain within this state, any fitting devices or machines which use fluoroscopic, X-ray or radiation principles for the purpose of selling footwear through commercial outlets. 90.200. Original rule filed Nov. 9, 1964, 10CODE OF STATE REGULATIONS 12CODE OF STATE REGULATIONS

Chapter 11 * - moved to 19 CSR 30

19 CSR 20-11.010 Mammography Authorization {#sec-19-csr-20-11.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-11.010}

(Moved to 19 CSR 30-11.010)

19 CSR 20-11.020 Requirements for Suppliers of Mammography Services {#sec-19-csr-20-11.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-11.020}

(Moved to 19 CSR 30-11.020)

19 CSR 20-11.030 Requirements and Responsibilities for Physician Consultants {#sec-19-csr-20-11.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-11.030}

(Moved to 19 CSR 30-11.030)

19 CSR 20-11.040 Requirements and Responsibilities for Interpreting Physicians {#sec-19-csr-20-11.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-11.040}

(Moved to 19 CSR 30-11.040)

19 CSR 20-11.050 Requirements for Operators of Mammography Equipment {#sec-19-csr-20-11.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-11.050}

(Moved to 19 CSR 30-11.050)

19 CSR 20-11.060 Requirements for Individuals Who Provide X-ray Physics Support {#sec-19-csr-20-11.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-11.060}

(Moved to 19 CSR 30-11.060)

19 CSR 20-11.070 Mammography Equipment Requirements {#sec-19-csr-20-11.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-11.070}

(Moved to 19 CSR 30-11.070)

19 CSR 20-11.080 Quality Assurance {#sec-19-csr-20-11.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-11.080}

(Moved to 19 CSR 30-11.080)

19 CSR 20-11.090 Maintenance of Mammography Records {#sec-19-csr-20-11.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-11.090}

(Moved to 19 CSR 30-11.090)

19 CSR 20-11.100 Right of Entry to Mammography Suppliers for Enforcement {#sec-19-csr-20-11.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-11.100}

(Moved to 19 CSR 30-11.100)

Rebecca McDowell Cook (6/30/98)

Chapter 11óRules for Mammography19 CSR 20-11

Chapter 12 Protection Against Non-Ionizing Radiation

PURPOSE: To establish a standard consent form to be used by all tanning facilities operating in Missouri.

(1) As used in this rule and the consent form included herein, the following terms mean:

(A) Tanning device is any equipment that emits electromagnetic radiation with wavelengths in the air between two hundred (200) and four hundred (400) nanometers used for tanning of the skin, including, but not limited to, a sunlamp, tanning booth, or tanning bed; and (B) Tanning facility is any location, place, area, structure, or business which provides persons access to any tanning device for a fee, membership dues, or any other form of compensation.

(2) Prior to any person less than seventeen (17) years of age using a tanning device in a tanning facility, a parent or guardian of such person shall annually appear in person at the tanning facility and sign a written statement acknowledging that the parent or guardian has read and understands the warnings given by the tanning facility and consents to the person’s use of a tanning device at the tanning facility.

(3) For purposes of obtaining the consent described in section (2) above, tanning facilities shall use the form included herein. This form is available in an electronic format at http://health.mo.gov/living/healthcondiseases/chronic/chronicdisease/TanningConsentForm.pdf.

4CODE OF STATE REGULATIONS

(3/31/15) JASONKANDER

AND SENIOR SERVICESPublic Health

History

AUTHORITY: section 577.665, RSMo Supp. 2014. Original rule filed Aug. 28, 2014, effective April 30, 2015. Original authority: 577.665, RSMo 2014.

Chapter 20 Communicable Diseases

19 CSR 20-20.010 Definitions Relating to Communicable, Environmental and {#sec-19-csr-20-20.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.010}

19 CSR 20-20.020 Reporting Infectious, Contagious, Communicable, or Dangerous {#sec-19-csr-20-20.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.020}

19 CSR 20-20.040 Measures to Determine the Prevalence and Prevent the Spread of Diseases which are Infectious, Contagious, Communicable, or {#sec-19-csr-20-20.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.040}

19 CSR 20-20.050 Quarantine or Isolation Practices and Closing of Schools and Places {#sec-19-csr-20-20.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.050}

19 CSR 20-20.075 Confidentiality of Information Obtained for Reporting of Communicable, Environmental and Occupational Diseases {#sec-19-csr-20-20.075 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.075}

19 CSR 20-20.090 Contact With Communicable Diseases by First Responders or {#sec-19-csr-20-20.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.090}

19 CSR 20-20.092 Blood-Borne Pathogen Standard Required for Occupational Exposure of Public Employees to Blood and Other Infectious {#sec-19-csr-20-20.092 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.092}

19 CSR 20-20.100 Tuberculosis Testing for Residents and Workers in Long-Term SERVICES Health {#sec-19-csr-20-20.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.100}

19 CSR 20-20.010 Definitions Relating to Communicable, Environmental and Occupational Diseases {#sec-19-csr-20-20.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.010}

PURPOSE: This rule defines terminology used throughout this

chapter and defines terms related to infectious waste.

(1) Administrator is the person in charge of an institution, such as the chief executive officer, chairperson of the board, administrator, clinician in charge, or any equivalent position.

(2) Adult respiratory distress syndrome (ARDS) is a syndrome with the following simultaneous characteristics:

(A) Hypoxemia due to intrapulmonary shunting of blood;

(B) Increased lung stiffness; and (C) Chest x ray evidencing diffuse infiltration.

(3) Board is the State Board of Health.

(4) Carrier is a person who harbors a specific infectious agent in the absence of discernible clinical disease and serves as a potential source or reservoir of infection for man.

(5) Case, as distinct from a carrier, is a person in whose tissues the etiologic agent of a communicable disease is present and which usually produces signs or symptoms of disease.

Evidence of the presence of a communicable disease also may be revealed by routine laboratory findings.

(6) Cluster is a group of individuals who manifest the same or similar signs and symptoms of disease.

(7) Communicable disease is an illness due to an infectious agent or its toxic products and transmitted, directly or indirectly, to a susceptible host from an infected person, animal or arthropod, or through the agency of an intermediate host or a vector, or through the inanimate environment.

(8) Contact is a person or animal that has been in association with an infected person or animal and through that association has had the opportunity to acquire the infection.

(9) Designated representative is any person or group of persons appointed by the director of the Department of Health and Senior Services to act on behalf of the director or the State Board of Health.

(10) Director is the state Department of Health and Senior Services director.

(11) Disinfection is the killing of pathogenic agents outside the body by chemical or physical means, directly applied.

(A) Concurrent disinfection is disinfection immediately after the discharge of infectious material from the body of an infected person or after the soiling of articles with the infectious discharges.

(B) Terminal disinfection is the process of rendering the personal clothing and immediate physical environment of a patient free from the possibility of conveying the infection to others after the patient has left the premises or after the patient has ceased to be a source of infection or after isolation practices have been discontinued.

(12) Environmental and occupational diseases are illnesses or adverse human health effects resulting from exposure to a chemical, radiological or physical agent.

(13) Exposure is defined as contact with, absorption, ingestion or inhalation of chemical, biologic, radiologic, or other physical agents by a human that results in biochemical, physiological or histological changes.

(14) Food is any raw, cooked or processed edible substance, ice, beverage or ingredient used or intended for use in whole or in

part for human consumption.

(15) Heat exhaustion means a reaction to excessive heat marked by prostration, weakness and collapse resulting from dehydration.

(16) Heat stroke means a severe illness caused by exposure to excessively high temperatures and characterized by severe headache; high fever with a dry, hot skin; tachycardia; and in serious cases, collapse, coma or death.

(17) Hyperthermia means a physician-diagnosed case of heat exhaustion or heat stroke.

(18) Hypothermia means a physician-diagnosed case of cold injury associated with a fall of body temperature to less than ninety-four and one-tenth degrees Fahrenheit (94.1°F) and resulting from exposure to a cold environment.

(19) Immediately reportable diseases are those diseases or findings listed in 19 CSR 20-20.020(1)(A)–(C) and shall be reported at once, without delay and with a sense of urgency by means of rapid communication to the Missouri Department of Health and Senior Services or to the local public health agency, regardless of the day or hour.

(20) Immunization is a treatment which renders an individual less susceptible to the pathologic effects of a disease or provides a measure of protection against the disease.

(21) Infectious waste is waste capable of producing an infectious disease. For a waste to be infectious, it must contain pathogens with sufficient virulence and quantity so that exposure to the waste by a susceptible host could result in an infectious disease.

Infectious waste generated by small quantity generators shall include the following categories:

(A) Sharps—all discarded sharps including hypodermic needles, syringes and scalpel blades. Broken glass or other sharp items that have come in contact with material defined as infectious are included;

(B) Cultures and stocks of infectious agents and associated biologicals—included in this category are all cultures and stocks of infectious organisms as well as culture dishes and devices used to transfer, inoculate and mix cultures; and (C)

Other wastes—those wastes designated by the medical authority responsible (physician, podiatrist, dentist, veterinarian) for the care of the patient which may be capable of producing an infectious disease.

(22) Institution is any public or private hospital, nursing home, clinic, mental health facility, home health agency, or medical or professional corporation composed of health care workers.

(23) Invasive disease is caused by a pathogen that invades the bloodstream and/or normally sterile bodily fluids and has the potential to cause severe morbidity and/or mortality.

Culturing organisms from blood, cerebrospinal fluid, joint fluid, or pleural fluid identifies invasive diseases. Examples of conditions caused by invasive organisms include:

(A) Haemophilus influenzae—meningitis, occult febrile bacteremia, epiglottitis, septic arthritis, pericarditis, abscesses, empyema, and osteomyelitis;

(B) Streptococcus pneumoniae—bacteremia, and meningitis;

(C)

Neisseria meningitidis—meningitis with or without meningococcemia, septicemia (purpura fulminans), bacteremia, pericarditis, myocarditis, arthritis, and epididymitis;

(D) Streptococcus pyogenes (group A)—bacteremia associated with cutaneous infection, deep soft tissue infection (necrotizing fasciitis), meningitis, peritonitis, osteomyelitis, septic arthritis, postpartum sepsis, neonatal sepsis, and non-focal bacteremia.

(24) Isolation is the separation for the period of communicability of infected individuals and animals from other individuals and animals, in places and under conditions as will prevent the direct or indirect transmission of the infectious agent from infected individuals or animals to other individuals or animals who are susceptible or who may spread the agent to others.

(25)

Laboratory means a facility for the biological, microbiological, serological, chemical, immuno-hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of a human. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. Facilities only collecting or preparing specimens (or both) or only serving as a mailing service and not performing testing are not considered laboratories. Laboratory includes hand-held testing equipment. All testing laboratories must be certified under the Clinical Laboratories Improvement Amendment of 1988 (CLIA—42 CFR part 493).

(26) Local health authority is the city or county health officer, director of an organized health department or of a local board of health within a given jurisdiction. In those counties where a local health authority does not exist, the health officer or administrator of the Department of Health and Senior Services district in which the county is located shall serve as a local health authority.

(27) Local public health agency is a legally constituted body provided by a city, county or group of counties to protect the public health of the city, county or group of counties.

(28)

Methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and nosocomial infection are:

(A) MRSA shall be defined as S. aureus strains that are resistant to oxacillin, nafcillin and methicillin; historically termed MRSA. These organisms are resistant to all b-lactam agents, including cephalosporins and carbapenems. (NOTE:

MRSA isolates are often resistant to other multiple, commonly used classes of antimicrobial agents, including erythromycin, clindamycin, and tetracycline.)

(B) VRE shall be defined as enterococci that possess intrinsic or acquired resistance to vancomycin. Several genes, including vanA, vanB, vanC, vanD, and vanE, contribute to resistance to vancomycin in enterococci.

(C) Nosocomial infection shall be defined by the national Centers for Disease Control and Prevention and applied to infections within hospitals, ambulatory surgical centers, and other facilities.

(29) Outbreak or epidemic is the occurrence in a community or region of an illness(es) similar in nature, clearly in excess of normal expectancy and derived from a common or a propagated source.

(30) Period of communicability is the period of time during which an etiologic agent may be transferred, directly or indirectly, from an infected person to another person or from an infected animal to a person.

(31) Person is any individual, partnership, corporation, association, institution, city, county, other political subdivision

(32) Pesticide poisoning means human disturbance of function, damage to structure or illness which results from the inhalation, absorption or ingestion of any pesticide.

(33) Poisoning means injury, illness or death caused by chemical means.

(34) Quarantine is a restriction of movement of persons or animals that have been exposed to a communicable disease, but have not yet developed disease. The period of quarantine will not be longer than the entire incubation period of the disease. The purpose of quarantine is to prevent effective contact with the general population.

(A) Complete quarantine is a limitation of freedom of movement of persons or animals exposed to a reportable disease, for a period of time not longer than the entire incubation period of the disease, in order to prevent effective contact with the general population.

(B) Modified quarantine is a selective, partial limitation of freedom of movement of persons or animals determined on the basis of differences in susceptibility or danger of disease transmission. Modified quarantine is designed to meet particular situations and includes, but is not limited to, the exclusion of children from school, the closure of schools and places of public or private assembly and the prohibition or restriction of those exposed to a communicable disease from engaging in a particular occupation.

(35) Reportable disease is any disease or condition for which an official report is required. Any unusual expression of illness in a group of individuals which may be of public health concern is reportable and shall be reported to the local health department, local health authority or the Department of Health and Senior Services by the quickest means.

(36) Small quantity generator of infectious waste is any person generating one hundred kilograms (100 kg) or less of infectious waste per month and as regulated in 10 CSR 80.

(37) Statewide pandemic is an outbreak of a particularly dangerous disease affecting a high proportion of the population, appearing in three (3) or more counties, as declared by the director of the Department of Health and Senior Services.

(38) Terrorist event is the unlawful use of force or violence committed by a group or individual against persons or property to intimidate or coerce a government, the civilian population, or any segment thereof, in furtherance of political or social objectives. Terrorist attacks are classified as chemical, biological, or radiological.

(A) Chemical means any weapon that is designed or intended to cause widespread death or serious bodily injury through the release, dissemination, or impact of toxic or poisonous chemicals or precursors of toxic or poisonous chemicals.

(B) Biological means any microorganism, virus, infectious substance, or biological product that may be engineered as a result of biotechnology, or any naturally occurring or bioengineered component of any such microorganism, virus, infectious substance, or biological product.

(C) Radiological means any weapon that is designed to release radiation or radioactivity at a level dangerous to human life.

(39) Toxic substance is any substance, including any raw materials, intermediate products, catalysts, final products or by-products of any manufacturing operation conducted in a commercial establishment that has the capacity through its physical, chemical or biological properties to pose a substantial risk of death or impairment, either immediately or later, to the normal functions of humans, aquatic organisms or any other animal.

(40) Unusual diseases—Examples include, but are not limited to, the following:

(A) Diseases uncommon to a geographic area, age group, or anatomic site;

(B) Cases of violent illness resulting in respiratory failure;

(41) Unusual manifestation of illness—Examples include, but are not limited to, the following:

(A) Multiple persons presenting with a similar clinical syndrome at a steady or increasing rate;

(B) Large numbers of rapidly fatal cases, with or without recognizable signs and symptoms;

history, presenting with convulsions;

(D) Persons presenting with grayish colored tissue damage; or (E) Adults under the age of fifty (50) years, without previous medical history, presenting with adult respiratory distress syndrome (ARDS).

(42) Varicella (Chickenpox) severity of illness shall include the following categories:

(A) Mild—less than fifty (50) lesions (able to count lesions within thirty (30) seconds);

(B) Moderate—fifty to five hundred (50–500) lesions (anything in between mild and severe); and (C) Severe—more than five hundred (500) lesions (difficult to see the skin) or lesions with complications.

Amended: Filed Feb. 15, 2006, effective Sept. 30, 2006. Emergency amendment filed June 15, 2007, effective July 6, 2007, expired Jan. 1, 2008. Amended: Filed June 15, 2007, effective Jan. 30, 2008. amended 1945, 1951, 2004; and 260.203, RSMo 1986, amended 1988, 1992, 1993.

History

authority, state agency or institution or federal agency or institution.
AUTHORITY: sections 192.006 and 260.203, RSMo 2000 and 192.020, RSMo Supp. 2006. This rule was previously filed as 13 CSR 50-101.010. Original rule filed July 15, 1948, effective Sept. 13, 1948. Rescinded and readopted: Filed Dec. 11, 1981, effective May 13, 1982. Amended: Filed Aug. 16, 1988, effective Dec. 29, 1988. Amended: Filed Aug. 14, 1992, effective April 8, 1993. amendment filed June 1, 2000, effective June 15, 2000, expired Dec. 11, 2000. Amended: Filed June 1, 2000, effective Nov. 30, 2000. Amended: Filed Oct. 1, 2004, effective April 30, 2005.

19 CSR 20-20.020 Reporting Infectious, Contagious, Communicable, or Dangerous Diseases {#sec-19-csr-20-20.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.020}

PURPOSE: This rule designates the diseases which are infectious, contagious, communicable, or dangerous and must be reported to the local health authority or the Department of Health and Senior Services. It also establishes when they must be reported.

(1) The diseases within the immediately reportable disease category pose a risk to national security because they can be easily disseminated or transmitted from person to person; result in high mortality rates and have the potential for major public health impact; might cause public panic and social disruption; and require special action for public health preparedness. Immediately reportable diseases or findings shall be reported to the local health authority or to the Department of Health and Senior Services immediately upon knowledge or suspicion by telephone (1 (800) 392-0272), facsimile, or other rapid communication. Immediately reportable diseases or findings are— (A) Selected high priority diseases, findings, or agents that occur naturally, from accidental exposure, or as the result of a bioterrorism event:

Anthrax Botulism Coronavirus Disease 2019 (COVID-19)

Paralytic poliomyelitis Plague Rabies (Human)

Ricin toxin Severe Acute Respiratory Syndrome-associated Coronavirus (SARS-CoV) Disease Smallpox Tularemia (suspected intentional release)

Viral hemorrhagic fevers, suspected intentional (e.g., Viral hemorrhagic fever diseases: Ebola, Marburg, Lassa, Lujo, new world Arenavirus (Guanarito, Machupo, Junin, and Sabia viruses), or Crimean-Congo);

(B) Instances, clusters, or outbreaks of unusual diseases or manifestations of illness and clusters or instances of unexplained deaths which appear to be a result of a terrorist act or the intentional or deliberate release of biological, chemical, radiological, or physical agents, including exposures through food, water, or air;

(C) Instances, clusters, or outbreaks of unusual, novel, and/ or emerging diseases or findings not otherwise named in this rule, appearing to be naturally occurring, but posing a substantial risk to public health and/or social and economic stability due to their ease of dissemination or transmittal, associated mortality rates, or the need for special public health actions to control.

(2) Reportable within one (1) day, diseases or findings shall be reported to the local health authority or to the Department of Health and Senior Services within one (1) calendar day of first knowledge or suspicion by telephone, facsimile, or other rapid communication. Reportable within one (1) day, diseases or findings are— (A) Diseases, findings, or agents that occur naturally, or from accidental exposure, or as a result of an undetected bioterrorism event— Animal (mammal) bite, wound, humans Brucellosis Chikungunya Cholera Dengue virus infection Diphtheria Glanders (Burkholderia mallei)

Haemophilus influenzae, invasive disease Hantavirus pulmonary syndrome Hemolytic uremic syndrome (HUS), postdiarrheal Hepatitis A Influenza-associated mortality Influenza-associated public and/or private school closures Lead (blood) level greater than or equal to forty-five micrograms per deciliter (≥45 μg/dl) in any person Legionellosis Measles (rubeola)

Melioidosis (Burkholderia pseudomallei)

Meningococcal disease, invasive Monkeypox virus (Orthopoxvirus/non-variola Orthopoxvirus)

Novel Influenza A virus infections, human Outbreaks (including nosocomial) or epidemics of any illness, disease, or condition that may be of public health concern, including any illness in a food handler that is potentially transmissible through food Pertussis Poliovirus infection, nonparalytic Q fever (acute and chronic)

Rabies (animal)

Rubella, including congenital syndrome Shiga toxin-producing Escherichia coli (STEC)

Shiga toxin positive, unknown organism Shigellosis Staphylococcal enterotoxin B Syphilis, including congenital syphilis T-2 mycotoxin Tetanus Tuberculosis disease Tularemia (all cases other than suspected intentional release)

Typhoid fever (Salmonella typhi)

Vancomycin-intermediate Staphylococcus aureus (VISA), and Vancomycin-resistant Staphylococcus aureus (VRSA)

Venezuelan equine encephalitis virus neuroinvasive disease Venezuelan equine encephalitis virus nonneuroinvasive disease Viral hemorrhagic fevers other than suspected intentional (e.g., Viral hemorrhagic fever diseases: Ebola, Marburg, Lassa, Lujo, new world Arenavirus (Guanarito, Machupo, Junin, and Sabia viruses), or Crimean-Congo)

Yellow fever Zika;

(B) Diseases, findings or adverse reactions that occur as a result of inoculation to prevent smallpox, including, but not limited to, the following:

Accidental administration Contact transmission (i.e., vaccinia virus infection in a contact of a smallpox vaccinee)

Eczema vaccinatum Erythema multiforme (roseola vaccinia, toxic urticaria)

Fetal vaccinia (congenital vaccinia)

Generalized vaccinia Inadvertent autoinoculation (accidental implantation)

Myocarditits, pericarditis, or myopericarditis Ocular vaccinia (can include keratitis, conjunctivitis, or blepharitis)

Post-vaccinial encephalitis or encephalamyelitis Progressive vaccinia (vaccinia necrosum, vaccinia gangrenosa, disseminated vaccinia)

Pyogenic infection of the vaccination site Stevens-Johnson Syndrome.

(3) Reportable within three (3) days diseases or findings shall be reported to the local health authority or the Department of Health and Senior Services within three (3) calendar days of first knowledge or suspicion. These diseases or findings are— Acquired immunodeficiency syndrome (AIDS)/Human immunodeficiency virus (HIV) infection, Stage 3 Babesiosis California serogroup virus neuroinvasive disease California serogroup virus non-neuroinvasive disease Campylobacteriosis Carbon monoxide exposure CD4+ T cell count and percent Chancroid Chemical poisoning, acute, as defined in the most current ATSDR CERCLA Priority List of Hazardous Substances; if terrorism is suspected, refer to subsection (1)(B)

Chlamydia trachomatis, infections Coccidioidomycosis Creutzfeldt-Jakob disease Cryptosporidiosis Cyclosporiasis Eastern equine encephalitis virus neuroinvasive disease Eastern equine encephalitis virus non-neuroinvasive disease Ehrlichiosis/Anaplasmosis (Ehrlichia chaffeensis infection, Ehrlichia ewingii infection, Anaplasma phagocytophilum infection, and Ehrlichiosis/Anaplasmosis, human, undetermined)

Giardiasis Gonorrhea Hansen’s disease (Leprosy)

Heavy metal poisoning including, but not limited to, arsenic, cadmium, and mercury Hepatitis B, acute Hepatitis B, chronic Hepatitis B surface antigen (prenatal HBsAg) in pregnant women Hepatitis B Virus infection, perinatal (HBsAg positivity in any infant aged equal to or less than twenty-four (≤24) months who was born to an HBsAg-positive mother)

Hepatitis C, acute Hepatitis C, chronic Human immunodeficiency virus (HIV) infection, exposed newborn infant (i.e., newborn infant whose mother is infected with HIV)

Human immunodeficiency virus (HIV) infection, including any test or series of tests used for the diagnosis or periodic monitoring of HIV infection. For series of tests which indicate HIV infection, all test results in the series (both positive and negative) must be reported Human immunodeficiency virus (HIV) infection, including any negative, undetectable, or indeterminate test or series of tests used for the diagnosis or periodic monitoring of HIV infection conducted within one hundred eighty (180) days prior to the test result used for diagnosis of HIV infection Human immunodeficiency virus (HIV) infection, pregnancy in newly identified or pre-existing HIV positive women Human immunodeficiency virus (HIV) infection, test results (including both positive and negative results) for children less than two (2) years of age whose mothers are infected with HIV Human immunodeficiency virus (HIV) infection, viral load measurement (including undetectable results)

Hyperthermia Hypothermia Lead (blood) level less than forty-five micrograms per deciliter (<45 μg/dl) in any person Leptospirosis Listeriosis Lyme disease Malaria Methemoglobinemia, environmentally induced Mumps Non-tuberculosis mycobacteria (NTM)

Occupational lung diseases including silicosis, asbestosis, byssinosis, farmer’s lung, and toxic organic dust syndrome Pesticide poisoning Powassan virus neuroinvasive disease Powassan virus non-neuroinvasive disease Psittacosis Rabies Post-Exposure Prophylaxis (Initiated)

Respiratory diseases triggered by environmental contaminants including environmentally or occupationally induced asthma and bronchitis Rickettsiosis, Spotted Fever Saint Louis encephalitis/virus neuroinvasive disease Saint Louis encephalitis virus non-neuroinvasive disease Salmonellosis Streptococcus pneumoniae, Invasive disease (IPD-Invasive Pneumococcal Disease)

Streptococcal toxic shock syndrome (STSS)

Toxic shock syndrome, non-streptococcal Trichinellosis Tuberculosis infection Varicella (Chickenpox)

Varicella deaths Vibriosis (non-cholera Vibrio species infections)

West Nile virus neuroinvasive disease West Nile virus non-neuroinvasive disease Western equine encephalitis virus neuroinvasive disease Western equine encephalitis virus non-neuroinvasive disease Yersiniosis.

(4) Reportable weekly diseases or findings shall be reported directly to the Department of Health and Senior Services weekly. These diseases or findings are— Influenza, laboratory-confirmed.

(5) Reportable quarterly diseases or findings shall be reported directly to the Department of Health and Senior Services quarterly. These diseases or findings are— Carbapenem-resistant enterobacteriaceae (CRE), nosocomial Methicillin-resistant Staphylococcus aureus (MRSA), nosocomial Vancomycin-resistant enterococci (VRE), nosocomial.

(6) A physician, physician’s assistant, nurse, hospital, clinic, or other private or public institution providing diagnostic testing, screening or care to any person with any disease, condition, or finding listed in sections (1)–(4) of this rule or who is suspected of having any of these diseases, conditions, or findings, shall make a case report to the local health authority or the Department of Health and Senior Services, or cause a case report to be made by their designee, within the specified time.

(A) A physician, physician’s assistant, or nurse providing care in an institution to any patient with any disease, condition, or finding listed in sections (1)–(4) of this rule may authorize, in writing, the administrator or designee of the institution to submit case reports on patients attended by the physician, physician’s assistant, or nurse at the institution. But under no other circumstances shall the physician, physician’s assistant, or nurse be relieved of this reporting responsibility.

(B) Duplicate reporting of the same case by health care providers in the same institution is not required.

(7) Except for influenza, laboratory-confirmed and Varicella (Chickenpox), a case report as required in section (6) of this

rule shall include the patient’s name, home address with zip code, date of birth, age, sex, race, home phone number, name of disease, condition or finding diagnosed or suspected, the date of onset of the illness, name and address of the treating facility (if any) and the attending physician, any appropriate laboratory results, name and address of the reporter, treatment information for sexually transmitted diseases, and the date of report.

(A) A report of an outbreak or epidemic as required in subsections (1)(B) and (1)(C) of this rule shall include the diagnosis or principal symptoms, the approximate number of cases, the local health authority jurisdiction within which the cases occurred, the identity of any cases known to the reporter, and the name and address of the reporter.

(B) Influenza, laboratory-confirmed reporting as required in

section (4) of this rule shall include the patient’s age group (i.e., 0–4, 5–24, 25–64, and 65+ years) and serology/serotype (i.e., A, B, and unknown), the local health authority jurisdiction within which the cases occurred, and the date of report. Aggregate patient data shall be reported weekly.

(C) Varicella (Chickenpox) reporting as required in section (3) of this rule shall include the patient’s name, date of birth, vaccination history, and severity of illness; the local health

(8) Any person in charge of a public or private school, summer camp, or child or adult care facility shall report to the local health authority or the Department of Health and Senior Services the presence or suspected presence of any diseases or findings listed in sections (1)–(4) of this rule according to the specified time frames.

(9) All local health authorities shall forward to the Department of Health and Senior Services reports of all diseases or findings listed in sections (1)–(4) of this rule. All reports shall be forwarded according to procedures established by the Department of Health and Senior Services director as listed in sections (1)–(4).

Reports will be forwarded immediately if a terrorist event is suspected or confirmed. The local health authority shall retain from the original report any information necessary to carry out the required duties in 19 CSR 20-20.040(2) and (3).

(10) Information from patient medical records received by local public health agencies or the Department of Health and Senior Services in compliance with this rule is to be considered confidential records and not public records.

(11) Reporters specified in section (6) of this rule will not be held liable for reports made in good faith in compliance with this rule.

(12) The following material is incorporated into this rule by reference:

(A) 2005 Agency for Toxic Substances and Disease Registry (ATSDR) 1825 Century Blvd., Atlanta, GA 30345, Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Priority List of Hazardous Substances, available at http://www.atsdr.cdc.gov/cercla. This rule does not incorporate any subsequent amendments or additions.

(13) Each hospital and ambulatory surgical center shall report on a quarterly basis antibiogram data for infection, not colonization, from all body sites monitored by that health care facility. Antibiogram data to be reported shall include nosocomial methicillin sensitive Staphylococcus aureus (S. aureus), nosocomial S. aureus, nosocomial vancomycin sensitive enterococci, and nosocomial enterococci isolates. Data shall be reported directly to the Department of Health and Senior Services. Reporting shall include only a patient’s first diagnostic nosocomial isolate per admission of Staphylococcus aureus (S. aureus) and enterococci and the isolates corresponding methicillin or vancomycin sensitivity; irrespective of location or of other anti-microbial sensitivity(ies). Intermediate methicillin or vancomycin sensitivity shall be reported as resistant (i.e., methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococci (VRE), respectively).

(A) Isolates from cultures performed for routine surveillance purposes are excluded from the requirement to report.

Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) nosocomial infections to be reported to the Department of Health and Senior Services are limited to those body sites monitored by the individual hospital or ambulatory surgical center.

(B) Aggregate antibiogram data for patients’ non-duplicative isolates, per admission, of nosocomial MRSA and VRE infections shall reflect susceptibility patterns and shall be reported as the— 1. Number of nosocomial isolates of S. aureus sensitive to methicillin (oxacillin, etc.);

Number of nosocomial isolates S. aureus;
Number of nosocomial isolates of enterococci sensitive to vancomycin; and 4. Number of nosocomial isolates enterococci.

(C) Aggregate data shall be reported for the quarters January–March, April–June, July–September, and October– December within ten (10) days of the end of the quarter. Each quarter’s aggregate report shall include only those data that are available within a ten- (10-) day reporting period from the end of that quarter.

rule filed July 15, 1948, effective Sept. 13, 1948. Amended: Filed Sept. 1, 1981, effective Dec. 11, 1981. Rescinded and readopted: Filed Nov. 23, 1982, effective March 11, 1983. Emergency amendment filed June 10, 1983, effective June 20, 1983, expired Sept. 10, 1983.

Amended: Filed June 10, 1983, effec tive Sept. 11, 1983. Amended:

Filed Nov. 4, 1985, effective March 24, 1986. Amended: Filed Aug. 4, 1986, effective Oct. 11, 1986. Amended: Filed June 3, 1987, effective Oct. 25, 1987. Emergency amendment filed June 16, 1989, effective June 26, 1989, expired Oct. 23, 1989. Amended: Filed July 18, 1989, effective Sept. 28, 1989. Amended: Filed Nov. 2, 1990, effective March 14, 1991. Emergency amendment filed Oct. 2, 1991, effective Oct. 12, 1991, expired Feb. 8, 1992. Amended: Filed Oct. 2, 1991, effective Feb. 6, 1992. Amended: Filed Jan. 31, 1992, effective June 25, 1992. Amended: Filed Aug. 14, 1992, effective April 8, 1993. Amended: Filed Sept. 15, 1994, effective March 30, 1995. amendment filed June 1, 2000, effective June 15, 2000, expired Dec. 11, 2000. Amended: Filed June 1, 2000, effective Nov. 30, 2000.

Emergency amendment filed Dec. 16, 2002, effective Dec. 26, 2002, expired June 23, 2003. Amended: Filed Dec. 16, 2002, effective June 30, 2003. Amended: Filed Oct. 1, 2004, effective April 30, 2005.

Amended: Filed Feb. 15, 2006, effective Sept. 30, 2006. Amended:

Filed Nov. 15, 2007, effective May 30, 2008. Amended: Filed Nov. 10, 2015, effective April 30, 2016. Emergency amendment filed Aug. 29, 2016, effective Sept. 8, 2016, expired March 6, 2017. Amended:

Filed Aug. 29, 2016, effective Feb. 28, 2017. Emergency amendment filed June 28, 2019, effective July 8, 2019, terminated Jan. 30, 2020.

Amended: Filed June 28, 2019, effective Jan. 30, 2020. ** Emergency amendment filed Jan. 27, 2020, effective Feb. 10, 2020, expired Aug. 7, 2020. Amended: Filed Jan. 27, 2020, effective July 30, 2020.

Emergency amendment filed Aug. 15, 2022, effective Aug. 29, 2022, expired Feb. 24, 2023. Amended: Filed Aug. 15, 2022, effective Feb. 28, 2023. amended 1945, 1951, 2004, 2016; 210.040, RSMo 1941, amended 1993; and 210.050, RSMo 1941, amended 1993. **Pursuant to Executive Order 21-09, 19 CSR 20-20.020, sections (1), (6), and (8) was suspended from March 23, 2020 through December 31, 2021; section (10) and section 192.067, RSMo was suspended from March 26, 2020 through December 31, 2021; section (6) was suspended from April 2, 2020 through December 31, 2021; 19 CSR 20-20.020 and sections 192.067 and 192.667, RSMo was suspended from April 3, 2020 through December 31, 2021; and 19 CSR 20-20.020 and sections 192.067 and 192.667, RSMo was suspended from April 8, 2020 through December 31, 2021.

History

authority jurisdiction within which the cases occurred, and the date of report.
AUTHORITY: sections 192.006, 192.020, 210.040, and 210.050, RSMo 2016. This rule was previously filed as 13 CSR 50-101.020. Original

19 CSR 20-20.030 Exclusion From School and Readmission {#sec-19-csr-20-20.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.030}

PURPOSE: This rule requires the exclusion of persons from school who have a reportable disease or who are liable to transmit a reportable disease. The methods of readmission to school are also established.

Editor’s Note: The secretary of state has determined that the publication of this rule in its entirety would be unduly cumbersome or expensive. The entire text of the material referenced has been filed with the secretary of state. This material may be found at the Office of the Secretary of State or at the headquarters of the agency and is available to any interested person at a cost established by state law.

(1) Persons suffering from a reportable disease or who are liable to transmit a reportable disease listed in 19 CSR 20-20.020(1)–(3) shall be barred from attending school.

(2) Any person excluded from school under section (1) of this

rule may be readmitted to school by one (1) of the following methods:

(A) Certification in writing by an attending physician attesting to the person’s noninfectiousness;

(B) After a period of time equal to the longest period of communicability of the disease as established in the 1990 fifteenth edition of the Control of Communicable Diseases in Man published by the American Public Health Association; the 1991 twenty-second edition of the Report of the Committee on Infectious Diseases published by the American Academy of Pediatrics; or the following recommendations of the Immunization Practices Advisory Committee published by the Centers for Disease Control in the Morbidity and Mortality Weekly Report: General Recom mendations on Im munization, April 7, 1989; Update on Adult Imm unization, November 15, 1991; New Recommended Schedule for Active Im munization of Normal Infants and Children, September 19, 1986; Pertussis Vac cination: Acel lular Per tussis Vac cine for Re inforcing and Boost er Use—Sup plementary ACIP Statement, February 7, 1992;

Diphtheria, Tetanus and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures, August 8, 1991; Haemophilus b Conjugate Vaccines for Prevention of Haemophilus influenza Type b Disease Among Infants and Children Two Months of Age and Older, January 11, 1991; Immunization of Children Infected With Human Immunodeficiency Virus—Sup plementary ACIP State ment, April 1, 1988; Im munization of Child ren In fected with Human T-Lympho tropic Virus Type III/Lymphadenopathy- Associated Virus, September 26, 1986; Prevention and Control of Influenza, May 15, 1992; Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP), December 29, 1989; Meningococcal Vaccines, May 10, 1985;

Mumps Prevention, June 9, 1989; Pneumococcal Polysaccharide Vaccine, February 10, 1989; Poliomyelitis Prevention: Enhanced- Potency Inactivated Poliomyelitis Vaccine Supplementary— Statement, December 11, 1987; Poliomyelitis Prevention, January 29, 1982; Rabies Prevention, March 22, 1991; Rubella Prevention, November 23, 1990; Varicella-Zoster Immune Globulin for the Prevention of Chickenpox, February 24, 1984; Hepatitis B Virus:

A Comprehensive Strategy for Eliminating Transmission in the United States Through Universal Childhood Vaccination, November 22, 1991; Plague Vaccine, June 11, 1982; Typhoid Immunization, July 13, 1990; Typhus Vaccine, June 2, 1978; and Yellow Fever Vaccine, May 4, 1990; or (C) When the local health authority declares that the designated health emergency is ended, after consultation and concurrence of the director of the Department of Health or his/ her designated representative.

rule was previously filed as 13 CSR 50-101.041. Original rule filed Dec. 11, 1981, effective May 13, 1982. Amended: Filed Sept. 16, 1982, effective Jan. 14, 1983. Amended: Filed Aug. 4, 1986, effective Oct. 11, 1986. Amended: Filed April 4, 1988, effective June 27, 1988.

Emergency amendment filed Jan. 13, 1989, effective Jan. 23, 1989, expired May 22, 1989. Amended: Filed Jan. 13, 1989, effective May 11, 1989. Amended: Filed Oct. 3, 1989, effective Feb. 25, 1990.

Amended: Filed Nov. 2, 1990, effective March 14, 1991. Amended:

Filed July 12, 1991, effective Oct. 31, 1991. Amended: Filed Aug. 14, 1992, effective Feb. 26, 1993. *Original authority: 192.005.2., RSMo 1985, amended 1993 and 192.020, RSMo 1939, amended 1945, 1951.

History

AUTHORITY: sections 192.005.2. and 192.020, RSMo 1994. This

19 CSR 20-20.040 Measures to Determine the Prevalence and Prevent the Spread of Diseases which are Infectious, Contagious, Communicable, or Dangerous in their Nature {#sec-19-csr-20-20.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.040}

PURPOSE: This rule defines investigative and control measures for reportable diseases and establishes who is responsible for them.

(1) The director shall use the legal means necessary to control, investigate, or both, any disease or condition listed in 19 CSR 20-20.020 which is a threat to the public health.

(2) It shall be the duty of the local health authority, the director of the department, or the director’s designated representative on receiving a report of a disease which is infectious, contagious, communicable, or danger ous in its nature as included in 19 CSR 20-20.020 to— (A) Inspect any premises that they have reasonable grounds to believe are in a condition conducive to the spread of the disease;

(B) Confer with the physician, laboratory or person making the report;

(C) Collect for laboratory analysis any samples or specimens that may be necessary to confirm the diagnosis or presence of the disease or biological, chemical, or physical agents and to determine the source of the infection, epidemic, or exposure. Health program representatives and other personnel employed by the department, after training and certification to perform venipuncture, and after specific authorization from a physician, are authorized to perform venipuncture utilizing procedures within the scope of the training they have been given. The content and scope of this training shall be established by the department. Training shall be provided by a physician or his/her designee and the certificate shall be signed by the physician. Nothing in this rule shall limit the authority of local public health departments to establish their own training policies, with or without certification, or to limit their voluntary participation in the certification program developed by the department, nor shall it apply to venipuncture for other purposes;

(D) Make a complete epidemiological, environmental or occupational industrial hygiene investigation and record of the findings on a communicable disease or exposure report form;

(E) Establish and maintain quarantine, isolation or other measures as required;

(F) Provide the opportunity to be immunized to all contacts of persons suffering from those diseases for which there is a reliable and approved means of immunization;

(G) This subsection was terminated as a result of Shannon (H) This subsection was terminated as a result of Shannon (I) This subsection was terminated as a result of Shannon (J) Investigate, as the local health authority, the disease within the local jurisdiction with assistance from the director of the department or his/her designated representative when any outbreak or unusual occurrence of a reportable disease is identified through reports required by 19 CSR 20-20.020. If, in the judgment of the director, the disease outbreak or unusual occurrence constitutes a medical emergency, the director may assume direct responsibility for the investigation.

(3) It shall be the duty of the local health authority, upon identification of a case of a reportable disease or upon receipt of a report of that disease, to take actions and measures as may be necessary according to any policies which have been or may be established by the director of the department, within the provisions of section (2) and subsections (2)(A)–(J) of this rule.

(A) When the local health authority is notified of a reportable disease or has reason to suspect the existence of a reportable disease within the local jurisdiction, the local health authority, either in person or through a designated representative, shall make an investigation as is necessary and immediately institute appropriate control measures as set forth in section (2) and subsections (2)(A)–(J) of this rule.

(B) The local health authority shall use every reasonable means to determine the presence of a communicable disease or the source of any disease listed in 19 CSR 20-20.020 or of any epidemic disease of unknown cause. In the performance of this duty, the local health authority shall examine or cause to be examined any person reasonably suspected of being infected or of being a source or contact of infection and any person who refuses examination shall be quarantined or isolated.

(4) It shall be the duty of the attending physician, immediately upon diagnosing a case of a reportable communicable disease, to give detailed instructions to the patient, members of the household and attendants regarding proper control measures.

When a person dies while infected with a communicable disease, it shall be the duty of the attending physician to learn immediately who is to prepare the body for burial or cremation and then notify the funeral director, embalmer or other responsible person regarding the communicable disease the deceased had at the time of death. A tag shall also be affixed to the body providing the name of the communicable disease likely to have been present at the time of death.

(5) Every practitioner of the healing arts and every person in charge of any medical care facility shall permit the director of the department or the director’s designated representative to examine and review any medical records which are in the practitioner’s or person’s possession or to which the practitioner or person has access, upon request of the director or the director’s designated representative in the course of investigation of reportable diseases in 19 CSR 20-20.020.

(6) This section was terminated as a result of Shannon Robinson, et al. v. Missouri Department of Health and Senior Services (cause number 20AC-CCO515) effective December 22, 2021.

(7) In order to prevent the spread of infectious diseases, contagious diseases, communicable diseases, or diseases that are dangerous in their nature within Missouri, it shall be the duty of the local health authority, the director of the department or the director’s designated representative to do the following:

(A) Notify or ensure adequate notice is given to potentially exposed individuals when such official determines that a case or outbreak of any such disease subjects such individuals to serious illness or death, if acquired; and (B) Notify or ensure adequate notice is given to the public when such official determines that a case or outbreak of any such disease subjects the public to serious illness or death, if acquired, and the identity of potentially exposed individuals is not known at such time or cannot be known.

Such notice shall provide necessary information for the recipient to avoid or appropriately respond to the exposure.

rule was previously filed as 13 CSR 50-101.050. Original rule filed July 15, 1948, effective Sept. 13, 1948. Rescinded and readopted:

Filed Dec. 11, 1981, effective May 13, 1982. Amended: Filed Sept. 16, 1982, effective Jan. 14, 1983. Amended: Filed March 21, 1984, effective July 15, 1984. Amended: Filed June 2, 1988, effective Aug. 25, 1988. Amended: Filed Nov. 15, 1989, effective Feb. 11, 1990. Amended: Filed Aug. 14, 1992, effective April 8, 1993. amendment filed June 13, 2002, effective July 1, 2002, expires Dec. 27, 2002. Amended: Filed June 13, 2002, effective Nov. 30, 2002.

Emergency amendment filed June 28, 2019, effective July 8, 2019, expired Feb. 27, 2020. Amended: Filed June 28, 2019, effective Jan. 30, 2020. ** Subsections (2)(G), (2)(H), and (2)(I) and section (6) terminated as a result of Shannon Robinson, et al. v. Missouri Department of Health and Senior Services effective December 22, 2021. *Original authority: 192.006, RSMo 1993, amended 1995 and 192.020, RSMo 1939, amended 1945, 1951. **Pursuant to Executive Order 21-07, 19 CSR 20-20.040 was suspended from March 24, 2020 through May 1, 2021.

History

authority shall be at least as stringent as those established by the director of the department and shall be subject to review and alteration by the director. If the local health authority fails to carry out appropriate control measures, the director or his/ her designated representative shall take steps necessary to protect the public health.
AUTHORITY: sections 192.006 and 192.020, RSMo 2016. This

19 CSR 20-20.050 Quarantine or Isolation Practices and Closing of Schools and Places of Public and Private Assembly {#sec-19-csr-20-20.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.050}

PURPOSE: This rule provides for the isolation or quarantine of persons and animals with a communicable disease and their contacts; it also authorizes the closing of schools and places of public and private assembly.

(1) The local health authority, the director of the Department of Health and Senior Services or the director’s designated representative shall require isolation of a patient or animal with a communicable disease, quarantine of contacts, concurrent and terminal disinfection, or modified forms of these procedures necessary for the protection of the public health. The isolation of a patient, animal or contact shall be carried out according to the methods of control in 19 CSR 20- 20.040(1).

(2) No person or animal infected with or suspected of having a communicable disease listed in 19 CSR 20-20.020(1)–(3) or any contact of a disease subject to quarantine or isolation shall move or be moved from one (1) health jurisdiction to another, unless necessary for medical care, without notice to and consent from the local health authority, the director of the Department of Health and Senior Services or the director’s designated representative. If a person is moved for the reason of medical care, the health authority who ordered the isolation or quarantine shall be notified within seventy-two (72) hours.

(3) This section was terminated as a result of Shannon Robinson, et al. v. Missouri Department of Health and Senior Services (cause number 20AC-CCO515) effective December 22, 2021.

History

AUTHORITY: section 192.020, RSMo Supp. 2006. This rule was previously filed as 13 CSR 50-101.061. Original rule filed Dec. 11, 1981, effective May 13, 1982. Emergency amendment filed June 15, 2007, effective July 6, 2007, expired Jan. 1, 2008. Amended: Filed June 15, 2007, effective Jan. 30, 2008. Section (3) terminated as a result of Shannon Robinson, et al. v. Missouri Department of Health and Senior Services effective December 22, 2021. Original authority: 192.020, RSMo 1939, amended 1945, 1951, 2004. Pursuant to Executive Order 21-07, 19 CSR 20-20.050 was suspended from March 24, 2020 through May 1, 2021.

19 CSR 20-20.060 Control Measures for Food Handlers {#sec-19-csr-20-20.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.060}

PURPOSE: This rule establishes control measures for persons working with food products who are suspected of having a communicable disease.

(1) For the purpose of this rule, a communicable disease is defined as a disease transmitted through handling food.

(2) No person infected with a communicable disease, whether actively infected or a chronic carrier, and no person with any one (1) of the signs and symptoms listed in this section, shall engage in the production, preparation, manufacture, packaging, storage, sale, distribution or transportation of food.

The following signs and symptoms indicate infection with a foodborne pathogen: diarrhea, vomiting, open skin sores, boils, fever, dark urine or jaundice, unless determined not to be caused by a pathogen able to be transmitted by food.

The local health authority, the director of the Department of Health or the director’s designated representative may order examinations necessary to determine the presence of a foodborne infection.

(3) Notice shall be sent immediately to the local health

(4) When the possibility of transmission of infection is suspected in any person engaged in the production, preparation, manufacture, packaging, storage, sale, distribution or transportation of food; the local health authority, the director of the Department of Health or the director’s designated representative is authorized to require any of the following measures:

(A) The immediate exclusion of that person from the production, preparation, manufacture, packaging, storage, sale, distribution or transportation of food;

(B) The immediate exclusion of the food supply concerned from distribution and use; and (C) Adequate medical examination of that person and his/ her associates, including necessary laboratory testing of blood, feces, sputum, throat cultures and other bodily secretions or excreta.

Original rule filed Dec. 11, 1981, effective May 13, 1982. Amended:

Filed Nov. 4, 1992, effective May 6, 1993. *Original authority: 192.005.2., RSMo 1985, amended 1993; 192.020, RSMo 1939, amended 1945, 1951; 196.045, RSMo 1943, amended 1993; and 196.225, RSMo 1939, amended 1977.

History

authority, to the director of the Department of Health or to the director’s designated representative by any person responsible for the production, preparation, manufacture, packaging, storage, sale, distribution or transportation of food if any infection or disease known to be transmissible through food occurs on the premises or among the employees.
AUTHORITY: sections 192.005.2., 192.020, 196.045 and 196.225, RSMo 1994. This rule was previously filed as 13 CSR 50-101.071.

19 CSR 20-20.070 Duties of Local Health Departments {#sec-19-csr-20-20.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.070}

PURPOSE: This rule establishes procedures for reporting communicable diseases to the Missouri Department of Health by local health departments.

(1) All local health authorities shall forward reports of all diseases and conditions mentioned in 19 CSR 20-20.020 to the Missouri Department of Health. These reports shall be forwarded within twenty-four (24) hours after they are received, according to procedures established by the Department of Health director. Local health authorities shall transcribe from the original reports information necessary to the conduct of their duties in 19 CSR 20-20.040(2), (2)(A)–(J), (3) and (3)(A)–(C) before forwarding the reports. All reports received by either the local health authority or the Department of Health are to be considered confidential records and not public records.

History

AUTHORITY: section 192.020, RSMo 1994. This rule was previously filed as 13 CSR 50-101.080. Original rule filed July 15, 1948, effective Sept. 13, 1948. Amended: Filed Dec. 11, 1981, effective May 13, 1982. Original authority: 192.020, RSMo 1939, amended 1945, 1951.

19 CSR 20-20.075 Confidentiality of Information Obtained for Reporting of Communicable, Environmental and Occupational Diseases and Conditions {#sec-19-csr-20-20.075 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.075}

PURPOSE: This rule requires local public health agencies to establish confidentiality policies and procedures which are as stringent as Missouri Department of Health (MDOH) policies and procedures for information obtained for reporting of communicable, environmental and occupational diseases. It also requires establishment of security policies and procedures for access to MDOH information systems.

(1) Local public health agencies shall adopt and abide by confidentiality policies and procedures which are as stringent as Missouri Department of Health (MDOH) policies and procedures for information obtained for the reporting of communicable, environmental and occupational diseases defined in 19 CSR 20-20.020.

(2) Such information may be used only for investigation to determine the source of exposure and/or potential for spread; follow-up screening to monitor disease, exposure status, or communicability; counseling and patient education regarding the disease or condition and its prevention; administration of immunizations and/or prophylactic medications to the case or contacts; isolation and/or restriction of the client’s or contact’s activities; environmental assessment and other activities undertaken to eliminate the source of exposure; or epidemiologic analysis to determine trends in incidence, prevalence, treatment, disease progression, and/or risk factors associated with diseases.

(3) Local public health agencies shall forward reports to MDOH in accordance with 19 CSR 20-20.020. Otherwise, such information shall be released only in a statistical aggregate form that precludes and prevents the identification of an individual, physician, or medical facility except when such release is specifically authorized by law.

(4) Local public health agencies that access MDOH information systems shall establish security policies and procedures which are as stringent as MDOH policies and procedures to protect information systems against unauthorized data disclosure, modification, or destruction and to protect the integrity of the information system. Local public health agencies and employees who use MDOH information systems to perform their duties shall abide by MDOH policies and procedures for access to and use of information systems.

(5) Local public health agencies shall provide comprehensive training to employees on confidentiality and security policies, laws, and the administrative, civil, and criminal penalties for violations. Local public health agencies shall monitor employees to assure compliance with confidentiality laws, rules, policies and procedures. Local public health agencies shall immediately report to MDOH any breaches of confidentiality and security as specified by MDOH policy.

(6) Contractors performing work for MDOH or local public health agencies that involves access to information obtained for the reporting of communicable, environmental and occupational diseases shall be required, through their contracts, to abide by sections (1)–(5) of this rule.

rule filed Aug. 4, 1999, effective Jan. 30, 2000. *Original authority: 167.183, RSMo 1992; 191.656, RSMo 1988, amended 1992, 1993, 1996; 192.006, RSMo 1993, amended 1995; 192.020, RSMo 1939, amended 1945, 1951; 192.067, RSMo 1988; 192.802, RSMo 1992; and 701.328, RSMo 1993, amended 1998.

History

AUTHORITY: sections 191.656, 192.006, 701.328, RSMo Supp. 1998 and 167.183, 192.020, 192.067 and 192.802, RSMo 1994. Original

19 CSR 20-20.080 Duties of Laboratories {#sec-19-csr-20-20.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.080}

PURPOSE: This rule establishes the responsibility of laboratories to report to the Missouri Department of Health and Senior Services specified results of tests and to submit isolates/specimens for certain diseases and conditions.

(1) The director, person in charge of any laboratory, or designee of the director or person in charge of any laboratory shall report to the local health authority or the Missouri Department of Health and Senior Services the result of any test that is positive for, or suggestive of, any disease or condition listed in 19 CSR 20-20.020. These reports shall be made according to the time and manner specified for each disease or condition following completion of the test and shall designate the test performed, all results of the test, including numeric results, if applicable, units of measure of the results, and reference ranges for normal and abnormal results, the name and address of the attending physician, the name of the disease or condition diagnosed or suspected, the date the test results were obtained, the name and home address (with zip code) of the patient and the patient’s age, date of birth, sex, race, and ethnicity.

(2) In reporting findings for diseases or conditions listed in 19 CSR 20-20.020, laboratories shall report— Arsenic—results of all biological specimens including time frame of urine specimen collection, if applicable;

Cadmium—results of all biological specimens including time frame of urine specimen collection, if applicable;

Carboxyhemoglobin proportion—all results;

Chemical/pesticide (blood or serum)—all results, including if none detected;

Lead level—results of all biological specimens;

Mercury—results of all biological specimens including time frame of urine specimen collection, if applicable; and Methemoglobin proportion—all results.

(3) Isolates or specimens positive for the following reportable diseases or conditions must be submitted to the State Public Health Laboratory for epidemiological or confirmation purposes:

Anthrax (Bacillus anthracis)

Cholera (Vibrio cholerae)

Diphtheria (Corynebacterium diphtheriae)

Escherichia coli O157:H7 Glanders (Burkholderia mallei)

Haemophilus influenzae, invasive disease Influenza Virus-associated mortality Listeriosis Malaria (Plasmodium species)

Measles (rubeola)

Melioidosis (Burkholderia pseudomallei)

Mycobacterium tuberculosis Neisseria meningitidis, invasive disease Orthopoxvirus (smallpox/cowpox-vaccinia/monkeypox)

Other Shiga Toxin positive organisms Pertussis (Bordetella pertussis)

Plague (Yersinia pestis)

Salmonella species Severe Acute Respiratory Syndrome-associated Coronavirus (SARS-CoV) disease Shigella species Tularemia (Francisella tularensis)

Potential Vancomycin Resistant Staphylococcus aureus (VRSA), with MIC greater than or equal to eight (> 8)

(4) Every laboratory performing culture and sensitivity testing on human specimens in Missouri for health care facilities shall annually report these results to the Missouri Department of Health and Senior Services (MDHSS) for each facility provided this service. The data submitted should be in the format of antibiograms as defined by the Clinical and Laboratory Standards Institute (CLSI), M39-A2, Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data. Only data from the first unique isolate from each patient should be included. Duplicate cultures must be excluded when compiling these antibiograms. The antibiograms for the preceding year are to be sent to MDHSS by July 1 of the following year (ex: 2006 data, January 1, 2006–December 31, 2006, will be due on July 1, 2007).

rule filed June 1, 2000, effective June 15, 2000, expired Dec. 11, 2000. Emergency rescission filed June 2, 2000, effective June 15, 2000, expired Dec. 11, 2000. Previous version of rule rescinded filed June 1, 2000, effective Jan. 30, 2001. Readopted: Filed June 1, 2000, effective Nov. 30, 2000. Amended: March 14, 2003, effective Sept. 30, 2003. Amended: Filed March 14, 2003, effective Sept. 30, 2003.

Amended: Filed April 15, 2005, effective Oct. 30, 2005. Amended:

Filed Feb. 15, 2006, effective Sept. 30, 2006. Amended: Filed Nov. 15, 2007, effective May 30, 2008. Amended: Filed Nov. 10, 2015, effective April 30, 2016. amended 1945, 1951, 2004; and 192.131, RSMo 2004.

History

AUTHORITY: section 192.006, RSMo 2000, and sections 192.020 and 192.131, RSMo Supp. 2013. This rule was previously filed as 13 CSR 50-101.090. Original rule filed July 15, 1948, effective Sept. 13, 1948. Amended: Filed Aug. 4, 1986, effective Oct. 11, 1986. Amended: Filed Aug. 14, 1992, effective April 8, 1993.

19 CSR 20-20.090 Contact With Communicable Diseases by First Responders or Emergency Medical Person and Mortuary Personnel {#sec-19-csr-20-20.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.090}

PURPOSE: This rule defines the procedures for notification to a first responder or emergency medical person and mortuary personnel who are exposed to an individual who is human immunodeficiency virus seropositive, hepatitis B infected or infected with any other reportable communicable disease as listed in 19 CSR 20-20.020(1)–(5).

(1) The following definitions shall be used in administering this rule:

(A) Authorized personnel—any individual who has the

(B) Emergency medical person—a licensed attendant who has been specially trained in emergency cardiac and noncardiac care, and who has successfully completed an emergency service training program certified by the Department of Health as meeting the requirements of sections 190.100–190.190, RSMo and any individual providing emergency medical services who is licensed under Chapters 334 and 335, RSMo;

(D) Employer—one who provides gainful work for wage earners and volunteers in the emergency care area;

(E) Exposure—any contact with an individual who is human immunodeficiency virus (HIV) seropositive or infected with any other reportable communicable disease as listed in 19 CSR 20-20.020(1)–(5), when the contact is consistent with the known means of transmission and occurs within the period of communicability of the disease;

(F) Facility—a facility licensed under Chapter 197 or 198, RSMo.

(G) First responder—an individual with training in first aid or emergency medical care, who is associated with a police department, sheriff's department, fire service or ambulance service and who is routinely dispatched to the scene of an accident or unforeseen emergency medical incident prior to or with the arrival of a licensed, staffed and equipped ambulance;

(H) Mortuary personnel—those persons having direct contact with a corpse prior to completion of embalming, cremating or enclosing the corpse in a sealed casket; and (I) To notify—within forty-eight (48) hours after confirming potential exposure, the facility shall report the potential exposure by phone or in person to the employer(s)/funeral director of the potentially exposed employee(s)/mortuary personnel.

(2) If a facility admits a patient who was in an emergency rescue operation, received medical treatment or was transported to the facility by a first responder or an emergency medical person and is subsequently diagnosed as HIV seropositive or infected with any other reportable communicable disease as listed in 19 CSR 20-20.020(1)–(5), the facility, after confirming the presence of the disease, shall notify the employer(s) of the potentially exposed employee(s). The employer(s) shall be provided with the ambulance run number, police incident report or sufficient information to enable identification of the potentially exposed employee without reference to the patient’s name. Notifications shall remain confidential and shall be released to authorized personnel only.

(3) If mortuary personnel remove a corpse from a facility or provide care to the corpse and the facility subsequently determines the presence at the time of death of HIV seropositivity or infection with any other reportable communicable disease as listed in 19 CSR 20-20.020(1)–(5), the facility shall notify the funeral director of the mortuary personnel’s contact.

(4) The employer/funeral director shall investigate the potential exposure of the employee/mortuary personnel to determine if it was consistent with the known means of transmission and occurred within the period of communicability of the disease in question.

(A) If the exposure was consistent with the known means of transmission and occurred within the period of communicability, the employer/funeral director shall notify the employee/mortuary personnel within forty-eight (48) hours.

(B) The employer/funeral director shall instruct the employee/ mortuary personnel to contact the facility for medical direction.

History

authority to hire or fire and demote or promote employees for a corporation, entity or organization;
AUTHORITY: sections 190.100–190.190 and 191.653, RSMo 1994. Original rule filed July 18, 1989, effective Nov. 11, 1989. Original authority: 190.100, RSMo 1973, amended 1987, 1989; 190.105–190.115, RSMo 1973; 190.120, RSMo 1973, amended 1980; 190.125–190.135, RSMo 1973; 190.140, RSMo 1973, amended 1987; 190.141, RSMo 1989; 190.145, RSMo 1973, amended 1975; 190.150–190.160, RSMo 1973; 190.165, RSMo 1973, amended 1978; 190.171, RSMo 1978; 190.175–190.180, RSMo 1973; 190.185, RSMo 1973, amended 1989, 1993; 190.190, RSMo 1973; and 191.653, RSMo 1988. Pursuant to Executive Order 21-09, 19 CSR 20-20.090, section (2) was suspended from April 14, 2020 through December 31, 2021.

19 CSR 20-20.091 Testing for Contagious or Infectious Disease {#sec-19-csr-20-20.091 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.091}

PURPOSE: This rule determines the contagious or infectious diseases for which testing is reasonable and appropriate and which may be administered pursuant to section 191.631, RSMo.

(1) Tests for the following contagious or infectious diseases may be administered pursuant to sections 191.630 to 191.631, RSMo:

(A) Hepatitis B;

(B) Hepatitis C;

History

AUTHORITY: section 191.631, RSMo Supp. 2002. Original rule filed March 14, 2003, effective Sept. 30, 2003. Original authority: 191.631, RSMo 2002.

19 CSR 20-20.092 Blood-Borne Pathogen Standard Required for Occupational Exposure of Public Employees to Blood and Other Infectious Materials {#sec-19-csr-20-20.092 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.092}

PURPOSE: This rule establishes standards for protection of public employees from occupational exposure to blood-borne pathogens in the workplace.

PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. Therefore, the material which is so incorporated is on file with the agency who filed this rule, and with the Office of the Secretary of State. Any interested person may view this material at either agency’s headquarters or the same will be made available at the Office of the Secretary of State at a cost not to exceed actual cost of copy reproduction. The entire text of the

rule is printed here. This note refers only to the incorporated by reference material.

(1) The blood-borne pathogen standard governing public employers in the state of Missouri having employees with occupational exposure to blood or other potentially infectious materials shall be the standard of the Occupational Safety and Health Administration as codified in 29 CFR 1910.1030. The Occupational Safety and Health Administration standard as codified in 29 CFR 1910.1030 is incorporated herein by reference.

(2) As part of the Occupational Safety and Health Administration blood-borne pathogen standard codified in 29 CFR 1910.1030, each public employer having employees with occupational exposure is required to establish a written Exposure Control Plan.

Such plan shall include a requirement that the most effective available needleless systems and sharps with engineered sharps injury protection be included as engineering and work practice controls. However, such engineering controls shall not be required if:

(A) None are available in the marketplace; or (B) An evaluation committee, as described in section 191.640.5, RSMo determines by means of objective product evaluation criteria that use of such devices will jeopardize patient or employee safety with regard to a specific medical procedure.

History

AUTHORITY: sections 191.640, RSMo Supp. 2002 and 192.006, RSMo 2000. Original rule filed March 14, 2003, effective Sept. 30, 2003. Original authority: 191.640, RSMo 2001; 192.006, RSMo 1993, amended 1995.

19 CSR 20-20.100 Tuber culosis Testi ng for Residents and Workers in Long-Term Care Facilities and State Correctional Centers {#sec-19-csr-20-20.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.100}

PURPOSE: This rule establishes tuberculosis testing re quirements for residents and work ers in long-term care facilities and state cor rection al cen ters.

(1) General Requirements. Long-term care facilities and state correctional centers shall screen their residents and staff for tuberculosis using the Mantoux method purified protein derivative (PPD) five tuberculin unit (5 TU) test. Each facility shall be responsible for ensuring that all test results are completed and that documentation is maintained for all residents, employees, and volunteers.

(A) In interpreting this rule, long-term care facilities shall include employees, volunteers, and residents of residential care facilities I, residential care facilities II, intermediate care facilities and skilled nursing facilities as defined in section 198.006, RSMo.

(B) In interpreting this rule, state correctional centers shall include all employees and volunteers of the Missouri Department of Corrections and the residents of all correctional institutions operated by the Missouri Department of Corrections.

(C) Whenever tuberculosis is suspected or confirmed, or tuberculosis infection is diagnosed among residents, employees or volunteers, the Department of Health or local health

(2) Long-Term Care Residents. Within one (1) month prior to or one (1) week after admission, all residents new to long-term care are required to have the initial test of a Mantoux PPD two (2)-step tuberculin test. If the initial test is negative, zero to nine millimeters (0–9 mm), the second test, which can be given after admission, should be given one to three (1–3) weeks later.

Documentation of chest X ray evidence ruling out tuberculosis disease within one (1) month prior to admission, along with an evaluation to rule out signs and symptoms compatible with infectious tuberculosis, may be accepted by the facility on an interim basis until the Mantoux PPD two (2)-step test is completed.

(A) All skin test results are to be documented in millimeters (mm) of induration.

(B) Bacillus of Calmette and Guerin (BCG) vaccination shall not prevent residents from receiving a tuberculin test.

(C) A reaction of ten millimeters (10 mm) or more shall be considered as infected with Mycobacterium tuberculosis for an individual with a history of BCG vaccination.

(D) Evidence of tuberculosis infection is considered to be a reaction of five millimeters (5 mm) or more for all contacts to infectious tuberculosis or for an individual who is immunosuppressed or has abnormal chest X-ray findings consistent with old healed tuberculosis disease, and ten millimeters (10 mm) or more for all others.

(E) Residents with a negative, zero to nine millimeters (0–9 mm), Mantoux PPD two (2)-step test need not be routinely retested unless exposed to infectious tuberculosis or they develop signs and symptoms which are compatible with tuberculosis disease.

(F) Residents with a documented history of tuberculosis infection or an adequate course of preventive treatment shall not be required to be retested. Residents with a documented

history of tuberculosis disease and adequate chemotherapy shall not be required to be retested. In the absence of documentation, a repeat test shall be required.

(G) All skin test results of five millimeters (5 mm) or more for contacts to infectious tuberculosis or for an individual who is immunocompromised, or ten millimeters (10 mm) or more for all others, shall require a chest X ray within one (1) week, or a review of the results of a chest X ray taken within the month prior to admission along with an evaluation to rule out signs and symptoms compatible with tuberculosis disease to rule out (H) Individuals with a positive finding presenting evidence of a recent, within one (1) month of the date of admission, chest X ray need not be given a new X ray. However, the results of the X ray must be reviewed in the light of the additional information of the identification of tuberculosis infection as indicated by the Mantoux PPD skin test.

(I) An individual who is skin-test positive with a normal chest X ray should be considered for preventive medication. Those who complete a recommended course of preventive treatment and those for whom preventive treatment is not medically indicated need have no further testing for tuberculosis unless (J) All residents of long-term care facilities who are exposed to a case of infectious tuberculosis or who develop signs and symptoms which are compatible with tuberculosis disease shall be medically evaluated. All long-term care facility residents shall have a documented annual evaluation to rule out signs and symptoms of tuberculosis disease.

(3) Long-Term Care Employees and Volunteers. All new longterm care facility employees and volunteers who work ten (10) or more hours per week are required to obtain a Mantoux PPD two (2)-step tuberculin test within one (1) month prior to starting employment in the facility. If the initial test is zero to nine millimeters (0–9 mm), the second test should be given as soon as possible within three (3) weeks after employment begins, unless documentation is provided indicating a Mantoux PPD test in the past and at least one (1) subsequent annual test within the past two (2) years. It is the responsibility of each facility to maintain a documentation of each employee’s and volunteer’s tuberculin status.

(A) All skin test results are to be documented in millimeters (mm) of induration.

(B) BCG vaccination shall not prevent employees and volunteers from receiving a tuberculin test.

(C) For an individual with a history of BCG vaccination, a reaction of ten millimeters (10 mm) or more shall be considered as infected with Mycobacterium tuberculosis.

(D) Evidence of tuberculosis infection is considered to be a reaction of five millimeters (5 mm) or more for all contacts to infectious tuberculosis or for an individual who is immunosuppressed or has abnormal chest X ray findings consistent with old healed tuberculosis disease, and ten millimeters (10 mm) or more for all others.

(E) Employees and volunteers with an initial zero to nine (F) Employees and volunteers with a documented history of a positive Mantoux PPD test shall not be required to be retested. In the absence of documentation, a repeat test shall be required.

(G) All positive findings shall require a chest X ray to rule out (H) Individuals with a positive finding need not have repeat (I) An individual who is skin-test positive with a normal (J) All employees and volunteers of long-term care facilities who are exposed to a case of infectious tuberculosis or who develop signs and symptoms which are compatible with tuberculosis disease shall be medically evaluated. All employees or volunteers of these facilities shall have a documented annual (4) State Correctional Centers Residents. All residents of state correctional centers are required to obtain a Mantoux PPD two (2)-step tuberculin test upon admission to rule out tuberculosis.

If the initial test is negative, zero to nine millimeters (0–9 mm), the second test should be given within ninety (90) days of entrance into the state correctional system.

(A) All skin test results are to be documented in millimeters (mm) of induration.

(B) BCG vaccination shall not prevent residents from receiving a tuberculin test.

(C) For an individual with a history of BCG vaccination, a reaction of ten millimeters (10 mm) or more shall be considered as infected with Mycobacterium tuberculosis.

(D) A positive test is defined as having a reaction of five millimeters (5 mm) or more for all contacts to infectious tuberculosis or for an individual who is immunosuppressed or has abnormal chest X ray findings consistent with old healed tuberculosis disease, and ten millimeters (10 mm) or more for all others.

(E) Individuals with an initial negative zero to nine (F) Individuals with a documented history of a positive Mantoux PPD test shall not be required to be retested. In the absence of documentation, a repeat test shall be required.

(G) All positive findings shall require a chest X ray to rule out (H) Individuals with a positive finding need not have repeat (I) An individual who is skin-test positive with a normal (J) All residents of state correctional centers who are exposed to a case of infectious tuberculosis or who develop signs and symptoms which are compatible with tuberculosis disease shall be medically evaluated. All residents shall have a documented annual evaluation to rule out signs and symptoms of tuberculosis disease.

(5) Missouri Department of Corrections New Employees and Volunteers. All new employees and volunteers who work ten (10) or more hours per week for the Missouri Department of Corrections are required to obtain a Mantoux PPD two (2)-step tuberculin test within three (3) weeks of starting employment.

If the initial test is negative, zero to nine millimeters (0–9 mm), the second test should be given one to three (1–3) weeks after the initial test. It is the responsibility of each state correctional center to maintain documenta tion of each employee’s or volunteer’s tuberculin status.

(A) All skin test results are to be documented in millimeters (mm) of induration.

(B) BCG vaccination shall not prevent new employees and volunteers from receiving a tuberculin test.

(C) For an individual with a history of BCG vaccination, a significant reaction of ten millimeters (10 mm) or more shall be considered as infected with Mycobacterium tuberculosis.

(E) Employees and volunteers with a negative zero to nine (F) Employees and volunteers with a documented history of a positive Mantoux PPD test shall not be required to be retested. In the absence of documentation, a repeat test shall be required.

Filed June 14, 2000, effective Nov. 30, 2000. *Original authority: 199.350, RSMo 1992.

History

authority shall be notified as required in 19 CSR 20-20.020(2).
AUTHORITY: section 199.350, RSMo 1994. Original rule filed April 17, 1995, effective Nov. 30, 1995. Emergency amendment filed June 14, 2000, effective June 24, 2000, expired Feb. 22, 2001. Amended:

19 CSR 20-20.200 COVID-19 Vaccine Priority Tier Evaluation Committee {#sec-19-csr-20-20.200 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-20.200}

Emergency rule filed Feb. 9, 2021, effective Feb. 25, 2021, terminated March 26, 2021.

History

AUTHORITY: sections 192.006 and 192.020, RSMo Supp. 2020.

Chapter 21SN * - moved to 19 CSR 70-21

19 CSR 20-21SN * - moved to 19 CSR 70-21 {#sec-19-csr-20-21sn omnilex-key=us-mo-regs-official--title-19--19 CSR 20-21SN}

MATTBLUNT(1/29/03)

Rules of Department of Health and Senior Services Division 20óDivision of Environmental Health and Epidemiology SPECIAL NOTICE

Chapter 21óCancer On September 1, 1988, Chapter 21 of Division 20óDivision of Environmental Health and Epidemiology was transferred to Division 70óDivision of Chronic Disease Prevention and Health Promotion. These rules may be found at 19 CSR 70. The chapter number is unchanged.

Chapter 22 Typhoid Carriers

19 CSR 20-22.010 Supervision of Typhoid Carriers {#sec-19-csr-20-22.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-22.010}

PURPOSE: This rule establishes procedures for the supervision of identified carriers of typhoid.

(1) Any person whose feces or urine contains typhoid bacilli (Salmonella typhi) and is not ill shall be considered a typhoid carrier. If a typhoid carrier has had typhoid fever within the past twelve (12) months s/he shall be considered a convalescent typhoid carrier. If a typhoid carrier continues to have typhoid bacilli in his/her feces or urine for more than twelve (12) months after having typhoid fever or in the absence of a history of typhoid fever, s/he shall be considered a chronic typhoid carrier.

(2) A typhoid carrier shall be under the supervision of the health officer having jurisdiction. No typhoid carrier shall prepare, serve or in any way handle water, milk or milk products or any other food to be consumed by persons other than those in his/her immediate family.

(3) The health officer shall prepare a case

history, including laboratory findings, for each chronic typhoid carrier within his/her jurisdiction and forward a copy to the Department of Health district health administrator in whose jurisdiction the carrier resides.

Typhoid carrier record forms will be supplied by the Department of Health for this purpose.

(4) The health officer or his/her representative shall instruct chronic typhoid carriers regarding their infection and the measures necessary to avoid transmission of infection to others. Chronic typhoid carriers may be permitted by the health officer to be in free communication with others upon the signing of and adherence to the following typhoid carrier agreement; one (1) copy of which will be retained by the carrier; one (1) by the health officer; and a third forwarded to the district health administrator having jurisdiction or to the Department of Health.

(5) The typhoid carrier agreement shall read as follows:

To Whom It May Concern Date:________________________________ I __________________, of ______________ hereby acknowledge that I am a typhoid carrier and that in order that I might be placed under modified isolation I hereby agree that:

(A) I will not at any time handle, prepare or cook any food or drink to be consumed by others than my immediate family.

(B) I will thoroughly wash my hands with soap and water after each visit to the toilet.

(D) If my residence is not connected to a municipal sewage treatment system, I agree to have an on-site sewage treatment facility that complies with minimum standards as determined by the Missouri Department of Health.

(E) I will notify the health officer or the local health department within one (1) week of any change of address.

(F) I will submit such fecal and urine specimens as may be requested by the health officer or local health department.

(G) If I become ill and require hospital or other institutional care, I will inform the superintendent or person in charge of the hospital or institution that I am a typhoid carrier.

(H) I understand that failure to abide by the provisions of this agreement subjects me to necessary enteric precautions as determined by the Missouri Department of Health.

Signed: ______________________________ Address: _____________________________ (I) I have explained these provisions to____________________ and in view of the above agreement I hereby grant permission for ______________________ to be in free communication with others as long as ______________________ complies with the conditions of the agreement.

Signed: ______________________________ Address: _____________________________ (6) A health officer may release a chronic typhoid carrier from further supervision if the carrier submits, under the supervision of the health officer, six (6) consecutive feces specimens (for intestinal carriers) or urine specimens (for urinary carriers) at monthly intervals which are found to be culturally negative for typhoid bacilli. The release shall be in the form of a written dated statement, signed by the health officer, indicating that the patient has met the requirements for release from supervision and is no longer classified as a typhoid carrier. One (1) copy of this statement shall be given to the carrier, one (1) retained by the local health department and one (1) forwarded to the district health office having jurisdiction or to the Department of Health.

Amended: Filed Aug. 4, 1986, effective Oct. 11, 1986. *Original authority: 192.005, RSMo 1985, 192.020, RSMo 1939, amended 1945, 1951.

MATTBLUNT(1/29/03)

Chapter 22óTyphoid Carriers19 CSR 20-22

History

AUTHORITY: sections 192.005.2 and 192.020, RSMo 1986. This rule previously filed as 13 CSR 50-103.010. Original rule filed July 15, 1948, effective Sept. 13, 1948.

Chapter 24 Dead Bodies Infected With a Communicable Disease

19 CSR 20-24.010 Procedures to be Followed When a Person Dies While Infected with a Communicable Disease {#sec-19-csr-20-24.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-24.010}

PURPOSE: This rule establishes procedures to be followed in handling a dead body infected with a communicable disease.

(1) The body of a person having a communicable disease subject to isolation at time of death shall be placed in a closed ambulance pouch while in transit to be embalmed.

(2) The body of a person having a communicable disease subject to isolation at time of death shall be buried or cremated within twenty-four (24) hours of death unless the body is properly embalmed according to recognized standards and the external surface thoroughly washed with a disinfectant fluid or unless the body is permanently encased in a sealed casket.

(3) Direct physical contact with the body of a person having, at time of death, a disease transmissible by direct personal contact is prohibited except for the contact necessary in embalming or preparation of the body prior to burial or cremation.

(4) Public funeral services for a person having a communicable disease subject to isolation at time of death may be held only under the following conditions:

(A) The body is properly embalmed in accordance with recognized standards and the external surfaces disinfected or the body is encased in a sealed casket; and (B) Household contacts and others subject to quarantine or isolation restrictions who attend the funeral services are completely segregated from the public.

MATTBLUNT(1/29/03)

Chapter 24óDead Bodies Infected with a Communicable Disease19 CSR 20-24

History

AUTHORITY: section 192.020, RSMo 1986. This rule previously filed as 13 CSR 50- 105.010. Original rule filed July 15, 1948, effective Sept. 13, 1948. Original authority: 192.020, RSMo 1939, amended 1945.

Chapter 26 Sexually Transmitted Diseases

19 CSR 20-26.010 Prevention of Blindness {#sec-19-csr-20-26.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-26.010}

PURPOSE: This rule prevents the newborn infant from contracting gonococcal ophthalmia neonatorum or chlamydia ophthalmia neonatorum, or both, during birth from an infected mother.

(1) It shall be the duty of every physician or other person in attendance upon a newborn infant or its mother to instill five-tenths percent (0.5%) erythromycin ophthalmic ointment or drops in single-use tubes or ampules; or tetracycline one percent (1%) ophthalmic ointment or drops in single-use tubes or ampules; or one percent (1%) silver nitrate solution into each eye of the newborn infant immediately after birth and to report this on the birth certificate.

History

AUTHORITY: section 192.020, RSMo 1986. This rule was previously filed as 13 CSR 50- 107.010. Original rule filed April 22, 1955, effective June 21, 1955. Amended: Filed Nov. 4, 1985, effective March 24, 1986. Original authority: 192.020, RSMo 1939, amended 1945, 1951.

19 CSR 20-26.020 HIV Treatment Program {#sec-19-csr-20-26.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-26.020}

(Rescinded July 8, 1991)

Amended: Filed June 3, 1988, effective Sept. 29, 1988. Amended: Filed July 18, 1989, effective Nov. 11, 1989. Emergency rescission filed March 19, 1991, effective March 31, 1991, expired July 28, 1991. Rescinded:

Filed March 19, 1991, effective July 8, 1991.

History

AUTHORITY: sections 192.005.2 and 192.020, RSMo 1986. Emergency rule filed Sept. 1, 1987, effective Sept. 11, 1987, expired Jan. 9, 1988. Original rule filed Sept. 1, 1987, effective Jan. 9, 1988. Emergency amendment filed June 3, 1988, effective June 13, 1988, expired Oct. 10, 1988.

19 CSR 20-26.030 Human Immunodeficiency Virus (HIV) Test Consultation and Reporting {#sec-19-csr-20-26.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-26.030}

(Rescinded October 30, 2012)

Rescinded and readopted: Filed April 14, 1992, effective Dec. 3, 1992. Emergency amendment filed June 1, 2000, effective June 15, 2000, expired Dec. 11, 2000. Amended:

Filed June 1, 2000, effective Nov. 30, 2000.

Rescinded: Filed March 1, 2012, effective Oct. 30, 2012.

History

AUTHORITY: sections 191.653, 191.656, and 192.006, RSMo Supp. 1999, and section 192.020, RSMo 1994. Original rule filed March 14, 1989, effective July 13, 1989.

19 CSR 20-26.040 Physician Human Immunodeficiency Virus (HIV) Test Consultation and Reporting {#sec-19-csr-20-26.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-26.040}

PURPOSE: This rule establishes guidelines specific to physicians and other health care professionals working under physician orders for HIV testing, pretest and posttest consultation (client-centered counseling), and for the reporting of persons diagnosed with HIV infection.

(1) The following definitions shall be used in administering this rule:

(A) Conduct means to direct, lead, order or undertake to perform or to provide guidance as a licensed physician to a patient;

(B) Confirmed HIV infection means the clinical diagnosis and conclusion that a patient is infected with HIV, made in the professional judgment of the physician based upon clinical history, physician examination, diagnostic or laboratory testing, or other available clinical information which allows the physician to make clinical and therapeutic decisions based upon this infected status;

(D) Physician means any person licensed to practice as a physician and surgeon under

Chapter 334, RSMo; and (E) Physician’s delegated representative means state-licensed professional involved in direct patient care, other than those persons licensed as physicians under Chapter 334, RSMo.

(2) The physician or the physician’s delegated representative shall provide consultation with the patient or his/her legal guardian or custodian prior to conducting HIV testing, and to the patient, guardian, or custodian during the reporting of the test results or diagnosis. The scope of the consultation shall be governed by the physician’s professional judgment based on the clinical situation and shall be consistent with Centers for Disease Control and Prevention (CDC) guidelines and recommendations as stated in the CDC’s Morbidity and Mortality Weekly Report, September 22, 2006 / 55(RR14);1-17:

Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings, which are incorporated by reference. Copies may be found at http://www.cdc.gov/mmwr/preview/mmwrht ml/rr5514a1.htm or by writing to the Department of Health and Human Services, Centers for Disease Control and Prevention, 1600 Clifton Rd., Atlanta, GA 30333. This rule does not include any later amendments or additions.

(A) The physician or the physician’s delegated representative shall only be allowed to provide consultation through the use of protocols and standing orders which shall be written, signed, and dated by the physician prior to their implementation or, in the case of a hospital, the policies and procedures as approved by the medical staff.

(3) The physician, or the person who performs or conducts HIV sampling, shall report to the department or its designated representative the identity of any person with confirmed HIV infection along with related clinical and identifying information within three (3) days of receipt of the test results on forms provided by the department (see Form #1) included herein.

(4) Physicians testing persons under the following situations shall be exempt from reporting the identity of the persons testing positive for HIV. In these situations, physicians shall report HIV positive test results as well as related clinical and other information within three (3) days of receipt of the test results on forms provided by the department (see Form #1) included herein, but shall be exempt from reporting the patient’s name and street address, instead a unique patient identifier shall be used:

(A) Persons tested anonymously at department-designated anonymous testing sites;

(B) Persons tested as part of a research project which is approved by an institutional review board and in which, as part of the research, subjects are tested for HIV infection. Written documentation of institutional review boards approval must be submitted to the department’s HIV surveillance program; or (C) Where prohibited by federal law or

regulation.

(5) If test results are positive, post-test counseling shall include a discussion of the client’s responsibility to ensure that sex and needle sharing partners are advised of their potential exposure to HIV. If the test results are negative, the person shall be advised of the window period and possible need for retesting if exposure has occurred within the window period. If the test result is equivocal, the person shall be counseled on the result and the significance of a retest.

(6) All persons reported with HIV infection to the department or its designated representative can be contacted by public health personnel for partner elicitation/notification services according to protocols and procedures established by the department.

(7) Laboratories which perform HIV testing shall report identifying information as specified in 19 CSR 20-20.080.

4CODE OF STATE REGULATIONS

6CODE OF STATE REGULATIONS

Emergency amendment filed June 1, 2000, effective June 15, 2000, expired Dec. 11, 2000. Amended: Filed June 1, 2000, effective Nov. 30, 2000. Amended: Filed March 1, 2012, effective Oct. 30, 2012. *Original authority: 191.653, RSMo 1988, amended 1996; 191.656, RSMo 1988, amended 1992, 1993, 1996, 1999; 192.006, RSMo 1993, amended 1995; 192.020, RSMo 1939, amended 1945, 1951.

History

AUTHORITY: sections 191.653 and 192.006, RSMo 2000, and sections 191.656 and 192.020, RSMo Supp. 2011. Original rule filed April 14, 1992, effective Dec. 3, 1992.

19 CSR 20-26.050 Preventing Transmission of Human Immunodeficiency Virus (HIV) and Hepatitis B Virus (HBV) from Health Care Workers to Patients {#sec-19-csr-20-26.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-26.050}

PURPOSE: This rule establishes training requirements relating to the prevention of transmission of human immunodeficiency virus, hepatitis B virus and other bloodborne pathogens from infected health care workers to patients as defined in section 191.694, RSMo.

(1) The following definitions shall be used in the interpretation of this rule:

(A) Community-based means practice in any clinic, group practice or solo practice not licensed under Chapters 197 and 198, RSMo where health care, including dentistry and podiatry, is provided;

(B) Department means the Missouri Department of Health;

(D) Employed means to be professionally affiliated with a facility either by contract, direct employment or extension of professional privileges;

(E) HBV means hepatitis B virus;

(F) Health care facilities means those facilities licensed under Chapters 197 and 198, (G) Health care professional means a member of any of the professional groups regulated by Chapters 330, 332 and 335, RSMo, and sections 334.010–334.265, (H) HIV means human immunodeficiency virus; and (I) Invasive procedures shall be defined as in 191.650(9), RSMo. Phlebotomy and insertion of intravenous lines which do not involve surgical incision are not considered invasive procedures.

(2) Health care professionals in both health care facility-based and community-based practice settings shall adhere to the training requirements contained in section 191.694, RSMo. The department shall investigate complaints of noncompliance in facilitybased practice settings. Complaints of noncompliance in community-based practice settings shall be referred to the appropriate licensing authority.

(3) Health care professionals performing invasive procedures who do not receive training in a health care facility regarding infection control procedures, universal precautions and prevention of percutaneous injuries shall obtain that training elsewhere on an annual

basis. Training shall be in compliance with Occupational Safety and Health Administration (OSHA) requirements in 29 CFR 1910.1030. Training shall be also be in compliance with section 191.694, RSMo and with recommendations published by the Centers for Disease Control and Prevention in the Morbidity and Mortality Weekly Report: Recommendations for Prevention of HIV Transmission in Health-Care Settings, August 21, 1987; Update: Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and Other Bloodborne Pathogens in Health-Care Settings, June 24, 1988; and Guidelines for Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health-Care and Public-Safety Workers, June 23, 1989. Documents that validate the completion of that training shall be maintained by the health care professional for a period of three (3) years and shall be made available to the department upon request.

History

AUTHORITY: section 191.694.4, RSMo 2000. Original rule filed April 17, 1995, effective Nov. 30, 1995. Emergency amendment filed May 10, 2002, effective July 1, 2002, expired Dec. 28, 2002. Amended: Filed May 10, 2002, effective Nov. 30, 2002. Original authority: 191.694, RSMo 1992.

19 CSR 20-26.060 Voluntary Evaluation for Human Immunodeficiency Virus (HIV)- and Hepatitis B Virus (HBV)- Infected Health Care Professionals Who Perform Invasive Procedures {#sec-19-csr-20-26.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-26.060}

PURPOSE: This rule establishes procedures for the voluntary evaluation of human immunodeficiency virus- and hepatitis B virusinfected health care professionals who perform invasive procedures in order to determine whether practice restrictions or limitations should be applied, as defined in

section 191.700, RSMo.

(1) The definitions in 19 CSR 20-26.050 shall be used in the interpretation of this rule.

(2) Any health care professional who performs invasive procedures is advised to know his/her human immunodeficiency virus (HIV) antibody status and hepatitis B surface antigen (HBsAg) status. If HBsAg is present, the presence or absence of hepatitis B e antigen (HBeAg) shall be determined. If a significant occupational exposure occurs which could place the health care professional at risk of acquiring HIV or hepatitis B virus (HBV) infection, appropriate post-exposure evaluation should be undertaken.

(3) HIV- or HBV-infected health care professionals who perform invasive procedures may be voluntarily evaluated by an expert review panel appointed by the department according to section 191.700, RSMo. This panel shall follow subsections (3)(A)–(P) of this rule.

(A) Health care professionals infected with HIV or HBV who perform invasive procedures and who choose to be evaluated by an expert review panel appointed by the department according to section 191.700, RSMo shall apply for the evaluation in writing to the director. Directors of health care facilities (chief administrative officers or equivalents) allowed by 191.700.2(1), RSMo to seek evaluation of infected health care professionals who perform invasive procedures shall, with the consent of the infected health care professional and after consultation with the professional’s private physician, apply in writing to the director of the Department of Health.

(B) Upon receipt of a written request for evaluation, the director shall appoint an expert review panel by utilizing the following criteria:

The panel shall include those individuals specified by 191.700.2(2)(a)–(d), RSMo and may include additional individuals if the director determines this is necessary; and 2. The director shall seek input from appropriate professional organizations in making his/her appointments.

(C) The subject of the evaluation shall provide the director with a list of all health care facilities and community-based practices, regardless of location, where the subject performs invasive procedures.

(D) The expert review panel shall utilize the following to evaluate the health care professional’s practice:

Criteria specified in 191.700.2(3), 2. Verification of the health care professional’s licensure status;
Current, scientific evidence that is available; and 4. Panel members’ professional judgments.

(E) Panel members shall be subject to the requirements of section 191.656, RSMo regarding the confidentiality of information on an HIV-infected health care professional’s infection status.

(F) The health care professional shall be allowed to appear before the panel and present any information which s/he believes to be pertinent to the panel’s task. The health care professional’s personal physician(s) and any other individual(s) the health care professional believes can provide pertinent input into the process shall be allowed to appear before the panel.

(G) The panel may recommend that restrictions or limitations be placed on the practice of the health care professional.

(H) The panel shall require the health care professional to notify any affected patient in a timely manner whenever a parenteral or mucous membrane exposure to the health care professional’s blood occurs.

(I) The panel’s findings and recommendations shall be conveyed in writing to the health care professional and to the director.

(J) The director shall disclose to the chief administrative officer or equivalent individual in each health care facility or communitybased practice where the health care professional is performing invasive procedures any restrictions or limitations placed on his/her practice by the panel.

(K) If the health care professional seeks to affiliate with an additional health care facility or community-based practice, regardless of its location, where s/he will be performing invasive procedures, s/he shall disclose to the individual in that facility or practice the findings of the review panel, and any restrictions or limitations placed on his/her practice by the panel, prior to the affiliation and the provision of patient care. S/he shall also advise the department of the new practice location.

(L) If the health care professional plans to begin performing invasive procedures at a health care facility or community-based practice where s/he is currently affiliated but not presently performing those procedures, s/he shall disclose to the chief administrative officer or equivalent individual in that facility or practice the findings of the review panel, and any restrictions or limitations placed on his/her practice by the panel, prior to the performance of any invasive procedures, and report his/her intention to begin performing invasive procedures in writing to the director prior to beginning to perform these procedures.

(M) If the review panel places restrictions or limitations on the health care professional’s practice, it shall be the responsibility of each health care facility where s/he is employed and performing invasive procedures to monitor him/her for compliance at appropriate intervals, at least annually, based on his/her medical status and the types and frequencies of invasive procedures s/he performs. If a facility finds the health care professional to be noncompliant, it shall report this in writing to the appropriate state board, as provided under Chapters 330, 332, 334 or 335, RSMo, and to the director.

(N) If the review panel places restrictions or limitations on the practice of a health care professional who performs invasive procedures in a community-based setting, it shall be the responsibility of the department to monitor him/her for compliance in this setting at appropriate intervals, at least annually, based on his/her medical status and the types and frequencies of invasive procedures s/he performs. If the department finds the health care professional to be noncompliant, it shall report this in writing to the appropriate state board, as provided under Chapters 330, 332, 334 or 335, RSMo, and to the director.

(O) If the director becomes aware that the infected health care professional is noncompliant with practice restrictions or limitations at any location where s/he is performing invasive procedures, the director shall report this noncompliance to the chief administrative officer or equivalent individual in each health care facility and community-based practice where the health care professional performs invasive procedures.

(P) The panel shall require, as necessary, that the infected health care professional undergo periodic reviews to determine if the decision to place or not to place restrictions or limitations on his/her practice needs to be modified because of changes in his/her medical condition or some other relevant circumstance. If a review results in the panel making such a modification, this modification shall be conveyed in writing to the health care professional and the director. If the modification results in restrictions or limitations, or further restrictions or limitations, being placed on the health care professional, the director shall disclose this modification to the individual in each health care facility or community-based practice where the health care professional is performing invasive procedures.

(Q) If restrictions or limitations have been placed on a health care professional’s practice by the panel and if later there is a change in the individual’s medical condition or some other relevant circumstance, and as a result s/he believes that the restrictions or limitations should be modified, s/he may request in writing to the director that the panel consider such a modification. A similar written request may also be made by the director or chief administrative officer of a health care facility with the consent of the infected health care professional and after consultation with his/her private physician. The panel shall review the information and determine whether modification is necessary. If a modification is made, this shall be conveyed in writing to the health care professional and the director. If the modification results in further restrictions or limitations being placed on the health care professional, the director shall disclose this modification to the chief administrative officer or equivalent individual in each health care facility or community-based practice where the health care professional is performing invasive procedures.

(4) As described in 191.700.2(5)(d), RSMo, a health care facility peer review panel may evaluate HIV- or HBV-infected health care professionals who perform invasive procedures. This evaluation process may be accessed directly by an infected health care professional, or by the director of a health care facility with the consent of the infected health care professional and after consultation with his/her private physician. This evaluation shall take place as follows:

(A) If a health care facility regulated under sections 197.010–197.120, RSMo maintains or establishes an internal peer review panel for the evaluation of HIV- or HBV-infected health care professionals who perform invasive procedures, this panel shall— 1. Maintain the confidentiality of the infected health care professional. Panel members shall be subject to the requirements of

section 191.656, RSMo regarding the confidentiality of information on an HIV-infected health care professional’s infection status;

Conduct an evaluation of the infected health care professional and his/her practice.

This evaluation and any recommendations shall be based on the premise that HIV or HBV infection alone does not justify limiting the health care professional’s duties;

Allow the health care professional to appear before the peer review panel and present any information which s/he believes to be pertinent to the panel’s task. The health care professional’s personal physician(s), as well as any other individual(s) the health care professional believes can provide input into 8CODE OF STATE REGULATIONS the process, shall be allowed to appear before the panel;
Establish, utilizing the criteria specified in subsection (3)(D) of this rule, whether restrictions or limitations shall be placed on the practice of the health care professional. If the panel is uncertain about whether a specific procedure may pose some risk of HIV or HBV transmission, it may recommend that this procedure be performed only after the patient has been informed of the health care professional’s infection status;
Require the health care professional to notify any affected patient in a timely manner whenever a parenteral or mucous membrane exposure to the health care professional’s blood occurs;
Report its findings and recommendations in writing to the health care professional;
Report its findings and recommendations in writing to the director including how the evaluation process was conducted. The department shall review the report to determine concurrence with 191.700.2(5)(d), RSMo and this rule. Results of the department’s review shall be reported back to the facility. In the event the health care professional later seeks an evaluation by a department-appointed panel, the findings and recommendations of the facility’s peer review panel shall be included as part of this evaluation; and 8. Require, as necessary, that the infected health care professional undergo periodic reviews to determine if the decision to place or not to place restrictions or limitations on his/her practice needs to be modified because of changes in his/her medical condition or some other relevant circumstance. If a review results in the panel making such a modification, this modification shall be conveyed in writing to the health care professional and the director; and (B) When a facility’s internal peer review panel conducts a review in concurrence with 191.700.2(5)(d), RSMo and this rule, the following shall be performed:
The infected health care professional shall provide a list to the director of all other health care facilities and community-based practices, regardless of location, where s/he performs invasive procedures. The director shall disclose to the chief administrative officer or equivalent individual in each of these other facilities and practices any restrictions or limitations placed on the health care professional’s practice by the panel;
If the health care professional seeks to affiliate with an additional health care facility or community-based practice, regardless of its location, where s/he will be performing invasive procedures, s/he shall disclose to the individual in that facility or practice the findings of the peer review panel, and any restrictions or limitations placed on his/her practice by the panel, prior to the affiliation and the provision of patient care, and notify the department of the new practice location;
If the health care professional plans to begin performing invasive procedures at a health care facility or community-based practice where s/he is currently affiliated but not presently performing those procedures, s/he shall disclose to the director or chief administrative officer in that facility or practice the findings of the peer review panel, and any restrictions or limitations placed on his/her practice by the panel, prior to the performance of any invasive procedures, and report the change in practice to the department;
It shall be the responsibility of each health care facility where the health care professional is employed and performing invasive procedures to monitor him/her for compliance with the practice restrictions or limitations at appropriate intervals, at least annually, based on his/her medical status and the types and frequencies of invasive procedures s/he performs. If a facility finds the health care professional to be noncompliant, it shall report this in writing to the appropriate state board, as provided under Chapters 330, 332, 334 or 335, RSMo, and to the director;
If the health care professional also performs invasive procedures in a community-based setting, it shall be the responsibility of the department to monitor him/her for compliance with the restrictions or limitations in this setting at appropriate intervals, at least annually, based on his/her medical status and the types and frequencies of invasive procedures s/he performs. If the department finds the health care professional to be noncompliant, it shall report this in writing to the appropriate state board, as provided under Chapters 330, 332, 334 or 335, RSMo, and to the director;
If the director becomes aware that the infected health care professional is noncompliant with practice restrictions or limitations at any location where s/he is performing invasive procedures, the director shall report this noncompliance to the director or chief administrator in each health care facility and community-based practice where the health care professional performs invasive procedures;
If the peer review panel, as a result of a periodic review of the infected health care professional’s status, makes a modification in its recommendations that results in restrictions or limitations, or further restrictions or limitations, being placed on the health care professional, the director shall disclose this modification to the chief administrative officer or equivalent individual in any other health care facilities or community-based practices where the health care professional is performing invasive procedures; and 8. If restrictions or limitations have been placed on a health care professional’s practice by the peer review panel and if later there is a change in the health care professional’s medical condition or some other relevant circumstance, and as a result s/he believes that the restrictions or limitations should be modified, s/he may request that the panel consider the modification. The panel shall review the pertinent evidence and determine whether such modification shall be made. If a modification is made, this shall be conveyed in writing to the health care professional and the director. If the modification results in further restrictions or limitations being placed on the health care professional, the director shall disclose the modification to the chief administrative officer or equivalent individual in any other health care facilities or communitybased practices where the health care professional is performing invasive procedures.

History

AUTHORITY: section 191.700.2, RSMo 2000. Original rule filed April 17, 1995, effective Nov. 30, 1995. Emergency amendment filed May 10, 2002, effective July 1, 2002, expired Dec. 28, 2002. Amended: Filed May 10, 2002, effective Nov. 30, 2002. Original authority: 191.700.2, RSMo 1992.

19 CSR 20-26.070 Notification of Results of Court-Ordered Human Immunodeficiency Virus (HIV) Testing of Sexual Offenders {#sec-19-csr-20-26.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-26.070}

PURPOSE: This rule establishes the procedure for notifying victims and jail or correctional facility administrators and the offenders of results when sexual offenders undergo court-ordered testing for human immunodeficiency virus.

(1) If a court orders a person to undergo HIV testing under section 191.663, RSMo, the following information shall be reported by the court to the Section of STD/HIV/AIDS Prevention and Care Services:

(A) The identity of the person to be tested;

(B) The name and address of the facility which will submit the sample for testing;

(D) The name, address and telephone number of each victim who has a right to access the HIV test results under section 191.663, RSMo; and (E) The name, address and telephone number of the administrator of the jail or correctional facility where the sexual offender is confined.

(2) All results of HIV testing performed under the provisions of section 191.663, RSMo, shall be reported by the laboratory performing the test to the Office of Surveillance.

(3) Section of STD/HIV/AIDS Prevention and Care Services counseling and intervention staff shall convey the results of the testing, along with appropriate counseling and any necessary referral assistance, to each victim.

(4) Section of STD/HIV/AIDS Prevention and Care Services staff shall convey the results of the testing, along with any necessary educational information relative to those results, to the administrator of the jail or correctional facility in which the sexual offender is confined.

(5) Section of STD/HIV/AIDS Prevention and Care Services staff shall ensure that the results of the HIV testing are conveyed to the sexual offender appropriately and confidentially.

10CODE OF STATE REGULATIONS

History

AUTHORITY: section 191.663, RSMo Supp. 1999. Emergency rule filed Nov. 2, 1994, effective Nov. 12, 1994, expired March 11, 1995. Emergency rule filed March 1, 1995, effective March 12, 1995, expired July 9, 1995. Original rule filed Nov. 2, 1994, effective May 28, 1995. Amended: Filed June 1, 2000, effective Nov. 30, 2000. Original authority: 191.663, RSMo 1990, amended 1992, 1993, 1996, 1999.

Chapter 28 Immunization

19 CSR 20-28.010 Immunization Require ments for School Children {#sec-19-csr-20-28.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-28.010}

PURPOSE: This rule establishes minimum immunization requirements for all students in accordance with recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Interstate Compact on Educational Opportunity for Military Children.

rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction.

This note applies only to the reference material. The entire text of the rule is printed here.

(1) The superintendent of each public, private, parochial, or parish school shall make a summary report to the Department of Health and Senior Services no later than October 15 of each school year. This date is necessitated by the law which prohibits the enrollment and attendance of students who are in noncompliance. This report shall include aggregate immunization information by grade by vaccine antigen, number of students enrolled, number of students in compliance with state immunization requirements, number of students in progress, number of students with signed medical exemption, number of students with signed religious exemption, number of students noncompliant with immunization record, and number of students with no immunization record. Each school superintendent or designee shall submit a summary report for all schools under the administrator’s jurisdiction. Separate reports for each school should not be submitted, although separate lists shall be maintained in each school for auditing purposes.

(A) Exclusion of students in noncompliance, section 167.181, RSMo. Students cannot attend school unless they are properly immunized and can provide satisfactory evidence of the immunization or unless they are exempted. The school administration shall exercise its power of pupil suspension or expulsion under section 167.161, RSMo, and possible summary suspension under section 167.171, RSMo, until the violation is removed. Transfer students in noncompliance shall not be permitted to enroll or attend school. Students enrolled during the previous school year shall be denied attendance for the current school year if not in compliance.

Under section 160.2000, RSMo, children of military families shall be given thirty (30) days from the date of enrollment to obtain any required immunization, or initial vaccination for a required series of immunizations. A student determined to be homeless by school officials may be enrolled in school for no more than thirty (30) days prior to providing satisfactory evidence of immunization. If the homeless student’s immunization record is not obtained within the thirty (30) days and the student is still eligible for services under the homeless education program, the student shall begin the immunization series and demonstrate that satisfactory progress has been accomplished within ninety (90) days. If the homeless student is exempted from receiving immunizations, then after the initial thirty- (30-) day enrollment, the student shall provide documentation in accordance with the exemption requirements included herein.

For the purpose of this subsection, a homeless student shall be defined as a student who lacks a fixed, regular, and adequate nighttime residence; or who has a primary nighttime residence in a supervised publicly or privately operated shelter or in an institution providing temporary residence or in a public or private place not designated for or ordinarily used as a regular sleeping accommodation for human beings.

(B) This rule is designed to govern any student, regardless of age, who is attending a public, private, parochial, or parish school. If the specific age or grade recommendations are not mentioned within this rule, the Missouri Department of Health and Senior Services should be consulted.

(C) It is unlawful for any student to attend school unless the student has been immunized according to this rule or unless a signed statement of medical or religious exemption is on file with the school administrator. In the event of an outbreak or suspected outbreak of a vaccine-preventable disease within a particular facility, the administrator of the facility shall follow the control measures instituted by the local health authority or the Department of Health and Senior Services pursuant to 19 CSR 20-20.040.

Medical exemption. A student shall be exempted from the immunization requirements of this rule as provided in section 167.181, RSMo, upon signed certification by a licensed doctor of medicine (MD), doctor of osteopathy (DO), or his or her designee indicating that either the immunization would seriously endanger the student’s health or life or the student has documentation of disease or laboratory evidence of immunity to the disease. The exemption shall be provided on an original Department of Health and Senior Services’ form Imm.P.12 and shall be placed on file with the school immunization health record for each student with a medical exemption. The Imm.P.12 form is incorporated by reference in this rule as published June 2012 by the Department of Health and Senior Services and may be obtained by contacting a medical provider, local public health agency, or the department’s Bureau of Immunization This need not be renewed annually.
Religious exemption. A student shall be exempted from the immunization requirements of this rule as provided in section 167.181, RSMo, if one (1) parent or guardian objects in writing to the school administrator that immunization of that student violates his/her religious beliefs. This exemption must be provided on an original Department of Health and Senior Services’ form Imm.P.11A, and shall be signed by the parent or guardian and placed on file with the school immunization health record. The Imm.P.11A form is incorporated by reference in this rule as published April 2012 by the Department of Health and Senior Services and may be obtained by contacting a medical provider, local public health agency, or the department’s Bureau of Immunization Assessment and Assurance at PO Box 570, Jefferson City, MO 65102-0570, or by calling 800-219-3224. This rule does not incorporate any subsequent amendments or additions. This need not be renewed annually.
Immunization in progress. Section 167.181, RSMo, provides that students may continue to attend school as long as they have started an immunization series and provide satisfactory evidence indicating progress is being accomplished. An original Department of Health and Senior Services’ form Imm.P.14 shall be completed and placed on file with the school immunization health record of each student with immunizations in progress. The Imm.P.14 form is incorporated by reference in this rule as published June 2012 by the Department of Health and Senior Services and may be obtained by contacting a medical provider, local public health agency, or the Failure to meet the next scheduled appointment constitutes noncompliance with the school immunization law and exclusion shall be initiated immediately. Refer to subsection (1)(A) of this rule regarding exclusion of students in noncompliance.

(2) Review of immunization requirements for school entry shall be conducted annually by each school superintendent or designee. Ageor grade-appropriate vaccine requirements shall be according to the Missouri School Immunization Requirements Vaccines Received 0–18 Years of Age, published on April 2014 or the Centers for Disease Control and Prevention’s Catch-up Immunization Schedule for Persons Aged 4 Months through 18 Years Who Start Late or Who Are More Than 1 Month Behind, published January 2014. These schedules are incorporated by reference in this rule and are available on the website at http://health.mo.gov/immunizations/schoolrequirements.php or by contacting the department’s Bureau of Immunization Revisions to school immunization requirements shall be required for school attendance one (1) full year after publication in the Code of State Regulations, beginning with the first day of school of that school year.

(3) The parent or guardian shall furnish the superintendent or designee satisfactory evidence of immunization or exemption from immunization.

(A) Satisfactory evidence of immunization means a statement, certificate, or record from a physician or his or her designee, other recognized health facility, immunization registry, school record, or child care record stating that the required immunizations have been given to the person and verifying the type of vaccine. This statement, certificate, or record shall provide documentation of the specific antigen and the month, day, and year of vaccine administration.

History

AUTHORITY: section 192.006, RSMo 2000, and sections 167.181 and 192.020, RSMo Supp. 2013. This rule was previously filed as

13 CSR 50-110.010. Original rule filed April 24, 1974, effective May 4, 1974. Rescinded and readopted: Filed April 17, 1980, effective Aug. 11, 1980. Amended: Filed Feb. 1, 1983, effective May 12, 1983. Amended: {#sec-13-csr-50-110.010. omnilex-key=us-mo-regs-official--title-19--13 CSR 50-110.010.}

Filed Oct. 3, 1986, effective Dec. 25, 1986.

Amended: Filed July 1, 1987, effective Sept. 11, 1987. Amended: Filed Aug. 4, 1988, effective Oct. 13, 1988. Amended: Filed May 31, 1989, effective Aug. 24, 1989. Amended:

Filed Nov. 2, 1990, effective March 14, 1991.

Amended: Filed April 2, 1991, effective Aug. 30, 1991. Amended: Filed Nov. 4, 1992, effective Aug. 1, 1993. Emergency amendment filed July 12, 1993, effective Aug. 1, 1993, expired Sept. 9, 1993. Amended: Filed April 5, 1993, effective Sept. 9, 1993.

Emergency amendment filed May 3, 1994, effective May 13, 1994, expired Sept. 9, 1994. Emergency amendment filed July 28, 1994, effective Aug. 6, 1994, expired Dec. 3, 1994. Amended: Filed April 18, 1994, effective Nov. 30, 1994. Amended: Filed May 3, 1994, effective Nov. 30, 1994. Emergency amendment filed Nov. 29, 1994, effective Dec. 8, 1994, expired April 6, 1995.

Amended: Filed Aug. 15, 1994, effective Feb. 26, 1995. Amended: Filed Aug. 16, 1996, effective Jan. 30, 1997. Amended: Filed Jan. 14, 1999, effective July 30, 1999. Amended:

Filed Sept. 16, 2002, effective Feb. 28, 2003.

Amended: Filed Sept. 23, 2003, effective April 30, 2004. Amended: Filed Oct. 1, 2008, effective March 30, 2009. Amended:

Filed Nov. 30, 2011, effective June 30, 2012.

Amended: Filed March 30, 2015, effective Oct. 30, 2015. *Original authority: 167.181, RSMo 1963, amended 1972, 1973, 1992, 1993, 1995, 1996, 2001; 192.006, RSMo 1993, amended 1995; and 192.020, RSMo 1939, amended 1945, 1951, 2004.

19 CSR 20-28.030 Distribution of Child hood Vaccines {#sec-19-csr-20-28.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-28.030}

(Rescinded March 30, 2009)

Original rule filed Nov. 15, 1988, effective July 1, 1989. Emergency amendment filed June 19, 1989, effective July 1, 1989, expired Oct. 26, 1989. Amended: Filed July 18, 1989, effective Sept. 28, 1989. Rescinded:

Filed Oct. 1, 2008, effective March 30, 2009.

History

AUTHORITY: section 192.020, RSMo 1986.

19 CSR 20-28.040 Day Care Immunization {#sec-19-csr-20-28.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-28.040}

Rule

PURPOSE: This rule establishes immunization requirements in accordance with recommendations of the Advisory Committee on Immunization Practices (ACIP) for all children attending public, private, or parochial day care, preschool or nursery schools caring for ten or more children, and describes actions to be taken to ensure compliance with

section 210.003, RSMo.

rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction.

This note applies only to the reference material. The entire text of the rule is printed here.

(1) As mandated by section 210.003, RSMo, the administrator of each public, private, or parochial day care center, preschool, or nursery school caring for ten (10) or more children shall have a record prepared showing the immunization status of every child enrolled in or attending a facility under the administrator’s jurisdiction. Each administrator caring for or licensed for ten (10) or more children shall complete an annual summary report showing the immunization status of each child enrolled and submit to the Department of Health and Senior Services no later than January 15 of each year. The summary report shall be submitted electronically through the department’s online system at http://health.mo.gov/immunizations/daycarerequirements.php or by completing and mailing the Imm.P-32 form to the Bureau of Immunization Assessment and Assurance, PO Box 570, Jefferson City, MO 65102-0570.

The Imm.P-32 form is incorporated by reference in this rule as published October 2013 by the Department of Health and Senior Services and may be obtained by contacting the department’s Bureau of Immunization (2) No child shall enroll in or attend a public, private, or parochial day care center, preschool, or nursery school caring for ten (10) or more children unless the child has been adequately immunized according to this rule.

Children attending elementary school who receive before or after school care, or both, shall meet the immunization requirements established in the School Immunization Rule, (9/30/15) JASONKANDER SENIOR SERVICESPublic Health

19 CSR 20-28.010. Age-appropriate vaccine requirements will be according to the Missouri Day Care Immunization Requirements Vaccines Received 0-18 Years of Ageor the Center for Disease Control and Prevention’s Catch-up Immunization Schedule for Persons Aged 4 Months through 18 Years Who Start Late or Who Are More Than 1 Month Behind. {#sec-19-csr-20-28.010. omnilex-key=us-mo-regs-official--title-19--19 CSR 20-28.010.}

These schedules are incorporated by reference in this rule as published February 2014 by the Department of Health and Senior Services and are available on the web at http://health.mo.gov/immunizations/daycarerequirements.php or by contacting the (3) Section 210.003, RSMo, provides that a child who has not completed all appropriate immunizations may enroll if— (A) Satisfactory evidence is produced that the child has begun the process of immunization. The child may continue to attend as long as they have started an immunization series and provide satisfactory evidence indicating progress is being accomplished. The form Imm.P.14 shall be completed and placed on file with the child’s immunization health record for each child with immunizations in progress. Failure to meet the next scheduled appointment constitutes noncompliance with the day care immunization law, and action shall be initiated immediately by the administrator to have the child excluded from the facility. The Imm.P.14 form is incorporated by reference in this rule as published June 2012 and may be obtained by contacting a medical provider, local public health agency, or the department’s Bureau of Immunization Assessment and Assurance at PO Box 570, Jefferson City, MO 65102-0570, or by calling 800-219-3224. This rule does not incorporate any subsequent amendments or additions.

(B) The parent or guardian has signed and placed on file with the day care administrator a statement of exemption which may be either of the following:

A medical exemption, by which a child shall be exempted from the requirements of this rule upon signed certification by a licensed doctor of medicine (MD), doctor of osteopathy (DO), or his or her designee indicating that either the immunization would seriously endanger the child’s health or life, or the child has documentation of disease or laboratory evidence of immunity to the disease. The Department of Health and Senior Services’ form Imm.P.12 shall be placed on file with the immunization record of each child with a medical exemption. The Imm.P.12 form is incorporated by reference in this rule as published June 2012 by the Department of Health and Senior Services and may be obtained by contacting a medical provider, local public health agency, or the The medical exemption need not be renewed annually; or 2. A parent or guardian exemption, by which a child shall be exempted from the requirements of this rule if one (1) parent or guardian files a written objection to immunization with the day care administrator. The form Imm.P.11 shall be signed by the parent or guardian and placed on file with the immunization record of each child with a parental exemption. The parental exemption must be renewed annually. The Imm.P.11 form is incorporated by reference in this rule as published July 2010 by the Department of Health and Senior Services and may be obtained by contacting a medical provider, local public health agency, or the department’s Bureau of Immunization Assessment and Assurance at PO Box 570, Jefferson City, MO 65102-0570, or by calling 800-219-3224.

This rule does not incorporate any subsequent amendments or additions.

(4) The parent or guardian shall furnish the day care administrator satisfactory evidence of completion of the required immunizations, exemption from immunization, or progress toward completing all required immunizations.

Satisfactory evidence of immunization means a statement, certificate, or record from a physician or his or her designee, other recognized health facility, or immunization registry stating that the required immunizations have been given to the person and verifying type of vaccine. This statement, certificate, or record shall provide documentation of the specific antigen and the month, day, and year of vaccine administration. However, if a child has had varicella (chickenpox) disease, a licensed healthcare provider (e.g., school or occupational clinic nurse, nurse practitioner, physician assistant, physician) may sign and place on file with the day care administrator a written statement documenting previous varicella (chickenpox) disease. The statement may contain wording such as: “This is to ver ify that (name of child) had varicella (chickenpox) disease on or about (date) and does not need varicella vaccine.”

Amended: Filed Jan. 3, 2001, effective July 30, 2001. Amended: Filed Oct. 1, 2008, effective March 30, 2009. Amended: Filed Nov. 30, 2011, effective June 30, 2012.

Amended: Filed March 30, 2015, effective Oct. 30, 2015. *Original authority: 192.006, RSMo 1993, amended 1995; 210.003, RSMo 1988.

History

AUTHORITY: sections 192.006 and 210.003, RSMo 2000. Emergency rule filed Aug. 1, 1995, effective Aug. 11, 1995, expired Dec. 8, 1995. Original rule filed April 17, 1995, effective Nov. 30, 1995. Emergency amendment filed June 14, 2000, effective June 24, 2000, expired Feb. 22, 2001. Amended: Filed June 14, 2000, effective Nov. 30, 2000.

19 CSR 20-28.060 Minimum Immuniza tion Coverage to Be Provided by Individual and Group Health Insurance Policies {#sec-19-csr-20-28.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-28.060}

PURPOSE: This rule identifies the immunizations which individual and group health insurance policies, as enumerated in H.B. 904, must provide for children from birth to five years of age.

(1) This rule requires that all individual and group health insurance policies providing coverage on an expense-incurred basis, individual and group service or indemnity-type contracts issued by a health services corporation, individual and group service contracts issued by a health maintenance organization and all self-insured group arrangements to the extent not preempted by federal law and all managed health care delivery entities of any type or description shall provide coverage for immunizations for children, birth to five (5) years of age, for all immunizations listed in section (2) of this rule.

(2) All immunization within the latest Recommended Childhood Immunization Schedule—United States, approved by the Advisory Committee on Immunization Practices (ACIP), shall be required under this

rule. As the schedule is updated, it will be available from and distributed by the Department of Health. The immunizations required under this rule and manner and frequency of their administration shall conform to recognized standards of medical practice.

(9/30/15) JASONKANDER

SENIOR SERVICESPublic Health

History

AUTHORITY: section 376.1215, RSMo Supp. 1998. Emergency rule filed Aug. 16, 1996, effective Aug. 29, 1996, expired Feb. 24, 1997. Original rule filed Aug. 16, 1996, effective Jan. 30, 1997. Amended: Filed May 14, 1999, effective Nov. 30, 1999. Original authority: 376.215, RSMo 1996.

Chapter 30 * - moved to 19 CSR 25-30

19 CSR 20-30.010 Definitions Relating to Testing for Blood Alcohol {#sec-19-csr-20-30.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.010}

19 CSR 20-30.011 General Provisions for the Determination of Blood, Breath, Saliva {#sec-19-csr-20-30.011 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.011}

19 CSR 20-30.030 Qualifications for Permits to Operate Breath Analyzers {#sec-19-csr-20-30.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.030}

19 CSR 20-30.040 Duties and Responsibilities of Permittees to Operate Breath Analyzers {#sec-19-csr-20-30.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.040}

19 CSR 20-30.050 Approved Breath Analyzers, Chemical Test Reagents and Standards {#sec-19-csr-20-30.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.050}

19 CSR 20-30.070 Approval of Methods for the Determination of Blood Alcohol Content From Samples of Blood, Urine or Saliva {#sec-19-csr-20-30.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.070}

19 CSR 20-30.080 Approval of Methods for the Analysis of Blood and Urine for the HEALTH Health and Epidemiology Alcohol by Blood, Breath, Saliva and Urine Analysis; and Determination for the Presence of Drugs in Blood and Urine {#sec-19-csr-20-30.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.080}

19 CSR 20-30.010 Definitions Relating to Testing for Blood Alcohol {#sec-19-csr-20-30.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.010}

19 CSR 20-30.011 General Provisions for the Determination of Blood, Breath, Saliva or Urine Analysis and Drug Testing {#sec-19-csr-20-30.011 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.011}

(Moved to 19 CSR 25-30.011)

19 CSR 20-30.020 Permits to Operate Breath Analyzers {#sec-19-csr-20-30.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.020}

19 CSR 20-30.021 Type I Permit {#sec-19-csr-20-30.021 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.021}

(Moved to 19 CSR 25-30.021)

19 CSR 20-30.030 Qualifications for Permits to Operate Breath Analyzers {#sec-19-csr-20-30.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.030}

19 CSR 20-30.031 Type II Permit {#sec-19-csr-20-30.031 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.031}

(Moved to 19 CSR 25-30.031)

19 CSR 20-30.040 Duties and Responsibilities of Permittees to Operate Breath Analyzers {#sec-19-csr-20-30.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.040}

19 CSR 20-30.041 Type III Permit {#sec-19-csr-20-30.041 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.041}

(Moved to 19 CSR 25-30.041)

19 CSR 20-30.050 Approved Breath Analyzers, Chemical Test Reagents and Standards {#sec-19-csr-20-30.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.050}

(Moved to 19 CSR 25-30.050)

19 CSR 20-30.060 Operating Procedures for Breath Analyzers {#sec-19-csr-20-30.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.060}

(Moved to 19 CSR 25-30.060)

19 CSR 20-30.070 Approval of Methods for the Determination of Blood Alcohol Content From Samples of Blood, Urine or Saliva {#sec-19-csr-20-30.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.070}

(Moved to 19 CSR 25-30.070)

19 CSR 20-30.080 Approval of Methods for the Analysis of Blood and Urine for the Presence of Drugs {#sec-19-csr-20-30.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-30.080}

(Moved to 19 CSR 25-30.080)

Rebecca McDowell Cook (2/28/97) and Determination for the Presence of Drugs in Blood and Urine19 CSR 20-30

Chapter 43 HIV/AIDS Medications Program

19 CSR 20-43.010 Definitions {#sec-19-csr-20-43.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-43.010}

PURPOSE: This rule defines the terms used in this chapter.

(1) AIDS is Acquired Immune Deficiency Syndrome, a medical condition that develops from the progression of human immunodeficiency virus (HIV) disease.

(2) Client is a Missouri resident with HIV disease (including AIDS) who has enrolled in the HIV/AIDS Service Coordination Program.

(3) Department is the Missouri Department of Health.

(4) Director is the director of the department.

(5) HIV/AIDS Service Coordination Program is a program administered by the department that provides client assessment and evaluation services, plus assistance in locating, coordinating, and monitoring medical, psychological, and other supportive services for persons with HIV disease, including AIDS.

(6) Missouri HIV/AIDS Medications Advisory Committee is an advisory committee composed of medical professionals and representatives of the HIV-infected/affected populations from across the state, the Medicaid agency pharmacy consultant, and department staff.

(7) Rural county is any county in the state which is not an urban county, as defined in

section (12) of this rule.

(8) Service coordinator or coordinator is an employee of the department, or an employee of a local health department or communitybased organization under contract to the department, who evaluates the status and healthcare and supportive service needs of clients and locates, coordinates, and monitors such services to persons with HIV or AIDS.

(9) Service plan is a written set of future actions pertaining to identified services that is developed by the service coordinator to meet the needs of a specific client.

(10) Service provider or provider is an individual or agency that provides services to persons with HIV disease.

(11) Services are medical, psychological, or other services necessary for the treatment of HIV, AIDS, and/or related conditions.

(12) Urban counties include Bates, Benton, Cass, Clay, Clinton, Franklin, Henry, Jackson, Jefferson, Johnson, Lafayette, Lincoln, Platte, Ray, St. Charles, St. Louis (including the City of St. Louis), and Warren counties. 1998 and 192.020 RSMo 1994.* Previously filed as 19 CSR 40-13.010. Emergency rule Dec. 10, 1996, effective May 30, 1997.

Moved to 19 CSR 20-43.010 and amended:

19 CSR 20-43.020 Administration of the HIV/AIDS Medications Program {#sec-19-csr-20-43.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-43.020}

PURPOSE: This rule specifies payment standards, confidentiality provisions, termination of clients from the program, antidiscrimination policy, distribution of funding, and delivery of services.

(1) The department shall not pay for any item or service if payment has been made or is expected to be made under any state compensation plan, including Medicaid, insurance, federal, or state health benefits programs or by an entity that provides health services on a prepaid basis.

(A) The department shall be billed only after all third party sources have been eliminated as payors.

(B) The department shall only reimburse providers for medications that are listed on the department’s current Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) formulary on the date of the claim.

The department shall include medications on the formulary which it has determined are— A. FDA approved;

B. Medically effective for HIV infected person; and C. Cost effective as determined by the department.

The department shall determine which medications are medically effective and appropriate for inclusion on the formulary based upon advice provided by the Missouri HIV/AIDS Medications Advisory Committee, the department’s medical consultants, and department staff.

(C) Reimbursement payments will only be made on behalf of enrolled clients as specified in 19 CSR 20-43.030, and will only be made for claims submitted within contractual time limits.

If a client becomes ineligible for medications assistance and the pharmacy or agent supplying medications should reasonably have been aware at the time the services were provided, as specified in the provider’s contract, that the client was ineligible, reimbursement will not be made.
The department or its agents may review client records and program invoices to ensure compliance with the program.

(2) Available medications funds will be allocated statewide. 1998 and 192.020, RSMo 1994 .* Previously filed as 19 CSR 40-13.020. Emergency rule Dec. 10, 1996, effective May 30, 1997.

Moved to 19 CSR 20-43.020 and amended:

19 CSR 20-43.030 Eligibility for the HIV/AIDS Medications Program {#sec-19-csr-20-43.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-43.030}

PURPOSE: This rule establishes the requirements for assistance from the HIV/AIDS Medications Program.

(1) Individuals may be admitted to the program at any time during any stage of Human Immunodeficiency Virus (HIV) infection.

(2) Individuals may be provided assistance by the medications program only pursuant to available funding, as delineated in 19 CSR 20-43.020. An individual is eligible if s/he meets the following criteria:

(A) Is a Missouri resident;

(B) Is not incarcerated in a state correctional facility nor an inpatient in a licensed heath care facility as defined in Chapter 197, RSMo;

(D) Is enrolled in the Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS) service coordination program;

Rebecca McDowell Cook (7/31/99)

(E) Has an income at or below three hundred percent (300%) of the federal poverty standard published annually in the Federal Registerby the U.S. Department of Health and Human Services. A client shall provide updated documentation of income and other medications assistance from other sources such as private insurance, other third-party insurance or Medicaid annually, or at any time when requested by the department or its contractors; and (F) Is ineligible for medications assistance from other sources such as private insurance, other third-party insurance or Medicaid.

(3) If an individual meets the requirements of subsections (2)(A) through (F), but available funding is insufficient to provide assistance, they will be placed on an access list.

(A) Individuals will be removed from the access list and will begin to receive assistance as funding becomes available.

(B) Individuals residing in rural counties will be given priority for being removed from the access list to receive medications assistance.

(C) Within the classification of rural or urban counties, individuals who have been on the access list the longest time will be given priority.

(D) Within the urban classification of urban counties, the department will collaborate with Title I grantees to assure client medications access at the local levels.

(4) A client may be terminated from the medications assistance program for any of the following reasons:

(A) A client shall be terminated from the medications program at any time that he/she no longer meets all program eligibility requirements described in subsections (2)(A) through (E) above.

It shall be the responsibility of the client to inform the department or a service coordinator if he or she no longer meets any one (1) or more of the program eligibility requirements and initiates an application for assistance through the service coordination system.
A client terminated from the medications program due to no longer meeting program eligibility requirements may be readmitted to the program at such time as the client again meets all program eligibility requirements; and (B) A client who knowingly provides false information or fails to meet applicable statutes and regulations may be terminated from the program at any time. 1998 and 192.020, RSMo 1994.* Previously filed as 19 CSR 40-13.030. Emergency rule Dec. 10, 1996, effective May 30, 1997.

Moved to 19 CSR 20-43.030 and amended:

4CODE OF STATE REGULATIONS

(7/31/99) Rebecca McDowell Cook

Chapter 44 Emergency Response and Terrorism

19 CSR 20-44.010 Volunteer Dispensing of Strategic National Stockpile Medications During Governor-Declared Disasters {#sec-19-csr-20-44.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-44.010}

PURPOSE: The Division of Community and Public Health, Department of Health and Senior Services has the authority to establish rules for dispensing medications according to the Strategic National Stockpile Plan during a governor-declared state of emergency. This

rule defines specific terms and procedures to follow when dispensing medications according to the Strategic National Stockpile Plan during a governor-declared state of emergency.

PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material, which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive.

This material as incorporated by reference in the rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction.

This note applies only to the reference material. The entire text of the rule is printed here.

(1) Definitions.

(A) Department—The Missouri Department of Health and Senior Services or its designee.

(B) Dispense—To deliver a drug to an ultimate user by or pursuant to the lawful order of a practitioner including the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for such delivery.

(D) Point of Dispensing (POD)—A preidentified mass medication dispensing site(s) that allows community members to quickly and easily receive treatment according to the state Strategic National Stockpile plan.

(E) Volunteer—A person who, of his or her own free will, performs any assigned duties for the department with no monetary or material compensation.

(F) Supervision—General oversight and the authorization to direct in any given situation.

This includes orientation, initial and ongoing direction, procedural guidance, and periodic inspection and evaluations.

(2) Volunteer Qualifications.

(A) A volunteer may include medical or non-medical personnel.

(B) A volunteer shall be authorized by the department prior to performance of the assigned task.

(C) A volunteer covered by the provisions of section 44.105, RSMo, shall— 1. Fill out an application prior to volunteering which shall include at a minimum, full name and current address, volunteer experience, work experience, any current professional licenses, registrations, or certifications, and any other information relevant for the duties to be assigned;

Sign an authorization for the department to conduct a background check that may include the department’s Employee Disqualification List and verification of professional licensure, if applicable;
Complete the same confidentiality training that a paid department employee is required to take;
Sign and abide by the same confidentiality statement that is required of a paid department employee;
Complete any health assessment form required by the department;
Submit to vaccinations, inoculation, or other medication if recommended and warranted; and 7. Sign a waiver to hold the department harmless.

(D) Department staff may function as volunteers when— 1. Providing services with no monetary or material compensation;

Providing services outside their normal work hours; and 3. Their duties are not part of their employment job expectations.

(3) Volunteer Training.

(A) Every person wishing to be a volunteer as defined by section 44.105, RSMo, must receive training, provided by the department or its designee, or demonstrate competencies that at a minimum address chain of command, POD structure and purpose, universal precautions relevant to dispensing of medications, medication identification and selection process, prescription labeling requirements, and patient education.

(B) For all individuals that volunteer, at the time of a governor-declared state of emergency, supervision and training specific and relevant to that event shall be provided by the department or its designee.

(4) Volunteer Management.

(A) Utilization of Volunteers—In the event of a governor-declared state of emergency, volunteers may be used to support the department in mass medication dispensing sites including the set up, operation, and break down of mass medication dispensing sites.

(B) The department shall keep accurate and current records of every volunteer who has been recruited, trained, and accepted by the department, including, at a minimum, volunteer applications and background checks.

(C) All volunteers must be equipped with proper personal protective equipment as appropriate for the situation and in accordance to Occupational Safety and Health Administration Standards (29 CFR Part 1910) 2007, which are incorporated by reference as published by the Office of the Federal Register, National Archives and Records Administration and are available on the web at www.osha.gov or by contacting the Occupational Safety and Health Administration, 200 Constitution Avenue NW, Washington, D.C. 20210. This rule does not incorporate any subsequent amendments or additions.

(5) The department may refuse to accept or assign any individual as a volunteer.

ROBINCARNAHAN(7/31/09)

History

AUTHORITY: section 44.105, RSMo Supp. 2008. Original rule filed Jan. 9, 2009, effective Aug. 30, 2009. Original authority: 44.105, RSMo 2007.

Chapter 50 Prescription Drug Repository Program

19 CSR 20-50.005 Definitions {#sec-19-csr-20-50.005 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-50.005}

PURPOSE: This rule contains definitions which establish the intended meaning of certain terms used throughout this chapter.

(1) As used in this chapter, the following terms shall have the meanings specified:

(A) ìDispenserî means a pharmacy, hospital, prescriber or other person who is licensed and authorized to independently dispense prescription drugs in Missouri;

(B) ìInstitutional facilityî means a longterm care, mental care or other licensed facility that provides health care to resident patients;

(C) ìOriginal sealed and tamper evident unit-dose packagingî means sealed and tamper-evident unit of use packaging by the original manufacturer, by a federally registered repackager, or by a licensed pharmacy in compliance with 4 CSR 220-2.130 and 4 CSR 220-3.040;

(D) ìProgramî means the Prescription Drug Repository Program established by the Department of Health and Senior Services pursuant to sections 196.970 through 196.984, RSMo to accept and dispense prescription drugs donated for the purpose of being dispensed to persons who are residents of Missouri and who meet eligibility requirements of the program.

19 CSR 20-50.010 Eligibility Requirements for Pharmacies, Hospitals and Nonprofit Clinics to Receive Donated Prescription clinics will be determined eligible to receive donated drugs under the Prescription Drug (1) Pharmacies, hospitals or nonprofit clinics may elect to participate in the Prescription Drug Repository Program pursuant to sections 196.970 to 196.984, RSMo. {#sec-19-csr-20-50.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-50.010}

(2) Any participating pharmacy shall be licensed as a pharmacy by the Missouri State Board of Pharmacy.

(3) Any participating hospital shall be licensed as a hospital by the Department of Health and Senior Services when required by law to be so licensed.

(4) Any participating nonprofit clinic shall be under the supervision of a physician licensed by the Missouri State Board of Registration for the Healing Arts.

(5) All participating pharmacies, hospitals or nonprofit clinics shall comply with all federal and state laws, rules and regulations applicable to the storage and distribution of drugs.

(6) All participating pharmacies, hospitals or nonprofit clinics shall comply with all state laws, rules and regulations applicable to the

19 CSR 20-50.015 Eligibility Requirements for Recipients in the Program clinics will determine eligibility of individual patients to receive donated drugs under the (1) A pharmacy, hospital, or nonprofit clinic that elects to participate in the Prescription Drug Repository Program shall determine if a person is eligible to receive drugs. A person shall meet the following requirements to become an eligible recipient of drugs from the Prescription Drug Repository Program: {#sec-19-csr-20-50.015 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-50.015}

(A) Is a resident of Missouri;

(B) Has a net family income below three hundred percent (300%) of the federal poverty level; and (C) Has no active third party prescription drug reimbursement coverage for the drug prescribed.

(2) The pharmacy, hospital or nonprofit clinic shall provide each individual recipient with an identification card after determining that the recipient is eligible to receive drugs from the program.

(A) The card shall confirm to other participating pharmacies, hospitals or nonprofit clinics that the recipient is eligible to receive drugs from the program.

(B) The card shall be prepared in a format obtained from the Department of Health and Senior Services and shall contain the follow- 1. The full name of the recipient;

The address of the recipient;
The Social Security number of the 4. The name of the issuing pharmacy, hospital or nonprofit clinic;
The address and telephone number of the issuing pharmacy, hospital or nonprofit clinic;
A statement that the issuing pharmacy, hospital or nonprofit clinic has determined that the recipient is eligible to receive drugs from the program;
The date the card was issued; and 8. The expiration date of the card, which shall be no later than twelve (12) months from the date the card was issued.

19 CSR 20-50.020 Standards and Procedures for Donating Prescription Drugs clinics will determine a person eligible to donate drugs under the Prescription Drug (1) The following may donate a prescription drug, pursuant to 19 CSR 30-5.025, to a pharmacy, hospital, or nonprofit clinic that elects to participate in the Prescription Drug Repository Program: {#sec-19-csr-20-50.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-50.020}

(A) A licensed dispenser of prescription drugs;

(B) A licensed wholesale distributor of prescription drugs; or (C) A person who was legally dispensed a prescription drug pursuant to a patient-specific prescription or drug order.

(2) An individual electing to donate a prescription drug shall not have taken custody of

Chapter 50óPrescription Drug Repository Program19 CSR 20-50 the drug prior to the donation. The individual may direct the donation through a dispenser of prescription drugs.

(3) A person designated to do so under a durable power of attorney, or acting in their capacity as legal guardian may make the decision to donate a prescription drug on behalf of another person who has lawful possession of the prescription drug.

(4) A person who resides in an institutional facility and was legally dispensed a prescription drug pursuant to a patient-specific prescription or order may elect to sign and date an ownership record prior to donating a drug, which shall state ìfrom this day forward I wish to donate all my remaining unused drugs, pursuant to 19 CSR 20-50.025, to a participating pharmacy, hospital or nonprofit clinic of the Prescription Drug Repository Program. I authorize the institutional facility in which I reside to make the donation on my behalf.î (A) The record shall include the residentís typed or printed name, and the name and address of the institutional facility.

(B) If the institutional facility is a covered entity under the Health Insurance Portability and Accountability Act (HIPAA), the facility shall comply with HIPAA regarding the transfer of any personal health information that may occur as part of the donation.

(5) Each donor must sign an ownership record stating that the donor is the owner of the drug and intends to voluntarily donate the drug to the drug repository program. The ownership record must be completed prior to any donation and include at least the follow- (A) The name of the person to whom the drug was originally dispensed, or the name of the dispenser of prescription drugs or wholesale distributor of prescription drugs that owns the drug;

(B) The signature of the donor or the donorís representative, or the signature of the responsible person or his/her designee from a dispenser of prescription drugs or a wholesale distributor of prescription drugs; and (C) The date the record was signed.

(6) The following donor information must also be documented on the original signed ownership record or on an alternate donor record that is kept with the ownership record:

(A) The name of the donor of the drug;

(B) The name and address of the institutional facility donor location, when applicable;

(D) Either the name of the manufacturer or the national drug code number (NDC #), if available;

(E) The lot number of the drug, if available;

(F) The strength of the drug;

(G) The quantity of the drug;

(H) The date the drug was donated to a participating pharmacy, hospital or nonprofit clinic;

(I) A statement that the drug has been stored according to manufacturer and/or United States Pharmacopoeiarequirements;

(J) A statement that the drug has been examined to determine that no controlled substance or drug that requires storage temperatures other than normal room temperature has been included; and (K) The name and address of the receiving pharmacy, hospital or nonprofit clinic.

(7) A copy of the ownership record or the alternate donor record that contains the required information shall be maintained by the donor or the institutional facility, when applicable, and the receiving pharmacy, hospital or nonprofit clinic.

19 CSR 20-50.025 Standards and Procedures for Accepting Donated Prescription clinics will determine drugs to be acceptable for donation under the Prescription Drug (1) No controlled substances or drugs that require storage temperatures other than normal room temperature as specified by the copoeiashall be donated or accepted as part of the Prescription Drug Repository Program. {#sec-19-csr-20-50.025 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-50.025}

(A) Controlled substances shall not be donated or accepted because a pharmacy, hospital or nonprofit clinic cannot accept controlled substances from a person to whom they have been dispensed, according to applicable state and federal law.

(B) Drugs that require storage temperatures other than normal room temperature as specified by the manufacturer and/or United States Pharmacopoeiashall not be donated or accepted because of the potential for these drugs to become adulterated.

(2) A prescription drug may only be accepted by a pharmacy, hospital, or nonprofit clinic that elects to participate in the drug repository program if the following requirements are met:

(A) The drug is in its original sealed and tamper-evident unit dose packaging;

(B) The packaging is unopened except that a drug packaged in single-unit doses may be accepted and dispensed when the outside packaging is opened if the single-unit-dose packaging is undisturbed;

(C) The drug has been in the possession of a licensed dispenser of prescription drugs, a licensed wholesale distributor of prescription drugs or a licensed health care professional and not in the possession of the ultimate user;

(D) The drug has been stored according to copoeiastorage requirements;

(E) The drug has an expiration date of six (6) months or greater;

(F) The packaging contains the lot number and expiration date of the drug;

(G) The drug does not have any physical signs of tampering or adulteration, and there is no reason to believe that the drug is adulterated as defined in section 196.095, RSMo;

(H) The packaging does not have any physical signs of tampering, deterioration, compromised integrity or adulteration; and (I) Drugs that were dispensed for individuals are packaged and labeled in compliance with 4 CSR 220-2.130, 4 CSR 220-2.140 and 4 CSR 220-3.040.

(3) Prior to receiving each donation of donated drugs, a pharmacy, hospital or nonprofit clinic shall inquire of the donor or donorís representative if the drugs have been examined to determine that no controlled substances or drugs that require storage temperatures other than normal room temperature as specified by the manufacturer and/or United States Pharmacopoeiaare included.

4CODE OF STATE REGULATIONS

(5/31/05) ROBINCARNAHAN 19 CSR 20-50óDEPARTMENT OF HEALTH AND SENIOR SERVICESCommunicable Disease Prevention

19 CSR 20-50.030 Standards and Procedures for Inspecting and Storing Donated Prescription Drugs clinics will determine drugs to be acceptable for dispensing under the Prescription Drug Repository Program. {#sec-19-csr-20-50.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-50.030}

This rule also establishes documentation of receipt of donated drugs.

(1) A pharmacy, hospital or nonprofit clinic shall inspect donated prescription drugs to determine that they are safe and suitable for dispensing, the drug and the packaging are in compliance with 19 CSR 20-50.025, and there are no controlled substances or drugs that require storage temperatures other than normal room temperature as specified by the copoeia. The person who inspects the drugs shall sign an inspection record stating the above and attach it to the copy of the ownership record or alternate donor record provided with the drugs.

(2) Donated drugs shall be stored in the pharmacy, hospital or nonprofit clinic in a location separate from other drugs.

(3) When donated drugs are not inspected immediately upon receipt, they shall not be placed in the dispensing area until they have been inspected.

(4) Donated non-controlled substances that are not suitable for dispensing, shall be destroyed and a record made of such destruction.

(5) Controlled substances found upon inspection shall not be accepted for donation.

(A) Controlled substances submitted for donation shall be documented and returned immediately to the donor or the donorís representative that provided the drugs.

(B) In the event that it is not possible to return the controlled substances to the donor or donorís representative due to inability to identify the donor or donorís representative or due to refusal by the donor or donorís representative to receive them, abandoned controlled substances shall be documented, quarantined and destroyed as required in this subsection.

Abandoned controlled substances shall be documented as required in subsection (C) of this section.
Abandoned controlled substances shall be quarantined separate from other controlled substances in a location that meets requirements of 19 CSR 30-1.
Abandoned controlled substances shall be destroyed beyond reclamation. Such destruction shall be performed by a pharmacist or other person that has authority to dispense controlled substances and witnessed by another responsible employee of the pharmacy, hospital or nonprofit clinic according to

19 CSR 30-1.078 and 21 CFR 1307.21. {#sec-19-csr-30-1.078 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.078}

(C) A controlled substance donor return or destruction record shall be prepared and retained by the pharmacy, hospital or nonprofit clinic. The controlled substance donor return or destruction record shall include the following when applicable:

The name and address of the pharmacy, hospital or nonprofit clinic;
The date the drug was received by the pharmacy, hospital or nonprofit clinic;
The brand name of the drug; or the generic name and either the name of the manufacturer or the national drug code number (NDC #) when available;
The strength of the drug;
The quantity of the drug;
The lot number of the drug when available;
The expiration date of the drug;
The name and address of the donor;
The name and address of the donorís representative;
The circumstances under which the drug was abandoned;
The signature of the donor or donorís representative when the drug is returned to the donor;
The signature of the representative of the pharmacy, hospital or nonprofit clinic when the drug is returned to the donor;
The signature of the individual performing the destruction of the drug;
The signature of the individual witnessing the destruction of the drug; and 15. The date the drug was returned or destroyed.

19 CSR 20-50.035 Standards and Procedures for Dispensing Donated Prescription clinics will dispense donated drugs under the (1) A pharmacy, hospital or nonprofit clinic shall dispense donated prescription drugs in compliance with applicable federal and state laws and regulations for dispensing prescription drugs. {#sec-19-csr-20-50.035 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-50.035}

(2) A pharmacy, hospital or nonprofit clinic shall dispense donated prescription drugs in compliance with section 338.059, RSMo Prescriptions, how labeled; 4 CSR 220-2.130 Drug Repackaging; and 4 CSR 220-3.040 Return and Reuse of Drugs and Devices.

(3) A pharmacy, hospital or nonprofit clinic shall have an established mechanism to notify recipients in the event of a drug recall.

(4) A pharmacy, hospital or nonprofit clinic shall remove the original donorís identification from the package when the drug is dispensed.

(5) Recipients of a donated drug from the drug repository program shall sign an immunity acceptance record form stating they understand the criminal and civil immunity provisions of the program pursuant to section 196.981, RSMo. The immunity acceptance record shall also include at least the follow- (A) The printed name and address of the (B) The signature of the recipient;

(C) The date the form was signed by the (D) The brand name of the drug received; or the generic name and either the name of the manufacturer or the national drug code number (NDC #);

(E) The lot number of the drug if available;

(F) The strength of the drug received by the recipient;

(G) The quantity of the drug received by the recipient;

(H) The name and address of the dispensing pharmacy, hospital or nonprofit clinic; and (I) The dispenserís initials.

(6) Each recipient of a donated drug from the drug repository program shall sign a waiver of the requirement for child-resistant packaging of the Poison Prevention Packaging Act.

(7) A pharmacy, hospital or nonprofit clinic may charge the recipient of a donated drug a handling fee, not to exceed a maximum of two hundred percent (200%) of the standard Medicaid professional dispensing fee to cover stocking and dispensing costs.

Chapter 50óPrescription Drug Repository Program19 CSR 20-50 6CODE OF STATE REGULATIONS (5/31/05) ROBINCARNAHAN 19 CSR 20-50óDEPARTMENT OF HEALTH AND SENIOR SERVICESCommunicable Disease Prevention (8) A pharmacy, hospital or nonprofit clinic may transfer donated drugs to another governmental entity or nonprofit private entity, to be dispensed to persons who meet the eligibility requirements of the program, when the other governmental entity or nonprofit private entity is a pharmacy, hospital or nonprofit clinic.

(A) The transferring pharmacy, hospital or nonprofit clinic shall be licensed as a drug distributor with the Board of Pharmacy.

(B) If the transferring pharmacy, hospital or nonprofit clinic is a covered entity under the Health Portability and Accountability Act (HIPAA), it shall comply with HIPAA regarding the disclosure of any personal health information that may occur as a result of the transfer of a donated drug. A copy of any authorization to release patient identifying information received by the transferring pharmacy, hospital or nonprofit clinic in relation to a donated drug shall be provided to the pharmacy, hospital or nonprofit clinic receiving any transferred drug.

The brand name of the drug received; or the generic name and either the name of the manufacturer or the national drug code number (NDC #);
The lot number of the drug, if available;
The strength of the drug;
The quantity of the drug;
The name and address of both the transferring and receiving pharmacy, hospital or nonprofit clinic; and 6. The date of the transfer.

June 30, 2005..

19 CSR 20-50.040 Record Keeping Requirements clinics will maintain records required under the Prescription Drug Repository Program. {#sec-19-csr-20-50.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-50.040}

(1) All records required to be maintained as a

part of the Prescription Drug Repository Program shall be maintained for a minimum of five (5) years by participating pharmacies, hospitals, nonprofit clinics and institutional facilities.

(2) Records required as part of the program shall be maintained separate from other records.

Chapter 51 Hemp Extract Registration

19 CSR 20-51.010 Hemp Extract Registration Card {#sec-19-csr-20-51.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-51.010}

PURPOSE: This rule establishes the application process for a hemp extract registration card.

(1) Definitions. For the purposes of this rule, the following definitions apply:

(A) “Applicant,” a Missouri resident eighteen (18) years of age or older with intractable epilepsy or a Missouri resident eighteen (18) years of age or older who is the parent or legal guardian responsible for the medical care of a minor with intractable epilepsy, who is applying for a hemp extract registration card under this rule;

(B) “Department,” the Department of Health and Senior Services;

(C) “Hemp extract,” an extract from a cannabis plant or a mixture or preparation containing cannabis plant material that— 1. Is composed of no more than three tenths percent (0.3%) tetrahydrocannabinol by weight;

Is composed of at least five percent (5%) cannabidiol by weight; and 3. Contains no other psychoactive substance.

(D) “Hemp extract registration card,” a card issued by the department under section 192.945, RSMo;

(E) “Intractable epilepsy,” epilepsy that, as determined by a neurologist, does not respond to three (3) or more treatment options overseen by the neurologist;

(F) “Neurologist,” a physician who is licensed under Chapter 334, RSMo, and board certified in neurology;

(G) “Parent,” a parent or legal guardian of a minor who is responsible for the minor’s medical care;

(H) “Registrant,” an individual to whom the department issues a hemp extract registration card under section 192.945, RSMo.

(2) Requirements for All Applicants.

(A) No person shall engage in any activity for which registration is required until the application for registration has been processed and the hemp extract registration card has been issued.

(B) Applications for registration and renewal shall be made on forms designated by the department.

(D) An application which does not contain or is not accompanied by the required information may be denied sixty (60) days after notifying the applicant of the deficiency.

(E) An application may be withdrawn by making a written request to the department.

(F) All applicants shall provide full, true, and complete answers on the application.

(3) Applications for Individual Registrations.

Missouri residents eighteen (18) years of age or older who suffer from intractable epilepsy may apply for a hemp extract registration card.

The application shall be made by completing the Missouri Hemp Extract Registration Card Application incorporated by reference in this

rule as published by the department in October 2014 and available on the department’s website at health.mo.gov or by contacting the department at PO Box 570, Jefferson City, MO 65102-0570. This rule does not incorporate any subsequent amendments or additions. A complete application shall also include:

(A) A copy of the applicant’s valid photo identification; and (B) A completed Missouri Hemp Extract Registration Card Neurologist Certification form as published by the department in Octorate any subsequent amendments or additions.

The certification shall be consistent with a record from the neurologist attached to the Hemp Extract Card Registration Application.

(4) Applications by Parents or Legal Guardians of Minors. A Missouri resident eighteen (18) years of age or older who is the parent or legal guardian who is responsible for the medical care of a minor with intractable epilepsy may apply for a hemp extract registration card. The application shall be made by completing the Missouri Hemp Extract Registration Card Application incorporated by reference in this

rule as published by the department in Octorate any subsequent amendments or additions.

A complete application shall also include:

(A) A copy of the parent’s or legal guardian’s valid photo identification; and (B) A completed Missouri Hemp Extract Registration Card Neurologist Certification form as published by the department in Octorate any subsequent amendments or additions. The certification shall be consistent with a record from the neurologist attached to the Hemp Extract Card Registration Application.

(5) Hemp extract registrants may possess up to twenty (20) ounces of hemp extract. A registrant or applicant may request a waiver to the twenty (20) ounce limit by submitting a completed Missouri Hemp Extract Registration Card Certification for Waiver form as published by the department in October 2014 and available on the department’s website at health.mo.gov or by contacting the department at PO Box 570, Jefferson City, MO 65102-0570. This rule does not incorporate any subsequent amendments or additions.

(6) Registrants shall— (A) Show their hemp extract registration card to the dispensing facility in order to obtain hemp extract, and allow the facility to make a photocopy of it; and (B) Provide their hemp extract registration card to law enforcement upon request.

(7) Registrants shall not sell or otherwise transfer hemp extract or a hemp extract registration card to others except as authorized by law.

(8) Renewals. Registration cards shall be valid for one (1) year from the date of issuance and may be renewed if the registrant meets the requirements in this rule for an initial registration. A waiver issued pursuant to this rule is valid through the end of the registration period during which it was issued.

(9) Registration Card. The hemp extract registration card issued by the department shall contain the following information at minimum:

(A) The registration number;

(B) The registration expiration date;

(D) The minor’s name and date of birth if the registrant is the parent or legal guardian responsible for the medical care of the minor with intractable epilepsy;

(E) If applicable, indication that the registrant has a waiver under section 195.207.4, RSMo, allowing possession of more than twenty (20) ounces of hemp extract;

(F) This statement: This card shall not be transferred or altered; and (G) This statement: This card certifies that the registrant has complied with the requirements for obtaining a hemp extract registration card under section 192.945, RSMo, and if noted on this card, the requirements for obtaining a waiver under section 195.207.4, RSMo. This card does not certify that the registrant is in compliance with any other laws and does not authorize the registrant to violate any laws.

(10) The department may deny or revoke a hemp extract registration card if— (A) The applicant or registrant does not comply with section 192.945, RSMo, or this

rule;

(B) The applicant or registrant supplies false or fraudulent information or documentation to the department;

(C) The applicant or registrant fails to notify the department within thirty (30) days of any change in legal name or address of the applicant, registrant, or patient;

(D) The applicant or registrant fails to notify the department within thirty (30) days that the applicant, registrant, or patient no longer meets the requirements for obtaining or holding a hemp extract registration card; or (E) The registrant or another has altered the hemp extract registration card.

4CODE OF STATE REGULATIONS

(2/28/15) JASONKANDER

AND SENIOR SERVICESPublic Health

History

AUTHORITY: section 192.945, RSMo Supp. 2014, and section 192.006, RSMo 2000. Emergency rule filed Oct. 8, 2014, effective Oct. 18, 2014, expired April 15, 2015. Original rule filed Oct. 8, 2014, effective March 30, 2015. Original authority: 192.006, RSMo 1993, amended 1995.

Chapter 60 Maternal and Neonatal Care

19 CSR 20-60.010 Levels of Maternal and Neonatal Care Designations {#sec-19-csr-20-60.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-60.010}

PURPOSE: This rule establishes criteria and procedures for reporting standardized assessments and levels of maternal and neonatal care designations for birthing facilities.

PUBLISHER’S NOTE: The secretary of state has determined that publication of the entire text of the material that is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproductions. This note applies only to the reference material. The entire text of the rule is printed here.

(1) The following definitions shall apply throughout this rule:

(A) “Birthing facility” means any hospital, as defined under

section 197.020, RSMo, with more than one (1) licensed obstetric bed or a neonatal intensive care unit, a hospital operated by a state university, or a birthing center licensed under sections 197.200 to 197.240, RSMo;

(B) “Department” means the Missouri Department of Health and Senior Services; and (C) “LOCATe” or “CDC Maternal and Neonatal Levels of Care Assessment Tool” refers to a web-based tool created by the Centers for Disease Control and Prevention (CDC) that assists in creating standardized assessments of levels of maternal and neonatal care. LOCATe is based on the most recent guidelines and policy statements issued by the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine.

(2) Each birthing facility shall use the electronic CDC Maternal and Neonatal Levels of Care Assessment Tool (LOCATe) to assess its designation as of December 31 preceding the due date of January 31 every three (3) years. If at any time the birthing facility has any change to its maternal or neonatal care capability that will affect its maternal or neonatal care designation as determined by LOCATe, then the birthing facility shall use LOCATe to reassess its designation within thirty (30) days of the change. If a facility submits an updated survey due to a change in designation, that will not change the schedule of the report required every three (3) years. The electronic LOCATe tool (version 9.2) is incorporated by reference in this rule as published by the Centers for Disease Control and Prevention and available at http://health.mo.gov/locate. This

rule does not incorporate any subsequent amendments or additions.

(3) The level of care designation for neonatal care selected by the birthing facility within LOCATe shall be based upon the most current standards published by the American Academy of Pediatrics (AAP). The level of care designation for maternal care selected by the birthing facility within LOCATe shall be based upon the most current standards published by the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine.

(4) Each birthing facility shall have the results of their LOCATe assessment and level of care designations verified by the department, AAP, or the Joint Commission once every three (3) years. When submitting the LOCATe assessment every three (3) years, birthing facilities shall notify the department through the LOCATe survey about how they will have their results verified. The results of the verification shall be submitted electronically to the department through a link provided by the department once the LOCATe assessment has been submitted.

(5)

Verification processes conducted by AAP or the Joint Commission may include criteria in addition to those included in LOCATe. Verification by the department will only include criteria collected in LOCATe.

(6)

The department may initiate a review and monitor compliance with the provisions set forth in this rule at any time. The department will provide electronic notification to a birthing facility if it finds that verification does not match the self-designated levels of care.

History

AUTHORITY: section 192.006, RSMo 2016, and section 192.380, RSMo Supp. 2022. Emergency rule filed Dec. 20, 2018, effective Dec. 30, 2018, expired June 27, 2019. Original rule filed Dec. 20, 2018, effective June 30, 2019. Amended: Filed Sept. 12, 2022, effective March 30, 2023. Original authority: 192.006, RSMo 1993, amended 1995, and 192.380, RSMo 2017.

Chapter 70 Community-Based Faculty Preceptor Tax Credit

19 CSR 20-70.010 Community-Based Faculty Preceptor Tax Credit {#sec-19-csr-20-70.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-70.010}

PURPOSE: This rule provides an income tax credit for qualified community-based faculty preceptors for physicians and physician assistants. This rule explains the Department of Health and Senior Services’ Preceptor Tax Credit eligibility and how the qualifying individual may claim the credit.

(1) Definitions. The following definitions shall be used in the interpretation and enforcement of this rule:

(A) Community-based faculty preceptor or preceptor means a physician or physician assistant who is licensed in Missouri and provides preceptorships to Missouri medical students or physician assistant students without direct compensation for the work of precepting;

(B) Department means the Missouri Department of Health and Senior Services;

(D) Division means the Division of Professional Registration of the Department of Commerce and Insurance;

(E) Health Professional Shortage Area (HPSA) means a geographic area, population group, or facility designated by the United States Department of Health and Human Services’ Health Resources and Services Administration (HRSA) with a shortage of primary care, dental health, or mental health providers and services;

(F) Medical student means an individual enrolled in a Missouri medical college approved and accredited as reputable by the American Medical Association or the Liaison Committee on Medical Education or enrolled in a Missouri osteopathic college approved and accredited as reputable by the Commission on Osteopathic College Accreditation;

(G) Medical student core preceptorship or physician assistant student core preceptorship means a Missouri preceptorship for a medical student or physician assistant student that provides a minimum of one hundred twenty (120) hours of community-based instruction in family medicine, internal medicine, pediatrics, psychiatry, or obstetrics and gynecology under the guidance of a community-based faculty preceptor. A community-based faculty preceptor may add together the amounts of preceptorship instruction time separately provided to multiple students in determining whether he or she has reached the minimum hours required under this subdivision, but the total preceptorship instruction time provided shall equal at least one hundred twenty (120) hours in order for such preceptor to be eligible for the tax credit authorized under this rule;

(H) Physician assistant student means an individual participating in a Missouri physician assistant program accredited by the Accreditation Review Commission on Education for the Physician Assistant or its successor organization;

(I) Preceptorship rotation means one hundred twenty (120) hours of community-based instruction. One hundred twenty (120) hours of community-based instruction can be comprised of one (1) or multiple students to equal the number of preceptorship hours. The total one hundred twenty (120) hours of community-based instruction equates to one (1) preceptorship rotation, two hundred forty (240) hours equates to two (2) preceptorship rotations, and three hundred sixty (360) hours equates to three (3) preceptorship rotations;

(J) Primary Care HPSA means the shortage designation in primary care physicians, as set forth by HRSA, including all the primary care specialties in which a primary care physician could be licensed, to determine the primary care HPSA score;

(K) Primary Care HPSA; score ranges from one (1) to twentyfive (25) and demonstrates the shortage level of providers providing primary care services in the HPSA; the higher the score, the greater the need; and (L) Taxpayer means any individual, firm, partner in a firm, corporation, or shareholder in an S corporation doing business in this state and subject to the state income tax imposed under Chapter 143, RSMo, excluding withholding tax imposed under sections 143.191 to 143.265, RSMo.

(2) Eligibility.

(A) In order to be eligible, the community-based faculty preceptor must— 1. Be a community-based faculty preceptor providing the preceptorship;

Hold a current and active license issued by the division;
Provide a medical or physician assistant student core preceptorship to one (1) or more medical student(s) or one (1) or more physician assistant student(s);
Complete a minimum of one (1) preceptorship rotation and up to three (3) preceptorship rotations during the tax year and not receive any direct compensation for the preceptorships; and 5. Provide a minimum of one hundred twenty (120) hours of community-based instruction in family medicine, internal medicine, pediatrics, psychiatry, or obstetrics and gynecology in the tax year for which the preceptorship is claimed.

(3) Application Process.

(A) A preceptor shall complete at least one hundred twenty (120) hours in at least one (1) type of instruction outlined in paragraph (2)(A)5. A community-based faculty preceptor may add together the amounts of preceptorship instruction time separately provided to multiple students in determining whether he or she has reached this minimum.

(B) A preceptor shall provide documentation of the following:

The name and address of the students’ college or university and the name of the department head or the program director;
Preceptor’s name;
Preceptor’s phone number;
Preceptor’s email address;
Preceptor’s mailing address;
Preceptor’s discipline and specialty, if applicable;
A statement that the preceptor agrees they did not and will not accept payment in any form for the preceptorship;
Total number of hours of instruction;
A signed statement on letterhead from preceptor’s employer and/or students’ university that verifies that the number of hours of instruction are correct;
The amount of tax credit claimed; and 11. The following information on each student:

A. First and last name;

B. Phone number;

C. Email address;

D. Type of rotation completed;

(11/30/23) John R. Ashcroft AND PUBLIC HEALTH SENIOR SERVICES E. Beginning and completed dates of the rotation; and F. Number of hours of completed rotation.

(C) Applications will be accepted during the entire calendar year and a preceptor shall submit documentation no later than January 31 for preceptorships completed the previous tax year. Applications completed in accordance with this

section will be accepted by electronic submission through the Preceptor Tax Credit webpage at https://health.mo.gov/living/ families/primarycare/precept/index.php, or by mail at ORHPC – Preceptor Tax Credit, PO Box 570, Jefferson City, MO 65102-0570.

(4) Selection Process.

(A) All applications will be processed on a first-come, firstserved basis as received by the department. The applications will be stamped with the date received by the department if the application is sent via regular mail or by UPS, USPS, FedEx, DHL, or other carrier. Applications received electronically will be considered received based on the date stamp on the electronic submission. It is the responsibility of the applicant to verify that an application has been received in a timely manner. Each application received by the department will be reviewed for completeness. Tax credits will be issued based on applicants’ qualifications and are subject to the availability of funds. Verification processing times may be delayed if a particular application requires follow-up. For the purposes of this regulation, an electronic submission is considered an original copy of the application.

No more than two hundred (200) preceptorship tax credits can be authorized nor can credits exceed two hundred thousand dollars ($200,000) for any one (1) calendar year. Tax credits are subject to the availability of funds.
Applications will be prioritized in the following manner:

A. First-come, first-served basis;

B. Applications received on the same day will be prioritized by highest HPSA score of the location of the preceptor’s employer;

C. Applications will be selected by the most underserved area as indicated by the highest HPSA score of the location of the preceptorship; and D. In the event that there are fewer remaining tax credits than qualified applicants, or a tie for the last remaining credit, and with all of those applicants having equal status in priority, the remaining tax credits will be selected by lottery.

(5) Tax Credit Issuance.

(A) Upon each determination, the department will issue, to the preceptors awarded, a certification affirming the taxpayer’s eligibility for the tax credits by March 1 of the year following the preceptorship. To receive the credit allowed by this rule, the certification provided to the taxpayer by the department shall be filed by the taxpayer with their income tax return for the year in which he or she completes the preceptorship rotations.

(B) Subject to the availability of funds, preceptors shall be allowed a credit against the tax otherwise due under

Chapter 143, RSMo, excluding withholding tax imposed under sections 143.191 to 143.265, RSMo, in an amount equal to one thousand dollars ($1,000) for each completed preceptorship rotation, up to a maximum of three thousand dollars ($3,000) per preceptor per tax year.

(C) The taxpayer shall not receive a preceptorship tax credit from the Department of Revenue, under this rule, that exceeds their tax liability for the tax year for which such credit is claimed. Nor shall a taxpayer be allowed a tax credit against his or her tax liability for any prior or succeeding tax year. This may result in a credit of less than one thousand dollars ($1,000).

(D) No amount of any tax credit allowed under this rule shall be refundable. No tax credit allowed under this rule shall be transferred, sold, or assigned. No taxpayer shall be eligible to receive the tax credit authorized under this rule if such taxpayer employs persons who are not authorized to work in the United States under federal law.

(E) The Department of Revenue shall be responsible for verifying that the tax credit does not result in exceeding the taxpayer’s income tax liability and shall only authorize the portion of the tax credit that does not result in a refund.

History

AUTHORITY: section 135.690, RSMo Supp. 2023. Original rule filed June 8, 2023, effective Dec. 30, 2023. Original authority: 135.690, RSMo 2022.

Chapter 80 Coroner Standards and Training Commission

19 CSR 20-80.010 Training Standards Relating to the Office of the Coroner Denny Hoskins (4/30/26) {#sec-19-csr-20-80.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-80.010}

SENIOR SERVICES AND PUBLIC HEALTH

SERVICES

Health Commission

19 CSR 20-80.010 Training Standards Relating to the Office of the Coroner {#sec-19-csr-20-80.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 20-80.010}

(Rescinded May 30, 2026)

History

AUTHORITY: section 58.035, RSMo Supp. 2024. Original rule filed May 31, 2024, effective Jan. 30, 2025. Rescinded: Filed Nov. 3, 2025, effective May 30, 2026.

Division 25 Missouri State Public Health Laboratory

Chapter 30 Determination of Blood Alcohol by Blood, Breath, Saliva, and Urine Analysis; and Determination for the Presence of Drugs in Blood, Saliva, and Urine

19 CSR 25-30.011 General Provisions for the Determination of Blood, Breath, Saliva, {#sec-19-csr-25-30.011 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-30.011}

19 CSR 25-30.070 Approval of Methods for the Analysis of Blood, Saliva, and Urine for the {#sec-19-csr-25-30.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-30.070}

19 CSR 25-30.080 Approval of Methods for the Analysis of Blood, Saliva, and Urine for the SERVICES Blood, Breath, Saliva, and Urine Analysis; and Determination for the Presence of Drugs in Blood, Saliva, and Urine {#sec-19-csr-25-30.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-30.080}

19 CSR 25-30.011 General Provisions for the Determination of Blood, Breath, Saliva, or Urine Analysis and Drug Testing {#sec-19-csr-25-30.011 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-30.011}

PURPOSE: This rule provides general information regarding the applicability of the rules in this chapter, definitions of terms, permits, and operation of breath analyzers.

(1) Only those laboratories or persons performing analysis of blood, breath, saliva, or urine for the determination of blood alcohol content, or of blood, saliva, or urine for the presence of drugs—at the direction of a law enforcement officer acting under the provisions of sections 577.001–577.041, RSMo—are subject to the rules in this chapter.

(2) The following definitions shall be used in the interpretation and enforcement of the rules in this chapter:

(A) Blood alcohol content is the alcohol content of blood expressed as a percentage based on grams of alcohol per one hundred (100) milliliters of blood or grams of alcohol per two hundred ten (210) liters of breath;

(B) Breath analyzer is an instrument which measures and expresses the blood alcohol content from a sample of expired air;

(D) Drugs are illegal or controlled chemical substances, other than alcohol, that are capable of impairing an individual’s ability to operate a motor vehicle;

(E) Field service and repairs are the service and repairs on breath analyzers at locations other than at a manufacturer’s facility;

(F) Maintenance checks are the standardized and prescribed procedures used to determine that a breath analyzer is functioning properly and is operating in accordance with the operational procedures established by the Department of Health and Senior Services;

(G) Permit is the written authorization from the Department of Health and Senior Services for an individual to perform analyses of blood, breath, saliva, or urine for blood alcohol content; to perform analyses of blood, saliva, or urine for drugs; to operate breath analyzers; to supervise operators of breath analyzers; to serve as instructors of training courses; and to perform field service and repairs and maintenance checks on breath analyzers;

(H) Observation period is the minimum fifteen- (15-) minute continuous period that ends when a breath sample has been provided into the approved breath analyzer, during which time the operator shall remain close enough to a subject to reasonably ensure, using the senses of sight, hearing, or smell, that a test subject does not smoke, vomit, or have any oral intake during the fifteen- (15-) minute observation period. Direct observation is not necessary to ensure the validity or accuracy of the test result;

(I) Oral intake is the act of placing a substance from outside the body into the mouth during the observation period. The mouthpiece used to provide a breath sample shall not constitute oral intake;

(J) Vomiting is the act of ejecting the solid and/or liquid contents of the stomach through the mouth, and does not include belching or burping;

(K) Examination is a limited visual examination of a test subject’s mouth and/or denial by a subject that he or she has any substance in his or her mouth; and (L) Substance is any foreign matter, solid or liquid, not to include dentures, dental work, studs, piercing, or tongue jewelry.

(3) The chemical analysis of a person’s blood, breath, saliva, or urine conducted under the provisions of sections 577.001– 577.041, RSMo, shall be performed by licensed medical personnel or by personnel possessing a valid permit issued by the department.

(A) Permits are valid for two (2) years from the date of issuance.

(B) A permittee is authorized to perform only those tests for analysis, or to operate or maintain those breath analyzers that are specified on the permit.

(4) Applications for permits and renewals of permits shall be made on forms available from the Breath Alcohol Program, Missouri State Public Health Laboratory. Forms are also available at http://health.mo.gov/lab/breathalcohol/. Requests for approval of instruments, methods, or training courses shall be made to the director, Missouri State Public Health Laboratory, c/o Breath Alcohol Program. Requests for copies of permits, submitted maintenance records, submitted permit applications, and simulator certifications shall also be made to the director, Missouri State Public Health Laboratory, c/o Breath Alcohol Program. Criteria and standards used for certification and approval purposes shall be provided upon request by the Missouri State Public Health Laboratory.

(5) Breath analyzers shall be operated strictly in accordance with the procedures set forth in 19 CSR 25-30.060.

(A) An operational checklist, including the certification section, shall be completed with each breath test at the time of the test, by the individual performing the test.

(B) An individual permitted to operate a breath analyzer shall— 1. Immediately suspend use of a breath analyzer that is not functioning properly; and 2. Submit to periodic reviews, examinations or surveys conducted by the department.

(6) The department may initiate proceedings to deny, suspend, or revoke a permit when there is evidence of false or misrepresented information given on an application or renewal for a permit; when there is evidence that the permittee has falsified reports, negligently performed analyses or reported results, used an instrument or method not approved by the department, performed analyses not authorized by the permit, or has used the permit for promotional or commercial purposes; or when the permittee has demonstrated an inability to accurately and properly perform analyses or satisfactorily meet the qualifications and competence standards required of the permit.

(A) The department shall provide written notice of the disciplinary action to the permittee and the employee of the permittee.

(B) The notice shall contain a summary of the evidence supporting the disciplinary action.

This rule previously filed as 19 CSR 20-30.011. Original rule filed July 15, 1988, effective Sept. 29, 1988. Changed to 19 CSR 25-30.011 Jan. 1, 1995. Emergency amendment filed May 10, 2001, effective May 22, 2001, expired Nov. 17, 2001. Amended: Filed May 10, 2001, effective Oct. 30, 2001. Amended: Filed May 31, 2012, effective Dec. 30, 2012. Amended: Filed Oct. 1, 2019, effective March 30, 2020. amended 1982, 1983, 1996, 1998, 2001, 2006, 2014; and 577.037, RSMo 1982, amended Collins v. Director of Revenue, 691 S.W.2d 246 (Mo. banc. 1985); Jannett v. King, 687 S.W.2d 252 (Mo. App. 1985); Stuart v. Director of Revenue, 761 S.W.2d 234 (Mo.

App. 1988). Prima facie case for admission of breath analysis test results is made if the test is administered by a certified operator in accordance with promulgated operating procedures.

Collins v. Director of Revenue, 691 S.W.2d 246 (Mo. banc 1985); Stuart v. Director of Revenue, 761 S.W.2d 234 (Mo. App. 1988). A contention that a breath analysis instrument was not functioning properly can only be made if supported by some evidence which suggests that a malfunction occurred despite adherence to correct test methods.

Williams v. Director of Revenue, 721 S.W.2d 797 (Mo. App. 1986). The results of approved breath analysis tests are measured by weight.

Daniels v. Director of Revenue, 48 S.W.3d 42 (Mo. App. 2001), overruled on other grounds by Verdoorn v. Director of Revenue, 119 S.W.3d 543 (Mo. 2003). “Belching” does not constitute “vomiting” because stomach contents are not disgorged through the mouth.

Misener v. Director of Revenue, 134 S.W.3d 761 (Mo. App. 2004). Subject waived any defense based upon the breath test result being contaminated by an antacid tablet in his mouth because he did not respond truthfully when asked whether he was taking any medication.

19 CSR 25-30.021 Type I Permit {#sec-19-csr-25-30.021 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-30.021}

PURPOSE: This rule establishes the qualifications, duties, and responsibilities of a Type I permittee and the standards for laboratories in which Type I permittees perform testing.

(1) A Type I permit, included herein, authorizes an individual to perform analyses of blood, saliva, or urine for blood alcohol content and to perform analyses of blood, saliva, or urine for the presence of drugs.

(2) An applicant for a Type I permit shall not be less than twenty-one (21) years of age and shall possess a baccalaureate degree in chemical, physical, or biological science from an accredited college or university. The applicant shall also complete an application for a Type I permit, included herein.

(A) To perform analyses of blood, saliva, or urine for drugs or blood alcohol content, the applicant shall have performed a biennial forensic proficiency test provided by an outside company for each type of substance, alcohol, or drugs, for which a permit is requested. A copy of the proficiency test results achieved shall accompany the permit application.

(B) If the applicant does not perform proficiency tests, the applicant may qualify for a permit to perform analysis of blood, saliva, or urine for blood alcohol content by satisfactorily analyzing three (3) check specimens provided from the department. The results reported on the three (3) samples shall be within five percent (5%) of the true value. A second set of three (3) check samples shall be sent to the applicant if the results from the first set were unsatisfactory. If the results from the second set of check samples are unsatisfactory, the department shall return the application. Any further efforts to meet this condition for completion of the application shall be made at the discretion of the department based on the nature of the problem; the ability of the applicant; and the facility, equipment, and methods that were employed. A copy of the check specimen results achieved shall accompany the permit application.

(3) Laboratories wherein analyses are performed by Type I permit holders shall maintain complete records of testing, quality assurance data, logbooks, and other documentation related to the performance of tests as established under general standards of laboratory practice and chain-of-custody procedures.

(A) Laboratories wherein analyses are performed by Type I permit holders shall be subject to audits by the department regarding any and all records referenced herein.

(B) Laboratories that perform analyses of blood, saliva, or urine for the presence of drugs shall hold a forensic drug testing accreditation through the College of American Pathologists (CAP), an accreditation through the American Board of Forensic Toxicologists (ABFT), or an accreditation through an accreditation body that is a signatory of the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA). This accreditation shall include an annual forensic proficiency test on each biological matrix (blood, saliva, or urine) tested. A copy of the certification for each laboratory shall be supplied to the Missouri State Public Health Laboratory upon request.

(4) Type I permits issued prior to the effective date of this rule (5) Type I permit applications completed prior to the effective and Determination for the Presence of Drugs in Blood, Saliva, and Urine19 CSR 25-30 This rule previously filed as 19 CSR 20-30.021. Original rule filed July 15, 1988, effective Sept. 29, 1988. Changed to 19 CSR 25-30.021 Jan. 1, 1995. Amended: Filed May 31, 2012, effective Dec. 30, 2012.

Amended: Filed Oct. 1, 2019, effective March 30, 2020. Amended:

Filed Nov. 1, 2022, effective June 30, 2023. amended 1982, 1983, 1996, 1998, 2001, 2006, 2014; and 577.037, RSMo 1982, amended Stuart v. Director of Revenue, 761 S.W.2d 234 (Mo. App. 1988). A Type II permittee is qualified to testify as an expert on technical matters and permissible temperature Miller v. Director of Revenue, 719 S.W.2d 787 (Mo. banc 1986); Elkins v. Director of Revenue, 728 S.W.2d 567 (Mo. App. 1987). Possession of a permit is a matter within the personal knowledge of the permittee. Testimony by a permittee is sufficient to

19 CSR 25-30.031 Type II Permit {#sec-19-csr-25-30.031 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-30.031}

PURPOSE: This rule establishes the qualifications, duties, and responsibilities of a Type II permittee and establishes a maintenance report to be used for each of the approved breath analyzers in 19 CSR 25-30.050.

(1) A Type II permit, included herein, authorizes an individual to operate a breath analyzer and to perform any of the following duties: to conduct training courses for the operation of breath analyzers that are approved by the department, to conduct training courses approved by the department to qualify for a Type II permit, to perform field service and repairs on breath analyzers as indicated on the permit, to perform maintenance checks on breath analyzers as required by the department, and to supervise operators of breath analyzers.

(2) An applicant for a Type II permit shall not be less than twenty-one (21) years of age. In addition, the applicant successfully shall complete a training course approved by the department for obtaining a Type II permit and complete an application for a Type II permit, included herein.

(3) A Type II permittee shall perform maintenance checks on breath analyzers under his/her supervision at intervals not to exceed thirty-five (35) days. The permittee shall retain the original report of the maintenance check and submit a copy of the report so that it shall be received by the department within fifteen (15) days from the date the maintenance check was performed. In addition, maintenance checks shall be completed when— (A) A new instrument is placed into service; or (B) The instrument has been serviced, repaired, or recalibrated.

(4) Type II permittees shall maintain complete records as required in 19 CSR 25-30.021(3) and in 19 CSR 25-30.011(5)(A). Type II permittees shall provide oversight and assistance to assure the competency of the operators under their supervision. They shall conduct training courses as approved by the department.

(5) To renew a Type II permit, the applicant shall have completed at least two (2) maintenance checks and at least ten (10) tests on drinking subjects, following the operational checklists, within the past year on each breath analyzer for which renewal is requested. If these conditions are not met or if the permit has expired for more than thirty (30) days, the applicant shall perform two (2) maintenance checks and five (5) self-administered tests for each breath analyzer for which renewal is requested.

Copies of the maintenance checks and the operational checklists and printouts for the five (5) self-administered tests shall accompany the application for renewal.

(6) Type II permits issued prior to the effective date of this rule (7) For the maintenance checks referred to in sections (3)–(5) of this rule, the appropriate maintenance report form for the specific instrument being checked shall be used— (A) When performing a maintenance check on the Intox DMT, the report incorporated in the instrument software shall be used (see Report No. 1 included herein for example);

(B) When performing a maintenance check on the CMI Intoxilyzer 8000, the report incorporated in the instrument software shall be used (see Report No. 2 included herein for example);

(C) When performing a maintenance check on the Intox EC/ IR II, the report incorporated in the instrument software shall be used (see Report No. 3 included herein for example); and (D) When performing a maintenance check on the Alco- Sensor IV with printer, Report No. 7 included herein shall be used.

(8) Maintenance report forms required in section (7) of this

rule prior to the effective date of this rule and completed on maintenance checks before that date shall be considered valid under this rule. Maintenance report forms completed on maintenance checks within ninety (90) days after the effective date of this rule shall be considered valid if the maintenance checks and maintenance report forms were completed in compliance with the rules in effect at the time the checks and forms were completed or the rules in effect immediately prior to the effective date of this rule.

(9) Type II permit applications completed prior to the effective (2/29/20) JOHN R. ASHCROFT and Determination for the Presence of Drugs in Blood, Saliva, and Urine19 CSR 25-30 (2/29/20) JOHN R. ASHCROFT and Determination for the Presence of Drugs in Blood, Saliva, and Urine19 CSR 25-30 and Determination for the Presence of Drugs in Blood, Saliva, and Urine19 CSR 25-30 This rule previously filed as 19 CSR 20-30.031. Original rule filed July 15, 1988, effective Sept. 29, 1988. Emergency amendment filed Dec. 2, 1992, effective Dec. 12, 1992, expired April 10, 1993.

Emergency amendment filed April 1, 1993, effective April 11, 1993, expired June 6, 1993. Amended: Filed Dec. 2, 1992, effective June 7, 1993. Emergency amendment filed Nov. 9, 1993, effective Nov. 19, 1993, expired March 18, 1994. Emergency amendment filed March 1, 1994, effective March 11, 1994, expired July 8, 1994. Emergency amendment filed July 12, 1994, effective July 22, 1994, expired Nov. 18, 1994. Emergency amendment filed Oct. 28, 1994, effective Nov. 7, 1994, expired March 6, 1995. Amended: Filed July 22, 1994, effective Dec. 30, 1994. Changed to 19 CSR 25-30.031 Jan. 1, 1995.

Emergency amendment filed March 3, 1995, e ffective March 13, 1995, expired July 1, 1995. Emergency amendment filed June 21, 1995, effective July 1, 1995, expired Oct. 28, 1995. Amended: Filed March 3, 1995, effective July 30, 1995. Emergency amendment filed March 15, 1996, effective March 25, 1996, expired Sept. 20, 1996.

Amended: Filed March 15, 1996, effective Aug. 30, 1996. Amended:

Filed Aug. 25, 1997, effective Feb. 28, 1998. Amended: Filed May 31, 2012, effective Dec. 30, 2012. Emergency amendment filed Sept. 4, 2013, effective Sept. 15, 2013, expired March 13, 2014. Amended:

Filed Sept. 4, 2013, effective Feb. 28, 2014. Amended: Filed Oct. 1, 2019, effective March 30, 2020. amended 1982, 1983, 1996, 1998, 2001, 2006, 2014; and 577.037, RSMo 1982, amended Stuart v. Director of Revenue, 761 S.W.2d 234 (Mo. App. 1988). A Type II permittee is qualified to testify as an expert on technical matters and permissible temperature Miller v. Director of Revenue, 719 S.W.2d 787 (Mo. banc 1986); Elkins v. Director of Revenue, 728 S.W.2d 567 (Mo. App. 1987). Possession of a permit is a matter within the personal knowledge of the permittee. Testimony by a permittee is sufficient to

19 CSR 25-30.041 Type III Permit {#sec-19-csr-25-30.041 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-30.041}

PURPOSE: This rule establishes the qualifications, duties, and responsibilities of a Type III permittee.

(1) A Type III permit, included herein, authorizes an individual to operate breath analyzers.

(2) An applicant for a Type III permit shall not be less than twenty-one (21) years of age. The applicant shall have successfully completed a training course approved by the department for operation of breath analyzers or shall offer proof of equivalent qualifications to the satisfaction of the department. The applicant must also complete an application for a Type III permit, included herein.

(3) To renew a Type III permit, the applicant shall have performed at least ten (10) tests on drinking subjects in the past year on each instrument for which renewal is requested. If this condition is not met or the permit has expired for more than thirty (30) days, the applicant shall complete a two- (2-) hour refresher training course under the supervision of an individual with a valid Type II permit. The refresher training course shall include the performance of the five (5) self-administered tests for each breath analyzer for which renewal is requested.

Copies of the completed operational checklists and printout for the self-administered tests shall accompany the renewal application.

(4) Type III permits issued prior to the effective date of this rule (5) Type III permit applications completed prior to the effective and Determination for the Presence of Drugs in Blood, Saliva, and Urine19 CSR 25-30 This rule previously filed as 19 CSR 20-30.041. Original rule filed July 15, 1988, effective Sept. 29, 1988. Amended: Filed March 15, 1996, effective Aug. 30, 1996. Changed to 19 CSR 25-30.041 Jan. 1, 1995. Emergency amendment filed June 19, 1998, effective July 1, 1998, expired Feb. 25, 1999. Amended: Filed June 19, 1998, effective Jan. 30, 1999. Amended: Filed May 31, 2012, effective Dec. 30, 2012.

Amended: Filed Oct. 1, 2019, effective March 30, 2020. amended 1982, 1983, 1996, 1998, 2001, 2006, 2014; and 577.037, RSMo 1982, amended Stuart v. Director of Revenue, 761 S.W.2d 234 (Mo. App. 1988). A Type II permittee is qualified to testify as an expert on technical matters and permissible temperature Miller v. Director of Revenue, 719 S.W.2d 787 (Mo. banc 1986); Elkins v. Director of Revenue, 728 S.W.2d 567 (Mo. App. 1987). Possession of a permit is a matter within the personal knowledge of the permittee. Testimony by a permittee is sufficient to

19 CSR 25-30.050 Approved Breath Analyzers {#sec-19-csr-25-30.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-30.050}

PURPOSE: This rule enumerates those breath analyzers which are approved by the Department of Health and Senior Services for the determination of the alcoholic content of blood from a sample of expired air.

(1) Approved breath analyzers are— NAME OR ITEM MANUFACTURER OR SUPPLIER Alco-Sensor IV Intoximeters, Inc. with printer, Intox EC/IR II, and Intox DMT Intoxilyzer, CMI/MPH, Operations Model 8000 of MPD, Inc.

(2) Breath analyzers are to be used within buildings or vehicles used for driving-while-intoxicated enforcement. These breath analyzers are not approved for mobile use in boats or in outside areas.

(3) Maintenance checks and breath tests performed on previously approved breath analyzers prior to the effective date of this rule shall be considered valid under this rule if such tests were completed in compliance with the rules in effect at the time the test was conducted.

This rule was previously filed as 13 CSR 50-140.050 and 19 CSR 20-30.050. Original rule filed Oct. 1, 1965, effective Oct. 13, 1965.

Amended: Filed Jan. 29, 1970, effective March 30, 1970. Amended:

Filed Sept. 10, 1970, effective Nov. 9, 1970. Amended: Filed Dec. 8, 1972, effective Feb. 6, 1973. Emergency amendment filed Aug. 4, 1977, effective Aug. 14, 1977, expired Dec. 12, 1977. Amended:

Filed Aug. 4, 1977, effective Nov. 11, 1977. Amended: Filed Feb. 8, 1982, effective May 13, 1982. Emergency amendment filed July 27, 1984, effective Aug. 6, 1984, expired Jan. 4, 1985. Amended:

Filed July 17, 1984, effective Dec. 13, 1984. Changed to 19 CSR 20-30.050, effective Aug. 15, 1986. Amended: Filed Oct. 3, 1986, effective Dec. 25, 1986. Emergency amendment filed Jan. 13, 1987, effective Jan. 23, 1987, expired May 22, 1987. Amended: Filed Jan. 16, 1987, effective April 11, 1987. Emergency rescission and emergency rule filed June 2, 1988, effective June 12, 1988, expired Sept. 19, 1988. Rescinded and readopted: Filed June 2, 1988, effective Aug. 25, 1988. Amended: Filed June 16, 1989, effective Sept. 11, 1989. Emergency amendment filed Sept. 5, 1991, effective Sept. 15, 1991, expired Jan. 12, 1992. Amended: Filed Sept. 5, 1991, effective Jan. 13, 1992. Amended: Filed Jan. 15, 1993, effective July 8, 1993.

Emergency amendment filed Nov. 9, 1993, effective Nov. 19, 1993, expired March 18, 1994. Emergency amendment filed March 1, 1994, effective March 11, 1994, expired July 8, 1994. Emergency amendment filed July 12, 1994, effective July 22, 1994, expired Nov. 18, 1994. Emergency amendment filed Oct. 28, 1994, effective Nov. 7, 1994, expired March 6, 1995. Amended: Filed July 22, 1994, effective Dec. 30, 1994. Changed to 19 CSR 25-30.050 Jan. 1, 1995.

Emergency amendment filed March 15, 1996, effective March 25, 1996, expired Sept. 20, 1996. Amended: Filed March 16, 1996, effective Aug. 30, 1996. Emergency amendment filed Aug. 22, 1997, effective Sept. 1, 1997, expired Feb. 27, 1998. Amended: Filed Aug. 25, 1997, effective Feb. 28, 1998. Emergency amendment filed May 10, 2001, effective May 22, 2001, expired Nov. 17, 2001. Amended:

Filed May 10, 2001, effective Oct. 30, 2001. Amended: Filed May 31, 2012, effective Dec. 30, 2012. Emergency amendment filed Sept. 4, 2013, effective Sept. 15, 2013, expired March 13, 2014. Amended:

Filed Sept. 4, 2013, effective Feb. 28, 2014. Amended: Filed Oct. 1, 2019, effective March 30, 2020. amended 1982, 1983, 1996, 1998, 2001, 2006, 2014; and 577.037, RSMo 1982, amended Eckhoff v. Director of Revenue, 745 S.W.2d 815 (Mo. App. 1988); Director of Revenue v. Martin, 752 S.W.2d 453 (Mo. App. 1988). For purpose of breath analysis tests, the procedural components of these tests include the testing techniques and methods, the qualifications of the person administering the tests, and the nature and description of the equipment and devices to be used. The designation of approved suppliers of test ampoules for breathalyzer test was procedural only and would be applied retrospectively.

19 CSR 25-30.051 Breath Analyzer Calibration and Accuracy Verification Standards {#sec-19-csr-25-30.051 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-30.051}

PURPOSE: This rule defines the standard simulator solutions or compressed ethanol-gas mixtures to be used in verifying and calibrating breath analyzers, as well as the annual checks required on simulators used in conjunction with the standard simulator solution.

(1) Standards used for the purpose of verifying and calibrating breath analyzers shall consist of standard simulator solutions or compressed ethanol-gas standard mixtures.

(2) Standard simulator solutions, used to verify and calibrate evidential breath analyzers, shall be solutions from approved suppliers. The standard simulator solutions used shall have a vapor concentration within five percent (5%) of the following values:

(A) 0.10%;

(B) 0.08%; or (C) 0.04%.

(3) Approved suppliers of standard simulator solutions are— (A) Alcohol Countermeasure Systems, Inc.;

(B) Guth Laboratories, Inc.;

(4) Any breath alcohol simulator used in the verification or calibration of evidential breath analyzers with the standard simulator solutions referred to in sections (2) and (3) of this

rule shall be certified against a National Institute of Standards and Technology (NIST) traceable reference thermometer or thermocouple between January 1, 2013, and December 31, 2013, and annually thereafter. Proof that the simulator is in certification shall be shown by entry of the simulator serial number and expiration date of the certification period on the maintenance report required under 19 CSR 25-30.031, or by certification report as issued by the department.

(5) Compressed ethanol-gas standard mixtures used to verify and calibrate evidential breath analyzers shall be mixtures provided from approved suppliers. The compressed ethanol-gas mixtures used shall have a concentration within five percent (5%) of the following values:

(A) 0.10%;

(B) 0.08%; or (C) 0.04%.

(6) Approved suppliers of standard compressed ethanol-gas mixtures are— (A) Intoximeters, Inc.;

(B) CMI, Inc.;

(D) ILMO Products Company, Inc.; and (E) Guth Laboratories, Inc.

(7) Maintenance reports completed prior to the effective date of this rule shall be considered valid under this rule if the maintenance report was completed in compliance with the rules in effect at the time the maintenance was conducted.

Emergency rule filed Aug. 22, 1997, effective Sept. 1, 1997, expired Feb. 27, 1998. Original rule filed Aug. 25, 1997, effective Feb. 28, 1998. Emergency rescission and emergency rule filed April 17, 1998, effective May 4, 1998, expired Oct. 30, 1998. Rescinded and readopted: Filed May 1, 1998, effective Oct. 30, 1998. Amended:

Filed Jan. 15, 2004, effective July 30, 2004. Amended: Filed May 31, 2012, effective Dec. 30, 2012. Amended: Filed Sept. 4, 2013, effective Feb. 28, 2014. Amended: Filed Oct. 1, 2019, effective March 30, 2020. amended 1982, 1983, 1996, 1998, 2001, 2006, 2014; and 577.037, RSMo 1982, amended

19 CSR 25-30.060 Operating Procedures for Breath Analyzers {#sec-19-csr-25-30.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-30.060}

PURPOSE: This rule establishes an operational checklist (including certification by the operator) for each of the approved breath analyzers in 19 CSR 25-30.050. Prosecuting attorneys have requested that these procedures be included as a rule so they can be introduced in court to show that operators of breath analyzers have adhered strictly to the operating procedures set forth and approved by the Department of Health and Senior Services.

(1) When using Alco-Sensor IV with printer, the procedures on the form included herein shall be performed and the form shall be completed (see form #8).

(2) When using Intox DMT, the procedures on the form incorporated within the instrument software shall be performed and the form shall be completed (see form #11 included herein for example).

(3) When using Intoxilyzer, Model 8000, the procedures on the form incorporated within the instrument software shall be performed and the form shall be completed (see form #12 included herein for example).

(4) When using Intox EC/IR II, the procedures on the form incorporated within the instrument software shall be performed and the form shall be completed (see form #13 included herein for example).

(5) The fifteen- (15-) minute observation of the subject, which is the second procedure on the forms in sections (1)–(6) of this

rule, shall be done by a current Type II or Type III permit holder.

The observation period is intended to ensure that any alcohol in a test subject’s mouth has time to dissipate before a breath sample is taken so that mouth alcohol does not affect the accuracy of a test result. A fifteen- (15-) minute observation period is deemed to be sufficient for the dissipation of any mouth alcohol to a reasonable degree of scientific certainty.

(6) Results of subject tests shall be recorded on the operational checklist in a manner consistent with the breath analyzer’s digital display and/or printout. For example, if the display and/or the printout reads one hundred forty-nine thousandths percent (0.149%), the result shall be recorded as one hundred forty nine thousandths percent (0.149%).

(7) Operational Checklists and breath tests completed prior to the effective date of this rule shall be considered valid if such tests were completed in compliance with the rules in effect at the time the test was conducted. Operational Checklists and breath tests completed within ninety (90) days after the effective date of this rule shall be considered valid if such tests were completed in compliance with the rules in effect at the time the tests were conducted or the rules in effect immediately prior to the effective date of this rule.

(8) When using the Alco-Sensor IV with printer, the use of the Manual button shall not be allowed to obtain a breath alcohol test result from a subject. and Determination for the Presence of Drugs in Blood, Saliva, and Urine19 CSR 25-30 and Determination for the Presence of Drugs in Blood, Saliva, and Urine19 CSR 25-30 This rule was previously filed as 13 CSR 50-140.060 and 19 CSR 20-30.060. Original rule filed July 11, 1979, effective Oct. 12, 1979.

Amended: Filed Feb. 8, 1982, effective May 13, 1982. Emergency amendment filed July 27, 1984, effective Aug. 6, 1984, expired Jan. 4, 1985. Amended: Filed Aug. 3, 1984, effective Dec. 13, 1984.

Changed to 19 CSR 20-30.060, effective Aug. 15, 1986. Emergency rescission and emergency rule filed June 2, 1988, effective June 12, 1988, expired Sept. 19, 1988. Rescinded and readopted: Filed June 2, 1988, effective Aug. 25, 1988. Emergency amendment filed July 11, 1988, effective July 21, 1988, expired Sept. 19, 1988. Amended:

Filed June 16, 1989, effective Sept. 11, 1989. Emergency amendment filed Sept. 5, 1991, effective Sept. 15, 1991, expired Jan. 12, 1992.

Amended: Filed Sept. 5, 1991, effective Jan. 13, 1992. Amended:

Filed Jan. 15, 1993, effective July 8, 1993. Emergency amendment filed Nov. 9, 1993, effective Nov. 19, 1993, expired March 18, 1994.

Emergency amendment filed March 1, 1994, effective March 11, 1994, expired July 8, 1994. Emergency amendment filed July 12, 1994, effective July 22, 1994, expired Nov. 18, 1994. Emergency amendment filed Oct. 28, 1994, effective Nov. 7, 1994, expired March 6, 1995. Amended: Filed July 22, 1994, effective Dec. 30, 1994. Changed to 19 CSR 25-30.060 Jan. 1, 1995. Emergency amendment filed March 3, 1995, effective March 13, 1995, expired July 1, 1995. Emergency amendment filed June 21, 1995, effective July 1, 1995, expired Oct. 28, 1995. Amended: Filed March 3, 1995, effective July 30, 1995. Emergency amendment filed March 15, 1996, effective March 25, 1996, expired Sept. 20, 1996. Amended:

Filed March 15, 1996, effective Aug. 30, 1996. Amended: Filed Aug. 25, 1997, effective Feb. 28, 1998. Amended: Filed May 31, 2012, effective Dec. 30, 2012. Emergency amendment filed Sept. 4, 2013, effective Sept. 15, 2013, expired March 13, 2014. Amended: Filed Sept. 4, 2013, effective Feb. 28, 2014. Amended: Filed Oct. 1, 2019, effective March 30, 2020. amended 1982, 1983, 1996, 1998, 2001, 2006, 2014; and 577.037, RSMo 1982, amended Eckhoff v. Director of Revenue, 745 S.W.2d 815 (Mo. App. 1988); Director of Revenue v. Martin, 752 S.W.2d 453 (Mo. App. 1988). For purpose of breath analysis tests, the procedural components of these tests include the testing techniques and methods, the qualifications of the person administering the tests, and the nature and description of the equipment and devices to be used. The designation of approved suppliers of test ampoules for breathalyzer test was procedural only and would be applied retrospectively.

Stuhr v. Director of Revenue, 760 S.W.2d 127 (Mo. App. 1988). Though the operational checklist which was used differed from the rule, the checklist exceeded the minimum established requirements and provided a proper foundation for admitting the results of the breath test.

Stuhr v. Director of Revenue, 760 S.W.2d 127 (Mo. App. 1988); Bradford v. Director of Revenue, 735 S.W.2d 208 (Mo. App. 1987). The time and date component of the BAC Verifier is a separate component from that of the sample collection portion of the unit.

The wrong date or time on the printout is not evidence of a malfunction.

19 CSR 25-30.070 Approval of Methods for the Analysis of Blood, Saliva, and Urine for the Determination of Blood Alcohol Content or the Presence of Drugs {#sec-19-csr-25-30.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-30.070}

PURPOSE: This rule establishes the methods and analytical principles approved for the determination of blood alcohol content or the presence of drugs from samples of blood, urine, or saliva.

(1) Samples of blood, saliva, or urine shall be collected in accordance with the provisions of sections 577.001–577.041, RSMo, and a sufficient volume of sample shall be collected to provide for duplicate testing.

(A) Blood samples shall be collected in commercially-manufactured blood collection tubes that contain sodium fluoride or an equivalent preservative, as well as potassium oxalate, sodium citrate, or an equivalent anticoagulant.

(B) Urine specimens shall be collected in clean, dry containers. If a preservative, such as sodium fluoride, is employed, a comment stating the type and amount of preservative used should accompany the specimen. Specimens shall be refrigerated or frozen if not tested within one (1) day of collection.

(C) Saliva specimens shall be collected in a commercially-manufactured collection device and collected according to collection device instructions.

(2) The laboratory in which these analyses are performed shall have a director who shall assume full responsibility for the accuracy of tests and reports.

(3) An individual shall have a valid Type I permit in order to perform analyses of blood, saliva, and urine for the presence of drugs.

(4) Methods based on the following analytical principles are approved for the determination of blood alcohol content from a sample of blood, saliva, or urine:

(A) Chromatography, in liquid or vapor phase;

(B) Spectrophotometry;

(5) Methods based on the following analytical principles are approved for the analysis of blood, saliva, and urine for the presence of drugs:

(A) Chromatography, in liquid or vapor phase;

(B) Spectrophotometry;

(6) All initial testing for the presence of drugs other than alcohol producing positive results shall be confirmed by a method employing mass spectrometry (MS).

(7) Blood, saliva, and urine tests for the determination of blood alcohol content or the presence of drugs performed prior to the effective date of this rule shall be considered valid under this

rule if such tests were completed in compliance with the rules in effect at the time the test was conducted.

This rule previously filed as 19 CSR 20-30.070. Emergency rule filed May 21, 1987, effective May 31, 1987, expired Sept. 28, 1987. Original

rule filed May 21, 1987, effective Aug. 27, 1987. Emergency rescission filed Aug. 14, 1987, effective Aug. 26, 1987, expired Dec 11, 1987.

Emergency amendment filed Feb. 16, 1988, effective Feb. 26, 1988, expired June 24, 1988. Amended: Filed Feb. 16, 1988, effective April 28, 1988. Changed to 19 CSR 25-30.070 Jan. 1, 1995. Emergency amendment filed May 10, 2001, effective May 22, 2001, expired Nov. 17, 2001. Amended: Filed May 10, 2001, effective Oct. 30, 2001.

Amended: Filed May 31, 2012, effective Dec. 30, 2012. Amended:

Filed Oct. 1, 2019, effective March 30, 2020. amended 1982, 1983, 1996, 1998, 2001, 2006, 2014; and 577.037, RSMo 1982, amended State v. Kummer, 741 S.W.2d 285 (Mo. App. 1987). The rules of the Department of Health approving methods of analysis for determining blood alcohol content are procedural and relate to the admissibility of evidence, and thus are to be applied retrospectively.

19 CSR 25-30.080 Approval of Methods for the Analysis of Blood, Saliva, and Urine for the Presence of Drugs {#sec-19-csr-25-30.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-30.080}

(Rescinded March 30, 2020)

Rescinded: Filed Oct. 1, 2019, effective March 30, 2020.

History

AUTHORITY: sections 192.006 and 577.026, RSMo 2000, and sections 306.114, 306.117, 577.020, 577.037, RSMo Supp. 2011. This rule previously filed as 19 CSR 20-30.080. Original rule filed July 15, 1988, effective Sept. 29, 1988. Changed to 19 CSR 20-30.080 Jan. 1, 1995. Emergency amendment filed May 10, 2001, effective May 22, 2001, expired Nov. 17, 2001. Amended: Filed May 10, 2001, effective Oct. 30, 2001. Amended: Filed May 31, 2012, effective Dec. 30, 2012.

Chapter 32 Milk-Testing Laboratories

19 CSR 25-32.010 State Approval of Milk-Testing Laboratories {#sec-19-csr-25-32.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-32.010}

(Rescinded May 30, 2026)

rule filed Jan. 31, 1966, effective Feb. 10, 1966. Rescinded and readopted: Filed Oct. 15, 1981, effective Feb. 11, 1982. Changed to 19 CSR 25-32.010, Jan. 1, 1995. Rescinded: Filed Nov. 3, 2025, effective May 30, 2026.

History

AUTHORITY: section 196.045, RSMo (1986). This rule was previously filed as 13 CSR 50-141.010 and 19 CSR 20-32.010. Original

Chapter 33 Laboratories for Serologic Tests for Human Immunodeficiency Virus Antibodies

19 CSR 25-33.010 Approval of Laboratories for the Performance of Serologic Tests for Human Immunodeficiency Virus Antibodies {#sec-19-csr-25-33.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-33.010}

PURPOSE: This rule establishes the procedures and requirements for laboratories performing serologic tests on serum or plasma for detection of antibodies to Human Immunodeficiency Virus in order to be approved to conduct HIV tests by the Department of Health.

PUBLISHERíS NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive.

Therefore, the material which is so incorporated is on file with the agency who filed this

rule, and with the Office of the Secretary of State. Any interested person may view this material at either agencyís headquarters or the same will be made available at the Office of the Secretary of State at a cost not to exceed actual cost of copy reproduction. The entire text of the rule is printed here. This note refers only to the incorporated by reference material.

(1) The director of a laboratory seeking Department of Health and Senior Services (DHSS) approval to perform serologic tests for detection of the Human Immunodeficiency Virus (HIV) antibodies shall make written application on form Lab 125, which is incorporated by reference, to the director, State Public Health Laboratory, DHSS.

(A) Hospitals licensed according to Chapter 197, RSMo shall be considered to be in compliance with departmental rules governing serologic tests for detection of HIV antibodies.

(B) In addition to applying for approval, the laboratory shall be in compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88). A copy of the currently valid CLIA certificate shall be initially submitted to the director, State Public Health Laboratory, DHSS to obtain DHSS approval.

(C) All laboratory testing shall be conducted at the address given when application for the approval is made. Written notice of change of address shall be given to DHSS prior to actually moving the testing facilities.

(2) DHSS shall issue a certificate of approval to a laboratory meeting the requirements of this rule. The certificate is effective until revoked.

(3) A certificate of approval may be revoked when a participating laboratory discontinues its testing services or fails to meet the requirements of CLIA 88 which relate to serologic testing for antibodies to HIV. Compliance will be monitored by Department of Health and Senior Services, Bureau of Health Facility Regulation, CLIA program.

MATTBLUNT(3/31/04)

Chapter 33óLaboratories for Serologic Tests for Human Immunodeficiency Virus Antibodies19 CSR 25-33

History

AUTHORITY: sections 191.653 and 192.006, RSMo 2000. This rule was previously filed as 19 CSR 20-33.010. Original rule filed Jan. 19, 1989, effective April 13, 1989. Rescinded and readopted: Filed Jan. 15, 1993, effective July 8, 1993. Changed to 19 CSR 25-33.010 Jan. 1, 1995. Amended: Filed Nov. 3, 2003, effective April 30, 2004. Original authority: 191.653, RSMo 1988, amended 1996; 192.006, RSMo 1993, amended 1995.

Chapter 34 Laboratories for Serologic Tests for Syphilis

19 CSR 25-34.010 Approval of Laboratories for the Performance of Serologic Tests for Syphilis on Prenatal Blood {#sec-19-csr-25-34.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-34.010}

PURPOSE: This rule deletes the requirement that test procedures for syphilis must be from the manual of tests for syphilis and allows for serologic testing by any method approved by the federal Food & Drug Administration (FDA) through compliance with CLIA 88 regulations.

Therefore, the material which is so incorporated is on file with the agency who filed this

(1) The director of a laboratory seeking Department of Health and Senior Services (DHSS) approval to perform serologic tests for syphilis on prenatal blood specimens shall make written application on form Lab 126, which is incorporated by reference, to the director, State Public Health Laboratory, DHSS.

(A) In addition to applying for approval, the laboratory shall be in compliance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88). A copy of the currently valid CLIA certificate shall be initially submitted to the director, State Public Health Laboratory, DHSS to obtain DHSS approval.

(B) All laboratory testing shall be conducted at the address given when application for the approval is made. Written notice of change of address shall be given to the DHSS prior to actually moving the testing facilities.

(2) DHSS shall issue a Certificate of Approval to a laboratory meeting the requirements of this rule. The certificate is effective until revoked.

(3) The Certificate of Approval may be revoked when a participating laboratory discontinues its testing services or fails to meet the requirements of CLIA 88 which relate to syphilis serology. Compliance with CLIA 88 will be monitored by DHSS Bureau of Health Facility Regulation, CLIA program.

Original rule filed Dec. 2, 1954, effective Jan. 1, 1955. Rescinded and readopted: Filed Dec. 7, 1981, effective April 11, 1982.

Rescinded and readopted: Filed Jan. 15, 1993, effective July 8, 1993. Changed to 19 CSR 25-34.010 Jan. 1, 1995. Rescinded and readopted: Filed Nov. 3, 2003, effective April 30, 2004. *Original authority: 192.006, RSMo 1993, amended 1995; 210.030, RSMo 1941, amended 1986, 1993, 1998, 2000.

MATTBLUNT(3/31/04)

Chapter 34óLaboratories for Serologic Tests for Syphilis19 CSR 25-34

History

AUTHORITY: sections 192.006 and 210.030, RSMo 2000. This rule was previously filed as 13 CSR 50-142.010 and 19 CSR 20-34.010.

Chapter 35 Laboratories for Serologic Tests for Hepatitis B

19 CSR 25-35.010 Approval of Laboratories for the Performance of Serologic Tests for Hepatitis B on Prenatal Blood {#sec-19-csr-25-35.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-35.010}

PURPOSE: This rule establishes uniform requirements for all laboratory approvals relating serologic tests for Hepatitis B prenatal blood.

(1) For a laboratory to be approved by the Missouri Department of Health to perform serologic tests for Hepatitis B on prenatal blood specimens, the laboratory shall have a current valid registration certificate showing compliance with the Clinical Laboratory Improvement Amendment of 1988 (CLIA 88).

rule filed Sept. 15, 1994, effective March 30, 1995. Changed to 19 CSR 25-35.010 Jan. 1, 1995. *Original authority: 192.006.1., RSMo (1993); 192.020, RSMo (1939), amended 1945, 1951; and 210.030, RSMo (1941), amended 1986, 1993.

Rebecca McDowell Cook (2/28/97)

History

AUTHORITY: sections 192.006.1., 192.020 and 210.030, RSMo (1994). This rule originally filed as 19 CSR 20-35.010. Original

Chapter 36 Testing for Metabolic Diseases

19 CSR 25-36.010 Testing for Metabolic and Genetic Disorders {#sec-19-csr-25-36.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-36.010}

PURPOSE: State law requires that all infants be tested for metabolic and genetic disorders as prescribed by the Department of Health and Senior Services. This rule establishes the collection and submission procedures to be used by health care providers in sending newborn screening specimens to the Missouri State Public Health Laboratory and establishes the fee for newborn screening.

(1) As used in this rule— (A) Newborn screening means the testing of infants for metabolic and genetic disorders pursuant to sections 191.331, 191.332, and 191.333, RSMo;

(B) Parent information sheet means the top sheet of the newborn screening specimen form that is to be detached and handed to the infant’s parent or guardian at the time of specimen collection which explains the parent’s or guardian’s options and process for opting out of the specimen storage and/or release for anonymous research pursuant to section 191.317, RSMo;

(C) Specimen storage means the five- (5-) year storage of the leftover newborn screening specimens at the Missouri State Public Health Laboratory after testing has been conducted pursuant to section 191.317, RSMo; and (D) Submitter(s) means a person or persons responsible for collecting specimens under

section 191.331, RSMo, for newborn screening tests.

(2) Submitters shall collect specimens on the newborn screening collection forms purchased from the Department of Health and Senior Services. The submitter of the specimen shall provide all information requested on the specimen collection form.

(3) Specimens shall be collected in accordance with instructions on the specimen collection form. At the time of specimen collection, the submitter shall detach the parent information sheet from the newborn screening collection form and give it to the infant’s parent or guardian. The timing of specimen collection shall be determined by the conditions specified in subsections (3)(A) through (C) below.

All specimens shall be sent within twenty-four (24) hours of collection to the Missouri State Public Health Laboratory in Jefferson City.

(A) A specimen shall be taken from all infants before being discharged from the hospital or birthing facility regardless of age. A specimen collected between twenty-four (24) and forty-eight (48) hours of age is considered optimum for newborn screening. A second, or repeat, specimen shall be required within fourteen (14) days of age if the initial specimen was collected before twenty-four (24) hours of age.

(B) Initial specimens from ill or premature infants shall be collected before a blood transfusion or between twenty-four (24) to fortyeight (48) hours of age. All ill or premature infants shall have a repeat screen collected between seven (7) to fourteen (14) days of age. All infants who are less than thirty-four (34) weeks gestational age or are less than two thousand (2000) grams at birth are recommended to have a third screen collected at twenty-eight (28) days of age.

(C) If an infant has been transferred from one hospital to another, the records shall clearly indicate if a specimen for newborn screening was collected and submitted. If no specimen was collected, the hospital the infant is transferred to shall collect a specimen and submit it within forty-eight (48) hours of the transfer.

(D) If it is discovered or highly suspected that a child has never received a newborn screen, a newborn screen is recommended regardless of the child’s age.

(4) Parents who object to testing on religious grounds shall state those objections in writing. The written objection shall be filed with the attending physician, certified nurse midwife, public health facility, ambulatory surgical center, or hospital. Upon receipt, the attending physician, certified nurse midwife, public health facility, ambulatory surgical center, or hospital shall send a copy of the written objection to the Department of Health and Senior Services, Bureau of Genetics and Healthy Childhood, PO Box 570, Jefferson City, MO 65102-0570.

(5) Parents or guardians who object to the storage or release of their child’s leftover newborn screening specimen for anonymous research shall state those objections in writing by submitting a letter to the Missouri State Public Health Laboratory Director requesting the remaining specimen to be destroyed, returned to the parents or guardians, or stored for five (5) years but not released for anonymous research. This letter shall be sent to the Missouri State Public Health Laboratory, Newborn Screening Laboratory, PO Box 570, Jefferson City, MO 65102-0570. The parents or guardians may submit this request at any point during the five- (5-) year storage process.

(6) The health care provider caring for an infant with an abnormal high-risk test result from newborn screening shall report a definitive diagnosis within thirty (30) days of the date of the diagnosis for that infant to the appropriate newborn screening contracted follow-up center as contracted by the Department of Health and Senior Services. The department shall prescribe and furnish all necessary reporting forms for this purpose.

(7) The health care provider responsible for the medical care of the infant shall provide newborn screening education to the parents or guardians. Educational materials regarding the newborn screening conducted by the state, including the disorders screened for and the management and treatment of these disorders, are made available by the Department of Health and Senior Services. The educational materials may be ordered at www.health.mo.gov/warehouse/eliterature.ht ml or by contacting the Department of Health and Senior Services’ Newborn Screening Program at 800-877-6246.

(8) Effective July, 1, 2019, a fee of up to one hundred thirty-five dollars ($135) shall be charged for each specimen collection form used to obtain a newborn screening blood specimen. If the Missouri State Public Health Laboratory determines a submitted blood specimen to be unsatisfactory for testing due to laboratory or transportation issues, then a replacement specimen collection form will be made available without the fee being imposed. The Department of Health and Senior Services may collect the fee from any entity or individual described in section 191.331.1, RSMo.

History

AUTHORITY: sections 191.331 and 192.006, RSMo 2016, and section 191.332, RSMo Supp. 2017. This rule was previously filed as

13 CSR 50-143.010 and 19 CSR 20-36.010. {#sec-13-csr-50-143.010 omnilex-key=us-mo-regs-official--title-19--13 CSR 50-143.010}

Original rule filed Sept. 29, 1965, effective Oct. 13, 1965. Amended: Filed April 6, 1967, effective April 16, 1967. Rescinded and readopted: Filed Sept. 30, 1980, effective April 11, 1981. Rescinded: Filed Aug. 1, 1986, effective Oct. 27, 1986. Readopted:

Filed Aug. 4, 1986, effective Oct. 27, 1986.

Amended: Filed March 16, 1987, effective May 28, 1987. Amended: Filed Jan. 15, 1993, effective Sept. 9, 1993. Changed to 19 CSR 25-36.010 Jan. 1, 1995. Emergency amendment filed Aug. 4, 1997, effective Aug. 28, 1997, expired Feb. 26, 1998. Amended:

Filed Aug. 4, 1997, effective Jan. 30, 1998.

Amended: Filed April 9, 2002, effective Oct. 30, 2002. Amended: Filed Feb. 1, 2005, effective July 30, 2005. Amended: Filed June 12, 2007, effective Jan. 30, 2008. Amended:

Filed Jan. 29, 2015, effective July 30, 2015.

Amended: Filed Jan. 25, 2019, effective July 30, 2019. *Original authority: 191.331, RSMo 1965, amended 1985, 1992, 1993, 1995, 1997, 2007; 191.332, RSMo 2001, amended 2005, 2016, 2017; and 192.006, RSMo 1993, amended 1995.

4CODE OF STATE REGULATIONS

(6/30/19) JOHNR. ASHCROFT

AND SENIOR SERVICES

Chapter 38 Laboratory Fees

19 CSR 25-38.010 Laboratory Handling Fees {#sec-19-csr-25-38.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-38.010}

PURPOSE: This rule establishes a charge for handling samples and specimens submitted for testing to the State Public Health Laboratory and defines those samples or specimens that are not subject to the handling fee.

(1) There shall be a charge of ten dollars ($10) for each sample or specimen submitted to the State Public Health Laboratory upon which one (1) test or a series of tests are performed, except as otherwise provided in section (2) of this rule.

(2) The following samples or specimens submitted to the State Public Health Laboratory are not subject to the handling fee:

(A) As determined by the director of the Department of Health, samples or specimens that are submitted for testing which is of vital importance to the public health;

(B) Samples or specimens for test which are part of an epidemiologic investigation, study or ongoing Department of Health disease surveillance program;

(C) Samples or specimens submitted by authorized representatives of the Department of Health, local health departments or the federal government;

(D) Samples or specimens submitted as

part of a contract or grant of which the Department of Health is a party;

(E) Specimens submitted for metabolic disease screening;

(F) Specimens submitted from other laboratories in Missouri for further testing and confirmation; and (G) Specimens from patients who are unable to pay the handling fee as certified in writing by their physician.

History

AUTHORITY: sections 192.005.2 and 192.015, RSMo 1986. This rule was previously filed as 13 CSR 50-144.010 and 19 CSR 20-38.010. Original rule filed Dec. 7, 1982, effective March 11, 1983. Rescinded and readopted: Filed July 18, 1989, effective Jan. 1, 1990. Emergency amendment filed Jan. 17, 1991, effective Feb. 1, 1991, expired May 31, 1991. Emergency amendment filed May 23, 1991, effective June 2, 1991, expired June 9, 1991. Amended: Filed Jan. 17, 1991, effective June 10, 1991. Changed to 19 CSR 25-38.010 Jan. 1, 1995. Original authority: 192.005, RSMo 1985, amended 1993 and 192.015 RSMo 1982.

19 CSR 25-38.020 Laboratory Fee for Tuberculosis Testing {#sec-19-csr-25-38.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 25-38.020}

PURPOSE: This rule establishes a fee for testing specimens for tuberculosis that are submitted to the State Public Health Laboratory.

(1) A fee of forty-eight dollars ($48) shall be charged for each clinical specimen submitted to the State Public Health Laboratory for tuberculosis testing. Clinical specimens include raw sputum samples, gastric lavage samples, urine specimens or pleural, spinal, and joint fluids, other exudates or tissue samples.

(2) The Department of Health and Senior Services (DHSS) may waive the fee for testing clinical specimens that are submitted from local public health departments or when the director of DHSS determines the specimens are of critical importance for the protection of the public health and safety.

MATTBLUNT(7/31/02)

History

AUTHORITY: section 701.322, RSMo Supp. 2001. Emergency rule filed Feb. 15, 2002, effective Feb. 26, 2002, expired Aug. 24, 2002. Original rule filed Feb. 15, 2002, effective Aug. 30, 2002. Original authority: 701.322, RSMo 1993, amended 2001.

Division 30 Division of Regulation and Licensure

Chapter 1 Controlled Substances

19 CSR 30-1.025 List of Exempt Anabolic Steroid Products {#sec-19-csr-30-1.025 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.025}

19 CSR 30-1.030 Requirements for Controlled Substances Registration {#sec-19-csr-30-1.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.030}

19 CSR 30-1.031 Physical Security Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25 {#sec-19-csr-30-1.031 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.031}

19 CSR 30-1.033 Hearing Procedures on Controlled Substances Registration {#sec-19-csr-30-1.033 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.033}

19 CSR 30-1.035 Requirements for Prescribing, Dispensing and Administering {#sec-19-csr-30-1.035 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.035}

19 CSR 30-1.036 Disposing of Unwanted Controlled Substances {#sec-19-csr-30-1.036 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.036}

19 CSR 30-1.040 Dispensing and Distribution of Controlled Substances in Certain {#sec-19-csr-30-1.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.040}

19 CSR 30-1.060 Determining Lawful Prescribing, Dispensing and Administering {#sec-19-csr-30-1.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.060}

19 CSR 30-1.062 Transmission of Prescriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33 SERVICES {#sec-19-csr-30-1.062 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.062}

19 CSR 30-1.002 Schedules of Controlled Substances {#sec-19-csr-30-1.002 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.002}

PURPOSE: The Department of Health and Senior Services has prepared a list of all drugs falling within the purview of controlled PUBLISHER’S NOTE: The secretary of state has determined that publication of the entire text of the material that is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here.

(1) Schedules of Controlled Substances.

(A) Schedule I shall consist of the drugs and other substances, name, or brand name designated, listed in this section. Each drug or substance has been assigned the Drug Enforcement Administration (DEA) Controlled Substances Code Number set forth opposite it.

Opiates. Unless specifically excepted or unless listed in another schedule, any of the following opiates, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation:

A. Acetyl-alpha-methylfentanyl (N-(1-(1-methyl-2-phenethyl)- 4-piperidinyl)-Nphenylacetamide) 9815 B. Acetylmethadol 9601 C. Acetyl fentanyl (N-(1- N-phenylacetamide) 9821 D. N-(1-phenethylpiperidin- 4-yl)-N-phenylacrylamide, its isomers, esters, ethers, names: acryl fentanyl, acryloylfentanyl) 9811 E. AH-7921(3,4-dichloro- N-[(1-dimethylamino) cyclohexylmethyl] benzamide) 9551 F. Allylprodine 9602 G. Alphacetylmethadol (except levoalphacetylmethadol also known as levo-alphaacetylmethadol levothadyl acetate or LAAM) 9603 H. Alphameprodine 9604 I. Alphamethadol 9605 J. alpha′-Methyl butyryl fentanyl (2-methyl-N-(1-phenethylpiperidin- 4-yl)-N-phenylbutanamide) 9864 K. Alpha-methylfentanyl (N-1-(alphamethyl-betaphenyl) ethyl-4-piperidyl) propionanilide; 1-(1-methyl- 2-phenylethyl)-4 ((Npropanilido) piperidine) 9814 L. Alpha-methylthiofentanyl (N-(1-methyl-2-(2-thienyl) ethyl-4-piperidinyl)-Nphenylpropanamide) 9832 M. Benzethidine 9606 N. Betacetylmethadol 9607 O. Beta-hydroxyfentanyl (N-(1-(2-hydroxy-2phenethyl)-4-piperidinyl)- N-phenylpropanamide) 9830 P. Beta-hydroxy-3methylfentanyl (other name:

N-(1-(2-hydroxy-2-phenethyl)- 3-methyl-4-piperidinyl)-Nphenylpropanamide) 9831 Q. N-[1-[2-hydroxy-2-(thiophen- 2-yl) ethyl]piperidin-4-yl]- N-phenylpropionamide beta-hydroxythiofentanyl) 9836 R. Betameprodine 9608 S. Betamethadol 9609 T. beta-Methyl fentanyl (N-phenyl-N-(1-(2phenylpropyl)piperidin-4-yl) propionamide (Other name: β-methyl fentanyl) 9856 U. beta-methylacetyl fentanyl (N-phenyl-N-(1-(2phenylpropyl)piperidin- 4-yl)acetamide) 9868 V. beta′-Phenyl fentanyl (N-(1-phenethylpiperidin-4-yl)- N,3-diphenylpropanamide (other names: β′-phenyl fentanyl; 3-phenylpropanoyl Fentanyl) 9842 W. Betaprodine 9611 X. Brorphine (1-(1-(1-(4-bromophenyl) ethyl)piperidin-4-yl)-1,3-dihydro-2Hbenzo[d]imidazol-2-one) 9098 Y. Butonitazene (2-(2-(4-butoxybenzyl)- 5-nitro-1H-benzimidazol-1-yl)- N,N-diethylethan-1-amine 9751 Z. Butyryl fentanyl (N- (1-phenethylpiperidin-4-yl)- N-phenylbutyramide) 9822 AA. Clonitazene 9612 BB. Crotonyl fentanyl ((E)-N-(1phenethylpiperidin-4-yl)-Nphenylbut-2-enamide) 9844 CC. N-(1-phenethylpiperidin- 4-yl)-N- Phenylcyclopentanecarboxamide (other name: cyclopentyl fentanyl) 9847 DD. Cyclopropyl fentanyl (N-(1phenethylpiperidin-4-yl)-Nphenylcyclopropanecarboxamide) 9845 EE. Dextromoramide 9613 F F. Diampromide 9615 GG. Diethylthiambutene 9616 HH. Difenoxin 9168 II. Dimenoxadol 9617 JJ. Dimepheptanol 9618 KK. 2′,5′-Dimethoxyfentanyl (N-(1-(2,5-dimethoxyphenethyl) piperidin-4-yl)-Nphenylpropionamide) 9861 LL. Dimethylthiambutene 9619 MM. Dioxaphetyl butyrate 9621 NN. Dipipanone 9622 OO. Ethylmethylthiambutene 9623 P P. 2-(2-(4-ethoxybenzyl)-1Hbenzimidazol-1-yl)-N, Ndiethylethan-1-amine (other names: etodesnitazene; etazene) 9765 QQ. Etonitazene 9624 RR. Etoxeridine 9625 SS. Fentanyl carbamate (ethyl (phenyl)carbamate) 9851 T T. Flunitazene (N,N-diethyl-2- (2-(4-fluorobenzyl)-5-nitro-1Hbenzimidazol-1-yl)ethan-1-amine) 9756 UU. N-(4-fluorophenyl)-N- (1-phenethylpiperidin-4yl)isobutyramide, its isomers, esters, ethers, names: 4-fluoroisobutyryl fentanyl, parafluoroisobutyryl fentanyl) 9824 V V. 2′-Fluoro orthofluorofentanyl (N-(1-(2fluorophenethyl) piperidin- 4-yl)-N-(2-fluorophenyl) propionamide (other names: 2′-fluoro 2-fluorofentanyl) 9855 W W. N-(1-phenethylpiperidin- 4-yl)-N-phenylfuran-2carboxamide (other names: furanyl fentanyl) 9834 XX. 3-Furanyl fentanyl (N- (1-phenethylpiperidin-4-yl)-Nphenylfuran-3-carboxamide) 9860 Y Y. Furethidine 9626 ZZ. Hydroxypethidine 9627 AAA. N-(1-phenethylpiperidin- 4-yl)-N-phenylisobutyramide (other name: isobutyryl fentanyl) 9827 BBB. Isotonitazene (N,N-diethyl-2-(2- (4-isopropoxybenzyl)-5-nitro- 1H-benzimidazol-1-yl) ethan-1-amine) 9614 CCC. Isovaleryl fentanyl (3-methyl- N-(1-phenethylpiperidin-4-yl)- N-phenylbutanamide) 9862 DDD. Ketobemidone 9628 EEE. Levomoramide 9629 FFF. Levophenacylmorphan 9631 GGG. meta-Fluorofentanyl (N- (3-fluorophenyl)-Npropionamide) 9857 HHH. meta-fluorofuranyl fentanyl (N-(3fluorophenyl)-N-(1-phenethylpiperidin- 4-yl)furan-2-carboxamide) 9871 III. meta-Fluoroisobutyryl fentanyl (N-(3-fluorophenyl)-Nisobutyramide) 9858 JJJ. Methoxyacetyl fentanyl (2-methoxy-N-(1- N-phenylacetamide 9825 KKK. 2-Methyl AP–237 (1-(2-methyl- 4-(3-phenylprop-2-en-1-yl) piperazin-1-yl)butan-1-one) 9664 LLL. 4′-Methyl acetyl fentanyl (N-(1-(4-methylphenethyl) piperidin-4-yl)-Nphenylacetamide) 9819 MMM. 3-Methylfentanyl (N-(3methyl-1-(2-phenylethyl)-4piperidyl)-Nphenylproanamide), its optical and geometric isomers, salts, and salts of isomers 9813 NNN. 3-Methylthiofentanyl (N- (3-methyl-1-(2thienyl)ethyl-4-piperidinyl)- N-phenylpropanamide) 9833 OOO. Metodesnitazene (N,N-diethyl-2-(2- (4-methoxybenzyl)-1Hbenzimidazol-1-yl) ethan-1-amine) 9764 PPP. Metonitazene (N,N-diethyl- 2-(2-(4-methoxybenzyl)-5-nitro-1Hbenzimidazol-1-yl)ethan-1-amine) 9757 QQQ. Morpheridine 9632 RRR. MPPP (1-methyl-4-phenyl-4propionoxypiperidine) 9661 SSS. MT–45 (1-cyclohexyl- 4-(1,2-diphenylethyl) piperazine) (9560)

TTT. Noracymethadol 9633 UUU. Norlevorphanol 9634 VVV. Normethadone 9635 WWW. Norpipanone 9636 XXX. 2-(4-ethoxybenzyl)-5-nitro-1- (2-(pyrrolidin-1-yl)ethyl)-1H- Benzimidazole (other names:

N-pyrrolidino etonitazene; etonitazepyne) 9758 YYY. N-(2-fluorophenyl)-2-methoxy-N-(1yl)acetamide, its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers (other name: ocfentanil) 9838 ZZZ. ortho-chlorofentanyl (N-(2chlorophenyl)-N-(1-phenethylpiperidin- 4-yl)propionamide 9828 AAAA. ortho-Fluoroacryl fentanyl (N-(2acrylamide) 9852 BBBB. ortho-Fluorobutyryl fentanyl (N-(2-fluorophenyl)-N-(1butyramide (other name: 2-fluorobutyryl fentanyl) 9846 CCCC. ortho-Fluorofentanyl (N-(2propionamide); other name: 2-fluorofentanyl) 9816 DDDD. ortho-Fluorofuranyl fentanyl (N-(2-fluorophenyl)furan-2-carboxamide) 9863 EEEE. ortho-Fluoroisobutyryl fentanyl (N-(2yl)isobutyramide) 9853 FFFF. ortho-Methyl acetylfentanyl (N-(2-methylphenyl)-N-(1acetamide (other name: 2-methyl acetylfentanyl) 9848 GGGG. ortho-methylcyclopropyl fentanyl (N-(2-methylphenyl)-N- (1-phenethylpiperidin- 4-yl) cyclopropanecarboxamide) 9849 HHHH. ortho-Methyl methoxyacetyl fentanyl (2-methoxy-N-(2methylphenyl)-N-(1acetamide (other name: 2-methyl methoxyacetyl fentanyl) 9820 IIII. N-(4-chlorophenyl)-N- (1-phenethylpiperidin- 4-yl)isobutyramide (other name: parachloroisobutyryl fentanyl) 9826 JJJJ. para-chlorofentanyl (N-(4chlorophenyl)-N-(1-phenethylpiperidin- 4-yl)propionamide) 9818 KKKK. para-Fluorobutyryl yl)butyramide) 9823 LLLL. para-Fluorofentanyl(N- (4-fluorophenyl)-N-(1-(2phenethyl)-4-piperidinyl) propanamide 9812 MMMM. para-Fluoro furanyl yl)furan-2-carboxamide) 9854 NNNN. para-fluoro valeryl fentanyl (N- (4-fluorophenyl)-N-(1-phenethylpiperidin- 4-yl)pentanamide) 9870 OOOO. para-Methoxybutyryl methoxyphenyl)-N-(1butyramide) 9837 PPPP. para-Methoxyfuranyl fentanyl (N-(4-methoxyphenyl)furan-2-carboxamide 9859 QQQQ. para-Methylcyclopropyl fentanyl (N-(4-methylphenyl)cyclopropanecarboxamide) 9865 RRRR. para-Methylfentanyl (N-(4-methylphenyl)-Npropionamide (other name: 4-methylfentanyl) 9817 SSSS. PEPAP (1-(-2-phenethyl)- 4-phenyl-4-acetoxypiperidine) 9663 TTTT. Phenadoxone 9637 UUUU. Phenampromide 9638 VVVV. Phenomorphan 9647 WWWW. Phenoperidine 9641 XXXX. Phenyl fentanyl (N-(1- N-phenylbenzamide (other name: benzoyl fentanyl) 9841 YYYY. Piritramide 9642 ZZZZ. Proheptazine 9643 AAAAA. Properidine 9644 BBBBB. Propiram 9649 CCCCC. N, N-diethyl-2-(5-nitro-2- (4-propoxybenzyl)-1H-benzimidazol- 1-yl)ethan-1-amine (other name:

Protonitazene) 9759 DDDDD. Racemoramide 9645 EEEEE. N-(1-phenethylpiperidin-4-yl)- N-phenyltetrahydrofuran- 2-carboxamide, its isomers, esters, ethers, name: tetrahydrofuranyl fentanyl) 9843 FFFFF. tetrahydrothiofuranyl fentanyl (also known as: tetrahydrothiophene fentanyl) (N-(1-phenethylpiperidin-4-yl)- N-phenyltetrahydrothiophene-2carboxamide) 9869 GGGGG. Thiofentanyl (N-phenyl- N-(1-(2-thienyl)ethyl-4piperidinyl)-propanamide 9835 HHHHH. Thiofuranyl fentanyl (N-(1-phenethylpiperidin- 4-yl)-N-phenylthiophene- 2-carboxamide (other names: 2-thiofuranyl fentanyl; thiophene fentanyl) 9839 IIIII. Tilidine 9750 JJJJJ. Trimeperidine 9646 KKKKK. U–47700 (3,4-Dichloro- N-[2-(dimethylamino) cyclohexyl]-Nmethylbenzamide) 9547 LLLLL. N-(1-phenethylpiperidin- 4-yl)-N-phenylpentanamide (other name: valeryl fentanyl) 9840 MMMMM. Zipeprol (1-methoxy-3-[4- (2-methoxy-2-phenylethyl) piperazin-1-yl]-1-phenylpropan-2-ol) 9873 2. Opium derivatives. Unless specifically excepted or unless listed in another schedule, any of the following opium derivatives, its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

A. Acetorphine 9319 B. Acetyldihydrocodeine 9051 C. Benzylmorphine 9052 D. Codeine methylbromide 9070 E. Codeine-N-Oxide 9053 F. Cyprenorphine 9054 G. Desomorphine 9055 H. Dihydromorphine 9145 I. Drotebanol 9335 J. Etorphine (except hydrochloride salt) 9056 K. Heroin 9200 L. Hydromorphinol 9301 M. Methyldesorphine 9302 N. Methyldihydromorphine 9304 O. Morphine methylbromide 9305 P. Morphine methylsulfonate 9306 Q. Morphine-N-Oxide 9307 R. Myrophine 9308 S. Nicocodeine 9309 T. Nicomorphine 9312 U. Normorphine 9313 V. Pholcodine 9314 W. Thebacon 9315 3. Hallucinogenic substances. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture or preparation which contains any quantity of the following hallucinogenic substances or which contains any of its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation (For purposes of paragraph (1)(A)3. of this rule only, the term isomer includes the optical, position, and geometric isomers.):

A. Alpha-ethyltryptamine 7249 Some trade or other names: etryptamine; Monase; alpha-ethyl- 1H-indole-3-ethenamine; 3-(2-aminobutyl)indole; alpha-ET; and AET;

B. 4-bromo-2,5-dimethoxyamphetamine 7391 Some trade or other names: 4-bromo-2, 5- dimethoxy-amethylphenethylamine; 4-bromo- 2, 5-DMA;

C. 4-bromo-2,5-dimethoxyphenethylamine 7392 D. 2,5-dimethoxyamphetamine 7396 Some trade or other names: 2,5-dimethoxyamethylphenethylamine; 2,5-DMA;

E. 2,5-dimethoxy-4-ethylamphetamine 7399 Some trade or other names: DOET;

F. 2,5-dimethoxy-4-(n)-propylthiophenethylamine (other name: 2C-T-7) 7348 G. 2-(2,5-Dimethoxy-4-(n)-propylphenyl) ethanamine (2C-P) 7524 H. 2-(2,5-Dimethoxy-4-ethylphenyl) ethanamine (2C-E) 7509 I. 2-(2,5-Dimethoxy-4-methylphenyl) ethanamine (2C-D) 7508 J. 2-(2,5-Dimethoxy-4-nitrophenyl) ethanamine (2C-N) 7521 K. 2-(2,5-Dimethoxyphenyl) ethanamine (2C-H) 7517 L. 2-(4-Chloro-2,5-dimethoxyphenyl) ethanamine (2C-C) 7519 M. 2-(4-Ethylthio-2,5-dimethoxyphenyl) ethanamine (2C-T-2) 7385 N. 2-(4-Iodo-2,5-dimethoxyphenyl) ethanamine (2C-I) 7518 O. 2-(4-Isopropylthio)-2,5-dimethoxyphenyl) ethanamine (2C-T-4) 7532 P. 4-methoxyamphetamine 7411 Some trade or other names: 4-methoxy-amethylphenethylamine; paramethoxyamphetamine; PMA;

Q. 5-methoxy-3,4methylenedioxyamphetamine 7401 R. 4-methyl-2,5-dimethoxyamphetamine 7395 Some trade and other names: 4-methyl-2, 5- dimethoxy-amethylphenethylamine; DOM; and STP;

S. 3,4-methylenedioxyamphetamine 7400 T. 3,4-methylenedioxymethamphetamine(MDMA) 7405 U. 3,4-methylenedioxy-Nethylamphetamine (also known as N-ethylalphamethyl-3,4 (methylenedioxy) phenethylamine, N-ethyl MDA, MDE, and MDEA) 7404 V. N-hydroxy-3,4methylenedioxyamphetamine (also known as N-hydroxyalpha-methyl-3,4 (methylenedioxy) phenethylamine and Nhydroxy MDA) 7402 W. 3,4,5-trimethoxyamphetamine 7390 X. 5-MeO-DMT or 5-methoxy- N,N-dimethyltryptamine 7431 Y. Alpha-methyltryptamine 7432 Z. Bufotenine 7433 Some trade and other names: 3-(b-Dimethylaminoethyl)- 5-hydroxyindole; 3-(2-dimethylaminoethyl)-5-indolol; N, N-dimethylserotonin; 5-hydroxy-N, N-dimethyltryptamine; mappine;

AA. Diethyltryptamine 7434 Some trade and other names: N, N-Diethyltryptamine; DET;

BB. Dimethyltryptamine 7435 Some trade or other names: DMT;

CC. 5-methoxy-N,N-diisopropyltryptamine (other name: 5-MeODIPT) 7439 DD. Ibogaine 7260 Some trade and other names: 7-Ethyl- 6,6β,7,8,9,10,12,13octahydro-2-methoxy-6, 9-methano-5H-pyrido [1’,2’:1,2] azepino[5,4-b] indole; Tabernanthe iboga;

EE. Lysergic acid diethylamide 7315 FF. Marihuana 7360 Some trade or other names: marijuana;

GG. Mescaline 7381 HH. Parahexyl 7374 Some trade or other names: 3-Hexyl-1- hydroxy-7,8,9,10tetrahydro-6,6,9-trimethyl-6H-dibenzo[b,d]pyran; Synhexyl;

II. Peyote 7415 Meaning all parts of the plant presently classified botanically as Lophophora williamsii Lemaire, whether growing or not; the seeds thereof; any extract from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds, or extracts;

JJ. N-ethyl-3-piperidyl benzilate 7482 KK. N-methyl-3-piperidyl benzilate 7484 LL. Psilocybin 7437 MM. Psilocyn 7438 NN. Tetrahydrocannabinols naturally contained in a plant of the genus Cannabis (cannabis 7370 plant), as well as synthetic equivalents of the substances contained in the cannabis plant or in the resinous extractives of such plant, and/or synthetic substances, derivatives, and their isomers, or both, with similar chemical structure and pharmacological activity to those substances contained in the plant, such as the following:

(I) 1 cis or trans tetrahydrocannabinol and their optical isomers;

(II) 6 cis or trans tetrahydrocannabinol and their optical isomers;

(III) 3,4 cis or trans tetrahydrocannabinol and its optical isomers; and (IV) Since nomenclature of these substances is not internationally standardized, compounds of these structures, regardless of numerical designation of atomic positions are covered;

OO. Ethylamine analog of phencyclidine 7455 Some trade or other names: N-ethyl-1- phenylcyclohexylamine, (1-phenylcyclohexyl) ethylamine, N-(1-phenylcyclohexyl)ethylamine, cyclohexamine, PCE;

PP. Pyrrolidine analog of phencyclidine 7458 Some trade or other names: 1-(1-phenylcyclohexyl)-pyrrolidine PCPy, PHP;

QQ. Thiophene analog of phencyclidine 7470 Some trade or other names: 1-(1-(2-thienyl)- cyclohexyl)piperidine, 2-thienyl analog of phencyclidine, TPCP, TCP;

RR. 1-(1-(2-thienyl)cyclohexyl) pyrrolidine 7473 Some other names: TCPy;

SS. Salvia divinorum TT. Salvinorin A UU. 3-Fluoromethcathinone 1233 VV. 4-Fluoromethcathinone 1238 WW. Mephedrone, or 4methylmethcathinone 1248 XX. Methylenedioxypyrovalerone, MDPV, or (1-(1,3-Benzodioxol-5-yl)- 2-(1-pyrrolidinyl)-1pentanone 7535 YY. Methylone, or 3,4- Methylenedioxymethcathinone 7540 ZZ. Quinolin-8-yl 1-pentyl- 1Hindole-3-carboxylate (PB-22; QUPIC) 7222 AAA. Quinolin-8-yl 1-(5fluoropentyl)-1H-indole- 3-carboxylate (5-fluoro- PB-22; 5F-PB-22) 7225 BBB. N-(1-amino-3-methyl-1oxobutan-2-yl)-1- (4-fluorobenzyl)-1Hindazole- 3-carboxamide (AB-FUBINACA) 7012 CCC. N-(1-amino-3, 3-dimethyl-1oxobutan-2-yl)-1-pentyl- (ADB-PINACA) 7035 DDD. (1-pentyl-1H-indol-3-yl)

(2,2,3,3-tetramethylcyclopropyl) methanone (other names:

UR-144, 1-pentyl-3-(2,2,3,3tetramethylcyclopropoyl)indole) 7144 EEE. 1-(5-fluoro-pentyl)- 1Hindol-3-yl methanone (other names: 5-fluoro-UR-144, 5-F-UR- 144, XLR11, 1-(5-fluoropentyl)-3-(2,2,3,3tetramethylcyclopropoyl)indole) 7011 FFF. N-(1-adamantyl)-1-pentyl- 1Hindazole-3-carboxamide (other names: APINACA, AKB48) 7048 GGG. 2-(4-iodo-2,5- (other names: 251-NBOMe; 2C-I- NBOMe; 25I; Cimbi-5) 7538 HHH. 2-(4-chloro-2,5- (other names: 25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) 7537 III. 2-(4-bromo-2,5- (other names: 25B- NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) 7536 JJJ. 4-methyl-N-ethylcathinone (other names: 4-MEC; 2- (ethylamino)-1-(4methylphenyl)propan-1-one) 1249 KKK. 4-methyl-alphapyrrolidinopropiophenone, (other names: 4-MePPP;

MePPP; 4-methyl- α-pyrrolidinopropiophenone; 1-(4-methylphenyl)-2- (pyrrolidin-1-yl)-propan-1-one) 7498 LLL. alphapyrrolidinopentiophenone (other names: α-PVP; αpyrrolidinovalerophenone; 1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one) 7545 MMM. Butylone (other names: bk-MBDB; 1-(1,3- (methylamino)butan-1-one) 7541 NNN. Pentedrone (other names: αmethylaminovalerophenone; 2-(methylamino)-1-phenylpentan-1-one) 1246 OOO. Pentylone (other names: bk-MBDP; 1-(1,3- (methylamino)pentan-1-one) 7542 PPP. Naphyrone naphthylpyrovalerone; 1- (naphthalen-2-yl)-2- (pyrrolidin-1-yl)pentan-1-one) 1258 QQQ. alpha-pyrrolidinobutiophenone (other names: α-PBP; 1-phenyl-2-(pyrrolidin-1-yl)butan-1-one) 7546 RRR. N-(1-amino-3-methyl-1oxobutan-2-yl)-1- (cyclohexylmethyl)- (other names: AB-CHMINACA) 7031 SSS. N-(1-amino-3-methyl-1oxobutan-2-yl)-1-pentyl- 1Hindazole-3-carboxamide AB-PINACA) 7023 TTT. [1-(5-fluoropentyl)- 1H-indazol-3-yl](naphthalen- 1-yl)methanone (other names: THJ-2201) 7024 UUU. N-(1-amino-3,3-dimethyl- 1-oxobutan-2-yl)-1- (cyclohexylmethyl)- (other names: MAB- CHMINACA; ADB-CHMINACA) 7032 VVV. methyl 2-(1-(5-fluoropentyl)dimethylbutanoate (other names:

5F–ADB; 5F–MDMB–PINACA) 7034

WWW. methyl 2-(1-(5-fluoropentyl)- 1H-indazole-3-carboxamido)-3- (other names: 5F–AMB) 7033 XXX. N-(adamantan-1-yl)-1-(5fluoropentyl)-1H-indazole- 3-carboxamide (other names: 5F–APINACA, 5F–AKB48) 7049 YYY. N-(1-amino-3,3-dimethyl- 1-oxobutan-2-yl)-1-(4fluorobenzyl)-1H-indazole- 3-carboxamide (other names: ADB–FUBINACA) 7010 ZZZ. methyl 2-(1-(cyclohexylmethyl)- 1H-indole-3-carboxamido)-3,3- (other names: MDMB–CHMICA, MMB–CHMINACA) 7042 AAAA. methyl 2-(1-(4-fluorobenzyl)- (other names: MDMB–FUBINACA) 7020 BBBB. methyl 2-(1-(4-fluorobenzyl)-1Hindazole-3-carboxamido)-3- (other names: FUB–AMB, MMB– FUBINACA, AMB–FUBINACA) (7021)

CCCC. 1-(1,3-benzodioxol- 5-yl)-2-(ethylamino) propan-1-one (ethylone) 7547 DDDD. Naphthalen-1-yl 1- (5-fluoropentyl)-1Hindole-3-carboxylate NM2201; CBL2201) 7221 EEEE. N-(1-amino-3-methyl- 1-oxobutan-2-yl)-1- (5-fluoropentyl)-1H- (other name: 5F-AB-PINACA) 7025 FFFF. 1-(4-cyanobutyl)-N-(2phenylpropan-2-yl)-1H- (other names: 4-CN- CUMYLBUTINACA; 4-cyano-CUMYL- BUTINACA; 4-CN- CUMYLBINACA;

CUMYL-4CNBINACA; SGT-78) 7089

GGGG. methyl 2-(1-(cyclohexylmethyl)-1Hindole-3-carboxamido)-3- (other names: MMB- CHMICA; AMB-CHMICA) 7044 HHHH. 1-(5-fluoropentyl)-N- (2-phenylpropan-2-yl)- 1H-pyrrolo[2,3-b] pyridine-3-carboxamide (other name: 5F-CUMYL-P7AICA) 7085 IIII. N-ethylpentylone (other names: ephylone, 1-(1,3- (ethylamino)-pentan-1-one) 7543 JJJJ. methyl 2-(1-(4-fluorobutyl)- 1H-indazole-3-carboxamido)-3, 3-dimethylbutanoate (4F–MDMB–BINACA, 4F–MDMB–BUTINACA) 7043 KKKK. 1-(4-methoxyphenyl)-Nmethylpropan-2-amine (other names: paramethoxymethamphetamine, PMMA) 1245 LLLL. ethyl 2-(1-(5-fluoropentyl)- (other name: 5F-EDMB-PINACA) 7036 MMMM. methyl 2-(1-(5-fluoropentyl)- 1H-indole-3-carboxamido)-3,3- Dimethylbutanoate (other names:

5F-MDMB-PICA; 5F-MDMB-2201) 7041

NNNN. N-(adamantan-1-yl)-1-(4fluorobenzyl)-1H-indazole-3carboxamide (other names:

FUB-AKB48; FUB-APINACA;

AKB48 N-(4-FLUOROBENZYL)) 7047

OOOO. 1-(5-fluoropentyl)-N-(2phenylpropan-2-yl)-1Hindazole-3-carboxamide (other names:

5F-CUMYL-PINACA; SGT-25) 7083

PPPP. (1-(4-fluorobenzyl)-1Hindol-3-yl)(2,2,3,3-tetramethylcyclopropyl) methanone (other name: FUB-144) 7014 QQQQ. N-Ethylhexedrone (other names: α-ethylaminohexanophenone; 2- (ethylamino)-1-phenylhexan-1-one) 7246 RRRR. alpha-Pyrrolidinohexanophenone (other names: α-PHP; αpyrrolidinohexanophenone; 1-phenyl-2-(pyrrolidin-1-yl)hexan-1-one) 7544 SSSS. 4-Methyl-alpha-ethylaminopentiophenone (other names: 4-MEAP; 2-(ethylamino)-1- (4-methylphenyl)pentan-1-one) 7245 TTTT. 4′-Methyl-alpha-pyrrolidinohexiophenone (other names: MPHP; 4′-methylalpha-pyrrolidinohexanophenone; 1- (4-methylphenyl)-2-(pyrrolidin-1-yl)hexan- 1-one) 7446 UUUU. alpha-Pyrrolidinoheptaphenone (other names: PV8; 1-phenyl-2- (pyrrolidin-1-yl)heptan-1-one) 7548 VVVV. 4′-Chloro-alpha-pyrrolidinovalerophenone (other names: 4-chloro-α-PVP; 4′-chloro-αpyrrolidinopentiophenone; 1-(4chlorophenyl)-2-(pyrrolidin-1-yl) pentan- 1-one) 7443 WWWW. 2-(ethylamino)-2- (3-methoxyphenyl)cyclohexan- 1-one (methoxetamine, MXE) 7286 XXXX. 1-(1,3-benzodioxol-5-yl)-2-9 (ethylamino)butan-1-one (other names: eutylone; bk-EBDB) 7549 YYYY. N-(1-amino-3,3-dimethyl-1oxobutan-2-yl)-1-butyl-1H- (other name: ADB–BUTINACA) 7027 ZZZZ. 4-methyl-1-phenyl-2- (pyrrolidin-1-yl)pentan-1-one (other names: α-PiHP; alpha-PiHP) 7551 AAAAA. 2-(methylamino)-1-(3methylphenyl)propan-1-one (other names: 3–MMC; 3-methylmethcathinone) 1259 BBBBB. 1-(1,3-benzodioxol-5-yl)-2- (dimethylamino)pentan-1-one (other names: dipentylone;

N,N-dimethylpentylone) 7552 CCCCC. Synthetic cannabinoids: Unless specifically exempted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances, or which contains their salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

(I) Any compound structurally derived from 3-(1-naphthoyl)indole or 1Hindol-3-yl-(1-naphthyl)methane by substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group, whether or not further substituted in the indole ring to any extent, whether or not substituted in the naphthyl ring to any extent. Including, but not limited to— (a) AM2201, or 1-(5-fluoropentyl)-3- (1-naphthoyl)indole 7201 (b) JWH-007, or 1-pentyl-2-methyl- 3-(1-naphthoyl)indole (c) JWH-015, or 1-propyl-2-methyl-3-(1- (d) JWH-018, or 1-pentyl- 3-(1-naphthoyl)indole 7118 (e) JWH-019, or 1-hexyl- 3-(1-naphthoyl)indole 7019 (f) JWH-073, or 1-butyl- 3-(1-naphthoyl)indole 7173 (g) JWH-081, or 1-pentyl-3-(4-methoxy-1naphthoyl)indole 7081 (h) JWH-098, or 1-pentyl-2-methyl-3-(4methoxy-1-naphthoyl)indole (i) JWH-122, or 1-pentyl-3-(4-methyl-1naphthoyl)indole 7122 (j) JWH-164, or 1-pentyl-3-(7-methoxy-1- (k) JWH-200, or 1-(2-(4-(morpholinyl)ethyl))- 3-(1-naphthoyl)indole 7200 (l) JWH-210, or 1-pentyl-3-(4-ethyl-1- (m) JWH-398, or 1-pentyl-3-(4-chloro-1naphthoyl)indole 7398 (II) Any compound structurally derived from 3-(1-naphthoyl)pyrrole by substitution at the nitrogen atom of the pyrrole ring by alkyl, haloalkyl, alkenyl, substituted in the pyrrole ring to any extent, whether or not substituted in the naphthyl ring to any extent;

(III) Any compound structurally derived from 1-(1-naphthylmethyl)indene by substitution at the 3-position of the indene ring by alkyl, haloalkyl, alkenyl, substituted in the indene ring to any extent, whether or not substituted in the naphthyl ring to any extent;

(IV) Any compound structurally derived from 3-phenylacetylindole by substitution at the nitrogen atom of the indole ring with alkyl, haloalkyl, alkenyl, substituted in the indole ring to any extent, whether or not substituted in the phenyl ring to any extent. Including, but not limited to— (a) JWH-201, or 1-pentyl-3-(4methoxyphenylacetyl)indole (b) JWH-203, or 1-pentyl-3-(2-chlorophenylacetyl)indole 7203 (c) JWH-250, or 1-pentyl- 3-(2-methoxypheny-lacetyl)indole 6250 (d) JWH-251, or 1-pentyl-3-(2methylphenylacetyl)indole (e) RCS-8, or 1-(2-cyclohexylethyl)-3-(2methoxypheny-lacetyl)indole 7008 (V) Any compound structurally derived from 2-(3-hydroxycyclohexyl)phenol by substitution at the 5-position of the phenolic ring by alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl) methyl or 2-(4-morpholinyl)ethyl group, whether or not substituted in the cyclohexyl ring to any extent. Including, but not limited to— (a) CP 47,497 and homologues, or 2-[(1R,3S)-3hydroxycyclohexyl]-5-(2-methyloctan-2-yl)phenol), where side chain n=5, and homologues where side chain n-4, 6, or 7 7297, 7298 (VI) Any compound containing a 3- (benzoyl)indole structure with substitution at the nitrogen atom of the indole ring by alkyl, haloalkyl, alkenyl, cycloalkylmethyl, cycloalkylethyl, 1-(N-methyl-2-piperidinyl)methyl or 2-(4-morpholinyl)ethyl group, whether or not further substituted in the indole ring to any extent and whether or not substituted in the phenyl ring to any extent. Including, but not limited to— (a) AM-694, or 1-(5-fluoropentyl)-3-(2iodobenzoyl)indole 7694 (b) RCS-4, or 1-pentyl-3-(4methoxybenzoyl)indole (SR-19 and RCS-4) 7104 (VII) CP 50,556-1, or [(6S,6aR,9R,10aR)-9-hydroxy-6methyl-3-[(2R)-5-phenylpentan-2-yl]oxy-5,6,6a,7,8,9,10,10aoctahydrophenanthridin- 1-yl] acetate;

(VIII) HU-210, or (6aR,10aR)-9-(hydroxymethyl)-6,6dimethyl-3-(2-methyloctan-2-yl)-6a,7,10,10a-tetrahydrobenzo[c] chromen-1-ol;

(IX) HU-211, or Dexanabinol,(6aS,10aS)-9- (hydroxymethyl)- 6,6-dimethyl-3-(2-methyloctan-2-yl)- 6a,7,10,10a-tetrahydrobenzo[c]chromen-1-ol;

(X) Dimethylheptylpyran, or DMHP.

Depressants. Unless specifically excepted or unless listed in another schedule, any material compound, mixture, system, including its salts, isomers, and salts of isomers A. Gamma-hydroxybutyric acid and other names GHB; gamma-hydroxybutyrate; 4-hydroxybutyrate; 4-hydroxybutonic acid; sodium oxybate; sodium oxybutryrate 2010 B. Mecloqualone 2572 C. Methaqualone 2565 5. Stimulants. Unless specifically excepted or unless listed system, including its salts, isomers, and salts of isomers:

A. Amineptine (7-[(10,11-dihydro-5Hdibenzo[a,d]cyclohepten-5-yl)amino] heptanoic acid) 1219 B. Aminorex 1585 Some trade or other names: aminoxaphen; 2-amino-5-phenyl- 2-oxazoline; 4,5-dihydro-5-phenyl-2-oxazolamine;

C. N-benzylpiperazine (some other names: BZP, 1-benzylpiperzaine) 7493 D. Cathinone (Some trade or other names: 2-amino-1phenyl-1-propanone, alphaaminopropiophenone, 2-aminopropiophenone and norephedrone) 1235 E. 4,4′-Dimethylaminorex (4,4′-DMAR; 4,5-dihydro-4methyl-5-(4-methylphenyl)-2oxazolamine; 4-methyl-5-(4methylphenyl)-4,5-dihydro- 1,3-oxazol-2-amine) 1595 F. Ethylphenidate (ethyl 2-phenyl- 2-(piperidin-2-yl)acetate) 1727 G. Fenethylline 1503 H. Mesocarb (N-phenyl-N′-(3- (1-phenylpropan-2-yl)-1,2,3-oxadiazol- 3-ium-5-yl)carbamimidate) 1227 I. Methcathinone 1237 Some trade or other names: 2-(methylamino)-propiophenone; alpha-(methylamino) propiophenone; 2-(methylamino)-1phenylpropan-1-one; alpha-N-methylaminopropiophenone; monomethylpropion; ephedrone; N-methylcathinone; methylcathinine; AL-464; AL-422; AL-463 and URI 432;

J. Methiopropamine (N-methyl-1- (thiophen-2-yl)propan-2-amine) 1478 K. 4-methoxymethcathinone L. cis-4-methylaminorex (cis-4,5-dihydro-4-methyl- 5-phenyl-2-oxazolamine) 1590 M. 4-Methyl-alphapyrrolidinobutiophenone, or MPBP N. N-ethylamphetamine 1475 O. N,N-dimethylamphetamine 1480 (some other names: N,N-alpha-trimethylbenzeneethanamine;

N,N-alpha-trimethylphenethylamine)

A temporary listing of substances subject to emergency scheduling under federal law shall include any material, compound, mixture, or preparation which contains any quantity of the following substances:

A. Fentanyl-related substances, their isomers, esters, ethers, esters, and ethers. 9850 (I) Fentanyl-related substance means any substance not otherwise listed under another Administration Controlled Substance Code Number, and for which no exemption or approval is in effect under section 505 of the Federal Food, Drug, and Cosmetic Act 21 U.S.C. 355, that is structurally related to fentanyl by one (1) or more of the following modifications:

(a) Replacement of the phenyl portion of the phenethyl group by any monocycle, whether or not further substituted in or on the monocycle;

(b) Substitution in or on the phenethyl group with alkyl, alkenyl, alkoxyl, hydroxyl, halo, haloalkyl, amino, or nitro groups;

(c) Substitution in or on the piperidine ring with alkyl, alkenyl, alkoxyl, ester, ether, hydroxyl, halo, haloalkyl, amino, or nitro groups;

(d) Replacement of the aniline ring with any aromatic monocycle whether or not further substituted in or on the aromatic monocycle; and/or (e) Replacement of the N-propionyl group by another acyl group.

B. 4-(2-chlorophenyl)-2-ethyl-9methyl-6H-thieno[3,2-f][1,2,4]triazolo [4,3-a][1,4]diazepine, its salts, isomers, and salts of isomers (other name: etizolam) 2780 C. 8-chloro-6-(2-fluorophenyl)-1methyl-4H-benzo[f][1,2,4]triazolo (other name: flualprazolam) 2785 D. 6-(2-chlorophenyl)-1-methyl-8nitro-4H-benzo[f][1,2,4]triazolo (other name: clonazolam) 2786 E. 8-bromo-6-(2-fluorophenyl)-1methyl-4H-benzo[f][1,2,4]triazolo (other name: flubromazolam) 2788 F. 7-chloro-5-(2-chlorophenyl)-1methyl-1,3-dihydro-2Hbenzo [e][1,4]diazepin-2-one, its salts, (other name: diclazepam) 2789 G. Methyl 3,3-dimethyl-2- (1-(pent-4-en-1-yl)-1H-indazole- 3-carboxamido)butanoate, its optical and geometric isomers, salts and salts of isomers (other name: MDMB–4en–PINACA) 7090 H. Methyl 2-[[1-(4-fluorobutyl) indole-3-carbonyl]amino]-3,3dimethyl-butanoate, its optical and geometric isomers, salts and salts of isomers (other names:

4F–MDMB–BUTICA; 4F–MDMB–BICA) 7091

I. N-(1-Amino-3,3-dimethyl-1-oxobutan- 2-yl)-1-(pent-4-en-1-yl)-1H-indazole- 3-carboxamide, its optical and geometric isomers, salts and salts of isomers (other name: ADB–4en–PINACA) 7092 J. 5-Pentyl-2-(2-phenylpropan-2-yl)pyrido [4,3-b]indol-1-one, its optical and geometric isomers, salts and salts of isomers (other names: CUMYL–PEGACLONE;

SGT–151) 7093

K. Ethyl 2-[[1-(5-fluoropentyl)indole-3carbonyl]amino]-3,3-dimethyl-butanoate, its optical and geometric isomers, salts and salts of isomers (other names:

5F–EDMB–PICA; 5F–EDMB–2201) 7094

L. Methyl 2-(1-(4-fluorobenzyl)-1H-indole- 3-carboxamido)-3-methyl butanoate, its optical and geometric isomers, salts and salts of isomers (other name:

MMB–FUBICA) 7095

M. N-ethyl-2-(2-(4-isopropoxybenzyl)-5nitro-1H-benzimidazol-1-yl)ethan-1-amine, of isomers, esters and ethers (other name:

N-desethyl isotonitazene) 9760 N. 2-(4-ethoxybenzyl)-5-nitro-1-(2- (piperidin-1-yl)ethyl)-1H-benzimidazole, of isomers, esters and ethers (other names:

N-piperidinyl etonitazene; etonitazepipne) 9761 O. 2-(4-methoxybenzyl)-5-nitro-1-(2- (pyrrolidin-1-yl)ethyl)-1H-benzimidazole, of isomers, esters and ethers (other names:

N-pyrrolidino metonitazene; metonitazepyne) 9762 P. 5-nitro-2-(4-propoxybenzyl)-1-(2- (pyrrolidin-1-yl)ethyl)-1H-benzimidazole, its isomers, esters, ethers, salts, and salts of isomers, esters and ethers (other names:

N-pyrrolidino protonitazene; protonitazepyne) 9763 7. Khat, to include all parts of the plant presently classified botanically as catha edulis, whether growing or not; the seeds thereof; any extract from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant, its seed, or extracts. 7032 (B) Schedule II shall consist of the drugs and other substances, name, or brand name designated, listed in this section. Each drug or substance has been assigned the Controlled Substances Code Number set forth opposite it.

Substances, vegetable origin, or chemical synthesis.

Unless specifically excepted or unless listed in another schedule, Schedule II shall include any of the following substances whether produced directly or indirectly by extraction from substances of vegetable origin or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis:

A. Opium and opiate; and any salt, compound, derivative, or preparation of opium or opiate, excluding apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, nalmefene, naloxegol, naloxone, and naltrexone and their respective salts, but including the following:

(I) Raw opium 9600 (II) Opium extracts 9610 (III) Opium fluid 9620 (IV) Powdered opium 9639 (V) Granulated opium 9640 (VI) Tincture of opium 9630 (VII) Codeine 9050 (VIII) Dihydroetorphine 9334 (IX) Ethylmorphine 9190 (X) Etorphine hydrochloride 9059 (XI) Hydrocodone 9193 (XII) Hydromorphone 9150 (XIII) Metopon 9260 (XIV) Morphine 9300 (XV) Oripavine 9330 (XVI) Oxycodone 9143 (XVII) Oxymorphone 9652 (XVIII) Thebaine 9333 B. Any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of the substances referred to in subparagraph (1)(B)1.A. of this rule shall be included in Schedule II, except that these substances shall not include the isoquinoline alkaloids of opium;

C. Opium poppy and poppy straw 9650 D. Coca leaves (9040) and any salt, compound, derivative, or preparation of coca leaves (including cocaine (9041) and ecgonine (9180) and their salts, isomers, derivatives, and salts of isomers and derivatives), and any salt, compound, derivative, or preparation thereof which is chemically equivalent or identical with any of these substances, except that the substances shall not include— (I) Decocainized coca leaves or extraction of coca leaves, which extractions do not contain cocaine or ecgonine; or (II) Ioflupane;

E. Concentrate of poppy straw (the crude extract of poppy straw in either liquid, solid, or powder form which contains the phenanthrene alkaloids of the opium poppy) 9670 2. Opiates. Unless specifically excepted or unless in another schedule any of the following opiates, including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, dextrorphan and levopropoxyphene excepted:

A. Alfentanil 9737 B. Alphaprodine 9010 C. Anileridine 9020 D. Bezitramide 9800 E. Bulk Dextropropoxyphene (Non-dosage Forms) 9273 F. Carfentanil 9743 G. Dihydrocodeine 9120 H. Diphenoxylate 9170 I. Fentanyl 9801 J. Isomethadone 9226 K. Levo-alphacetylmethadol Some other names: levo-alphaacetylmethadol, levomethadyl acetate, LAAM 9648 L. Levomethorphan 9210 M. Levorphanol 9220 N. Metazocine 9240 O. Methadone 9250 P. Methadone-Intermediate, 4-cyano-2-dimethylamino- 4,4-diphenyl butane 9254 Q. Moramide-Intermediate, 2methyl-3-morpholino-1, 1-diphenylpropane-carboxylic acid 9802 R. Oliceridine (N-[(3-methoxythiophen-2-yl) methyl] ({2-[(9R)-9-(pyridin-2-yl)-6-oxaspiro [4.5]decan-9-yl]ethyl})amine fumarate) 9245 S. Pethidine (Meperidine) 9230 T. Pethidine-Intermediate-A, 4-cyano-1-methyl-4-phenylpiperidine 9232 U. Pethidine-Intermediate-B, ethyl-4-phenylpiperidine-4-carboxylate 9233 V. Pethidine-Intermediate-C, 1methyl-4-phenylpiperidine- 4-carboxylic acid 9234 W. Phenazocine 9715 X. Piminodine 9730 Y. Racemethorphan 9732 Z. Racemorphan 9733 AA. Remifentanil 9739 BB. Sufentanil 9740 CC. Tapentadol 9780 DD. Thiafentanil 9729 3. Stimulants. Unless specifically excepted or unless listed system:

A. Amphetamine, its salts, optical isomers, and salts of its optical isomers 1100 B. Lisdexamfetamine, its salts, isomers, and salts of its isomers 1205 C. Methamphetamine, its salts, isomers, and salts of its isomers 1105 D. Phenmetrazine and its salts 1631 E. Methylphenidate 1724 4. Depressants. Unless specifically excepted or unless system, including its salts, isomers, and salts of isomers A. Amobarbital 2125 B. Glutethimide 2550 C. Pentobarbital 2270 D. Phencyclidine 7471 E. Secobarbital 2315 5. Hallucinogenic substances:

A. Nabilone 7379 Another name for nabilone: (±)trans-3-(1, 1- dimethylheptyl)-6, 6a,7,8,10,10a-hexahydro- 1-hydroxy-6, 6-dimethyl-9Hdibenzo(b,d) pyran-9-one.

B. Dronabinol [(-)-delta-9-trans tetrahydrocannabinol] in an oral solution in a drug product approved for marketing by the United States Food and Drug Administration. (7365)

Immediate precursors. Unless specifically excepted or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances:

A. Immediate precursor to amphetamine and methamphetamine:

(I) Phenylacetone 8501 Some trade or other names: phenyl-2-propanone; P2P; benzyl methyl ketone; methyl benzyl ketone;

B. Immediate precursors to phencyclidine (PCP):

(I) 1-phenylcyclohexylamine 7460 (II) 1-piperidinocyclohexanecarbonitrile (PCC) 8603 C. Immediate precursor to fentanyl:

(I) 4-anilino-N-phenethyl-4piperidine (ANPP) 8333 (II) N-phenyl-N-(piperidin- 4-yl)propionamide (norfentanyl) 8366 7. Any material, compound, mixture, or preparation which contains any quantity of the following alkyl nitrites:

A. Amyl nitrite;

B. Butyl nitrite.

(C) Schedule III shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this section. Each drug or substance has been assigned the DEA Controlled Substances Code Number set forth opposite it.

Stimulants. Unless specifically excepted or unless listed system, including its salts, isomers (whether optical, position, or geometric), and salts of such isomers whenever the existence of such salts, isomers, and salts of isomers is possible within the specific chemical designation:

A. Those compounds, mixtures, or preparations in dosage unit form containing any stimulant substances listed in Schedule II which compounds, mixtures, or preparations were listed on August 25, 1971, as excepted compounds under 21 CFR 308.32 and any other drug of the quantitive composition shown in that list for those drugs or which is the same except that it contains a lesser quantity of controlled substances 1405 B. Benzphetamine 1228 C. Chlorphentermine 1645 D. Clortermine 1647 E. Phendimetrazine 1615 2. Depressants. Unless specifically excepted or unless listed in another schedule, any material compound, mixture, system:

A. Any compound, mixture, or preparation containing— (I) Amobarbital 2126 (II) Secobarbital 2316 (III) Pentobarbital 2271 or any salt thereof and one (1) or more other active medicinal ingredients which are not listed in any schedule;

B. Any suppository dosage form containing— (I) Amobarbital 2126 (II) Secobarbital 2316 (III) Pentobarbital 2271 or any salt of any of these drugs and approved by the Food and Drug Administration for marketing only as a suppository;

C. Any substance which contains any quantity of a derivative of barbituric acid or any salt thereof 2100 D. Chlorhexadol 2510 E. Embutramide 2020 F. Any drug product containing gamma hydroxybutyric acid, including its salts, isomers, and salts of isomer, for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act; 2012 G. Ketamine, its salts, isomer, and salts of isomers (some other names for ketamine:

(±)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone) 7285 H. Lysergic acid 7300 I. Lysergic acid amide 7310 J. Methyprylon 2575 K. Perampanel, and its salts, isomers, and salts of isomers 2261 L. Sulfondiethylmethane 2600 M. Sulfonethylmethane 2605 N. Sulfonmethane 2610 O. Tiletamine and zolazepam or any salt thereof 7295 Some trade or other names for a tiletaminezolazepam combination product: Telazol.

Some trade or other names for tiletamine: 2- (ethylamino)-2-(2thienyl)-cyclohexanone.

Some trade or other names for zolazepam: 4-(2-fluorophenyl)- 6-8-dihydro-1,3,8- trimethylpyrazolo-(3,4-e) (1,4)-diazepin- 7(1H)one, flupyrazapon.

Nalorphine 9400 4. Narcotics drugs. Unless specifically excepted or unless or preparation containing limited quantities of any of the following narcotic drugs or any salts thereof:

A. Not more than one and eight-tenths grams (1.8 gm) of codeine per one hundred milliliters (100 mL) or not more than ninety milligrams (90 mg) per dosage unit, with an equal or greater quantity of an isoquinoline alkaloid of opium 9803 B. Not more than one and eight-tenths grams (1.8 gm) of codeine per one hundred milliliters (100 mL) or not more than ninety milligrams (90 mg) per dosage unit, with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts 9804 C. Not more than one and eight-tenths grams (1.8 gm) of dihydrocodeine per one hundred milliliters (100 mL) or not more than ninety milligrams (90 mg) per dosage unit, with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts 9807 D. Not more than three hundred milligrams (300 mg) of ethylmorphine per one hundred milliliters (100 mL) or not more than fifteen milligrams (15 mg) per dosage unit, with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts 9808 E. Not more than five hundred milligrams (500 mg) of opium per one hundred milliliters (100 mL) or per one hundred grams (100 gm) or not more than twenty-five milligrams (25 mg) per dosage unit, with one (1) or more active nonnarcotic ingredients in recognized therapeutic amounts 9809 F. Not more than fifty milligrams (50 mg) of morphine per one hundred milliliters (100 mL) or per one hundred grams (100 gm), with one (1) or more active, nonnarcotic ingredients in recognized therapeutic amounts 9810 5. Any material, compound, mixture, or preparation containing any of the following narcotic drugs or their salts, as set forth below:

A. Buprenorphine 9064 6. Anabolic steroids. Unless specifically excepted or unless listed in another schedule, any substance meeting the definition of anabolic steroid as set forth in 21 CFR 1300.01, of the August 1, 2023, Code of Federal Regulations, as published by the Office of the Federal Register, National Archives and Records Administration, 700 Pennsylvania Avenue, Washington, DC 20408, which is hereby incorporated by reference and does not include later amendments or additions, including any material, compound, mixture or preparation containing any quantity of the following substances, including its salts, esters, and ethers (4000):

A. 5α-androstan-3,17-dione;

B. 5α-androstan-3,6,17-trione;

C. 1-androstenediol (3β,17β-dihydroxy-5α-androst-1-ene);

D. 1-androstenediol (3α,17β-dihydroxy-5α-androst-1-ene);

E. 4-androstenediol (3β,17β-dihydroxy-androst-4-ene);

F. 5-androstenediol (3β,17β-dihydroxy-androst-5-ene);

G. 1-androstenedione (5α-androst-1-en-3,17-dione);

H. 4-androstenedione (androst-4-en-3,17-dione);

I. 5-androstenedione (androst-5-en-3,17-dione);

J. bolasterone (7α,17α-dimethyl-17β-hydroxyandrost-4-en- K. boldenone (17β-hydroxyandrost-1,4-diene-3-one);

L. boldione (androsta-1,4-diene-3,17-dione);

M. 6-bromo-androsta-1,4-diene-3,17-dione;

N. 6-bromo-androstan-3,17-dione;

O. calusterone (7β,17α-dimethyl-17β-hydroxyandrost-4- P. 4-chloro-17α-methyl-androsta-1,4-diene-3,17β-diol;

Q. 4-chloro-17α-methyl-androst-4-ene-3β,17β-diol;

R. 4-chloro-17α-methyl-17β-hydroxy-androst-4-en-3-one;

S. 4-chloro-17α-methyl-17β-hydroxy-androst-4-ene-3,11dione;

T. clostebol (4-chloro-17β-hydroxy-androst-4-en-3-one);

U. dehydrochloromethyltestosterone (4-chloro-17βhydroxy-17α-methyl-androst-1,4-dien-3-one);

V. desoxymethyltestosterone (17α-methyl-5α-androst-2en-17β-ol) (a.k.a. “madol”);

W. 4-dihydrotestosterone (17β-hydroxy-androstan-3-one);

X. Δ1-dihydrotestosterone (a.k.a. “1-testosterone”)

(17β-hydroxy-5α-androst-1-en-3-one);

Y. 3β,17β-dihydroxy-5α-androstane;

Z. 3α,17β-dihydroxy-5α-androstane;

AA. 2α,17α-dimethyl-17β-hydroxy-5β-androstan-3-one;

BB. drostanolone (17β-hydroxy-2α-methyl-5α-androstan- CC. 2α,3α-epithio-17α-methyl-5α-androstan-17β-ol;

DD. estra-4,9,11-triene-3,17-dione;

EE. 13β-ethyl-17β-hydroxygon-4-en-3-one;

FF. ethylestrenol (17α-ethyl-17β-hydroxyestr-4-ene);

GG. fluoxymesterone (9-fluoro-17α-methyl-11β,17βdihydroxyandrost-4-en-3-one);

HH. formebolone (2-formyl-17α-methyl-11α,17βdihydroxyandrost-1,4-dien-3-one);

II. furazabol (17α-methyl-17β-hydroxyandrostano[2,3-c] furazan);

JJ. [3,2-c]furazan-5α-androstan-17β-ol;

KK. 18a-homo-3-hydroxy-estra-2,5(10)-dien-17-one;

LL. 4-hydroxy-19-nortestosterone (4,17β-dihydroxy-estr-4- MM. 4-hydroxy-androst-4-ene-3,17-dione;

NN. 17β-hydroxy-androstano[2,3-d]isoxazole;

OO. 17β-hydroxy-androstano[3,2-c]isoxazole;

PP. 3β-hydroxy-estra-4,9,11-trien-17-one;

QQ. 4-hydroxytestosterone (4,17β-dihydroxy-androst-4- RR. mestanolone (17α-methyl-17β-hydroxy-5α-androstan- SS. mesterolone (1α-methyl-17β-hydroxy-5α-androstan-3one);

TT. methandienone (17α-methyl-17β-hydroxyandrost-1,4dien-3-one);

UU. methandriol (17α-methyl-3β,17β-dihydroxyandrost-5- VV. methasterone (2α,17α-dimethyl-5α-androstan-17β-ol- 3-one or 2α,17α-dimethyl-17β-hydroxy-5α-androstan-3-one);

WW. methenolone (1-methyl-17β-hydroxy-5α-androst-1- XX. 17α-methyl-androsta-1,4-diene-3,17β-diol;

YY. 17α-methyl-5α-androstan-17β-ol;

ZZ. 17α-methyl-androstan-3-hydroxyimine-17β-ol;

AAA. 6α-methyl-androst-4-ene-3,17-dione;

BBB. 17α-methyl-androst-2-ene-3,17β-diol;

CCC. 17α-methyl-3β,17β-dihydroxy-5α-androstane;

DDD. 17α-methyl-3α,17β-dihydroxy-5α-androstane;

EEE. 17α-methyl-3β,17β-dihydroxyandrost-4-ene;

FFF. 17α-methyl-4-hydroxynandrolone (17α-methyl-4hydroxy-17β-hydroxyestr-4-en-3-one);

GGG. methyldienolone (17α-methyl-17β-hydroxyestra- 4,9(10)-dien-3-one);

HHH. 17α-methyl-Δ1-dihydrotestosterone (17β-hydroxy- 17α-methyl-5α-androst-1-en-3-one) (a.k.a. “17-α-methyl-1testosterone”);

III. methyltestosterone (17α-methyl-17β-hydroxyandrost- JJJ. methyltrienolone (17α-methyl-17β-hydroxyestra- 4,9,11-trien-3-one);

KKK. mibolerone (7α,17α-dimethyl-17β-hydroxyestr-4-en- LLL. nandrolone (17β-hydroxyestr-4-en-3-one);

MMM. 19-nor-4-androstenediol (3β,17β-dihydroxyestr-4- NNN. 19-nor-4-androstenediol (3α,17β-dihydroxyestr-4- OOO. 19-nor-5-androstenediol (3β,17β-dihydroxyestr-5- PPP. 19-nor-5-androstenediol (3α,17β-dihydroxyestr-5- QQQ. 19-nor-4,9(10)-androstadienedione (estra-4,9(10)diene-3,17-dione);

RRR. 19-nor-4-androstenedione (estr-4-en-3,17-dione);

SSS. 19-nor-5-androstenedione (estr-5-en-3,17-dione);

TTT. norbolethone (13β,17α-diethyl-17β-hydroxygon-4-en- UUU. norclostebol (4-chloro-17β-hydroxyestr-4-en-3-one);

VVV. norethandrolone (17α-ethyl-17β-hydroxyestr-4-en-3one);

WWW. normethandrolone (17α-methyl-17β-hydroxyestr- XXX. oxandrolone (17α-methyl-17β-hydroxy-2-oxa-5αandrostan-3-one);

YYY. oxymesterone (17α-methyl-4,17β-dihydroxyandrost- ZZZ. oxymetholone (17α-methyl-2-hydroxymethylene- 17β-hydroxy-5α-androstan-3-one);

AAAA. prostanozol (17β-hydroxy-5α-androstano[3,2-c] pyrazole or [3,2-c]pyrazole-5α-androstan-17β-ol);

BBBB. [3,2-c]pyrazole-androst-4-en-17β-ol;

CCCC. stanozolol (17α-methyl-17β-hydroxy-5α-androst-2eno[3,2-c]-pyrazole);

DDDD. stenbolone (17β-hydroxy-2-methyl-5α-androst-1- EEEE. testolactone (13-hydroxy-3-oxo-13,17-secoandrosta- 1,4-dien-17-oic acid lactone);

FFFF. testosterone (17β-hydroxyandrost-4-en-3-one);

GGGG. tetrahydrogestrinone (13β,17α-diethyl-17βhydroxygon-4,9,11-trien-3-one); and HHHH. trenbolone (17β-hydroxyestr-4,9,11-trien-3-one).

Dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a United States Food and Drug Administration approved drug product 7369 (Some other names for dronabinol: (6αRtrans)- 6a,7,8,10αtetrahydro-6.6.9-trimethyl-3-pentyl-6H-dibenzo (b,d) pyran-1ol, or (-) -delta-9-(trans)-tetrahydrocannabinol.)

(D) Schedule IV shall consist of the drugs and other substances, by whatever official name, common or usual name, chemical name, or brand name designated, listed in this subsection. Each drug or substance has been assigned the DEA Controlled Substances Code Number set forth opposite it.

Narcotic drugs. Unless specifically excepted or unless or preparation containing limited quantities of any of the following narcotic drugs or any salts thereof:

A. Not more than one milligram (1 mg) of difenoxin (DEA Drug Code No. 9168) and not less than twenty-five micrograms (25 mcg) of atropine sulfate per dosage unit 9167 B. Dextropropoxyphene (alpha-(+)-4-dimethylamino-1,2diphenyl-3-methyl-2-propionoxybutane) 9278 C. 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl) cyclohexanol, its salts, optical and geometric isomers, and salts of these isomers (including tramadol) 9752 D. Narcotic drugs containing nonnarcotic active medicinal ingredients. Any compound, mixture, or preparation containing any of the following limited quantities of narcotic drugs or salts thereof, which shall include one (1) or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by the narcotic drug alone:

(I) Not more than two hundred milligrams (200 mg) of codeine per one hundred milliliters (100 mL) or per one (II) Not more than one hundred milligrams (100 mg) of dihydrocodeine per one hundred milliliters (100 mL) or per one hundred grams (100 gm); or (III) Not more than one hundred milligrams (100 mg) of ethylmorphine per one hundred milliliters (100 mL) or per one hundred grams (100 gm).

Depressants. Unless specifically excepted or unless substances, including its salts, isomers, and salts of isomers A. Alfaxalone 2731 B. Alprazolam 2882 C. Barbital 2145 D. Brexanolone 2400 E. Bromazepam 2748 F. Camazepam 2749 G. Carisoprodol 8192 H. Chloral betaine 2460 I. Chloral hydrate 2465 J. Chlordiazepoxide 2744 K. Clobazam 2751 L. Clonazepam 2737 M. Clorazepate 2768 N. Clotiazepam 2752 O. Cloxazolam 2753 P. Daridorexant 2410 Q. Delorazepam 2754 R. Diazepam 2765 S. Dichloralphenazone 2467 T. Estazolam 2756 U. Ethchlorvynol 2540 V. Ethinamate 2545 W. Ethyl loflazepate 2758 X. Fludiazepam 2759 Y. Flunitrazepam 2763 Z. Flurazepam 2767 AA. Fospropofol 2138 BB. Halazepam 2762 CC. Haloxazolam 2771 DD. Ketazolam 2772 EE. Lemborexant 2245 FF. Loprazolam 2773 GG. Lorazepam 2885 HH. Lormetazepam 2774 II. Mebutamate 2800 JJ. Medazepam 2836 KK. Meprobamate 2820 LL. Methohexital 2264 MM. Methylphenobarbital (Mephobarbital) 2250 NN. Midazolam 2884 OO. Nimetazepam 2837 PP. Nitrazepam 2834 QQ. Nordiazepam 2838 RR. Oxazepam 2835 SS. Oxazolam 2839 TT. Paraldehyde 2585 UU. Petrichloral 2591 VV. Phenobarbital 2285 WW. Pinazepam 2883 XX. Prazepam 2764 YY. Quazepam 2881 ZZ. Remimazolam 2846 AAA. Suvorexant 2223 BBB. Temazepam 2925 CCC. Tetrazepam 2886 DDD. Triazolam 2887 EEE. Zaleplon 2781 FFF. Zolpidem 2783 GGG. Zopiclone 2784 HHH. Zuranolone 2420 3. Lorcaserin. Any material, compound, mixture, or substances, including its salts, isomers, and salts of isomers, isomers is possible:

A. Lorcaserin 1625 4. Stimulants. Unless specifically excepted or unless listed system, including its salts, isomers, and salts of isomers:

A. Cathine ((+)-norpseudoephedrine) 1230 B. Diethylpropion 1610 C. Fencamfamin 1760 D. Fenproporex 1575 E. Mazindol 1605 F. Mefenorex 1580 G. Modafinil 1680 H. Pemoline (including organometallic complexes and chelates thereof) 1530 I. Phentermine 1640 J. Pipradrol 1750 K. Serdexmethylphenidate 1729 L. Sibutramine 1675 M. Solriamfetol (2-amino-3-phenylpropyl carbamate; benzenepropanol, betaamino-, carbamate (ester)) 1650 N. SPA (-)-1-dimethylamino-1,2diphenylethane 1635 5. Other substances. Unless specifically excepted or unless substances, including its salts:

A. Pentazocine 9709 B. Butorphanol (including its optical isomers) 9720 C. Eluxadoline (5-[[[(2S)-2-amino-3-[4aminocarbonyl)-2,6-dimethylphenyl]-1oxopropyl] [(1S)-1-(4-phenyl-1 H-imidazol-2-yl) ethyl]amino]methyl]-2-methoxybenzoic acid)

(including its optical isomers) and its salts, isomers, and salts of isomers 9725 6. Ephedrine. Any material, compound, mixture, or system including their salts, isomers, and salts of isomers:

A. Ephedrine or its salts, optical isomers, or salts of optical isomers as the only active medicinal ingredient or contains ephedrine or its salts, optical isomers, or salts of optical isomers and therapeutically insignificant quantities of another active medicinal ingredient.

(E) Schedule V shall consist of the drugs and other substances, name, or brand name designated, listed in this subsection.

Narcotic drugs containing nonnarcotic active medicinal ingredients. Any compound, mixture, or preparation containing any of the following narcotic drugs, or their salts calculated as the free anhydrous base or alkaloid, in limited quantities as follows, which shall include one (1) or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by the narcotic drug alone:

A. Not more than one hundred milligrams (100 mg) of dihydrocodeine per one hundred milliliters (100 mL) or per one B. Not more than one hundred milligrams (100 mg) of ethylmorphine per one hundred milliliters (100 mL) or per one C. Not more than two and five-tenths milligrams (2.5 mg) of diphenoxylate and not less than twenty-five micrograms (25 mcg) of atropine sulfate per dosage unit;

D. Not more than one hundred milligrams (100 mg) of opium per one hundred milliliters (100 mL) or per one hundred grams (100 gm); and E. Not more than five-tenths milligram (0.5 mg) of difenoxin (DEA Drug Code No. 9168) and not less than twentyfive micrograms (25 mcg) of atropine sulfate per dosage unit.

Stimulants. Unless specifically exempted or excluded or unless listed in another schedule, any material, compound, mixture, or preparation which contains any quantity of the following substances having a stimulant effect on the central nervous system including its salts, isomers, and salts of isomers:

A. Pyrovalerone 1485 3. Any compound, mixture, or preparation containing any detectable quantity of pseudoephedrine or its salts or optical isomers, or salts of optical isomers or any compound, mixture, or preparation containing any detectable quantity of ephedrine or its salts or optical isomers, or salts of optical isomers if the drug preparations are starch-based solid dose forms, if such preparations are sold over the counter without a prescription.

The following drug preparations containing ephedrine and pseudoephedrine are not scheduled controlled substances:

A. Drug preparations in liquid form; and B. Drug preparations that require a prescription in order to be dispensed.

Unless specifically exempted or excluded or unless system, including its salts:

A. Ezogabine [N-[2-amino-4(4fluorobenzylamino)-phenyl]carbamic acid ethyl ester] 2779 B. Ganaxolone (3α-hydroxy-3β-methyl- 5α-pregnan-20-one) 2401 C. Lacosamide [(R)-2-acetoamido-N-benzyl- 3-methoxy-propionamide] 2746 D. Pregabalin [(S)-3-(aminomethyl)-5methylhexanoic acid] 2782 E. Brivaracetam ((25)-2-[(4R)- 2-oxo-4-propylpyrrolidin-1yl]butanamide) (also referred to as BRV; UCB-34714; Briviact) 2710 F. Lasmiditan [2,4,6-trifluoro-N-(6-(1methylpiperidine-4-carbonyl) pyridine-2yl-benzamide] 2790 G. Cenobamate ([(1R)-1-(2chlorophenyl)-2-(tetrazol- 2-yl)ethyl] carbamate; 2Htetrazole-2-ethanol, alpha-(2chlorophenyl)-, carbamate (ester), (alphaR)-; carbamic acid (R)-(+)-1-(2-chlorophenyl)-2-(2Htetrazol-2-yl)ethyl ester) 2720 (2) Excluded Nonnarcotic Substances. The following nonnarcotic substances which, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) and section 201(g)(1) of the federal Controlled Substances Act (21 U.S.C. 811(g)(1)), may be lawfully sold over the counter without a prescription are excluded from all schedules pursuant to section 195.015(5), RSMo.

Amended: Filed Sept. 30, 2016, effective May 30, 2017. Emergency amendment filed Oct. 25, 2018, effective Nov. 4, 2018, expired May 2, 2019. Amended: Filed Oct. 25, 2018, effective April 30, 2019.

Emergency amendment filed Oct. 30, 2020, effective Nov. 16, 2020, expired May 14, 2021. Amended: Filed Oct. 30, 2020, effective April 30, 2021. Emergency amendment filed Sept. 28, 2021, effective Oct. 13, 2021, expired April 10, 2022. Amended: Filed Sept. 28, 2021, effective March 30, 2022. Emergency amendment filed Sept. 12, 2022, effective Oct. 3, 2022, expired March 31, 2023. Amended: Filed Sept. 12, 2022, effective March 30, 2023. Emergency amendment filed Sept. 25, 2023, effective Oct. 10, 2023, expired April 6, 2024.

Amended: Filed Sept. 5, 2023, effective March 30, 2024. Emergency amendment filed Sept. 24. 2024, effective Oct. 8, 2024, expired April 5, 2025. Amended: Filed Sept. 24, 2024, effective April 30, 2025. Emergency amendment filed Oct. 15, 2025, effective Oct. 29, 2025, expired April 26, 2026. Amended: Filed Oct. 15. 2025, effective April 30, 2026. *Original authority: 195.015, RSMo 1971, amended 1989, 2014, 2020, and 195.195, RSMo 1957, amended 1971, 1989, 1993, 2014.

History

AUTHORITY: section 195.015, RSMo Supp. 2025, and section 195.195, RSMo 2016. Material found in this rule previously filed as 19 CSR 30-1.010. Original rule filed April 14, 2000, effective Nov. 30, 2000. Amended: Filed Jan. 31, 2003, effective July 30, 2003.

19 CSR 30-1.004 List of Excepted Substances {#sec-19-csr-30-1.004 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.004}

PURPOSE: The Department of Health is authorized to except by rule any compound, mixture or preparation containing any stimulant or depressant substance if one or more active medicinal ingredients not having a stimulant or depressant effect on the central nervous system is included to negate the potential for abuse. The compounds, mixtures and preparations excluded are listed in this rule. or expensive. Therefore, the material which is so incorporated is on file with the agency who filed this rule, and with the Office of the Secretary of State. Any interested person may view this material at either agency’s headquarters or the same will be made available at the Office of the Secretary of State at a cost not to exceed actual cost of copy reproduction. The entire text of the

rule is printed here. This note refers only to the incorporated by reference material.

(1) Excepted Stimulant or Depressant Compounds—Exempt Prescription Products. The listed drugs in dosage unit form and any other drug of the quantitative composition shown in Part 1300 to end of Title 21, the Code of Federal Regulations, April 1998 or which is the same except that it contains a lesser quantity of controlled substances or other substances which do not have a stimulant, depressant or hallucinogenic effect and which are restricted by law to dispensing or prescription, are excepted from the provisions of sections 195.030, 195.040, 195.050 and 195.100, RSMo as provided for in section 195.017.6(5) and .8(3), RSMo. The rules of the Drug Enforcement Administration, 21 CFR Part 1300 to the end of Title 21, are hereby incorporated by reference and made a part of this rule.

(2) Excepted Chemical Preparations—Exempt Chemical Preparations. The listed preparations in unit form and any other preparation of the quantitative composition shown in

Part 1300 to end of Title 21, the Code of Federal Regulations, April 1998 which is the same except that it contains a lesser quantity of controlled substances or other substances which do not have a stimulant, depressant or hallucinogenic effect are excepted from the provisions of sections 195.030, 195.040, 195.050 and 195.110, RSMo as provided for in section 195.017.6(5) and .8(3), RSMo. The rules of the Drug Enforcement Administration, 21 CFR Part 1300 to the end of Title 21, are hereby incorporated by reference and made a part of this rule.

rule previously filed as 19 CSR 30-1.020. Original rule filed April 14,

History

AUTHORITY: section 195.195, RSMo 1994. Material found in this

19 CSR 30-1.006 List of Exempt Anabolic Steroid Products {#sec-19-csr-30-1.006 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.006}

PURPOSE: This rule maintains a list of anabolic steroid products excluded from 19 CSR 30-1.002(1)(C)6. in conformance with federal law.

(1) Persons who in the course of legitimate business handle products listed in the Table of Exempt Anabolic Steroid Products in this section shall be exempt from the registration, records, reports, prescriptions, physical security, and import and export requirements associated with Schedule III substances.

Excluded Nonnarcotic Products mg or Company Trade Name NDC Code Form Controlled Substance mg/mL Bioline Laboratories Theophed 00719-1945 TB Phenobarbital 8.00 Aphena Pharma Nasal decongestant/ Levometamfetamine 50.00 Solutions—New York, LLC inhaler/vapor (l-desoxyephedrine)

Goldline Laboratories Guiaphed Elixir 00182-1377 EL Phenobarbital 4.00 Goldline Laboratories Tedrigen Tablets 00182-0134 TB Phenobarbital 8.00 Hawthorne Products, Inc. Choate’s Leg Freeze LQ Chloral hydrate 246.67 Parke-Davis & Co. Tedral 00071-0230 TB Phenobarbital 8.00 Parke-Davis & Co. Tedral Elixir 00071-0242 EX Phenobarbital 40.00 Parke-Davis & Co. Tedral S.A. 00071-0231 TB Phenobarbital 8.00 Parke-Davis & Co. Tedral Suspension 00071-0237 SU Phenobarbital 80.00 Parmed Pharmacy Asma-Ese 00349-2018 TB Phenobarbital 8.10 Rondex Labs Azma-Aids 00367-3153 TB Phenobarbital 8.00 Smith Kline Consumer Benzedrex 49692-0928 IN Propylhexedrine 250.00 Sterling Drug, Inc. Bronkolixir 00057-1004 EL Phenobarbital 0.80 Sterling Drug, Inc. Bronkotabs 00057-1005 TB Phenobarbital 8.00 Vicks Chemical Co. Vicks Inhaler 23900-0010 IN I-Desoxyephedrine 113.00 White Hall Labs Primatene 00573-2940 TB Phenobarbital 8.00 (P-tablets)

(A) Trade NameCompany NDC or DIN No.

Androgyn L.A.Forest Pharmaceuticals, St. Louis, MO0456-1005 2. Andro-Estro 90-4Rugby Laboratories, Rockville Center, NY0536-1605 3. Component E-H in process granulationIvy Laboratories, Inc., Overland Park, KS 4. Component E-H in process pelletsIvy Laboratories, Inc., Overland Park, KS 5. Component TE-S in process granulationIvy Laboratories, Inc., Overland Park, KS 6. Component TE-S in process pelletsIvy Laboratories, Inc., Overland Park, KS 7. depANDROGYNForest Pharmaceuticals, St. Louis, MO0456-1020 8. Depo-TestadiolThe Upjohn Company, Kalamazoo, MI0009-0253 9. DEPO-T.E.Quality Research Pharmaceuticals, Camel, IN52765-257 10. depTESTROGENMartica Pharmaceuticals, Phoenix, AZ51698-257 11. DuomoneWintec Pharmaceutical, Pacific, MO52047-360 12. DURATESTRINW.E. Hauck, Alpharetta, GA43797-016 13. DUO-SPAN IIPrimedics Laboratories, Gardena, CA0684-0102 14. EssianPharmaceuticals International Inc., Hunt Valley, MD 15. Essian H.S.Pharmaceuticals International Inc., Hunt Valley, MD 16. Esterified Estrogens and Methyltestosterone 1.25 mg/2.5 mg D.S.

ECI Pharmaceuticals, LLC 17. Esterified Estrogens and Methyltestosterone 0.625 mg/1.25 mg H.S.

ECI Pharmaceuticals, LLC 18. Esterified Estrogens and Methyltestosterone, USP (0.625 mg/1.25 mg)

Interpharm, Inc.

Esterified Estrogens and Methyltestosterone, USP (1.25 mg/2.5 mg)

Interpharm, Inc.

Esterified Estrogens/ Methyltestosterone, (0.625 mg/1.25 mg) Tablet ANDAPharm, LLC 21. Esterified Estrogens/Methyltestosterone, (1.25 mg/2.5 mg) Tablet ANDAPharm, LLC 22. Estratest Solvay Pharmaceuticals, Marietta, GA0032-1026 23. Estratest H.S. Solvay Pharmaceuticals, Marietta, GA0032-1023 24. MenogenSage Pharmaceuticals, Shreveport, LA59243-570 25. Menogen H.S.Sage Pharmaceuticals, Shreveport, LA59243-560 26. Methyltestosterone and Esterified Estrogens (2.5 mg/1.25 mg)Lannett Company, Inc.
Methyltestosterone and Esterified Estrogens (Half Strength)

(1.25 mg/0.625 mg)

Lannett Company, Inc.

PAN ESTRA TESTPan American Labs, Covington, LA0525-0175 29. Premarin with MethyltestosteroneAyerst Labs., Inc., New York, NY0046-0879 30. Premarin with MethyltestosteroneAyerst Labs., Inc., New York, NY0046-0878 31. Synovex H in process bulk pelletsSyntex Animal Health, Palo Alto, CA 32. Synovex H pellets in process granulationSyntex Animal Health, Palo Alto, CA 33. Synovex Plus in-process granulationFort Dodge Animal Health, Fort Dodge, IA 34. Synovex Plus in-process bulk pelletsFort Dodge Animal Health, Fort Dodge, IA 35. Syntest D.S. Syntho Pharmaceuticals, Inc.66576-231 36. Syntest H.S.Syntho Pharmaceuticals, Inc.66576-230 37. TestagenClint Pharmaceuticals, Nashville, TN55553-257 38. TEST-ESTRO CypionatesRugby Laboratories, Rockville Centre, NY 0536-9470 39. Testoderm 4 mg/dAlza Corp., Palo Alto, CA17314-4608 40. Testoderm 6 mg/dAlza Corp., Palo Alto, CA17314-4609

rule previously filed as 19 CSR 30-1.025. Original rule filed April 14, 2000, effective Nov. 30, 2000. Amended: Filed July 25, 2025, effective Feb. 28, 2026.

History

AUTHORITY: section 195.195, RSMo 2016. Material found in this

19 CSR 30-1.008 List of Excluded Veterinary Anabolic Steroid Implant Products {#sec-19-csr-30-1.008 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.008}

PURPOSE: This rule maintains a list of veterinary anabolic steroid products excluded from 19 CSR 30-1.002(1)(C)5. in conformance with federal law.

(1) The following products containing an anabolic steroid that are expressly intended for administration through implants to cattle or other nonhuman species and which have been approved by the Secretary of Health and Human Services for such administration and are excluded from all schedules pursuant to section 195.017.5, RSMo.

Trade Name Company NDC or DIN No.

(A) Component E-H Vetlife, Inc., 021641-002 (B) Component E-H Elanco, 01968327 Scarborough, ON (C) Component TE-S Vetlife, Inc., 021641-004 (D) Component T-H Vetlife, Inc., 021641-006 (E) Component T-S Vetlife, Inc., 021641-005 (F) F-TO Animal Health, 00093351 Upjohn International, Kalamazoo, MI (G) Finaplix-H Hoechst Roussel Vet, 12799-807-10 (H) Finaplix-S Hoechst Roussel Vet, 12799-807-07 (I) Heifer-oid Anchor Division, Boehringer Ingelheim, St. Joseph, MO (J) Heifer-oid Bio-Ceutic Division, Boehringer Ingelheim, St. Joseph, MO (K) Heifer-oid Ivy Laboratories, Inc., Overland Park, KS (L) Implus-H The Upjohn Co., 0009-0434-01 Kalamazoo, MI (M) Implus-H Upjohn Co., Animal 06-0434-01 Health Division, 01968327 Orangeville, ON (N) Revalor-G Hoechst Roussel Vet, 12799-811 (O) Revalor-H Hoechst Roussel Vet, 12799-810 (P) Revalor-S Hoechst Roussel Vet, 12799-809 (Q) Synovex H Fort Dodge Labs, 0856-3901 Fort Dodge, IA (R) Synovex H Syntex Laboratories, Palo Alto, CA (S) Synovex Plus Fort Dodge Labs, 0856-3904 Fort Dodge, IA

History

AUTHORITY: section 195.195, RSMo 1994 and 195.017, RSMo Supp. 1999. Original rule filed April 14, 2000, effective Nov. 30, 2000. Original authority: 195.017, RSMo 1971, amended 1987, 1989, 1994, 1996, 1997, 1998

19 CSR 30-1.010 Schedules of Controlled Substances {#sec-19-csr-30-1.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.010}

Original rule filed Jan. 31, 1972, effective April 1, 1972. Amended:

Filed Oct. 4, 1972, effective Oct. 14, 1972. Amended: Filed April 4, 1973, effective April 14, 1973. Amended: Filed Sept. 28, 1973, effective Nov. 4, 1973. Amended: Filed Jan. 3, 1974, effective Jan. 13, 1974. Amended: Filed Oct. 9, 1974, effective Oct. 19, 1974. Amended:

Filed July 17, 1975, effective July 27, 1975. Amended: Filed Oct. 8, 41. Testoderm with Adhesive 4 mg/dAlza Corp., Palo Alto, CAExport only 42. Testoderm with Adhesive 6 mg/dAlza Corp., Palo Alto, CA17314-2836 43. Testoderm in-process filmAlza Corp., Palo Alto, CA 44. Testoderm with Adhesive in-process filmAlza Corp., Palo Alto, CA 45. Testosterone Cyp 50 Estradiol Cyp 2I.D.E.-Interstate, Amityville, NY0814-7737 46. Testosterone Cypionate Estradiol Cypionate InjectionBest Generics, N. Miami Beach, FL 54274-530 47. Testosterone Cypionate Estradiol Cypionate InjectionSchein Pharmaceuticals, Port Washington, NY0364-6611 48. Testosterone Cypionate-Estradiol Cypionate InjectionSteris Labs., Inc., Phoenix, AZ0402-0257 49. Testosterone Cypionate-Estradiol Cypionate InjectionGoldline Labs, Ft. Lauderdale, FL0182-3069 50. Testosterone Enanthate-Estradiol Valerate InjectionGoldline Labs., Ft. Lauderdale, FL0182-3073 51. Testosterone Enanthate-Estradiol Valerate InjectionSchein Pharmaceuticals, Port Washington, NY0364-6618 52. Testosterone Enanthate-Estradiol Valerate InjectionSteris Labs., Inc., Phoenix, AZ0402-0360 53. Testosterone Ophthalmic SolutionsAllergan, Irvine, CA 54. Tilapia Sex Reversal Feed (Investigational)Allergan, Irvine, CA 1975, effective Oct. 18, 1975. Refiled: March 24, 1976. Amended:

Filed Oct. 12, 1976, effective Jan. 13, 1977. Amended: Filed March 15, 1977, effective March 24, 1977. Amended: Filed Nov. 14, 1977, effective Nov. 6, 1977. Amended: Filed Sept. 28, 1977, effective Jan. 13, 1978. Amended: Filed March 9, 1978, effective Feb. 24, 1978.

Amended: Filed Oct. 2, 1978, effective Sept. 27, 1978. Amended:

Filed Nov. 14, 1978, effective June 16, 1978. Amended: Filed Nov. 14, 1978, effective Oct. 25, 1978. Amended: Filed Feb. 13, 1979, effective Feb. 9, 1979. Amended: Filed Feb. 19, 1980, effective Feb. 11, 1980. Amended: Filed Oct. 14, 1980, effective July 24, 1980.

Amended: Filed Oct. 14, 1980, effective Aug. 21, 1980. Amended:

Filed Oct. 14, 1981, effective Oct. 30, 1980. Amended: Filed Oct. 14, 1981, effective May 8, 1981. Amended: Filed Oct. 14, 1981, effective Aug. 20, 1981. Amended: Filed Nov. 1, 1982, effective Dec. 11, 1982.

Amended: Filed Jan. 12, 1983, effective Feb. 11, 1983. Amended:

Filed March 11, 1983, effective April 1, 1983. Amended: Filed Sept. 2, 1983, effective Dec. 11, 1983. Amended: Filed Nov. 7, 1983, effective Dec. 11, 1983. Amended: Filed July 12, 1984, effective Aug. 11, 1984.

Amended: Filed Sept. 20, 1984, effective Nov. 11, 1984. Amended:

Filed Jan. 15, 1985, effective Feb. 11, 1985. Amended: Filed May 29, 1985, effective June 27, 1985. Amended: Filed July 24, 1985, effective Aug. 26, 1985. Amended: Filed Sept. 12, 1985, effective Oct. 11, 1985. Changed to 19 CSR 10-130.010, effective Oct. 11, 1985.

Amended: Filed Jan. 3, 1986, effective Jan. 16, 1986. Changed to 19 CSR 30-1.010, effective Aug. 11, 1986. Amended: Filed April 17, 1987, effective May 14, 1987. Amended: Filed July 3, 1987, effective Aug. 27, 1987. Amended: Filed May 3, 1988, effective May 26, 1988.

Amended: Filed Sept. 25, 1989, effective Oct. 27, 1989. Emergency amendment filed April 3, 1991, effective April 13, 1991, expired Aug. 10, 1991. Emergency amendment filed May 1, 1991, effective May 11, 1991, expired Sept. 7, 1991. Emergency amendment filed July 23, 1991, effective Aug. 2, 1991, expired Nov. 28, 1991. Amended: Filed April 3, 1991, effective Sept. 30, 1991. Amended: Filed May 1, 1991, effective Sept. 30, 1991. Amended: Filed March 2, 1992, effective Aug. 6, 1992. Amended: Filed July 6, 1993, effective Dec. 9, 1993.

Emergency amendment filed Jan. 5, 1994, effective Jan. 15, 1994, expired May 14, 1994. Amended: Filed Jan. 5, 1994, effective July 30, 1994. Rescinded: Filed April 14, 2000, effective Nov. 30, 2000.

State v. Miller, 588 SW2d 237 (Mo. App. 1979). Evidence of the presence of amphetamine is sufficient to support a controlled substances conviction; no quantitative analysis is necessary.

Those rules refiled between January 1 and March 31, 1976 were not required to be published under section 536.021, RSMo. Also, courts must take judicial notice of the contents of the Code of State Regulations.

Selvey v. State, 578 SW2d 64 (Mo. App. 1979). Phenmetrazine, originally established statutorily as a Schedule III controlled substance, was rescheduled by the Division of Health to Schedule II. Such a rescheduling is within the statutory power granted the Division of Health and does not usurp the legislative power of the general assembly.

State v. Davis, 450 SW2d 168 (Mo. App. 1970). Statutes which direct the Division of Health to prepare a list of drugs classified as barbiturates and stimulants, the sale of which are made unlawful by statute, does not violate the Missouri Constitution prohibition in Article I, section 31 against delegation of authority to an agency to make a rule fixing a fine or imprisonment as punishment for its violation.

History

AUTHORITY: section 195.195, RSMo Supp. 1993. This rule was previously filed as 13 CSR 50-130.010 and 19 CSR 10-130.010.

19 CSR 30-1.011 Definitions {#sec-19-csr-30-1.011 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.011}

PURPOSE: This rule contains definitions which establish the intended meaning of certain terms used throughout this chapter.

(1) As used in this chapter, the following terms shall have the meanings specified:

(A) Commercial container means any bottle, jar, tube, ampule or other receptacle in which a substance is held for distribution or dispensing to an ultimate user and, in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term commercial container does not include any package liner, package insert of other material kept with or within a commercial container, nor any carton, crate, drug or other package in which commercial containers are stored or are used for shipment of controlled substances;

(B) Controlled substances administration record means the form used to record information when administering individual drug doses to patients;

(C) Dispenser means an individual practitioner, institutional practitioner, pharmacy or pharmacist who dispenses a controlled substance;

(D) Hospice means a public agency or private organization or subdivision of either of these that is primarily engaged in providing care to dying persons and their families and meets the standards specified in 19 CSR 30-35;

(E) Hospital employee means a nurse, physician, pharmacist or other responsible patient-care employee;

(F) Individual practitioner means a physician, dentist, veterinarian, optometrist or other individual licensed, registered or otherwise permitted by the United States or Missouri to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy or an institutional practitioner;

(G) Institutional practitioner means a hospital or other person (other than an individual) licensed, registered or otherwise permitted by the United States or Missouri to dispense a controlled substance in the course of professional practice, but does not include a pharmacy;

(H) Long-term care facility means a nursing home, retirement care, mental care, or other facility or institution which provides extended health care to resident patients;

(I) Name means the official name, common or usual name, chemical name or brand name of a substance;

(J) Nurse means a registered or licensed practical nurse licensed under Chapter 335, RSMo;

(K) Patient care areas means any area of a hospital where medical attention is rendered to a patient;

(L) Pre-hospital emergency medical service means an emergency medical services system as defined in Chapter 190, RSMo providing services to persons prior to admission to a hospital;

(M) Prescription means an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user. (For example, an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription.);

(N) Readily retrievable means that certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in a manner that they can be separated out from all other records; and/or records are kept on which certain items are asterisked, redlined, highlighted or in some other manner visually identifiable apart from other items appearing on the records; and records are provided within three working days of a request;

(O) Registration means a Missouri controlled substances registration;

(P) Reregistration means a registration issued to a person who was previously registered and whose application for reregistration was received by the Department of Health prior to the expiration of the previous registration;

(Q) Temporary location registration means a registration issued to an individual practitioner who:

Has a current Missouri professional license to practice and is registered with the Department of Health at the address listed on his/her professional license;
Has a federal Drug Enforcement Administration registration that is valid in Missouri;
Anticipates practicing in Missouri within the next 12 months;
Does not practice for more than 90 consecutive calendar days at any location;
Maintains a record of the date(s) and location(s) of all practice activity in Missouri and makes the record available to the Bureau of Narcotics and Dangerous Drugs. This record shall be retained for two years;
Maintains all required controlled substance records at each location;
Does not receive or stock controlled substances at any location;

(2) Any term not defined in this rule shall have the definition set forth in Chapter 195, RSMo. effective July 30, 2003.

19 CSR 30-1.013 Miscellaneous Fees {#sec-19-csr-30-1.013 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.013}

PURPOSE: This rule establishes and fixes certain fees and charges statutorily authorized to be made by the Department of Health in provisions codified in Chapters 195 and 610, RSMo.

(1) Fees for copies of public records or other documents:

(A) Copy, per page $ 0.25 (B) Research fee, per hour $15.00 (2) Payment of fee may be required in advance.

(3) Fees are nonrefundable.

History

AUTHORITY: section 195.030, RSMo Supp. 1999 and 195.195, RSMo 1994. Original rule filed April 14, 2000, effective Nov. 30, 2000. Original authority: 195.030, RSMo 1939, amended 1971, 1989, 1993, 1995, 1997, 1999

19 CSR 30-1.015 Registrations and Fees {#sec-19-csr-30-1.015 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.015}

PURPOSE: This rule establishes fees for various types of registration, a late registration fee, manner of payment, and exemption from the registration fee.

(1) For each registration or re-registration to— (A) Manufacture controlled substances, the registrant shall pay a fee of sixty-six dollars ($66);

(B) Distribute controlled substances, the registrant shall pay a fee of sixty-six dollars ($66);

(C) Dispense controlled substances listed in Schedules II–V including dispensing of controlled substances by individual practitioners in training programs or to conduct research or instructional activities with those substances, the registrant shall pay a fee of thirty dollars ($30);

(D) Conduct research or instructional activities with a controlled substance listed in Schedule I, the registrant shall pay a fee of thirty dollars ($30);

(E) Conduct chemical analysis with controlled substances listed in any schedule, the registrant shall pay a fee of thirty dollars ($30); and (F) Import or export controlled substances listed in any schedule, the registrant shall pay a fee of sixty-six dollars ($66).

(2) Lapsed Registration Fee. A late charge of ten dollars ($10) must be submitted with the original registration fee if an application is submitted more than fifteen (15) days after a previous registration has expired.

(3) Time and Method of Payment and Refunds. Registration and re-registration fees shall be paid at the time the application for registration or re-registration is submitted for filing. This is a nonrefundable processing fee. Payment should be made in the form of an online credit card payment, payable to the Department of Health and Senior Services. Personal, certified, or cashier’s checks, money orders, or other payments made in the form of stamps, foreign currency, or third-party endorsed checks will not be accepted. Applications and fees shall be submitted electronically online and applicants shall use the online payment system provided on the department’s website.

In the event the online application registration process becomes unavailable, applicants may contact the department for alternative options to apply for registration.

(4) Persons Exempt From Fee. The Department of Health and Senior Services shall exempt the following persons from payment of a fee for registration or re-registration:

(A) Any official or agency of the United States Army, Navy, Marine Corps, Air Force, Coast Guard, Veterans Administration, or Public Health Service who is authorized to procure or purchase controlled substances for official use;

(B) Any official, employee or other civil officer, or agency of the United States or state or any political subdivision or agency who is authorized to purchase controlled substances, to obtain these substances from official stocks, to dispense or administer these substances, to conduct research, instructional activities, or chemical analysis with these substances, or any combination of them, in the course of his/her official duties or employment;

(C) In order to claim exemption from payment of a registration or re-registration fee, the registrant shall apply for exemption by completing appropriate sections of the application;

(D) Exemption from payment of a registration or reregistration fee does not relieve the registrant of any other requirements or duties prescribed by law; and (E) Any registration that is exempt from payment pursuant to this section shall be valid only when authorized persons are conducting activities in the course of their official duties or employment at their government practice location. If the person conducts controlled substance activities away from his or her government practice location, the person shall apply and submit the required fee for a non-exempt registration.

rule filed April 14, 2000, effective Nov. 30, 2000. Amended: Filed Jan. 31, 2003, effective July 30, 2003. Amended: Filed April 29, 2011, effective Nov. 30, 2011. Amended: Filed Aug. 10, 2022, effective Feb. 28, 2023. *Original authority: 195.030, RSMo 1939, amended 1971, 1989, 1993, 1995, 1997, 1999, 2014, and 195.195, RSMo 1957, amended 1971, 1989, 1993, 2014.

History

AUTHORITY: sections 195.030 and 195.195, RSMo 2016. Original

19 CSR 30-1.017 Registration Process {#sec-19-csr-30-1.017 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.017}

PURPOSE: This rule establishes the period and expiration of registration, the process of applying for registration, and information required to complete an application for registration.

(1) Database and Survey Process.

(A) Applicants may apply for and receive a registration that is effective for up to twelve (12) months.

(B) Applicants shall apply through the department’s electronic online system.

(C) Simultaneously with completing an application for a controlled substances registration, practitioners may also complete an annual voluntary census to assist the department in determining practitioner shortages and underserved regions of the state. Required questions and fields for controlled substance registrations are marked with an asterisk (*) in the electronic online system.

(2) Period of Registration.

(A) Any registration shall be current and effective for twelve (12) months from the date issued or until the expiration date assigned at the time the registration is issued. No person who is required to be registered shall conduct any activity for which registration is required without a current registration.

No controlled substance activities shall take place after a registration expires until a new registration has been issued.

(B) At the time any registration is issued, the registration shall be assigned to one (1) of twelve (12) groups which shall correspond to the months of the year. The expiration date of all registrations within any group shall be the last day of the month designated for that group.

(C) Registrations for manufacturers and distributors may be assigned to a single group, and the expiration date may be less than twelve (12) months from the date the registration was issued.

(D) Training program registrations may be assigned to a single group, and the expiration date may be less than twelve (12) months from the date the registration was issued.

(E) A certificate of registration shall be made available online and printable to the registrant which shall include the name and address of the registrant, the expiration date of the registration, and a registration number for the convenience of identifying a registration or a registrant. The same registration number may be used for a new registration for the same person.

(3) Requirements for All Applicants.

(A) Any person who is required to be registered and who is not so registered may apply online for registration at any time. No person required to be registered shall engage in any activity for which registration is required until the application for registration is processed and the registration is issued. All applications are for new registrations.

(B) Applications for registration shall be made on online forms designated by the Department of Health and Senior Services. Application for registration shall be completed online and submitted electronically via the Missouri Department of Health and Senior Services’ website at https://health.mo.gov/ safety/bndd/ along with the required fee.

(C) An application shall contain the electronic signature of the applicant and shall be provided to the Department of Health and Senior Services with any required fee. This is a nonrefundable processing fee.

(D) An application which does not contain or is not accompanied by the required information or fee may be denied sixty (60) days after notifying the applicant of the deficiency.

(E) An application may be withdrawn by making a written request to the Department of Health and Senior Services.

(F) A person who is registered may conduct activities with controlled substances in Schedules II, III, IV, and V, as authorized by statute, unless a registration is restricted as to schedules or activities because of a settlement agreement, probation, or other disciplinary action taken by the Department of Health and Senior Services, the Drug Enforcement Administration, or a professional licensing board. Authority to conduct activities with controlled substances in Schedule I requires a separate application and registration.

(4) All applicants shall make full, true, and complete answers on the application. The Department of Health and Senior Services may require an applicant to submit documents or written statements of fact relevant to the application as considered necessary to determine whether the application should be granted. The failure of the applicant to provide these documents or statements within sixty (60) days after being requested to do so shall be considered to be a waiver by the applicant of an opportunity to present these documents or facts for consideration in granting or denying the application.

(5) Applications for Individual Practitioner Registrations.

Applications by physicians, veterinarians, optometrists, podiatrists, and researchers for Missouri Controlled Substance Registrations shall include:

(A) The applicant’s full legal name (first name, middle name, and last name), including any suffixes such as junior, senior, or III, gender, race, and ethnicity;

(B) A listing of all addresses and practice locations where controlled substance activities will be taking place. The applicant’s street addresses, cities, zip codes, counties, and state.

The number of hours worked per week for each location shall be provided for performing direct patient care (non-hospital), administration, research, teaching, in-patient hospital care, and other. The applicant shall also identify his or her primary, principle practice location, where he or she spends the most time. This will be the principle practice address that appears on the controlled substances registration. A physical street address is required and post office box addresses shall not be accepted;

(D) His or her anticipated drug activities such as administering, prescribing, or dispensing;

(E) The required fee and fee information. If claiming an exemption from a fee, the applicant shall identify the name of the government agency that employs him or her;

(F) His or her business telephone number, fax number, email address, federal controlled substances registration number, if applicable; professional degree, if applicable; and professional license number, if applicable. If the applicant has an application pending for a federal controlled substances registration number, the applicant shall indicate the application is pending;

(G) Whether the applicant, or any officer of a corporate applicant, or individual employed by any applicant having access to controlled substances, has ever entered a plea of guilty, no contest, nolo contendere, or otherwise been convicted of any violation of any state or federal law related to the possession, manufacture, distribution, dispensing, or prescribing of controlled substances. If the answer is yes, the applicant shall provide an explanation;

(H) If the applicant is an individual or a registrant that holds a professional license, whether he or she is currently licensed and registered to practice his or her profession under the laws of this state;

(I) If the applicant is not an individual or registrant that holds a professional license, the applicant shall answer yes or no to whether the applicant is currently authorized to conduct business under the laws of this state;

(J) Previous Discipline. If the applicant currently holds or has previously held a state or federal controlled substance registration or state professional license or registration, the applicant shall answer yes or no to whether the applicant’s license, registration, or application or renewal thereof has ever been surrendered, revoked, suspended, denied, restricted, or placed on probation and if any such action is pending. If the answer is yes, the applicant shall provide an explanation;

(K) Whether the applicant is abusing or has abused or been treated for or diagnosed with addiction regarding controlled substances during the past year. For purposes of this subsection, “abusing” or “abused” means using or having used a controlled substance in a manner not authorized under Chapter 195, RSMo;

(L) Copies and attachments of any guilty pleas, convictions, or disciplinary actions identified in subsections (G) and (J) of this section, if the department does not already have them on file;

(M) The electronic signature of the individual applicant;

(N) His or her Social Security number and date of birth (MM/ DD/YYYY);

(O) The date the application is signed;

(P) What drug schedules the applicant is requesting authority in; and (Q) A listing of mid-level practitioners by name and license number with whom applicant has agreements pursuant to

Chapter 334, RSMo.

(6) Applications for Pharmacies and Businesses. Applications for retail pharmacies and ambulance services, ambulatory surgery centers, analytical laboratories, correctional centers, distributors, exporters, hospices, hospitals, importers, manufacturers, narcotic treatment programs, long-term care facility E-kits, teaching institutions, researchers, or other applicants not listed in sections (5)–(8), shall include:

(A) The applicant’s full legal name, and if applicable, d/b/a name;

(B) The applicant’s tax ID number, if applicable;

(C) The applicant’s facility license number, if applicable, and federal controlled substances registration number. If the applicant has an application pending for a federal controlled substances registration number, the applicant shall indicate an application is pending;

(D) The applicant’s email address;

(E) The applicant’s principle Missouri business street address, city, state, county, and zip code as it will appear on the controlled substances registration certificate. Post office box numbers shall not be accepted. A separate mailing address may also be provided;

(F) The applicant’s business telephone number and fax (G) The applicant’s type of business activity, licensure type, licensure agency, and license number;

(H) What controlled substance schedules the applicant is requesting authority in;

(I) The applicant’s criminal history information as it pertains no as to whether the owner, CEO or administrator, corporate officer, medical director, pharmacist in charge, or any employee with access to controlled drugs has ever pled guilty, no contest, nolo contendere, or ever been convicted of any violation of state or federal law relating to controlled substances;

(J) Whether there are any previous or pending disciplinary actions regarding the applicant’s professional license or any controlled substance registration, whether the applicant’s privileges or authority have been revoked, surrendered, suspended, restricted, or placed on probation, or if any application for a state license or any drug registration has ever been denied;

(K) The application shall be submitted online with the required fee and fee information. If claiming an exemption from a fee, the applicant must identify the name of the government agency;

(L) Copies and attachments of any guilty pleas, convictions, or disciplinary actions identified in subsections (I) and (J) of this

section, if the department does not already have them on file;

(M) If the applicant is a retail business, the applicant shall provide a letter from the Missouri Department of Revenue that documents that no Missouri taxes are due and the applicant is in good standing; and (N) The applicant shall electronically sign and date an application. An application may be signed by the owner, chief executive officer or administrator, corporate officer, medical director, or pharmacist in charge.

(7) Applications for Dentists. Applications for dentists with the degrees of D.D.S. or D.M.D. shall include:

(A) The applicant’s full legal name (first name, middle name, and last name), including any suffixes such as junior, senior, or III;

(B) His or her Social Security number and date of birth (MM/ DD/YYYY);

(C) The applicant’s federal controlled substances registration number. If the applicant has an application pending for a federal controlled substances registration number, the applicant shall indicate the application is pending;

(D) The applicant’s gender, race, and ethnicity;

(E) The applicant’s email address;

(F) The applicant’s primary specialty and any board certification;

(G) Whether the applicant is licensed to practice and conduct activities and the applicant’s licensure type, license number, and name of licensing agency;

(H) What drug schedules the applicant is requesting to conduct activities in;

(I) The applicant’s anticipated drug activities such as administering, prescribing, or dispensing;

(J) The applicant’s street addresses, city, zip code, county, and state of their primary, principle practice location, where they spend the most time. This will be the address that appears on the controlled substances registration. Post office box numbers shall not be accepted. Applicants shall also provide any secondary practice locations and the number of chair-side work hours per week at each location. The number of hours worked per week for each location shall be provided for performing direct patient care (non-hospital), administration, research, teaching, in-patient hospital care, and other;

(K) The applicant’s business phone number and fax number;

(L) The applicant’s criminal history information as it pertains no as to whether the applicant or any employees with access to controlled drugs have ever pled guilty, no contest, nolo contendere, or ever been convicted of any violation of state or federal law relating to controlled substances;

(M) Information regarding any previous or pending disciplinary actions regarding the applicant’s professional license or any controlled substance registration, as to whether the applicant’s privileges or authority have been revoked, surrendered, suspended, restricted, or placed on probation, or if any application for a state license or any drug registration has ever been denied;

(N) Whether the applicant is abusing or has abused or been treated for or diagnosed with addiction regarding controlled substances during the past year. For purposes of this subsection, “abusing” or “abused” means using or having used a controlled substance in a manner not authorized under Chapter 195, RSMo;

(O) The application shall be submitted with the required fee and fee information. If claiming an exemption from a fee, the applicant shall identify the name of the government agency that employs him or her;

(P) The applicant shall provide copies and attachments of any guilty pleas, convictions, or disciplinary actions identified in subsections (L) and (M) of this section, if the department does not already have them on file; and (Q) The applicant shall sign and date an application submitted electronically.

(8) Applications for Mid-Level Practitioners. Applications for mid-level practitioners as defined by 21 CFR 1300.01(b)(28) such as advanced practice nurses and physician assistants shall include:

(A) The applicant’s full legal name (first name, middle name, and last name), including any suffixes such as junior, senior, or III;

(B) The applicant’s social security number and date of birth (MM/DD/YYYY);

(D) The applicant’s gender, race, and ethnicity;

(E) The applicant’s email address;

(F) Whether the applicant is licensed to practice and conduct activities and the applicant’s licensure type, license number, and name of licensing agency;

(G) What controlled substance schedules (III, IV, or V) the applicant is requesting to conduct activities in;

(H) Which physicians the applicant has collaborative or supervision agreements with;

(I) A copy of the applicant’s collaborative or supervision agreements with physicians, and a list of controlled substances from each physician that the mid-level practitioner is authorized to conduct activities with, in that agreement;

(J) The applicant’s street address, city, zip code, county, and state of the applicant’s primary, principle practice location.

This will be the principle address that appears on the controlled substances registration. Post office boxes shall not be accepted.

Applicants shall also provide any secondary practice location addresses and the number of hours worked per week for each location for performing direct patient care (non-hospital), administration, research, teaching, in-patient hospital care, and other;

(K) The applicant’s business phone number and fax (L) The applicant’s criminal history information as it pertains no as to whether the applicant or any employee with access to controlled drugs has ever pled guilty, no contest, nolo contendere, or ever been convicted of any violation of state or federal law relating to controlled substances;

(N) Whether the applicant has abused or been treated for or diagnosed with addiction regarding controlled substances during the past year. For purposes of this subsection, “abusing” or “abused” means using or having used a controlled substance in a manner not authorized under Chapter 195, RSMo;

History

AUTHORITY: section 195.195, RSMo 2016. Original rule filed April effective July 30, 2003. Amended: Filed April 29, 2011, effective Nov. 30, 2011. Amended: Filed Aug. 10, 2022, effective Feb. 28, 2023.

19 CSR 30-1.019 Registration Location {#sec-19-csr-30-1.019 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.019}

PURPOSE: This rule establishes requirements for the physical location of a registration.

(1) A controlled substance registration shall be issued at a U.S.

Postal Service street address.

(2) A controlled substance registration shall be issued to an individual practitioner at a Missouri practice location where controlled substance and other patient care activities occur. effective July 30, 2003. Amended: Filed April 29, 2011, effective Nov. 30, 2011.

19 CSR 30-1.020 List of Excepted Substances {#sec-19-csr-30-1.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.020}

Amended: Filed Oct. 14, 1981, effective Nov. 2, 1981. Amended: Filed Nov. 1, 1982, effective Dec. 11, 1982. Amended: Filed Nov. 7, 1983, effective Dec. 11, 1983. Amended: Filed Oct. 2, 1991, effective Feb. 6, 1992. Rescinded: Filed April 14, 2000, effective Nov. 30, 2000.

History

AUTHORITY: section 195.195, RSMo Supp. 1989. This rule was previously filed as 13 CSR 50-130.020. Original rule filed Sept. 28, 1977, effective Jan. 13, 1978. Amended: Filed Nov. 14, 1978, effective Dec. 11, 1978. Amended: Filed Oct. 12, 1979, effective Nov. 11, 1979.

19 CSR 30-1.023 Registration Changes {#sec-19-csr-30-1.023 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.023}

PURPOSE: This rule establishes procedures for modifying an existing registration, describes the conditions under which a registration automatically terminates, and prohibits the transfer of a registration.

(1) Modification of Registration.

(A) Any registrant may apply to modify his/her registration to authorize the handling of controlled substances in additional schedules by submitting a request in writing to the department.

No fee shall be required to be paid for the modification. The application for modification shall be handled in the same manner as an application for registration.

(B) Any registrant may request to modify his or her name or address as shown on the registration provided that such a modification does not constitute a change of ownership or location. The request shall be made in writing and no fee shall be required to be paid for the modification. The request for changes may be submitted electronically using the department’s online database system. Requests submitted in paper form shall contain the registrant’s signature.

(C) When the registrant’s name or address as shown on the registration changes, the registrant shall notify the Department of Health and Senior Services in writing, including the registrant’s signature, prior to or within thirty (30) days subsequent to the effective date of the change. No fee shall be required to be paid for the modification.

(D) Collector of Unwanted Controlled Substances. A current registrant with the department may request to have their registration modified to authorize the collection of unwanted controlled substances. Requests shall be submitted in writing to the Bureau of Narcotics and Dangerous Drugs, PO Box 570, Jefferson City, MO, 65102-0570. Requests shall provide the requesting registrant’s name, address, and current Missouri Controlled Substances Registration number. Requests shall identify the method of collection such as either a collection receptacle box or mail-back return system, or both, and shall identify the exact physical address of the receptacle.

Collection receptacles located in long term care facilities shall be maintained by a retail pharmacy or a hospital/clinic with an on-site pharmacy. The bureau will respond to the registrant’s request in writing. Registrants authorized by the department to collect unwanted controlled substances shall comply with all requirements for record keeping and security in accordance with federal regulations. The privilege of being a collector may be terminated if the registrant’s authority to collect is terminated by the United States Drug Enforcement Administration, a judicial order, an act by a state licensing board or agency, or if the collector’s registration is restricted as a matter of public discipline by the department. An authorized collector who wishes to cease being a collector shall notify the bureau in writing of the date that collections will cease.

(2) Termination of Registration.

(A) The registration of any person shall terminate— 1. On the expiration date assigned to the registration at the time the registration was issued;

If and when the person dies;
If and when the person ceases legal existence;
If and when a business changes ownership, except— A. The registration shall not terminate for thirty (30) days from the effective date of the change if the new owner applies for a registration within the thirty- (30-) day period and the corresponding Drug Enforcement Administration registration remains effective as provided for by the Drug Enforcement Administration;
If and when the person discontinues business or changes business location, except— A. The registration shall not terminate for thirty (30) days from the effective date of the change if the person applies for a new registration or modification within the thirty- (30-) day period; or 6. Upon the written request of the registrant.

(B) A mid-level practitioner’s registration shall be contingent upon the physician with whom he or she has entered into an agreement pursuant to Chapter 334, RSMo, having a current and valid registration. When such physician’s registration expires, closes, or is no longer valid, any mid-level practitioner(s) with whom he or she has entered into an agreement shall no longer have controlled substance authority. The midlevel practitioner(s) shall cease controlled drug activities until the physician has obtained a new registration or the mid-level practitioner(s) obtain(s) another agreement with another physician pursuant to Chapter 334, RSMo. Mid-level practitioners and any physician with whom he or she has entered into an agreement pursuant to Chapter 334, RSMo, shall notify the Department of Health and Senior Services of the termination of any such agreement.

(C) Any registrant who ceases legal existence or discontinues business or professional practice shall notify the Department of Health and Senior Services of the effective date of this action and promptly return his/her registration certificate to the Department of Health and Senior Services.

(3) Transfer of Registration. No registration or any authority conferred by registration shall be assigned or otherwise transferred.

History

AUTHORITY: section 195.195, RSMo Supp. 2018. Original rule filed April 14, 2000, effective Nov. 30, 2000. Amended: Filed Jan. 31, 2003, effective July 30, 2003. Amended: Filed April 29, 2011, effective Nov. 30, 2011. Emergency amendment filed Sept. 17, 2018, effective Sept. 27, 2018, expired March 25, 2019. Amended: Filed Sept. 17, 2018, effective March 30, 2019.

19 CSR 30-1.025 List of Exempt Anabolic Steroid Products {#sec-19-csr-30-1.025 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.025}

History

AUTHORITY: section 195.015.4, RSMo Supp. 1989. Original rule filed July 6, 1993, effective Dec. 9, 1993. Rescinded: Filed April 14,

19 CSR 30-1.026 Separate Registrations {#sec-19-csr-30-1.026 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.026}

PURPOSE: This rule defines the requirements for controlled substance registrations for separate activities and for separate sites, and defines when a separate registration is not required.

(1) Independent Activities. The following eight groups of activities are deemed to be independent of each other and require separate registration:

(A) Manufacturing controlled substances;

(B) Distributing controlled substances, except:

A dispenser distributing less than 5% of the total combined dosage units of controlled substances distributed and dispensed in a calendar year shall be exempt from obtaining a separate registration for distributing;
A dispenser distributing more than 5% of the total combined dosage units of controlled substances distributed and dispensed in a calendar year must obtain a separate registration as a distributor but shall be exempt from maintaining separate inventories under 19 CSR 30-1.042;

(D) Conducting research and instructional activities with controlled substances listed in Schedule I;

(E) Conducting research with controlled substances listed in Schedules II–V;

(F) Conducting a narcotic treatment program with narcotic controlled substances listed in Schedules II–V;

(G) Conducting instructional activities with controlled substances listed in Schedules II–V;

(H) Importing controlled substances;

(I) Exporting controlled substances;

(J) Conducting chemical analysis with controlled substances listed in any schedule.

(2) No activity shall be conducted with any controlled substance in any schedule not requested for and shown on the current registration.

(3) Separate Locations. A separate registration is required for each principal place of business or professional practice at one (1) general physical location where controlled substances are manufactured, distributed, or dispensed by a person.

(A) For purposes of registration only, the following locations shall be deemed not to be places where controlled substances are manufactured, distributed, or dispensed:

A warehouse where controlled substances are stored by or on behalf of a registered person, unless these substances are distributed directly from the warehouse to registrants other than the registered person or to persons not required to register;
An office used by agents of a registrant where sales of controlled substances are solicited, made, or supervised but which neither contains these substances (other than substances for display purposes or lawful distribution as samples only) nor serves as a distribution point for filling sales orders;
An office used by a practitioner (who is registered at another location) where controlled substances are prescribed but neither administered nor otherwise dispensed as a regular

part of the professional practice of the practitioner at the office and where no supplies of controlled substances are maintained;

A location on the immediate or contiguous property of a hospital, provided that the location is owned and operated by the hospital and controlled substances are not dispensed for use away from the location;
A separate location from a registered pre-hospital emergency medical service location where an emergency vehicle is housed that does not have a permanent location of operation; and 6. A pre-hospital emergency medical service located outside the state of Missouri that renders assistance to a pre-hospital emergency medical service located in the state of Missouri under a mutual aid contract in the case of an emergency, major catastrophe, or other unforeseen event that jeopardizes the ability of the local Missouri pre-hospital emergency medical service to promptly respond.

(B) A separate registration is not required for each separate practice location for an individual practitioner who has a temporary location registration.

History

AUTHORITY: section 195.195, RSMo 2016. Original rule filed April 14, 2000, effective Nov. 30, 2000. Amended: Filed Oct. 30, 2020, effective April 30, 2021.

19 CSR 30-1.027 Investigative and Administrative Procedures {#sec-19-csr-30-1.027 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.027}

PURPOSE: This rule establishes procedures for the handling and disposition of information indicating violations of Chapter 195, RSMo by the Department of Health, pursuant to the mandates of

section 195.040.

(1) The Department of Health may allow officers of state and federal administrative agencies to attend and participate in informal conferences conducted with Missouri controlled substances registrants, Missouri regulated chemical registrants or applicants in order to assist the Department of Health in its deliberations.

19 CSR 30-1.030 Requirements for Controlled Substances Registration {#sec-19-csr-30-1.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.030}

Amended: Filed May 31, 1989, effective Oct. 1, 1989. Amended: Filed Nov. 26, 1991, effective April 9, 1992. Amended: Filed Aug. 26, 1992, effective April 8, 1993. Amended: Filed Nov. 1, 1994, effective June 30, 1995. Rescinded: Filed April 14, 2000, effective Nov. 30, 2000.

History

AUTHORITY: section 195.195, RSMo 1994. This rule was previously filed as 13 CSR 50-131.010. Original rule filed Jan. 31, 1972, effective April 1, 1972. Amended: Filed April 12, 1983, effective July 11, 1983.

19 CSR 30-1.031 Physical Security Requirements {#sec-19-csr-30-1.031 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.031}

PURPOSE: This rule requires applicants and registrants to maintain security controls and procedures to prevent theft and diversion of controlled substances.

(1) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Department of Health shall use the security requirement set forth in 19 CSR 30-1.032–19 CSR 30-1.034 as standards for the physical security controls and operating procedures necessary to prevent diversion. Substantial compliance with these standards may be deemed sufficient by the Department of Health after evaluation of the overall security system and needs of the applicant or registrant.

(2) Physical security controls shall be commensurate with the schedules and quantity of controlled substances in the possession of the registrant in normal business operations. If a controlled substance is transferred to a different schedule, or a noncontrolled substance is listed on any schedule, or the quantity of controlled substances in the possession of the registrant in normal business operations significantly increases, physical security controls shall be expanded and extended accordingly.

(3) All registrants who receive or transfer substantial quantities of controlled substances in normal business operations shall employ security procedures to guard against in-transit losses.

19 CSR 30-1.032 Security for Nonpractitioners {#sec-19-csr-30-1.032 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.032}

PURPOSE: This rule describes specific actions required of nonpractitioner registrants to maintain effective security.

(1) Before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry either with the federal Drug Enforcement Administration (DEA) or with the Department of Health and Senior Services to determine that the person is registered to possess the controlled substance.

(2) The registrant shall design and operate a system to disclose to the registrant suspicious orders of controlled substances.

The registrant shall inform the Department of Health and Senior Services of suspicious orders when discovered by the registrant. Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern and orders of unusual frequency.

(3) The registrant shall notify the Department of Health and Senior Services of any theft or significant loss of any controlled substances upon discovery of this theft or loss.

(A) The registrant shall complete and submit a Report of Loss, Theft or Diversion of Controlled Substances or Regulated Chemicals to the Department of Health and Senior Services no later than seven (7) business days after the discovery of such a loss. If the extent of the loss cannot be fully determined in that time frame, the registrant shall contact the Department of Health and Senior Services to request permission to submit an interim report and arrange for a complete report to be completed and submitted. The registrant may attach a copy of a completed Drug Enforcement Administration Loss Form in lieu of completing the back or second page of a Report of Loss, Theft or Diversion of Controlled Substances or Regulated Chemicals form. In the event of theft, diversion or suspected theft or diversion, the report submitted to the Department of Health and Senior Services shall be accompanied by or followed by a summary of the internal investigation performed, the outcome of the investigation, and a copy of any law enforcement agency report completed if applicable.

(B) If an insignificant amount of a controlled substance is lost during lawful activities authorized under Chapter 195, RSMo, the reason for the loss or a description of what occurred, the name of the drug and the amount lost shall be documented in writing, signed by the registrant and attached or filed with the last completed annual inventory.

(4) The registrant shall not distribute any controlled substance as a complimentary sample to any potential or current customer without the prior written request of the customer, to be used only for satisfying the legitimate medical needs of patients of the customer and only in reasonable quantities. The request must contain the name, address and registration number of the customer and the name of the specific controlled substance desired. The request shall be preserved by the registrant with other records of distribution of controlled substances. In addition, the requirements for order forms shall be complied with for any distribution of a controlled substance listed in Schedule I or II.

(5) Entities registered with the Department of Health and Senior Services as distributors shall be deemed to have met security requirements for storage of Schedule V controlled substance drug products containing ephedrine or pseudoephedrine if those products are stored in compliance and consistent with the regulated chemicals requirements set forth by the United States Drug Enforcement Administration and 21 CFR 1309.71 which is hereby incorporated by reference in this rule, as published on April 1, 2005 by the U.S. Government Printing Office, U.S. Superintendent of Documents, Washington, DC 20402-001; www.gpoaccess.gov/cfr/retrieve.html. This rule does not incorporate any subsequent amendments or additions.

Distributors will be required to conduct background checks on employees with access to these substances and to report losses of controlled substances as required in 19 CSR 30-1.034.

Emergency amendment filed Aug. 18, 2005, effective Aug. 28, 2005, expired Feb. 23, 2006. Amended: Filed Sept. 1, 2005, effective Feb. 28, 2006. *Original authority: 195.017, RSMo 1971, amended 1987, 1989, 1994, 1996, 1997, 1998, 2001, 2005 and 195.195, RSMo 1957, amended 1971, 1989, 1993.

History

AUTHORITY: sections 195.017, RSMo Supp. 2005 and 195.195, RSMo 2000. Original rule filed April 14, 2000, effective Nov. 30, 2000.

19 CSR 30-1.033 Hearing Procedures on Controlled Substances Registration {#sec-19-csr-30-1.033 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.033}

Original rule filed Aug. 26, 1992, effective April 8, 1993.

Rescinded: Filed April 14, 2000, effective Nov. 30, 2000.

History

AUTHORITY: sections 195.040.11 and 195.195, RSMo Supp.

19 CSR 30-1.034 Security for Practitioners {#sec-19-csr-30-1.034 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.034}

PURPOSE: This rule describes specific actions required of practitioner registrants to maintain effective security. This rule also creates and defines the form which must be used by a registrant to report any theft or loss of controlled substances to the Department of Health.

(1) Physical Security.

(A) Controlled substances listed in Schedules I and II shall be stored in a securely locked, substantially constructed cabinet.

(B) Controlled substances listed in Schedules III, IV and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies may disperse these substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled (C) This rule also shall apply to nonpractitioners authorized to conduct research or chemical analysis under another registration.

(2) Other Security.

(A) The registrant shall not employ as an agent or employee who has access to controlled substances any person who has been found guilty or entered a plea of guilty or nolo contendere in a criminal prosecution under the laws of any state or of the United States for any offense related to controlled substances or who has had an application for a state or federal controlled substance registration denied or has had his/her registration revoked or surrendered for cause at any time. For purposes of this subsection, the term for cause means a surrender in place of or as a consequence of any federal or state administrative, civil or criminal action resulting from an investigation of the individual’s handling of controlled substances.

A registrant may apply in writing to the Department of Health and Senior Services for a waiver of subsection (2)(A) of this rule for a specific employee.
The Department of Health and Senior Services may issue a written waiver to any registrant upon determination that a waiver would be consistent with the public health and safety.

In making this determination, the Department of Health and Senior Services shall consider—the duties of the employee, the circumstances surrounding the conviction, the length of time since the conviction was entered, whether a waiver has been granted by the federal Drug Enforcement Administration (DEA) pursuant to 21 CFR 1301.76, the security measures taken by the employer to prevent the theft and diversion of controlled substances, and any other factors consistent with public health and safety.

(B) A registrant shall notify the Department of Health and Senior Services of the theft, diversion or significant loss of any controlled substances or regulated chemicals upon discovery.

The registrant shall complete and submit a report of the loss or diversion of controlled substances to the Department of Health and Senior Services no later than seven (7) business days after the discovery of such a loss. The loss report form shall contain the following information: name and address of registrant, business phone number; Missouri Controlled Substance Registration Number; federal Drug Enforcement Administration Registration number; date of theft or loss; date of discovery of theft or loss; county of location; principal type of registration such as M.D., D.O., D.P.M., O.D., D.V.M., D.D.S., D.M.D., A.N.P., emergency medical service, pharmacy, hospital, manufacturer, nursing home kit, narcotic treatment program, teaching institution, distributor, importer, exporter, or other specified business; whether or not the loss or theft was reported to law enforcement; the name and phone number of the law enforcement agency reported to; the number of losses or thefts the registrant has experienced in the past twenty-four (24) months; the type of loss or diversion such as, break in/burglary, robbery, employee theft, forged or falsified records, lost in transit, or other explained type of loss; if lost in transit, the name of the common carrier and name of consignee; the name(s) of the individual diverting controlled substances who was responsible for the theft or loss; copy of registrant’s internal investigative report involving the loss or theft; the full name, date of birth and Social Security number of the individual(s) responsible for the theft or diversion, if known; a copy of the police report if law enforcement was notified; if the loss or diversion was in transit, identify the origin of the delivery, the name of the carrier(s) used and the name of the consignee; a list of all controlled substances lost, stolen or diverted by their generic name, trade name, the dosage strength, dosage form and quantity; the signature of the person completing the loss report and their title and the date of their signature. If the extent of the loss cannot be fully determined in that time frame, the registrant shall contact the Department of Health and Senior Services to request permission to submit an interim report and arrange for a complete report to be completed and submitted. The registrant may attach a copy of a completed Drug Enforcement Administration Loss Form in lieu of completing the back or second page of a loss report form provided by the Department of Health and Senior Services. In the event of theft, diversion or suspected theft or diversion, the report submitted to the Department of Health and Senior Services shall be accompanied by or followed by a summary of the internal investigation performed, the outcome of the investigation, and a copy of any law enforcement agency report completed if applicable.
If an insignificant amount of a controlled substance is lost during lawful activities authorized under Chapter 195, RSMo, the reason for the loss or a description of what occurred, the name of the drug and the amount lost shall be documented in writing, signed by the registrant and attached or filed with the last completed annual inventory. effective July 30, 2003.

19 CSR 30-1.035 Requirements for Prescribing, Dispensing and Administering Controlled Substances {#sec-19-csr-30-1.035 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.035}

Amended: Filed Aug. 26, 1992, effective April 8, 1993. Amended:

Filed Nov. 1, 1994, effective June 30, 1995. Rescinded: Filed April 14,

History

AUTHORITY: sections 195.040.3(2), 195.050.6 and 195.195, RSMo 1994. Original rule filed Nov. 14, 1988, effective Feb. 24, 1989.

19 CSR 30-1.036 Disposing of Unwanted Controlled {#sec-19-csr-30-1.036 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.036}

History

AUTHORITY: section 195.050.6, RSMo 1986. Original rule filed Jan. 18, 1989, effective April 27, 1989. Rescinded: Filed April 14, 2000, effective Nov. 30, 2000.

19 CSR 30-1.040 Dispensing and Distribution of Controlled Substances in Certain Situations {#sec-19-csr-30-1.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.040}

(Rescinded July 30, 2003)

History

AUTHORITY: section 195.195, RSMo 1986. This rule was previously filed as 13 CSR 50-132.010. Original rule filed Jan. 31, 1972, effective April 1, 1972. Rescinded: Filed Jan. 31, 2003, effective July 30, 2003.

19 CSR 30-1.041 Records Requirements {#sec-19-csr-30-1.041 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.041}

PURPOSE: This rule defines the record keeping and inventory requirements for various classes of registrants.

(1) Persons Required to Keep Records.

(A) Each registrant shall maintain the records and inventory required by 19 CSR 30-1.041–19 CSR 30-1.052, except as exempted by 19 CSR 30-1.041–19 CSR 30-1.052.

(B) Registered individual practitioners and institutional practitioners are required to keep records with respect to controlled substances which are prescribed, administered or dispensed.

(C) A registered person using any controlled substance in research conducted in conformity with an exemption granted under section 505(i) or 512(j) of the federal Food, Drug and Cosmetic Act (21 U.S.C. 355(i) or 360(j)) at a registered establishment which maintains records in accordance with either of those sections is not required to keep records if s/he notifies the Department of Health of the name, address and registration number of the establishment maintaining these records.

(D) A registered person using any controlled substance in preclinical research or in teaching at a registered establishment which maintains records with respect to these substances is not required to keep records if s/he notifies the Department of Health of the name, address and registration number of the establishment maintaining the records.

(E) Notice required by subsection (1)(D) of this rule shall be given at the time the person applies for registration or reregistration and shall be made in the form of an attachment to the application, which shall be filed with the application.

(2) Maintenance of Records and Inventories. Every inventory and other record required to be kept under 19 CSR 30-1.041–19 CSR 30-1.052, shall be kept by the registrant and be available, for at least two years from the date of the inventory or record, for inspecting and copying by authorized employees of the Department of Health, except that financial and shipping records (such as invoices and packing slips, but not executed order forms) may be kept at a central location rather than at the registered location if the registrant obtains from the Department of Health approval of his/her central record keeping system and a permit to keep central records. The permit to keep central records shall be subject to the following conditions:

(A) The permit shall specify the nature of the records to be kept centrally and the exact location where the records will be kept;

(B) The registrant agrees to deliver all or any part of these records to the registered location within three working days of receipt of a written request from the Department of Health for these records and if the Department of Health chooses to do so in lieu of requiring delivery of records to the registered location, to allow authorized employees of the Department of Health to inspect the records at the central location upon request by the employees without a warrant of any kind;

(C) The failure of the registrant to perform his/her agreements under the permit shall revoke, without further action, the permit and all other such permits held by the registrant under other registrations. In the event of a revocation of other permits under subsection (2)(C) of this rule, the registrant, within 30 days after the revocation, shall comply with the requirement that all records be kept at the registered location.

(3) Each registered individual practitioner, institutional practitioner, manufacturer, distributor, importer and exporter shall maintain inventories and records of controlled substances as follows:

(A) Inventories and records of controlled substances listed in Schedules I and II shall be maintained separately from all of the records of the registrant;

(B) Inventories and records of controlled substances listed in Schedules III, IV and V shall be maintained either separately from all other records of the registrant or in a form that the information required is readily retrievable from the ordinary business records of the registrant.

(4) Each registered pharmacy shall maintain the inventories and records of controlled substances as follows:

(A) Inventories and records of all controlled substances listed in Schedules I and II shall be maintained separately from all other records of the pharmacy and prescriptions for these substances shall be maintained in a separate prescription file;

(B) Inventories and records of controlled substances listed in Schedules III, IV and V shall be maintained either separately from all other records of the pharmacy or in a form that the information required is readily retrievable from ordinary business records of the pharmacy and prescriptions for those substances shall be maintained in a separate prescription file.

History

AUTHORITY: sections 195.050 and 195.195, RSMo 1994 and 195.030, RSMo Supp. 1999. Original rule filed April 14, 2000, effective Nov. 30, 2000. Original authority: 195.030, RSMo 1939, amended 1971, 1989, 1993, 1997, 1999; 195.050, RSMo 1939, amended 1971, 1989; and 195.195, RSMo 1957, amended 1971, 1989, 1993.

19 CSR 30-1.042 Inventory Requirements {#sec-19-csr-30-1.042 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.042}

PURPOSE: This rule defines requirements for the form and maintenance of controlled substance inventories.

(1) General Requirements.

(A) Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory was taken. Controlled substances shall be deemed to be on hand if they are in the possession of or under the control of the registrant, including substances returned by a customer, substances ordered by a customer but not yet invoiced, substances stored in a warehouse on behalf of the registrant and substances in the possession of employees of the registrant and intended for distribution as complimentary samples.

(B) A separate inventory shall be made by a registrant for each registered location. In the event controlled substances are in the possession or under the control of the registrant at a location for which s/he is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. Each inventory for a registered location shall be kept at the registered location.

(D) A registrant may take an inventory either as of the opening of business or as of the close of business on the inventory date. The registrant shall indicate on the inventory records whether the inventory is taken as of the opening or as of the close of business and the date the inventory is taken.

(E) An inventory must be maintained in a permanent written, typewritten or printed form. An inventory taken by use of an oral recording device must be transcribed promptly.

(2) Initial Inventory Date.

(A) Every person required to keep records who is registered with the Department of Health after May 1, 1971 and who was not registered previously shall take an inventory of all stocks of controlled substances on hand on the date s/he first engages in the manufacture, distribution or dispensing of controlled (B) Compliance with federal initial inventory date requirements is deemed satisfactory. Duplicate inventories are not required.

(3) Annual Inventory Date. After the initial inventory is taken, the registrant shall take a new inventory of all stocks of controlled substances on hand at least once a year. The annual inventory may be taken on any date that is within one year of the previous annual inventory date.

(4) Inventory Date for Newly Controlled Substances. On the effective date of a rule by the Department of Health adding a substance to any schedule of controlled substances, which substance was not listed immediately prior to that date in any such schedule, every registrant required to keep records who is manufacturing, distributing or dispensing that substance shall take inventory of all stocks of the substance on hand. After that, this substance shall be included in each inventory made by the registrant.

(5) Inventories of Manufacturers. Each registered manufacturer shall include the following information in his/her inventory:

(A) For each controlled substance in bulk form to be used in (or capable of use in) the manufacture of the same or other controlled or noncontrolled substances in finished form, the name of the substance and the total quantity of the substance to the nearest metric unit weight consistent with unit size (except that for inventories made in 1971, avoirdupois weights may be utilized where metric weights are not readily available);

(B) For each controlled substance in the process of manufacture on the inventory date the name of the substance, the quantity of the substance in each batch, stage of manufacture, or both, identified by the batch number or other appropriate identifying number and the physical form which the substance is to take upon completion of the manufacturing process (for example, granulations, tablets, capsules or solutions), identified by the batch number or other appropriate identifying number and if possible the finished form of the substance (for example, ten milligram (10 mg) tablet or ten milligram (10 mg) concentration per fluid ounce or milliliter) and the number or volume;

(C) For each controlled substance in finished form, the name of the substance; each finished form of the substance (for example, ten milligram (10 mg) tablet or ten milligram (10 mg) concentration per fluid ounce or milliliter); the number of units or volume of each finished form in each commercial container (for example, four 100 tablet bottles or three milliliter (3 ml) vials); the number of commercial containers of each finished form (for example, four 100 tablet bottles or six three milliliter (3 ml) vials);

(D) For each controlled substance not included in subsections (5)(A)–(C) of this rule (for example, damaged, defective or impure substances awaiting disposal, substances held for quality control purposes or substances maintained for extemporaneous compoundings), the name of the substance; the total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; the reason for the substance being maintained by the registrant and whether the substance is capable of use in the manufacture of any controlled substance in finished form.

(6) Inventories of Distributors. Each registered distributor shall include in his/her inventory the same information required of manufacturers in subsections (5)(C) and (D) of this rule.

(7) Inventories of Dispensers and Researchers. Each person registered to dispense or conduct research with controlled substances and required to keep records shall include in his/ her inventory the same information required of manufacturers in subsections (5)(C) and (D) of this rule. In determining the number of units of each finished form of a controlled substance in a commercial container which has been opened, the dispenser shall do as follows:

(A) If the substance is listed in Schedule I or II, s/he shall make an exact count or measure of the contents;

(B) If the substance is listed in Schedule III, IV or V, s/he shall make an estimated count or measure of the contents, unless the container holds more than 1,000 tablets or capsules in which case s/he must make an exact count of the contents.

(8) Inventories of Importers and Exporters. Each registered importer or exporter shall include in his/her inventory the same information required of manufacturers in subsections (5)(A), (C) and (D) of this rule. Each registered importer and exporter who also is registered as a manufacturer or as a distributor shall include in his/her inventory as an importer or exporter only those stocks of controlled substances that actually are separated from his/her stocks as a manufacturer or as a distributor (for example, in-transit or in storage for shipment).

(9) Inventories for Chemical Analysts. Each analytical laboratory registered to conduct chemical analysis with controlled substances shall include in its inventory the same information required of manufacturers in subsections (5)

(A), (C) and (D) of this rule as to substances which have been manufactured, imported or received by the laboratory conducting the inventory. If less than one kilogram (1 kg) of any controlled substance (other than a hallucinogenic controlled substance listed in Schedule I) or less than twenty grams (20 g) of a hallucinogenic substance listed in Schedule I (other than lysergic acid diethylamide) or less than point five gram (0.5 g) of lysergic acid diethylamide, is on hand at the time of inventory, those substances need not be included in the inventory. Laboratories of the division may process up to one hundred fifty grams (150 g) of any hallucinogenic substance in Schedule I without regard to a need for an inventory of those

History

AUTHORITY: sections 195.030, RSMo Supp. 1999 and 195.195, RSMo 1994. Original rule filed April 14, 2000, effective Nov. 30, 2000. Original authority: 195.030, RSMo 1939, amended 1971, 1989, 1993, 1995, 1997, 1999 Pursuant to Executive Order 21-07, 19 CSR 30-1.042, section (3) was suspended from March 31, 2020 through May 1, 2021.

19 CSR 30-1.044 Continuing Records General Requirements {#sec-19-csr-30-1.044 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.044}

PURPOSE: This rule sets requirements for the maintenance of ongoing controlled substance records.

(1) Every registrant required to keep records shall maintain on a current basis a complete and accurate record of each such substance manufactured, imported, received, sold, delivered, exported or otherwise disposed of by him/her.

(2) Separate records shall be maintained by a registrant for each registered location except as provided in 19 CSR 30-1.041(2). In the event controlled substances are in the possession or under the control of a registrant at a location for which s/he is not registered, the substance shall be included in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.

(3) Separate records shall be maintained by a registrant for each independent activity for which s/he is registered.

(4) In recording dates of receipt, importation, distribution, exportation or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported or otherwise transferred shall be used as the date of receipt or distribution of any documents of transfer (for example, invoices or packing slips).

(5) Records must be provided to the Department of Health within three working days upon request. *Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957,

19 CSR 30-1.046 Records for Manufacturers, Distributors, Importers and Exporters {#sec-19-csr-30-1.046 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.046}

PURPOSE: This rule sets requirements for record keeping by manufacturers, distributors, importers and exporters of controlled (1) Records for Manufacturers. Each registered manufacturer shall maintain records with the following information:

(A) For each controlled substance in bulk form to be used in or capable of use in or being used in the manufacture of the same or other controlled or noncontrolled substances in finished form— 1. The name of the substance;

The quantity manufactured in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch manufactured;
The quantity received from other persons including the date and quantity of each receipt and the name, address and registration number of the other person from whom the substance was received;
The quantity imported directly by the registrant (under a registration as an importer) for use in manufacture by him/her, including the date, quantity and import permit or declaration number for each importation;
The quantity used to manufacture the same substance in finished form including the date and batch or other identifying number of each manufacture; the quantity used in the manufacture; the finished form (for example, ten milligram (10 mg) tablets or ten milligram (10 mg) concentration per fluid ounce or milliliter); the number of units of finished form manufactured; the quantity used in quality control; the quantity lost during manufacturing and the causes for the loss, if known; the total quantity of the substance contained in the finished form; the theoretical and actual yields and other information as is necessary to account for all controlled substances used in the manufacturing process;
The quantity used to manufacture other controlled and noncontrolled substances, including the name of each substance manufactured and the information required in paragraph (1)(A)5. of this rule;
The quantity distributed in bulk form to other persons, including the date and quantity of each distribution and the name, address and registration number of each person to whom a distribution was made;
The quantity exported directly by the registrant, including the date, quantity and export permit or declaration number of each exportation;
The quantity distributed or disposed of in any other manner by the registrant (for example, distribution of complimentary samples or by destruction) including the date registration number of the person to whom distributed and the quantity distributed or disposed;

(B) For each controlled substance in finished form— 1. The name of the substance;

Each finished form (for example, ten milligram (10 mg) form in each commercial container (for example, 100 tablet bottle or three milliliter (3 ml) vial);
The number of containers of each such commercial finished form manufactured from bulk form by the registrant, including the information required in paragraph (1)(A)5. of this

rule;

The number of units of finished forms, commercial containers, or both, received from other persons, including the date of and number of units, commercial containers, or both, in each receipt and the name, address and registration number of the person from whom the units were received;
The number of units of finished form, commercial containers, or both, imported directly by the registrant, including the date of and the number of units, commercial containers, or both, in each importation;
The number of units, commercial containers, or both, manufactured by the registrant from units in finished form received from others or imported including: the date and batch or other identifying number of each manufacture; the operation performed (for example, repackaging or relabeling); the number of units of finished form used in the manufacture, the number manufactured and the number lost during the manufacture, with the causes for these losses, if known, and other information as is necessary to account for all controlled substances used in the manufacturing process;
The number of commercial containers distributed to other persons including the date of and number of containers in each distribution and the name, address and registration number of the person to whom the containers were distributed;
The number of commercial containers exported directly by the registrant, including the date, number of containers and export permit or declaration number for each exportation;
The number of units of finished forms, commercial containers, or both, distributed or disposed of in any other manner by the registrant (for example, by distribution of complimentary samples or by destruction), including the date registration number of the person to whom distributed and the quantity in finished form distributed or disposed.

(2) Records for Distributors. Each registered distributor shall (A) The name of the substance;

(B) Each finished form (for example, ten milligram (10 mg) form in each commercial container (for example, 100 tablet bottle or three milliliter (3 ml) vial);

(C) The number of commercial containers of each such finished form received from other persons, including the date of and number of containers in each receipt and the name, address and registration number of the person from whom the containers were received;

(D) The number of commercial containers of each finished form imported directly by the registrant including the date of and the number of containers in each importation;

(E) The number of commercial containers of each finished form distributed to other persons, including the date of and number of containers in each distribution and the name, address and registration number of the person to whom the containers were distributed;

(F) The number of commercial containers of the finished form exported directly by the registrant, including the date of and the number of containers in each exportation;

(G) The number of units or volume of finished forms, commercial containers, or both, distributed or disposed of in any other manner by the registrant (for example, by distribution as complimentary samples) including the date registration number of the person to whom distributed and the quantity of the substance in finished form distributed or disposed.

(3) Records for Importers. Each registered importer shall (A) The name of the substance;

(B) The quantity (or number of units or volume in finished form) imported, including the date, quantity (or number of units or volume) and import permit or declaration number for each importation;

(C) The quantity (or number of units or volume in finished form) distributed to other persons, including the date, quantity (or number of units or volume) of each distribution and the name, address and registration number of each person to whom a distribution was made;

(D) The quantity disposed of in any other manner by the registrant except quantities used in manufacturing by an importer under a registration as a manufacture, which quantities are to be recorded, including the date and manner of disposal and the quantity disposed.

(4) Records for Exporters. Each registered exporter shall (A) The name of the substance;

(B) The quantity (or number of units or volume in finished form) received from other persons, including the date and quantity (or number of units or volume) of each receipt and the name, address and registration number of each person from whom the substance was received;

(C) The quantity (or number of units or volume in finished form) exported, including the date, quantity (or number of units or volume) and the export permit or declaration number for each exportation, but excluding all quantities (and numbers of units and volumes) manufactured by an exporter under a registration as a manufacture, which quantities (and numbers of units and volumes) are to be recorded;

(D) The quantity disposed of in any other manner by the registrant including the date and manner of disposal and the quantity disposed. *Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957,

19 CSR 30-1.048 Records for Practitioners and Researchers {#sec-19-csr-30-1.048 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.048}

PURPOSE: This rule sets requirements for record keeping for practitioners and researchers. It also sets requirements for the use of facsimile and electronic prescriptions.

(1) Each individual practitioner, institutional practitioner, and pharmacy shall maintain records with the following information for each controlled substance received, maintained, dispensed, or disposed:

(A) The name of the substance;

(B) Each finished form (for example, ten milligram (10 mg) form in each commercial container (for example, one hundred (100) tablet bottle or three milliliter (3 ml) vial);

(C) The number of commercial containers of each finished form received from other persons, including the date of and number of containers in each receipt and the name, address and registration number of the person from whom the containers were received;

(D) The number of units or volume of the finished form dispensed including the name and address of the person to whom it was dispensed, the date of dispensing, the number of units or volume dispensed, and the written or typewritten name or initials of the individual who dispensed or administered the substance; and (E) The number of units or volume of the finished forms, commercial containers, or both, disposed of in any other manner by the registrant, including the date and manner of disposal and the quantity of the substance in finished form disposed.

(2) Each individual practitioner shall maintain a record of the date, full name and address of the patient, the drug name, strength, dosage form, and quantity for all controlled substances prescribed or administered. This record may be maintained in the patient’s medical record. When the controlled substance record is maintained in the patient’s medical record and the practitioner is not the custodian of the medical record, the practitioner shall make the controlled substance record available as required in 19 CSR 30-1.041 and 19 CSR 30-1.044.

(3) Individual practitioners shall maintain the records listed in subsections (1)(A)–(E) of this rule separately from patient medical records.

(4) A registrant who transfers a controlled substance to or receives a controlled substance from another registrant shall maintain a written record of the transfer which contains the following information: the date of transfer, drug name, strength, dosage form, quantity, name, address and registration number of the transferring registrant, and the name, address and registration number of the receiving registrant.

(5) Drug Enforcement Administration official order forms shall be used for transfers of Schedule II controlled substances.

(6) A prescription may not be issued for an individual practitioner to obtain controlled substances for dispensing or administering to patients.

(7) Prescriptions which are transmitted by facsimile to a pharmacy for dispensing shall include the telephone number of the facsimile machine or computer from which it is sent and the date and time of transmission. Immediately after a Schedule III, IV or V prescription or a Schedule II prescription for a long-term care facility patient or hospice patient or for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion is transmitted to a pharmacy by facsimile equipment, the practitioner or the practitioner’s agent shall sign and date the face of the prescription. The prescriptions shall be maintained in chronological order separately from patient medical records in a manner so each prescription is readily retrievable for inspection at the transmitting practitioner’s office. In the event the facsimile is transmitted from a long-term care facility or hospital, the prescription shall be maintained at the long-term care facility or hospital in chronological order separately from the patient medical records in a manner so each prescription is readily retrievable, or maintained in the patient medical records.

(8) Any pharmacy receiving a controlled substance prescription transmitted by facsimile equipment shall maintain the facsimile copy of the prescription along with the date and time of transmission and the telephone number of the facsimile machine from which it originated, as a part of its original prescription records.

(9) The creation, signature, transmission, and processing of controlled substance prescriptions electronically and record keeping for electronic controlled substance prescriptions shall meet the requirements of 21 CFR Parts 1300 to end, which are hereby incorporated by reference in this rule as published April 1, 2014, by the Office of Federal Register, National Archives and Records Administration, and are made available to the public by the U.S. Government Printing Office, 732 N. Capitol Street NW, Washington, D.C. 20401, or at www.gpoaccess.gov/cfr/. This

rule does not incorporate any subsequent amendments or additions.

History

AUTHORITY: section 195.050, RSMo 2000, and section 195.195, RSMo Supp. 2014. Original rule filed April 14, 2000, effective Nov. 30, 2000. Amended: Filed Jan. 29, 2015, effective July 30, 2015. Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957,

19 CSR 30-1.050 Records for Chemical Analysts {#sec-19-csr-30-1.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.050}

PURPOSE: This rule sets requirements for record keeping for chemical analyst registrants.

(1) Each person registered to conduct chemical analysis with controlled substances shall maintain records with the following information (to the extent known and reasonably ascertainable by him/her) for each controlled substance:

(A) The name of the substance;

(B) The form(s) in which the substance is received, imported or manufactured by the registrant (for example, powder, granulation, tablet, capsule or solution) and the concentration of the substance in that form (for example, Chemically Pure (CP), United States Pharmacopeia (USP), National Formulary (NF), ten milligram (10 mg) tablet or ten milligram (10 mg) concentration per milliliter);

(C) The total number of the forms received, imported or manufactured (for example 100 tablets, 30 one milliliter (1 ml) vials or ten grams (10 g) powder), including the date and quantity of each receipt, importation or manufacture and the name, address and registration number, if any, of the person from whom the substance was received; and (D) The quantity distributed, exported or destroyed in any manner by the registrant (except quantities used in chemical analysis or other laboratory work), including the date and manner of distribution, exportation or destruction and the name, address and registration number, if any, of each person to whom the substance was distributed or exported.

(2) Order forms, import and export permits, import invoices and export declarations relating to controlled substances shall be maintained separately from all other records of the registrant.

(3) Records of controlled substances used in chemical analysis or other laboratory work are not required.

(4) Records relating to known or suspected controlled substances received as samples for analysis are not required under section (1) of this rule. *Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957,

19 CSR 30-1.052 Records for Long-Term Care Facilities (LTCF) {#sec-19-csr-30-1.052 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.052}

PURPOSE: This rule sets requirements for record keeping by longterm care facility registrants.

(1) Long-term care facilities (LTCFs) and their suppliers shall maintain written records of transfers of controlled substances from the supplier to the LTCF emergency kit.

(2) The records shall include the date of transfer; the name of each controlled substance, the strength, dosage form and quantity; the name, address and controlled substance registration number of the supplier and the name, address and controlled substance registration number of the LTCF. Federal Drug Enforcement Administration (DEA) official order forms shall not be used to record transfers of controlled substances to LTCF emergency kits.

(3) No physician’s order or prescription shall be used for initial stocking or replacement of controlled substances in the emergency kit. Controlled substances contained in the kit shall be obtained from a pharmacy, hospital or practitioner who holds a controlled substances registration.

(4) The administration and medical staff of the LTCF, in conjunction with the primary supplier, shall designate in written protocols and procedures who may have access to the emergency kit, who may administer controlled substances from the emergency kit and under what circumstances and a list of the controlled substances it intends to maintain in the emergency kit. These protocols and procedures shall be subject to review and approval by the Department of Health.

Only those individuals designated in the LTCF’s written policies and procedures shall have access to or administer controlled substances from the emergency kit.

(5) Each administration of controlled substances from the emergency kit shall be based upon a practitioner’s order and shall be recorded in an administration record separate from the patient’s medical record. This administration record shall include: the date, patient’s name, drug name, drug strength, dosage, ordering practitioner’s name and name of the person administering the controlled substance. *Original authority: 195.050, RSMo 1939, amended 1971, 1989 and 195.195, RSMo 1957,

19 CSR 30-1.060 Determining Lawful Prescribing, Dispensing and Administering of Controlled Substances {#sec-19-csr-30-1.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.060}

PURPOSE: This rule defines the statutory and regulatory basis for determining what is lawful prescribing, dispensing and administering of controlled substances.

When determining if controlled substances are being lawfully prescribed, dispensed and administered by practitioners, the Department of Health shall enforce Chapter 195, RSMo, the Department of Health rules in 19 CSR 30 pertaining to controlled substances, and the federal Controlled Substances Act 21 U.S.C. 801–966, and its regulations, 21 CFR 1300–1399. In determining lawful prescribing, dispensing and administering of controlled substances, the Department of Health also shall consider the provisions of Chapters 330, 332, 334, 335, 336, 338 and 340, RSMo, the rules in 4 CSR 110, 4 CSR 150, 4 CSR 200, 4 CSR 210, 4 CSR 220, 4 CSR 230 and 4 CSR 270, and protocols relating to the respective practitioners established and on file at the respective licensing boards.

History

AUTHORITY: sections 195.030, RSMo Supp. 1999 and 195.195, RSMo 1994. Original rule filed April 14, 2000, effective Nov 30, 2000. Original authority: 195.030, RSMo 1939, amended 1971, 1989, 1993, 1995, 1999 and 195.195, RSMo 1957, amended 1971, 1989, 1993.

19 CSR 30-1.062 Transmission of Prescriptions {#sec-19-csr-30-1.062 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.062}

PURPOSE: This rule sets requirements governing the transmission of prescription information.

(1) Prescriptions in Schedule II. A pharmacist may dispense a controlled substance in Schedule II only under a written prescription signed by the practitioner, except as provided in section 195.060.3, RSMo. A prescription for a Schedule II controlled substance may be transmitted from the prescribing practitioner to a pharmacy by facsimile equipment, provided the original written, signed prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance, except that— (A) A prescription written for a Schedule II narcotic substance to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion may be transmitted by the practitioner or the practitioner’s agent to the pharmacy by facsimile. The facsimile which has been reduced to writing shall serve as, and shall be maintained in the same manner, as an original written (B) A prescription written for a Schedule II substance for a resident of a long-term care facility may be transmitted by the practitioner or the practitioner’s agent to the pharmacy by facsimile. The facsimile which has been reduced to writing shall serve as, and shall be maintained in the same manner, as an original written prescription.

(C) A prescription written for a Schedule II substance for a patient of a hospice may be transmitted by the practitioner or the practitioner’s agent to the pharmacy by facsimile.

The practitioner or the practitioner’s agent shall note on the prescription that the patient is a hospice patient. The facsimile which has been reduced to writing shall serve as, and shall be maintained in the same manner, as an original written (2) Prescriptions in Schedule III, IV, or V. A pharmacist may dispense directly a controlled substance in Schedule III, IV, or V only under a written prescription signed by a practitioner or a facsimile of a written, signed prescription transmitted by the practitioner or his/her authorized agent or under an oral prescription made by an individual practitioner whether communicated by the practitioner or his/her authorized agent by the authorizing practitioner or the practitioner’s agent to the pharmacy. All oral prescriptions shall be promptly reduced to writing by the pharmacist containing all information required in section 195.060, RSMo, except for the signature of the practitioner.

(3) Written Prescriptions. All written controlled substance prescriptions shall be signed by the prescribing practitioner on the date prescribed. No controlled substance prescription shall be signed prior to the actual date it is issued.

(4) Prescriptions Transmitted by Electronic Computer Transmission. A pharmacist may dispense a controlled substance in Schedule II, III, IV, or V under a prescription transmitted from the prescribing practitioner to a pharmacy by electronic computer transmission provided that the prescription and its transmission complies with federal law regarding electronic prescriptions as found in the Code of Federal Regulations, Title 21 Part 1300 to end. The federal rules regarding electronic prescriptions are hereby incorporated by reference in this rule as published April 1, 2014, by the Office of Federal Register, National Archives and Records Administration, and are made available to the public by the U.S. Government Printing Office, 732 N. Capitol Street NW, Washington, D.C. 20401, or at www.gpoaccess.gov/cfr/. This rule does not incorporate any subsequent amendments or additions.

History

AUTHORITY: section 195.195, RSMo Supp. 2014. Original rule filed April 14, 2000, effective Nov. 30, 2000. Amended: Filed Jan. 29, 2015, effective July 30, 2015.

19 CSR 30-1.064 Partial Filling of Controlled Substance Prescriptions {#sec-19-csr-30-1.064 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.064}

PURPOSE: This rule sets requirements for the partial filling of controlled substance prescriptions.

(1) The partial filling of a controlled substance listed in Schedule II is permitted as provided in this rule and federal regulations.

(A) Insufficient supply on hand. The partial filling of a prescription for a controlled substance listed in Schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription, and s/he makes a notation of the quantity supplied on the face of the written prescription (or written record of the emergency oral prescription), or in the electronic record. The remaining portion of the prescription may be filled within seventy-two (72) hours of the first partial filling; however, if the remaining portion is not or cannot be filled within the seventy-two- (72-) hour period, the pharmacist shall so notify the prescribing individual practitioner. No further quantity may be supplied beyond seventy-two (72) hours without a new prescription.

(B) Long-term care or terminally ill patient. A prescription for a Schedule II controlled substance written for a patient in a long-term care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness may be filled in partial quantities to include individual dosage units.

If there is any question whether a patient may be classified as having a terminal illness, the pharmacist must contact the practitioner prior to partially filling the prescription.

Both the pharmacist and the prescribing practitioner have a corresponding responsibility to assure that the controlled substance is for a terminally ill patient. The pharmacist must record on the prescription whether the patient is “terminally ill” or an “LTCF patient.” A prescription that is partially filled and does not contain the notation “terminally ill” or “LTCF patient” shall be deemed to have been filled in violation of

Chapter 195, RSMo. For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained and readily retrievable) the date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist. The total quantity of Schedule II controlled substances dispensed in all partial fillings must not exceed the total quantity prescribed. Schedule II prescriptions for patients in a LTCF or patients with a medical diagnosis documenting a terminal illness shall be valid for a period not to exceed sixty (60) days from the issue date unless sooner terminated by the discontinuance of medication.

(C) Patient or prescriber request. For a patient who is not terminally ill or a patient in a long-term care facility, the partial filling of a prescription for a controlled substance listed in Schedule II may occur at the request of a patient or it may be directed by the prescriber in the manner established by applicable federal regulations. The dispensing of a partial filling under this subsection shall not occur beyond thirty (30) days from the date of the issuance of the prescription.

(2) The partial filling of a prescription for controlled substances listed in Schedules II, III, IV, or V is permissible, provided that— (A) Each partial dispensing is recorded in the same manner as a refilling would be;

(B) With each partial dispensing, the pharmacy must document the date and quantity dispensed on the original prescription record or their electronic computer applications, provided that the electronic system meets all of the federal requirements for handling of electronic prescriptions for controlled substances, including the ability to retrieve the information pertaining to partially filled controlled substances;

(D) No dispensing occurs— 1. For controlled substances listed in Schedule II written for a patient in a long-term care facility (LTCF) or for a patient with a medical diagnosis documenting a terminal illness, sixty (60) days after the date on which the original prescription was issued;

For a partial filling of a prescription of a controlled substance listed in Schedule II at the request of a prescribing practitioner or patient, thirty (30) days after which the original prescription was issued;
For emergency oral prescriptions for controlled substances listed in Schedule II, seventy-two (72) hours after which the original emergency oral prescription was issued; and 4. For controlled substances listed in Schedules III and IV, six (6) months after the date on which the original prescription was issued;

(E) A partial dispensing is not considered a “refill” if the patient does not receive the full authorized amount at one time; and (F) The prescription was written and filled in accordance with all other applicable laws and regulations.

Emergency amendment filed Sept. 17, 2018, effective Sept. 27, 2018, expired March 25, 2019. Amended: Filed Sept. 17, 2018, effective March 30, 2019. Amended: Filed Oct. 30, 2020, effective April 30, 2021. Amended: Filed Feb. 27, 2024, effective Aug. 30, 2024. *Original authority: 195.080, RSMo 1939, 1965, 1971, 1987, 1989, 1997, 2005, 2010, 2012, 2014, 2018, 2019, and 195.195, RSMo 1957, amended 1971, 1989, 1993, 2014.

History

AUTHORITY: section 195.080, RSMo Supp. 2023, and section 195.195, RSMo 2016. Original rule filed April 14, 2000, effective Nov. 30, 2000. Amended: Filed Jan. 29, 2015, effective July 30, 2015.

19 CSR 30-1.066 Dispensing by Individual Practitioners {#sec-19-csr-30-1.066 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.066}

PURPOSE: This rule sets requirements for individual practitioners who dispense controlled substances.

(1) An individual practitioner who dispenses controlled substances shall— (A) Provide direct supervision to employees or agents who assist in the administering or dispensing of controlled substances. Controlled substances shall not be dispensed from an individual practitioner’s inventory unless a practitioner is physically in the registered location except pursuant to the provisions of section (2) of this rule;

(B) Package all controlled substances dispensed from an individual practitioner’s inventory in compliance with the Poison Prevention Packaging Act of 1970, 15 U.S.C. 1471–1476;

(C) Permanently affix a label to the exterior of the drug container which includes: the date, the name and address of the dispensing practitioner, the name of the patient, directions for use, and the exact name and strength of the drug dispensed for all controlled substances dispensed;

(D) Dispense only to individuals with whom the practitioner has established and documented a practitioner/patient relationship. An individual practitioner shall not dispense under the order of another practitioner not practicing at that location.

(2) Mid-level practitioners shall not independently purchase, stock, administer, and dispense controlled substances.

Controlled substances may be administered or dispensed from an individual practitioner’s inventory by a mid-level practitioner with whom he or she has entered into an agreement pursuant to Chapter 334, RSMo, when the practitioner is not present at the registered location. 14, 2000, effective Nov. 30, 2000. Amended: Filed April 29, 2011, effective Nov. 30, 2011.

19 CSR 30-1.068 Administering In Emergency Rooms {#sec-19-csr-30-1.068 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.068}

PURPOSE: This rule sets requirements for administering controlled substances in hospital emergency rooms.

(1) Controlled substances may be administered to a hospital emergency room patient under a verbal order of a registered practitioner who is not physically present if— (A) The order is for a legitimate medical purpose and the practitioner who orders the administration of a controlled substance is acting in the usual course of his/her medical practice, after sufficient examination and establishment of a practitioner/patient relationship;

(B) The practitioner who orders the administration of a controlled substance is a medical staff member of the hospital;

(D) The patient is assessed in the hospital by a practitioner, when available, or a registered nurse. If the patient is not assessed by a practitioner in the hospital, a registered nurse shall assess the patient and confirm and document in the patient’s medical record the existence of a preestablished practitioner/patient relationship with the practitioner who ordered administration of a controlled substance;

(E) The order is written in the patient’s medical record and is authenticated by the ordering practitioner within a time frame and manner as defined by the medical staff in cooperation with nursing and administration. This policy shall be included in the hospital’s written policies and procedures.

19 CSR 30-1.070 Emergency Dispensing of Schedule II {#sec-19-csr-30-1.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.070}

PURPOSE: This rule provides for the prescribing and dispensing of Schedule II drugs in an emergency situation.

(1) In the case of a bona fide emergency situation, as defined by the Department of Health, a pharmacist may dispense a Schedule II controlled substance upon receiving oral authorization of a prescribing practitioner; provided, that— (A) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period. Prescribing or dispensing beyond the emergency period must be pursuant to a written prescription;

(B) The prescription immediately shall be reduced to writing by the pharmacist and shall contain all information, except for the prescribing practitioner’s signature;

(C) If the prescribing practitioner is not known to the pharmacist, s/he must make reasonable effort to determine that the oral authorization came from a practitioner, by verifying his/her phone number against that listed in the directory and other good faith efforts to insure his/her identity;

(D) Within seven days after authorizing an emergency oral prescription, the prescribing practitioner must cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. The prescription shall have written on its face authorization for emergency dispensing. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the seven-day period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription which had earlier been reduced to writing. The pharmacist shall notify the Department of Health if the prescribing practitioner fails to deliver a written prescription to him/her; failure of the pharmacist to do so shall void the authority conferred by this section to dispense without a written prescription of a prescribing practitioner.

(2) Definition of Emergency Situation. For the purpose of authorizing an oral prescription of a controlled substance listed in Schedule II of the controlled substances law (sections 195.010–195.320, RSMo), the term emergency situation means those situations in which the prescribing practitioner determines that— (A) Immediate administration of a controlled substance is necessary for proper treatment of the intended ultimate user;

(B) No appropriate alternative treatment is available, including administration of a drug which is not a controlled substance under Schedule II;

(C) It is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance prior to the dispensing.

19 CSR 30-1.072 Dispensing of Schedule V Substances {#sec-19-csr-30-1.072 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.072}

PURPOSE: This rule provides for the prescribing, administering and dispensing of Schedule V drugs.

(1) A pharmacist may dispense directly a controlled substance listed in Schedule V pursuant to a prescription. A prescription for a controlled substance listed in Schedule V may be refilled only as expressly authorized by the prescribing individual practitioner. If this authorization is not given, the prescription may not be refilled. A pharmacist dispensing those substances pursuant to a prescription shall label the substance and file the (2) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule V in the course of his/her professional practice without a prescription.

(3) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule V only pursuant to a written prescription signed by the prescribing individual practitioner or pursuant to an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist (containing all information required except for the signature of the prescribing individual practitioner) or pursuant to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user.

19 CSR 30-1.074 Dispensing Without a Prescription {#sec-19-csr-30-1.074 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.074}

PURPOSE: This rule provides for dispensing Schedule V controlled substances without a prescription in certain situations.

(1) Definitions. For the purposes of this rule, the following terms shall apply:

(A) “Dispenser” means a pharmacist, intern pharmacist, or registered pharmacy technician who sells, dispenses, or otherwise provides methamphetamine precursor products to purchasers.

(B)“Methamphetamine precursor products” means both Schedule V pseudoephedrine products and any other drug product containing any detectable amount of ephedrine, pseudoephedrine, or phenylpropanolamine, including the salts or optical isomers or salts of optical isomers or ephedrine, its salts or optical isomers, or salts of optical isomers of ephedrine, pseudoephedrine, or phenylpropanolamine.

(C) “Valid photo identification” means a photo identification that is issued by a state or the federal government or a document that, with respect to identification, is considered acceptable and showing the date of birth of the person, including forms of identification acceptable under federal regulations 8 CFR 274a.2(b)(1)(v)(A) and (B).

(2) Dispensing Without a Prescription. A controlled substance listed in Schedule V which is not a prescription drug under the federal Food, Drug and Cosmetic Act, and is not a methamphetamine precursor product, may be dispensed by a pharmacist without a prescription to a purchaser at retail; provided, that— (A) Dispensing is made only by a pharmacist and not by a non-pharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his/ her professional and legal responsibilities, the actual cash transaction, credit transaction, or delivery may be completed by a non-pharmacist); and (B) Dispensing, sale, distribution, or otherwise providing is limited to not more than two hundred forty cubic centimeters (240 cc) or eight ounces (8 oz.) of any controlled substance containing opium, nor more than one hundred twenty cubic centimeters (120 cc) or four ounces (4 oz.) of any other controlled substance, nor more than forty-eight (48) dosage units of any controlled substance containing opium, nor more than twenty-four (24) dosage units of any other controlled substance may be dispensed at retail to the same purchaser in any given forty-eight (48)-hour period.

(3) Methamphetamine precursor products may be sold, dispensed, distributed, or otherwise provided only as follows:

(A) Products that are designated Schedule V controlled substances which contain any detectable amount of pseudoephedrine, ephedrine, phenylpropanolamine, their salts or optical isomers, or salts of their optical isomers may be sold, distributed, or otherwise provided only by a pharmacist or pharmacy ancillary personnel as authorized by the Missouri State Board of Pharmacy;

(B) Dispensers of methamphetamine precursor products shall exercise reasonable care in assuring that the purchaser has not exceeded the three and six-tenths- (3.6-) gram limit per day or the seven and two-tenths- (7.2-) gram limit per thirty- (30-) day period. Within any twelve- (12-) month period, no person shall sell, dispense, or otherwise provide the same individual, and no person shall purchase, receive, or otherwise acquire more than forty-three and two-tenths- (43.2-) grams, without regard to the number of transactions;

(C) Dispensers shall utilize the real-time electronic pseudoephedrine tracking system established and maintained by the Missouri Department of Health and Senior Services (DHSS). No prescription shall be required for the sale or dispensing of these drug products; however, prescribers and patients may voluntarily choose to use a prescription by voluntary choice when deemed appropriate by the prescriber in the course of his or her professional practice;

(D) Methamphetamine precursor products regulated by Missouri law as controlled substances shall only be sold to customers eighteen (18) years of age or older who present a valid photo identification;

(E) Any dispenser who sells, dispenses, or otherwise provides any methamphetamine precursor product shall submit the following information to the DHSS electronic database at the time of purchase:

Date and time of transaction;
Pharmacy identification information, including:

A. National Council for Prescription Drug Programs identification number; or B. National Association of Boards of Pharmacy identification number; or C. Vendor assigned site and/or pharmacy identifier;

Purchaser information, including the following fields:

A. Purchaser’s given or first name;

B. Purchaser’s middle name (if any);

C. Purchaser’s surname or last name;

D. The purchaser’s full name shall be entered into the database without the use of initials or nicknames;

E. Purchaser’s date of birth; and F. Purchaser’s address, including number, street, city, state, and zip code;

Identification of the form of valid photo identification presented by the purchaser; including issuing agency of the photo identification and identification number appearing on the photo identification;
Purchaser’s signature;
Dispenser identification, including:

A. The name of the individual performing the transaction; or B. The initials of the individual performing the transaction;

Transaction number, assigned by the database provider/ vendor;
Purchase transaction information, including the following:

A. Product Universal Product Code (UPC);

B. Product National Drug Code (NDC) (optional);

C. Unique product description; and D. Purchase quantity, in grams as— (I) Product grams per box and number of boxes in transaction;

(II) Product grams per dosage form such as tablet, capsule, or milliliter, and number of dosages per transaction; or (III) Other mechanism identified by the database provider/vendor; and 9. Form of pseudoephedrine in a manner defined by the database provider/vendor, including but not limited to:

A. Tablet;

B. Capsule;

C. Liquid-filled gelcap; or D. Liquid;

(F) Purchaser information provided and entered into the DHSS electronic database shall be the same as that on the presented identification. Full names shall be used and not merely initials or a nickname;

(G) If the DHSS electronic database is not available at the time of the sale of the methamphetamine precursor product, the information to be provided in subsection (3)(E) above shall be recorded manually and entered into the DHSS electronic database as soon as practicable after the system is back online, as specified in subsection (3)(I). Signatures shall be captured on paper and then may be scanned to the database;

(H) Every dispenser who sells, dispenses or otherwise provides any methamphetamine precursor product shall maintain a bound logbook in addition to the electronic database system.

The logbook shall be used for documenting a clear audit trail of any alterations, changes, or deletions to the original transaction record, and sales that occurred during system failures, including date and time of entry into the database, justification, and resultant contacts with law enforcement because the override button was used;

(I) In the event that the DHSS electronic database is unavailable for five (5) minutes or more due to a failure on the DHSS network or because of a failure attributable to systems other than the DHSS, the dispenser may continue with the transaction until the system is available. All information required to be captured with each transaction shall be retained and documented. The information may be entered into the database where it may be held pending until the system comes back on line, or all of the required information for transactions occurring during the time the DHSS electronic database is unavailable must be recorded manually and entered into the DHSS electronic database by the registrant as soon as is practicable, but within no more than forty-eight (48) hours following the resumption of operability. Documentation shall also identify the reason for the late entry into the DHSS electronic database;

(J) At least once each month, the pharmacist-in-charge shall review the logbook of changes and the changes captured by the database to see what changes and alterations pharmacy employees have entered regarding sales of methamphetamine precursors. The date and time that the pharmacist-in-charge conducts this monthly review shall be documented in the bound logbook maintained by the pharmacy in addition to the electronic system;

(K) Documentation in the bound logbook shall be maintained in a readily retrievable manner for two (2) years from the date of the transaction and available for inspection and copying by authorized DHSS employees and law enforcement;

(L) Denials of Sales and Dispensings.

Except as provided in subsection (D) of this section, if an individual attempts to purchase a methamphetamine precursor product in violation of the three and six-tenths (3.6) gram per day or seven and two-tenths (7.2) gram per month quantity restrictions or age restriction established by sections 195.017 and 195.417, RSMo, the dispenser shall refuse to make the sale. The purchaser must be at least eighteen (18) years of age.
Sales of methamphetamine precursor products shall be denied to purchasers who are not able to produce a valid government issued identification card with the required information displayed on it.
In the event that the dispenser perceives that refusal of the purchase may place him or her in imminent physical harm, then the dispenser may use the database safety override function to proceed with the transaction, provided that— A. When jeopardy is no longer perceived, the dispenser shall immediately contact local law enforcement to report the purchase; and B. The dispenser shall document in their manual log, the circumstance, the individual contacted at the local law enforcement agency, and the date and time of that contact;

(M) Pharmacy Employees. Employees in a pharmacy shall be assigned individual personal passwords to identify their own transactions in the database.

Pharmacy employees shall only use their own passwords for their own transactions and shall not dispense or make a sale under the password of another person.
The database computer shall not be left on and unattended so that another person can use the previous user’s password. Users shall close out their personal access when their activities are completed.
The pharmacist-in-charge shall be responsible for insuring pharmacy employees have adequate password privileges. The pharmacist-in-charge shall insure that new employees have their own personal passwords and also insure that ex-employees have their passwords removed from the system;

(N) Access to Database by Law Enforcement and Regulatory Agencies.

Access to the database and controlled substance records shall be made available to those agencies with authority under

Chapter 195 and Chapter 338, RSMo.

Law enforcement agencies and regulatory agencies shall only have the ability to read and review and shall not be able to enter data or change records.
It shall be the responsibility of each agency’s administrator, chief, sheriff, or other chief executive officer to insure— A. Only authorized employees have access to the database;

B. Employees only use their own passwords and passwords are not shared;

C. Each employee adheres to all state and federal laws regarding confidentiality; and D. As employees change, that new passwords are assigned to new employees and passwords of ex-employees or transferred employees are removed. The chief, sheriff, or chief executive officer of the law enforcement or regulatory agency shall notify the DHSS in writing when an employee’s access is to be added or removed; and (O) Method for Enforcement Agencies to Gain or Alter Access to the Database.

Requests submitted to the DHSS to add or remove an employee from access to the database shall— A. Be submitted in writing on the agency’s letterhead;

B. State whether this is a request for an employee to be granted access to the database or a request to remove an employee’s access;

C. Provide the employee’s full name and title;

D. Provide the employee’s Missouri POST certification number if the employee is a sworn law enforcement officer; and E. Be signed by the chief, sheriff, or chief executive officer of the requesting agency.

Multiple requests for multiple employees and actions may be submitted on one (1) letter.
The DHSS shall notify the provider of the database in writing of persons who are given access or have access removed.
The DHSS may restrict access to the database to a limited number of people in each agency, depending on the size of the agency, their locations, and number of sworn officers engaged in the actual enforcement of controlled substance laws.

rule filed April 14, 2000, effective Nov. 30, 2000. Emergency amendment filed Aug. 18, 2005, effective Aug. 28, 2005, expired Feb. 23, 2006. Amended: Filed Sept. 1, 2005, effective Feb. 28, 2006.

Emergency amendment filed July 9, 2010, effective Sept. 28, 2010, expired March 26, 2011. Amended: Filed June 29, 2010, effective Jan. 30, 2011. Amended: Filed Oct. 30, 2020, effective April 30, 2021. *Original authority: 195.017, RSMo 1971, amended 1987, 1989, 1994, 1996, 1997, 1998, 2001, 2005, 2006, 2008, 2010, 2011, 2014, 2018, 2020; 195.030, RSMo 1939, amended 1971, 1989, 1993, 1995, 1997, 1999, 2014; 195.050, RSMo 1939, amended 1971, 1989, 2014; 195.195, RSMo 1957, amended 1971, 1989, 1993, 2014; and 195.417, RSMo 2001, amended 2003, 2005, 2008, 2014, 2020.

History

AUTHORITY: section 195.017, RSMo Supp. 2020, and sections 195.030, 195.050, 195.195, and 195.417, RSMo 2016. Original

19 CSR 30-1.076 Emergency Distribution by a Pharmacy {#sec-19-csr-30-1.076 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.076}

PURPOSE: This rule provides for dispensing of controlled substances by a pharmacy in emergency situations.

(1) An emergency means a situation where a quantity of a controlled substance must be dispensed by a pharmacy to a patient who does not have an alternative source for that substance reasonably available to him/her and the pharmacy cannot obtain that substance through its normal distribution channels within the time required to meet the immediate needs of the patient for that substance. In the event of an emergency, a pharmacy may distribute (without being registered as a distributor) a controlled substance in Schedule III, IV or V to a second pharmacy in order for that pharmacy to dispense the substance; provided, that— (A) The amount distributed does not exceed the amount required by the second pharmacy for his/her immediate dispensing;

(B) The distribution is recorded as being dispensed by the first pharmacy and the second pharmacy records the substance as being received. Each pharmacy will retain a signed receipt of the distribution;

(D) If the substance is a Schedule II controlled substance, the official order form designated by the federal Drug Enforcement Administration must be used to document the transfer.

19 CSR 30-1.078 Disposing of Unwanted Controlled {#sec-19-csr-30-1.078 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.078}

PURPOSE: This rule establishes procedures for disposing of unwanted controlled substances.

(1) A registrant in possession of any controlled substance(s) and desiring or required to dispose of such substance(s) shall:

(A) Return the controlled substances to the original supplier;

(B) Transfer the controlled substances to a distributor authorized to accept controlled substances for the purpose of disposal;

(D) Become an Authorized Collector of Controlled Substances.

Registrants shall dispose of all unwanted controlled substances and keep records in accordance with federal regulations.

Only manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an on-site pharmacy, and retail pharmacies that have modified their state and federal controlled substances registrations may possess a collection receptacle for medication disposal or participate in the DEA approved mail-back system;

(E) Contact the Bureau of Narcotics and Dangerous Drugs (BNDD), Department of Health and Senior Services for information pertaining to subsections (1)(A), (B), (C) or (D) of this rule.

(2) Destruction of controlled substances in patient care areas.

(A) Controlled substances that have been contaminated by patient contact are to be destroyed on site. An excess volume of a controlled substance which must be discarded from a dosage unit just prior to administration shall also be destroyed on site.

(B) Controlled substances that have not been contaminated by patient contact or are not excess volumes of a dosage unit shall not be destroyed on site unless the registrant maintains a DEA Form 41 in compliance with federal regulation. Unwanted controlled substances that have been expired, discontinued, or are otherwise unwanted shall be disposed of by methods listed previously in section (1) of this rule.

(C) In a patient care area of a hospital with an on-site pharmacy, unwanted controlled substances that have not been contaminated by patient contact shall be returned to the pharmacy for final disposal.

(D) The destruction of controlled substances shall be in such a manner that it renders the medication unrecoverable and beyond reclamation so that it cannot be diverted.

(E) The destruction and documentation of destruction shall be performed and completed by two (2) people. One of the people must be a licensed physician, nurse, pharmacist, intern pharmacist, or pharmacy technician, assistant physician, physician assistant, podiatrist, optometrist, dentist or veterinarian. The second person, the witness, is not required to be a licensed medical professional, but must be an employee of the registrant, unless in an EMS setting.

(F) The following shall be entered in the controlled substance administration record or a separate controlled substance destruction record when the controlled substance is destroyed in the patient care area: the date and hour of destruction, the drug name and strength, the amount destroyed, the reason for destruction, and the patient’s name and room number if applicable, and the names or initials of the two (2) persons performing the destruction. The controlled substance administration and destruction records are to be retained for two (2) years and available for inspection by the Department of Health and Senior Services;

(3) In the event the registrant is a hospital, the following procedures are to be used for the destruction of controlled substance(s):

(A) When disposal of controlled substance(s) is in patient care areas— 1. Controlled substances which are contaminated by patient body fluids are to be destroyed by a physician, nurse, or a pharmacist in the presence of another hospital employee;

An excess volume of a controlled substance which must be discarded from a dosage unit just prior to use shall be destroyed by a nurse, pharmacist, or physician in the presence of another hospital employee;
The remaining contents of opened glass ampules of controlled substance(s) shall be destroyed by a nurse, pharmacist, or physician in the presence of another hospital employee;
Single units of single dose packages of controlled substance(s) which are contaminated other than by patient body fluids and are not an infectious hazard, have been removed from their original or security packaging, are partially used, or are otherwise rendered unsuitable for patient use shall be destroyed by a nurse, pharmacist, or physician in the presence of another hospital employee or returned to the pharmacy for destruction;
The following shall be entered in the controlled substance administration record or a separate controlled substance destruction record when the controlled substance(s) is destroyed in the patient care area: the date and hour of destruction, the drug name and strength, the amount destroyed, the reason for destruction, and the patient’s name and room number. The nurse, pharmacist, or physician and the witnessing hospital employee shall sign the entry. The drug shall be destroyed so that it is beyond reclamation. The controlled substance administration or destruction records are to be retained for two (2) years and available for inspection by Department of Health investigators;
All other controlled substances which are not patient contaminated but which are to be disposed of shall be returned to the pharmacy for disposal;

(B) When disposal of controlled substance(s) is in the pharmacy— 1. Single units of controlled substance(s) which are contaminated other than by patient body fluids and are not an infectious hazard, have been removed from their original or security packaging, are partially used, or are otherwise rendered unsuitable for patient use shall be destroyed by a pharmacist in the presence of another hospital employee or held for later destruction;

All other controlled substances which are not patient contaminated but are to be disposed of shall be placed in a suitable container for storage and disposed of as described in

section (1) of this rule.

(4) Collection Receptacle Boxes and Mail-Back Programs for Patients’ Unwanted Controlled Substance Prescriptions.

(A) Manufacturers, distributors, reverse distributors, narcotic treatment programs, hospitals/clinics with an onsite pharmacy, and retail pharmacies are authorized to install collection receptacle boxes or participate in a DEA approved mail-back method to collect unwanted controlled substance prescription medications from patients. Registrants must comply with federal regulations regarding security and record keeping. Collection receptacles shall be used only for patients’ unwanted medications and not for the expired or unwanted stock of a practitioner or facility.

(B) All facilities and locations with collection receptacle boxes and mail-back systems shall comply with federal regulations.

Patients’ medications from long-term care facilities and narcotic treatment programs shall be placed in a receptacle within three (3) days of the expiration date on the medication; or upon a discontinuation of use authorized by a prescriber; or upon the death of a patient.

Registrants or their employees shall not inventory the contents of the collection receptacle box. The collection receptacle box is to be opened by two (2) people; one shall be an employee of the pharmacy and the other may be an employee of the facility receiving pharmaceutical services. All registrants with collection receptacle boxes shall maintain a perpetual log that documents entry into the collection receptacle box, changing of liners, and transfers of drugs from the registrant to a reverse distributor. These logs shall be maintained on file at the registered location for inspection and shall document the date of entries into the collection receptacle box, the names of the employees entering the collection receptacle box, the reason for entering the receptacle, the serial number of a liner being removed, and the serial number of a new liner being installed.

This log shall also be used to document the transfer of a liner from the registrant to a reverse distributor by documenting the date of transfer, serial number of the liner, names of the persons involved in the transfer, and the DEA number of the reverse distributor. The log shall also document when the pharmacy changes out the interior liner bags and document the serial number of the bag being removed and of the new bag being installed.

History

AUTHORITY: sections 195.050 and 195.195, RSMo Supp. 2018. Original rule filed April 14, 2000, effective Nov. 30, 2000. Emergency amendment filed Sept. 17, 2018, effective Sept. 27, 2018, expired March 25, 2019. Amended: Filed Sept. 17, 2018, effective March 30, 2019. Original authority: 195.050, RSMo 1939, amended 1971, 1989, 2014 and 195.195, RSMo 1957, amended 1971, 1989, 1993, 2014.

19 CSR 30-1.080 Electronic Prescribing Waiver {#sec-19-csr-30-1.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-1.080}

PURPOSE: This rule establishes the process for practitioners to obtain waivers to the electronic prescribing requirements established by section 195.550, RSMo.

(1) Practitioners required to utilize electronic prescribing pursuant to section 195.550, RSMo may request a waiver of this requirement from the Department of Health and Senior Services.

(A) Applications shall only be submitted by practitioners with active Missouri Controlled Substance Registrations.

Applications shall not be submitted by a registrant’s designee or representative.

(B) Applicants requesting a waiver shall submit an application for a waiver by sending their application to BNDDRxWaiver@ health.mo.gov. A sample application may be found on the Department’s website, www.health.mo.gov/safety/bndd.

Applicant’s first and last name;
Applicant’s licensure type;
Applicant’s Missouri Controlled Substance Registration 4. Applicant’s email address;
The Applicant shall indicate for which of the following reasons they are seeking a waiver:

A. Economic hardship;

B. Technological limitations; or C. Other exceptional circumstances;

The Applicant shall provide any additional details they consider necessary to support their waiver request;
The Applicant shall certify that the information included in their application is true and accurate; and 8. The Applicant shall sign and date the application. An electronic signature will satisfy this requirement.

(D) Waivers granted by the department shall be valid for one (1) year after the date on which they are issued.

(E) Waivers shall be kept on file at the practitioner’s primary, principle practice location and available for review by the department.

Original rule filed Dec. 15, 2020, effective June 30, 2021. *Original authority: 195.550, RSMo 2019.

History

AUTHORITY: section 195.550, RSMo Supp. 2020. Emergency rule filed Dec. 15, 2020, effective Dec. 31, 2020, expired June 28, 2021.

Chapter 10 * - moved to 19 CSR 10-10

19 CSR 30-10.010 Birth {#sec-19-csr-30-10.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-10.010}

(Moved to 19 CSR 10-10.010)

19 CSR 30-10.020 Vital Records {#sec-19-csr-30-10.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-10.020}

(Moved to 19 CSR 10-10.020)

19 CSR 30-10.030 Filing a Delayed Birth Certificate {#sec-19-csr-30-10.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-10.030}

(Moved to 19 CSR 10-10.030)

19 CSR 30-10.040 Filing a Certificate of Live Birth {#sec-19-csr-30-10.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-10.040}

(Moved to 19 CSR 10-10.040)

19 CSR 30-10.050 Death Certificate Form {#sec-19-csr-30-10.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-10.050}

(Moved to 19 CSR 10-10.050)

19 CSR 30-10.060 Report of Fetal Death {#sec-19-csr-30-10.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-10.060}

(Moved to 19 CSR 10-10.060)

19 CSR 30-10.070 Certificate of Dissolution of Marriage {#sec-19-csr-30-10.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-10.070}

(Moved to 19 CSR 10-10.070)

19 CSR 30-10.080 Report of Marriage {#sec-19-csr-30-10.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-10.080}

(Moved to 19 CSR 10-10.080)

19 CSR 30-10.090 Access to Vital Records {#sec-19-csr-30-10.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-10.090}

(Moved to 19 CSR 10-10.090)

19 CSR 30-10.100 Authorization for Cremation {#sec-19-csr-30-10.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-10.100}

(Moved to 19 CSR 10-10.100)

19 CSR 30-10.110 Amending Vital Records {#sec-19-csr-30-10.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-10.110}

(Moved to 19 CSR 10-10.110)

19 CSR 30-10.120 New Certificate Through Legitimation {#sec-19-csr-30-10.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-10.120}

(Moved to 19 CSR 10-10.120)

MATTBLUNT(6/30/98)*

Chapter 11 Rules for Mammography

19 CSR 30-11.010 Mammography Authorization ments for mammography authorization and payment of fees by mammography suppliers. {#sec-19-csr-30-11.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-11.010}

(1) All mammography suppliers shall meet the requirements of applicable rules of Chapter 10 of 19 CSR 20.

(2) Each applicant for mammography authorization shall submit a registration fee to the Department of Health prior to issuance of the mammography authorization. Fees are as follows: three (3)-year authorization, six hundred dollars ($600); temporary authorization for twelve (12) months, two hundred dollars ($200); and temporary authorization for six (6) months, one hundred dollars ($100).

(A) Each radiation machine shall be individually registered for mammography autho- (B) Application for authorization renewal shall be submitted not more than ninety (90) days and not less than thirty (30) days prior to the expiration date of the current authorization.

(C) Registration fees shall not be required for reinstatement of a mammography authorization which has been withdrawn by the Department of Health; reinstatement shall be effective only for the remainder of the original period of authorization.

(3) The Department of Health shall perform an initial inspection of each machine during the first year of authorization and annual inspections after that. A reinspection shall be performed after a mammography authorization has been withdrawn by the Department of Health. Fees for initial inspection, annual inspection and reinspection shall be one hundred dollars ($100) respectively, per radiation machine.

(A) Fees for initial inspection shall be submitted with the application for mammography authorization.

(B) Fees for annual inspection shall be submitted ten (10) working days prior to the anniversary date of the mammography autho- (C) Fees for reinspection shall be submitted upon application for reinstatement of mammography authorization.

(4) The Department of Health may accept mammography accreditation certificates issued by the American College of Radiology (ACR) as evidence of compliance with criteria for authorization. Suppliers who submit ACR accreditation certificates as evidence of compliance shall inform the Department of Health, in writing, of any change in their ACR accreditation status within thirty (30) days of that change. If the Department of Health evaluates mammography systems to determine compliance with criteria for authorization, evaluation shall be performed every three (3) years and shall include review and on-site evaluation of staff qualifications, equipment, quality control and quality assurance programs, phantom image quality, breast dose and processor quality control. In addition, the supplier shall submit two (2) sets of clinical films, one (1) of a fatty and one (1) of a dense breast, for image quality evaluation to the Department of Health or its designee. Each set shall consist of two (2) views of each breast totaling four (4) films for each type of breast. Failure to meet clinical image quality evaluation criteria shall result in the withholding or withdrawal of mammography authorization. The supplier may submit additional clinical films for reevaluation; however, all costs incurred for additional clinical image quality evaluation shall be the responsibility of the supplier. Fees for evaluation shall be five hundred dollars ($500) for the first radiation machine and four hundred dollars ($400) for each additional radiation machine. Fees for the Department of Health evaluation shall be submitted prior to the evaluation. The supplier shall provide to the Department of Health all evidence required to determine compliance with criteria for authorization.

(5) Failure of the supplier, upon inspection or evaluation, to meet the requirements of this

chapter that significantly affect clinical image quality or interpretation shall result in immediate withdrawal of authorization. The Department of Health shall provide an opportunity for a hearing within five (5) working days after withdrawal of authorization. Whenever the Department of Health finds upon inspection or evaluation that there is a violation of other provisions of this chapter, the Department of Health shall notify the supplier of the nature of the violation and order that prior to a time fixed by the Department of Health, which shall not be later than thirty (30) days from the date of service of the notice, the supplier shall cease and abate causing, allowing or permitting the violation.

Failure to meet this requirement shall result in withdrawal of authorization.

(6) Fees submitted to the Department of Health under this rule are nonrefundable.

Failure to submit fees as required shall result in withdrawal of the mammography autho-

History

AUTHORITY: sections 192.760, 192.762, 192.764 and 192.766, RSMo Supp. 1992. This rule was previously filed as 19 CSR 20- 11.010. Emergency rule filed Oct. 5, 1992, effective Oct. 15, 1992, expired Feb. 12, 1993. Emergency rule filed Feb. 3, 1993, effective Feb. 13, 1993, expired June 12, 1993. Original rule filed Nov. 4, 1992, effective June 7, 1993. Changed to 19 CSR 30- 11.010 July 30, 1998.

19 CSR 30-11.020 Requirements for Suppliers of Mammography Services ments for suppliers of mammography services, including responsibility for the quality of mammographic examinations. {#sec-19-csr-30-11.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-11.020}

(1) The supplier shall be responsible for the overall quality of mammography examinations conducted in each facility. The supplier shall have available the services of a physician consultant and a radiation physicist, either on staff or through arrangement.

(2) The supplier shall provide satisfactory assurances, as documented in its medical records, that the images or films of the first and subsequent mammography procedures and the related written reports of the physicians’ interpretations for each patient are either placed in the patient’s medical record kept by the supplier or sent to another person— including the patient—for placement in the patient’s medical record as directed by the patient or by the patient’s physician. If the records of the examination are retained by the supplier, they shall be retained for at least sixty (60) months following the date of service. If the supplier should cease to exist before the end of the sixty (60)-month period, the records shall be transferred to the patient or the patient’s primary care provider.

(3) With the consent of the patient, reasonable efforts shall be made by the supplier of the current examination to obtain any of the patient’s previous mammography records— including original images and films—copies of written reports prepared by interpreting physicians, and other relevant information pertinent to previous mammographies that might be available from others, for comparison with the current mammography records.

Records of previous mammographies obtained and of current mammographies performed by the supplier shall be properly preserved and made available to other qualified mammography suppliers or others who submit a written request authorized by the patient.

(4) The supplier shall make a record for each patient of the mammography services it provides. This record shall include:

(A) The date the mammography procedure was performed and the date of the interpretation;

(B) The name of the patient;

(D) A description of the procedures performed;

(E) The name of the referring physician, if any, or other physician, if any, identified by the patient to receive the interpreting physician’s written report; and (F) The date the physician’s written report was sent to the appropriate physician or patient.

(5) The mammography supplier shall have an orientation program for operators of mammography equipment based on a procedures manual that is available to all staff. The manual shall incorporate relevant documents concerning the following:

(A) Precautions to protect the operator of the equipment, the patient and individuals in the surrounding area from unnecessary exposure to radiation;

(B) Determination of the area that will receive the primary beam-breast positioning;

(C) Pertinent information on compression, exposure levels, resolution, contrast, noise, examination identification, artifacts and average glandular dose per view;

(D) Proper use and maintenance of the equipment, including a discussion of the image receptors appropriate for use with mammography and the kilovoltage (kV)-target-filter combination to be used with each image receptor;

(E) Proper maintenance of records; and (F) Possible technical problems and solutions.

(6) The supplier shall have a mechanism in place which provides for the notification/recall of patients if mammographic examination results are equivocal; notification shall be within two (2) working days after interpretation by the interpreting physician.

(7) The supplier shall maintain all documentation and records required by this rule for review by the Department of Health. filed as 19 CSR 20-11.020. Emergency rule Feb. 3, 1993, effective Feb. 13, 1993, expired CSR 30-11.020 July 30, 1998.

19 CSR 30-11.030 Requirements and Responsibilities for Physician Consultants ments for physician consultants including qualifications and supervisory responsibilities. {#sec-19-csr-30-11.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-11.030}

(1) The physician consultant shall meet the requirements for the interpreting physician as specified in 19 CSR 20-11.040(1) and (2).

(2) The physician consultant shall document in writing annually that— (A) S/he has checked the procedural manuals and observed, at least monthly, the operator’s performance;

(B) S/he has verified that equipment and personnel meet applicable rules of this chapter;

(C) Safe operating procedures are used; and (D) All other requirements of this chapter are being met. filed as 19 CSR 20-11.030. Emergency rule Feb. 3, 1993, effective Feb 13, 1993, expired CSR 30-11.030 July 30, 1998.

19 CSR 30-11.040 Requirements and Responsibilities for Interpreting Physicians ments for interpreting physicians including qualifications, the mammography reporting process and responsibility to the patient. {#sec-19-csr-30-11.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-11.040}

(1) The results of all mammography procedures shall be interpreted by a qualified physician who is licensed to practice medicine in Missouri and— (A) Has completed two (2) months of documented, formal training in reading mammograms with instruction in medical radiation physics, radiation effects and radiation protection; or is certified by the American Board of Radiology (ABR) or the American Osteopathic Board of Radiology (AOBR); and (B) Has completed forty (40) hours of documented continuing medical education credits in mammography. Time spent in residency specifically devoted to mammography shall be accepted, if documented in writing.

(2) The interpreting physician shall obtain at least fifteen (15) hours of continuing education in mammography interpretation, technical aspects and subjects related to mammography every three (3) years.

(3) The interpreting physician shall— (A) Prepare and sign a written report on his/her interpretation of the results of the mammography procedure;

(B) Provide a copy of the written report and the original images or films to the patient’s mammography supplier for inclusion in the patient’s medical record; and (C) Provide a written statement to the patient, either through a referring physician or the referring physician’s designate or, if a referring physician is not available, directly to the patient. The statement shall describe the test results, the next steps if the results are positive, the date of the procedure, the name of the facility providing the procedure, the physician—if any—to whom the patient wants a copy to be sent and shall indicate that the original images or films are being provided to the mammography supplier for inclusion in the patient’s medical record. filed as 19 CSR 20-11.040. Emergency rule Feb. 3, 1993, effective Feb. 13, 1993, expired CSR 30-11.040 July 30, 1998.

4CODE OF STATE REGULATIONS

(6/30/98) Rebecca McDowell Cook

19 CSR 30-11.050 Requirements for Operators of Mammography Equipment ments for operators of mammography equipment, including qualifications, certification and continuing education. {#sec-19-csr-30-11.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-11.050}

(1) Operators of mammography equipment shall be certified by the American Registry of Radiological Technologists (ARRT), the American Registry of Clinical Radiographic Technologists (ARCRT), Missouri or shall possess equivalent certification. Operators also shall meet the following requirements:

(A) Shall have completed a minimum of forty (40) hours of documented formal mammography instruction or on-the-job training as outlined in Appendix A, “Topics to be Covered in Mammography Instruction.” Onthe-job training shall be documented to include the business address and qualifications of the instructor, a brief description of the training, the date and length of the training, and an evaluation of the student’s performance signed and dated by the instructor; and (B) Shall obtain at least fifteen (15) hours of continuing education in technical aspects of mammography and related subjects every three (3) years.

(2) Individuals who hold a current ARRT Certificate of Advanced Qualification in Mammography or equivalent certification are exempt from the provisions of subsection (1)(A) of this rule. filed as 19 CSR 20-11.050. Emergency rule Feb. 3, 1993, effective Feb. 13, 1993, expired CSR 30-11.050 July 30, 1998.

19 CSR 30-11.060 Requirements for Individuals Who Provide X-ray Physics Support ments for radiation physicists including qualifications and responsibilities for quality assurance. {#sec-19-csr-30-11.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-11.060}

(1) A radiation physicist who provides diagnostic X-ray physics support to a supplier of mammography services shall be certified by the American Board of Radiology as a radiation physicist or shall possess other qualifications acceptable to the Department of Health.

(2) Under the direction of the physician consultant, a radiation physicist shall establish a mammography quality assurance program.

(3) At least annually, a radiation physicist shall provide on-site consultation to the supplier, including, but not limited to, a complete evaluation of the entire mammography system to ensure compliance with 19 CSR 20-11.070 and 19 CSR 20-11.080.

rule filed Feb. 3, 1993, effective Feb. 13, 1993, expired June 12, 1993. Original rule filed Nov. 4, 1992, effective June 7, 1993.

Changed to 19 CSR 30-11.060 July 30, 1998.

History

AUTHORITY: sections 192.760, 192.762 and 192.766, RSMo Supp. 1992. This rule was previously filed as 19 CSR 20-11.060. Emergency rule filed Oct. 5, 1992, effective Oct. 15, 1992, expired Feb. 12, 1993. Emergency

19 CSR 30-11.070 Mammography Equipment Requirements ments for mammography equipment, including radiation machines and other components of mammography systems. {#sec-19-csr-30-11.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-11.070}

Editor's Note: The secretary of state has determined that the publication of this rule in its entirety would be unduly cumbersome or expensive. The entire text of the material referenced has been filed with the secretary of state. This material may be found at the Office of the Secretary of State or at the headquarters of the agency and is available to any interested person at a cost established by state law.

(1) The equipment used for mammography shall be specifically designed for mammography and shall meet the following requirements:

(A) Equipment shall meet the Food and Drug Administration (FDA) performance standards for diagnostic X-ray systems and their major components in 21 CFR 1020.30 and FDA standards for radiographic equipment in 21 CFR 1020.31 upon installation and while in use;

(B) The image receptor systems and all their individual components shall be designed specifically for mammography and shall function properly;

(C) The equipment shall be limited to providing kilovoltage (kV)-target-filter combinations appropriate to image receptors meeting the requirements of subsection (1)(B);

(D) The half value layer (HVL) in millimeters of aluminum of the useful beam for systems operating at X-ray tube potentials of less than thirty-five kilovoltage potential (35 kVp) shall be equal to or greater than the product of the tube potential in kilovolts multiplied by one-hundredth (0.01) and shall not exceed this calculated product by more than plus one-tenth millimeter (+0.1 mm) of aluminum;

(E) Devices parallel to the imaging plane shall be available to adequately immobilize and compress the breast;

(F) Film-screen units shall have the capability for using anti-scatter grids;

(G) Film-screen units shall have the capability of automatic exposure control;

(H) The equipment shall have a control panel that includes a device, usually a milliammeter, or a means for an audible signal to give positive indication of the production of X rays whenever the X-ray tube is energized.

The control panel shall include appropriate indicators—labeled control settings or meters that show the physical factors, such as kVp, milliamperes (mA), milliampere-seconds (mAs), exposure time or whether timing is automatic—when used for exposure;

(I) The developer temperature of the photographic processor shall be maintained as specified by the film manufacturer for the particular film-developer-processor-development time combination; and (J) The focal spot size and source-to-image receptor distances shall be limited to those appropriate for mammography. filed as 19 CSR 20-11.070. Emergency rule Feb. 3, 1993, effective Feb. 13, 1993, expired 1992, effective June 7, 1993. Amended: Filed April 28, 1993, effective Nov. 8, 1993.

Changed to 19 CSR 30-11.070 July 30, 1998.

19 CSR 30-11.080 Quality Assurance ments for calibration of mammography equipment and monitoring of the mammography system. {#sec-19-csr-30-11.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-11.080}

(1) All variable parameters of the equipment shall be calibrated as follows:

(A) When the equipment is first installed;

(B) After any major changes or replacement of parts;

(2) The following parameters of the system shall be monitored as follows:

(A) Processor performance shall be monitored on a daily basis to include solution temperatures, sensitometric-densitometric evaluation through the use of control charts which shall include speed step or mid-density step with a control limit of plus or minus fifteenhundredths optical density (±0.15 OD), contrast index or density difference with a control limit of plus or minus fifteen-hundredths optical density (±0.15 OD) and base plus fog with a control limit of plus three-hundredths optical density (+.03 OD) of the operating level;

(B) Processor chemical replenishment rates shall be monitored at least quarterly;

(C) Half-value layer shall be determined at least annually with the compression device located in the primary beam, halfway between the image receptor assembly and the X-ray tube;

(D) Milliampere-seconds (mAs) linearity shall be determined at least annually based on the average ratios of exposure to the indicated milliampere-seconds product (mR/mAs) obtained at any two (2) consecutive tube current settings, which shall not differ by more than ten-hundredths (0.10) times their sum as measured with a minimum of four (4) consecutive exposures or a maximum of ten (10) consecutive exposures at commonly used settings;

(E) Manual and automatic exposure control (AEC) reproducibility shall be determined at least annually based on the coefficient of variation of exposures, which shall not be greater than plus or minus five percent (±5%) as measured with a minimum of four (4) consecutive exposures or a maximum of ten (10) consecutive exposures at a commonly used setting;

(F) Kilovoltage potential (kVp) accuracy shall be determined at least annually. The actual kVp shall be maintained within plus or minus five percent (±5%) of the indicated kVp;

(G) kVp reproducibility shall be determined at least annually based on the coefficient of variation of kVp values, which shall not be greater than plus or minus five percent (±5%) as measured with a minimum of four (4) consecutive exposures or a maximum of ten (10) consecutive exposures at commonly used kVp settings;

(H) AEC thickness response shall be determined at least annually based on film density, which shall be maintained within plus or minus three-tenths optical density (±0.3 OD) of the average OD over the kVp range used for phantom thicknesses of two, four and six centimeters (2, 4 and 6 cm). If the OD cannot be maintained to within plus or minus three-tenths (‰0.3) of the average of each clinically used setting, a technique chart shall be developed that alters kVp and density control settings as a function of breast thicknesses and densities to produce optical densities within this range under phototimed conditions;

(I) Compression device response shall be monitored at least annually;

(J) Adequacy of film storage shall be monitored at least annually, both before use and after exposure, if processing does not occur immediately;

(K) Availability and use of technique charts that shall include an indication of the kV-target-filter combination to be used with each image receptor shall be monitored at least annually;

(L) The use of kV-target-filter combination appropriate to the image receptor shall be monitored daily before patient irradiation;

(M) Darkroom integrity, for light-tight conditions and use of proper safelight, shall be monitored at least semiannually and whenever bulbs or filters are changed or when fog is suspected; darkroom fog levels shall have a variance of not greater than five-hundredths (0.05) density units between the fogged and unfogged film based on a two (2)-minute exposure to the darkroom safelight;

(N) Image quality, using one (1) of the following mammography phantoms; the RMI 152, the RMI 156, the CIRS, the Nuclear Associates phantom or other equivalent phantom acceptable to the Department of Health, which simulates the composition of the breast and provides indicators of disease conditions allowing objective analysis of clinical image quality, shall be monitored at least monthly and each time the mammographic equipment is moved or altered in any major way including the replacement of parts; a phantom image shall be made and evaluated for mobile units and vans at each location prior to the performance of mammography;

(O) Average glandular dose shall be determined at least annually based on measurements of estimated skin entrance exposure; the average glandular dose shall be calculated from those used for imaging a four and fivetenths centimeters (4.5 cm) compressed breast in the cranial caudal view and the measurement point shall be four and five-tenths centimeters (4.5 cm) from the surface of the grid or cassette as appropriate; and (P) Film-screen contact shall be monitored at least semiannually and when new or repaired cassettes/screens are placed in service, using a contact test tool specifically designed for mammography; cassettes/ screens shall be cleaned at least weekly; for xeroradiography, the photoreceptor plates shall be maintained in accordance with the manufacturer’s specifications.

(3) Evaluation of monitoring results— (A) Standards of image quality giving acceptable ranges of value for each of the parameters tested shall be established to aid in the evaluation of monitoring results. The standards of image quality related to dose shall include a requirement that the average glandular dose for one (1) cranial caudal view of a four and five-tenths centimeters (4.5 cm) compressed breast fifty percent (50%) glandular/fifty percent (50%) adipose composition shall not exceed one hundred (100), three hundred (300) and four hundred (400) millirads (mrads) for film/screen units without grids, film/screen units with grids, and xeroradiography units, respectively; and (B) The monitoring results shall be compared routinely to the standards of image quality established by the Department of Health. If the results fall outside the acceptable range, the test shall be repeated. If the results continue to be unacceptable, the source of the problem shall be identified and corrected before further examinations are conducted.

(4) A program to analyze retakes shall be established to detect and correct problems affecting image quality or exposure. This analysis shall be performed at least quarterly or after two hunndred fifty (250) patients, whichever comes first.

(5) All quality assurance test equipment shall be in good operating order and calibrated according to the manufacturer’s specifications.

RSMo. Supp. 1992.* This rule was previously filed as 19 CSR 20-11.080. Emergency rule Feb. 3, 1993, effective Feb. 13, 1993, expired CSR 30-11.080 July 30, 1998.

6CODE OF STATE REGULATIONS

(6/30/98) Rebecca McDowell Cook

19 CSR 30-11.090 Maintenance of Mammography Records ments for maintenance of quality assurance records by the supplier. {#sec-19-csr-30-11.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-11.090}

(1) Records of all quality assurance tests for mammography X-ray equipment shall include the following:

(A) The initial mammographic equipment performance evaluation and subsequent evaluations and testing;

(B) Verification that the mammographic Xray equipment is in safe operating order; and (C) Quality assurance test results.

(2) Records or written logs of maintenance and any repairs of mammographic X-ray equipment shall be kept for at least three (3) years.

(3) Film processor control charts used to regulate proper processor function shall be kept for at least two (2) years.

(4) Film processor maintenance logs shall include all of the following records and these records shall be kept for at least two (2) years: preventive maintenance; corrective maintenance; and cleaning and replacement of chemicals.

(5) Each film processor record entry shall be dated and signed or initialed by the individual who performed the quality assurance test.

(6) Records of calibration, monitoring results, the radiation physicist’s on-site consultation and the physician consultant’s annual review shall be documented in the supplier’s records and shall be readily available for review by agents of the Department of Health. filed as 19 CSR 20-11.090. Emergency rule Feb. 3, 1993, effective Feb. 13, 1993, expired CSR 30-11.090 July 30, 1998.

19 CSR 30-11.100 Right of Entry to Mammography Suppliers for Enforcement {#sec-19-csr-30-11.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-11.100}

PURPOSE: This rule authorizes the right of entry by agents of the Department of Health.

(1) Agents of the Department of Health charged with the enforcement of the provisions of this chapter shall have the right of entry and free access during normal business hours to any building or structure for the purposes of inspection, evaluation and examination of records and equipment. filed as 19 CSR 20-11.100. Emergency rule Feb. 3, 1993, effective Feb. 13, 1993, expired CSR 30-11.100 July 30, 1998.

Appendix A Topics to be Covered in Mammography Instruction A. Anatomy and Physiology of the Female Breast 1. Mammary glands 2. External anatomy 3. Subdivision for localization 4. Retromammary space 5. Central portion 6. Cooper’s ligament 7. Vessels, nerves, lymphatics 8. Breast tissue B. Classification of Breast Tissue 1. Fibro-granular 2. Fibro-fatty 3. Fatty 4. Lactating C. Epidemiology of the Breast, Breast Cancer Detection Methods and Information Sources D. Influence of Technical Factors E. Positioning of the Breast 1. Cranio-caudad 2. Medial lateral oblique 3. Axillary 4. Magnification 5. Errors in positioning 6. Special techniques for mammography for the postoperative breast and the augmented breast 7. Special radiographic techniques for breast localization and specimen radiography F. Film or Image Evaluation, or both, and Critique 1. What constitutes optimum quality mammography radiographs or images 2. “Scanning” radiographs and images 3. Detection of pathology 4. Benign and malignant lesions 5. Mass lesion borders a. Smooth b. Irregular c. Calcification G. Radiation Biology and Radiation Protection H. Quality Assurance

Chapter 15 * - moved to 19 CSR 10-15

19 CSR 30-15.010 Report of Induced Termination of Pregnancy {#sec-19-csr-30-15.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-15.010}

(Moved to 19 CSR 10-15.010)

19 CSR 30-15.020 Complication Report for Post-Abortion Care {#sec-19-csr-30-15.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-15.020}

(Moved to 19 CSR 10-15.020)

19 CSR 30-15.030 Content and Filing of Tissue Report {#sec-19-csr-30-15.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-15.030}

(Moved to 19 CSR 10-15.030)

(Moved to 19 CSR 10-15.040)

Rebecca McDowell Cook (6/30/98)

Chapter 17SN * - moved to 19 CSR 20-21

19 CSR 30-17SN * - moved to 19 CSR 20-21 {#sec-19-csr-30-17sn omnilex-key=us-mo-regs-official--title-19--19 CSR 30-17SN}

MATTBLUNT(1/29/03)

Rules of Department of Health and Senior Services Division 30óDivision of Health Resources SPECIAL NOTICE

Chapter 17óCancer On September 11, 1987, Division 30óDivision of Health Resources transferred to Division 20óDivision of Environmental Health and Epidemiology. These rules of the Division of Health Resources may be found at 19 CSR 20-21.

Chapter 20 Hospitals

19 CSR 30-20.001 Anesthesiologist Assistants in Hospitals {#sec-19-csr-30-20.001 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.001}

19 CSR 30-20.021 Organization and Management for Hospitals {#sec-19-csr-30-20.021 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.021}

19 CSR 30-20.040 Definitions Relating to Long-Term Care Units in Hospitals {#sec-19-csr-30-20.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.040}

19 CSR 30-20.060 Construction Standards for New Long-Term Care Units in Hospitals {#sec-19-csr-30-20.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.060}

19 CSR 30-20.097 Safe Patient Handling and Movement in Hospitals {#sec-19-csr-30-20.097 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.097}

19 CSR 30-20.098 Pathology and Medical Laboratory Services {#sec-19-csr-30-20.098 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.098}

(Rescinded

19 CSR 30-20.108 Fire Safety, General Safety and Operating Features {#sec-19-csr-30-20.108 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.108}

19 CSR 30-20.110 Orientation and Continuing Education {#sec-19-csr-30-20.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.110}

19 CSR 30-20.112 Quality Assessment and Performance Improvement Program {#sec-19-csr-30-20.112 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.112}

19 CSR 30-20.126 Obstetrical and Newborn Services in Hospitals {#sec-19-csr-30-20.126 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.126}

19 CSR 30-20.130 Post-Anesthesia Recovery Services in Hospitals SERVICES {#sec-19-csr-30-20.130 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.130}

19 CSR 30-20.001 Anesthesiologist Assistants in Hospitals {#sec-19-csr-30-20.001 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.001}

rule filed Jan. 16, 2007, effective Aug. 30, 2007. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019.

History

AUTHORITY: sections 192.006 and 197.080, RSMo 2000. Original

19 CSR 30-20.011 Definitions Relating to Hospitals {#sec-19-csr-30-20.011 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.011}

PURPOSE: This rule defines terminology used throughout this

chapter.

(1) Automated Dispensing System—An automated system that is used to dispense medication to patients pursuant to a patient-specific prescription or patient-specific medication order using an electronic verification system. An automated dispensing system does not include an automated system used for compounding medication or an automated filling system governed by 20 CSR 2220-2.950.

(2) Chemical Restraint—A drug or medication when it is used as a restriction to manage the patient’s behavior or restrict the patient’s freedom of movement and is not a standard treatment or dosage for the patient’s condition.

(3) Chief Executive Officer—The individual appointed by the governing body to act in its behalf in the overall management of the hospital.

(4) Chief Operating Officer—The individual appointed by the chief executive officer on behalf of the governing body or the individual who is responsible for the management of one (1) hospital in a multi-hospital organization under the direction of the chief executive officer of the organization.

(5) Compounding—The preparation, incorporation, mixing and packaging, or labeling of a drug or device as the result of a prescriber’s prescription or prescription drug order based on the prescriber/patient/pharmacist relationship in the course of professional practice. Compounding may also be defined as the preparation, incorporation, mixing and packaging, or labeling of a drug or device, for the purpose of, or as an incident to, research, teaching or chemical analysis and not for sale or dispensing purposes.

(6) Defined Service Area—The geographic area served by a defined group of hospitals and emergency services.

(7) Department—Missouri Department of Health and Senior Services.

(8) Diversion—Temporary closure of a hospital emergency department to ambulance traffic.

(A) Defined service area—The geographic area served by a defined group of hospitals and emergency services. In areas where there is a community-based emergency medical services diversion plan, the service area(s) defined as the catchment area by the plan will be the defined service area(s).

In areas where there is not a community-based emergency medical services diversion plan, the defined service area will be a twenty- (20-) mile radius from a hospital.

(9) Hospital— (A) A facility that provides inpatient care for medical or surgical patients, or both, and may include pediatric, obstetrical and newborn, psychiatric, or rehabilitation patients; and (B) A facility that is devoted primarily for the diagnosis, treatment, or care for not less than twenty-four (24) consecutive hours in any week of three (3) or more nonrelated individuals suffering from illness, disease, injury, deformity, or other abnormal physical conditions, or devoted primarily to provide for not less than twenty-four (24) consecutive hours in any week medical or nursing care for three (3) or more nonrelated individuals and includes— 1. Building(s)— A. Constructed to hospital standards as outlined in 19 CSR 30-20.030; and B. Identified on the hospital’s license application as part of the facility;

(C) The term “hospital” shall include a facility designated as a rural emergency hospital by the Centers for Medicare & Medicaid Services; and (D) The term “hospital” does not include convalescent, nursing, shelter, or boarding homes as defined in Chapter 198, (10) Immediate and Serious Threat—A situation in which a hospital’s non-compliance with one (1) or more requirements established under the Hospital Licensing Law or section 197.005, RSMo has caused, or is likely to cause, serious injury, harm, impairment, or death to a resident or patient. Unless the language or context clearly indicates otherwise, this definition is intended to have the same meaning, to the extent practicable, as the definition of immediate jeopardy in 42 CFR

section 488.1 (2018). The Code of Federal Regulations is published by the U.S. Government and is available by calling toll-free (866) 512-1800 or going to https://bookstore.gpo.gov/. The address is U.S. Government Publishing Office, U.S. Superintendent of Documents, Washington, DC 20402-0001. This rule does not incorporate later amendments or additions to 42 CFR section 488.1 (2018).

(11) Infectious Waste—Waste capable of producing an infectious disease. Infectious waste shall include the following categories:

(A) Blood and blood products—All human blood and blood products including serum, plasma, and other components known or suspected to be contaminated with a transmissible agent;

(B) Microbiologic cultures and stocks of infectious agents and associated biological agents;

(C) Isolation wastes—Discarded waste contaminated with excretions, exudates, and secretions from patients with highly communicable diseases treated in isolation;

(D) Pathology wastes include human tissues and body parts that are removed during surgery and autopsy;

(E) Contaminated sharps—All discarded sharps including needles, syringes scalpels broken glass or other sharp items that have come in contact with potentially infectious material;

(F) Animal waste—Discarded material originating from animals inoculated with infectious agents during research, production of biological or pharmaceutical testing.

(12) Inpatient—A person admitted into a hospital by a member of the medical staff for diagnosis, treatment, or care.

(13) Intern Pharmacist—An individual seeking to earn pharmacy practice experience in Missouri.

(14) Licensed Practitioner—Any individual who is licensed in Missouri or in another state and is qualified to practice a health care profession.

(15) Long-term Care Unit—A unit attached to or contained within a hospital that is operated as a skilled nursing unit.

(16) Operator—A person with— (A) Ultimate responsibility for making and implementing decisions regarding the operation of the hospital; and (B) Ultimate financial control of the operation of the hospital, including any management consultant or contracted entity who exercises control over the operation of the facility on a day-to-day basis.

(17) Patient—A person who presents to the hospital seeking diagnosis, treatment, or care.

(18) Pharmacist—An individual who is currently licensed under Chapter 338, RSMo, to practice pharmacy in the state of Missouri.

(19) Pharmacy Technician—An individual who is currently registered under Chapter 338, RSMo, as a pharmacy technician in the state of Missouri.

(20) Physician—An individual who is currently licensed under

Chapter 334, RSMo, to practice medicine in Missouri.

(21) Registered Professional Nurse—An individual who is licensed under Chapter 335, RSMo, to practice as a registered professional nurse in the state of Missouri.

(22) Repackage—To remove any drug from the original manufacturer’s container and place the drug in a dispensing container for other than immediate dispensing to a patient.

(23) Resident—A person who by reason of aging, illness, disease, or physical or mental infirmity requires care and services furnished by a long-term care unit and who resides within the unit for care and treatment.

(24) Respiratory Care Practitioner—An individual who is licensed under Chapter 334, RSMo, to practice respiratory care in the state of Missouri.

(25) Root Cause Analysis—A process for identifying the basic or causal factor(s) that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event.

(26) Unit—A functional division or facility of the hospital.

(27) Unlicensed Assistive Personnel (UAP)—unlicensed health care personnel who provide direct patient care twenty-five percent (25%) or more of the time, under the delegation and supervision of a registered professional nurse. Individuals who provide a specific job function such as, but not limited to, phlebotomist, radiology technician, or patient transporter are not included in this definition.

Amended: Filed Nov. 21, 1995, effective July 30, 1996. Amended:

Filed Oct. 6, 1998, effective April 30, 1999. Amended: Filed June 28, 2001, effective Feb. 28, 2002. Amended: Filed Sept. 20, 2005, effective April 30, 2006. Amended: Filed March 20, 2019, effective Nov. 30, 2019. Amended: Filed Aug. 28, 2023, effective March 30, 2024. amended 1993, 1995, 2017; 197.154, RSMo 2004; 197.293, RSMo 2000, amended 2004, 2017; and 338.165, RSMo 2014.

History

AUTHORITY: sections 192.006, 197.154, and 338.165, RSMo 2016, and sections 197.080 and 197.293, RSMo Supp. 2023. This rule was previously filed as 13 CSR 50-20.011. Original rule filed June 2, 1982, effective Nov. 11, 1982. Amended: Filed June 2, 1987, effective Sept. 11, 1987. Amended: Filed Aug. 16, 1988, effective Dec. 29, 1988.

19 CSR 30-20.013 Incorporation of Medicare Conditions of Participation {#sec-19-csr-30-20.013 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.013}

PURPOSE: This rule incorporates the Medicare Conditions of Participation into the hospital regulations.

PUBLISHER’S NOTE: The secretary of state has determined that publication of the entire text of the material that is incorporated or expensive. This material as incorporated by reference in this

rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed (1) State Licensure Requirements.

(A) This rule incorporates by reference 42 CFR Part 485 (2017), Medicare Conditions of Participation: Critical Access Hospitals, for Missouri licensed critical access hospitals. The Code of Federal Regulations is published by the U.S. Government and is available by calling toll-free (866) 512-1800 or going to https:// bookstore.gpo.gov/. The address is U.S. Government Publishing additions to 42 CFR Part 485 (2017). Missouri licensed critical access hospitals shall strictly meet the Medicare Conditions of Participation, and surveys performed for state licensure will be conducted per Medicare standards.

(B) This rule incorporates by reference 42 CFR Part 482 (2017), Medicare Conditions of Participation: Hospitals, for Missouri licensed hospitals. The Code of Federal Regulations is published by the U.S. Government and is available by calling toll-free (866) 512-1800 or going to https://bookstore. gpo.gov/. The address is U.S. Government Publishing Office, U.S.

Superintendent of Documents, Washington, DC 20402-0001.

This rule incorporates later amendments and additions to 42 CFR Part 482 (2017). Missouri licensed hospitals shall strictly meet the Medicare Conditions of Participation and surveys performed for state licensure will be conducted per Medicare standards.

(C) This rule incorporates by reference 42 CFR Part 482 (2017), Medicare Conditions of Participation: Psychiatric Hospitals, for Missouri licensed psychiatric hospitals. The Code of Federal Regulations is published by the U.S. Government and is available by calling toll-free (866) 512-1800 or going to https://bookstore. gpo.gov/. The address is U.S. Government Publishing Office, U.S.

Superintendent of Documents, Washington, DC 20402-0001.

This rule incorporates later amendments and additions to 42 CFR Part 482 (2017). Missouri licensed psychiatric hospitals shall strictly meet the Medicare Conditions of Participation and surveys performed for state licensure will be conducted per Medicare standards.

(D) This rule incorporates by reference 42 CFR Part 485,

Subpart E (2022), Medicare Conditions of Participation:

Rural Emergency Hospitals (REHs), as published by the U.S. Government Publishing Office, 732 N. Capitol St. NW, Washington, DC 20401-0001 and available by calling tollfree (866) 512-1800 or at its website at https://www.govinfo. gov/content/pkg/CFR-2022-title42-vol5/pdf/CFR-2022-title42vol5.pdf. This rule incorporates later amendments and additions to 42 CFR Part 485 (2022). Missouri licensed hospitals shall strictly meet the Medicare Conditions of Participation, and surveys performed for state licensure will be conducted per Medicare standards.

History

AUTHORITY: sections 197.005, 197.080, and 536.031, RSMo Supp. 2023. Emergency rule filed Feb. 14, 2019, effective Feb. 24, 2019, expired Aug. 22, 2019. Original rule filed Feb. 14, 2019, effective July 30, 2019. Amended: Filed Aug. 28, 2023, effective March 30, 2024. Original authority: 197.005, RSMo 2017, amended 2023; 197.080, RSMo 1953, amended 1993, 1995, 2013, 2017; and 536.031, RSMo 1975, amended 1976, 1989, 2004, 2016, 2018, 2019.

19 CSR 30-20.015 Administration of the Hospital Licensing Program {#sec-19-csr-30-20.015 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.015}

PURPOSE: This rule formalizes the hospital licensing policies being carried out by the Department of Health. It prescribes procedures for the review of hospital records, acceptance of plans of deficiency correction and suspension of a hospital license.

PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed (1) Persons intending to operate a hospital shall submit information to the Department of Health and Senior Services, as set out in the application form (MO 580-0007(8-18)) which is included herein. Within thirty (30) days after receipt of the application, the applicant will be notified of any omitted information or documents. After sixty (60) days any incomplete application is null. The department may deny a license application in any case which it finds that there has been a substantial failure to comply with the requirements for hospitals in Chapter 197, RSMo, and the regulations promulgated thereunder. Each application for license to operate a hospital shall be accompanied by the appropriate licensing fee, except applications from governmental units, required by section 197.050, RSMo.

(2) Each license shall be issued only for the premises identified on the application for hospital license and entity named in the application. All locations included in the hospital application for hospital license shall meet the definition of “premises” as stated in 19 CSR 30-20.011. No license shall be issued unless the applicant is in substantial compliance with Chapter 197, RSMo and the regulations promulgated thereunder. A license, unless sooner revoked, shall be issued for a period of up to a year. If during the period in which a license is in effect, a licensed operator which is a partnership, limited partnership, or corporation undergoes any of the following changes, whether by one (1) or by more than one (1) action, the operator shall within fifteen (15) working days of such change apply for a new license:

(A) With respect to a partnership, a change in the majority interest of general partners;

(B) With respect to a limited partnership, a change in the general partner or in the majority interest of limited partners;

(C) With respect to a corporation, a change in the persons who own, hold, or have the power to vote the majority of any class of securities issued by the corporation. If the corporation does not have stock, a change of owner occurs when the emerging entity has a new federal tax number; or (D) The board of directors with management control is an entity other than the licensed operator.

(3) The operator of a licensed hospital shall notify the department in writing within fifteen (15) days of— (A) A change of ownership of the hospital; or (B) Any extensive modification, modification, or reconstruction of the licensed premis es, as identified in the life safety code standards in 42 CFR Part 482 (2018) and 42 CFR Part 485 (2018), which are incorporated by reference in this rule. The Code of Federal Regulations is published by the U.S. Government and is available by calling toll-free (866) 512-1800 or going to https://bookstore.gpo.gov/. The address is: U.S. Government Publishing Office, U.S. Superintendent of Documents, Washington, DC 20402-0001. This rule incorporates later amendments and additions to 42 CFR Part 482 (2018) and 42 CFR Part 485 (2018).

(4) An operator of two (2) or more licensed hospitals may submit an initial application to the Department of Health and Senior Services to operate the hospitals as a single licensed hospital. The two (2) or more licensed hospitals may be separated by a distance which can be traveled in no more than one (1) hour by customary ground transportation in normal weather conditions. The operator shall designate a permanent hospital base from which the one- (1-) hour travel distance is determined. If the application is approved, the hospitals may be named on the licensure application and a single license issued. Before the Department of Health and Senior Services approves the application, the applicant shall submit an operational proposal to the director of the Department of Health and Senior Services for approval. At a minimum the proposal shall include:

(A) Approval from the Certificate of Need program if a Certificate of Need is required under sections 197.300–197.367, RSMo;

(B) Assurance that the applicant presented the initial proposal at a public hearing within the community where the currently licensed hospital(s) is located. The proposal shall provide evidence that the entire community was adequately notified at least two (2) weeks in advance, of the public hearings. The written record of the hearings, including the community response to the proposal, shall be submitted to the Department of Health and Senior Services as a part of the applicant’s proposal. The Department of Health and Senior Services shall be given two (2) weeks advance notice of the public hearings. The Department of Health and Senior Services may consider the information presented as part of the determination process; and (C) Assurance that the initial applicant is in compliance with Chapter 197, RSMo, and the regulations promulgated thereunder.

The above criteria is for initial application for single hospital licensure. The annual renewal for the single licensed hospitals will follow the annual licensure process.

(5) The license shall state the maximum licensed bed capacity, the hospital name, issue date, expiration date, and additional information, such as a specialty hospital designation, that the department may require. At least forty-five (45) days prior to the expiration date of an existing license, the department shall notify the operator that the license application is due for renewal. An annual application shall be submitted no more than ninety (90) days and not less than thirty (30) days prior to the expiration date of the existing license. Each application for license, except application from governmental units, shall be accompanied by a licensing fee in accordance with section 197.050, RSMo.

(6) Appointed representatives of the Department of Health and Senior Services, Bureau of Hospital Standards shall be allowed to review patient medical records and hospital employee personnel records in the course of conducting an investigation of allegations against an employee or previous employees of a hospital or allegations of substandard care regarding a patient.

(7) The nursing service administrator shall be a full-time employee and shall have the authority and be accountable for assuring the provision of quality nursing care for those patient areas delineated in the organizational structure.

(8) Survey Process.

(A) The department shall conduct licensure compliance surveys of hospitals as required by section 197.100, RSMo. Initial surveys shall be announced. Complaint investigations shall be unannounced.

(B) Interviews with staff, patients, and visitors shall be conducted in private, unless otherwise requested by the person being interviewed. Staff serving as a witness to an interview or an observation shall only observe and not participate.

Chapter 197, RSMo.

(D) In addition to the powers to deny, suspend, or revoke a license in the case of a substantial failure to comply provided in

section 197.070, RSMo, the department shall use the standards for enforcing hospital licensure regulations in section 197.293, (9) Plan of Correction.

(A) If the facility believes that deficiencies are not applicable or are not based upon laws or rules, a request for review may be submitted to the office of the director of the depart ment.

If a request for reconsideration is submitted, the request shall contain a rationale or documentation to provide evidence that the deficiency should not have been cited. Failure of the facility to submit a plan of correction or a request for reconsideration of the deficiency acceptable to the director of the department or designee—within the time frame specified—shall be grounds for the department to take disciplinary action against the facility’s license if there remains a substantial failure to comply with the requirements for hospitals established under

Chapter 197, RSMo and regulations promulgated thereunder.

The operator has the right to appeal the department’s decision in accordance with section 197.071, RSMo.

(B) Upon receipt of the required plan of correction for achieving licensure compliance, the department shall review the plan to determine the appropriateness of the corrective action. If the plan is acceptable, the department shall notify the chief executive officer or designee, in writing, and indicate that implementation of the plan should proceed. If the plan is not acceptable, the department shall notify the chief executive officer or designee, in writing, and indicate the reasons why the plan is not acceptable. Within ten (10) calendar days from the receipt of the notice, a revised, acceptable plan of correction shall be provided to the department.

(10) Follow-up Surveys.

(A) Upon expiration of the target dates for correction of deficiencies specified in the approved plan of correction, the department may make a follow-up survey to determine whether the required corrective measures have been acceptably accomplished. If the follow-up survey, conducted in accordance with 197.080, RSMo, if applicable, finds the facility fails to comply with the requirements for hospitals in

Chapter 197, RSMo, and regulations promulgated thereunder, the department may deny, suspend, or revoke a license in the case of a substantial failure to comply. The operator has the right to appeal the department’s decision in accordance with

section 197.071, RSMo.

(B) The powers to deny, suspend, or revoke a license in the case of a substantial failure to comply in section 197.070, RSMo, are in addition to the standards the department shall use for enforcing hospital licensure regulations in section 197.293, (11) If, for a period in excess of fourteen (14) days, a facility ceases to provide patient care or to otherwise operate as a hospital within the definition of section 197.020.2, RSMo, except in the case of a strike, an act of God, manmade disaster or written approval of the department, the facility shall surrender its license to the department. The facility shall not operate again as a hospital until an application for a hospital license is submitted with assurance that the facility complies with the requirements for hospitals in Chapter 197, RSMo, and regulations promulgated thereunder and the Department of Health and Senior Services issues a license.

(12) Requested Suspension of License. If any hospital wishes to cease operation for a period of time but retain its current hospital license, the Department of Health and Senior Services, upon written request from the licensed operator, may grant approval for suspension of the hospital’s license for a specified time.

(A) Not less than fourteen (14) days prior to cessation of patient services at the hospital, the licensed operator shall submit to the department a written request for continuance.

(B) The written request for the suspension of the license shall include the reasons for cessation of patient services, the anticipated length of cessation of patient services, what safeguards the hospital will institute to provide security to the institution, the preventive maintenance measures used to assure that all equipment will be kept in good working order and evidence that the hospital is financially solvent to meet the conditions of the request and will remain so throughout the period of cessation of patient services.

(C) Approval may be granted only for the suspension of a hospital’s current license if the cessation of patient services is for one (1) of the following reasons:

The renovation of the hospital’s facility to upgrade to current licensure standards and to correct licensure or federal certification physical plant deficiencies;
The transfer of the operation of the hospital to a new operator to allow sufficient time for the new operator to obtain a new license; or 3. Other reasons which will not result in a deterioration of the hospital physical plant or its programs and which will be in the best interest of the citizens it serves.

(D) The suspension of a hospital’s current license shall not exceed ninety (90) days beyond the date of cessation of patient services for ownership transfer. The suspension of a hospital’s current license shall not exceed one hundred eighty (180) days beyond the date of cessation of patient services for renovation construction. The department may not grant more than one (1) suspension to a hospital’s licensed operator within any twelve- (12-) month period and shall grant no suspension for a period of more than one hundred eighty (180) days from the date of cessation of inpatient services.

(E) No inpatients shall be housed within the hospital from the initial date of cessation of inpatient services until operation of the hospital is restored with Department of Health and Senior Services approval.

(F) No inpatient services shall be provided in the hospital during the period of time that inpatient services are discontinued.

(G) When suspension of the license is requested for a renovation or construction proposal, the licensed operator shall submit plans for the renovation to the department for review and shall have received the department’s approval of those plans prior to the date of cessation of inpatient services at the hospital.

(H) The licensed operator shall notify the department no less than fourteen (14) days prior to the resumption of inpatient services that the hospital is ready for review/inspection for approval to reoccupy the hospital with inpatients.

(I) Within ten (10) working days of notification, the department shall respond in writing to the licensed operator with the findings of its review/inspection for the resumption of licensed hospital services at the hospital.

(13) A certificate of live birth shall be prepared for each child born alive and shall be forwarded to the local registrar, or as otherwise directed by the state registrar within five (5) days after the date of delivery. If the physician or other person in attendance does not certify to the facts of birth within five (5) days after the birth, the person in charge of the institution shall complete and sign the certificate.

(14) When a dead fetus is delivered in an institution, the person in charge of the institution or his/her designated representative shall prepare and, within seven (7) days after delivery, file a report of fetal death with the local registrar or as otherwise directed by the state registrar.

(15) Medical records of deceased patients shall contain the date and time of death, autopsy permit, if granted, disposition of the body, by whom received and when.

(16) The State Anatomical Board shall be notified of an unclaimed dead body. A record of this notification shall be maintained.

(17) The patient’s medical records shall be maintained to safeguard against loss, defacement, unauthorized access, and tampering and to prevent damage from fire and water. Medical records shall be preserved in a permanent file in the original, on microfilm, or other electronic media. Patients’ medical records shall be retained for a minimum of ten (10) years, except that a minor shall have his/her record retained until his/ her twentieth birthday, whichever occurs later. Preservation of medical records may be extended by the hospital for clinical, educational, statistical, or administrative purposes.

(18) Requests for variance from the requirements of 19 CSR 30-20 shall be in writing to the Department of Health and Senior Services. Department determinations in response to variance requests shall be in writing and both requests and determinations shall be made a part of the Department of Health and Senior Services permanent records for the facility.

(A) Requests shall contain at a minimum— 1. The section number and text of the rule in question;

Specific reasons why compliance with the rule would impose an undue hardship on the operator, including an estimate of any additional cost which might be involved;
An explanation of the extenuating factors which may be relevant;
A complete description of the individual characteristics of the facility or patients or any other factors which would fulfill the intent of the rule in question to safeguard the health, safety, and the welfare of the patient, staff, or public if the variance from the requirement is granted; and 5. A length of time the variance is being requested.

(19) The department’s written determination shall identify a variance expiration date, if approved. The facility may re-apply for a variance up to ninety (90) days prior to the expiration of a department-approved variance.

(20) Any facility granted a variance by the department shall inform the department in writing if the conditions warranting the variance change. This written notification to the department shall be made within thirty (30) days of the change affecting the variance. The department may revoke the granted variance if the changes in conditions detrimentally impact the health, safety, and the welfare of the patient, staff, or public, as determined by the department.

(21) All previously approved variances shall be submitted at the time of annual licensure renewal.

Amended: Filed Nov. 21, 1995, effective July 30, 1996. Amended:

Filed Oct. 6, 1998, effective April 30, 1999. Amended: Filed June 28, 2001, effective Feb. 28, 2002. Amended: Filed April 30, 2004, effective Dec. 30, 2004. Amended: Filed March 20, 2019, effective Nov. 30, 2019. ** *Original authority: 192.006, RSMo 1993, amended 1995; 197.065, RSMo 2004, amended 2017; 197.080, RSMo 1953, amended 1993, 1995, 2017; and 197.297, RSMo 2000. **Pursuant to Executive Order 21-07, 19 CSR 30-20.015, subsection (8)(A) was suspended from April 2, 2020 through August 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 30-20.015, sections (2) and (5) was suspended from March 20, 2020 through December 31, 2021.

History

AUTHORITY: sections 192.006, 197.065, and 197.297, RSMo 2016, and section 197.080, RSMo Supp. 2019. This rule was previously filed as 13 CSR 50-20.015. Original rule filed April 9, 1985, effective July 11, 1985. Amended: Filed Nov. 4, 1992, effective June 7, 1993.

19 CSR 30-20.021 Organization and Management for {#sec-19-csr-30-20.021 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.021}

(Rescinded February 29, 2008) 197.154, RSMo Supp. 2005. This rule was previously filed as 13 CSR 50-20.021 and 19 CSR 10-20.021. Original rule filed June 2, 1982, effective Nov. 11, 1982. Amended: Filed April 9, 1985, effective Sept. 28, 1985. Amended: Filed June 2, 1987, effective Sept. 11, 1987.

Amended: Filed Nov. 16, 1987, effective March 26, 1988. Amended:

Filed June 14, 1988, effective Oct. 13, 1988. Amended: Filed Aug. 16, 1988, effective Dec. 29, 1988. Amended: Filed Nov. 21, 1995, effective July 30, 1996. Amended: Filed Oct. 6, 1998, effective April 30, 1999. Amended: Filed June 28, 2001, effective Feb. 28, 2002.

Amended: Filed April 30, 2004, effective Dec. 30, 2004. Emergency amendment filed Sept. 1, 2005, effective Sept. 11, 2005, expired March 9, 2006. Amended: Filed Feb. 1, 2006, effective July 30, 2006.

Rescinded: Filed June 27, 2007, effective Feb. 29, 2008.

19 CSR 30-20.030 Construction Standards for New Hospitals {#sec-19-csr-30-20.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.030}

PURPOSE: This rule establishes up-to-date construction standards for new hospitals to help ensure accessible, functional, fire-safe, and sanitary facilities.

(1) New Hospital General Requirements.

(A) A new hospital is one (1) for which plans are submitted to the Department of Health and Senior Services for review and approval after January 1, 2018, for the construction of a new facility, expansion or renovation of an existing hospital, or the conversion of an existing facility not previously and continuously licensed as a hospital under Chapter 197, RSMo.

A new hospital shall be designed to provide all of the facilities required by this rule and arranged to accommodate all of the functions required by this rule and to provide comfortable, sanitary, fire-safe, secure, and durable facilities for the patients.

In major alteration projects and additions to an existing licensed hospital, only that part of the total hospital affected by the project is subject to this rule.

(B) These minimum requirements are not intended in any way to restrict innovations and improvements in design, construction or operating techniques. Plans and specifications and operational procedures which contain deviations from these requirements may be approved if it is determined that the purposes of the minimum requirements have been fulfilled. Some facilities may be subject to the requirements of more than one (1) regulatory agency. While every effort has been made to ensure coordination, facilities making requests for changes in services and request for new construction or renovations are cautioned to verify requirements of other agencies involved.

rule shall be in writing to the Department of Health and Senior Services. Approvals for deviations shall be in writing and both requests and approvals shall become a part of the permanent Department of Health and Senior Services records for the facility.

(D) Alterations or additions to existing hospitals shall be programmed so construction will minimize disruptions of existing functions. Access to exits and fire protections shall be maintained so the safety of the occupants will not be jeopardized during construction.

(E) The owner of each new facility or the owner of an existing facility being added to or undergoing major alterations shall provide a program scope of services which describes space requirements, staffing patterns, departmental relationships, and other basic information relating to the objectives of the facility. The program may be general but it shall include a description of each function to be performed, approximate space needed for these functions, and the interrelationship of various functions and spaces. The program also shall describe how essential services can be expanded in the future as the demand increases. Appropriate modifications or deletions in space requirements may be made when services are shared or purchased, provided the program indicates where the services are available and how they are to be provided.

(2) Planning and Construction Procedure.

(A) Plans and specifications shall be prepared for the construction of all new hospitals and additions to and modifications or reconstruction of existing hospitals. The plans and specifications shall be prepared by an architect or a professional engineer licensed to practice in Missouri.

(B) Construction shall be in conformance with plans and specifications approved by the Engineering Consulting Unit of the Department of Health and Senior Services. The Department of Health and Senior Services shall be notified within five (5) days after construction begins. If construction of the project is not started within one (1) year after the date of approval of the plans and specifications, the plans and specifications shall be resubmitted to the Department of Health and Senior Services for its approval and shall be amended, if necessary, to comply with the then current rules before construction work commences.

(3) Design and Construction Requirements.

(A) New hospitals or portions of hospitals constructed or remodeled after the effective date of this amendment shall be maintained so that the building and its various operating systems comply with the life safety code standards in 42 CFR Part 482 (2017) and 42 CFR Part 485 (2017), which are incorporated by reference in this rule. The Code of Federal Regulations is published by the U.S. Government and is available by calling toll-free (866) 512-1800 or going to http:// bookstore.gpo.gov/. The address is: U.S. Government Publishing additions to 42 CFR Part 482 (2017) and 42 CFR Part 485 (2017).

This rule does not incorporate the following chapters of National Fire Protection Association (NFPA) 99, 2012 edition:

chapter 7 – Information Technology and Communications Systems for Heath Care Facilities; chapter 8 – Plumbing;

chapter 12 – Emergency Management; and chapter 13 – Security Management. Existing hospital facilities constructed prior to the effective date of this amendment shall maintain and operate the building in compliance with the design and safety regulations in effect at the time of their construction.

(B) New hospitals or portions of hospitals constructed or remodeled after the effective date of this amendment must be constructed so that the building and its various operating systems comply with the standards contained in The Facility Guidelines Institute (FGI) Guidelines for the Design and Construction of Health Care Facilities (2010 edition) or the FGI Guidelines for Design and Construction of Hospitals and Outpatient Facilities (2014 edition), which are incorporated by reference in this rule and are published by the FGI at 350 N.

Saint Paul Street, Ste. 100, Dallas TX 75201, or so that the building and its various operating systems comply with other standards and guidelines that provide equivalent design criteria. Prior to the department granting approval of the construction plans and specifications required in this rule, the architect or professional engineer submitting the plans shall identify the equivalent design criteria used. This rule does not incorporate any subsequent amendments or additions. This rule does not incorporate the following chapter of FGI, 2010 edition: 1.2-8 – Commissioning. This rule does not incorporate the following

chapter of FGI, 2014 edition: 1.2-7 – Commissioning. Existing hospital facilities constructed prior to the effective date of this amendment shall maintain and operate the building in compliance with the design and construction regulations in effect at the time of their construction.

(4) Additional Requirements.

(A) The facility shall have at least two (2) pressure sterilizers located in the Central Sterile Processing designed to maintain two hundred fifty degrees Fahrenheit (250 °F) or one hundred twenty-one degrees Celsius (121 °C) at fifteen pounds (15 lbs.) pressure.

(B) If a facility is located outside of a service area or range of a public fire department, arrangements shall be made to have the nearest fire department respond in the case of fire. A copy of the agreement shall be kept on file in the facility and a copy shall be forwarded to the Department of Health and Senior Services. If the agreement is changed, a copy shall be forwarded to the Department of Health and Senior Services.

(C) Manual fire alarm initiating devices shall be installed at each nurses’ station or other patient care control station and at the telephone switchboard.

rule filed June 2, 1982, effective Nov. 11, 1982. Amended: Filed June 14, 1988, effective Oct. 13, 1988. Rescinded and readopted: Filed March 20, 2019, effective Nov. 30, 2019. ** *Original authority: 192.006, RSMo 1993, amended 1995; 197.065, RSMo 2004, amended 2017; 197.080, RSMo 1953, amended 1993, 1995, 2017; and 197.100, RSMo 1953, amended 1988, 2013, 2017. **Pursuant to Executive Order 21-09, 19 CSR 30-20.030 was suspended from March 20, 2020 through December 31, 2021.

History

AUTHORITY: sections 192.006 and 197.065, RSMo 2016, and sections 197.080 and 197.100, RSMo Supp. 2019. This rule was previously filed as 13 CSR 50-20.031 and 19 CSR 10-20.031. Original

19 CSR 30-20.040 Definitions Relating to Long-Term Care Units in Hospitals {#sec-19-csr-30-20.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.040}

rule was previously filed as 13 CSR 50-20.040 and 19 CSR 10- 20.040. Original rule filed Nov. 29, 1982, effective March 11, 1983.

Amended: Filed May 31, 1989, effective Aug. 24, 1989. Rescinded:

History

AUTHORITY: sections 192.005.2 and 197.080, RSMo 1986. This

19 CSR 30-20.050 Standards for the Operation of Long-Term Care Units {#sec-19-csr-30-20.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.050}

PURPOSE: This rule establishes standards for the administration, nursing staff, and overall operation of long-term care units in hospitals to provide a high level of care.

(1) Swing beds located in the hospital which may be used intermittently for long-term care are exempt from the requirements of this rule.

(2) Administration.

(A) A long-term care unit shall be licensed as part of the hospital in which it is located or attached. The hospital governing body shall be the legal authority for the long-term care unit and shall be responsible for the overall planning, directing, control, and management of the activities and functions of the long-term care unit.

(B) The administration of the long-term care unit shall be the responsibility of the chief executive officer of the hospital.

This authority may be delegated to a qualified assistant in accordance with the governing body bylaws of the hospital.

Regular daily visiting hours shall be established.
Relatives or guardians and clergy, if requested by the resident or family, shall be allowed to see critically-ill residents at any time in keeping with the orders of the physician.

(D) Medical records shall comply with 19 CSR 30-20.015. All medical orders shall be renewed at least monthly.

(E) All residents shall have a comprehensive, accurate, standardized assessment completed within fourteen (14) days of admission utilizing the resident assessment instrument developed by the Centers for Medicare and Medicaid Services (CMS) for use in long-term care facilities. The assessment shall be documented and become the basis for the care and treatment to be provided.

(3) The hospital shall assure that individuals who are employed as nursing assistants in the long-term care unit are trained and tested, including successful completion of a final examination, pursuant to the provisions of 19 CSR 30-84.010.

(4) Orientation In-Service Training and Continuing Education.

(A) The chief executive officer of the hospital shall assure the development of an in-service orientation and continuing education program offered by qualified instructors for the development of all personnel in the long-term care unit that is appropriate to their job functions. Orientation for all new personnel shall begin the first day of employment in the longterm care unit and shall cover, at a minimum, prevention and control of infection and hospital policies and procedures, including emergency protocol, job responsibilities, lines of

(B) The continuing education program for nursing assistants shall focus on basic nursing skills, personal care skills, mental health and social service needs, and basic restorative services.

(5) Training Record. Written records of the employee’s training and testing shall be maintained in the employee’s personnel file.

(6) Medical Care.

(A) Medical care in long-term care units shall be under the direction of a physician member of the medical staff and appointed by the governing body.

(B) Each resident shall have the privilege of selecting his/her own physician consistent with hospital medical staff bylaws.

(C) Each resident shall be visited by the attending physician as often as medically necessary but no less than every thirty (30) days for the first ninety (90) days and every sixty (60) days thereafter.

(D) There shall be a process for the review and evaluation on a regular basis of the quality and appropriateness of medical care in the long-term care unit.

(7) Long-Term Care Unit.

(A) A long-term care unit as defined in 19 CSR 30-20.011 shall have a registered professional nurse on duty eight (8) hours a day and seven (7) days a week.

(B) The nursing service administrator shall be responsible for the quality of nursing care supervision of personnel providing nursing care and for a program of in-service education for nursing personnel.

(C) Skilled nursing units shall employ nursing personnel in sufficient numbers and sufficiently qualified to meet the needs of the residents. Exclusive of supervisory staff, the minimum ratio of nursing staff engaged in direct patient care and treatment to residents shall be as follows:

Time Ratio of Staff to Residents* 7 a.m. to 3 p.m. 1 staff person for each 10 residents plus 1 (day) additional staff person for any remainder of 6 or more residents 3 p.m. to 11 p.m. 1 staff person for each 15 residents plus 1 (evening) additional staff person for any remainder of 8 or more residents 11 p.m. to 7 a.m. 1 staff person for each 20 residents plus 1 (night) additional staff person for any remainder of 11 or more residents. *The number of residents is based on occupied beds.

(D) On every shift there shall be a registered professional nurse or a licensed practical nurse on duty.

(E) A registered professional nurse shall be available in the hospital to assist during the time a licensed practical nurse is in charge.

(F) In a multi-story long-term care unit, at least one (1) directcare staff person shall be on duty at all times for each occupied floor.

(G) All medications shall be administered in accordance with state law and the provisions of 42 CFR 482.23 (2017), Condition of Participation for Nursing Services. The Code of Federal Regulations is published by the U.S. Government and is available by calling toll-free (866) 512-1800 or going to https:// bookstore.gpo.gov/. The address is: U.S. Government Publishing additions to 42 CFR Part 482.23 (2017).

(H) A physical examination by a licensed physician shall be completed and recorded on the clinical record of each resident, preferably before admission, but not later than seven (7) days after admission, unless the resident is accompanied on admission from a hospital or long-term care unit by a record of a physical examination completed within the past six (6) months. Physical examinations shall be performed at least annually.

(I) The unit shall not knowingly admit or continue to care for residents whose needs cannot be met by the unit directly or in cooperation with community resources or other providers of care with which it is affiliated or has contracts.

(J) Provision shall be made for the care of residents with a communicable disease either in the hospital or in a suitable room in the unit. Infection control policies and procedures shall be followed.

(8) Resident’s Rights and Grievance Procedures for Long-Term Care Units.

(A) A complete copy of each official notification from the Department of Health and Senior Services of violations, deficiencies, licensure approvals, disapprovals, and responses shall be retained and made available at the unit for inspection when requested by staff, residents, families or legal representatives of the residents, and the public.

(B) Each resident shall be informed of his/her rights and responsibilities as a resident and of all rules governing resident conduct and responsibilities. A copy of all the information shall be posted in a conspicuous location in the facility and copies shall be available to anyone requesting the information. Prior to or at the time of admission, a copy of the information shall be provided to each resident or his/her designee, next of kin, or legal guardian.

(C) Each resident shall be informed in writing, prior to or at the time of admission and during his/her stay, of services available in the unit and of related charges, including any charges for services not covered under the federal or state programs or not covered by the facility’s per-diem rate.

(D) Each resident shall be informed by a physician of his/her health and medical condition unless medically contraindicated (as documented by a physician in the resident’s record); shall be given the opportunity to participate in the planning of his/ her total care and medical treatment and to refuse treatment; and shall participate in experimental research only upon his/ her informed written consent.

(E) Each resident shall be transferred or discharged only for medical reasons, for his/her welfare or that of other residents, or for nonpayment for his/her stay.

(F) Each resident shall be encouraged and assisted, throughout his/her period of stay, to exercise his/her rights as a resident and as a citizen and to this end may voice grievances and recommend changes in policies and services to facility staff or to outside representatives of his/her choice and shall be free from restraint, interference, coercion, discrimination, or reprisal.

(G) Each resident may manage his/her personal financial affairs and, to the extent that the facility assists in the management, may have his/her personal financial affairs managed in accordance with section (9) of this rule.

(H) No resident shall be mentally or physically abused. Each resident shall be free from chemical and physical restraints except when the restraints are authorized in writing by a physician for a specific period of time or when the restraints are necessary in an emergency to protect the resident from injury to him/herself or others. In an emergency, physical restraints may be authorized by a registered professional nurse.

This action shall be reported immediately to a physician to obtain an order.

(I) Each resident shall be assured confidential treatment of all information contained in his/her records, including information contained in an automatic data bank; his/her written consent shall be required for the release of information to persons not otherwise authorized under law to receive it.

(J) Each resident shall be treated with consideration, respect, and full recognition of his/her dignity and individuality, including privacy in treatment and in care for his/her personal needs.

(K) No resident shall be required to perform services for the unit that are not included for therapeutic purposes in the plan of care.

(L) Each resident may communicate, associate, and meet privately with persons of his/her choice, unless to do so would infringe upon the rights of other residents. Each resident may send and receive his/her personal mail unopened.

(M) Each resident may participate in activities of social, religious, and community groups at his/her discretion, unless contraindicated for reasons documented by a physician in the resident’s medical record.

(N) Each resident may retain and use his/her personal clothing and possessions as space permits.

(O) If married, a resident shall be insured privacy for visits by his/her other spouse; if both are residents in the facility, they shall be permitted to share a room unless medically contraindicated.

(P) Each resident shall be allowed to purchase or rent any goods or services not included in the per-diem or monthly rate as long as the quality and delivery of those goods or services conform with policies and procedures of the hospital.

(9) Personal Funds and Property of Residents.

(A) No hospital shall be required to hold any personal funds or money in trust unless some other governmental agency placing residents in the facility imposes this requirement.

(B) Authorizations by the resident, his/her designee, or legal guardian for the hospital to use the personal funds of the resident shall be in writing and kept with the resident’s record or with the personal funds account.

(C) When a resident is admitted, s/he and his/her next of kin or legal guardian shall be provided with a statement explaining the resident’s rights regarding personal funds.

(D) Resident’s personal funds that are held in trust shall be kept separate from the hospital funds.

(E) There shall be a written account for each resident showing receipts to and disbursements from the personal funds of each resident.

(F) A written statement of all receipts and disbursements showing the current balance shall be given on a quarterly basis to the resident, his/her designee, or legal guardian.

(G) When personal funds and possessions held in trust by the hospital are returned to the resident or his/her designee or guardian before or after the resident’s discharge, the resident or his/her designee or guardian shall give the hospital a receipt for the funds and possessions returned.

(H) There is no duty on the part of the hospital to invest a resident’s funds held in trust or to increase the principal.

(I) Any owner, manager, employee, or affiliate of an owner who receives any personal property or anything else with a value of ten dollars ($10) or more from a resident shall give the resident a written statement giving the date it was received, from whom it was received, and its estimated value.

(J) No owner, manager, employee, or affiliate of an owner, in one (1) calendar year, shall receive any personal property or anything else with a total value exceeding one hundred dollars ($100) from a resident of any facility. This does not apply to bequests.

(K) The recordkeeping and other requirements of section (9) of this rule apply only to those personal possessions and funds which the facility accepts to hold in trust for the resident and does not apply to other possessions residents have in their rooms or bring into the facility.

Amended: Filed March 20, 2019, effective Nov. 30, 2019. ** amended 1993, 1995, 2017; and 197.297, RSMo 2000. **Pursuant to Executive Order 21-09, 19 CSR 30-20.050, subsection (2)(C) was suspended from March 19, 2020 through December 31, 2021 and 19 CSR 30-20.050 was suspended from March 20, 2020 through December 31, 2021.

History

authority, confidentiality of patient information, resident’s rights, and preservation of patient dignity.
AUTHORITY: sections 192.006 and 197.297, RSMo 2016, and section 197.080, RSMo Supp. 2019. This rule was previously filed as 13 CSR 50-20.050 and 19 CSR 10-20.050. Original rule filed Nov. 29, 1982, effective March 11, 1983. Amended: Filed May 31, 1989, effective Aug. 24, 1989. Amended: Filed July 12, 1991, effective Feb. 6, 1992.

19 CSR 30-20.060 Construction Standards for New Long- Term Care Units in Hospitals {#sec-19-csr-30-20.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.060}

rule was previously filed as 13 CSR 50-20.060 and 19 CSR 10- 20.060. Original rule filed Nov. 29, 1982, effective March 11, 1983.

History

AUTHORITY: sections 192.005.2 and 197.080, RSMo 1986. This

19 CSR 30-20.070 Registration as a Hospital Infectious Waste Generator {#sec-19-csr-30-20.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.070}

PURPOSE: This rule establishes standards and procedures for the registration of hospitals to ensure a high level of public safety in the handling and disposal of infectious waste.

(1) Application for Registration as a Hospital Infectious Waste Generator.

(A) Annually every hospital shall submit to the Department of Health and Senior Services an application for registration as an infectious waste generator. The application shall be furnished by the Department of Health and Senior Services and is included herein.

(B) Each application shall include:

An operational plan for the handling and treatment of infectious waste as specified in 19 CSR 30-20.114(1)(C);
A statement that the applicant understands and complies with sections 260.200–260.345, RSMo; 19 CSR 30-20.011; 19 CSR 30-20.114(1)(C); 10 CSR 80-2.010; and 10 CSR 80-7.010; and 3. The signature of the hospital’s chief executive officer and the director of the infectious waste management program.

(C) The application shall be submitted annually. It shall be reviewed and denial or acceptance given within thirty (30) days after the Department of Health and Senior Services receives the application. If denied, specific reasons, with references, shall be given for the denial.

(D) The date of annual registration of a licensed hospital as an infectious waste generator shall be the hospital license renewal date and a nonlicensed hospital shall be assigned an annual registration date.

History

AUTHORITY: section 197.080, RSMo Supp. 2013, and section 260.203, RSMo 2000. Original rule filed Aug. 15, 1988, effective Dec. 29, 1988. Amended: Filed Dec. 31, 2013, effective Aug. 30, 2014. Original authority: 197.080, RSMo 1953 and 260.203, RSMo 1986, amended 1988, 1992.

19 CSR 30-20.080 Governing Body of Hospitals previously filed as 19 CSR 30-20.021(2)(A). Original rule filed June {#sec-19-csr-30-20.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.080}

19 CSR 30-20.082 Chief Executive Officer in Hospitals previously filed as 19 CSR 30-20.021(2)(B). Original rule filed June {#sec-19-csr-30-20.082 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.082}

19 CSR 30-20.084 Patients’ Rights in Hospitals previously filed as 19 CSR 30-20.021(2)(B)17. Original rule filed June {#sec-19-csr-30-20.084 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.084}

19 CSR 30-20.086 Medical Staff in Hospitals 30-20.021(2)(C). Original rule filed June 27, 2007, effective Feb. 29, 2008. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019. {#sec-19-csr-30-20.086 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.086}

19 CSR 30-20.088 Central Services 30-20.021(3)(A). Original rule filed June 27, 2007, effective Feb. {#sec-19-csr-30-20.088 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.088}

19 CSR 30-20.090 Food and Nutrition Services 30-20.021(3)(B). Original rule filed June 27, 2007, effective Feb. {#sec-19-csr-30-20.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.090}

19 CSR 30-20.092 Diversion {#sec-19-csr-30-20.092 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.092}

PURPOSE: This rule establishes the requirements for emergency services in a hospital.

(1) A hospital shall have a written plan that details the hospital’s criteria and process for diversion. Diversion may be due to the emergency department being overwhelmed with significantly critically ill or injured patients, or an overwhelming number of minor emergency patients, to the extent that the hospital is unable to provide quality care or protect the health or welfare of the patients it serves. A diversion also may be implemented if the hospital has resource limitations, such as, no available beds in specialty care units or general acute care, no surgical suites or shortages of equipment or personnel. The plan must be reviewed and approved by the Missouri Department of Health and Senior Services prior to being implemented by the hospital. A hospital may continue to operate under a plan in existence prior to the effective date of this section while awaiting approval of its plan by the department.

(A) The diversion plan shall:

Identify the individuals by title who are authorized by the hospital to implement the diversion plan;
Define the process by which the decision to divert will be made;
Specify that the hospital will not implement the diversion plan until the authorized individual has reviewed and documented the hospital’s ability to obtain additional staff, open existing beds that may have been closed, or take any other actions that might prevent a diversion from occurring;
Include that all ambulance services within a defined service area will be notified of the intent to implement the diversion plan upon the actual implementation. Ambulances that have made contact with the hospital before the hospital has declared itself to be on diversion shall not be redirected to other hospitals. In areas served by a real time, electronic reporting system, notification through such system shall meet the requirements of this provision so long as such system is available to all EMS agencies and hospitals in the defined service area;
Include procedures for assessment, stabilization, and transportation of patients in the event that services, including but not limited to, ICU beds or surgical suites become unavailable or overburdened. These procedures must also include the evaluation of services and resources of the facility that can still be provided to patients even with the implementation of the diversion plan;
Include procedures for implementation of a resource diver sion in the event that specialized services are overburdened or temporarily unavailable; and 7. Include that all other acute care hospitals within a defined service area will be notified upon the actual implementation of the diversion plan. For defined service areas with more than two (2) hospitals, if more than one-half (1/2) of the hospitals implement their diversion plans, no hospital will be considered on diversion. For a defined service area with two (2) hospitals, if both hospitals implement their diversion plans, neither will be considered on diversion. Participation in a real time, electronic reporting system shall meet the notification requirements of this section. If a hospital participates in an approved community-wide plan, the community-wide plan may set the requirement for the number of hospitals to remain open.

(B) Each incident of diversion plan implementation must be reviewed by the hospital’s existing quality assurance committee. Minutes of these review meetings must be made available to the Missouri Department of Health and Senior Services upon request.

(C) The hospital shall assure compliance with screening, treatment, and transfer requirements as required by the Emergency Medical Treatment and Active Labor Act (EMTALA).

(D) A hospital or its designee shall report to the department, by phone or electronically, upon actual implementation of the diversion plan. This implementation report shall contain the time the plan will be implemented. The hospital or its designee shall report to the department, by phone or electronically, with in eight (8) hours of the termination of the diversion. This termination report shall contain the time the diversion plan was implemented, the reason for the diversion, the name of the individual who made the determination to implement the diversion plan, the time the diversion status was terminated, and the name of the individual who made the determination to terminate the diversion. In areas served by real time, electronic reporting system, reporting through such system shall meet the requirements of this provision so long as such system generates reports as required by the department.

(E) Each hospital shall implement a triage system within its emergency department. The triage methodology shall continue to apply during periods when the hospital diversion plan is implemented.

(F) Any hospital that has a written approved policy, which states that the hospital will not go on diversion or resource diversion, except as defined in the hospital’s disaster plan in the event of a disaster, is exempt from the requirements of this

section.

(G) If a hospital chooses to participate in a community-wide plan, the requirement of the number of hospitals to remain open, defined service areas, as well as community notification may be addressed within the community plan. Community plans must be approved by the department. Community plans must include that each hospital has a policy addressing diversion and the criteria used by each hospital to determine the necessity of implementing a diversion plan. Participation in a community plan does not exempt a hospital of the requirement to notify the department of a diversion plan implementation.

History

AUTHORITY: sections 192.006 and 197.154, RSMo 2016, and section 197.080, RSMo Supp. 2019. This rule previously filed as 19 CSR 30-20.021(3)(C). Original rule filed June 27, 2007, effective Feb. 29, 2008. Amended: Filed March 20, 2019, effective Nov. 30, 2019. amended 1993, 1995, 2017; and 197.154, RSMo 2004. Pursuant to Executive Order 21-09, 19 CSR 30-20.092 was suspended from March 19, 2020 through December 31, 2021.

19 CSR 30-20.094 Medical Records 30-20.021(3)(D). Original rule filed June 27, 2007, effective Feb. {#sec-19-csr-30-20.094 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.094}

19 CSR 30-20.096 Nursing Services 30-20.021(3)(E). Original rule filed June 27, 2007, effective Feb. 29, 2008. Amended: Filed Oct. 22, 2008, effective June 30, 2009. {#sec-19-csr-30-20.096 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.096}

19 CSR 30-20.097 Safe Patient Handling and Movement in {#sec-19-csr-30-20.097 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.097}

History

AUTHORITY: section 197.080, RSMo 2000. Original rule filed April 29, 2011, effective Nov. 30, 2011. Rescinded: Filed March 20, 2019,

19 CSR 30-20.098 Pathology and Medical Laboratory Services 30-20.021(3)(F). Original rule filed June 27, 2007, effective Feb. {#sec-19-csr-30-20.098 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.098}

19 CSR 30-20.100 Pharmacy Services and Medication Management {#sec-19-csr-30-20.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.100}

PURPOSE: This rule establishes the requirements for pharmacy services and medication management in a hospital to ensure optimal selection, safe use, and security of medications.

(1) There shall be evidence of the education, training, experience, and demonstrated competency for all duties assigned in the pharmacy technicians’ personnel records.

(2) In addition to other authorized duties, a pharmacy technician may perform the following duties:

(A) Authenticate medication selected by another pharmacy technician when a pharmacist is present for purposes of distribution within the hospital for subsequent administration by hospital staff authorized to administer medication, provided the final product is verified by authorized hospital staff prior to administration. A pharmacy technician shall not be authorized to authenticate compounded medications or the repackaging activities of another pharmacy technician. In order to authenticate medication as described in this section, the pharmacy technician must— 1. Hold an active pharmacy technician certification issued by a certification entity accredited by the National Commission for Certifying Agencies;

Have an initial and annual documented assessment of competency; and 3. Have assisted in the practice of pharmacy as a registered or licensed pharmacy technician in the state of Missouri or another U.S. state or territory for a minimum of one (1) year;

(B) Perform assigned duties under visual and auditory supervision of a pharmacist at a different site, including, technology assisted medication authentication. Documentation of electronic authentication shall be maintained at the dispensing site.

The pharmacy technician shall have a current certificate issued by a certification entity accredited by the National Commission for Certifying Agencies.
The pharmacy technician shall have completed training and documented competency in the assigned responsibilities being performed remotely as attested by the director of pharmacy.
The director of pharmacy is responsible for developing and implementing standards to ensure adequate supervision of electronically supervised technicians.

(3) An intern pharmacist licensed by the Board of Pharmacy may also perform any activity authorized for pharmacy technicians pursuant to this rule.

(4) Persons involved in compounding, repackaging, dispensing, administration, and controlled substance disposal shall be identified and the records shall be retrievable. Retention time for records of bulk compounding, repackaging, administration, and all controlled substance transactions shall be a minimum of two (2) years. Retention time for records of dispensing and extemporaneous compounding, including sterile medications, shall be a minimum of six (6) months.

(5) All variances, discrepancies, inconsistencies, or noncompliance involving controlled substances—including inventory, audits, security, record keeping, administration, and disposal—shall be reported to the director of pharmacy services for review and investigation.

(6) Patient medications may be received from an authorized provider. The medications shall— (A) Be delivered directly to the pharmacy and not to a patient care area unless the pharmacist is not available;

(B) When a pharmacist is present, be identified, determined suitable for use and documented by the pharmacist. When a pharmacist is not present, be identified and documented by an authorized practitioner. Unused doses of medication shall be identified by the pharmacist when the pharmacist is present;

(C) The pharmacy may compound, repackage, or re-label medications received from an outside provider, including prescriptions dispensed by a pharmacy, as necessary for proper distribution and administration. Records of compounding, repackaging, or relabeling of prescriptions dispensed by a pharmacy shall allow identification of the original prescription.

(7) Sample medications, if allowed, shall be received and distributed only by the pharmacy.

(8) Medications may be provided to patients for use outside the hospital, by persons other than the pharmacist.

(A) When the patient is a registered patient of the emergency department or is being discharged from the hospital— 1. Medications shall be provided according to the hospital’s policies and procedures, including:

A. Circumstances when medications may be provided;

B. Practitioners authorized to order;

C. Specific medications;

D. Limited quantities;

E. Prepackaging and labeling by the pharmacist;

F. Final labeling to facilitate correct administration;

G. Delivery;

H. Counseling; and I. A transaction record;

Medications shall be labeled with the date, patient’s name, prescriber’s name, name and address of the hospital, exact medication name and strength, instructions for use, and other pertinent information;
Medications may be provided only when prescription services from a pharmacy are not reasonably available.

Reasonably available includes a pharmacist on duty in the hospital or a community pharmacy that is reasonably accessible to the patient;

The medication provided shall be limited to urgently needed treatment;
The quantity of medication provided shall be limited to the amount necessary until pharmacy services are available;
The provisions of paragraph (A)3. and paragraph (A)5. of this subsection shall not apply when the patient is being treated for an acute condition and it is believed that the immediate health and welfare of the patient and/or the community are in jeopardy. The quantity limit may be extended to provide single-course therapy; and 7. Final labeling, delivery, and counseling shall be performed by a pharmacist, the prescriber or a registered nurse, except that final labeling and delivery may be performed by an automated dispensing system.

(B) Automated dispensing systems may be used in accordance with all requirements of this section— 1.When the automated dispensing system is controlled by the prescriber it may be used only during times when no pharmacy services are reasonably available, except as allowed in paragraph (A)6. of this section; and 2. When the automated dispensing system is controlled by a pharmacy according to regulations of the Missouri Board of Pharmacy, including, but not limited to 20 CSR 2220-2.900.

(C) Medications in multidose containers that were administered to or used for the patient during the patient’s hospital stay may be sent with the patient at discharge when so ordered by an authorized practitioner.

Examples of multidose medication containers include, but are not limited to, inhalers, ointments, creams, medications requiring the original container for dispensing, insulin pens, eye drops, ear drops, and infusions that are currently connected to the patient’s infusion device.
Written instructions for use shall be provided by a pharmacist, prescriber, or registered nurse at the time of discharge.
Controlled substances shall not be sent with the patient, except that controlled substance infusions or continuous delivery systems currently connected to the patient may be sent as follows:

A. The medication is necessary for administration during transport of the patient; and B. The quantity of controlled substance sent is documented in the patient’s medical record by the person sending the medication.

(9) The director of pharmacy services or his/her pharmacist designee shall be an active member of the pharmacy and therapeutics committee or its equivalent, which shall advise the medical staff on all medication matters.

(10) Medications shall be ordered only by practitioners who have independent statutory authority to prescribe or who are authorized to order medications by their professional licensing agency as provided by state law. Authority to order medications may be granted to a non-physician licensed practitioner in accordance with state law.

(11) Medications in the possession of the patient at time of admission shall be given to the patient’s representative unless there is an identified need to retain them.

(A) Medications that are not given to the patient’s representative and that are not to be administered shall be documented, sealed, and stored in a locked area accessible only to individuals authorized to access medications.

(B) Controlled substances shall be security sealed and stored in a locked area accessible only to individuals authorized to administer controlled substances or to authorized pharmacy personnel.

section 197.080, RSMo Supp. 2021.* This rule previously filed as 19 CSR 30-20.021(3)(G). Original rule filed June 27, 2007, effective Feb. 29, 2008. Rescinded and readopted: Filed March 20, 2019, effective Nov. 30, 2019. Amended: Filed June 25, 2021, effective Dec. 30, 2021. amended 1993, 1995, 2013, 2017; and 338.165, RSMo 2014.

History

AUTHORITY: sections 192.006 and 338.165, RSMo 2016, and

19 CSR 30-20.102 Radiology Services in Hospitals 30-20.021(3)(H). Original rule filed June 27, 2007, effective Feb. 29, 2008. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019. {#sec-19-csr-30-20.102 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.102}

19 CSR 30-20.106 Inpatient Care Units in Hospitals 197.154, RSMo Supp. 2007. {#sec-19-csr-30-20.106 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.106}

This rule previously filed as 19 CSR 30- 20.021(3)(J)1. Original rule filed June 27, 2007, effective Feb. 29, 2008. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019.

19 CSR 30-20.108 Fire Safety, General Safety and Operating Features (K). Original rule filed June 27, 2007, effective Feb. 29, 2008. {#sec-19-csr-30-20.108 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.108}

19 CSR 30-20.110 Orientation and Continuing Education (L). Original rule filed June 27, 2007, effective Feb. 29, 2008. {#sec-19-csr-30-20.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.110}

Amended: Filed June 6, 2013, effective Jan. 30, 2014. Rescinded:

19 CSR 30-20.112 Quality Assessment and Performance Improvement Program 30-20.021(3)(M). Original rule filed June 27, 2007, effective Feb. {#sec-19-csr-30-20.112 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.112}

19 CSR 30-20.114 Environmental Waste Management and Support Services {#sec-19-csr-30-20.114 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.114}

PURPOSE: This rule specifies the requirements for environmental and support services provided by a hospital.

(1) Each hospital shall have an organized service which maintains a clean and safe environment.

(A) Housekeeping Services.

The housekeeping services shall have a director who is qualified by education, training, and experience in the principles of hospital housekeeping. This individual shall report to a designated administrative officer or his or her designee.
Approved written policies and procedures shall define and describe the scope of housekeeping services. These shall be reviewed in cooperation with the infection prevention control program, kept current per hospital policy, and be readily available to staff.
Adequate space for housekeeping services shall be provided.
There shall be sufficient trained personnel to meet the needs of housekeeping services.
All solid waste generated within the hospital shall be collected in appropriate containers for disposal.
There shall be a process for the review and evaluation on a regular basis of the quality of housekeeping services provided.

(B) Laundry and Linen Services.

The hospital shall have organized services which ensure that adequate supplies of clean linens are available. There shall be specific written procedures for the processing, distribution, and storage of linen. These shall be reviewed in cooperation with the infection control committee and kept current.
Soiled linen processing functions shall be physically separated from both clean linen storage and soiled linen holding areas. Only commercial laundry equipment shall be used to process hospital linen.
Clean linen shall be stored and distributed to the point of use in a way that minimizes microbial contamination from surface contact or airborne particles.
Soiled linen shall be collected at the point of use and transported to the soiled linen holding room in a manner that minimizes microbial dissemination into the environment.
If a commercial laundry service is used, verification shall be provided to assure the hospital that the processing and handling of linen complies with paragraphs (1)(B)1.–4. of this

rule and by following manufacturer recommendations.

There shall be a process for the review and evaluation on a regular basis of the quality of laundry and linen services provided.

(C) Infectious Waste Management 1. The director of this program shall be qualified by education, training, and experience in the principles of infectious waste management.

Every hospital shall write an infectious waste management plan with an annual review identifying infectious waste generated on-site, the scope of the infectious waste program, and policies and procedures to implement the infectious waste program. The plan shall include at least the following:

A. Contact information for responsible individuals; organizational chart; schematic(s) of waste disposal routes; definition of those wastes handled by the system; department and individual responsibilities; hospital policies and procedures for waste identification, segregation, containment, transport, treatment, and disposal; emergency and contingency procedures; training and educational procedures; and appendices (rules and other applicable institutional policy statements).

B. Any hospital exempt from infectious waste processing facility permit requirements of 10 CSR 80-7.010 and that accepts infectious waste from off-site shall include in its plan requirements for storage, processing, and record keeping of this waste and the cleanup of potential spills in the unloading area.

C. Manufacturers’ specifications for temperature, residence time, and control devices for any infectious waste processing devices shall be included in the plan.

A trained operator shall operate the equipment during any infectious waste treatment procedures.
Infectious waste shall be segregated from other wastes at the point of generation and shall be placed in distinctive, clearly marked, leakproof containers or plastic bags appropriate for the characteristics of the infectious waste. Containers for infectious waste shall be identified with the universal biological hazard symbol. All packaging shall maintain its integrity during storage and transport. Infectious waste shall not be placed in a gravity waste disposal chute.
Pending disposal, infectious waste shall be stored, separated from other wastes, in a limited-access enclosure posted with the biological hazard symbol. This enclosure shall afford protection from vermin, be a dry area, and be provided with an impervious floor with a perimeter curb. The floor shall slope to a drain connected to the sanitary sewage system or collection device. If infectious waste is compacted, the mechanical device shall contain the fluids and aerosols and shall not release aerosols or fluids when opened and the container is removed. Provisions for waste stored seventytwo (72) hours or more shall be separately addressed in the infectious waste management plan to include proper storage, handling, and disposal by commercial vendors when utilized.
Hospital infectious waste treated on site shall be rendered innocuous, using one (1) of the following methods:

A. Sterilization of the waste in an autoclave is permitted, provided that the unit is operated in accordance with the manufacturer’s recommendations and that the autoclave’s effectiveness is verified at least weekly with a biological spore assay containing Bacillus Stearothermophilus. If the autoclave is used for other functions, the infectious waste management plan will develop specific guidelines for its use;

B. Decontamination of the infectious waste by other technologies in a manner acceptable to the Department of Health and Senior Services shall be permitted;

C. Bulk blood, suctioned fluids, excretions, and secretions may be carefully poured down a drain connected to a sanitary sewer; or D. Infectious waste rendered innocuous by the methods in subparagraphs (1)(C)6.A. or B. of this rule shall be disposed of in accordance with the requirements of 10 CSR 80-7.010.

An infectious waste treatment program shall include records of biological spore assay tests if required by treatment methods and the approximate amount of waste disinfected per hour measured by weight per load. The program director shall maintain records demonstrating the proper operation of the disinfection equipment.
All infectious waste when transported off the premises of the hospital shall be packaged and transported as provided in sections 260.200–260.207, RSMo.
Any hospital which accepts infectious waste from small quantity generators as defined by 10 CSR 80-7.010 or from other Missouri hospitals—in quantities exceeding fifty percent (50%) of the total poundage of infectious waste generated on-site at the hospital—shall notify the Department of Natural Resources and comply with permitting requirements of sections 260.200– 260.207, RSMo. The weight of infectious waste generated on-site shall be calculated by multiplying one and five-tenths (1.5) pounds per day times the number of beds complying with Department of Health and Senior Services standards for hospital licensure. Infectious waste generated off-site may be accepted by a hospital only if packaged according to 10 CSR 80-7.010(2)(A)–(D).

(D) Medication Waste Management.

Disposal of unwanted medications and medication waste shall be identified in the following categories: general, controlled substances, radiologic, infectious, and hazardous.

Medication waste shall include materials contaminated with such medications.

A. Specific waste streams shall be identified for each category including storage container type, storage prior to disposal, and final disposition.

B. Medications shall be returned to the pharmacy for disposal except— (I) Single doses that may be disposed of by medication staff at the time of administration;

(II) Doses that are an infectious hazard; and (III) Radiopharmaceuticals.

C. Medications shall be disposed of according to the Missouri Department of Natural Resources, the United States Food and Drug Administration, and the United States Environmental Protection Agency.

D. Disposal of controlled substances shall be according to 19 CSR 30-1.078.

E. Unused radiopharmaceuticals shall be returned to the supplier or held and disposed of according to Nuclear Regulatory Commission guidelines.

F. Disposal of hazardous medications including, but not limited to, antineoplastic medications shall be handled as follows:

(I) Personnel who handle hazardous medications and/ or medication waste shall be trained regarding collection, transportation, containment, segregation, manifest, and disposal; and (II) Waste shall be contained and segregated from other waste in leak proof containers clearly labeled with a statement such as CAUTION: HAZARDOUS CHEMICAL WASTE and held in a secure place until disposed. and 197.154, RSMo Supp. 2013.* This rule previously filed as 19 CSR 30-20.021(5)(A), (C), and (D). Original rule filed June 27, 2007, effective Feb. 29, 2008. Amended: Filed June 6, 2013, effective Jan. 30, 2014. amended 1993, 1995, 2013; and 197.154, RSMo 2004.

19 CSR 30-20.116 Infection Prevention and Control {#sec-19-csr-30-20.116 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.116}

History

AUTHORITY: section 192.006, RSMo 2000, and sections 197.080, 197.150, and 197.154, RSMo Supp. 2013. This rule previously filed as 19 CSR 30-20.021(5)(B). Original rule filed June 27, 2007, effective Feb. 29, 2008. Amended: Filed Dec. 31, 2013, effective Aug. 30, 2014.

19 CSR 30-20.118 Outpatient Services in Hospitals 30-20.021(4)(A). Original rule filed June 27, 2007, effective Feb. {#sec-19-csr-30-20.118 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.118}

19 CSR 30-20.120 Anesthesia Services in Hospitals 30-20.021(4)(B). Original rule filed June 27, 2007, effective Feb. 29, 2008. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019. {#sec-19-csr-30-20.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.120}

19 CSR 30-20.122 Home-Care Services in Hospitals {#sec-19-csr-30-20.122 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.122}

(Rescinded January 30, 2014)

section 197.154, RSMo Supp. 2007. This rule previously filed as 19 CSR 30-20.021(4)(C). Original rule filed June 27, 2007, effective Feb. 29, 2008. Rescinded: Filed June 6, 2013, effective Jan. 30, 2014.

History

AUTHORITY: sections 192.006 and 197.080, RSMo 2000, and

19 CSR 30-20.124 Medical Services 30-20.021(4)(D). Original rule filed June 27, 2007, effective Feb. {#sec-19-csr-30-20.124 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.124}

19 CSR 30-20.125 Unlicensed Assistive Personnel Training Program {#sec-19-csr-30-20.125 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.125}

PURPOSE: This rule requires hospitals to have a personnel training policy that requires unlicensed health care personnel who provide direct patient care under the delegation and supervision of a registered nurse to complete the Unlicensed Assistive Personnel (UAP) Training Program, which shall be used to prepare individuals for employment in hospitals. This program shall be designed to teach the knowledge and skills that will qualify students to perform uncomplicated nursing procedures and assist in direct patient care.

PUBLISHER’S NOTE: The secretary of state has determined that publication of the entire text of the material that is incorporated or expensive. This material as incorporated by reference in this

(2) The hospital training policy for UAPs shall include the following minimum standards:

(A) The curriculum of the UAP Program shall consist of a standard plan of instruction to include:

A minimum of seventy-five (75) hours of classroom instruction;
Computer or paper-based learning modules that provide documentation of completion may be substituted for up to sixty (60) hours of classroom time;
Comparable certified medical assistant training from an accredited medical assistant program may be substituted for up to fifty (50) hours of classroom time of comparable subject matter;
A minimum of one hundred (100) hours of clinical practicum; and 5. Curriculum content of the program shall include procedures and instructions on basic patient care skills including but not limited to the areas of— A. The Role of the UAP (ethics, law, team member communication, observation, reporting, documentation, medical terminology);

B. Patient/Client Rights (Health Insurance Portability and Accountability Act (HIPAA), privacy, confidentiality, advanced directives, abuse and neglect, age specific care, cultural diversity, pain management, restraint-free care, end-oflife care, death and dying, do not resuscitate (DNR) orders, post-mortem care);

C. Vital Signs;

D. Quality (basic human needs: age specific cognitive/ psychological/social needs, activities of daily living, ambulation, positioning, personal care, elimination and toileting, nutrition, hydration, feeding, bed making);

E. Infection Control (universal precautions, bloodborne pathogens, safe needle devices, aseptic technique, hand washing, gloving, isolation);

F. Skin Care (wound care, pressure ulcers, and prevention); and G. Safety (cardiopulmonary resuscitation (CPR), allergies, fall prevention, environmental safety issues, fire/electrical, hazardous materials transportation safety information (HAZMAT), emergency procedures, body mechanics);

(B) The clinical practicum of one hundred (100) hours shall start after the student has enrolled and started the course curriculum;

(C) Skill validation and knowledge verification is to be used (10/31/23) John R. Ashcroft to determine student competence; and (D) Annual in-service training also shall occur as required by 19 CSR 30-20.

(3) Hospitals shall not be required to meet the UAP training requirements if an employee demonstrates competency in the content areas required by this rule; in the duties specific to their job and the patient population assigned and— (A) Is enrolled in a professional or practical nursing education program and has or will complete within ninety (90) days a fundamentals of nursing course; or (B) Was a professional nursing or practical nursing licensure candidate who failed to pass the state licensure examinations in the past three (3) years; or (C) Is certified as a nursing assistant as defined in section 198.082, RSMo; or (D) Has documentation of current registration as a certified nursing assistant in another state that meets the requirements listed in 42 CFR 483.151 and 483.152 (April 2012) which are incorporated by reference in this rule and are published by the U.S. Government Printing Office, 710 North Capitol Street, NW, Washington, DC 20401. This rule does not incorporate any subsequent amendments or additions; or (E) Has documented experience as a nurse assistant, emergency medical technician, or surgical technician in the past three (3) years; or (F) Has proof of completion of a patient care technician training program which meets the curriculum requirements of this rule or UAP training program in Missouri or another state which meets the requirements of this rule within the last three (3) years;

(G) Has completed a professional or licensed practical nursing program outside the United States and is awaiting the licensure examination in this country; or (H) Has proof of certification as a patient care technician.

(4) The hospital training policy for UAPs shall meet the following faculty qualifications and responsibilities:

(A) A registered professional nurse shall be designated as the course coordinator and shall be responsible for all aspects of the course, and must supervise all classroom and clinical instruction;

(B) Instructors shall hold a current license or temporary permit to practice as a registered professional nurse in Missouri or in another Nurse Licensure Compact state and have a minimum of two (2) years of nursing experience in an acute care, long-term care, or ambulatory surgery facility within the prior five (5) years, or an experience as a clinical faculty member in a nursing program within the prior five (5) years.

An instructor’s nursing license shall not be under current disciplinary action;

(C) A clinical supervisor’s or preceptor’s nursing license shall not be under current disciplinary action; and (D) UAPs who have satisfied the training requirements of this

rule and Licensed Practical Nurses may assist with the clinical practicum under the direction of the course coordinator.

(5) A hospital or ambulatory surgical center that provides training for UAPs shall meet the following training site requirements:

(A) Provide designated space sufficient to accommodate the classroom teaching portion of the course or have a written agreement with another acute care hospital, an area vocational-technical school, a high school offering a health service occupation program, a community college, or a provider agency to provide the classroom portion of the course;

(B) Provide on-the-job clinical practicum or have a written agreement with one (1) or more hospitals or ambulatory surgical centers in their vicinity to do so;

(C) Assess and review the program and outcomes of any training provided by another facility to ensure that all of the requirements of this rule have been met;

(D) Maintain, either electronically or on paper records of course completion and competency for a minimum of three (3) years. Records shall be signed and dated by the course coordinator and each of the instructors and clinical supervisors verifying classroom time, clinical time, and competency for each student; and (E) Provide a signed copy of the course completion and competency record to the student, that includes the elements in subsection (5)(D) of this rule.

(6) The UAP training shall be completed within one hundredeighty (180) days of employment for any individual who is hired as a UAP. Quality and Safety curriculum shall be covered within ninety (90) days of employment. A UAP shall not work in direct patient care, except as part of their supervised practicum, until the entire UAP training requirements have been met.

Filed May 22, 2023, effective Nov. 30, 2023. *Original authority: 197.287, RSMo 2000, amended 2017. **Pursuant to Executive Order 21-07, 19 CSR 30-20.125, section (6) was suspended from April 2, 2020 through May 1, 2021. Pursuant to Executive Order 21-09, 19 CSR 30-20.125, section 197.287, RSMo was suspended from April 2, 2020 through December 31, 2021 and section (6) was suspended from October 13, 2021 through December 31, 2021.

History

AUTHORITY: section 197.287, RSMo Supp. 2023. Original rule filed Jan. 31, 2008, effective Sept. 30, 2008. Amended: Filed Dec. 31, 2013, effective Aug. 30, 2014. Emergency amendment filed May 22, 2023, effective June 6, 2023, expired Dec. 2, 2023. Amended:

19 CSR 30-20.126 Obstetrical and Newborn Services in 30-20.021(4)(E). Original rule filed June 27, 2007, effective Feb. 29, 2008. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019. {#sec-19-csr-30-20.126 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.126}

19 CSR 30-20.128 Pediatric Services in Hospitals 30-20.021(4)(F). Original rule filed June 27, 2007, effective Feb. 29, 2008. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019. {#sec-19-csr-30-20.128 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.128}

19 CSR 30-20.130 Post-Anesthesia Recovery Services in 197.154, RSMo Supp. 2007. {#sec-19-csr-30-20.130 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.130}

This rule was previously filed as 19 CSR 30-20.021(4)(G). Original rule filed June 27, 2007, effective Feb. 29, 2008. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019.

19 CSR 30-20.132 Psychiatric Services in Hospitals 197.154, RSMo Supp. 2007. {#sec-19-csr-30-20.132 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.132}

This rule previously filed as 19 CSR 30- 20.021(4)(H). Original rule filed June 27, 2007, effective Feb. 29, 2008. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019.

19 CSR 30-20.134 Rehabilitation Services in Hospitals 30-20.021(4)(I). Original rule filed June 27, 2007, effective Feb. 29, 2008. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019. {#sec-19-csr-30-20.134 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.134}

19 CSR 30-20.136 Respiratory Care Services and 197.154, RSMo Supp. 2013. {#sec-19-csr-30-20.136 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.136}

This rule previously filed as 19 CSR 30-20.021(4)(J). Original rule filed June 27, 2007, effective Feb.

19 CSR 30-20.138 Specialized Inpatient Care Services 30-20.021(4)(K). Original rule filed June 27, 2007, effective Feb. {#sec-19-csr-30-20.138 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.138}

19 CSR 30-20.140 Surgical Services 30-20.021(4)(L). Original rule filed June 27, 2007, effective Feb. {#sec-19-csr-30-20.140 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.140}

19 CSR 30-20.142 Variance Requests and 197.154, RSMo Supp. 2013. {#sec-19-csr-30-20.142 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.142}

This rule previously filed as 19 CSR 30-20.021(1) and (1)(A). Original rule filed on June 27, 2007, effective Feb. 29, 2008. Amended: Filed June 6, 2013, effective Jan. 30, 2014. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019.

19 CSR 30-20.144 Standards and Guidelines for Essential Caregiver Program {#sec-19-csr-30-20.144 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-20.144}

PURPOSE: This rule establishes the standards and guidelines regarding the essential caregiver program established under

section 191.2290, RSMo.

(1) As used in this rule, the following terms and phrases shall mean— (A) Department shall mean the Department of Health and Senior Services;

(B) Essential caregiver shall mean a family member, friend, guardian, or other individual selected by a hospital patient who has not been adjudged incapacitated under Chapter 475, RSMo, or the guardian or legal representative of the patient;

(2) Every hospital within Missouri shall develop an essential caregiver program which shall allow a patient who has not been adjudged incapacitated under Chapter 475, RSMo, a patient’s guardian, or a patient’s legally authorized representative to designate an essential caregiver for in-person contact with the patient in accordance with the provisions of section 191.2290, RSMo, and the standards and guidelines developed by the department under this rule.

(3) The essential caregiver program shall be operable during a state of emergency declared pursuant to Chapter 44, RSMo, relating to infectious, contagious, communicable, or dangerous diseases.

(4) The essential caregiver program established by the hospital shall— (A) Allow at least two (2) individuals per patient to be designated as essential caregivers, although the hospital may limit the in-person contact to one (1) caregiver at a time. The caregiver shall not be required to have previously served in a caregiver capacity prior to the declared state of emergency;

(B) Include a reasonable in-person contact schedule to allow the essential caregiver to provide care to the patient for at least four (4) hours each day, including evenings, weekends, and holidays, but shall allow for twenty-four- (24-) hour in-person care as necessary and appropriate for the well-being of the patient. The essential caregiver shall be permitted to leave and return during the scheduled hours or be replaced by another essential caregiver;

(C) Include procedures to enable physical contact between the patient and the essential caregiver. The hospital may not require the essential caregiver to undergo more stringent screening, testing, hygiene, personal protective equipment, and other infection control and prevention protocols than required of hospital employees; and (D) Specify in its protocols the criteria that the hospital will use to determine that in-person contact by a particular essential caregiver is inconsistent with the patient’s therapeutic care and treatment or is a safety risk to other patients or staff at the facility. Any limitations placed upon a particular essential caregiver shall be reviewed and documented every seven (7) days to determine if the limitations remain appropriate.

(5) A hospital shall inform, in writing, patients who have not been adjudged incapacitated under Chapter 475, RSMo, or guardians or legal representatives of patients, of the essential caregiver program and the process for designating an essential caregiver. Consistent with 42 CFR 482.12(h), a hospital shall inform each patient, or such patient’s guardian or legal representative, where appropriate, of his or her visitation rights and right to access an essential caregiver in accordance with this rule.

(10/31/23) John R. Ashcroft (6) A hospital may restrict or revoke in-person contact by an essential caregiver who fails to follow required protocols and procedures established under section (4) of this rule.

(7) A hospital may request from the department a suspension of in-person contact by essential caregivers for a period not to exceed seven (7) days. A hospital may request from the department an extension of a suspension for more than seven (7) days, but such extension period shall not be for a period longer than seven (7) days at a time. Under the provisions of this section, a hospital shall not suspend in-person caregiver contact for more than fourteen (14) consecutive days in a twelve- (12-) month period or for more than forty-five (45) total days in a twelve- (12-) month period. Requests for a suspension of in-person contact of essential caregivers or an extension of a suspension under this section shall be submitted in writing to the department. Department determinations in response to suspension requests shall be in writing and both requests and determinations shall be made a part of the department’s permanent records for the hospital.

(A) Requests for a suspension of in-person contact by essential caregivers shall contain at a minimum the following:

The specific reason or reasons why allowing in-person contact by essential caregivers poses a serious community health risk;
An explanation of the extenuating factors which may be relevant to granting a suspension to the particular requesting hospital; and 3. The length of time, not to exceed seven (7) days, the suspension is being requested.

(8) The department’s written determination shall identify a suspension expiration date, if approved. The hospital may reapply for an extension of the suspension up to one (1) day prior to the expiration of the department’s originally approved suspension. The department may deny a hospital’s request to suspend in-person contact with essential caregivers if the department determines that such in-person contact does not pose a serious community health risk.

(9)

The department shall suspend in-person contact by essential caregivers under this rule if it determines that doing so is required under federal law, including a determination that federal law requires a suspension of in-person contact by members of the patient’s care team.

(10) The provisions of this rule shall not apply to those patients whose particular plan of therapeutic care and treatment necessitates restricted or otherwise limited visitation for reasons unrelated to the stated reasons for the declared state of emergency.

(11) The provisions of this rule shall not be construed to require an essential caregiver to provide necessary care to a patient and a hospital shall not require an essential caregiver to provide necessary care.

History

AUTHORITY: sections 191.2290 and 197.080, RSMo Supp. 2022. Emergency rule filed Sept. 15, 2022, effective Sept. 29, 2022, expired March 27, 2023. Original rule filed Sept. 15, 2022, effective March 30, 2023. Original authority: 191.2290, RSMo 2022, and 197.080, RSMo 1953, amended 1993, 1995, 2013, 2017.

Chapter 22 Rehabilitation Hospitals

19 CSR 30-22.010 General Design and Construction Standards for Rehabilitation Hospitals {#sec-19-csr-30-22.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-22.010}

PURPOSE: The Department of Health, Division of Health Resources has the authority to establish construction standards for rehabilitation hospitals. This rule provides standards for facilities to ensure functional, sanitary and fire-safe facilities.

PUBLISHERS NOTE: The publication of the full text of the material that the adopting agency has incorporated by reference in this

rule would be unduly cumbersome or expensive. Therefore, the full text of that material will be made available to any interested person at both the Office of the Secretary of State and the office of the adopting agency, pursuant to section 536.031.4, RSMo. Such material will be provided at the cost established by state law.

(1) All new rehabilitation hospitals and additions to and remodeling of existing licensed rehabilitation hospitals shall be designed to provide all of the facilities required by these rules and fire safety standards, arranged to accommodate with maximum convenience all of the functions required by these rules and arranged to provide comfortable, attractive, sanitary, fire-safe, secure and durable facilities for the patients. Any additions or alterations to a rehabilitation hospital shall comply with these rules and shall provide all required facilities proportional to the number of beds. These rules are applicable to rehabilitation hospitals which began operation or one which began operation or one which began construction or renovation of a building for the purpose of operating a rehabilitation hospital on any date after November 21, 1969.

(A) General Construction—Related Authorities.

Construction of all rehabilitation hospitals and additions to or remodeling of rehabilitation hospitals shall comply with all local and state regulations and codes. Facilities and equipment shall comply with the American Standards Association Specification A 117.1- 1961 (R-1971) entitled “American Standard Specifications for Making Buildings and Facilities Accessible to, and Usable by, the Physically Handicapped”.

(B) Planning and Construction Procedure.

Plans and specifications shall be prepared for the construction of all rehabilitation hospitals and additions to and remodeling of rehabilitation hospitals. The plans and specifications shall be prepared by an architect or a professional engineer licensed to practice in Missouri.
Construction shall be undertaken only after the plans and specifications have received the written approval of the Department of Health and the construction shall be in conformance with the approved plans and specifications. The Department of Health shall be notified within five (5) days after construction begins. If construction of the project is not started within one (1) year after the date of approval of the plans and specifications, the plans and specifications shall be resubmitted to the Department of Health for its approval and shall be amended, if necessary, to comply with the then current rules before construction work commences.

A. Preliminary Plans and Sketches.

(I) When construction is contemplated, either for new buildings, additions to existing buildings or material alterations to existing buildings, the preliminary plans or sketches shall be submitted in duplicate to the Department of Health for review and approval before the preparation of working drawings is undertaken. The preliminary plans may be reviewed by the Department of Health in schematic form, but before they are declared acceptable for procedure with working drawings and specifications, they should also include the following information, stated briefly and not in detailed form required in working drawings and specifications: site plan showing scale, orientation, street names, topography, walks, drives, parking areas and utilities, including fire plug location; plans and elevations of the buildings at a scale of not less than one-eighth inch to one foot (1/8"-1'); rooms and corridors, designated by name and number; windows, note wired glass where it is required; doors, including door swings; identify fire doors by time rating and Underwriters’ Laboratories label; plumbing fixtures; show fixtures in proper shape and scale for positive recognition; identify special types such as service sinks and clinic sinks; brief descriptive notes on type of supplies, vacuum breakers, and the like are advisable; plans of patient rooms shall indicate principle items of furniture accurately scaled; all other principle items of equipment such as boiler(s), chiller(s), cooling tower(s), electrical substation(s), tank(s), air handler(s), fan-coil unit(s), kitchen equipment, laundry equipment, cabinet(s), counter(s) and any other item(s) which take up space and affect the final layout; fire- and smoke-barrier partition designations; floor lines, top ceiling line and grade lines, designated and preferably dimensioned and with basic elevations shown; ceiling height; only one (1) typical room of a group need be so shown; area of each room for which the rules establish a minimum area; only one (1) typical room of a group need be so noted; and brief noted descriptions of the general construction and finish, the structural system, the heating, ventilating and air-conditioning system, including the fuel supply, the plumbing system, including the water supply and sewage disposal and the electrical system.

(II) In the case of a project which is an addition to an existing building, it will be necessary to give the Department of Health sufficient information about the existing building on which to base a determination of acceptability of the plans for the addition.

This information shall cover all items required to be provided in a rehabilitation hospital by the rules of the Department of Health and shall be submitted in such form as required by the Department of Health for the particular project.

B. Working Drawings and Specifications.

(I) Working drawings and specifications, complete in all respects, shall be submitted in duplicate covering all phases of the construction project including: site preparation; paving; general construction; mechanical work, including plumbing, heating, ventilating and air conditioning; electrical work; and all built-in equipment, including elevators, kitchen equipment, cabinet work, and the like; each sheet of the plans and each set of the specifications shall identify the project by name and location and shall bear the names and addresses of the architect or professional engineer and the owner; each sheet of the plans and each set of specifications shall bear the official seal and signature of the registered architect or registered professional engineer who prepared it; each sheet of the plans and each set of specifications shall bear the date of its completion or its latest revision; and the plans shall be on sheets of the same size, securely bound into complete sets, with the sheets in the proper order; and the specifications shall be securely bound into complete sets.

(II) The plans and specifications are to include a survey and soil investigation of the proposed site. The following information shall be provided: items previously listed under subparagraph (1)(B)2.A. Preliminary Plans and Sketches; courses and distances of property lines; dimensions and locations of any buildings, structures, easements, rightsof-way or encroachments on the site; details of party walls or walls and foundations adjacent to lot lines; the position of trees, dimensions, position and elevation of all cellars, evacuations, wells, backfilled areas and the elevation of any water; detailed information by the city engineer or other official report as to established curbs, building lines, streets, alleys and sidewalks; all utilities including size, characteristics and location of these services; piping, mains, sewers, poles, wires, hydrants and manholes upon, over or under this or the adjacent site; complete information as to the disposal of sanitary, storm water and subsoil drainage; official date upon which elevations are based and benchmark established on or adjacent to the site; contours on elevations at two foot (2') intervals over site and elevations at the bottom of excavation; contemplated date and description of proposed improvements to approaches or utilities adjacent to the site; thickness, consistency, character and estimated safe bearing value of various strata encountered; amount and elevation of groundwater encountered in each test pit; elevation of rock, if known and probability of encountering quicksand; average depth of frost effect below ground; high and low water levels of nearby bodies of water affecting groundwater level; whether the soil contains alkali in sufficient quantities to effect the concrete; elevation and location of mine shafts or excavations if the site is underlaid with mines or old workings; and whether the site is subject to mineral rights which have not been developed.

The facility shall be located reasonably accessible to the center of population of the community served, close to where competent medical and professional consultation is readily available and where employees can be recruited and retained.
The site shall be away from nuisances detrimental to the proposed project’s program.
Adequate vehicular and pedestrian access shall be provided within the lot lines to the main entrance, ambulance entrance, community activities and services including loading and unloading space for delivery trucks.

Roads, walks, ramps and entrances, etc., are to comply with the “American Standards Associations Specification” A 117.1-1961 (R-1971), entitled “American Standard Specifications for Making Buildings and Facilities Accessible to, and Usable by, the Physically Handicapped.”

Adequate off-street parking shall be provided.

(D) General Construction—Structural Requirements.

All new rehabilitation hospitals and additions to and remodeling of existing rehabilitation hospitals shall be of sufficient structural strength to resist all stresses imposed by dead loads, live loads and lateral or uplift forces, such as wind, without exceeding, in any of the structural materials, the allowable working stresses established for these materials by generally accepted good engineering practice.
Compliance with the Basic Building Codes of the Building Officials Conference of America (BOCA Code) insofar as it may apply, shall be deemed to be in compliance with this rule.

(E) General Design—Facilities.

Rehabilitation hospitals shall provide the following facilities:

A. Administrative area. Business office with information counter, telephone, switchboard and cashier’s window; administrator’s office; director of nurse’s office; medical records room; medical library; lobby and waiting room; public telephone booth; public toilets and personnel toilets;

B. Evaluation and treatment facilities.

Clinical laboratory; radiology and radiographic room adjoining dark room, toilet and office; pharmacy, drug room with minimum facilities for compounding; conference room; offices, examination rooms and work space for medical personnel; office and work space for provision of appropriate dental treatment; office and work space for physical therapy staff; rehabilitation gymnasium; hydrotherapy area; electro-diagnosis area; thermotherapy and massage area; storage for physical therapy supplies and equipment; office and work space for occupational therapy staff; occupational therapy area; storage space for occupational therapy supplies and equipment; facilities for teaching activities of daily living; artificial appliance facilities; space for fitting and adjustment service; office and work space for psychological testing, evaluation and counseling; office space for private interview and counseling; office and work space for counseling, evaluation, pre-vocational programs and placement; schoolroom for children if children are included in program; locker, toilet for outpatients; and clean and soiled linen facilities;

C. Nursing unit for adults. This unit shall be located convenient to the treatment area; each patient’s rooms shall have a lavatory, mirror, convenience electrical outlet and wardrobe space; toilet room shall be accessible to each patient room; nursing unit shall not exceed fifty (50) beds; patients’ room area shall be at least eighty (80) square feet per bed in multi-bed patients’ rooms and one hundred (100) square feet per bed in private patients’ rooms and a continuous aisle not less than three feet (3') wide shall be available around the foot and along both sides of each bed; nurses’ station with medicine preparation area; nurses’ toilet; clean and soiled utility rooms; accessible examination and treatment room with lavatory; floor pantry with lavatory; recreation area of twenty (20) square feet per bed; a toilet room for each sex at a ratio of one (1) water closet to each five (5) beds and one (1) of the water closet enclosures in each centralized toilet room shall be at least five feet by six feet (5' × 6') to permit toilet training unless toilets in patient rooms are five feet by six feet (5' × 6'); bedpan cleaning facilities; separate bathroom with tub for each sex; one (1) shower to each eight (8) beds; stretcher and wheelchair parking space; clean linen storage; all rooms occupied by patients shall be outside rooms; each patient room shall have a minimum window area of not less than one-eighth (1/8) of the floor area; equipment and supply storage; janitor’s closet; and one (1) telephone alcove per floor;

D. Nursing unit for children is the same as for adults except at least sixty (60) square feet per bed is to be provided in crib rooms; and E. Service departments. Central sterilizing and supply room shall include receiving and clean-up room; clean workroom including sterilizing facilities and unsterile supply storage area; dietary facilities shall include food preparation area with handwashing facilities, food serving facilities for makeup of patient trays, commercial-type dishwashing equipment adequately isolated and ventilated, lavatory in dishwashing area, three (3) compartment sinks, refrigerated and freezer storage, day storage, food cart storage area, trash and waste disposal facilities, canwashing facilities, staff dining facilities, patient dining facilities at ratio of twenty (20) square feet per bed; janitor’s closet with floor receptor or service sink and space for housekeeping supplies and equipment; lockers and toilet facilities; housekeeping supply storage facilities; unless commercial or other laundry facilities are available, each rehabilitation facility shall have a laundry of sufficient capacity to process full seven (7) days’ laundry in a work week and contain a soiled sorting area, processing area, clean linen and sewing room separate from laundry; mechanical facilities, including boiler and pump room(s), mechanical room(s), engineers’ space and maintenance shops, at least one (1) room; female staff and volunteers’ locker room including lockers and toilet and shower room; female help locker room, including lockers and toilet and shower room; male 4CODE OF STATE REGULATIONS staff and volunteers’ locker room including lockers and toilet and shower room; male help locker room, including toilet and shower room; and twenty (20) square feet of general storage space per bed and to be concentrated in one (1) area.

(I) When no laundry is provided in the hospital, a soiled linen room and clean linen and sewing room shall be provided.

(F) General Design—Details.

All new rehabilitation hospitals and additions to and remodeling of existing rehabilitation hospitals shall comply with the following general design details:

A. Required corridors and aisles shall be at least eight feet (8') wide and no less than ten feet (10') wide at elevators. No part of the area of any required corridor or aisle shall be counted as part of the required area of any space adjacent to the corridor or aisle.

A continuous system of unobstructed corridors and aisles shall extend through the enclosed portion of each story of the building, connecting all rooms and spaces with each other and with all entrances, exitways and elevators with the following exceptions: work suites such as the administrative suite and the dietary area, which are occupied primarily by employed personnel, may have within them, corridors or aisles as are deemed advisable; but these are not subject to the regulations applicable to required corridors or aisles;

B. The width of stairways shall be not less than three feet eight inches (3' 8"). The width shall be measured between handrails where handrails project more than three and one-half inches (3 1/2");

C. Doors through which residents will pass, including exit doors, shall be at least forty-four inches (44") wide except doors to toilets and bathrooms, which shall be at least thirty-six inches (36") wide;

D. Exits shall swing outward. Doors to rooms shall generally swing into the rooms they serve. Doors to small toilet rooms may swing outward into the adjacent room and if they swing inward they shall be equipped for emergency access. No doors shall swing into required corridors or aisles except doors to janitors’ closets, linen closets or doors to similar small spaces which are open only temporarily;

E. Ceilings in corridors, storage rooms, patients’ toilet rooms and other minor rooms shall not be less than seven feet six inches (7' 6"). Ceilings in all other rooms shall not be less than eight feet (8’);

F. Drinking fountains shall be located in or near the lobby and recreation area and in each nursing unit corridor. The fountain shall be accessible to residents in wheelchairs;

G. Toilet room doors shall be equipped with privacy and release-type hardware;

H. The floors of toilets, baths, bedpan rooms, floor pantries, utility rooms and janitors’ closets shall have smooth, waterproof surfaces which are wear-resistant. The floors of residents’ rooms and corridors shall be easily cleanable. The floors of kitchens and food preparation areas shall be waterproof, greaseproof, smooth, slip-resistant and durable;

I. The walls of kitchens, utility rooms, baths, showers, dishwashing rooms, janitors’ closets and spaces with sinks shall have waterproof painted, glazed or similar finishes to a point at least thirty inches (30”) above the sink or countertop. The remaining wall surfaces of such rooms and rooms where food is stored shall have a smooth surface with painted or equally washable finish in light color. The base shall be waterproof and free from spaces which may harbor insects;

J. The ceilings of all kitchens, dishwashing and other rooms where food and drink are prepared shall have a smooth washable finish;

K. Wall and ceiling surfaces of all occupied rooms and of all exitways shall be of such material or so treated as not to have a flame-spread classification of more than fifty (50) according to the method for the “Fire Hazard Classification of Building Materials” of Underwriters’ Laboratories, Inc. Floor finish shall have a flame-spread rating of not more than seventy-five (75). Carpeting, including the backing or underpad, shall have a flame-spread rating of not more than seventy-five (75);

L. Adequate space, consistent with the need, shall be provided for residents using crutches, walkers, wheelchairs, wheel stretchers, and the like. Accessibility to all required facilities, including toilets, lavatories, baths, showers, drinking fountains, telephones, furniture, and the like, shall be provided;

M. Showers shall be at least four feet (4') square. Curbs shall not exceed one inch (1") in height and shall have sloped edges;

N. Handrails or grab bars shall be placed in positions to be reached from any point within a toilet or bathroom area. Grab bars or handrails shall be provided adjacent to all bathtubs, within all showers and on both sides of all water closets.

O. Lavatories for patients’ use shall be positioned to be accessible to wheelchair patients and shall not have cabinets underneath or any other unnecessary obstruction to the maneuverability of wheelchairs;

P. Mirror sizes and positions shall be such as to make the mirrors convenient both for residents in wheelchairs and those in a standing position;

Q. Bathtubs other than therapeutic tubs are not to be elevated;

R. Paper towel dispensers shall be provided at all lavatories used for handwashing; and S. Telephone alcoves shall be a minimum of four (4) feet square. Telephone shall be located on a shelf convenient for residents in wheelchairs. Doors to telephone booths are not recommended.

(G) General Construction—Specifications and Details.

All rehabilitation hospitals and additions to and remodeling of existing rehabilitation hospitals shall be constructed to provide safe, comfortable, secure, fire-safe, sanitary and durable facilities for the patients. Existing buildings, if converted to use as rehabilitation hospitals, shall be considered to be new rehabilitation hospitals and shall comply with all of the requirements for new rehabilitation hospitals.
The requirements of the Life Safety Codeby the National Fire Protection Association shall be complied with insofar as they may apply and to the extent they are not superseded by requirements specifically stated in these rules.
Specific requirements.

A. The following elements of the building shall be constructed to qualify for fire-resistance ratings not less than the following: one (1)-hour exterior walls of one (1)-story buildings thirty feet (30') or more from any other building(s) or from a lot line; two (2)-hour exterior walls of one (1)-story buildings less than thirty feet (30') from another building(s) or from a lot line; two (2)-hour exterior walls of multi-story buildings; two (2)-hour noncombustible fire walls; two (2)-hour columns, interior bearing walls and other structural elements supporting floor construction; one (1)-hour columns, interior bearing walls and other structural elements supporting roof construction only and in buildings not more than one (1) story in height, exclusive of the basement; one (1)hour for other construction, including nonbearing partitions, curtain walls, and the like.

B. The height and area of each building, or fire section between fire walls, shall be within the limitations established by the BOCA Codefor buildings of the same occupancy and the next less restrictive type of construction.

C. Doors between rooms and the required corridors shall not have louvers or transoms. Doors shall be one and threefourths inches (1 3/4") solid core wood or metal doors with equivalent or greater fire resistance.

D. If linen and refuse chutes are used, they shall be designed as follows: service openings to chutes shall have approved class B, one and one-half (1 1/2)-hour fire doors; service openings to chutes shall be located in a room or closet of not less than one (1)-hour fire-resistive construction and the entrance door to the room or closet shall be a class C, three-fourths (3/4)-hour fire door; minimum diameter of gravity-type chutes shall be two feet and no inches (2' 0"); chutes shall terminate in or discharge directly into a refuse room or linen chute room separated from the incinerator or laundry, the rooms shall be of not less than two (2)-hour fire-resistive construction and the entrance door shall be class B, one and one-half (1 1/2)-hour fire door; chutes shall extend at least four feet (4') above the roof and shall be covered by a metal skylight glazed with thin plain glass.

E. Dumbwaiters, conveyors and material handling systems shall not open into any corridor or exitway but shall open into a room enclosed by not less than one (1)-hour fire-resistive construction. The entrance door to the room shall be a class C, three-fourths (3/4)-hour fire door.

F. Any penetrations of fire walls other than doors, such as openings for ducts, shall be protected by approved automatic protective assemblies with a fire-resistance rating at least as high as that of the wall.

G. Each floor of a rehabilitation hospital shall have at least two (2) exits remote from each other and so located that the distance of travel to the exit shall not be more than one hundred feet (100') from the door to any room nor one hundred fifty feet (150') from any point in a room. If the entire building is completely protected by a standard automatic sprinkler system, these distances may be increased by fifty feet (50').

H. Every exit shall be so arranged that no corridor has a pocket or dead end exceeding thirty feet (30') in which occupants might be trapped. Distance shall be measured from the door of the room to the exit.

I. Interior exitways shall be isolated from the rest of the building by floors, ceilings and walls with a two (2)-hour fire-resistance rating as determined by the Underwriters’ Laboratories and shall have one and one-half (1 1/2)-hour B-label interior fire doors.

J. Horizontal exits are permissible where located in compliance with subparagraphs (1)(G)3.G. and H. of this rule. A horizontal exit shall be through a fire wall to a fire-safe area on the same story of the building and shall be subject to all requirements of other exits except that the door may swing in either direction. The fire-safe area on either side of the fire wall shall be sufficiently large to provide a floor area of at least thirty (30) square feet per person for all persons who would normally occupy the space on both sides of the fire wall. The fire wall shall have a fire-resistance rating of not less than two (2) hours and shall extend from floor-to-floor or roof, from exterior wall to exterior wall, shall have no doors except the required exit and shall have no other penetrations except ducts with automatic fire dampers.

K. Each story of a facility or each portion of a story between fire walls, which is in excess of five thousand (5000) square feet in floor area, shall be subdivided by smoke-barrier partitions located to provide floor areas between them of not more than five thousand (5000) square feet, and located to provide a total floor area on either side of each such partition of at least thirty (30) square feet each for all patients on the entire floor. Smoke-barrier partitions shall be provided where necessary to separate elevator lobbies and required aisles from adjoining required corridors as directed.

L. Smoke-barrier partitions shall have a fire-resistance rating of not less than one (1)

hour. They shall be continuous from exterior wall to exterior wall and from the floor to the floor or roof deck above and shall be penetrated only to the extent allowed by subparagraphs (1)(G)3.P. and Q. of this rule.

M. Doors in smoke-barrier partitions required by subparagraph (1)(G)3.K. of this

rule shall be located only in main corridors or in rooms open to the public. They shall be one and three-fourths inches (1 3/4") thick solid core wood doors or one and threefourths inches (1 3/4") thick metal doors with three-fourths (3/4)-hour fire-resistance rating and if glazed shall be glazed with wired glass.

N. Any penetrations of smoke-barrier partitions other than doors, such as openings for ducts, shall be equipped with automatic fire dampers.

O. All doors to required exitways and to the outside at grade level and all vestibule doors shall swing outward in the direction of exit travel. They shall be self-closing and shall be normally closed.

P. All exit doors to required exitways shall be one and one-half (1 1/2)-hour B-label doors. All doors in horizontal exits shall be one and one-half (1 1/2)-hour B-label doors.

All doors in smoke-barrier partitions, required corridor partitions and one (1)-hour partitions around hazardous areas shall be one and three-fourths inches (1 3/4") solid core wood doors or metal doors with equivalent or greater fire resistance. Doors in two (2)-hour partitions at boiler rooms, furnace rooms, incinerator rooms and rooms for similar hazardous occupancy shall be one and one-half (1 1/2)-hour B-label doors.

Q. Doors in fire separations, horizontal exits and smoke-stop partitions may be held open only by electric hold-open devices.

If these doors are in main corridors, they shall be a pair of doors not less than five feet four inches wide (5'4"). The doors shall close upon actuation of the fire alarm system and shall be capable of being opened and closed manually. In addition, these doors shall close by at least one (1) of the following methods: activation of the sprinkler system; and actuation of a smoke detector.

R. Any door to stairway enclosures or in walls surrounding hazardous areas shall not be equipped with hold-open devices.

S. The aggregate width of required exitways shall be such as to provide twentytwo inch (22") wide exit units at the rate of one (1) exit unit of stair width for each fifteen (15) persons served and one (1) exit unit of width for passageways within the exitways other than stairs for each thirty (30) persons served.

(H) Mechanical Requirements.

Prior to completion of the contract and final acceptance of the facility, the architect or engineer shall obtain from the contractor certification that all mechanical systems have been tested and performance of these systems conform to the requirements of the plans and specifications. Upon completion of the contract, the contractor shall furnish the owner with a complete set of specifications and as-built drawings and a bound volume containing operating instructions, manufacturers’ catalog number(s) and description and parts list for each piece of equipment.
Incinerators, if provided, shall be gas- , electric- or oil-fired and shall be capable of, but need not be limited to, complete destruction of pathological wastes. Design and construction of incinerators and refuse chutes shall be in accordance with Part III of the NFPA Standard No. 82. Incinerators shall conform to current rules of the Air Conservation Commission.
Steam and hot water systems.

A. Boilers shall have the capacity, based upon the published Steel Boiler Institute or Institute of Boiler and Radiator Manufacturers’ Net Ratings, to supply the normal requirements of all systems and equipment.

The number and arrangement of boilers shall 6CODE OF STATE REGULATIONS be such that when one (1) boiler breaks down or when routine maintenance requires that one (1) boiler be temporarily taken out-ofservice, the capacity of the remaining boiler(s) shall be no less than seventy percent (70%) of the total required capacity.

B. Boiler feed pumps, condensate return pumps, fuel oil pumps and circulating pumps shall be connected and installed to provide standby service when any pump breaks down.

C. Supply and return mains and risers of space heating and process steam systems shall be valved to isolate the various sections of each system. Each piece of equipment shall be valved at the supply and return end.

D. Boilers, smoke breeching, steam piping, high pressure steam return piping and hot water space heating supply and return piping shall be insulated with insulation having a flame spread rating of twenty-five (25) or less and a smoke-developed rating of fifty (50) or less.

Air-conditioning, heating and ventilating systems.

A. A minimum temperature of seventy-five degrees Fahrenheit (75°F) shall be provided for all occupied areas at winter design conditions.

B. All air-supply and air-exhaust systems shall be mechanically operated. All fans serving exhaust systems shall be located at or near the point of discharge from the building.

The ventilation rates shown on Table I shall be considered as minimum acceptable rates and shall not be construed as precluding the use of higher ventilation rates if they are required to meet design conditions.

C. Outdoor ventilation air intakes, other than for individual room units, shall be located as far away as practicable but not less than twenty-five feet (25') from the exhaust from any ventilating system or combustion equipment. The bottom of outdoor intakes serving central air systems shall be located as high as possible but not less than eight feet (8') above the ground level or, if installed through the roof, three feet (3') above roof level.

D. The ventilation systems shall be designed and balanced to provide the general pressure relationship to adjacent areas shown in Table I.

E. Room supply air inlets, recirculation and exhaust air registers shall be located not less than three inches (3") above the floor. This does not apply to cabinet units.

F. Corridors shall not be used to supply air to or exhaust air from any room, except that exhaust air from corridors may be used to ventilate rooms such as bathrooms, toilet rooms or janitors’ closets which open directly on corridors.

G. Central systems designed for recirculation of air shall be equipped with a minimum of two (2) filter beds. Filter bed No. 1 shall be located upstream of the conditioning equipment and shall have a minimum efficiency of thirty percent (30%). Filter bed No. 2 shall be located downstream of the conditioning equipment and shall have a minimum efficiency of ninety percent (90%).

H. Central systems using one hundred percent (100%) outdoor air shall be provided with filters rated at eighty percent (80%) efficiency.

I. The stated filter efficiencies shall be warranted by the manufacturer and shall be based on theNational Bureau of Standards Dust Spot Test Method with Atmospheric Dust.

J. Filter frames shall be durable and carefully dimensioned and shall provide an airtight fit with the enclosing ductwork. All joints between filter segments and the enclosing ductwork shall be gasketed or sealed to provide a positive seal against air leakage.

K. A manometer shall be installed across each filter bed serving central air systems.

L. Ducts shall be constructed of iron, steel, aluminum or other approved materials such as clay, fiberglass or asbestos cement.

M. Duct interiors or linings shall meet the Erosion Test Method described in UL Pub. No. 181. Duct linings, coverings, vapor barriers and the adhesives used for applying them shall have a flame-spread classification of not more than twenty-five (25) and a smoke-developed rating of not more than fifty (50).

N. Ducts which pass through fire walls shall be provided with approved automatic fire dampers on both sides of the wall except that three-eighths inch (3/8") steel plates may be used in lieu of fire dampers for openings not exceeding eighteen inches (18") in diameter. An approved fire damper shall be provided on each opening through each fire partition and on each opening through the walls of a vertical shaft. Ducts which pass through a required smoke barrier shall be provided with dampers which are actuated by products of combustion other than heat.

Access for maintenance shall be provided at all dampers.

O. Cold air ducts shall be insulated wherever necessary to maintain the efficiency of the system or to minimize condensation problems.

P. The air from dining areas may be used to ventilate the food preparation areas only after it has passed through a filter with eighty percent (80%) efficiency.

Q. Exhaust hoods in food preparation centers shall have a minimum exhaust rate of one hundred (100) cubic feet per minute per square foot of hood face area. All hoods over cooking ranges shall be equipped with automatic fire extinguishing systems and heatactuated fan controls. Extinguishing systems shall be provided with steam, dry powder or carbon dioxide. Cleanout openings shall be provided every twenty feet (20') in horizontal exhaust duct systems serving hoods.

R. Boiler rooms shall be provided with sufficient outdoor air to maintain combustion rates of equipment and reasonable temperatures in the rooms and in adjoining areas.

Plumbing and other piping systems.

A. The requirements of the current edition of the National Plumbing Code shall be complied with insofar as they may apply and to the extent they are not superceded by requirements specifically stated in these rules.

B. The material used for plumbing fixtures shall be of nonabsorptive material.

C. Lavatories and sinks required in patient-care areas shall have the water supply spout mounted so that its discharge point is a minimum distance of five inches (5") above the rim of the fixture. All lavatories used by medical and nursing staff and food handlers shall be trimmed with valves which can be operated without the use of hands. Where blade handles are used for this purpose, they shall not exceed four and one-half inches (4 1/2") in length, except the handles on clinical sinks shall not be less than six inches (6") long.

D. Clinical sinks shall have an integral trap in which the upper portion of a visible trap seal provides a water surface.

E. Water supply systems shall be designed to supply water to the fixtures and equipment on the upper floors at a minimum pressure of fifteen (15) pounds per square inch during maximum demand periods.

F. Each water service main, branch main, riser and branch to a group of fixtures should be valved.

TABLE I

PRESSURE RELATIONSHIPS AND VENTILATION OF CERTAIN HOSPITAL AREAS

All SupplyMinimum Total PressureChanges ofMinimum AirExhaustedAll Air AreaRelationship toAir FromOutdoor AirAir ChangesDirectlyRecirculated DesignationAdjacent AreasOutdoorsPer HourPer Hourto OutdoorsWithin Room Intensive care+—26—No Patient room0—22—— Patient area corridor0—24—— Isolation room0—26YesNo Isolation anteroom0—26YesNo Treatment room0—26—No X-ray, fluoroscopy room –—26YesNo Physical therapy & hydrotherapy–—26—— Soiled workroom–—24—No Clean workroom+—24—— Autopsy and darkroom–—212YesNo Toilet room–——10YesNo Bedpan room–——10YesNo Bathroom–——10YesNo Janitor’s closet–——10YesNo Sterilizer equipment room –——10YesNo Linen and trash chute rooms–——10YesNo Laboratory, general–—26—— Food preparation centers 0—210YesNo Dishwashing room–——10YesNo Dietary day storage0——2—No Laundry, general0—210YesNo Soiled linen sorting and storage–——10YesNo Clean linen storage+—22—— Central medical and surgical supply Soiled or decontamination room–—24—No Clean workroom+—24—— Unsterile supply storage 0—22—— +=Positive –=Negative 0=Equal —=Optional Stop valves shall be provided at each fixture.

8CODE OF STATE REGULATIONS

G. Hot, cold and chilled water piping and waste piping on which condensation may occur shall be insulated. Insulation of cold and chilled water lines shall include an exterior vapor barrier.

H. Backflow preventers (vacuum breakers) shall be installed on hose bibbs and on all fixtures to which hoses or tubing can be attached such as janitors’ sinks and bedpan flushing attachments.

I. Flush valves installed on plumbing fixtures shall be of a quiet operating type, equipped with silencers.

J. Hot water distribution systems shall be arranged to provide hot water and at each fixture at all times.

K. Plumbing fixtures which require hot water and which are intended for patient use shall be supplied with water which is controlled to provide a maximum water temperature of one hundred ten degrees Fahrenheit (110°F) at the fixture.

L. The hot water heating equipment shall have sufficient capacity to supply the water at the temperatures and amounts indicated in the following:

Use Clinical Dietary Laundry gal/hr/bed 6 1/244 1/2 Temp °F110° 180° 180° M. Storage tank(s) shall be provided and shall be fabricated of corrosion-resistant metal.

N. Piping over food preparation centers, food serving facilities, food storage areas and other critical areas shall be kept to a minimum and shall not be exposed. Special precautions shall be taken to protect these areas from possible leakage of or condensation from necessary overhead piping systems.

O. Building sewers shall discharge into a community sewage system. Where such a system is not available, the facility shall provide a private sewage disposal system approved by the Department of Health, the Water Pollution Board, or both.

P. Automatic fire-extinguishing systems shall be installed in areas such as central soiled linen holding rooms, maintenance shops, trash rooms, bulk storage rooms and adjacent corridors, attics accessible for storage, range hoods and laundry and trash chutes. Storage rooms of less than a one hundred (100) square foot area and spaces used for storage of nonhazardous materials are excluded from this requirement. Sprinkler heads shall be installed at the top and at alternate floor levels of trash and laundry chutes.

Q. Nonflammable medical gas system installations shall be in accordance with the requirements of NFPA Standard No. 565.

(H) Electrical Requirements.

All material including equipment, conductors, controls and signaling devices shall be installed to provide a complete electrical system with the necessary characteristics and capacity to supply the electrical facilities shown in the specifications or indicated on the plans. All materials shall be listed as complying with applicable standards of Underwriters’ Laboratories, Inc. or other similarly established standards.
The installing contractor shall be responsible for testing all electrical installations and systems and shall show that the equipment is correctly installed and operated as planned or specified.
Circuit breakers or fuses that provide disconnecting means and overcurrent protection for conductors connected to switchboards and distribution panelboards shall be enclosed or guarded to provide a dead-front type of assembly. The main power distribution panel shall be located so as to be accessible only to authorized persons. It shall be readily accessible for maintenance, clear of traffic lanes and in a dry ventilated space devoid of corrosive fumes or gases. Overload protective devices shall be suitable for operating properly in the ambient temperature conditions.
Lighting and appliance panelboards shall be provided for the circuits on each floor. This requirement does not apply to emergency-system circuits.
All spaces occupied by people, machinery and equipment within buildings and the approaches thereto and parking lots shall have electric lighting. Patients’ bedrooms shall have general lighting and night lighting. A reading light shall be provided for each patient. At least one (1) luminaire for night lighting shall be switched at the entrance to each patient room. Patients’ reading lights and other fixed lights not switched at the door shall have switch controls convenient for use at the luminaire. All switches for control of lighting in patient areas shall be of the quiet operating type.
Each patient bedroom shall have duplex receptacles as follows: one (1) on each side of the head of each bed (for parallel adjacent beds); receptacles for luminaires, television and motorized beds, if used; and one (1) receptacle on another wall.
Single receptacles for equipment such as floor cleaning machines shall be installed approximately fifty feet (50') apart in all corridors. Duplex receptacles for general use shall be installed approximately fifty feet (50') apart in all corridors and within twentyfive feet (25') of ends of corridors.
A nurses’ calling station shall be installed at each patient bed and in each patient toilet, bath and shower room. The nurses’ call-in toilet, bath or shower rooms shall be an emergency call. All calls shall register at the nurses’ station and shall actuate a visible signal in the corridor at the patient’s door, in the clean workroom, soiled workroom and nourishment station of the nursing unit. In multi-corridor nursing units, additional visible signals shall be installed at corridor intersections. In rooms containing two (2) or more calling stations, indicating lights shall be provided at each calling station. Nurses’ call systems which provide two (2)-way voice communication shall be equipped with an indicating light at each calling station which lights and remains lighted as long as the voice circuit is operative.
A manually-operated, electricallypowered fire alarm system which will serve to alert all areas of the hospital when activated shall be installed in each facility. In multistory buildings or in multi-building facilities, the signal shall be coded or otherwise arranged to indicate the location of the station operated. Pre-signal systems will not be permitted, except when telephone switchboard is attended at all times.
To provide electricity during an interruption of the normal electric supply that could affect the nursing care, treatment or safety of the occupants, an emergency source of electricity shall be provided and connected to certain circuits for lighting and power.
The source of this emergency electric service shall be an emergency generating set when the normal service is supplied by one (1) or more central station transmission line(s) or an emergency generating set or a central station transmission line, when the normal electric supply is generated on the premises.
The required emergency generating set shall be located on the premises and shall be reserved exclusively for supplying the emergency electrical system. The emergency generator set shall be of sufficient kilowatt capacity to supply all lighting and power load demands of the emergency system. The power factor rating of the generator shall be not less than eighty percent (80%).
Emergency electric service shall be provided to at least the following circuits:

A. Lighting. Exitways and all necessary ways of approach including exit signs and exit direction signs, exterior of exits, exit doorways, stairways and corridors; dining and recreation rooms (if located other than on grade level); nursing station and medication preparation area; generator set location, switch gear location and boiler room; elevator (if required for emergency); telephone switchboard; and kitchen, X ray and laboratory;

B. Equipment. Nurses’ calling system; alarm system including fire alarm actuated at manual stations; water flow alarm devices of sprinkler systems if electrically operated; fire detecting and smoke detecting systems; paging or speaker systems if intended for issuing instructions during emergency conditions; and alarms required for nonflammable medical gas systems, if installed; fire pump, if installed; sewerage or sump lift pump, if installed; all required duplex receptacles in patient corridors; one (1) elevator, where elevators are used for vertical transportation of patients; equipment such as burners and pumps necessary for operations of one (1) or more boilers and their necessary auxiliaries and controls, required for heating and sterilization; and equipment necessary for maintaining telephone service;

C. Where electricity is the only source of power normally used for space heating, the emergency service shall provide for heating of patient rooms. Emergency heating of patient rooms will not be required in areas where the design temperature is higher than plus twenty degrees Fahrenheit (+20°F) based on the Median of Extremes as shown in the current edition of the ASHRAE Handbook of Fundamentalsor when the hospital is supplied by at least two (2) utility service feeders, each supplied by separate generating sources, or a network distribution system fed by two (2) or more generators, with the hospital feeders so routed, connected and protected that a fault any place between the generators and the hospital will not likely cause an interruption of more than one (1) of the hospital service feeders; and D. The emergency electrical system shall be so controlled that after interruption of the normal electric power supply, the generator is brought to full voltage and frequency and connected within ten (10) seconds through one (1) or more primary automatic transfer switches to all emergency lighting, all alarms, nurses’ call, equipment necessary for maintaining telephone service and receptacles in patient corridors. All other lighting and equipment required to be connected to the emergency system shall either be connected through the previously described primary automatic transfer switching or shall be subsequently connected through other automatic or manual transfer switching. Receptacles connected to the emergency system shall be distinctively marked for identification.

Storage-battery-powered lights, provided to augment the emergency lighting or for continuity of lighting during the interim of transfer switching immediately following an interruption of the normal service supply, shall not be used as a substitute for the requirement of a generator. Where fuel is normally stored on the site, the storage capacity shall be sufficient for twenty-four (24)-hour operation of required emergency electric services. Where fuel is normally piped underground to the site from a utility distribution system, storage facilities on the site will not be required.

(I) Elevators.

All rehabilitation hospitals where either patients’ beds or facilities such as diagnostic, recreation, patient dining or therapy rooms are located on other than the first floor, shall have electric or electrohydraulic elevators as follows:

A. At least one (1) hospital-type elevator shall be installed where one to fiftynine (1–59) patient beds are located on any floor other than the first (for purposes of these requirements, the first floor is that floor first reached from the main front entrance);

B. At least two (2) hospital-type elevators shall be installed where sixty to two hundred (60–200) patient beds are located on floors other than the first or where inpatient facilities are located on a floor other than that containing the patient beds;

C. At least three (3) hospital-type elevators shall be installed where two hundred one to three hundred fifty (201–350) patient beds are located on floors other than the first or where inpatient facilities are located on a floor other than that containing the patient beds;

D. For hospitals with more than three hundred fifty (350) beds, the number of elevators shall be determined from a study of the hospital plan and the estimated vertical transportation requirements;

E. Elevator cars and platforms shall be constructed of noncombustible material except that fire-retardant-treated material may be used if all exterior surfaces of the car are covered with metal. Cars of hospital-type elevators shall have inside dimensions that will accommodate a patient’s bed and attendants and shall be at least five feet wide by seven feet six inches (5' × 7' 6") deep, with a capacity of four thousand (4000) pounds. The car door shall have a clear opening of not less than three feet ten inches (3' 10");

F. Elevators shall have automatic leveling of the two (2)-way automatic maintaining type with accuracy within plus or minus one-half inch (±1/2"); and G. Elevators (except freight elevators) shall be equipped with a two (2)-way special service switch to permit cars to bypass all landing button calls and be dispatched directly to any floor.

The contractor shall be required to cause inspections and tests to be made and shall deliver to the owner written certification that the installation meets the requirements set forth in this section and all pertinent safety requirements.

rule filed Nov. 21, 1969, effective Jan. 21, 1970. *Original authority 1953, amended 1993.

History

AUTHORITY: section 197.080, RSMo Supp. 1993. This rule previously filed as 13 CSR 50-22.010 and 19 CSR 10-22.010. Original

19 CSR 30-22.020 Administration Standards for Rehabilitation Hospitals {#sec-19-csr-30-22.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-22.020}

(Rescinded August 30, 2014)

This rule previously filed as 13 CSR 50- 22.020 and also 19 CSR 10-22.020. Original

rule filed Nov. 21, 1969, effective Jan. 21, 1970. Amended: Filed June 14, 1988, effective Oct. 13, 1988. Rescinded: Filed Dec. 31, 2013, effective Aug. 30, 2014.

Op. Atty. Gen. No. 40, Graham (4-23-75).

The State Board of Health is authorized by law to adopt and enforce regulations requiring hospitals licensed by the state to submit reports containing certain data relating to hospital discharges.

History

AUTHORITY: section 197.080, RSMo 1986.

19 CSR 30-22.030 Standards for Registration as a Hospital Infectious Waste Generator {#sec-19-csr-30-22.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-22.030}

(Rescinded August 30, 2014)

10CODE OF STATE REGULATIONS

History

AUTHORITY: sections 197.080 and 260.203, RSMo Supp. 1993. Original rule filed Aug. 15, 1988, effective Dec. 29, 1988. Rescinded: Filed Dec. 31, 2013, effective Aug. 30, 2014.

Chapter 24 Psychiatric Hospitals

19 CSR 30-24.010 General Design and Construction Standards for Psychiatric Hospitals {#sec-19-csr-30-24.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-24.010}

19 CSR 30-24.020 Administration Standards for Psychiatric Hospitals {#sec-19-csr-30-24.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-24.020}

19 CSR 30-24.030 Preparation of Plans and Specifications for Psychiatric Hospitals {#sec-19-csr-30-24.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-24.030}

19 CSR 30-24.040 Standards for Registration as a Hospital Infectious Waste Generator HEALTH AND SENIOR SERVICES Licensure {#sec-19-csr-30-24.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-24.040}

19 CSR 30-24.010 General Design and Construction Standards for Psychiatric Hospitals 1993. {#sec-19-csr-30-24.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-24.010}

This rule was previously filed as 13 CSR 50-24.010 and also 19 CSR 10-24.010.

Original rule filed Jan. 31, 1974, effective March 1, 1974. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019.

19 CSR 30-24.020 Administration Standards for Psychiatric Hospitals 1999. {#sec-19-csr-30-24.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-24.020}

This rule was previously filed as 13 CSR 50-24.020 and also 19 CSR 10-24.020.

Original rule filed Jan. 31, 1974, effective March 1, 1974. Amended: Filed June, 14, 1988, effective Oct. 13, 1988. Amended:

Filed June 14, 2000, effective Jan. 30, 2001.

Rescinded: Filed March 20, 2019, effective Nov. 30, 2019.

Op. Atty. Gen. No. 40, Graham (4-23-75).

The State Board of Health is authorized by law to adopt and enforce regulations requiring hospitals licensed by the state to submit reports containing certain data relating to hospital discharges.

19 CSR 30-24.030 Preparation of Plans and Specifications for Psychiatric Hospitals 1993. {#sec-19-csr-30-24.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-24.030}

This rule previously filed as 13 CSR 50-24.030 and also 19 CSR 10-24.030. Original rule filed Jan. 31, 1974, effective March 1, 1974. Rescinded: Filed March 20, 2019, effective Nov. 30, 2019.

19 CSR 30-24.040 Standards for Registration as a Hospital Infectious Waste Generator {#sec-19-csr-30-24.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-24.040}

(Rescinded August 30, 2014)

History

AUTHORITY: sections 197.080 and 260.203, RSMo Supp. 1993. Original rule filed Aug. 16, 1988, effective Dec. 29, 1988. Rescinded: Filed Dec. 31, 2013, effective Aug. 30, 2014.

Chapter 25SN Special Notice-Home Health Agencies

19 CSR 30-25SN Special Notice-Home Health Agencies {#sec-19-csr-30-25sn omnilex-key=us-mo-regs-official--title-19--19 CSR 30-25SN}

MATTBLUNT(1/29/03)

Rules of Department of Health and Senior Services Division 30óDivision of Health Resources SPECIAL NOTICE

Chapter 25óHome Health Agencies Title 19 CSR 30-25.010Definitions Relating to Home Health Agencies 19 CSR 30-25.020Organization and Management of Home Health Agencies 19 CSR 30-25.030Home Health Aide Basic Course In a resolution dated February 4, 1986, the Joint Committee on Administrative Rules took ìthe position that any rule promulgated pursuant to section 197.445, RSMo was not valid for failure to comply with Section 3.î The secretary of state has removed these rules from the Code of State Regulations.

Chapter 26 Home Health Agencies

19 CSR 30-26.010 Home Health Licensure {#sec-19-csr-30-26.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-26.010}

Rule

PURPOSE: This rule defines the minimum requirements for the provision of home health services by state licensed home health programs.

PUBLISHER’S NOTE: The publication of the full text of the material that the adopting agency has incorporated by reference in this

(1) State Licensure Requirements.

(A) This rule incorporates by reference 42 CFR 484, Medicare Conditions of Participation: Home Health Agencies, for Missouri licensed home health agencies. Missouri licensed home health agencies shall strictly meet the currently applicable Medicare Conditions of Participation and surveys performed for state licensure will be conducted per Medicare standards.

(B) Licensed home health agencies shall provide dementia-specific training about Alzheimer’s disease and related dementias to their employees and those persons working as independent contractors who provide direct care to or may have daily contact with residents, patients, clients, or consumers with Alzheimer’s disease or related dementias.

The training required for persons providing direct care shall address the following areas, at a minimum:

A. An overview of Alzheimer’s disease and related dementias;

B. Communicating with persons with dementia;

C. Behavior management;

D. Promoting independence in activities of daily living; and E. Understanding and dealing with family issues.

Employees or independent contractors who do not provide direct care for, but may have daily contact with, persons with Alzheimer’s disease or related dementias shall receive dementia-specific training that includes, at a minimum:

A. An overview of Alzheimer’s disease and related dementias; and B. Communicating with persons with dementia.

Dementia-specific training about Alzheimer’s disease and related dementias shall be incorporated into orientation for new employees with direct patient contact and independent contractors with direct patient contact. The training shall be presented by an instructor who is qualified by education, experience, and knowledge in the current standards of practice regarding individuals with Alzheimer’s disease and other related dementias. The training shall be provided annually and updated as needed.

(2) State Licensure Management.

(A) All licensed home health agencies shall be licensed and shall conduct all their business in their legal name or in their doing business as (d/b/a) name as properly registered with the secretary of state.

(B) Initial Application Procedure for Home Health Agencies.

The applicant shall provide the Department of Health and Senior Services (department) with a completed application for home health license, included herein, copy of registration with secretary of state, a completed State Disclosure of Ownership and Control Interest Statement form, included herein, and sufficient evidence that the home health agency has established appropriate policies and procedures for providing home health services according to sections 197.400 to 197.478, RSMo. The licensure fee must accompany the application and is nonrefundable.
The applicant shall establish a business location (not in a private residence) with established business hours.
A Medicare-certified home health agency of a bordering state, sharing a reciprocal agreement with Missouri, wishing to serve Missouri residents, must complete the application process for initial licensure and establish a business location as described in 19 CSR 30-26.010(2)(B)2. A valid Missouri license must be maintained at all times in order for the home health agency to serve Missouri residents. The area served in Missouri must be contiguous to the area served by the agency in the bordering state.

A license shall be renewed annually upon approval of the department when the following conditions have been met:

A. The application for renewal is accompanied by a six hundred dollar ($600) nonrefundable license fee;

B. The home health agency is in compliance with the requirements established under the provisions of sections 197.400 to 197.478, RSMo, as evidenced by a survey inspection by the department. No license shall be renewed unless the department has been able to verify compliance through clinical record review and home visits. In lieu of department survey, such survey as provided in section 197.415.4, RSMo;

C. The application is accompanied by a statement of any changes in the information previously filed with the department under

section 197.410, RSMo, and the effective date for that change from the information previously filed; and D. Proof of registration with secretary of state’s office in Missouri.

The agency shall submit the Application for Home Health Agency License, included herein, and licensure fee prior to the license expiration date. If the license fee is not paid by the expiration date, the department may begin the revocation process.

(D) Change of Ownership. A license shall not be transferable or assignable.

When a home health agency is sold or ownership or management is transferred, or the corporate legal organization status is substantially changed, the license of the agency shall be voided and new license obtained.
The owner shall apply for a new license at least ninety (90) calendar days prior to the effective date of sale, transfer, or change in corporate status.
The department may issue a temporary operating permit for the continuation of the operation of the home health agency for a period of not more than ninety (90) days pending the survey inspection and the final disposition of the application.

(E) Inspection Process.

The home health agency management shall allow representatives of the department to survey the home health agency to determine eligibility for licensing and/or renewal of license. On-site surveys may be unannounced.
After completion of each department survey, a written report of the findings with respect to compliance or noncompliance with the provisions of sections 197.400 to 197.478, RSMo, and the standards established thereunder, as well as a list of deficiencies found shall be prepared.

A. A copy of the deficiency list shall be sent to the home health agency within fifteen (15) business days following the survey inspection.

B. The agency management or designee shall have ten (10) calendar days following receipt of the written survey report to provide the department with a written plan for correcting the cited deficiencies.

C. Upon receipt of the required plan of correction for achieving license compliance, the department shall review the plan to determine the appropriateness of the corrective action and respond to the agency. If the plan is not acceptable, the department shall notify the management or designee and indicate the reasons why the plan was not acceptable. A revised plan of correction shall be provided to the department.

D. If an agency does not acknowledge the deficiencies, the agency must, within ten (10) calendar days, request in writing a resurvey by the department. If, after the resurvey, the home health agency still does not agree with the findings of the department, it may seek a review of the findings of the department by the Administrative Hearing Commission. A copy of the letter requesting the review must be sent to the department.

E. Upon expiration of the completion date for correction of deficiencies specified in the approved plan of correction, the department shall determine if the required corrective measures have been acceptably accomplished. The department shall document that the corrective action has been satisfactorily completed. If the department finds the home health agency still fails to comply with sections of 197.400 to 197.478, RSMo, the department may rewrite the deficiencies and request another plan of correction or may take action to suspend or revoke the license.

(F) Refusal to Issue/Suspension/Revocation of License. The department shall refuse to issue or shall suspend or shall revoke the license of any home health agency for failure to comply with any provision of sections 197.400 to 197.478, RSMo, or with any rule or standard of the department adopted under the provisions of sections 197.400 to 197.478, RSMo, or for obtaining the license by means of fraud, misrepresentation, or concealment of material facts.

Any home health agency which has been refused a license or which has had its license revoked or suspended by the department may seek a review of the department’s action by the Administrative Hearing Commission. A copy of the letter requesting the review must be sent to the department.
The department will not consider application for home health licensure for a period of twelve (12) months after revocation or denial of the agency’s license.

(G) Voluntary Termination.

To voluntarily terminate a home health agency license, the agency must submit to the department, in writing, on agency letterhead the following information:

A. A request for termination of their state license (include license number);

B. State the effective date of termination;

C. State disposition of active caseload; and D. Location of medical record storage.

The agency must enclose the original voided license with the voluntary termination letter.

(H) Complaint Procedure. The department may accept complaints by phone or in writing.

Any person wishing to make a complaint against a home health agency licensed under the provisions of sections 197.400 to 197.478, RSMo, may file the complaint in writing with the department setting forth the details and facts supporting the complaints.
The department may also accept complaints regarding a licensed home health agency by phone and may document that the complaint was received.
The nature of the complaint will determine if an investigation is appropriate or if referral of the complaint to another agency is needed.
An on-site visit may be made by a department representative and deficiencies may be written.
The process for documentation of complaints will be determined by the department.
The agency must comply with paragraph (2)(E)3. in response to deficiencies written as a result of a complaint investigation.

(5/31/20) JOHN R. ASHCROFT

(2/28/22) JOHN R. ASHCROFT

Pursuant to Executive Order 21-09, 19 CSR 30-26.010, subsection (1)(A) and section 197.400(3), RSMo was suspended from April 9, 2020 through December 31, 2021.

History

AUTHORITY: section 197.445, RSMo 2000 and section 660.050, RSMo Supp. 2008. Original rule filed Aug. 17, 1998, effective Jan. 30, 1999. Amended: Filed Oct. 22, 2008, effective June 30, 2009. Original authority: 197.445, RSMo 1983, amended 1993, 1995, 1997 and 660.050, RSMo 1984, amended 1988, 1992, 1993, 1994, 1995, 2001. Pursuant to Executive Order 21-07, 19 CSR 30-26.010, subsection (1)(B) was suspended from April 22, 2020 through August 31, 2021.

Chapter 30 Ambulatory Surgical Centers and Abortion Facilities

19 CSR 30-30.010 Definitions and Procedures for Licensing Ambulatory Surgical {#sec-19-csr-30-30.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.010}

19 CSR 30-30.030 General Design and Construction Standards for Ambulatory {#sec-19-csr-30-30.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.030}

19 CSR 30-30.040 Preparation of Plans and Specifications for Ambulatory Surgical {#sec-19-csr-30-30.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.040}

19 CSR 30-30.061 Complication Plans for Certain Drug- and Chemically-Induced {#sec-19-csr-30-30.061 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.061}

19 CSR 30-30.062 Complication Plans for Certain Drug- and Chemically Induced {#sec-19-csr-30-30.062 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.062}

19 CSR 30-30.080 Definitions Relating to Birthing Centers and Procedures for {#sec-19-csr-30-30.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.080}

19 CSR 30-30.100 General Design and New Construction Standards for Birthing {#sec-19-csr-30-30.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.100}

19 CSR 30-30.110 General Design and Construction Standards for Existing Birthing SERVICES {#sec-19-csr-30-30.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.110}

19 CSR 30-30.010 Definitions and Procedures for Licensing Ambulatory Surgical Centers {#sec-19-csr-30-30.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.010}

PURPOSE: The Division of Regulation and Licensure, Department of Health and Senior Services has the authority to establish rules for ambulatory surgical centers. This rule defines specific terms and presents procedures to follow in making application for a license.

(1) Definitions.

(A) Administrator means a person who is delegated the responsibility of carrying out the policies and programs established by the governing body.

(B) Ambulatory surgical center. Any public or private establishment operated primarily for the purpose of performing surgical procedures or primarily for the purpose of delivering newborns, and which does not provide services or other accommodations for patients to stay more than twelve (12) hours within the establishment. However, nothing in this definition shall be construed to include the offices of dentists currently licensed under Chapter 332, RSMo.

A facility operated primarily for the purpose of performing surgical procedures is one that provides surgical services to fifty-one percent (51%) or more of the patients treated or seen for any health condition, or one that derives fifty-one percent (51%) or more of its revenues from the provision of surgical services or related procedures.
The term ambulatory surgical center does not apply to any facility licensed as part of a hospital or any facility used as an office or clinic for the private practice of a physician, dentist or podiatrist.
A facility licensed as an ambulatory surgical center shall not use the term hospital in the name of the facility without approval of the Department of Health and Senior Services.

(C) Anesthesiologist. A physician licensed under Chapter 334, RSMo, who has successfully completed a postgraduate medical education program in anesthesiology approved by the Accreditation Council on Graduate Medical Education or the American Osteopathic Association.

(D) Anesthesiologist assistant. A person who meets each of the following conditions:

Has graduated from an anesthesiologist assistant program accredited by the American Medical Association’s Committee on Allied Health Education and Accreditation or by its successor agency;
Has passed the certifying examination administered by the National Commission on Certification of Anesthesiologist Assistants;
Has active certification by the National Commission on Certification of Anesthesiologist Assistants;
Is currently licensed as an anesthesiologist assistant in the state of Missouri; and 5. Provides health care services delegated by a licensed anesthesiologist.

(E) Certified nurse anesthetist. A registered nurse licensed under Chapter 335, RSMo, who has been graduated from a school of nurse anesthesia accredited by the Council on Accreditation of Educational Programs of Nurse Anesthesia or its predecessor, and is certified or is eligible for certification as a nurse anesthetist by the Council on Certification of Nurse Anesthetists.

(F) Dentist means a person licensed to practice dentistry pursuant to Chapter 332, RSMo.

(G) Department means the Department of Health and Senior Services.

(H) Governing body means an individual owner, partnership, corporation or other legally established authority in whom the ultimate authority and responsibility for management of the ambulatory surgical center is vested.

(I) Governmental unit means any city, county or other political subdivision of this state, or any department, division, board or other agency of any political subdivision of this state.

(J) Infection control officer. An individual who is a licensed physician, licensed registered nurse, has a bachelor’s degree in laboratory science, or has similar qualifications and has additional training or educational preparation in infection control, infectious diseases, epidemiology and principles of quality improvement.

(K) Licensed practical nurse (LPN). A person who holds a valid license issued by the State Board of Nursing pursuant to

Chapter 335, RSMo.

(L) Medical staff. A formal organization of physicians which may include dentists and podiatrists who are appointed by the governing body to attend patients within the ambulatory surgical center.

(M) Patient. A person admitted to the ambulatory surgical center by and upon the order of a physician, or dentist, or podiatrist in accordance with the orders of a physician.

(N) Person. Any individual, firm, partnership, corporation, company or association, or the legal successors of any of them.

(O) Physician means a person licensed to practice medicine pursuant to Chapter 334, RSMo and who has active or associate staff membership and privileges in a licensed hospital in the community.

(P) Physician with training or experience in the administration of anesthetics. A person licensed to practice medicine under

Chapter 334, RSMo whose training and experience (credentials) have been evaluated by the medical staff and privileges granted to direct the anesthesia service or to administer anesthetics or both.

(Q) Podiatrist means a person licensed to practice podiatry pursuant to Chapter 330, RSMo.

(R) Qualified anesthesia personnel. An anesthesiologist who is a physician with training or experience in the administering of anesthetics, a certified registered nurse anesthetist or an anesthesiologist assistant.

(S) Registered nurse (RN). A person who holds a valid license issued by the State Board of Nursing pursuant to Chapter 335, RSMo.

(T) Root cause analysis. A process for identifying the basic or causal factor(s) that underlie variation in performance, including the occurrence or possible occurrence of a sentinel event.

(U) Sentinel event. An unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase “or the risk thereof” includes any process variation for which a reoccurrence would carry a significant chance of a serious adverse outcome.

(2) Procedure for Licensing.

(A) Application for a license to establish and operate an ambulatory surgical center shall be made in writing to the Department of Health on forms provided by it. Each application for a license, except applications from a governmental unit, shall be accompanied by an annual license fee of two hundred dollars ($200).

(B) In any facility, except hospitals where surgical procedures may be performed or licensed abortion facilities, a license to establish and operate an ambulatory surgical center shall be required in the absence of evidence demonstrating that the facility does not meet the definition established in subsection (1)(A) and paragraph (1)(A)1. of this rule. The evidence required shall include, but need not be limited to, statistical records of individuals treated, individuals receiving surgical procedures, and financial reports including revenue from surgical and related procedures and total revenues.

(D) A license shall not be issued or renewed by the Department of Health until a facility has been surveyed by a representative of the Bureau of Hospital Licensing and Certification and found to be in substantial compliance with the requirements of 19 CSR 30-30.020 and 19 CSR 30-30.030. Ambulatory surgical centers which also provide abortion services shall comply with the social service and counseling required by the Department of Health for the licensure of abortion facilities in 19 CSR 30- 30.060(3)(H).

(E) The licensee shall notify the Department of Health in writing of any change of name of the administration.

(F) Separate licenses are required for facilities maintained on separate sites even though operated by the same owner.

(G) The license shall be conspicuously posted in a public area in the facility.

(H) If a facility ceases to provide patient care or to otherwise operate as an ambulatory surgical center within the definition in section 197.200.1, RSMo 1986 for a period in excess of fourteen (14) days without written approval of the Department of Health, the facility shall surrender its license to the Department of Health. The facility shall not operate again as an ambulatory surgical center until an application for an ambulatory surgical center license is submitted with assurance that the facility complies with the requirements of the rules of this chapter and a license is issued.

(I) An ambulatory surgical center which is licensed as part of a hospital does not require a separate license.

rule filed Dec. 2, 1975, effective Feb. 1, 1976. Amended: Filed Jan. 3, 1990, effective April 12, 1990. Amended: Filed Sept. 20, 2005, effective April 30, 2006. Amended: Filed Jan. 16, 2007, effective Aug. 30, 2007. *Original authority: 197.154, RSMo 2004 and 197.225, RSMo 1975, amended 1996.

History

AUTHORITY: section 197.225, RSMo 2000 and 197.154, RSMo Supp. 2006. This rule was previously filed as 13 CSR 50-30.010. Original

19 CSR 30-30.020 Administration Standards for Ambulatory Surgical Centers {#sec-19-csr-30-30.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.020}

PURPOSE: The Division of Regulation and Licensure, Department of Health and Senior Services has the authority to establish standards for the operation of ambulatory surgical centers. This

rule provides standards for the administration, medical staff, nursing staff and supporting services to ensure high quality services to users of ambulatory surgical centers.

(1) Organization, Administration, Medical Staff, Nursing Staff and Supporting Services.

(A) Governing Body.

The governing body is to establish and adopt bylaws by which it shall abide in conducting all business of the facility.

Bylaws so adopted and changes are to be submitted to the Department of Health for its records.

Bylaws of the governing body shall provide for the selection and appointment of medical staff members based upon defined criteria and in accordance with an established procedure for processing and evaluating applications for membership. Applications for appointment and reappointment shall be in writing and shall signify agreement of the applicant to conform with bylaws of both the governing body and medical staff and to abide by defined professional ethical standards. Initial appointments to the medical staff shall not exceed twelve (12) months. Reappointments, which may be processed and approved at the discretion of the governing body on a monthly or other cyclical pattern, shall not exceed two (2) years.
The governing body shall select and employ an administrator who is a physician licensed in Missouri, a registered nurse (RN) licensed in Missouri or an individual who has at least one (1) year of administrative experience in health care; and shall notify the Department of Health of any change of administration within thirty (30) days after change has been made.
The governing body shall require in its bylaws that the ambulatory surgical center and medical staff abide by acceptable professional ethical standards.
Representatives of the Department of Health shall have access to inspect the ambulatory surgical center during normal working hours.
A written plan shall provide for the evacuation of patients, visitors and personnel in the event of fire or other disaster within the facility and for an alarm system to notify personnel. Personnel are to be acquainted with the evacuation plan to properly perform their duties in the event of a fire or disaster.
All fires occurring on the ambulatory surgical center premises shall be reported to the Department of Health within one (1) week giving the cause, location and extent of damage and personal injury, if any.
The administrator shall be responsible for the development and enforcement of written policies which prohibit smoking throughout the ambulatory surgical center except specific designated areas where smoking may be permitted. Each designated area shall have one hundred percent (100%) of the air supplied to the room exhausted.
Written smoking control policies shall be posted throughout the ambulatory surgical center.
Smoking shall be prohibited in any room or compartment where flammable liquids, combustible gases or oxygen are used or stored and in any other hazardous location.

Those areas shall be posted with NO SMOKING signs.

The administrator shall assure that all patients admitted to the facility are under the care of a physician who is a member of the staff.
The administrator shall develop written procedures for receiving and investigating complaints regarding the facility, its physicians, dentists, podiatrists and employees practicing or working in the facility.
The administrator shall designate an individual duly qualified to act in his/her capacity during his/her absence.
The administrator shall assure the provision of adequate equipment in good repair within the facility to provide efficient services and protection to the patient and staff.
Personnel records shall be maintained on each employee and shall include job application, professional licensing information and health information.
If a patient is transferred to another health facility, essential medical information, including diagnosis, is to be transmitted with the patient to insure continuity of care.

(B) Medical Staff.

The medical staff of an ambulatory surgical center shall be an organized group which shall initiate and adopt, with approval of the governing body, bylaws, rules and policies governing their professional activities in the facility.
Each member of the medical staff shall be a physician, dentist or podiatrist legally licensed to practice in Missouri.
Each member of the medical staff shall submit a written application for staff membership on an approved form to the 4. Surgical procedures shall be performed only by physicians, dentists or podiatrists who at the time are privileged to perform surgical procedures in at least one (1) licensed hospital in the community in which the ambulatory surgical center is located, thus providing assurance to the public that patients treated in the center shall receive continuity of care should the services of a hospital be required. As an alternative, the facility may submit a copy of a current working agreement with at least one (1) licensed hospital in the community in which the ambulatory surgical center is located, guaranteeing the transfer and admittance of patients for emergency treatment whenever necessary.
There shall be a chief of staff acceptable to the governing body and other officers and committees as is deemed necessary to meet the goals of the ambulatory surgical center.
The medical staff shall develop and utilize appropriate procedures for review and evaluation of surgical practices and techniques at least annually. In those instances when the medical staff membership numbers fewer than three (3), arrangements shall be made with the hospital medical staff where the physicians are privileged or with the medical staff of the hospital guaranteeing the transfer and admittance of patients for emergency treatment for an independent review and evaluation of surgical practices and techniques at least annually. Complete records shall be kept of these reviews and evaluations.
The medical staff shall assist in the maintenance of complete records on each patient.
The medical staff shall comply with professional ethical standards established, defined and approved by the medical staff.
The medical staff of each facility shall develop a policy stipulating which surgically removed tissues shall be sent to the pathologist for review. This policy shall be approved by the 10. The medical staff shall establish policies for the recommendation of discharge of a member by the governing body.
The medical staff bylaws shall require at least one (1) physician member of the medical staff to be on duty in the ambulatory surgical center at all times a patient is receiving or recovering from an anesthetic (local, general or intravenous sedation). Staffing shall be adequate to meet the needs of the patients.
The medical staff, as a body or through a committee, shall review and evaluate the quality and appropriateness of all aspects of medical care given at the facility.
The administrator shall bring to the attention of the chief of the professional staff any failure by members of that staff to conform with established policies of the facility regarding administrative matters, professional standards and the maintenance of adequate medical records.

There shall be an organized nursing service under the direction of a professional RN with postgraduate education or experience in surgical nursing.
There shall be at least one (1) professional RN on duty in the ambulatory surgical center at all times a patient is in the 3. Written policies and procedures consistent with generally accepted nursing practices are to be developed for the direction and guidance of nursing personnel.
All licensed practical nurses and other nursing personnel involved in patient care shall be under the direct supervision of a professional RN.
At least one (1) professional RN other than the individual administering anesthesia shall be available in each operating room during surgical procedures.
At least one (1) RN shall be in the recovery room during the patients’ postanesthetic recovery period at a ratio of no more than four (4) patients to one (1) nurse.
Nursing personnel are to be familiar with the location, operation and use of electrocardiogram (EKG or ECG) equipment, pulse oximeter, blood pressure equipment and emergency and resuscitative equipment.
There shall be a mechanism for the review and evaluation on a regular basis of the quality and appropriateness of nursing 9. Policies shall be developed regarding the use of overtime.

The policies shall be based on the following standards:

A. Overtime shall not be mandated for any licensed nursing personnel except when an unexpected nurse staffing shortage arises that involves a substantial risk to patient safety, in which case a reasonable effort must be applied to secure safe staffing before requiring the on-duty licensed nursing personnel to work overtime. Reasonable efforts undertaken shall be verified by the ambulatory surgical center. Reasonable efforts shall include pursuing all of the following:

(I) Reassigning on-duty staff;

(II) Seeking volunteers to work extra time from all available qualified nursing staff who are presently working;

(III) Contacting qualified off-duty employees who have made themselves available to work extra time, per diem staff, float pool and flex team nurses; and (IV) Seeking personnel from a contracted temporary agency or agencies when such staffing is permitted by law or an applicable collective bargaining agreement and when the employer regularly uses the contracted temporary agency or agencies;

B. In the absence of nurse volunteers, float pool nurses, flex team nurses or contracted temporary agency staff secured by the reasonable efforts as described in (1)(C)9.A. and if qualified reassignments cannot be made, the ambulatory surgical center may require the nurse currently providing the patient care to fulfill his or her obligations based on the Missouri Nurse Practice Act by performing the patient care which is required;

C. The prohibition of mandatory overtime does not apply to overtime work that occurs because of an unforeseeable emergency or when an ambulatory surgical center and a subsection of nurses commit, in writing, to a set, predetermined staffing schedule or prescheduled on-call time. An unforeseeable emergency is defined as a period of unusual, unpredictable or unforeseeable circumstances such as, but not limited to, an act of terrorism, a disease outbreak, adverse weather conditions, or natural disasters which impact patient care and which prevent replacement staff from reporting for duty;

D. The facility is prohibited from requiring a nurse to work additional consecutive hours and from taking action against a nurse on the grounds that a nurse failed to work the additional hours or when a nurse declines to work additional consecutive hours beyond the nurse’s predetermined schedule of hours because doing so may, in the nurse’s judgement, jeopardize patient safety;

E. Subparagraph 19 CSR 30-30.020(1)(C)9.D. is not applicable if overtime is permitted under subparagraphs 19 CSR 30-30.020(1)(C)9.A., B., and C; and F. Nurses required to work more than twelve (12) consecutive hours under subparagraphs 19 CSR 30-30.020(1)

(C)9.A., B., or C. shall be provided the option to have at least ten (10) consecutive hours of uninterrupted off-duty time immediately following the worked time.

(D) Emergency Equipment.

Equipment shall be provided to handle emergencies resulting from the services rendered in the facility. The following shall be provided as a minimum: portable ECG oscilloscope, portable defibrillator, portable suction equipment, inhalationresuscitation equipment, emergency tray and equipment for use in airway obstructions.
Procedures are to be developed to insure that emergency equipment is kept in good working order.

(E) Anesthesia Service.

The anesthesia service shall be under the direction of an anesthesiologist or a physician with training or experience in the administration of anesthetics. The clinical privileges of qualified anesthesia personnel shall be reviewed by the director of anesthesia service and the medical staff and approved by the governing body.
An anesthesiologist or physician with training or experience in the administration of anesthetics shall be on the premises and readily accessible during the administration of anesthetics—whether local, general or intravenous sedation— and the postanesthetic recovery period until all patients are alert or medically discharged. Qualified anesthesia personnel shall be present in the room throughout the conduct of all general anesthetics, regional anesthetics and monitored anesthesia care and shall continually evaluate the patient’s oxygenation, ventilation, circulation and temperature. Oxygen analyzers, pulse oximeter and electrocardiography equipment shall be available.
Policies and procedures on the administration of anesthetics and drugs which produce conscious and deep sedation shall be developed by the medical staff in consultation with at least one (1) anesthesiologist and approved by the 4. Prior to undergoing general anesthesia, patients shall have a history and physical examination by a physician on the patient’s record including the results of any necessary laboratory examinations. Each administration of a regional, general or intravenous sedation anesthetic shall be ordered by an anesthesiologist or a physician with training and experience in the administration of anesthetics. The patient records shall contain a preanesthetic evaluation and a postanesthetic note by qualified anesthesia personnel.
Periodic inspections shall be made of all areas where flammable anesthetics are administered or stored to insure safeguards are being observed by personnel and equipment meets safety standards. A written record of inspections shall be kept. If the administration of the facility provides written assurance to the Department of Health and Senior Services that no flammable anesthetics will be administered and the area is posted to that effect, safety inspections will not be required.
All anesthetics shall be administered by anesthesiologists, physicians with training or experience in the administration of anesthetics, certified registered nurse anesthetists or anesthesiologist assistants supervised by an anesthesiologist, except for local anesthetic agents which may be administered by the attending physician, dentist or podiatrist.

Notwithstanding the provisions of sections 334.400 to 334.430, RSMo, or the rules of the Missouri State Board of Registration for the Healing Arts, the governing body of every ambulatory surgical center shall have full authority to limit the functions and activities that an anesthesiologist assistant performs in such ambulatory surgical center. Nothing in this paragraph shall be construed to require any ambulatory surgical center to hire an anesthesiologist who is not already employed as a physician prior to August 28, 2003.

Written procedures and criteria for discharge from the recovery service shall be approved by the medical staff.
There shall be a mechanism for the review and evaluation on a regular basis of the quality and scope of anesthesia (F) Medical Records.
A medical record shall be maintained for every patient cared for in an ambulatory surgical center.
Medical records are to be filed for easy accessibility and available for inspection by duly authorized representatives of the Department of Health.
The medical record shall support the diagnosis or need for medical services and shall include the following: patient identification; chief complaint, pertinent history and preoperative physician’s physical exam, including copies of any laboratory, X-ray, pathology, anesthesia record, preanesthesia and postanesthesia evaluation record and consultation reports; description of surgical procedures, treatments or observations on care provided, including complications, if any; signature or initials of physician on each clinical entry; signature or initials of nursing personnel on notes or observations; condition of patient on discharge; instructions given to patient on release from facility; copy of transfer form if patient is transferred to another health facility; and operative and anesthesia consent forms.
The facility shall establish and have approved by the facility governing body a medical record retention policy that meets its needs for clinical, educational, statistical or administrative purposes. All medical records shall be safeguarded against loss and unofficial use.

(G) Sterilizing and Supply.

Policies and procedures shall be established in writing for storage, maintenance and distribution of supplies and equipment.
Sterile supplies and equipment shall not be mixed with unsterile supplies and shall be stored in dustproof and moisture-free units. They shall be properly labeled.
Sterilizers and autoclaves shall be provided of appropriate type and necessary capacity to adequately sterilize instruments, utensils, dressings, water, operating room materials, as well as laboratory equipment and supplies. The sterilizers shall have approved control and safety features. The accuracy of instruments shall be checked periodically by an approved method. Adequate surveillance methods for checking sterilization procedures shall be employed. When contractual arrangements for sterile supplies, equipment and instruments have been approved by the Department of Health, on-premises sterilizing equipment is not required other than the required highspeed sterilizer.
The date of sterilization or date of expiration shall be marked on all sterile supplies and unused items shall be resterilized in accordance with written policies.

(H) Radiological and Pharmaceutical Services.

For radiology services performed in the center, the rules authorized by section 192.420, RSMo shall be met. Radiation protection shall be provided in accordance with 19 CSR 20- 10.010—19 CSR 20-10.200 and the recommendations of the National Council on Radiation Protection and Measurements.

There shall be written policies and procedures and records shall be kept of at least annual checks and calibrations of all X-ray and gamma beam therapy equipment. Only qualified personnel shall operate radiological equipment.

The use of drugs in the facility shall be under the direction of a designated individual in accordance with accepted standards of practice and applicable state and federal laws. There shall be procedures relating to procuring, storage, security, records, labeling, preparation, orders, administration, adverse reactions and disposal or other disposition of drugs.

There shall be specific procedures for controlled drug security and recordkeeping.

All radiological services shall be under the direction of a qualified physician.
There shall be a mechanism for the review and evaluation on a regular basis of the quality and scope of radiological and pharmaceutical services.

(I) Laboratory Services.

Laboratory procedures performed in an ambulatory surgical center shall be limited to routine tests (such as hemoglobin, hematocrit, leucocyte count, glucose, urinalysis and pregnancy tests). Laboratory services obtained under contract shall be from a laboratory located in a hospital licensed under section 197.010, RSMo 1986 or from a laboratory certified as an independent laboratory by the federal Health Care Financing Administration.
Procedures performed in the facility shall be appropriate for the services provided and shall be performed according to written or printed instructions. Instructions shall include calibration and control methods that assure the accuracy and precision of each patient test. Equipment shall be calibrated and maintained in conformance with manufacturers’ instructions.

All instructions shall be available in the facility.

The facility shall have access to a blood bank located in a hospital licensed under section 197.010, RSMo 1986 or to a regional blood center licensed by the federal Food and Drug Administration to provide blood for transfusion purposes. The blood bank or blood center shall have crossmatching capability and written procedures for investigating transfusion reactions.
Laboratory services shall be under the direction of a physician member of the medical staff.

(J) Supportive Services.

Provision shall be made in writing for the laundering and processing of institutional linen and washable goods.

Services may be provided by an on-premises laundry operated by the facility or by an outside laundry through contractual agreement.

If food services are provided, services shall comply with 19 CSR 20-1.010.

(K) Infection Control.

There shall be an active multidisciplinary infection control committee responsible for implementing and monitoring the infection control program. The committee shall include, but not be limited to, the infection control officer, a member of the medical staff, registered professional nursing staff, quality improvement staff and administration. This program shall include measures for preventing, identifying, and investigating health-care-associated infections (HAI) and shall establish procedures for: collecting data, conducting root cause analysis, reporting sentinel events and implementing corrective actions. These measures and procedures shall be applied throughout the ambulatory surgical center, including as part of the employee health program.
The ambulatory surgical center shall provide reports to the department as required by 19 CSR 10-33.050.
The infection control committee shall conduct an ongoing review and analysis of HAI data and risk factors.

Priorities and goals related to preventing the acquisition and transmission of potentially infectious agents will be established based on risks identified.

Ambulatory surgical centers shall implement written policies and procedures outlining infection control measures for all patient care and support departments. These measures shall include, but are not limited to, an ambulatory surgical centerwide hand hygiene program that complies with the current Centers for Disease Control and Prevention (CDC) Guideline for Hand Hygiene in Health-Care Settings, which is incorporated by reference in this rule. A copy of the CDC Guideline for Hand Hygiene in Health-Care Settings may be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800.

This rule does not incorporate any subsequent amendments or additions. At a minimum, the program shall require every health care worker to properly wash or sanitize his or her hands immediately before and immediately after each and every episode of patient care. Procedures shall include, at a minimum, requirements for the facility’s infection control program to conduct surveillance of personnel in accordance with section 197.150, RSMo. Surveillance procedures also may include monitoring the employees’ and medical staff’s use of hand hygiene products. A mechanism approved by the ambulatory surgical center infection control committee for reporting and monitoring patient and employee infections shall be developed and implemented for all patient care and support departments in the ambulatory surgical center.

Orientation and ongoing education shall be provided to all personnel on the cause, effect, transmission and prevention of infections.
There shall be a mechanism for the review and evaluation on a regular basis of the quality and effectiveness of infection control throughout the facility.

(L) Any person having a complaint pertaining to the care rendered a patient in an ambulatory surgical center may direct the complaint in writing to the Missouri Department of Health, Bureau of Hospital Licensing and Certification, P.O. Box 570, Jefferson City, MO 65102. The person making the complaint shall be contacted by the Department of Health within five (5) working days of receipt of the complaint and the complaint shall be investigated by the Department of Health within twenty (20) working days of receipt of the complaint.

(M) Requests for deviations from the requirements of this rule shall be in writing to the Department of Health. Requests and approvals shall be made a part of the permanent Department of Health records for the facility. Licensed ambulatory surgical centers participating in innovative projects may be granted a waiver of exemption from certain requirements. Waivers may be granted by the chief of the Bureau of Hospital Licensing and Certification with the approval of the director of the Division of Health Resources.

rule filed Dec. 2, 1975, effective Feb. 1, 1976. Amended: Filed June 14, 1988, effective Oct. 13, 1988. Amended: Filed Jan. 3, 1990, effective April 12, 1990. Amended: Filed Sept. 20, 2005, effective April 30, 2006. Amended: Filed Jan. 16, 2007, effective Aug. 30, 2007. *Original authority: 197.154, RSMo 2004 and 197.225, RSMo 1975, amended 1996.

History

AUTHORITY: section 197.225, RSMo 2000 and 197.154, RSMo Supp. 2006. This rule was previously filed as 13 CSR 50-30.020. Original

19 CSR 30-30.030 General Design and Construction Standards for Ambulatory Surgical Centers {#sec-19-csr-30-30.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.030}

PURPOSE: The Division of Health Resources, Department of Health has the authority to establish construction standards for ambulatory surgical centers. This rule provides standards for facilities to ensure sanitary and fire-safe facilities.

(1) All new ambulatory surgical centers and additions to and remodeling of existing licensed ambulatory surgical centers shall be designed to provide all of the facilities required by this rule and fire-safety standards, arranged to accommodate with maximum convenience all of the functions required by this rule and arranged to provide comfortable, attractive, sanitary, fire-safe, secure and durable facilities for the patients.

This rule is applicable to ambulatory surgical centers which began operation or construction or renovation of a building to operate an ambulatory surgical center on any date after April 12, 1990. Existing ambulatory surgical centers licensed by the Department of Health prior to April 12, 1990 shall be maintained in compliance with the rules under which they were initially licensed and are not required to comply with the construction requirements for new ambulatory surgical centers until they are remodeled or expanded. The Department of Health, within its discretion and for good reason, may grant exceptions to this rule. These exceptions shall be in writing and shall be made a part of the Department of Health records for the facility.

(A) General Construction—Related Authorities.

Construction of all ambulatory surgical centers and additions to or remodeling of ambulatory surgical centers shall comply with all local and state regulations and codes.

(B) Planning and Construction Procedure.

Plans and specifications complying with 19 CSR 30- 30.040 shall be prepared for the construction of all ambulatory surgical centers and any additions to and remodeling of ambulatory surgical centers. Plans for ambulatory surgical centers which in addition to other surgical procedures will offer abortion services shall incorporate facilities for patient counseling as required for licensed abortion facilities in 19 CSR 30-30.070(2)(Z). The plans and specifications shall be prepared by an architect or a professional engineer licensed to practice in Missouri. The plans and specifications shall have received written approval of the Department of Health prior to the submission of an application for licensure of the new facility.

The license for a new ambulatory surgical center will not be issued prior to the facility being inspected and found in substantial compliance with this rule.

The Department of Health shall be notified within five (5) days after construction begins. If construction of the project is not started within one (1) year after the date of approval of the plans and specifications, the plans and specifications shall be amended if necessary to comply with the then current regulations before construction work commences (see 19 CSR 30-30.040 Preparation of Plans and Specifications for Ambulatory Surgical Centers).

Adequate vehicular and pedestrian access shall be provided within the lot lines to the main entrance, ambulance entrance, community activities and services, including loading and unloading space for delivery trucks. Roads, walks, ramps and entrances shall be accessible to the physically handicapped.

Details for accommodation of the handicapped shall be consistent with the guidelines contained in A Guidebook to: The Minimum Federal Guidelines & Requirements for Accessible Design published January 6, 1981, by the United States Architectural and Transportation Barriers Compliance Board.

Adequate off-street parking shall be provided. Space shall be provided at the ratio of two (2) spaces for each patient cart in the recovery room plus parking space to accommodate the maximum number of staff on duty at any one (1) time. A minimum of two (2) handicapped-accessible parking spaces shall be provided for use by the staff and patients.
Plans for proposed new ambulatory surgical centers and additions to ambulatory surgical centers should be reviewed by the local fire protection agency assigned to that area. Fire lanes shall be provided and kept clear to provide immediate access for fire-fighting equipment.

(D) General Design—Facilities.

The arrangement of the physical plant shall provide for separation of the administrative, business and public areas from patient service areas.

A. Administrative area—at a minimum shall consist of a business office with information center and telephone, administrator’s office, medical records storage (may be in patient service area), sufficient to satisfy the requirements of 19 CSR 30-30.020(1)(F)4., lobby and waiting room, telephone available to public, handicapped-accessible public toilets for each sex, handicapped-accessible drinking fountain, and janitor’s closet.

B. Patient service areas—at a minimum shall consist of two (2) or more patient change areas per sex with access to toilets; secure storage facilities for each patient’s street clothing and belongings; staff lounge with storage for staff’s clothing and personal effects, and handwashing facilities; examination room of at least one hundred (100) square feet with handwashing facilities; preoperative holding room sized for at least two (2) patients per operating room with each patient location being at least thirty-five (35) square feet; janitors’ closet with sufficient space for equipment for maintaining the patient service area; laboratory, unless provisions have been made for off-premises laboratory services; postanesthesia recovery room with handwashing facilities, sized to accommodate at least two (2) patient stretchers per operating room with three feet (3') of clear space around the sides and foot of each stretcher; nurses’ work station with medication storage and preparation facilities, storage space for emergency equipment; doctors’ dressing room, toilet and handwashing facilities arranged to provide a one (1)-way traffic pattern so that personnel entering from outside surgery can change and move directly into the surgical suite corridor; nurses’ dressing room, toilet and handwashing facilities; one (1) scrub-up facility for each operating room; materials processing facilities including a decontamination utility room with workcounter, sink, clinic sink with bedpan cleanser and space for holding soiled materials and trash, and a pass-thru window to an adjacent clean workroom with workcounter, sink, high speed sterilizer and space for storing sterilized and packaged clean supplies; and one (1) or more operating rooms.

(I) Operating rooms shall have a floor area of not less than two hundred twenty-five (225) square feet with a minimum dimension of not less than fifteen feet (15').

(II) The administration of general anesthetics in new ambulatory surgical centers is restricted to nonflammable agents. Any new ambulatory surgical center desiring to administer flammable anesthetics shall first receive the written permission of the Missouri Department of Health and will be required to include National Fire Protection Association (NFPA) safety design features for flammable anesthetizing locations into the building.

C. Support facilities—space for mechanical equipment, standby electric generator with automatic transfer switch, medical gas storage, housekeeping supply storage and a general storage room providing at least one hundred (100) square feet per operating room.

(E) General Design—Details.

A continuous system of unobstructed corridors and aisles shall extend through the enclosed portion of each story of the facility, connecting all rooms and spaces with each other and with all entrances, exitways and elevators except that mechanical equipment space need not be connected to the corridor system. Corridors providing access to operating rooms and postanesthesia recovery rooms shall be at least eight feet (8') wide, all other corridors shall be at least five feet (5') wide.
At least two (2) exits, remote from each other, shall be provided for each floor.
Exit doors and doors to operating rooms and recovery rooms shall be at least forty-four inches (44") wide. All other doors through which patients and personnel will pass shall be at least thirty-two inches (32") wide.
The width of stairways except stairways, to mechanical spaces, shall not be less than forty-four inches (44").
Exit discharge doors shall swing in the direction of exit traffic.
Ceilings in operating rooms shall not be less than nine feet (9'). Ceilings in all other rooms shall not be less than eight feet (8'), except that ceilings in corridors and storage rooms may be seven feet six inches (7' 6").
Ceilings in operating rooms shall have a smooth washable surface. All other ceilings may be of acoustical material.
The floor finish in operating rooms shall be seamless with an integral base covered with the floor and tightly sealed with the wall.
Walls shall be smooth and easily cleanable. Walls in operating rooms and recovery rooms shall have waterproof painted, glazed or similar washable surfaces.
Floors in the lobby, waiting room and offices shall be easily cleanable. Floors in operating rooms and recovery rooms shall be smooth, slip-resistant and washable.
Wall and ceiling surfaces of all required corridors and exitways shall be of a material treated so it does not have a flame-spread classification of more than twenty-five (25) according to the method for the Fire Hazard Classification of Building Materials of Underwriters’ Laboratories, Inc. Rooms and small office spaces shall have wall and ceiling surfaces with a flame-spread rating of not more than seventy-five (75) when tested according to American Society of Testing and Materials (ASTM) Standard E-84. All floor covering shall have a minimum flame-spread rating of forty-five one hundredths (0.45) watts per square centimeter when tested according to NFPA 253-1978 (Flooring Radiant Panel Test).
Paper towel dispensers and soap dispensers shall be provided at all lavatories used for handwashing.

(F) Fire Safety Construction—Specifications and Details.

One (1)-story buildings shall be of not less than Type II (111) construction as described in the Standard on Types Building Construction 1979 published by the NFPA. Fully sprinklered one (1)-story buildings may be of type II (000) construction.
Multistory buildings shall be of not less than Type II (222) construction. Fully sprinklered multistory buildings may be of not less than Type II (111) construction.
Walls enclosing stairways, elevator shafts, other vertical openings between floors and boiler rooms shall be of construction having a fire rating not less than that required for the structure.
The number of stories in any building housing an ambulatory surgical center shall be determine by counting the number of occupiable levels in the structure regardless of their location above or below grade.
Ambulatory surgical centers with a floor area of two thousand (2000) square feet or more shall be divided by one (1)-hour rated walls into at least two (2) smoke zones; each zone not exceeding one hundred fifty feet (150') in any dimension.

Each smoke zone shall have at least one (1) means of egress which discharges directly to the outside.

In a building of multitenant occupancy, the ambulatory surgical center and the entirety of the surgical center’s access to exit system shall be separated from other tenants by walls having a fire-resistance rating of at least one (1) hour.
Smoke detectors shall be installed in all habitable spaces in the ambulatory surgical center and in the access to exit corridor system at intervals not exceeding seventy-five feet (75') and no more than thirty feet (30') from the ends of corridors.

(G) Elevators.

If patient services are located on any floor other than the grade level, at least one (1) elevator is to be provided.
Inside dimensions of the elevator shall be at least five feet by seven feet (5' × 7') clear inside to accommodate a wheeled stretcher and attendants. The elevator car door shall have a clear opening of not less than forty-four inches (44").

(H) Electrical Requirements.

Every room, including storage rooms, corridors and all other areas shall be sufficiently illuminated to facilitate efficient performance of all necessary work.
Operating and recovery rooms shall have general lighting in addition to special lighting units at the surgical tables and for each recovery unit.
All sources of light and power in the operating room shall comply with the Standard for the use of Inhalation Anesthetics (Flammable and Nonflammable 1978) published by the NFPA.
An approved automatically-operated, electricallypowered fire alarm system which will alert all areas of the facility when activated shall be installed including audible and visual alarm devices located throughout the ambulatory surgical center and its access-to-exit corridor system, manual pull stations near each exit door. The fire alarm system shall be interconnected with all required smoke detectors and extinguishment systems, if provided. The fire alarm system shall be connected directly to the fire department or a dispatch service.
An intercom, nurse call system or other means of communication connecting each operating room and the recovery room area to a constantly staffed location shall be installed to summon assistance during emergencies.
A generator with on-site fuel storage for at least four (4) hours of operation under load shall be provided as an emergency source of electricity and connected by an automatic transfer switch to certain circuits for lighting and power. The emergency electrical service shall be installed and arranged so that full voltage and frequency is available and supplying power to emergency loads within ten (10) seconds after normal power is interrupted. Emergency electric services shall be provided for the following:

A. Lighting—exitways, including exit signs; all operating room lights; all recovery room lights; minimal task lighting in all clinical areas; generator set location; and elevator if required; and B. Power—all alarm systems; receptacles in operating and recovery rooms; the operating room communication system; the pump for central suction system, if provided; and elevator, if required.

(I) Heating, Ventilating and Air-Conditioning Equipment.

Air-conditioning, heating and ventilating equipment shall be provided, maintained and operated so as to provide an adequate degree of comfort to all occupants.
All air delivered to operating rooms shall be delivered at or near the ceiling of the room served and all air returned or exhausted shall be removed near the floor level. At least two (2) return or exhaust outlets shall be used in each operating room and located not closer than three inches (3") to the floor and not more than twelve inches (12") above the floor.
The ventilation systems shall be designed and balanced to provide the pressure relationship shown in Table I.
For the clinical areas, requirements for outdoor air changes may be deleted or reduced and total air changes per hour supplied may be reduced to twenty-five percent (25%) of the figures listed in Table I when the room is unoccupied and unused, provided that indicated pressure relationships are maintained. An interconnect with the general illumination light switch for each operating room shall be included to insure that the required ventilation rates including outdoor air are automatically resumed upon reoccupancy of the space.

This does not apply to certain areas such as toilets and storage which would be considered as in use even though unoccupied.

Ventilation systems for the surgical suite which includes the operating rooms, surgical corridor and support areas, and recovery rooms shall have two (2) filter beds. Filter bed no. 1 shall be located upstream of the air-conditioning equipment and have an efficiency rating of not less than twenty-five percent (25%). Filter bed no. 2 shall be located downstream of the air-conditioning equipment and have an efficiency rating of not less than ninety percent (90%). The ventilation systems serving all other areas shall have at least one (1) filter having an efficiency rating of not less than twenty-five percent (25%).
Space and access panels shall be provided for the easy maintenance and replacement of all filters installed in the ventilation equipment.
Ducts supplying air to the operating suite and recovery rooms shall be externally insulated downstream from the final filter.
Variable volume-ventilation systems may be used only in the administrative areas of ambulatory surgical centers.

(J) Plumbing.

The requirements of the current edition of the National Plumbing Code shall be complied with insofar as they may apply and to the extent they are not superseded by requirements specifically stated in these regulations.

A. Systems shall be designed to supply water to the fixtures and equipment on every floor at a minimum pressure of fifteen pounds per square inch (15 psi) during maximum demand periods.

B. Each water service main, branch main, riser and branch to a group of fixtures should be valved. Stop valves shall be provided at each fixture.

C. Hot, cold and chilled water piping and waste piping on which condensation may occur shall be insulated. Insulation of cold and chilled water lines shall include an exterior vapor barrier.

D. Backflow preventers (vacuum breakers) shall be installed on hose bibbs and on all fixtures to which hoses or tubing can be attached such as janitor’s sinks and laboratory fixtures.

E. Hot water distribution systems with recirculating loops and pumps shall be arranged to provide hot water service at each fixture at all times.

F. The hot water-heating equipment shall have sufficient capacity to supply the water at temperatures between one hundred five degrees and one hundred fifteen degrees Fahrenheit (105°F–115°F) at a rate not less than five (5) gallons per hour per recovery stretcher.

G. Lavatories and sinks in patient service areas shall have the water supply spout mounted so that its discharge point is a minimum distance of five inches (5") above the rim of the fixture. All lavatories used by medical and nursing staff and food handlers except those in public toilets shall be trimmed with valves which can be operated without the use of hands.

H. Scrub sinks shall be equipped with faucets which can be operated without the use of hands.

History

AUTHORITY: section 197.225, RSMo 1986. This rule was previously filed as 13 CSR 50-30.030. Original rule filed Dec. 2, 1975, effective Feb. 1, 1976. Amended: Filed Jan. 3, 1990, effective April 12, 1990.

19 CSR 30-30.040 Preparation of Plans and Specifications for Ambulatory Surgical Centers {#sec-19-csr-30-30.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.040}

PURPOSE: The Division of Health Resources, Department of Health has the authority to establish construction standards for ambulatory surgical centers. This rule provides procedures to follow in the submission of plans and specifications for new construction.

(1) Preliminary Plans and Sketches.

(A) When construction is contemplated, either for new buildings additions to existing buildings or material alterations to existing buildings, the preliminary plans or sketches shall be submitted in duplicate to the Department of Health for review and approval before the preparation of working drawings is undertaken. The preliminary plans may be reviewed by the Department of Health in schematic form, but before they are declared acceptable for procedure with working drawings and specifications, they should also include the following information, stated briefly and not in detailed form required in working drawings and specifications:

Site plan showing scale, orientation, street names, topography, walks, drives, fire lanes, parking areas and utilities including fire hydrant location;
Plans and elevations of the buildings at a scale of not less than one-eighth inch to one foot no inches (1/8":1' 0");
Rooms and corridors, designated by name and number;
Windows. Note, wired glass where it is required;

TABLE I

Pressure Relationships and Ventilation of Certain Areas Pressure Minimum Air Minimum Total All Air Recirculated Relationship to Changes of Outdoor Air Changes Exhausted Within Area Designation Adjacent Areas Air Per Hour Per Hour Directly to Outdoors Room Operating Room P 5 15 Optional No Recovery P 2 26 Optional No Patient Area Corridor E 2 24 Optional No Treatment Room E 2 6 Optional No Laboratory N 2 6 Optional No Soiled Workroom N 2 4 Yes No Clean Workroom P 2 4 Optional Optional Toilet Room N 10 Yes No Janitor’s Closet N 10 Yes No P=Positive N=Negative E=Equal 5. Doors, including door swings. Identify fire doors by time rating and Underwriters’ Laboratories label;

Plumbing fixtures. Show fixtures in proper shape and scale for positive recognition. Identify special types such as service sinks and clinic sinks;
Plans of rooms shall indicate principal items of furniture accurately scaled;
All other principal items of equipment such as boilers, chiller, cooling tower, electrical substations, tanks, air handlers, fan-coil units, kitchen equipment, laundry equipment, cabinets, counters and any other items which take up space and affect the final layout;
Fire and smoke-barrier partition designations;
Floor lines, top ceiling line and grade lines, designated and preferably dimensioned, and with basic elevations shown;
Ceiling heights of principal rooms and also of each room for which the rules establish a minimum ceiling height.

Only one (1) typical room of a group need be so shown;

Area of each room for which the rules establish a minimum area. Only one (1) typical room of a group need be so noted; and 13. Brief noted descriptions of the general construction and finish; the structural system; the heating, ventilating and air-conditioning systems, including the fuel supply; the plumbing system including the water supply and sewage disposal; and the electrical system.

(B) In the case of a project which is an addition to an existing building, it will be necessary to give the Department of Health sufficient information about the existing building on which to base a determination of acceptability of the plans for the addition. This information shall cover all items required to be provided in an ambulatory surgical center by the rules of the Department of Health and shall be submitted in the form as required for the particular project by the Department of Health.

(2) Working Drawings and Specifications.

(A) Working drawings and specifications, complete in all respects, shall be submitted in duplicate, covering all phases of the construction project, including site preparation; paving; general construction; mechanical work, including plumbing, heating, ventilating and air conditioning; electrical work and all built-in equipment, including elevators, kitchen equipment, cabinet work, etc.

Each sheet of the plans and each set of the specifications shall identify the project by name and location and shall bear the names and addresses of the architect or professional engineer and the owner.
Each sheet of the plans and each set of specifications shall bear the official seal and signature of the registered architect or registered professional engineer who prepared it.
Each set of the plans and each set of specifications shall bear the date of its completion or its latest revision.
The plans shall be on sheets of the same size, securely bound into complete sets, with the sheets in the proper order.

The specifications shall be securely bound into complete sets.

(B) The working drawings and specifications shall include the following: the material set out in paragraphs (1)(A)1.–12. of this rule; courses and distances of property lines; dimensions and locations of any building, structures, easements, rights-ofway or encroachments on the site; details of party walls, and walls and foundation adjacent to lot line; detailed information by the city engineer or other official report as to established curbs, buildings lines, streets, alleys, sidewalks; all utilities including size, characteristics and location of these services, piping, mains, sewers, poles, wires, hydrants and manholes upon, over or under the site and location of high pressure gas lines within one thousand two hundred feet (1200') of the building; complete information as to the disposal of sanitary, storm water and subsoil drainage; official datum upon which elevations are based and benchmark established on or adjacent to the site; contours on elevations at two foot (2') intervals over site and elevations at the bottom of excavation; and thickness, consistency, character and estimated safe bearing value of various strata encountered.

History

AUTHORITY: section 197.225, RSMo 1986. This rule was previously filed 13 CSR 50-30.040. Original rule filed Dec. 2, 1975, effective Feb. 1, 1976.

19 CSR 30-30.050 Definitions and Procedures for Licensing {#sec-19-csr-30-30.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.050}

PURPOSE: This rule defines terminology used in 19 CSR 30-30.060 and 19 CSR 30-30.070, and establishes the procedures for applying for an abortion facility license.

(1) The following definitions shall be used in the interpretation and enforcement of 19 CSR 30-30.060 and 19 CSR 30-30.070:

(A) Abortion—The act of using or prescribing any instrument, device, medicine, drug, or any other means or substance with the intent to destroy the life of an embryo or fetus in his or her mother’s womb; or, the intentional termination of the pregnancy of a mother by using or prescribing any instrument, device, medicine, drug, or other means or substance with an intention other than to increase the probability of a live birth or to remove a dead or dying unborn child;

(B) Abortion facility—Any clinic, physician’s office, or any (C) Administrator—A person who is designated by an abortion facility to provide daily supervision over the abortion facility and who is a physician licensed in Missouri, a registered nurse licensed in Missouri, or an individual who has at least one (1) year of administrative experience in health care;

(D) Complication—Includes, but is not limited to, incomplete abortion, hemorrhage, endometritis, parametritis, pyrexia, pelvic abscess, uterine perforation, failed abortion, cervical lacerations, retained products, or diagnosable psychiatric condition;

(E) Department—The Missouri Department of Health and Senior Services;

(F) Discharge summary—A statement completed by a physician or registered nurse regarding the condition of the patient at the time of discharge;

(G) First trimester—The first thirteen (13) weeks of gestation, based upon gestational age;

(H) Gestational age—The length of pregnancy measured from the onset of the last menstrual period, and except in the case of a medical emergency as defined in section 188.015, RSMo, determined by a physician in a manner consistent with accepted obstetrical and neonatal practices and standards after performing or causing to be performed such medical examinations, imaging studies, and tests as a reasonably prudent physician, knowledgeable about the medical facts and conditions of both the woman and the unborn child involved, would consider necessary to perform and consider in making an accurate diagnosis;

(I) Health assessment—A determination of a patient’s physical and mental status;

(J) Licensed practical nurse (LPN)—A person licensed to practice practical nursing pursuant to Chapter 335, RSMo;

(K) OB/GYN—A physician who is board-certified or boardeligible by the American Board of Obstetrics and Gynecology or the American Osteopathic Board of Obstetrics and Gynecology;

(L) Person—Any individual, firm, partnership, corporation, association, or other business entity;

(M) Physician—Any person licensed to practice medicine pursuant to Chapter 334, RSMo;

(N) Registered professional nurse—An individual who is a graduate of an approved school of nursing and who is licensed to practice professional nursing under Chapter 335, RSMo; and (O) Surgical technologist—An individual who is certified by the National Board of Surgical Technology and Surgical Assisting.

(2) Procedures for Licensing Abortion Facilities.

(A) No abortion shall be performed or induced in any place or facility including a clinic or physician’s office, without a license issued by the department, except that abortions may be performed or induced in hospitals without a separate abortion facility license issued by the department.

(B) Application for an abortion facility license shall be made in writing to the department on forms provided by the department by the person who will operate the facility.

The forms shall require at least the following information: date of application; name of facility to appear on license; street address, city, county, zip code, telephone number, and email address of facility; facility website address, if any; name of person who will operate facility; organizational chart showing ownership and control of facility; name of chief officer of governing body of facility; name and qualifications of administrator; name and qualifications of OB/GYN consultant; types of abortions that will be performed at the facility (i.e., surgical and/or drug- or chemically-induced); estimated number of each type of abortion that will be performed and/or induced annually at facility; number of facility staff; number of physicians on staff; number of physicians routinely performing or inducing abortions at facility; number of anesthesiologists or CRNAs on staff, if any; usual days and hours of facility operation; usual days and times that abortions are induced or performed at facility; number of procedure rooms; and notarized certification by chief officer of governing body and administrator that application is accurate and facility will follow all applicable laws and regulations.

(C) Each application for an abortion facility license shall be sent to the Missouri Department of Health and Senior Services, Bureau of Ambulatory Care, PO Box 570, Jefferson City, MO 65102, and shall be accompanied by an annual fee of two hundred dollars ($200).

(D) Each license, unless sooner suspended or revoked, shall be issued for a period of one (1) year.

(E) Each license shall be issued only for the persons and premises named in the application.

(F) The facility shall notify the department in writing if the operator of the facility, name of the facility, or premises of the facility changes. The facility shall provide the notification at least thirty (30) days before the change.

(G) Separate licenses are required for abortion facilities maintained on separate sites even if operated by the same person.

(H) The abortion facility license shall be conspicuously posted in a public area in the facility.

(I) No license shall be issued or renewed by the department until the department has inspected the facility and determined that it is in compliance with all requirements of applicable regulations and statutes.

History

AUTHORITY: section 197.225, RSMo Supp. 2017. Original rule filed July 15, 1987, effective Oct. 25, 1987. Amended: Filed Oct. 24, 2017, effective April 30, 2018.

19 CSR 30-30.060 Standards for the Operation of Abortion Facilities {#sec-19-csr-30-30.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.060}

PURPOSE: This regulation establishes standards for the operation of abortion facilities to ensure safe, quality care in accordance with legal requirements.

(1) Governing Body, Administration, and Medical Staff.

(A) The facility shall have a governing body which may be an individual owner or owners, partnership, corporate body, association, or public agency.

The governing body shall have full legal responsibility for determining, implementing, and monitoring policies governing a facility’s total operation and for ensuring that the policies are administered in a manner to provide acceptable care in a safe environment and in accordance with all legal requirements and standards of care.
The governing body shall select and employ an administrator who is a physician licensed in Missouri, a registered nurse licensed in Missouri, or an individual who has at least one (1) year of administrative experience in health care.
If there is any change in the designation of the administrator, the governing body shall notify the department within ten (10) calendar days of the change.
The governing body shall ensure that, in the absence of the administrator from the facility, a person who meets the qualifications of an administrator as defined in this regulation shall be present at the facility and fulfill the administrator’s duties.
Bylaws of the governing body shall acknowledge that department surveyors shall be allowed to inspect the facility at any time the facility is in operation. Surveyors shall have due regard for the medical condition and reasonable privacy of the on-site patients.
Bylaws of the governing body shall require that the medical staff, facility personnel, and all others providing services relative to the facility shall be directly or indirectly responsible to the governing body through the administrator.
The governing body, through the administrator, shall establish criteria for the content of patient records and shall provide for timely completion of those records and disciplinary action for noncompliance.
The governing body, through the administrator, shall ensure that the abortion facility abides by all applicable state and federal laws and regulations. This shall include, but not be limited to, compliance with Chapter 188, RSMo, 13 CSR 70- 3.030(3), and:

A. Notifying pathology lab of failed abortion within twenty-four (24) hours;

B. Ensuring that the physician providing informed consent to the patient is the physician who performs the procedure;

C. Ensuring that all medical records associated with abortions accurately reflect the date and time the record was created;

D. Ensuring that the physician who performs the abortion performs a pelvic exam at least seventy-two (72) hours before an abortion unless, in the physician’s clinical judgment, such pelvic exam is not medically necessary and said physician documents the reason for such determination;

E. Ensuring that any physician, nurse, or other health care provider, or their contracted agents, cooperate with any Department of Health and Senior Services investigator upon written request of the investigator;

F. Ensuring that all employees participate in an annual fire drill;

G. Ensuring that policies are written in accordance with regulatory requirements;

H. Ensuring that endotracheal equipment is maintained and that staff is aware of the location of the equipment;

I. Following all acceptable sterilization standards for surgery instruments and equipment; and J. Maintaining controlled substance logs in accordance with published regulations.

Any violation of law or regulation shall be immediately referred, in writing, with details of said violation or violations, to the Medicaid Audit and Compliance Unit of the Department of Social Services.
The governing body, through the administrator, shall be responsible for developing, implementing, and enforcing a policy to ensure protection of facility employees, physicians, and volunteers from retaliation or adverse employer actions by the facility for disclosing information regarding alleged infection control concerns; alleged facility mismanagement or fraudulent activity; or alleged violations of state of federal law or regulations regarding patient care, patient safety, or facility safety.

(B) An administrator shall organize the administrative functions of the facility.

The administrator shall be responsible for establishing effective security measures to protect patients, employees, and visitors.
The reporting of suspected incidences of child abuse shall be made to the Department of Social Services as required by section 210.115.1, RSMo.
The administrator shall be responsible for developing a written plan for evacuation of patients and personnel in the event of fire, explosion, active shooter, or other disaster.

The plan shall be kept current and all personnel shall be knowledgeable of the plan. Disaster drills with participation of all staff shall be conducted and documented at least annually.

The administrator shall be responsible for reporting all fires, explosions, and disasters affecting the abortion facility and physical actions taken against the facility to the department within twenty-four (24) hours.
The administrator shall be responsible for establishing, posting, and enforcing written policies prohibiting smoking throughout the facility.
The administrator shall be responsible for establishing, implementing, enforcing, and maintaining comprehensive programs for identifying and preventing infections as further detailed in this regulation and for maintaining a safe environment.
The administrator shall develop written personnel policies which contain at least the following:

A. Provisions for orientation of all personnel to the policies and objectives of the facility;

B. Provisions for participation by all personnel in training and orientation periods appropriate to the needs and level of preparation as required by the individual job description;

C. Provision for periodic evaluation of each employee’s performance;

D. Provisions for written job descriptions, including job qualifications;

E. Provisions for licensed personnel to have current cardiopulmonary (CPR) training so that at least one (1) licensed and trained personnel is at the facility at all times when patients are present for abortions; and F. Provisions for criminal background checks and department Employee Disqualification List (EDL) checks for every person within the facility who will have contact with patients within the facility, including physicians, staff, and volunteers. These checks shall be completed before allowing the person to have unsupervised contact with patients within the facility. Provisions shall be made for periodic EDL checks thereafter.

The administrator shall be responsible for ensuring that a personnel record is maintained regarding each employee and includes documentation of the employee’s job description, qualifications, orientation period, health status, criminal background, EDL status, performance assessment, CPR training, if applicable, education, and training. Each personnel record for a physician, Registered Nurse (RN), or Licensed Practical Nurse (LPN) shall contain verification of current licensure.

(C) The medical staff shall develop and, with the approval of the governing body, shall adopt policies governing physician activities in the abortion facility.

Medical staff membership shall be limited to physicians.
Each physician requesting staff membership shall submit a written application to the administrator of the facility on a form approved by the governing body. Each application shall be accompanied by evidence of education, training, professional qualifications, licensure, and standards of performance.
The governing body, acting upon recommendations of the medical staff, shall approve or disapprove appointments to the medical staff. There shall be written criteria for determining privileges of medical staff. Medical staff shall use a formal method for making recommendations to the governing body regarding delineation of privileges; curtailment, suspension, or revocation of privileges; and appointments and reappointments to the medical staff.
Physicians performing abortions at the facility shall have staff privileges at a hospital within fifteen (15) minutes’ travel time from the facility or the facility shall show proof there is a working arrangement between the facility and a hospital within fifteen (15) minutes’ travel time from the facility granting the admittance of patients for emergency treatment whenever necessary.
Each abortion facility shall arrange for at least one (1) OB/GYN to be available either as a staff member or as a consultant for the purpose of providing consultation as needed and advising staff members regarding maintenance of a satisfactory quality of patient treatment.

(2) Direct patient care services.

(A) An abortion shall be performed or induced only by a physician.

(B) Each patient shall be given all the information required by sections 188.027 and 188.039, RSMo, in the formats and timeframes required, by the type of professional required.

(C) The physician who is to perform or induce the abortion shall provide the information required in section 188.027.6, RSMo, orally and in person to the patient at least seventy-two (72) hours before the abortion.

(D) A written medical history shall be obtained for each patient. At least seventy-two (72) hours before the abortion, a health assessment and a pelvic examination shall be performed by the physician who is to perform or induce the abortion, unless in the clinical judgment of that physician such pelvic examination is not medically indicated at such time for that individual patient, in which case such pelvic examination shall be completed on the day of the abortion by the physician performing or inducing the abortion. The

basis for the determination to delay the pelvic examination shall be documented in detail in the patient’s medical record. Pregnancy shall be confirmed by clinical evidence and laboratory tests. This information shall be used in determining the duration of gestation, identifying preexisting medical or other complications, and detecting any factors which could influence the choice of the procedure, anesthesia, or preoperative and postoperative management. If the physician determines gestation is beyond the first trimester, an ultrasound examination shall be performed and results shall be recorded in the patient’s medical record.

(E) Ultrasounds at an abortion facility to confirm gestational age and for other imaging purposes such as ultrasounds per

section 188.027(4), RSMo, shall be performed by a physician or a person who holds a current certification by the American Registry for Diagnostic Medical Sonography (ARDMS) with advanced training in obstetric/gynecological imaging, or other certified training deemed acceptable by the department.

(F) Nursing services shall be under the direction of an RN.

An RN shall be present in the clinical area whenever there is a patient in the procedure room or recovery room. For surgical abortions, an RN, LPN, or a surgical technician shall be present in the procedure room whenever there is a patient in the procedure room. The surgical technician shall be a surgical technologist or shall provide documentation of adequate training in assisting surgical procedures, including surgical abortions.

(G) At facilities performing surgical procedures, an RN or an LPN shall be present in the recovery room when a patient is in the recovery room.

(H) At facilities performing surgical procedures, a physician shall be on the premises and immediately available for any assistance to a patient in the recovery room following a surgical procedure.

(I) No patient shall be discharged from the facility until she is fully reactive and her vital signs are stable.

(J) Written instructions shall be issued to all patients and shall include at least the following:

Symptoms of complications;
Activities to be avoided; and 3. Abortion facility phone numbers. Numbers provided shall include the number for the OB/GYN or OB/GYN group providing complication care under a complication plan as required by section 188.021, RSMo, and 19 CSR 30-30.061.

(K) The facility shall ensure that each patient is prepared for the abortion in a manner that facilitates her safety and comfort.

(L) The facility shall assist each patient in deciding what method of birth control she will use, if any, after the procedure, respecting her choices.

(M) Facilities performing surgical procedures shall have an emergency tray equipped to treat seizures, bleedings, anaphylactic shock, respiratory arrest, and cardiac arrest immediately available to the procedure room and recovery room of the facility.

(N) Facilities performing surgical procedures shall have emergency drugs, oxygen, and intravenous fluids in the procedure room to stabilize the patient’s condition when necessary. A manual breathing bag, suction machine, and endotracheal equipment shall be located in the clinical area for immediate access.

(3) Records and reports.

(A) The facility shall maintain a daily roster of all patients receiving abortion services. The facility shall retain the roster for seven (7) years.

(B) The facility shall maintain a medical record according to professional standards for each patient.

(D) The medical record shall contain— 1. Documentation with a unique identifying record number; patient identifying information; name of physician; diagnosis; medical history and physical examination record; laboratory reports; anesthesia administered; allergies/drug reactions; physician’s orders; clinical notes; counseling notes; patient consent form; medication administration records; and discharge summary;

Documentation establishing that the patient was given all the information required by sections 188.027 and 188.039, RSMo, in the formats and timeframes required, by the type of professional required. If any of the informed consent requirements are performed by a referring physician or qualified professional (where authorized by sections 188.027 or 188.039, RSMo) before the patient presented at the abortion facility, the facility shall obtain documentation from the referring physician or qualified professional establishing such performance in compliance with the law, and shall place the documentation in the patient’s medical record;
Method used to determine gestational age; gestational age; informed consent checklist required by section 188.027.3, RSMo; copy of abortion report required by section 188.052, RSMo, and 19 CSR 10-15.010; for surgical abortions, copy of tissue report required by section 188.047, RSMo, and 19 CSR 10- 15.030; where applicable, copy of complication report required by section 188.052, RSMo, and 19 CSR 10-15.020; and 4. For any patient transferred from the facility due to an emergency or complication, the medical record shall include a report detailing the reason for the transfer. The abortion facility shall attempt to obtain the treatment record of the receiving facility and shall place it in the patient’s medical record.

(E) The facility shall retain medical records for adults for seven (7) years from the time of discharge. For minors, the facility shall retain medical records for seven (7) years from the time of discharge or two (2) years past the age the patient reaches majority, whichever is longer.

(F) The facility shall safeguard medical records against loss and unofficial use.

(G) The facility shall ensure that an individual abortion report for each abortion performed or induced via the facility is submitted to the department within forty-five (45) days of the abortion as required by section 188.052, RSMo, and 19 CSR 10-15.010.

(H) The facility shall ensure that an individual complication report for any complication care provided via the facility is submitted to the department within forty-five (45) days of the care as required by section 188.052, RSMo, and 19 CSR 10-15.020.

(4) Infection Control Program. The facility shall establish a comprehensive program for identifying and preventing infections. The infection control program shall be appropriate for scope and type of abortion procedures performed at the (A) Infection control standards of the facility must be identified in writing, in compliance with generally-agreed upon national standards such as those of the Centers for Disease Control and Prevention (CDC), Association for Professionals in Infection Control and Epidemiology (APIC), Association of peri-Operative Registered Nurses (AORN), or other standards determined acceptable by the department.

(B) The facility shall have in place procedures for monitoring and enforcing compliance with infection control standards in accordance with section 197.150, RSMo.

(C) The facility shall report healthcare associated infection rates to the department in accordance with section 192.667, RSMo, and 19 CSR 10-33.050.

(D) In accordance with section 192.667, RSMo, the facility shall, in consultation with medical staff, establish an antimicrobial stewardship program for evaluating the judicious use of antimicrobials, especially antibiotics that are the last line of defense against resistant infections.

(E) Infectious and pathological wastes at the facility shall be segregated from other wastes at the point of generation and shall be placed in distinctive, clearly marked, leak-proof containers, or plastic bags appropriate for the characteristics of the infectious wastes. Containers for infectious waste shall be identified with the universal biological hazard symbol.

All packaging shall maintain its integrity during storage and transport.

(F) If kept on-site for more than twelve (12) hours, tissue removed during an abortion shall be refrigerated.

(G) The facility shall ensure that all reportable diseases, disabilities, conditions, and findings regarding facility patients are reported in accordance with 19 CSR 20-20.020.

(H) Upon request, the facility shall provide the department access to data and information related to infection control practices, rates, or treatments of infections as required by

section 197.160, RSMo.

(I) The facility shall have policies and procedures for the handling, processing, storing, and transporting of clean and dirty laundry. The facility may provide laundry services at the facility or contract for these services.

(5) Pathology, Laboratory, and Pharmaceutical Services.

(A) All fetal tissue from surgical abortions shall be grossly examined at the time of the procedure by the physician. The results of the tissue examination shall be recorded in the patient’s medical record.

(B) Facilities performing surgical abortions shall ensure that all requirements of section 188.047, RSMo, and 19 CSR 10- 15.030 are met, including timely submission of tissue reports to the department. If the facility does not perform pathology services internally, the facility shall have a written agreement with a pathology laboratory that shall clearly delineate the laboratory’s duties under section 188.047, RSMo, and 19 CSR 10-15.030 regarding tissue reports. The facility shall perform periodic checks to ensure that the laboratory is in compliance with the agreement.

(C) The following laboratory procedures shall be performed on every abortion patient: hemoglobin; urinalysis, including pregnancy test; and Rh typing.

(D) Anti-Rh immune globulin therapy shall be given to all Rh negative patients upon completion of the abortion procedure.

If for any reason a patient refuses this therapy, this refusal shall be noted by the physician in the patient’s record, and, if possible, documented by the patient’s signature on appropriate forms.

(E) The use of drugs in the facility shall be under the direction of a designated individual in accordance with accepted standards of practice and applicable state and federal laws. Drugs must be prepared and administered according to established policies and acceptable standards of practice. The facility shall have procedures regarding procurement, storage, security, records, labeling, preparation, orders, administration, adverse reactions, and disposal or other disposition of drugs.

(F) The facility shall follow all applicable laws and regulations pertaining to controlled substances.

(6) Medical emergencies.

(A) The facility shall develop, implement, and enforce a written protocol for managing medical emergencies including the transfer of any patient requiring further emergency care to a hospital within a reasonable distance from the abortion (B) The facility shall develop, implement, and enforce a written policy to ensure its compliance with section 574.200, RSMo, regarding the offense of interference with medical assistance.

(7) Complaints.

(A) The facility shall develop, implement, and enforce a policy that provides patients with an efficient means of communicating complaints regarding care provided via the (B) The facility shall document details of each complaint and the facility’s response to each complaint. This documentation shall be available to the department for review upon request.

(C) Anyone with a complaint pertaining to patient care via an abortion facility may send the complaint in writing to the Missouri Department of Health and Senior Services, Bureau of Ambulatory Care, PO Box 570, Jefferson City, MO 65102. The complainant shall provide his or her contact information with the complaint. The department shall contact the complainant within five (5) working days of receipt of the complaint and shall investigate the complaint within twenty (20) working days of receipt of the complaint.

(8) Quality Assessment and Performance Improvement Program.

(A) Each abortion facility shall develop a quality assessment and performance improvement (QAPI) program that includes all health and safety aspects of patient care and shall include a review of appropriateness of care. Results of the QAPI program shall be reviewed at least quarterly by the administrator, director of patient care, a representative of the medical staff, and the governing body.

(B) The facility QAPI program shall include a documented review of at least the following criteria:

Completeness of clinical records;
Incidence of morbidity and mortality;
Complications, including number and percentage of patients affected by the most common types of complications for both surgical and drug- or chemically-induced abortions, as applicable;
Specific review of any significant or unusual complications;
All cases transferred to a hospital, including a review of assessment and patient risk factors that may have existed before the procedure;
All cases that resulted in a length of stay within the facility of more than eight (8) hours;
Errors in diagnosis;
Problems in compliance with laws and regulations, including violations cited by the department and reports required by Chapter 188, RSMo;
All cases in which the gestational age was determined to be beyond eighteen (18) weeks;
For drug- or chemically-induced abortions, the number and percentage of patients who failed to return to the facility for follow-up to confirm the completion of the abortion, and common reasons why the patients failed to return (unless termination of pregnancy was otherwise confirmed); and 11. Periodic evaluation and review of all contracted services, including, but not limited to, pathology services.

(C) The QAPI program shall show evidence of action the facility took regarding problems identified and shall identify opportunities for improvement.

History

AUTHORITY: section 197.225, RSMo Supp. 2021. Original rule filed July 15, 1987, effective Oct. 25, 1987. Amended: Filed June 14, 1988, effective Oct. 13, 1988. Amended: Filed Oct. 24, 2017, effective April 30, 2018. Emergency amendment filed June 21, 2019, effective July 1, 2019, expired Feb. 27, 2020. Amended: Filed June 21, 2019, effective Feb. 29, 2020. Emergency amendment filed Sept. 28, 2021, effective Oct. 13, 2021, expired April 10, 2022. Amended: Filed Sept. 28, 2021, effective April 30, 2022.

19 CSR 30-30.061 Complication Plans for Certain Drug- and Chemically-Induced Abortions Via Abortion Facilities {#sec-19-csr-30-30.061 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.061}

PURPOSE: This rule establishes the standards governing complication plans required by section 188.021, RSMo, for abortions induced by physicians via abortion facilities. This rule also explains the process for submitting such complication plans to the Department of Health and Senior Services for approval.

(1) For purposes of this rule, the following terms mean:

(B) Abortion facility—Any clinic, physician’s office, or any (C) Complication—Includes, but is not limited to, incomplete abortion, excessive hemorrhage, endometritis, parametritis, pyrexia, pelvic abscess, uterine perforation, failed abortion, retained products, cervical lacerations, or psychiatric issues;

(D) Department—The Missouri Department of Health and Senior Services;

(F) OB/GYN—

A physician who is board-certified or board-eligible by the American Osteopathic Board of Obstetrics and Gynecology, or who is in a residency approved by that board; or 2. A physician who is board-certified by the American Board of Obstetrics and Gynecology (ABOG); or who is an ABOG Registered Residency Graduate or an ABOG Active Candidate; or who is in an ABOG-approved residency;

(G) Physician—A person licensed to practice medicine pursuant to Chapter 334, RSMo.

(2) Complication plans for certain drug- and chemicallyinduced abortions.

(B) Each abortion facility shall ensure that no drug is prescribed or administered via its facility until the facility has received written approval from the department of the complication plan of the physician who will prescribe or administer the drug.

(C) To ensure the safety of all patients, a primary objective of complication plans shall be to recognize the importance of the physician-patient relationship by providing for continuity of care and ensuring communication among the physician who induced the abortion and all subsequent health care providers involved in treating the patient’s complication.

(D) Every complication plan shall provide that an OB/GYN is on-call and available twenty-four hours a day, seven days a week (24/7) to treat complications related to drugs prescribed or administered via the facility. To ensure this required twentyfour hours a day, seven days a week (24/7) coverage, the complication plan for each physician who will prescribe or administer drugs shall include a written agreement between the physician and an OB/GYN or group of OB/GYNs to treat complications, or in the alternative, a written agreement between the abortion facility and an OB/GYN or group of OB/ GYNs to treat complications.

(E) If the physician who will prescribe or administer drugs is an OB/GYN, that physician’s complication plan may provide that the physician treats complications, but the physician and/ or the abortion facility must have a written agreement with an OB/GYN or group of OB/GYNs to ensure the required twentyfour hours a day, seven days a week (24/7) coverage when the physician is unavailable to treat complications.

(F) An OB/GYN who is a staff member or consultant to the abortion facility as required in 19 CSR 30-30.060 may have a written agreement to treat complications under a complication plan.

Personally treat all complications, including those requiring surgical intervention, except in any case where doing so would not be in accordance with the standard of care, or in any case where it would be in the patient’s best interest for a different physician to treat her; and 2. Assess each patient suffering a complication individually, and shall not, as a matter of course, refer all patients to the emergency room or other facilities or physicians unless the patient is experiencing an immediately life-threatening complication.
This regulation does not prohibit screening or triage of patients by a nurse or physician to determine whether or when it is necessary to contact the OB/GYN.

(J) The abortion facility shall ensure that before discharge, every patient who receives a drug via the facility also receives the phone number, in writing, for the OB/GYN or OB/GYN group providing complication coverage. The phone number given may be for the on-call service rather than the OB/GYN’s direct number.

(K) The physician or abortion facility shall submit complication plans to the department for approval in writing using the complication plan submission form provided by the department. The form shall require at least the following information:

The full name of each physician whose prescription or administration of drugs via the facility will be covered by the plan;
The full name of the OB/GYN who will provide complication coverage, or if an OB/GYN group will provide coverage, the full legal name of the group and the full name of each OB/GYN who is part of the group; and 3. A description of how the complication plan meets each requirement in this regulation, including treating complications requiring surgical intervention.

(L) With the completed complication plan forms, the facility shall also submit:

Documents establishing that each OB/GYN who will provide complication coverage under the plan is board-eligible or board-certified by the American Board of Obstetrics and Gynecology or the American Osteopathic Board of Obstetrics and Gynecology; and 2. A copy of the executed written agreement between the physician(s) whose prescription or administration of drugs via the facility will be covered by the plan (and/or the abortion facility) and the OB/GYN or group of OB/GYNs that will provide the complication coverage. The written agreement shall cite this regulation and specify that complication coverage under the written agreement shall be provided in compliance with this regulation.

(M) If any change occurs that prevents full compliance with a complication plan as approved by the department, the facility shall immediately notify the department in writing, providing details regarding the change. If the change results in the facility being unable to provide twenty-four hours a day, seven days a week (24/7) OB/GYN coverage for complications as required by this regulation, the facility shall ensure that no drugs are prescribed or administered via the facility until 1) full compliance with the plan is achieved and the facility has so notified the department in writing, or 2) a new or revised complication plan has been submitted to and approved by the department in writing.

(N) The facility shall ensure that each complication plan approved by the department and currently in use is on file at the facility. The facility shall maintain copies of complication plans no longer in use for seven (7) years following the last use. The facility shall make current and past complication plans available to patients or the department for review upon request.

History

AUTHORITY: sections 188.021 and 197.225, RSMo Supp. 2017. Emergency rule filed Oct. 24, 2017, effective Nov. 3, 2017, expired May 1, 2018. Original rule filed Oct. 24, 2017, effective April 30, 2018. Original authority: 188.021, RSMo 2013, amended 2017 and 197.225, RSMo 1975, amended 1986, 2017.

19 CSR 30-30.062 Complication Plans for Certain Drug- and Chemically Induced Abortions {#sec-19-csr-30-30.062 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.062}

PURPOSE: This rule establishes the standards governing complication plans required by section 188.021, RSMo. This rule also explains the process for submitting such complication plans to the Department of Health and Senior Services for approval.

(1) For purposes of this rule, the following terms mean— (A) Abortion—The act of using or prescribing any instrument, device, drug, or any other means or substance resulting in the intentional destruction of an embryo or fetus in a woman’s uterus or the intentional termination of a pregnancy of a woman with intent other than to increase the probability of a live birth or to remove a dead or dying embryo or fetus;

(B) Abortion facility—Any clinic, physician’s office, or any (C) Complication—Includes but is not limited to incomplete abortion, excessive hemorrhage, endometritis, parametritis, pyrexia, pelvic abscess, uterine perforation, failed abortion, retained products, cervical lacerations, or psychiatric issues;

(D) Department—The Missouri Department of Health and Senior Services (DHSS);

(F) Local area—The area within a twenty-five- (25-) mile radius of the location where the physician dispenses the abortion producing drug;

(G) OB/GYN—

A physician who is board-certified or board-eligible by the American Osteopathic Board of Obstetrics and Gynecology, or who is in a residency approved by that board; or 2. A physician who is board-certified by the American Board of Obstetrics and Gynecology (ABOG), or who is an ABOG Registered Residency Graduate or an ABOG Active Candidate, or who is in an ABOG approved residency; and (H) Physician—A person licensed to practice medicine pursuant to Chapter 334, RSMo.

(2) Complication plans for certain drug- and chemically induced abortions.

(D) Each abortion facility shall confirm with the patient the location where the patient will complete the drug-induced abortion. Complication plans shall provide for situations when the patient will complete the abortion in the local area as specified in section (3) and situations where the patient will complete the abortion outside the local area as specified in

section (4).

(3) Complication plans for facilities that provide drug-induced abortions to ten (10) or more women a month in the local area.

(A) Every complication plan shall provide that an OB/GYN is on call and available twenty-four hours a day, seven days a week (24/7) to treat complications related to drugs prescribed or administered via the facility for patients in the local area.

To ensure this required twenty-four hours a day, seven days a week (24/7) coverage, the complication plan for each physician who will prescribe or administer drugs shall include a written agreement between the physician and an OB/GYN or group of OB/GYNs to treat complications or, in the alternative, a written agreement between the abortion facility and an OB/GYN or group of OB/GYNs to treat complications. A facility need not have an on-call OB/GYN available more than seven (7) days after the most recent chemically induced abortion.

(B) If the physician who will prescribe or administer drugs is an OB/GYN, that physician’s complication plan may provide that the physician treats complications, but the physician and/ or the abortion facility must have a written agreement with an OB/GYN or group of OB/GYNs to ensure the required twenty four hours a day, seven days a week (24/7) coverage when the physician is unavailable to treat complications.

(C) An OB/GYN who is a staff member or consultant to the abortion facility may have a written agreement to treat complications under a complication plan.

(D) Every complication plan shall provide that the OB/GYN with whom there is a written agreement or member of the group of OB/GYNs with which there is a written agreement, or the physician who prescribes or administers drugs if he or she is an OB/GYN, shall— 1. Personally treat all complications, including those requiring surgical intervention, except in any case where doing so would not be in accordance with the standard of care, or in any case where it would be in the patient’s best interest for a different physician to treat the patient;

Assess each patient suffering a complication individually, and shall not, as a matter of course, refer all patients to the emergency room or other facilities or physicians unless the patient is experiencing an immediately life-threatening complication; and 3. This regulation does not prohibit screening or triage of patients by a nurse or physician to determine whether or when it is necessary to contact the OB/GYN.

(E) Every complication plan shall provide that, in any case where it would not be in accordance with the standard of care or would not be in the patient’s best interest for the OB/GYN to personally treat the complication (e.g., surgery in a hospital is required, and it is not in the patient’s best interest to travel to a hospital where the OB/GYN has privileges), the OB/GYN shall arrange for hand-off of the patient to an appropriately qualified physician and shall fully brief such physician regarding the patient at the time of hand-off.

(F) Every complication plan shall require that the OB/GYN treating a patient’s complication shall prepare a complication report as required by section 188.052, RSMo, and ensure that it is submitted to the department.

(G) The abortion facility shall ensure that before discharge every patient from the local area who receives a drug via the facility also receives the phone number, in writing, for the OB/ GYN or OB/GYN group providing complication coverage. The phone number given may be for the on-call service rather than the OB/GYN’s direct number.

(H) An abortion facility may request a waiver to the requirement that an OB/GYN or OB/GYN group be on call to treat complications. If an abortion facility cannot contract with an OB/GYN or OB/GYN group to provide treatment for abortion-pill complications, the abortion facility must request to contract with another qualified physician or physician group to fulfill the requirements in section (3) of this rule. The waiver request shall include— 1. An explanation of the abortion facility’s recent, unsuccessful efforts to contract with an OB/GYN or OB/GYN group. The explanation shall include the OB/GYN or OB/GYN groups that were contacted and the date they were contacted;

The name of the physician or physician group that will provide treatment for complications instead of the OB/GYN or OB/GYN group;
An explanation of how the physician or physician group is qualified to address complications to a similar degree as an OB/GYN; and 4. A statement that the physician will comply with all of the requirements in section (3) of this rule that would normally by fulfilled by an OB/GYN or OB/GYN group.

(4) Complication plans for all facilities for drug-induced abortions for patients outside the local area.

(A) Every complication plan shall include provisions for patients who will complete the abortion outside of the abortion facility’s local area. When a physician determines that a patient will complete the abortion outside the local area, the complication plan shall require that the physician do the following:

Identify the patient’s primary care physician or OB/ GYN. If the patient does not have a primary care physician or OB/GYN, the physician shall identify an OB/GYN within a reasonable distance of the location where the patient will complete the abortion;
Identify the closest emergency room to the location where the patient will complete the abortion and to the patient’s home, if that is a different location;
Inform the patient about the steps to take in the event the patient has complications from the abortion. The physician shall explain the possible complications from abortion inducing drugs as set out on the United States Food and Drug Administration’s approved label for the abortion-inducing drug and explain that the FDA has recognized that up to four and six-tenths percent (4.6%) of women receiving chemically induced abortions have sought treatment at an emergency room;
Provide the patient with a letter describing the patient’s relevant medical history and prescribed medications, including all medications prescribed to induce the abortion, to present to the patients local OB/GYN practice or emergency room in the event the patient suffers complications. The letter must include the prescribing physician’s name and contact information, information about the abortion drugs prescribed, and an overview of the patient’s relevant medical history;
If complications occur, the prescribing physician must attempt to contact the treating physician or patient as soon as reasonably possible after learning about the complication in order to fully brief the treating physician on the patient’s relevant medical history. If the prescribing physician is unable to contact the treating physician within eight (8) hours, the prescribing physician may leave a message and contact information at the facility where the patient is being treated; and 6. The physician who prescribed the abortion-inducing drugs must take all reasonable measures to follow up with any patient who has suffered complications from an abortioninducing drug within twenty-four (24) hours of learning of the complication. If the physician is unable to contact the patient within twenty-four (24) hours, he or she must continue to attempt to contact the patient once a day for an additional seventy-two (72) hours. If the physician is unable to contact the patient after ninety-six (96) hours, the physician must document the attempts to contact the patient and the reason for the inability to schedule the follow-up appointment. The follow-up appointment may be in person or via a telehealth visit.

(B) If the prescribing physician does not treat a patient’s complications, the prescribing physician shall explain to the physician treating a patient’s complication the need to prepare a complication report as required by section 188.052, RSMo, and ensure that it is submitted to the department.

(5) Submission of complication plans to the department.

(A) The physician or abortion facility shall submit complication plans to the department for approval in writing.

In addition to the plan, the physician or abortion facility shall provide at least the following information in writing:

The full name of each physician whose prescription or administration of drugs via the facility will be covered by the plan;
The full name of the OB/GYN or other physician who will provide complication coverage for patients in the local area or, if an OB/GYN or other physician group will provide coverage, the full legal name of the group and the full name of each OB/ GYN or other physician who is part of the group;
A description of how the complication plan meets each requirement in this regulation, including treating complications requiring surgical intervention;
Documents establishing that each OB/GYN who will provide complication coverage for patients in the local area under the plan is board-eligible or board-certified by the American Board of Obstetrics and Gynecology or the American Osteopathic Board of Obstetrics and Gynecology, subject to the exception in the waiver described in subsection (3)(H) of this

rule; and 5. A copy of the executed written agreement between the physician(s) whose prescription or administration of drugs via the facility will be covered by the plan (and/or the abortion facility) and the OB/GYN or group of OB/GYNs that will provide the complication coverage for patients in the local area, subject to the waiver in subsection (3)(H) of this rule. The written agreement shall cite this regulation and specify that complication coverage under the written agreement shall be provided in compliance with this regulation.

(B) If any change occurs that prevents full compliance with a complication plan as approved by the department, the facility shall immediately notify the department in writing, providing details regarding the change. If the change results in the facility being unable to provide twenty-four hours a day, seven days a week (24/7) OB/GYN or physician coverage for complications as required by this regulation, the facility shall ensure that no drugs are prescribed or administered via the facility until 1) full compliance with the plan is achieved and the facility has so notified the department in writing, or 2) a new or revised complication plan has been submitted to and approved by the department in writing.

(C) The facility shall ensure that each complication plan approved by the department and currently in use is on file at the facility. The facility shall maintain copies of complication plans no longer in use for seven (7) years following the last use. The facility shall make current and past complication plans available to patients or the department for review upon request.

(6) The department will assess whether to rescind this rule if the preliminary injunction prohibiting enforcement of 19 CSR 30-30.061 is lifted.

History

AUTHORITY: section 188.021, RSMo Supp. 2024. Emergency rule filed March 13, 2025, effective March 27, 2025, expired Sept. 22, 2025. Original rule filed March 13, 2025, effective Sept. 30, 2025. Original authority: 188.021, RSMo 2013, amended 2017.

19 CSR 30-30.070 Physical Standards for Abortion Facilities Health and Senior Services to establish physical standards for abortion facilities in order to provide acceptable care in a safe environment. Abortion facilities are defined in section 197.200(1), RSMo and are subject to licensure under section 197.205, RSMo. {#sec-19-csr-30-30.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.070}

(1) This regulation does not apply to abortion facilities that do not perform surgical abortions or surgical intervention for abortion complications.

(2) Requests for deviations from requirements on physical facilities shall be in writing to the Department of Health and Senior Services. Approvals for deviations shall be in writing and both requests and approvals shall be made a part of the permanent Department of Health and Senior Services records for the abortion facility.

(3) Any abortion facility constructed or renovated after October 25, 1987 shall have plans prepared by an architect or engineer registered in Missouri. These plans shall be submitted to the department for review and approval prior to construction. New abortion facilities shall have the following:

(A) At least two (2) remote exits shall be provided for each floor directly to the outside or through an enclosed stairway or passageway to the outside;

(B) Corridors serving patients shall be at least six feet (6') wide;

(D) One- (1-) story buildings shall be at least of Type II (111) protected noncombustible construction as described in Standard on Types of Building Construction 1979 published by the National Fire Protection Association;

(E) Multistory buildings shall be constructed of at least Type II (222) fire-resistive construction as described in Standard on Types of Building Construction published by the NFPA, or shall system;

(F) Multistory buildings shall have at least one (1) elevator.

The elevator cab shall be at least five feet by seven feet (5' × 7') clear inside. The car door shall have a clear opening of not less than forty-four inches (44");

(G) Trickle-charge battery pack units shall be located to provide emergency lighting in the procedure room, recovery room, exit corridors, and exit stairs to grade;

(H) A manual fire alarm break station shall be located near each exit and connected to a local audible alarm which can be heard throughout the facility;

(I) At least two (2) ABC-type fire extinguishers are to be located in the facility, one (1) in the clinical area;

(J) Illuminated exit signs shall be located above each exit and illuminated directional exit signs shall be located where needed to direct patients and personnel to exits in event of an emergency;

(K) Ceiling, wall, and floor finishes in the clinical area including the procedure rooms, recovery room, personnel change rooms, central sterile and supply, janitor’s closet, and laboratory shall be smooth and easily cleanable;

(L) Scrub-up facilities shall be knee- or foot-operated and provided at the rate of one (1) per procedure room. Scrub-up facilities shall be located outside but immediately available to the procedure room;

(M) Procedure rooms shall have the following:

A minimum length and width of twelve feet (12');
A minimum ceiling height of nine feet (9');
A door with a minimum width of forty-four inches (44"); and 4. There shall be no windows in the room except there may be a fixed-view window in the wall between the procedure room and the adjacent corridor;

(N) The recovery room shall be separated from the procedure room and be of sufficient size to accommodate at least four (4) recovery beds or recliners for each procedure room. There shall be three feet (3') of clear space on both sides and at the foot of each recovery bed or recliner;

(O) The procedure room and recovery room shall be provided with a minimum of six (6) air changes per hour. Air supplied to all areas shall be filtered through a filter with at least a twentyfive percent (25%) efficiency rating;

(P) Personnel change rooms shall be provided for each sex and located convenient to the procedure room. Each change room shall be equipped with a toilet and lavatory;

(Q) The laboratory shall be equipped with a counter, sink, and refrigerator;

(R) The procedure room shall be equipped with a ceilingmounted surgical light, operating table or a conventional gynecological examining table with accessories, closed cabinets for equipment, and sufficient tables to hold an emergency tray and other necessary equipment;

(S) There shall be one (1) electrical outlet in the procedure room for the emergency light and at least one (1) duplex outlet on each wall;

(T) There shall be one (1) electrical outlet in the recovery room for the emergency light and at least one (1) duplex outlet for each two (2) recovery beds or recliners;

(U) Piped-in or portable oxygen and suction equipment shall be located in the recovery room;

(V) The sterilizing room shall be equipped with a steam sterilizer, counter and sink, and storage space for clean supplies. Air pressure in this room shall be positive in relation to adjacent areas;

(W) The soiled/decontamination room shall be equipped with a counter and sink. This room shall be equipped with a constant running exhaust;

(X) A patient toilet with lavatory shall be located convenient to the recovery room. This room shall be equipped with a constant running exhaust;

(Y) At least two (2) patient change rooms with secure storage for personal effects shall be provided; and (Z) Office space, waiting room, record storage space, and counseling rooms shall be provided. Counseling rooms shall be separate and not smaller than ten feet by ten feet (10' × 10').

(4) Any abortion facility in operation at the time these rules are adopted shall comply with the following:

(A) Smoke detectors shall be located in all rooms and in corridors at thirty-feet (30') intervals unless the building is rated Type II (222) fire-resistive or if it is a one- (1-) story building rated Type II (111) protected-noncombustible as described in Standard on Types of Building Construction 1979 published by the NFPA. If the building is multistoried and rated combustible, it shall be protected throughout by an approved automatic sprinkler system;

(B) There shall be a system of corridors, passageways, and elevators adequate in size and arrangement to allow a patient on a stretcher to be moved from any point in the abortion facility to a street-level exit;

This space shall be equipped with suitable furnishings and accommodations;

(D) Dressing rooms shall be provided for the privacy, physical comfort, and convenience of patients and personnel;

(E) At least one (1) procedure room shall be adequately equipped, supplied, and staffed to safely perform abortions.

The procedure room shall be equipped with an operating table or a conventional gynecologic examining table with accessories, a closed cabinet for equipment, and tables to hold an emergency tray and other necessary equipment. The procedure room shall be well-lighted and maintained at a comfortable temperature;

(F) Personnel change rooms and scrub-up facilities shall be located convenient to the procedure room;

(G) A utility room with facilities for steam sterilization and space for storage of clean and sterilized supplies shall be provided. There shall be sufficient surgical instruments sterilized and available for each patient who presents herself for an abortion. The room shall be arranged to prevent cross traffic of clean and dirty material;

(H) The recovery room shall be separate from the procedure room and be of sufficient size to accommodate at least four (4) recovery beds or recliners for each procedure room. The recovery room shall be well-lighted and maintained at a comfortable temperature. Recovery beds or recliners shall be spaced to permit easy staff access to each patient;

(I) Piped-in or portable oxygen and suction equipment shall be located in the recovery room;

(J) Trickle charge battery pack units shall be located to provide emergency lighting in the procedure room, recovery room, exit corridors, and exit stairs to grade;

(K) A manual fire alarm break station shall be located near each exit and connected to a local audible alarm which can be heard throughout the facility;

(L) At least two (2) ABC-type fire extinguishers shall be located in the facility, one (1) in the clinical area;

(M) Illuminated exit signs shall be located above each exit door and illuminated directional exit signs shall be located where needed to direct patients and personnel to exits in event of an emergency;

(N) Wall and floor finishes in the procedure room, recovery room, and the sterilization area shall be smooth and easily cleanable;

(O) The laboratory shall be equipped with a counter, sink, and refrigerator; and (P) At least two (2) remote exits shall be provided for each floor. Each exit shall discharge directly to the outside or through an enclosed stairway or passageway to the outside.

History

AUTHORITY: section 197.225, RSMo Supp. 2017. Original rule filed July 15, 1987, effective Oct. 25, 1987. Amended: Filed Oct. 24, 2017, effective April 30, 2018.

19 CSR 30-30.080 Definitions Relating to Birthing Centers and Procedures for Licensing Birthing Centers {#sec-19-csr-30-30.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.080}

PURPOSE: This rule defines terminology used in this chapter and establishes procedures for licensing birthing centers.

(1) The following definitions shall be used in the interpretation and enforcement of 19 CSR 30-30.090 through 19 CSR 30-30.110:

(A) Administrator—A person who is designated to provide daily supervision and the administration of the birthing center;

(B) Birthing center—A facility, not licensed as part of a hospital, which provides maternity care away from the mother’s usual residence and where low risk births are planned to occur following a normal uncomplicated pregnancy;

(C) Certified nurse-midwife (CNM)—A person licensed to practice professional nursing under section 335.046, RSMo and currently certified by examination by the American College of Nurse-Midwives;

(D) Complication—A condition according to written risk criteria of the birthing center that contraindicates continued care in the birthing center;

(E) Department—The Missouri Department of Health;

(F) Discharge plan—A plan for continuing maternal and infant health care following birth;

(G) Health assessment—A determination of a patient’s physical and mental status;

(H) Low risk—Normal, uncomplicated prenatal course as determined by adequate prenatal care and prospects for a normal, uncomplicated birth as defined by reasonable and currently accepted criteria of maternal and fetal health;

(I) Person—Any individual, firm, partnership, corporation or association;

(J) Physician—A person licensed to practice medicine under

Chapter 334, RSMo who has admitting privileges at a hospital;

(K) Primary care giver—A physician or a certified nursemidwife who has attended the mother during the prenatal period, will be present at delivery and will be responsible for care during the puerperium period; and (L) Qualified personnel—A person trained and competent in the services which s/he provides and is licensed or certified as required by statute or professional standard.

(2) The following procedures are required for licensing a birthing center:

(A) A license to establish and operate a birthing center shall be required of any facility other than a hospital or the mother’s residence where births are planned to occur and where childbirth deliveries may be performed;

(B) Application for licensure of a birthing center shall be made in writing to the department on forms provided by the department. Each application for a license shall be accompanied by an annual license fee of two hundred dollars ($200);

(D) The licensee shall notify the department in writing of any change in the name of the facility or change in the ownership;

(E) Separate licenses are required for facilities maintained on separate sites even though operated by the same owner;

(F) The license shall be conspicuously posted in a public area in the facility; and (G) A license shall not be issued by the department until a facility is in compliance with all requirements of 19 CSR 30- 30.090. In addition, a facility shall be in compliance with 19 CSR 30-30.100 or 19 CSR 30-30.110, depending on the number of birthing rooms in the facility.

May 1, 1995, effective May 10, 1995, expired Sept. 7, 1995.*

19 CSR 30-30.090 Organization and Management Standards for Birthing Centers {#sec-19-csr-30-30.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.090}

PURPOSE: This rule establishes standards for the operation of birthing centers in order to provide care in a safe environment.

(1) The center shall have a governing body which may be individual owner(s), partnership, corporate body, association or public agency.

(A) The governing body shall have full legal responsibility for determining, implementing and monitoring policies governing the center’s total operation and for ensuring that the policies are administered in a manner to provide acceptable care in a safe environment.

(B) The governing body shall select and employ one (1) of the following as an administrator: a physician licensed in Missouri, a certified nurse-midwife (CNM), a registered nurse licensed in Missouri or an individual with a bachelor’s degree in a related field and at least one (1) year of administrative experience in health care.

(C) The governing body shall require that an individual who complies with subsection (1)(B) of this rule shall be in charge when the administrator is unavailable in person or by telecommunications.

(D) Governing body bylaws shall acknowledge that duly appointed representatives of the department shall be allowed to inspect the center operation at any time, with consideration for client privacy and confidentiality.

(E) Bylaws of the governing body shall require that the clinical staff, center personnel and all auxiliary organizations directly or indirectly be responsible to the governing body through the administrator.

(F) The governing body, through the administrator, shall establish criteria for the content of patients’ records, provision for their timely completion and disciplinary action on occasion of noncompliance.

(G) The governing body shall ensure that the birthing center abides by all applicable state and local laws.

(2) The administrator shall organize the administrative functions of the center and establish a system of authorization, record procedures and internal controls.

(A) The administrator shall be responsible for establishing effective security measures to protect patients, employees and visitors.

(B) The administrator is responsible for assuring that all patients admitted to the center are under the care of a physician or CNM practicing pursuant to a collaborate agreement with a physician who is a member of the clinical staff.

section 193.085, RSMo.

(D) The administrator shall develop procedures and have a written agreement with a licensed ambulance service for emergency transportation. If a written agreement with the ambulance service cannot be achieved due to reasons that are neither regulatory or statutory, the administrator can request a waiver or mediation from the department.

(E) The administrator shall have procedures and a written transfer agreement with a hospital providing emergency, obstetrical and newborn services. If a written agreement with a licensed hospital cannot be achieved due to reasons that are neither regulatory or statutory, the administrator can request a waiver or mediation from the department. Peer review report may be submitted as evidence for mediation.

(F) The administrator shall be responsible for a written plan for evacuation of patients and personnel in the event of fire, explosion or natural disaster. The plan shall be kept current and all personnel shall be knowledgeable of the plan.

(G) The administrator shall be responsible for developing, enforcing and posting written policies which prohibit smoking throughout the birthing center.

(H) Smoking or open flames shall be prohibited in any room or compartment where flammable liquids, combustible gases or oxygen are used or stored and in any other hazardous location. These areas shall be posted with NO SMOKING OR OPEN FLAME signs.

(I) The administrator shall establish a program for identifying and preventing infections and for maintaining a safe environment. The center shall be responsible for identifying infections up to thirty (30) days postpartum in the mother and the infant unless and until they are transferred to another health-care provider prior to thirty (30) days. Infectious and pathological wastes shall be segregated from other wastes at the point of generation and shall be placed in distinctive, clearly marked, leak-proof containers or plastic bags appropriate for the characteristics of the infectious wastes. Containers for infectious waste shall be identified with the universal biological hazard symbol. All packaging shall maintain its integrity during storage and transport. Infectious waste shall be disposed of in accordance with provisions of 10 CSR 80-7.010.

(J) The administrator shall establish policies and procedures for the handling, processing, storing and transporting of clean and dirty laundry. The facility may provide laundry services on-site or utilize contract services.

(K) The administrator shall develop written personnel policies which contain at least the following:

Provision for orientation of all personnel to the policies and objectives of the center and participation by all personnel in appropriate employee training;
Provision for periodic evaluation of employees’ performance including clinical skills, resuscitation and use of equipment; and 3. Provision for written job descriptions, including job qualifications system for the completion and storage of medical records.

(L) A personnel record shall be maintained on each employee and shall include documentation of each employee’s orientation, education, training and health information, as well as verification of current licenses for physicians, registered nurses and licensed practical nurses and documentation of certification for nurse-midwives.

(3) Clinical practice guidelines for the management of routine and emergency care of the mother and her fetus/newborn in pregnancy, birth and postpartum until discharge from care by the center, whether through completion of the program or referral or transfer to other levels of care, shall be drafted by a physician or certified nurse midwife who has clinical staff membership at the birthing center. The guidelines shall be available on-site at all times. Documentation of periodic review and revision are required.

(A) Clinical staff membership shall include physicians or CNMs, or both, but, as defined by the birth center bylaws, may also include other health professionals to provide service at the birth center. A physician or CNM practicing pursuant to a collaborative practice agreement with a physician shall be in attendance and responsible for intrapartum management.

(B) On a form approved by the governing body, each health professional requesting clinical staff membership shall submit a written application to the administrator of the center. Each application shall be accompanied by evidence of education, training, professional qualification, health status certification and licensure.

(C) A written procedure shall be established for recommending to the governing body delineation of privileges; curtailment, suspension or revocation of privileges; and appointments and reappointments to the clinical staff. The governing body, acting upon recommendations of the clinical staff, shall approve or disapprove appointments. Written criteria shall be developed for privileges extended to each member of the clinical staff.

(D) Each birth center shall have at least one (1) physician who is responsible for the following:

Sign collaborative practice agreement and meet any other requirements of Missouri law for collaborative practice;
Review and sign clinical practice guidelines and risk assessment criteria at least annually; and 3. Be available in person or by telecommunication for consultation.

(4) The center shall maintain a system for the completion and storage of medical records.

(A) The daily patient roster shall be retained for two (2) years.

(B) The medical record shall contain 1. A unique identifying medical record number;

Client identifying information;
Allergies;
Consent;
Maternal history;
Maternal and newborn physical examinations;
Laboratory test results;
Initial risk assessment and periodic updates;
Interval prenatal evaluations;
Problem identification, plan, and follow-up;
Labor and birth records, including apgars;
Newborn and postpartum recovery records;
Medication record, including any drug, and the dose, time, date and person administering;
Discharge plan; and 15. Postpartum and infant follow-up visits up to thirty (30) days after the birth or documentation of transfer to another health care provider.

(C) All medical records shall be safeguarded against loss and unofficial use. Medical records for adults and newborns shall be retained as required by the statute of limitations under

section 516.105, RSMo.

(D) Medical records are the property of the birthing center and shall not be removed from the center except by court order, subpoena, for microfilming or for off-site storage approved by the governing body. Information provided for statistical purposes shall contain the unique identifying number, not the patient’s name.

(5) Patient care services shall be under the direction of a physician or a CNM practicing pursuant to a collaborative practice arrangement with a physician.

(A) Women registering for care at the birthing center and their families shall be informed and shall provide written acknowledgment that they have been informed of the benefits and risks of the services available at the center. They shall be made aware of the risk criteria used for admission and referral.

(B) Birth center clients are limited to those women who are initially determined to be at low maternity risk and who are evaluated regularly throughout pregnancy to assure that they remain at low risk for a pregnancy outcome.

Each birth center shall establish a written risk assessment system which shall be a part of the clinical practice guidelines.

The individual risk assessment shall be included in the client’s medical record.

The general health status and risk assessment shall be determined by a physician, CNM or other advanced practice nurse after obtaining a detailed medical history, performing a physical examination and taking into account family circumstances and other social and psychological factors. The client shall be transferred to a hospital if complications occur requiring medical or surgical intervention under the center’s written risk criteria.

(C) The center shall provide at least one (1) CNM or physician for each three (3) women in active labor. In addition a qualified staff member shall be available for each client during the entire time the client is in the birth center. All clinical staff shall provide services during labor and delivery in accordance with the policies developed by clinical staff and approved by the governing body.

(D) Qualified personnel and clinical staff of the birth center shall be trained in infant and adult resuscitation and recertified according to standards set by the American Heart Association and the American Pediatric Association.

(E) A primary care giver shall remain on the premises and be immediately available for assistance to the patient during labor, delivery and immediate postpartum stages.

(F) A primary care giver shall be responsible for ensuring and documenting prenatal care, health history, physical examination, and appropriate laboratory studies which shall be placed in the medical record at time of admission in preparation for delivery.

(G) A patient shall meet discharge criteria as defined in the clinical practice guidelines prior to discharge from the facility.

(H) Labor shall not be inhibited, stimulated or augmented with chemical agents during the first or second stage of labor.

(I) General and induction anesthesia shall not be administered.

Local and pudendal anesthesia may be administered by a physician or CNM practicing pursuant to a collaborative practice arrangement with a physician if use of the drugs conforms with Missouri law and written clinical practice guidelines of the birth center.

(J) A program for prompt follow-up care and postpartum evaluation after discharge shall be developed and implemented.

The follow-up shall include assessment of infant health including physical examination, laboratory screening tests at appropriate times, maternal postpartum status, instruction in child care including immunizations, referral to sources of pediatric care, provision of family planning services, and assessment of mother-child relationship including breast feeding.

(K) The center shall be responsible for detection of Rh incompatibility and administration of RhoGAM as appropriate.

(L) At a minimum, there shall be provision for nutritious liquids and snacks in accordance with 19 CSR 20-1.010.

(M) Prophylactic eye treatment as required in section 210.070, RSMo shall be provided.

(N) Drugs shall be stored and handled under proper security and environmental conditions and shall be accessible only to authorized persons. Drugs shall be administered and disposed only by licensed practitioners in accordance with applicable state laws and rules. The use of IV’s shall be restricted to hydration only or to the establishment of a central line prior to transport to emergency facilities. No IV drugs such as pitocin shall be used for inducement or augmentation of labor.

(O) An emergency drug kit shall be available which includes oxygen, a Deelee suctioning trap or other appropriate equipment for emergency suctioning.

(P) An adequate supply of sterile items shall be available.

(6) The birthing center shall provide a quality assurance program that includes all health and safety aspects of patient care for both mother and newborn and shall include a review of appropriateness of care. Results of the quality assurance program shall be reviewed at least quarterly by the governing body.

(A) The quality assurance program shall include, but not be limited to, the following:

A review of the medical record;
A determination that every mother-infant pair have an identified source of primary care and have available methods by which to contact that individual after discharge;
Incidences of morbidity and mortality of mother and infant;
Postpartum infections;
A review of all cases transferred to a hospital for delivery, care of the infant or postpartum care of the mother;
A review of all cases that resulted in a length of stay of more than twelve (12) hours beyond the birth of the baby;
Incidents, problems, and potential problems identified by the staff of the birthing center; and 8. Problems with compliance with state laws and rules.

(B) The quality assurance program shall show evidence of action taken as a result of the identification of a problem, including documented outcome and evaluation.

(7) A birthing center shall provide for essential laboratory services, including, but not limited to, hemoglobin or hematocrit, urinalysis, microscopic analysis and culture, blood type and Rh, syphilis, hepatitis B, rubella, pap smears and pregnancy tests.

(A) Laboratory services may be provided on-site or through a certified laboratory in accordance with federal regulations.

(B) When services are provided by arrangement with an outside provider, the original copy of the signed and dated report shall become part of the mother’s permanent record at the birthing center.

(C) Results of tests completed at the birthing center shall be entered, dated and signed in the mother’s or child’s record by the individual who performed the test. Abnormal test results shall be followed up by the primary provider in accordance with birth center risk criteria and clinical practice guidelines.

19 CSR 30-30.100 General Design and New Construction Standards for Birthing Centers Health to establish physical standards for birthing centers in order to provide care in a safe environment. Birthing centers are considered ambulatory surgical centers as defined by section 197.200(1), RSMo and are subject to licensure as required by section 197.205, RSMo. {#sec-19-csr-30-30.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.100}

This rule establishes up-to-date construction requirements for new birthing center construction to help ensure accessible, functional, fire-safe and sanitary facilities. A new birthing center is one for which plans are submitted to the Department of Health after the adoption of this rule for the construction of a new facility, expansion or renovation of an existing birthing center or the conversion of an existing facility not previously and continuously licensed as a birthing center under

Chapter 197, RSMo.

(1) Planning and Construction Procedures.

(A) Any birthing center constructed or renovated after the date of the adoption of this rule shall have plans and specifications prepared by an architect registered in Missouri.

These plans and specifications shall be submitted to the department for review and approval prior to beginning of construction. The design and construction of birthing centers shall conform to the most stringent requirements of this rule and the local governing building code.

(B) The Department of Health shall be notified in writing within five (5) days after construction begins. If construction of the project is not started within one (1) year after the date of the approval of the plans and specifications, the plans and specifications shall be resubmitted to the Department of Health for its approval and shall be amended, if necessary, to comply with the then current rules before construction work begins.

(C) Requests for variations from requirements on physical facilities shall be requested in writing to the Department of Health and must contain information which demonstrates the providers ability to meet the intent or objectives of the rule through alternative methods. Approvals for deviations shall be requested in writing and both requests and approvals shall be made a part of the permanent Department of Health records for the birthing center.

(D) Where renovation or replacement work is done within an existing facility, all new work or additions, or both, shall comply with the applicable sections of this rule.

(E) Birthing centers which expand their capacity to four (4) or more birthing rooms must comply throughout the facility with the applicable requirements for birthing centers of this size or larger.

(F) References in this rule to, National Fire Protection Association (NFPA), publications are those contained in the twelve (12)- volume 1994 Compilation of NFPA Codes, Standards, Recommended Practices and Guides. Where there are discrepancies between referenced NFPA publication requirements and this rule, the requirements of this rule shall apply.

(2) Design Considerations for the Physically Handicapped.

Roads, parking facilities, walks, ramps and entrances shall be accessible and usable by persons who are physically disabled.

At least one (1) toilet, telephone and drinking fountain which are accessible for use by handicapped public and clinic patients shall be provided on each floor of a birthing center.

Elevator controls and alarms shall be accessible to wheelchair occupants and shall be provided with tactile signage for the visually impaired. Design details for handicapped accessible facilities shall be consistent with the Guidebook to: The Minimum Federal Guidelines of Requirements for Accessible Design published January 6, 1981 by the United States Architectural and Transportation Barriers Compliance Board.

(3) Site.

(A) Adequate vehicle and pedestrian access, including loading and unloading space for delivery vehicles, shall be provided within the lot lines to the main entrance, emergency vehicular entrance, community activities and services.

(B) Adequate off-street parking shall be provided. Space shall be provided at the ratio of one (1) space for each of the maximum number of staff persons on duty at any given time plus one (1) parking space for the patient capacity of the birthing and examination rooms in the licensed facility.

(4) General Birthing Center Design Considerations. The arrangement of the physical plant for a birthing center shall provide for separation of administrative/public, prenatal clinic and birthing suite areas. The birthing suite shall be in a location in the facility that precludes unnecessary traffic through the suite.

(5) Administrative/Public Areas. These areas shall include a business office with a public information center and staff telephone, administrator’s enclosed office, medical records storage for at least two (2) years of patient records, public lobby and waiting room, public telephone, public toilet and a drinking fountain.

(6) Staff Areas. An area shall be provided to include secure storage for personal effects, handicapped accessible toilet, shower, change and lounge area sufficient to accommodate staff needs as defined by the program.

(7) Prenatal Clinic and Preadmission Screening Area. This area shall include:

(A) At least one (1) room with a minimum size of two hundred fifty (250) square feet for group education. In birthing centers with fewer than four (4) birthing rooms in response to the program of the facility but in no case shall it be smaller than one hundred twenty (120) square feet;

(B) At least one (1) examination room of not less than ninety (90) square feet and a minimum dimension of nine feet (9’).

Each examination room shall be equipped with hand washing facilities. In birthing facilities with only one (1) birthing room, the required examination room shall be equipped to serve as a stand-by birthing room. Examination facilities shall be separate from, but adjacent to, the waiting room and birthing suite; and (C) A laboratory equipped with a counter, sink and refrigerator which is required if the laboratory performs on-site laboratory work. This requirement may be met by a contractual provision for off-premises laboratory services.

(8) Birthing Suite. The birthing suite shall include at least one (1) birthing room with the following minimum dimensions: length and width of twelve feet (12'), ceiling height of eight feet (8'), and a door three feet (3') in width.

(A) Hand washing facilities shall be located in each birthing room. Lavatories shall be sized for scrubbing and equipped with faucets which are knee, foot or otherwise designed to operate without the use of hands.

(B) Each birthing room shall be equipped with a labor/ delivery bed large enough for mother and baby, examination light, capacity to keep the infant warm, storage facilities for supplies and sufficient tables to hold an emergency tray and other necessary equipment.

(C) A toilet with lavatory shall be directly accessible to the birthing room so patients will not be required to enter the corridor. One (1) toilet may serve up to two (2) birthing rooms.

No fewer than ten percent (10%) of the birthing rooms shall be served by handicapped accessible toilets. In birthing centers with fewer than four (4) birthing rooms, one (1) handicappedaccessible patient toilet may be provided which is conveniently located to and easily accessible from the birthing rooms without having patients traverse public areas.

(D) A shower shall be conveniently located to and easily accessible from the birthing rooms without requiring patients to traverse public areas. One (1) shower may serve not more than twelve (12) birthing rooms. At least one (1) patient shower shall be handicapped-accessible.

(E) Piped-in oxygen and clinical vacuum shall be provided in each birthing room. Birthing centers with fewer than four (4) birthing rooms may use portable medical gas and vacuum (F) Emergency equipment including intravenous fluids and resuscitation equipment shall be located in near the birthing rooms.

(9) Service and Staff Support Facilities. The birthing suite shall include:

(A) A clean work and sterile storage room equipped with a sterilizer, counter and sink, and storage space for clean supplies;

(B) A separate soiled/decontamination utility room equipped with a clinic sink, counter and sink;

(C) A separate staff-only toilet with a constant running exhaust and a lavatory conveniently located to the birthing suite;

(D) A staff station providing visual supervision of the birthing rooms and support facilities;

(E) A medication storage and preparation station equipped with a sink and refrigerator;

(F) Storage space for emergency equipment; and (G) Janitor’s closet equipped with a mop sink and having sufficient space for the cleaning equipment used to maintain the birthing procedure area. Birthing centers with fewer than four (4) birthing rooms are required to have only one (1) janitor’s closet to serve the entire facility. In multi-storied birthing centers at least one (1) janitor’s closet shall be provided on each floor.

(10) General Support Facilities. Each birthing center shall include:

(A) Adequate space for the housing and maintenance of mechanical, plumbing and electrical equipment;

(B) Oxygen storage facilities which, if located inside the birthing center, shall be exhausted to prevent the accumulation of quantities of spilled gases. Medical gas storage and distribution systems shall comply with “NFPA 99, Standard for Health Care Facilities, 1993 Edition” in 1994 National Fire Codes, Volume 5;

(D) A janitor’s closet, including a mop sink, to serve the public, business and preadmission clinic areas;

(E) In birthing centers proposing to process laundry on-site, laundry facility design and laundry equipment of a quality to be capable of producing sanitized linen; and (F) At a minimum, provisions for shelf storage and refrigerated storage of prepackaged nourishments. Provisions shall be made for serving prepackaged nourishments to birthing patients. In birthing centers proposing to prepare food on-site, the design of the dietary facilities must be acceptable to the department and comply with 19 CSR 20-1.010.

(11) Details and Finishes.

(A) A continuous system of unobstructed corridors and aisles shall be provided which connects all rooms and space with each other and all entrances, exits and elevators. Corridors shall be separated from other areas by walls which resist the passage of smoke.

(B) Each exit shall discharge to the outside or through an enclosed stairway or passageway to the outside.

(C) Required exit stairs shall discharge directly to the outside or into a rated fire corridor which extends from the stair discharge to the outside. The fire-resistance rating of fire corridor walls shall be not less than the rating of the stair enclosure requirement located in section (12) of this rule.

(D) Corridors shall be at least six feet (6') wide. All other corridors and aisles shall be at least four feet (4') wide.

(E) Exit doors shall swing in the direction of exit travel.

(F) All doors, procedure rooms and exits shall be at least three feet (3') wide.

(G) All corridor doors shall be of solid wood construction or its equivalent.

(H) Each birthing room shall have an operable window in the outside wall. The window sill shall be not more than three feet (3') above the floor. Easily washable window treatments, such as vertical hanging vinyl blinds, shall be installed to control light and glare. All window treatments shall be inherently flame retardant.

(I) At least one (1) ABC-type fire extinguisher, compliant with “NFPA 10, Standard for Portable Fire Extinguisher,” 1990 Edition, 1994 National Fire Code, Volume 1, shall be located near each exit on each floor of the birthing center and at the birthing suite’s staff station.

(J) A paper towel dispenser and soap dispenser shall be provided at all lavatories used for hand washing.

(K) Finish materials installed on the walls, floors and ceilings in the birthing rooms shall be smooth and washable.

(L) Ceiling, wall and floor finishes shall be smooth and easily cleanable in toilets and bath facilities. Utility and storage rooms used for washing, sterilization and supplies shall have smooth and easily cleanable ceiling, wall and floor finishes.

(M) Floor and wall penetrations by pipes, ducts, and conduits shall be tightly sealed to minimize entry of rodents and insects.

Joints of structural elements shall be similarly sealed.

(12) Construction, Including Fire-Resistive Requirements.

(A) Construction of freestanding birthing centers shall comply with “NFPA 101 Section 12-6, New/Ambulatory Health Care Centers, 1994 Edition”, 1994 National Fire Codes, Volume 5 and this rule.

(B) Multistoried buildings rated combustible Type V shall system. The number of stories in a building housing a birthing center shall be determined by counting all occupiable levels in the building.

(C) Birthing centers shall be separated from other tenants and occupancies by walls having at least a one (1)-hour fireresistance rating. These walls shall extend from the floor slab below to the floor or roof slab above.

(D) Every stairway, elevator shaft, light and ventilation shaft, chute and other openings between stories shall be enclosed or protected to prevent the spread of fire or smoke from one (1) floor to another. The fire-resistance rating of the enclosure or protection shall be not less than the structural floor separation requirements of “NFPA 220, Standard on Types of Building Construction, 1992 Edition,” 1994 National Fire Code, Volume 5 for the fire-resistive building type classification required by subsection (12)(A).

(13) Elevators.

(A) Multistoried buildings shall have at least one (1) elevator if birthing room services are located on any floor other than the grade level (main entrance) floor.

(B) The elevator cab shall be at least five feet by seven feet (5' x 7') clear inside. The car door shall have a clear opening of not less than three feet (3').

(C) Elevators shall be equipped with a two (2)-way special service switch to permit cars to bypass all landing button calls and be dispatched directly to any floor.

(D) Elevators shall be equipped with an automatic leveling device of the two (2)-way automatic maintaining type with an accuracy of plus or minus one-half inch (±1/2").

(E) Elevator call buttons, controls and door safety stops shall be of a type that will not be activated by heat or smoke.

(14) Mechanical Requirements.

(A) Heating, ventilating and air conditioning (HVAC) equipment shall be mandated to operate at an ambient temperature of sixty-eight to eighty-five degrees Fahrenheit (68–85°F).

(B) Air supplied to all areas shall be filtered through a filter with at least a twenty-five percent (25%) efficiency rate. Filter efficiencies shall be average atmospheric dust spot efficiencies.

(C) Required exhaust fans shall be nonswitched and constant running. All exhaust fans shall be installed at the discharge end of the duct.

(D) The HVAC systems shall be designed and balanced to provide pressure relationships and air change rates shown in the following table:

(15) Plumbing and Other Piping Systems.

(A) Systems shall be designed to supply water to the fixtures and equipment on every floor at a minimum pressure of fifteen pounds per square inch (15 psi) during maximum demand periods.

(B) Each water service main, branch main, riser and branch to a group of fixtures shall be valved. Stop valves shall be provided at each fixture.

(C) Cold and chilled water piping and waste piping shall be insulated. Insulation of cold and chilled water lines shall include an exterior vapor barrier.

(D) Reduced pressure backflow preventers shall be installed where the water service enters the building and on hose bibbs and on all fixtures to which hoses or tubing can be attached such as janitors’ sinks and laboratory fixtures.

(E) Hot water distribution systems shall provide one hundred ten degree Fahrenheit (110°F) water at each fixture at all times.

(F) Sinks in patient service areas shall have the water supply spout mounted so that its discharge point is a minimum distance of five inches (5") above the rim of the fixture. All lavatories used by medical and nursing staff shall have valves which can be operated without the use of hands.

(16) Electrical Requirements.

(A) Every room, including storage rooms, corridor and all other areas shall be sufficiently illuminated.

(B) Trickle charge battery pack units, complying with the standards of “Article 700, Emergency Systems, NFPA 70, National Electrical Code, 1994 Edition,” in National Fire Code, Volume 3, shall be located to provide emergency lighting in the birthing rooms, exit corridors, exit signs, electrical branch panel rooms and exit stairs to point of discharge at grade. These fixtures shall be tested at least quarterly with the tests documented in writing. An emergency stand-by power system is not required in birthing centers.

(C) There shall be one (1) electrical outlet in each birthing room for the trickle charge emergency light and at least one (1) duplex outlet on each wall.

(D) Electrical outlets installed in wet locations, such as the patient toilet areas, shall be ground fault interrupter types.

(E) In birthing center of four (4) or more birthing rooms, an electrically powered fire alarm system shall be installed which will alert all areas of the facility when activated. A fire alarm manual pull station shall be located near each exit and at the staff station. The initiation of this fire alarm system shall be by manual means and by automatic means of any required detection devices.

(F) Birthing centers shall have smoke detectors interconnected with the fire alarm system in all rooms and at thirty-foot (30') intervals in corridors. Birthing centers located in completely sprinklered buildings require only the corridor detectors. In birthing centers of fewer than four (4) birthing rooms, the fire alarm system may consist of the individual required smoke detectors, provided the local alarm may be heard throughout the occupied areas of the birthing center.

19 CSR 30-30.110 General Design and Construction Standards for Existing Birthing Centers Health to establish physical standards for birthing centers in order to provide care in a safe environment. Birthing centers are considered ambulatory surgical centers as defined by section 197.200(1), RSMo and are subject to licensure as required by 197.205, RSMo. {#sec-19-csr-30-30.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-30.110}

This rule establishes physical plant requirements for licensing existing birthing centers. Existing birthing centers are those birthing facilities already in operation at the time these rules are adopted.

Pressure Relationships and Ventilation of Areas in Birthing Centers Pressure Minimum Minimum Relationship Air Changes Total Air All Air to of Outside Air Changes Per Exhausted Area Adjacent Per Hour Supplied Hour Supplied Directly to Recirculated Designation Areas to Room to Room Outdoors Within Room Birthing Room P 2 10 Optional No Birthing Suite Corridor E 2 4 Optional No Examination Rooms E 2 6 Optional No Soiled/Decontamination Workroom N 2 10 Yes No Clean/Sterile Workroom P 2 4 Optional Optional Laboratory N 2 6 Optional No Toilet Room N — 10 Yes No Janitor’s Closet N — 10 Yes No Other Area E 2 4 Optional No P=Positive N=Negative E=Equal (1) General Standards.

(A) Any birthing center existing and in continuous operation prior to the date of the adoption of this rule will be inspected by the Department of Health to determine compliance with this

rule. Existing birthing centers shall comply with all applicable local regulations and codes and shall hold a certificate of occupancy from the local building authority.

(B) Requests for deviations from requirements on physical facilities shall be requested in writing to the Department of Health and must contain information which determines that the respective intent or objectives of this rule have been met.

Approvals for deviations shall be requested in writing and both requests and approvals shall be made a part of the permanent Department of Health records for the birthing center.

(C) References in this rule to, National Fire Protection Association (NFPA), publications are those contained in the twelve (12)-volume 1994 compilation of National Fire Codes.

Where there are discrepancies between referenced NFPA publication requirements and this rule, the requirements of this rule shall apply.

(2) Access for the Physically Handicapped. Existing birthing centers are required by the United States Department of Justice to currently comply with the federal requirements for accessible design established under the Americans With Disabilities Act. Evidence of compliance as determined by a local authority or other independent third party shall be provided to the department by the owner of the facility.

(3) Site.

(A) Adequate vehicular and pedestrian access shall be provided to the main entrance, emergency vehicular entrance and service entrance.

(B) Adequate parking shall be available in proportion to the number of patients and staff normally occupying the facility.

(C) Means of immediate access to the building for fire fighting and ambulance service personnel and equipment shall be provided.

(4) Administrative/public areas shall include business office with staff telephone and administrator’s office, medical records storage for at least two (2) years of active patient records, public lobby and waiting room, telephone, toilet, at least one (1) room for education and training and at least one (1) examination room. In existing birthing centers having only one (1) regular birthing room, one (1) examination room shall be sized and equipped to serve as a stand-by birthing room.

(5) Birthing rooms shall include at least one (1) birthing room sized to accommodate the equipment, personnel and circulation area necessary to accomplish infant delivery; each birthing room door shall be ample in width and conformation to accommodate ambulance stretchers or infant transport warmer.

(A) Hand washing facilities operable without the use of hands shall be accessible within each birthing room and each examination room.

(B) Each birthing room shall be equipped with a bed or delivery chair, storage facilities for supplies, and sufficient tables to hold emergency and other necessary equipment.

(C) A toilet with lavatory and shower shall be easily accessible from the birthing rooms without traversing public areas.

(D) Piped-in or portable oxygen and vacuum service shall be available to each birthing room.

(6) Service and Staff Support Facilities for the Birthing Suite.

These facilities shall include:

(A) A clean work and sterile storage area, and storage space for clean supplies;

(B) A separate soiled/decontamination utility area equipped with a counter and sink;

(D) An area shall be provided for the preparation and storage of medication; and (E) A staff work area for charting located to permit visual supervision of the birthing suite.

(7) General Support Facilities. These facilities shall include:

(A) Adequate space for the housing and maintenance of mechanical, plumbing and electrical equipment;

(B) Medical gas shall be stored and distributed in accordance with “NFPA 99, Standard for Health Care Facilities, 1993 Edition,” in 1994 National Fire Code, Volume 5; and (C) Housekeeping supply and general storage areas appropriate to fulfill the needs of the facility.

(8) Details and Finishes.

(A) A continuous system of unobstructed corridors and aisles shall extend through the enclosed portion of each story of the birthing facility, connecting all rooms and spaces with each other and with all entrances, exitways and elevators.

Mechanical equipment space need not be connected to the corridor system. Corridors shall be separated from all other areas by partitions constructed to resist the passage of smoke.

(B) At least two (2) remote exits shall be provided for each patient floor. Each exit shall discharge to the outside or through an enclosed stairway or passageway to the outside.

(C) Required exit stairs shall discharge directly to the outside or into an enclosed corridor which extends from the stair discharge to the outside. The fire-resistance rating of the enclosure of a corridor extension of a stair shall be not less than the rating required for the stair enclosure as stated in subsection (9)(D) of this rule.

(D) Corridors serving as a means of access to exit for patients in the birthing suite shall be arranged and of sufficient width to facilitate the movement of patients on stretchers.

(E) Exit doors shall swing in the direction of exit travel.

(F) All doors through which birthing patients pass to access birthing rooms and exits shall be of ample width to accommodate ambulance stretchers and warmers.

(G) Where outside windows exist in the birthing room, washable window treatments shall be installed to control light and glare.

(H) Where outside windows are provided in other areas of the facility, window treatments shall be installed to control light and glare.

(I) At least one (1) ABC-type fire, extinguisher, compliant with “NFPA 10, Standard for Portable Fire Extinguishers, 1990 Edition” 1994 National Fire Code, Volume 1, shall be located on each floor occupied by the birthing center, including the basement.

(J) A paper towel dispenser and soap dispenser shall be provided at all lavatories used for hand washing.

(K) Ceiling, wall and floor finishes in toilets, bath facilities and utility and storage rooms designed for washing, sterilizing and storage shall be easily cleanable.

(L) Finish materials installed on the walls, floors, and ceilings in the birthing rooms shall be washable. The floors shall not be physically affected by frequent wet cleaning with cleaning and germicidal cleaning agents.

(M) Floor and wall penetrations by pipes, ducts and conduits shall be tightly sealed to minimize entry of rodents and insects.

Joints of structural elements shall be similarly sealed.

(9) Construction, Including Fire-Resistive Requirements.

(A) Construction of freestanding birthing centers shall comply with “NFPA 101, Section 13-6, Existing Ambulatory Health Care Centers, 1994 Edition,” in 1994 National Fire Codes, Volume 5 and to the minimum requirements of this rule.

(B) Multistoried buildings rated combustible Type V shall system.

(D) The number of stories in a building housing a birthing center shall be determined by counting all patient care areas in the building.

(E) Every stairway, elevator shaft, light and ventilation shaft, chute and other openings between stories shall be enclosed or protected to prevent the spread of fire or smoke from one (1) floor to another. The fire-resistance rating of the enclosure or protection shall be not less than the structural floor separation requirements of “NFPA 220, Standard on Types of Building Construction, 1992 Edition,” in 1994 National Fire Codes, Volume 5 for the fire-resistive building type classification required by subsection (9)(A) of this section.

(10) Elevators.

(A) Multistory buildings shall have at least one (1) elevator if patient services are located on any floor other than the grade level (birthing center’s main entrance) floor.

(B) The elevator cab and door opening shall be of sufficient size to facilitate the movement of a patient on an ambulance stretcher.

(11) Mechanical Requirements.

(A) Heating, ventilating and cooling equipment shall be provided, maintained and operated to provide ambient temperatures of sixty-eight to eighty-five degrees Fahrenheit (68–85°F).

(B) All toilets and soiled materials holding/workrooms shall be exhausted to the outside by exhaust fans.

(12) Plumbing and Other Piping Systems.

(A) Systems shall be designed to supply water to the fixtures and equipment on every floor at an adequate pressure for their practical use.

(B) Reduced pressure backflow preventers shall be installed where the water service enters the building and on hose bibbs and on all fixtures, such as janitors’ sinks and laboratory fixtures, to which hoses or tubing can be attached.

(C) Hot water distribution systems shall be delivered to each fixture at a temperature which precludes the hazard of scalding.

(13) Electrical Requirements.

(A) Every room, including storage rooms, corridor and all other areas shall be sufficiently illuminated to facilitate efficient performance of all necessary tasks.

(B) Trickle charge battery pack units, complying with the standards of “Article 700, NFPA 70, National Electrical Code, 1994 Edition,” in National Fire Codes, Volume 3 shall be located to provide emergency lighting in the birthing rooms, exit corridors, exit signs, electrical branch panel rooms and exit stairs to point of discharge at grade. These fixtures shall be tested at least quarterly with the tests documented in writing.

An emergency stand-by power system is not required in birthing centers.

(C) There shall be one (1) electrical outlet for the emergency light and at least two (2) additional duplex outlets in each birthing room.

(D) The fire alarm system in existing birthing rooms may consist of the local alarms from the required smoke detectors provided the alarm from any one (1) of the detectors may be heard throughout the occupied areas of the birthing center.

Existing birthing centers with building configurations which preclude a local alarm from alerting all birthing center occupants must have an electrically powered fire alarm system which will alert all areas of the facility when activated.

(E) Existing birthing centers shall have smoke detectors installed at thirty-foot (30') intervals in all rooms and in corridors. All required smoke detectors in existing birthing centers may be battery powered. Battery-powered smoke detectors shall be tested at least quarterly with the tests documented in writing.

Chapter 33 * - moved to 19 CSR 10-33

19 CSR 30-33.010 Reporting Patient Abstract Data by Hospitals and Ambulatory Surgical Centers {#sec-19-csr-30-33.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-33.010}

(Moved to 19 CSR 10-33.010)

19 CSR 30-33.020 Reporting Charges for Leading Diagnoses and Procedures by Hospitals and Ambulatory Surgical Centers {#sec-19-csr-30-33.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-33.020}

(Moved to 19 CSR 10-33.020)

19 CSR 30-33.030 Reporting Financial Data by Hospitals {#sec-19-csr-30-33.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-33.030}

(Moved to 19 CSR 10-33.030)

Rebecca McDowell Cook (6/30/98)

Chapter 35 Hospices

19 CSR 30-35.010 Hospice Program Operations {#sec-19-csr-30-35.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-35.010}

PURPOSE: This rule defines the minimum requirements for the provision of hospice services by state certified hospice programs.

(1) General Provisions.

(A) Definitions Relating to Hospice Care Agencies.

Attending physician – a person who – A. Is licensed as a doctor of medicine or osteopathy in Missouri or a bordering state; or B. Is recognized by Missouri as a nurse practitioner and who complies with the requirements of Chapter 335, RSMo, 20 CSR 2200-4.200, and 42 CFR 410.75; or C. Is licensed as a physician assistant (PA) in Missouri and who complies with the requirements in Chapter 334, RSMo, 20 CSR 2150-7.135, and 42 CFR 410.74(c); and D. Is identified by the patient, at the time the patient elects to receive hospice care, as having the most significant role in the determination and delivery of the patient’s medical care.
Automated dispensing system—a mechanical system that performs functions that may include, but are not limited to, storing, packaging or dispensing medications, and that collects, controls and maintains all transaction information.
Branch/multiple location—a location from which a hospice provides services within a portion of the total geographic area served by the parent hospice and the area served by the branch/multiple location is contiguous to or part of the area served by the parent hospice.
Certified medication technician—a person who has successfully completed the certified medication technician training program and any examination component required in compliance with the standards in 19 CSR 30-84.020. The certified medication technician shall remain current as a certified nursing assistant with the Department of Health and Senior Services in order to continue to be current as a certified medication technician.
Certified pharmacy technician—a person who is credentialed by a nationally recognized pharmacy technician credentialing authority. 6.

Contracted provider—individuals or entities who furnish services to hospice patients under contractual arrangements between the hospice and the contracted provider. 7.

Coordinating provider—any individual or agency which independently provides services to the patient in their place of residence.

Department—the Missouri Department of Health and Senior Services.
Dietary counselor—an individual who is a registered nurse, registered dietitian, nutritionist, physician assistant or physician.
Direct employee—an individual paid directly by the hospice.
Emergency medication supply—a limited number of prescription medications approved by the medical director and the pharmacist that may be administered to a patient in an emergency situation or for initial doses of a necessary medication when a pharmacist cannot provide medication services for a patient within a reasonable time based on the patient’s clinical needs at the time.
Employee—an employee of the hospice or an individual under contract who is appropriately trained and assigned to the hospice program. Employee also refers to a person volunteering for the hospice program.
Family—broadly defined to include not only persons bound by biology or legalities but also those who function for the patient in a familial way.
Homemaker—a hospice aide, volunteer or other individual who assists the patient/family with light housekeeping chores.
Hospice—a public agency or private organization or subdivision of either that– A. Is primarily engaged in providing care to dying persons and their families; and B. Meets the standards specified in 19 CSR 30-35.010 and in 19 CSR 30-35.030. If it is a hospice that provides inpatient care directly in a hospice facility, it must also meet the standards of

19 CSR 30-35.020 and 19 CSR 30-35.030. {#sec-19-csr-30-35.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-35.020}

Hospice administrator—the employee designated by the governing body as responsible for the overall functioning of the hospice. Hospice administrators appointed by the governing body after July 1, 2023, shall have the following:

A. Be a licensed practical nurse, be a licensed registered nurse, or hold an undergraduate degree; and B. Have at least one (1) year of administrative experience in a related healthcare field.

Hospice aide—a person who meets the training and skill requirements specified in the Medicare hospice program at 42 CFR 418.76 which is incorporated by reference as last amended on August 6, 2009, and published by the Office of the Federal Register, 732 N. Capitol Street NW, Washington, DC 20401 or can be found at https://govinfo.gov. This rule does not incorporate any subsequent amendments or additions.
Hospice patient—a person with a terminal illness or condition for whom the focus of care is on comfort and palliation rather than cure.
Legal representative—a person who because of the patient’s mental or physical incapacity is legally authorized in accordance with state law to make health care decisions on behalf of the dying person.
Licensed practical nurse—a person licensed under

Chapter 335, RSMo, to engage in the practice of practical nursing.

Meal preparation—meals planned, offered, or served to all patients from prepared menus.
Medical director—a person licensed in Missouri or a bordering state as a doctor of medicine or osteopathy who assumes overall responsibility for the medical component of the hospice’s patient care program.
Nutritionist—a person who has graduated from an accredited four- (4-) year college with a bachelor’s degree including or supplemented by at least fifteen (15) semester hours in food and nutrition including at least one (1) course in diet therapy.
Occupational therapist—a person who is licensed under Chapter 324, RSMo, as an occupational therapist and licensed to practice in Missouri.
Occupational therapy assistant—a person who has graduated from an occupational therapy assistant program accredited by the Accreditation Council for Occupational Therapy Education and licensed to practice in Missouri.
Pharmacist—a person licensed as a pharmacist under

Chapter 338, RSMo.

Pharmacy technician—a person who is registered as a pharmacy technician under Chapter 338, RSMo.
Physical therapist—a person who is licensed as a physical therapist under Chapter 334, RSMo.
Physical therapy assistant—a person who has graduated from at least a two- (2-) year college level program accredited by the American Physical Therapy Association and licensed to practice in Missouri.
Registered nurse—a person licensed under Chapter 335, RSMo, to engage in the practice of professional nursing.
Registered nurse coordinator—a registered nurse, who is a direct employee, designated by the hospice to direct the overall provisions of clinical services.
Skilled nursing—those services which are required by law to be provided by a registered nurse or a licensed practical nurse.
Snack—a single meal or item prepared on demand which does not include food items that produce grease-laden vapors.
Social worker—a person who – A. Has a Master of Social Work (MSW) degree from a school of social work accredited by the Council on Social Work Education and has one (1) year of social work experience in a health care setting; or B. Has a baccalaureate degree in social work (BSW) from an institution accredited by the Council on Social Work Education; is supervised by an MSW as described in subparagraph (1)(A)34.A. of this rule and has one (1) year of social work experience in a health care setting; or C. Has a baccalaureate degree from a school of social work accredited by the Council on Social Work Education and is employed by the hospice before December 2, 2008, and therefore is not required to be supervised by an MSW.
Speech language pathologist—a person who is licensed under Chapter 345, RSMo, as a speech language pathologist.
Spiritual counselor—a person who has education with emphasis in counseling or related subjects and has, within ninety (90) days of hire, completed specific training to include common spiritual issues in death and dying, belief systems of comparative religions related to death and dying, spiritual assessment skills, individualizing care to patient beliefs, and varied spiritual practices/rituals.
Standing order—An order by an authorized prescriber that can be implemented by other health care professionals when predetermined criteria are met as per 19 CSR 30-35.010(2)

(E)3.–(2)(E)4.A., B., and C.

(B) Eligibility Requirements. A hospice shall have written admission criteria including the hospice’s policies regarding palliative care (that includes treatment modalities such as chemotherapy or radiation).

A patient who wishes to receive hospice care, shall sign a consent form for hospice services.
The consent form shall include the following:

A. Identification of the particular hospice that will provide care to the patient;

B. The patient’s or legal representative’s acknowledgment that the patient or legal representative has been advised and has an understanding of the palliative nature of hospice care as it relates to the patient’s terminal illness; and C. The specific type of care and services that may be provided as hospice care during the course of the illness.

(D) Discontinuance of Hospice Care.

A patient or legal representative may discontinue the patient’s hospice care at any time.
If a patient transfers to another provider, including another hospice provider, the hospice transferring care shall provide to the receiving provider pertinent written information which shall include at a minimum— A. Current medication profile;

B. Advance directive (if applicable);

C. Problems that require intervention or follow-up; and D. Current hospice plan of care.

The hospice shall have written policies for hospice patient discharge which identify specific circumstances in which the patient is discharged.

A. The hospice shall immediately notify the patient or legal representative and shall include the date that the discontinuance is effective.

B. Patient’s/family’s continuing care needs, if any, are assessed at discharge, and the patient/family are referred to appropriate resources.

The attending physician shall be notified in all instances of discontinuance of hospice care and such notification shall be documented in the patient record.

(E) General Requirements.

A hospice shall maintain compliance with the standards in 19 CSR 30-35.010 and in 19 CSR 30-35.030. A hospice that operates a facility for hospice care shall also maintain compliance with 19 CSR 30-35.020.
A hospice shall be primarily engaged in providing the care and services described in 19 CSR 30-35.010 and in 19 CSR 30-35.020 of this rule, and shall— A. Provide twenty-four- (24-) hour nursing coverage for telephone consultation and visits as needed;

B. Assure all other services that are reasonable and necessary for the palliation and management of terminal illness and related conditions are available on a twenty-four- (24-) hour basis;

C. Provide bereavement counseling; and D. Assure services are provided in a manner consistent with accepted standards of practice in accordance with local, state, and federal law.

The hospice shall conduct criminal background checks in accordance with state law.
The hospice shall adhere to state and federal law relating to advance directives.

(F) Patient Rights. The hospice shall have a written statement of patient rights which shall include, but need not be limited to, those specified herein— 1. Each patient of a hospice program shall be informed in writing of his/her rights as a recipient of hospice services;

The hospice shall document that it has informed patients of their rights in writing and shall protect and promote the exercise of these rights; and 3. The patient’s family, legal representative, or guardian may exercise the patient’s rights when all reasonable efforts to communicate with the patient have failed. These rights shall include— A. The patient and family’s right for respect of property and person, including the right to be free of abuse, neglect, and/or misappropriation of funds;

B. The right to voice grievances regarding treatment or care that is, or fails to be, furnished or regarding lack of respect of property or person by anyone who is furnishing services on behalf of the hospice and the patient/family shall not be subjected to discrimination or reprisal for doing so;

C. The right to be informed about his/her care alternatives available from the hospice and payment resources;

D. The right to participate in the development of the plan of care and planning changes in the care;

E. The right to be informed in advance about the care to be furnished;

F. The right to be informed in advance of the disciplines that will furnish care and the frequency of visits proposed to be furnished;

G. The right to be informed in advance of any change in the plan of care before the change is made;

H. The right to confidentiality of the clinical records maintained by the hospice and to be informed of the hospice’s policy for disclosure of clinical records;

I. The right to be informed in writing of the extent to which payment may be required from the patient and any changes in liability within thirty (30) days of the hospice becoming aware of the new amount of the liability; and J. The right to access the Missouri home health and hospice toll-free hotline and to be informed of its telephone number, the hours of operations, and its purpose for the receipt of complaints and questions regarding hospice services.

(G) Code of Ethics.

A hospice shall develop a written code of ethics and have a process for reviewing ethical issues.

(H) Twenty-four- (24-) Hour Response.

The hospice shall have written policies and procedures defining access to all services, medications, equipment, and supplies during regular business hours, after hours, and in emergency situations including a plan for prompt telephone response.
Unscheduled non-emergent visits shall be provided as agreed upon by the hospice and patient/caregiver.
When clinically indicated, emergent visits shall be made within ninety (90) minutes from the time the need is identified.

(I) Infection Control.

The hospice shall identify person(s) responsible for implementing, maintaining, and documenting an infection control program for surveillance, identification, prevention, control, and investigation of infections and communicable diseases.
The infection control program shall include a system for periodic review and update of infection control policies and procedures; infection control education of staff, patients, and caregivers; and monitoring for compliance with policies and procedures.
The infection control policies and procedures shall conform with accepted standards of practice, including the use of standard precautions, to prevent the transmission of infections and communicable diseases.

(J) Safety and Emergency Preparedness.

The hospice shall have a safety plan that includes— A. Policies and procedures for reporting, monitoring, and following up on all accidents, injuries, and safety concerns;

B. Documentation of monitoring activity and follow-up actions; and C. A safe and sanitary system for identifying, handling, and disposing of hazardous wastes in compliance with all federal, state, and local laws.

The hospice shall have an emergency preparedness program that shall meet all federal, state, and local requirements and shall include at a minimum— A. An emergency plan based on a facility and community all-hazards risk assessment;

B. Policies and procedures reviewed and updated at least annually;

C. A communication plan;

D. Training of staff; and E. Annual exercises to test the emergency plan.

(K) Branch/Multiple Locations.

If the hospice represents to the public that they have a branch/multiple location(s), each location shall be approved prior to serving patients. Each branch/multiple location(s) shall have a designated interdisciplinary group with documented group meetings, on-site maintenance of current active patient records, and telephone reception during normal business hours.
The branch/multiple locations shall be located within one hundred (100) miles of the parent office.
The standard of care and clinical services shall be the same out of the branch/multiple locations as the parent office.

(2) Administration.

(A) Governing Body.

A hospice shall have a governing body that assumes full legal responsibility for the hospice’s total operation.
The governing body shall meet, at a minimum, once a year.
The governing body shall designate an administrator in writing and list the date the administrator was designated.

(B) Administrator Provisions.

The administrator organizes and directs the agency’s ongoing functions; maintains ongoing liaison among the governing body, the interdisciplinary group(s) and the staff; employs qualified personnel; implements an effective budgeting and accounting system; and enforces written policies and procedures.
A person shall be authorized, in writing, to act in the absence of the hospice administrator.
A registered nurse coordinator shall be designated to direct the overall provisions of clinical services.

A hospice may arrange for another individual or entity to furnish services to the hospice’s patients except as otherwise provided in these regulations. If services are provided under contract, the hospice shall meet the following standards:

A. Assure the continuity of patient/family care in home, outpatient, and inpatient settings;

B. Have a written agreement for the provision of contracted services. The agreement shall include the following:

(I) Identification of the services to be provided in accordance with the plan of care;

(II) The manner in which services are coordinated by the hospice to maintain hospice professional management responsibility;

(III) Delineation of the role(s) of the hospice and the contracted services;

(IV) Assurance that the contracted provider shall be appropriately licensed;

(V) Provision for transfer and updating the plan of care on inpatient admission (if applicable).

Such contracts shall not relieve the hospice of the primary responsibility for ensuring patient care or otherwise complying with these regulations.

(D) Plan of Care.

A written plan of care shall be established for each patient by the interdisciplinary group with attending physician involvement.
The plan shall be established within seven (7) days of admission.
The care provided to a patient shall be in accordance with the plan.
The plan shall include:

A. Identification of the patient’s/family’s problems and needs;

B. The scope and frequency of services needed to meet the patient’s and family’s needs and by whom the services will be provided, prescribed and required medical equipment, supplies, medications, treatments, and the level of care;

C. Realistic and achievable goals; and D. All physician orders.

The plan shall be reviewed and updated by the interdisciplinary group at a minimum of every two (2) weeks.

These reviews shall be documented in the patient record.

Documentation on the plan of care shall reflect the changing needs of the patient/family and the services required to meet those needs.

(E) Authorized Prescriber’s Orders.

Medications, treatments, and procedures shall be administered only with an order by an authorized prescriber.
Written orders shall be dated and signed at the time of writing.
Oral orders, including authorization to use a standing order, shall be received only by persons authorized within their scope of practice, immediately reduced to writing, signed and dated by the person receiving the order, and signed and dated by the prescriber within thirty (30) days.
A standing order may be used as part of the plan of care if the following guidelines are met:

A. Standing orders shall be in compliance with all applicable state statutes and regulations and shall— (I) Include the purpose or conditions under which a standing order will be implemented;

(II) Be drug, treatment, or procedure specific and not allow for non-prescriber’s choice;

(III) Be individualized, signed and dated by the prescriber, and included in the patient’s record;

B. Agency policy shall define the time frame for authorized prescriber notification when a standing order has been implemented; and C. Standing order content shall be reviewed and approved by the medical director at least annually.

(F) Interdisciplinary Group.

The hospice shall designate an interdisciplinary group or groups composed of qualified individuals who provide or supervise the care and services offered by the hospice. The interdisciplinary group shall meet as frequently as the patient’s condition requires, but no less frequently than every fifteen (15) calendar days.
The interdisciplinary group shall include at least the following individuals who are employees of the hospice:

A. A doctor of medicine or osteopathy (may be contracted);

B. A registered nurse;

C. A social worker; and D. A spiritual counselor.

The interdisciplinary group shall be responsible for— A. Participation in the establishment, review and updates of the plan of care;

B. Provision or coordination of hospice care and services;

C. Making recommendations regarding policies governing the day-to-day provision of hospice care and (G) Clinical Services. The hospice shall routinely provide through direct employees the following services:

Nursing services.

A. Services shall be provided in accordance with recognized standards of practice.

B. Nursing services shall be staffed to assure that the nursing needs of patients are met.

C. A registered nurse shall conduct and document an initial assessment visit to assess the patient’s immediate physical, psychosocial, emotional, and spiritual status and needs within forty-eight (48) hours of election. The ongoing assessment, planning, and provision of nursing services shall be the responsibility of the registered nurse.

D. When nursing services are delegated to a licensed practical nurse— (I) The licensed practical nurse shall be supervised by a registered nurse who is available to the licensed practical nurse at least by phone during the hours that the licensed practical nurse is providing services or is on call; and (II) The registered nurse shall make on-site supervisory visits at least monthly to assess and document that the licensed practical nurse is routinely providing nursing services in accordance with the plan of care.

E. The registered nurse shall develop a written aide assignment based upon the patient’s/family’s needs when hospice aide services are provided.

F. When aide services are being provided, a hospice registered nurse shall visit the home at least every two (2) weeks. The visit shall include an assessment of the aide services.

G. Written documentation shall show that the aide is providing services in accordance with the plan of care.

H. When an aide is permanently assigned to a hospice facility, the every two- (2-) week supervisory requirement does not apply, however there must be evidence of an annual performance review in the aide’s personnel file.

Medical director services. The medical director shall be a direct or contract employee. The medical director’s or designee’s services and responsibilities include— A. Consulting with attending physicians regarding pain and symptom control;

B. Reviewing patient appropriateness for hospice services;

C. Acting as medical resource for the interdisciplinary group;

D. Acting as liaison to physicians in the community;

E. Assuring medical services are provided in the event the medical needs of the patient are not met by the attending physician; and F. Routinely attending the interdisciplinary group meetings.

Medical social services.

A. Medical social services shall be provided in accordance with recognized standards of practice.

B. Social services shall be staffed to assure that the medical social service needs of each patient and family are met.

C. The assessment, planning, and provision of medical social services shall be the responsibility of the social worker.

D. The social services assessment visit shall be completed within five (5) days of admission or sooner if indicated.

Spiritual care services.

A. Spiritual care shall be available to all patients and families.

B. The spiritual counselor is responsible for assuring there is a documented assessment of the spiritual needs of the patient and family within five (5) days of admission or sooner if indicated and that spiritual care provided reflects assessed needs.

C. The spiritual assessment shall include, at a minimum— (I) The identification of any religious affiliation the patient and family may have; and (II) The nature and scope of any spiritual concerns or needs identified.

D. A visit by the spiritual counselor shall be offered to each patient. If the patient declines spiritual counselor visits, the spiritual counselor will serve as a resource for other interdisciplinary team members assessing spiritual needs and providing care, and will be available to coordinate with other spiritual care providers the patient/family may have identified.

Bereavement care services.

A. There shall be an organized program for the provision of bereavement services under the supervision of a qualified professional who is a person with training or experience related to death, dying, and bereavement.

B. Within two (2) months following the patient’s death, there shall be an encounter (other than funeral attendance/ visitation) to assess the risk of the bereaved individual(s). A plan of care shall be developed that extends for one (1) year following the death appropriate to the level of risk assessed.

C. At least one (1) additional bereavement encounter shall occur within six (6) months after the death of the patient.

Other clinical services. The hospice shall provide the following services directly by hospice employees or through a contracted provider. The assessment, planning, and provision of these services shall be the responsibility of the applicable licensed or registered clinician.

A. Dietary counseling, when required, shall be planned by a qualified dietary counselor.

B. Physical therapy services, occupational therapy services, and speech language pathology services shall be offered in a manner consistent with accepted standards of practice.

(I) Therapy services delegated to the physical therapy assistant or the occupational therapy assistant shall be supervised by a licensed physical therapist or registered occupational therapist as appropriate who is available to the physical therapy assistant or occupational therapy assistant at least by phone during the hours that the assistant is providing (II) When the assistant is providing services to a patient, the licensed or registered therapist shall make a supervisory visit to the residence of the patient at least every thirty (30) days.

(III) Written documentation shall show that the assistant is providing therapy services in accordance with the plan of care.

C. Additional counseling services. Any additional counseling services provided by the hospice shall be provided by qualified personnel, coordinated with all hospice services, included in the plan of care and documented in the clinical record.

D. Waiver.

(I) These requirements shall be waived by the department for areas of the state in which no licensed therapists/dietitians/nutritionists are available provided a good faith effort to provide the service is being made.

(II) A hospice seeking this waiver shall submit a written request to the department along with evidence of efforts made by the hospice to provide the service. If approved, a request for waiver shall be resubmitted annually for review.

Hospice aide and homemaker services. Hospice aide and homemaker services shall be available to meet the needs of the patients.

A. If homemaker needs are identified, a member of the interdisciplinary group shall assign and coordinate the B. Hospice aide services shall be provided by a qualified person as set forth in this rule at 19 CSR 30-35.010(1)(A)17.

C. A hospice aide is not considered to have completed a training and competency program or a competency evaluation program if, since the individual’s most recent completion of such program(s), there has been a continuous period of twenty-four (24) consecutive months during none of which the individual furnished services described in 42 CFR 418.76 for compensation.

D. The hospice aide shall follow written instructions for patient care which are prepared by a registered nurse who has physically assessed the patient. The hospice aide shall document care provided. Duties include, but shall not be limited to, the duties specified in the regulations pertaining to the Medicare hospice aide (42 CFR 418.76).

E. Twelve (12) hours of in-service training per aide per twelve- (12-) month period shall be provided or assured by the hospice. The hospice shall maintain a record of in-service training provided.

(H) Medications. The hospice shall develop policies and procedures for the safe and effective use of medications, in accordance with accepted professional standards and applicable laws and regulations.

A medication list shall be maintained for each patient.
Medication orders shall include the medication name, dose, frequency, and route of administration.
Orders with variable doses or frequencies shall specify a maximum dose or frequency and the reason for administration.
Medications shall be provided on a timely basis and medication services shall be available on a twenty-four- (24-) hour basis for emergencies.
When controlled substance medications are delivered to the patient’s residence by hospice staff, the date, patient name, medication name and strength, quantity indicated on the prescription container, and signatures of the hospice staff member and the receiver shall be documented.
The hospice shall identify and document any misuse of controlled substances and shall notify the prescriber.
Medication use shall be reviewed with the patient, family, or both and medication information, counseling, and education shall be provided when appropriate.
Current medication reference material shall be available to professional staff for all medications used.
Medications shall be administered by persons who have statutory authorization, the patient, or a family member.
Administration by the patient or by a family member shall be evaluated for appropriateness and ability and this evaluation documented by the nurse.
Medication incidents, including medication errors and adverse medication reactions, shall be reported to the prescriber, the registered nurse coordinator, and the pharmacist.
The hospice shall have a policy for the disposal of controlled substances maintained in the patient’s home when those medications are no longer needed by the patient. The policy shall include at a minimum, information shared with family regarding disposition of medications when no longer required.
Medications shall not be transferred to other patients and shall not be removed from the residence by hospice staff.

(I) Medical Supplies and Equipment.

The provision of medical supplies and equipment shall be coordinated as needed for the palliation and management of the terminal illness and related conditions. Hospices shall make every effort to assure that patient needs for medical supplies and equipment are met.
Hospice shall provide education for patient/family, employees, and volunteers on the safe use of medical equipment.
Hospice shall provide evidence that all hospice-owned patient care related equipment has been inspected and maintained on an annual basis and in accordance with manufacturers specifications.
Hospice shall have policies and procedures for cleaning, storing, accessing, and distributing hospice-owned equipment.
Supplies shall be stored and maintained in a clean and proper manner.

(J) Volunteers.

Each hospice shall document and maintain a volunteer staff sufficient to provide administrative and direct patient care hours in an amount that, at a minimum, equals five percent (5%) of the total patient care hours of all paid hospice employees and contract staff. The hospice shall document a continuing level of volunteer activity.
Care and services through the use of volunteers, including the type of services and the time worked, shall be recorded.
The hospice shall document initial screening and active and ongoing efforts to recruit and retain volunteers.
The hospice shall provide task-appropriate orientation and training consistent with acceptable standards of hospice practice, that includes at a minimum— A. Hospice philosophy, goals, and services;

B. The volunteer role in hospice;

C. Confidentiality;

D. Instruction in the volunteer’s particular duties and responsibilities;

E. Whom to contact if in need of assistance or instruction regarding the performance of their specific duties and responsibilities; and F. Documentation and record keeping as related to the volunteer’s duties.

The hospice shall, in addition, provide orientation for patient care volunteers that includes at a minimum— A. Concepts of death and dying;

B. Communication skills;

C. Care and comfort measures;

D. Psychosocial and spiritual issues related to death and dying;

E. The concept of hospice patient and family as the unit of care;

F. Procedures to be followed in an emergency or following the death of the patient;

G. Concepts of grief and loss;

H. Universal precautions;

I. Safety;

J. Patient/family rights;

K. Hospice and the nursing home; and L. Alzheimer’s disease and dementia-specific training as specified at 19 CSR 30-35.010(2)(M)1.B.(XIII).

The hospice shall document orientation and ongoing in- 7. Volunteers functioning in accordance with professional practice acts shall show evidence of current professional standing and licensure, if applicable.

(K) Clinical Records.

In accordance with accepted principles of practice, the hospice shall establish and maintain a clinical record for every patient receiving care and services.
The record shall be complete, legible, readily accessible, and systematically organized to facilitate retrieval.

Documentation shall be prompt and accurate. 3.

Each clinical record shall be a comprehensive compilation of information. Entries shall be made for all services provided.

Entries shall be made and signed by the person providing the services.
The record shall include all services whether furnished directly or through contracted providers. Each clinical record shall contain— A. Physician’s orders;

B. Complete documentation of all assessments, services, visits, and events;

C. The plan of care and updates to the plan of care;

D. Identification data;

E. Consent form;

F. Pertinent medical history;

G. Determination of financial responsibility; and H. Documentation of communication with coordinating providers.

The hospice shall safeguard the clinical record against loss, destruction, and unauthorized use.

(L) Facility Resident.

When the hospice patient resides in a nursing facility, the hospice collaborates with the nursing facility providing care to the patient/family to ensure coordination of services.
Collaboration activities shall include the following:

A. There shall be a coordinated single plan of care in the nursing facility which may be multiple documents, that— (I) Reflects coordination and input from both the hospice and the nursing facility;

(II) Identifies the care and services which each shall provide; and (III) Is updated to reflect changes in patient/family condition, needs, and care.

B. Services usually identified as hospice services shall remain the responsibility of the hospice, and are provided or arranged by the hospice to meet the needs of the patient at the same level that the hospice normally furnishes to patients in their homes.

C. A registered nurse is designated from the hospice to coordinate the implementation of the plan of care, and to respond to questions and concerns from the nursing facility.

D. The hospice shall provide education to nursing facility staff that includes at a minimum— (I) The purpose and nature of hospice care;

(II) Services provided by the hospice;

(III) Care plan coordination;

(IV) When and how to contact hospice staff.

The hospice shall document education provided and/or education offered and declined by the nursing home.
The hospice shall enter into arrangements only with nursing facilities which are appropriately licensed.

(M) Employee Training and Orientation.

Each hospice shall provide initial orientation for each direct employee that is specific to the employee’s job duties.

A. All employees shall be oriented to— (I) Hospice philosophy, goals, and services;

(II) Confidentiality;

(III) Specific job duties;

(IV) Hospice policies and procedures as appropriate to the position.

B. Patient care employees shall also be oriented to— (I) Interdisciplinary group function and responsibility;

(II) Communication skills;

(III) Physical, psychosocial, and spiritual assessment;

(IV) Plan of care;

(V) Symptom management;

(VI) Universal precautions;

(VII) Patient/family safety issues;

(VIII) Patient/family rights;

(IX) Documentation;

(X) Concepts of grief and loss;

(XI) Facility resident care;

(XII) Levels of hospice care; and (XIII) Alzheimer’s disease and related dementias.

Hospice agencies shall provide dementia-specific training about Alzheimer’s disease and related dementias to their employees and those persons working as independent contractors who provide direct care to or may have daily contact with residents, patients, clients, or consumers with Alzheimer’s disease or related dementias.

(a) At a minimum, the training required shall address the following areas:

I. An overview of Alzheimer’s disease and related dementias;

II. Communicating with persons with dementia;

III. Behavior management;

IV. Promoting independence in activities of daily living; and V. Understanding and dealing with family issues.

(b) Employees or independent contractors who do not provide direct care for, but may have daily contact with, persons with Alzheimer’s disease or related dementias shall receive dementia-specific training that includes at a minimum— I. An overview of Alzheimer’s disease and related dementias; and II. Communicating with persons with dementia.

(c) Dementia-specific training about Alzheimer’s disease and related dementias shall be incorporated into orientation for— I. New employees with direct patient contact;

II. Independent contractors with direct patient contact; and III. Employees who do not provide direct care for, but may have daily contact with, persons with Alzheimer’s disease or related dementias. The training shall be provided annually and updated as needed.

C. Ongoing in-service training shall include a broad range of topics that reflect identified educational needs.

D. The hospice shall document initial orientation and inservice topics presented.

Volunteers are exempt from these provisions, except for dementia-specific training as specified at 19 CSR 30-35.010 (2)

(M)1.B.(XIII), as their orientation and in-service requirements are defined in 19 CSR 30-35.010(2)(J)4., 5., and 6.

Contract employees shall receive orientation to dementia-specific training as specified at 19 CSR 30-35.010(2)

(M)1.B.(XIII), confidentiality, hospice philosophy, and to their specific job duties.

(N) Quality Assessment and Performance Improvement.

The hospice shall follow a written plan for assessing and improving program operations which includes— A. Goals and objectives;

B. The identity of the person responsible for the program;

C. A method for resolving identified problems.

The plan and performance improvement activities shall be reviewed at least annually by a designated group and the governing body and revised as appropriate.
When problems are identified in the provision of hospice services, the hospice shall document any evidence of corrective actions taken, including ongoing monitoring, revisions of policies and procedures, educational intervention, and changes in the provision of services.
The effectiveness of actions taken to improve services or correct identified problems shall be evaluated.
A designated group shall review and document the quality assessment and performance improvement activities and monitor corrective actions.

rule filed March 8, 1996, effective Oct. 30, 1996. Rescinded and readopted: Filed Jan. 3, 2001, effective Aug. 30, 2001. Amended:

Filed Sept. 11, 2007, effective March 30, 2008. ** Amended: Filed July 9, 2020, effective Jan. 30, 2021. Amended: Filed Sept. 15, 2022, effective March 30, 2023. *Original authority: 192.2000, RSMo 1984, 1988, 1992, 1993, 1995, 2001, 2014, and 197.270, RSMo 1992, amended 1993. **Pursuant to Executive Order 21-07, 19 CSR 30-35.010, part (2)(M)1.B.(XIII) was suspended from April 22, 2020 through August 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 30-35.010, paragraph (1)(A)1. was suspended from April 9, 2020 through December 31, 2021.

History

AUTHORITY: sections 192.2000 and 197.270, RSMo 2016. Original

19 CSR 30-35.020 Hospice Providing Direct Care in a Hospice Facility {#sec-19-csr-30-35.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-35.020}

PURPOSE: This rule defines the minimum requirements necessary for the construction and operation of hospice inpatient facilities in order to be certified as part of the hospice program.

(1) A hospice that delivers care in a facility operated by the hospice and not otherwise licensed shall comply with this rule in addition to 19 CSR 30-35.010 and 19 CSR 30-35.030.

(2) Each patient shall receive treatment, medications and diet as prescribed and shall be kept comfortable, clean, wellgroomed and protected from accident, injury and infection.

(3) Organization and Management of Hospice Facilities.

(A) 24-Hour Staffing.

The hospice shall provide 24-hour staffing which is sufficient to meet the patients’ total needs in accordance with the patient plan of care.
All hospices shall employ qualified staff at the ratio of no less than one for every ten (1:10) patients per shift, per patient unit, 24 hours a day.
Staffing personnel shall be on duty at all times on each patient-occupied floor, with no less than two staff personnel in a facility at all times.
Minimum staff personnel shall be no less qualified than one home health aide or companion/volunteer and one licensed practical nurse.
A registered nurse shall be available for telephone consultation or on-site visit as needed, 24 hours a day.
Facility personnel shall have a telephone access to administrative staff, 24 hours a day.

(B) Disaster Preparedness.

The hospice shall have a written plan, annually rehearsed with staff, which includes procedures to be followed in the event of an internal or external disaster and for the care of casualties arising from disasters.
Each facility shall conduct quarterly fire drills so that each shift participates at least annually.

Make available a practical freedom of choice diet offering at least three meals and snacks, or their equivalent, that accommodate patient’s needs and preferences each day at regular times, with not more than 14 hours between a substantial evening meal and breakfast;
Prepare and serve foods using methods that conserve nutritive value, flavor and appearance;
Give special attention to the texture of food served to patients who have chewing difficulty;
Provide assurance that hot food is served hot and cold food is served cold;
Give a minimum of 30 minutes for eating meals.

Patients who eat slowly or who need assistance shall be given as much time to eat as necessary;

Make tray service and dining room service attractive for patients and ensure that each patient receives appropriate table service;
Provide each patient who is served meals in bed or in a chair not within the dining area with either a table, an overbed table or an overbed tray of sturdy construction which is positioned so that the patient can eat comfortably;
Provide assistance upon tray delivery to all patients requiring assistance at mealtimes, whether it be preparation of the food items or actual feeding. Dining room supervision shall be provided during meals;
Establish an identification system to assure that each patient receives the diet as ordered;
Provide sufficient equipment and personnel trained in their duties to assure adequate preparation and serving of food if meals are prepared on-site;
Review menus for special prescribed diets and approve in writing by either a qualified dietitian, a registered nurse, or a physician;
Keep a current record of purchased food to show the kind and amount of food purchased each month, if meals are prepared on-site;
Plan menus for all diets at least two weeks in advance if meals are prepared on-site. If cycle menus are used, the cycle shall cover a minimum of three weeks and shall be different each day of the week;
Make fresh water readily accessible to all patients at all times;
Procure, store, prepare, distribute and serve all food under sanitary conditions;
Permit family to bring, prepare and serve food to their loved one; and 17. Permit staff to prepare a single patient snack upon request.

(D) Patient Areas.

The hospice shall design and equip areas for the comfort and privacy of each patient and family member.
The hospice shall have accommodations for family privacy after a patient’s death that do not infringe on other patients’ rights and decor which is homelike in design and function;
Patients shall be permitted to receive visitors, including small children, at any hour;
The facility shall have a policy regarding pets; and 5. Smoking may be permitted in the hospice consistent with the smoking policy of the facility. Smoking may be permitted in the patient’s room and in designated smoking areas. Individual patients may be permitted to smoke in their rooms with the consent of any other patients occupying the room and with the permission of his/her attending physician.

If a patient is confined to bed or classified as not being responsible, smoking is permitted only under the direct supervision of an authorized individual.

(E) Infection Control.

The hospice shall make disease-specific provision for isolating patients with infectious diseases.
Infectious waste management control.

A. Every inpatient hospice facility shall write an infectious waste management plan with an annual review identifying infectious waste generated on-site, the scope of the infectious waste program and policies and procedures to implement the infectious waste program. The plan shall include at the least the following: administrator’s endorsement letter; introduction and purpose; objectives; phone number of responsible individuals; definition of those wastes handled by the facility; identification of responsible individuals; procedures for waste identification, segregation, containment, transport, treatment and disposal; emergency and contingency procedures and training; and educational procedures.

B. Infectious waste shall be segregated from other wastes at the point of generation and shall be placed in distinctive, clearly marked, leakproof containers or plastic bags appropriate for the characteristics of the infectious waste.

C. Containers for infectious waste shall be identified with the universal biological waste symbol. All packaging shall maintain its integrity during storage and transport. Infectious waste shall not be placed in a gravity disposal chute.

D. Pending disposal, infectious waste shall be stored separately from other wastes in a room limited to staff access.

E. When transported off the premises of the hospice, all infectious waste shall be packaged and transported as provided in sections 260.200–260.245, RSMo.

F. Hospices generating 100 kilograms or less of infectious waste per month must comply with section 260.203.10, RSMo.

Written policies and procedures shall define and describe the scope and conduct of laundry and linen services.

There shall be a mechanism for the review and evaluation on an annual basis of the quality of laundry services.

Written policies and procedures shall define and describe the scope and conduct of on-site cleaning of dietary ware. There shall be a mechanism for the review and evaluation on an annual basis of the quality of dietary-ware sanitizing services provided.

(F) Pharmacy Services. The hospice shall comply with all provisions of 19 CSR 30-35.010 regarding medications.

The hospice shall employ or contract with a pharmacist.

A. The pharmacist shall assist in the development of policies and procedures for medication use, shall advise the hospice on all other matters pertaining to the use of medications, shall serve as a member of, or consultant to, the interdisciplinary team and shall provide medication information to professional staff as required.

B. A pharmacist shall be available on a twenty-four (24)hour basis for emergencies.

Medication acquisition and labeling.

A. Prescription medications shall be maintained as individual patient prescriptions or in an automated dispensing system.

B. Each facility shall maintain an emergency medication supply. When the emergency medication supply is separate from an automated dispensing system and contains controlled substances the facility shall be registered with the Missouri Bureau of Narcotics and Dangerous Drugs.

C. Automated dispensing systems may be controlled by the facility or may be controlled on-site or remotely by a pharmacy.

(I) When an automated dispensing system is controlled by the facility:

(a) A pharmacist shall be responsible for the operation of the automated dispensing system and training of facility staff in its use;

(b) A pharmacist shall review and confirm each new medication order prior to administration of the first dose;

(c) The facility shall have a policy and procedure to allow removal of initial doses of approved emergency medication supply medications in lieu of maintaining a separate emergency medication supply;

(d) A pharmacist or pharmacy technician shall place medications in the automated dispensing system. Medications to be placed in the automated dispensing system shall be checked and approved by a pharmacist;

(e) When the automated dispensing system contains controlled substances, the facility shall be registered with the Missouri Bureau of Narcotics and Dangerous Drugs and the Drug Enforcement Administration; and (f) When the automated dispensing system is for the purpose of an emergency medication supply only, subparts (b) and (c) of this part shall not apply and the facility shall not be required to be registered with the Drug Enforcement Administration.

(II) When an automated dispensing system is controlled by a pharmacy:

(a) A pharmacist shall review and confirm each new medication order prior to releasing the medication from the system;

(b) The pharmacy and the facility shall have a policy and procedure to allow removal of initial doses of approved emergency medication supply medications when the automated dispensing system is used in lieu of maintaining a separate emergency medication supply;

(c) A pharmacist or pharmacy technician shall place medications in the automated dispensing system. Medications to be placed in the automated dispensing system shall be checked and approved by a pharmacist;

(d) The pharmacy shall comply with all requirements of paragraph 3. of this subsection;

(e) The automated dispensing system shall be licensed by the Board of Pharmacy and shall be used in compliance with 20 CSR 2220-2.900;

(f) When the automated dispensing system contains controlled substances it shall be registered with the Missouri Bureau of Narcotics and Dangerous Drugs and the Drug Enforcement Administration; and (g) When the automated dispensing system is for the purpose of an emergency medication supply only, subparts (a) and (e) of this part shall not apply and it shall not be required to be registered with the Drug Enforcement Administration.

(III) A facility employee who registers with the Board of Pharmacy as a pharmacy technician shall be a nurse, certified pharmacy technician, or certified medication technician.

The pharmacist shall be responsible for the training of the employee and shall supervise the employee in compliance with 20 CSR 2220-2.700 when pharmacy technician functions are being performed.

D. Patient prescription medications shall be labeled with at least the patient name, medication name, strength and date dispensed. They shall also contain accessory information and the expiration date when applicable.

E. Prescription medication labels shall not be altered by hospice staff and medications shall not be repackaged by hospice staff except as allowed by (3)(F)4.E.

F. When the patient’s own medications are used, they shall be examined prior to use for suitability and positively identified by a pharmacist or nurse in writing.

G. Non-prescription medications may be obtained as stock or individual patient supplies. They shall not be repackaged, except as allowed by (3)(F)4.E., and supplies for individual patients shall be labeled with the patient’s name.

Medication storage and control.

A. All medications shall be stored in locked compartments under proper temperature controls, separate from food and other substances. Medications shall be accessible only to persons authorized to administer them, pharmacists or pharmacy technicians.

B. Controlled substances shall be stored in locked compartments separate from other medications.

C. The pharmacist shall inspect medication storage areas and the emergency medication supply monthly and shall document this inspection.

D. Records of receipt and disposition of all controlled substances shall be maintained separate from other records.

(I) Inventories of Schedule II controlled substances shall be reconciled each shift when they are not maintained in an automated dispensing system.

(II) Inventories of Schedule III–V controlled substances shall be reconciled daily when they are not maintained in an automated dispensing system.

(III) Inventories of controlled substances shall be reconciled at least every seventy-two (72) hours when they are maintained in an automated dispensing system.

(IV) Receipt records shall include the date, source of supply, patient name and prescription number when applicable, medication name and strength, quantity and signatures of the supplier and receiver.

(V) Administration records shall include the date, time, patient name, medication name, dose administered and signature of the person administering.

(VI) Documentation of waste at the time of administration shall also include the reason for the waste and the signature of an authorized employee witness.

E. The pharmacist shall review controlled substance record keeping monthly.

F. All variances of controlled substance records shall be reported to the registered nurse coordinator and the pharmacist for review and investigation.

G. All losses of controlled substances shall be reported to the Missouri Bureau of Narcotics and Dangerous Drugs and to other federal, state and local authorities when required.

H. All controlled substance records shall be maintained for two (2) years.

Medication administration.

A. Medication administration by the patient or a family member shall be ordered by the physician. Instructions for administration shall be provided.

B. Non-controlled substances may be stored in a locked compartment in the patient’s room.

C. Single doses of controlled substances may be placed in the locked compartment or provided directly to the patient or family member prior to the time of administration.

D. Administration of the patient’s own medications brought to the facility shall be ordered by the authorized prescriber.

E. Medications for administration when a patient temporarily leaves the facility shall be labeled by the pharmacy with instructions for administration, except that a single dose of each medication may be provided by the nurse in containers labeled with the patient’s name, medication name and strength, instructions for administration, and other necessary information.

F. Medication administration shall be documented on a separate record. Administration by the patient or a family member shall be monitored by nursing staff and documented.

Other medication disposition.

A. Medications may be sent with a patient at the time of discharge only if they have been labeled by the dispensing pharmacy with instructions for administration and ordered by the authorized prescriber.

B. Records of this disposition shall include the date, patient name, prescription number, drug name and strength, quantity and signatures of the persons releasing and receiving the medications.

C. Patient prescription medications that have been discontinued shall be destroyed within sixty (60) days if they are controlled substances or if they are not in unit-dose packaging.

D. Patient prescription medications of expired patients shall be destroyed within five (5) days if they are controlled substances or if they are not in unit-dose packaging or if they were brought from home.

E. Other expired or nonusable medications shall be destroyed within five (5) days.

F. Medications shall be destroyed by a pharmacist and a nurse or two (2) nurses, and a record of destruction shall be maintained which includes the date, patient name, prescription number, medication name and strength, quantity, method of destruction and signatures of the persons destroying the medications.

G. Unit-dose packaged medications returnable to the pharmacy shall be returned within ten (10) days.

H. Medications shall not be transferred to other patients and shall not be removed from the facility by hospice staff, except those being returned to the pharmacy.

(4) General Design and Construction Standards for New Inpatient Hospice Facilities.

(A) Health and Safety Laws. The hospice shall meet all federal, state and local laws, ordinances, regulations and codes pertaining to health and safety, including but not limited to, provisions regulating construction, maintenance and equipment.

General Requirements.

A. After October 30, 1996, a new hospice facility shall submit plans for approval to the Department of Health for the construction of a new facility, expansion or renovation of an existing state certified hospice or the conversion of an existing facility not previously and continuously state certified and operated as a hospice facility under section 197.250, RSMo.

B. New hospice facilities shall be designed and constructed in conformance with this rule.

C. This rule is not intended to restrict innovations and improvements in design or construction techniques.

Accordingly, the Department of Health may approve plans and specifications which contain deviations from this rule. Requests for deviations from requirements on physical facilities shall be in writing to the Department of Health and shall contain information which determines that the respective intent or objectives of this rule have been met. Approvals for deviations shall be in writing and both requests and approvals shall be made a part of the permanent Department of Health records for the hospice.

D. Where renovation or replacement work is done within an existing licensed facility, all new work, additions, or both, shall comply with the applicable sections of this rule. Where existing major structural elements make total compliance impractical or impossible, alternative proposals which result in an equivalency may be considered by the department.

E. In renovation projects and additions to existing state certified hospice facilities, only that portion of the total facility affected by the project shall comply with the applicable sections of this rule. However, upon construction completion, the facility shall satisfy all functional requirements for state certified hospices.

F. Those existing portions of the facility which are not included in the renovation but which are essential to the functioning of the complete facility as well as existing state certified building areas that receive less than substantial amounts of new work shall, at a minimum, comply with the state certification requirements which were in effect at the time that the existing portion of the building was state certified.

G. All required fire exits shall be maintained throughout the construction and the work shall be phased as necessary to minimize disruption of the existing hospice operation.

Planning and Construction Procedures.

A. Any hospice facility constructed or renovated after October 30, 1996 shall have plans and specifications prepared in conformance with Chapter 327, RSMo by an architect or engineer duly registered in Missouri. The owner of each new facility or the owner of an existing licensed inpatient hospice being added to or undergoing major alterations shall provide a program—scope of services—which describes space requirements, staffing patterns, departmental relationships and other basic information relating to the objectives of the facility. The program may be general but it shall include a description of each function to be performed, approximate space needed for these functions and the interrelationship of various functions and spaces. The program shall describe how essential services can be expanded in the future as the demand increases. Appropriate modifications or deletions in space requirements may be made when services are shared or purchased, provided the program indicates where the services are available and how they are to be provided. This program shall be submitted to the Department of Health for review along with the plans developed for the project. Schematic and preliminary plans showing the basic layout of the building and the general types of construction, mechanical and electrical systems and details may be submitted to the department before the larger and more complicated working drawings and specifications so that necessary corrections can be easily made before final plans are completed. Working drawings and specifications, complete in all respects, shall be prepared and submitted to the Department of Health for approval. These plans shall cover all phases of the construction project, including site preparation: paving; general construction; mechanical work, including plumbing, heating, ventilating and air conditioning; electrical work; and all built-in equipment, including elevators, kitchen equipment, cabinet work, and the like.

B. The Department of Health shall be notified in writing within five (5) days after construction begins. Construction shall be in conformance with plans and specifications approved by the Department of Health. The department may elect to inspect the construction of hospice projects at any time during the development of the project. If construction of the project is not started within one (1) year or completed within a period of three (3) years after the date of the approval of the plans and specifications, the plans and specifications shall be resubmitted to the Department of Health for its approval and shall be amended, if necessary, to comply with the then current rules before construction work is started or continued.

C. References in this rule to National Fire Protection Association (NFPA) publications are those contained in the 12-volume 1994 Compilation of NFPA Codes, Standards, Recommended Practices and Guides. Where there are discrepancies between referenced NFPA publication requirements and this rule, the requirements of this rule shall apply.

D. The design and construction of hospices shall conform to the most stringent requirements of this rule and the local governing building code and zoning ordinances.

Site.

A. Adequate paved pedestrian access shall be provided within the lot lines to the main entrance. Loading and unloading space for delivery vehicles shall be paved.

B. Adequate paved parking shall be provided. Parking space needs shall be determined by the local zoning requirement and the operational program but shall not be less than one (1) space for each of the maximum number of staff persons on duty at any given time plus one (1) parking space for each licensed inpatient bed in the facility.

C. Fire lanes shall be provided as required by local

D. The site shall provide reasonable access for those individuals to be served by the facility. The facility shall be on an all-weather road for easy access by vehicular traffic.

Consideration should be given to locating the hospice to provide easy access to public transportation services which may be available in the community.

E. The site shall be located within the service area of a public fire department.

Roads, parking facilities, walks, ramps and entrances shall be accessible and usable by persons with various physical handicaps.

A. At least one toilet, telephone and drinking fountain shall be provided on each floor of a hospice which is accessible for use by handicapped public and staff.

B. Elevator controls and alarms shall be accessible to wheelchair occupants and shall be provided with tactile signage for the visually impaired.

C. Design details for handicapped accessible facilities should be consistent with the Guidebook to: The Minimum Federal Guidelines of Requirements for Accessible Design published January 6, 1981, by the U.S. Architectural and Transportation Barriers Compliance Board.

D. At least ten percent (10%) of the patient beds shall be located in handicapped-accessible rooms with accessible toilet rooms which open directly into the patient room. All other clinical areas to which patients have common access shall be handicapped-accessible.

Administrative and public areas shall be provided.

A. All hospices shall provide adequate work areas to support the administrative personnel and governing body.

The facilities shall allow business to be conducted in a setting which provides confidentiality and privacy as required. The administrative offices may be located remotely from a hospice inpatient unit or may be housed within the inpatient facility.

B. Where administration is included within the inpatient facility, the following shall be provided:

(I) Administrator’s office;

(II) Business office including a work area for quality assurance;

(III) Storage and work area for archived medical records;

(IV) Conference room for governing board meetings and personnel in-service training; and (V) Office for director of patient-care services.

C. Each inpatient hospice facility shall provide the following public areas in a location separated from the clinical and service areas of the facility:

(I) Lobby/waiting room with reception;

(II) Wheelchair accessible public toilet;

(III) Wheelchair accessible public drinking fountain;

(IV) Wheelchair accessible public phone.

Design of patient-care units.

A. One or more patient-care units shall be provided.

Each unit shall not exceed a maximum of twenty (20) beds.

B. Each patient-care unit shall be a continuous area which does not require patient-care traffic to traverse other areas and shall be restricted to only one (1) floor level. If justified by the program submitted under subparagraph (2)

(A)2.A. of this rule, the department may consider approval of designs which provide for larger capacity patient-care units.

C. The bed area in a patient room exclusive of toilet rooms, closets, alcoves or vestibules, shall not be less than one hundred twenty (120) square feet in a private room and not less than two hundred (200) square feet in a semi-private room.

Heating units and lavatories may protrude into this space.

D. No dimension for the bed area in any patient room shall be less than ten (10) feet.

E. No patient room shall house more than two (2) patients.

F. Each patient-care unit shall have not greater than fifty percent (50%) of its beds housed in semi-private rooms and the remaining rooms shall be limited to occupancy by one (1) patient. If justified by the program submitted under subparagraph (2)(A)2.A. of this rule, the department may consider approval of designs which provide other ratios of semi-private to private patient rooms.

G. Each patient shall have access to a toilet room without entering the general corridor area.

H. One (1) toilet may serve not more than two (2) adjacent rooms.

I. The toilet room shall contain a lavatory and water closet and shall be sized to permit access for the patient and an assisting member of the staff. The lavatory may be omitted from the toilet room if a lavatory is provided in the patient room.

J. At least one (1) patient room per patient-care unit shall be provided to be used for isolation. This unit shall have a toilet room equipped with a bathing facility which serves this room exclusively.

K. Mirrors shall be provided in each patient room or adjoining toilet room. Mirrors shall be at least three (3) feet high located with the bottom edge no more than three feet four inches (3'4") above the floor.

L. Patients shall have separate wardrobes, lockers or closets located within their respective patient rooms. A clothes rod and shelf shall be provided.

M. One or more windows shall be provided, with the sash not more than three (3) feet above the floor and with a gross area of not less than ten percent (10%) of the floor area of the room. In each patient room at least one (1) window to the outside shall be operable. Patient room windows shall be exposed to an outside area not less than thirty (30) feet horizontally opposite the window which contains no construction or grading which would further diminish the view and the exposure of the window to natural light.

N. Social spaces (dining, recreation, meditation) shall be provided throughout the facility with a cumulative area of not less than thirty (30) square feet per patient bed. One social space may serve more than one patient-care unit provided it is directly accessible from each unit and is sized proportionate to the total number of patient beds it serves. No social space shall be smaller than one hundred fifty (150) square feet in area.

O. Unless bathing facilities are included in the toilets serving each patient room, central bathing facilities shall be provided in each patient-care unit at a ratio of not fewer than one for each ten (1:10) beds.

P. Each bathing facility shall be located in its own room and shall be directly accessible from the general corridor. The bathing facility may be either a tub, shower or tub/shower combination.

Q. However, at least one (1) handicapped accessible shower shall be provided on each patient unit.

R. A locked cabinet for the storage of cleaning supplies shall be available in or near each bathroom.

Support and services areas. The following staff support and service areas shall be located directly accessible to each patient care unit:

A. Clean work and storage facilities shall be equipped with counter and sink and storage space provided for clean linen and supplies;

B. A separate soiled/decontamination utility room shall be equipped with a clinic sink (this fixture is not required where bedpan-flushing devices have been installed at each patient toilet), counter and sink and sufficient floor space shall be provided to accommodate storage containers for soiled linen, trash and infectious waste;

C. Space shall be provided for secure storage of staff personal items;

D. A staff station shall be located to provide visual supervision of the patient-care unit corridors. The station shall consist of a work counter and secure storage space for charts;

E. A medication storage and preparation station which has a means of locked storage for all medications shall be equipped with a work counter, sink, and refrigerator;

F. Separate locked storage facilities shall be provided in the station for controlled substances;

G. If medications are held in each patient room, the room shall include separate locked storage facilities for each patient’s medications;

H. A nourishment station shall be equipped with a work counter, sink, and refrigerator and shall be provided physically remote from the medication preparation station;

I. Storage space shall be provided for mobile equipment used on the unit;

J. A janitor’s closet shall be provided which is equipped with a mop sink and has sufficient space for the cleaning equipment and open supplies used to maintain the patientcare unit; and K. All clean support functions may be located in one clean workroom provided the room is carefully designed to provide adequate storage and function separations.

Food service facilities shall be designed and equipped to meet the requirements of the scope of services outlined as follows:

A. Dietary facilities shall comply with 19 CSR 20-1.010;

B. In hospice facilities where food is prepared on-site, the dietary facilities shall, as a minimum, have—a storage space including cold storage for four-day supply, space and equipment for food preparation to facilitate efficient food preparation and to provide for a safe and sanitary environment, conveniently located handwashing facilities, space for preparing food for distribution to patients, warewashing facilities which are isolated from the food preparation and serving area, and storage facilities for waste which is inaccessible for insects and rodents and accessible to the outside for pickup or disposal.

C. The warewashing processes shall produce dietary ware which is free of pathogenic organisms; and D. In hospice facilities where the food service is provided through a vendor contract, dietary facilities shall, as a minimum, include space for receiving and holding the food transport equipment, utility connections for food transport equipment to maintain appropriate serving temperatures, and a holding area for soiled dietary ware transport equipment which is out of the patient area and located near the service entrance for pick-up.

(B) Service Facilities Shall Meet the Following Standards:

Services including linen service.

A. Service facilities shall be provided in each inpatient hospice facility and located to be out of the normal public and clinical traffic flow.

B. A weather-protected service entrance shall be provided separate from entrances used by public and patients.

C. Space and facilities shall be provided for the sanitary storage and disposal of waste. Exterior dumpsters will suffice provided they can be accessed under the protection provided at the service entrance.

D. A general storage room shall be provided with an area not less than ten (10) square feet per bed for the first fifty (50) beds, plus eight (8) square feet per bed for the next twentyfive (25) beds, plus five square feet per bed for any additional beds over seventy-five (75). No storage room shall be less than one hundred (100) square feet of floor space. Off-site storage is acceptable, however, one half (1/2) of the required storage space shall be located in the inpatient hospice facility. General storage shall be concentrated in one area.

E. Space shall be provided to house mechanical equipment. The space shall be adequate for initial installation and ongoing maintenance access for each component of the systems housed in it. Mechanical equipment shall not be installed in rooms designated to house other functions.

F. A housekeeping room shall be provided with a janitor’s sink and space to store opened containers of cleaning supplies and housekeeping equipment used to maintain the facility. This room is not required if the hospice is maintained by a contract cleaning service which transports the necessary cleaning supplies and equipment to the facility on a daily

basis.

G. An oxygen storage room shall be provided. This room shall be enclosed with one-hour rated construction and shall have a powered or gravity vent to the outside. Permanent racks or fasteners shall be provided and used in the oxygen storage room to prevent accidental damage or dislocation of oxygen cylinders. In facilities storing quantities of oxygen less than one thousand five hundred (1,500) cubic feet in total, a power ventilated storage cabinet will comply. No ventilated gas storage facilities are required in hospices which store no medical gases within the building.

H. Laundry services may be provided by the hospice operator or may be obtained through contract with a linen service vendor. If laundry for the facility is done commercially, either entirely or in part, space shall be provided for the sorting, processing and storing of both soiled and clean linen.

Storage space shall be located to facilitate convenient pickup and delivery by commercial laundry personnel. Hospices with only one patient-care unit may accommodate these functions within the utility facilities provided in the unit’s staff support area.

I. Hospice-operated laundry facilities shall be designed and procedures instituted to prevent cross-contamination of clean and dirty linen. The laundry room shall be in a separate room from the kitchen, patients’ rooms, the dining room and the bathrooms or the nursing utility room. Adequate space shall be provided in the laundry room for the storing, sorting and processing of soiled linen. The processes of the laundry operation shall be appropriate to the production of patient linens which are free of pathogenic organisms. Space shall be provided for the storage of clean linen in a separate room from the laundry.

J. As may be required by the program, laundry facilities provided for cleaning patients’ clothing exclusively shall be located in the patient-care unit but in a room separate from other functions. A residential-style laundry equipment installation is acceptable.

K. As required by the program, living and sleeping quarters, separate from patients’ facilities, shall be provided for the employees and their families who may reside in the facility;

Elevators.

A. All inpatient hospice facilities having patient-care facilities located on any floor other than the main entrance floor shall have at least one (1) electric or electrohydraulic elevator. Hospice facilities with more than thirty (30) beds located on any floor other than the main entrance floor shall have at least two (2) elevators. Hospice facilities with more than two hundred (200) beds located on any floor other than the main entrance floor shall provide passenger and service elevators in numbers and at locations determined by a professionally conducted study of the hospice operation and its estimated vertical transportation needs.

B. Inside dimensions of patient-use elevators shall be not less than five feet four inches (5'4") by eight feet (8')with a capacity of 3,500 pounds. Cab and hoistway doors shall be not less than three feet ten inches (3'10") clear opening.

C. Elevators shall be equipped with an automatic leveling device of the two-way automatic maintaining type with an accuracy of plus or minus one-half inch.

D. Elevator call buttons, controls and door safety stops shall be of a type that will not be activated by heat or smoke.

E. Elevator controls, alarm buttons and telephones shall be accessible to wheelchair occupants and usable by others with various physical disabilities.

F. Elevator hoistway doors shall be fire rated to maintain the integrity of the fire-rated shaft enclosure;

Chutes and dumbwaiters.

A. Chutes and dumbwaiters may be installed in hospice facilities as required by the operational program.

B. Linen and trash chutes shall be of fire-resistant material and shall be installed with flushing ring, vent to atmosphere and floor drain at the floor of the chute discharge.

An automatic sprinkler shall be provided at the top of each linen and trash chute.

C. Service openings to chutes shall not be located in corridors or passageways but shall be located in a room having a fire-resistant construction of not less than one hour. Doors to the rooms shall be not less than 3/4-hour labeled doors equipped with an automatic closing device.

D. Service openings to chutes and other vertical openings shall have an approved self-closing labeled fire door rating not less than the fire-resistant rating of the shaft in which the chute is installed.

E. Chutes shall discharge directly into collection rooms separate from the incinerator, laundry or other services.

Separate collection rooms shall be provided for trash and for linen. These rooms shall have a fire-resistant construction of not less than one hour. Doors to these rooms shall be not less than 3/4-hour labeled doors equipped with an automatic closing device.

F. Dumbwaiters, conveyors and material-handling systems shall not open directly into a corridor or exitway but shall open into a room enclosed by construction having a fire resistance of not less than one hour and provided with a 3/4hour labeled fire door with a self-closing device.

G. Where horizontal conveyors and material-handling systems penetrate fire-rated walls or smoke walls, the penetrations shall be protected to maintain the integrity of the wall;

General design, finish and life safety requirements.

A. A continuous system of unobstructed corridors, referred to as required corridors, shall extend through the enclosed portion of each story of the building, connecting all rooms and spaces with each other and with all entrances, exitways and elevators, with the following exceptions: work suites such as the administrative suite and dietary area, which are occupied primarily by employed personnel, may have within them corridors or aisles as considered advisable, but are not subject to the regulations applicable to required corridors. Areas may be open to the required corridor system as permitted by NFPA 101 (1994), The Life Safety Code.

B. The arrangement of the physical plant shall provide for separation of the administrative/business, service and public areas from patient service areas.

C. Ceilings shall be at a height of at least eight feet.

Ceilings in corridors, storage rooms, toilet rooms and other minor rooms shall not be less than seven feet six inches (7'6").

Suspended fixtures located in the path of normal traffic shall not be less than six feet eight inches (6'8") above the floor.

D. Handrails may be provided on both sides of all corridors and aisles used by patients and, if provided, corridor handrails shall have ends return to the wall.

E. New inpatient hospice facilities shall be designed and constructed in compliance with Chapters Five through Seven and Chapter Twelve of NFPA 101 (1994), Life Safety Code and NFPA 99 (1993) Standard for Health Care Facilities, NFPA 13 (1994) Standard for Installation of Sprinkler Systems and NFPA 90A (1993) Standard for the Installation of Air Conditioning and Ventilation Systems. Section 12-6 of NFPA 101 shall not apply to these facilities.

F. Hardware on toilet room doors shall be operable from both the inside and the outside. All toilet room doors shall provide a net clear opening of not less than 32 inches.

G. The corridor doors from all patient-use areas as well as all doors through which patients may need to pass for emergency exit shall be not less than thirty-six (36) inches wide.

H. Every window in patient-use areas shall be provided with shades, curtains or drapes. Curtains and drapes shall be made of fabric which is treated to be or is inherently flameretardant.

I. The floors of toilets, baths, utility rooms and janitor’s closets shall have smooth, waterproof surfaces which are wearresistant. The floors of kitchens and food preparation areas shall be waterproof, greaseproof, smooth and resistant to heavy wear.

J. The walls of all rooms where food and drink are prepared, served or stored shall have a smooth surface with painted or equally washable finish. At the base they shall be waterproof and free from spaces which may harbor insects.

The walls of kitchens, utility rooms, baths, warewashing rooms, janitor’s closets and spaces with sinks shall have waterproof, painted, glazed, or similar finishes to a point above the splash and spray line.

K. The ceilings of all kitchens, sculleries and other rooms where food and drink are prepared shall be painted with washable paint.

L. All casework in the facility shall be finished with at least a sealer on all interior surfaces. Casework with sinks installed in the counter shall be caulked to provide a watertight joint between the backsplash and the wall.

M. All floor covering used in inpatient hospice facilities shall have either Class A or B fire ratings as required by Chapter Twelve of NFPA 101 (1994), The Life Safety Code.

N. Stairways, ramps, elevator hoistways, light or ventilation shafts, chutes and other vertical openings between stories shall be enclosed with construction which is equal to or greater than the required floor assembly rating of the building’s construction type.

O. The number of stories in a building housing a hospice facility shall be determined by counting the number of occupiable levels in the building regardless of their location at, above or below grade.

P. Each room or patient-use area shall be conspicuously and unmistakably identifiable at its entrance by patients, visitors and staff.

Q. All signage within six feet (6') of the floor shall be tactile to be usable by visually impaired persons.

R. Fire-resistant ratings— (I) Definitions— (a) Fire-separation distance is the distance in feet measured from the build ing face to the closest interior lot line, to the centerline of a street or public way or to an imaginary line between two (2) buildings on the same property.

(b) Fire-protection rating is the time in hours, or fractions of an hour, that an opening protective assembly will resist fire exposure as determined in accordance with the test procedures set forth in ASTM E119.

(II) Exterior walls with a fire-separation distance less than five feet (5') shall have a fire-resistant rating of one (1) hour.

(III) In exterior walls with a fire-separation distance of three feet or less, no openings will be allowed, from three feet (3') to five feet (5') no unprotected openings will be allowed, and protected openings will be allowed with a total aggregate area of fifteen percent (15%) of the wall surface.

(IV) Approved fire protective assemblies shall be fixed, self-closing or equipped with approved automatic-closing devices, a fire-resistant rating of not less than three-quarters (3/4) of an hour shall be required.

(V) Fire protective assemblies are not required where outside automatic sprinklers are installed for the protection of the exterior openings. The sprinklers shall be installed in accordance with NFPA 13;

Structural design.

A. All new facilities and additions to all areas of existing licensed facilities which undergo major remodeling, in all their parts, shall be of sufficient strength to resist all stresses imposed by dead loads, live loads and lateral or uplift forces such as wind, without exceeding, in any of the structural materials, the allowable working stress established for these materials by generally accepted good engineering practice.

B. Foundations shall rest on solid ground or properly compacted fill and shall be carried to a depth of not less than one foot below the estimated frost line or shall rest on leveled rock or load-bearing piles when solid ground is not encountered. When engineered fill is used, site preparation and placement of fill shall be done under the direct full-time supervision of the soils engineer. The soils engineer shall issue a final report on the compacted fill operation and certify its compliance with the job specifications. Reasonable care shall be taken to establish proper soil-bearing values for soil at the building site. If the bearing capacity of the soil is in question, a recognized load test may be used to determine the safe bearing value. Footings, piers and foundation walls shall be adequately protected against deterioration from the action of groundwater;

Electrical systems.

A. The entire electrical system shall be designed, installed and tested in compliance with NFPA 70 (1993) The National Electrical Code and NFPA 99 (1993) Standard for Health Care Facilities.

B. Emergency lighting shall be provided for exits, stairs and exit access corridors which shall be supplied by an emergency service and automatic electric generator or battery lighting system. This emergency lighting system shall be equipped with an automatic transfer switch. If battery lights are used, they shall be wet cell units or other rechargeable-type batteries equipped with automatic trickle charger. These units shall be rated at four (4) hours.

C. Patient rooms shall have a minimum general illumination of ten foot-candles, a night-light and a patient’s reading light. The general illumination fixtures and the nightlight shall be switched at the patient room door.

D. Ceiling lighting fixtures, if used, shall be of a type which are shaded or globed to minimize glare.

E. Each patient room shall have not less than one duplex receptacle on each wall in the room. The spacing of receptacles around the perimeter of the room shall not be greater than twelve (12) feet.

F. All occupied areas shall be adequately lighted as required by the duties performed in the space.

G. Night-lights shall be provided in corridor, stairways and patient rooms. Toilets adjacent to patient rooms are not required to have night-lights.

H. An electrically powered communication system shall be provided which allows staff to respond to patient calls regardless of patient location.

I. An electrically powered fire alarm system shall be provided as required by NFPA 101 (1994) The Life Safety Code.

The fire alarm system shall have an emergency back-up source of electrical power and a direct connection for notifying the fire department or fire department dispatch service. Fire alarm manual pull stations shall be provided at each exit and at each staff workstation in the patient-care units. Smoke detectors shall be installed in social space rooms which open directly to the corridor, in the vicinity of any smoke or fire door which is permitted to be held open by a magnetic hold-open device, and in the corridors at intervals not exceeding 30 feet.

J. Portable fire extinguishers shall be provided as required by NFPA 101 (1994) The Life Safety Code and the local authority;

Mechanical systems.

A. The heating, ventilation and air-conditioning systems shall be capable of providing temperature ranges between 72°F–80°F in all patient-care areas. The heating system shall be capable of maintaining a winter indoor temperature of not less than 72°F in all nonpatient areas. The air-conditioning system shall be capable of maintaining a summer indoor temperature of not more than 80°F in all nonpatient areas.

B. The heating system shall have automatic controls adequate to provide comfortable conditions in all portions of the building at all times.

C. Heating, ventilation and air-conditioning systems installed in inpatient hospice facilities shall be designed, installed and balanced in compliance with NFPA 90A (1993)

Standard for the Installation of Air Conditioning and Ventilation Systems, and shall provide the pressure relationships and at least the minimum air change rates indicated in Table 1.

TABLE 1—VENTILATION REQUIREMENTS

Minimum Minimum Pressure Air Changes of Total Air All Air Relationship Outdoor Air Per Changes Per Exhausted Air Returned to Adjacent Hour Supplied Hour Supplied Directly From This Area Designation Areas to Room to Room to Outdoors Room Patient Room E 2 2 Optional Optional Patient Area Corridor and Patient Living Room P 2 2 Optional Optional Soiled Workroom and Soiled Linen Holding N Optional 6 Yes No Clean Staff Work Area P 2 6 Optional Optional Toilet Room N Optional 6 Yes No Clean Linen Storage P Optional 2 Optional Optional Designated Smoking Area N Optional 10 Yes No Food Preparation Area E 2 6 Yes No Warewashing N Optional 6 Yes No Dietary and General Storage V Optional 2 Optional Optional Linen and Trash Chute Room N Optional 6 Yes No Medical Gas Storage and Manifold Rooms N Optional 6 Yes No Administrative and Public Areas E 2 2 Optional Optional P = Positive N = Negative V = Variable E = Equal D. All air-moving, heating, ventilation and airconditioning equipment shall be equipped with at least one filter located upstream of the conditioning equipment.

If a pre-filter is employed, the pre-filter shall be upstream of the conditioning equipment and the main filter shall be located farther downstream. All filters shall be easily accessible for maintenance. Filter frames shall be durable and carefully dimensioned and shall provide an airtight fit with the enclosing ductwork. All joints between the filter segments and the enclosing ductwork shall be sealed to preclude air leakage.

E. Outside air intakes shall be located no less than 25 feet from exhaust outlets of ventilation systems, combustion equipment stacks, clinical suction discharges and plumbing vent stacks or from areas which may collect vehicular exhaust and other noxious fumes.

F. Corridors shall not be used to supply air to or exhaust air from any room, except that air from corridors may be used to ventilate bathrooms, toilet rooms, janitor’s closets and small electrical or telephone closets opening directly onto corridors provided that ventilation can be accomplished by the undercutting of doors. The installation of louvers in corridor doors is prohibited. The space above the finished ceiling may be used as a plenum for return air only.

G. Exhaust hoods in meal preparation areas shall comply with the requirements of NFPA 96 (1994). All hoods and cooktop surfaces in meal preparation areas shall be equipped with automatic fire suppression systems, automatic fan controls and fuel shutoff;

Plumbing systems.

A. The entire plumbing system, its design, operation and maintenance shall comply with the requirements of all applicable local and state codes including the requirements set forth in this rule.

B. Plumbing fixtures.

(I) All plumbing fixtures shall be of nonabsorptive acid-resistant material.

(II) Clinical sinks shall have a bedpan-flushing device and shall have an integral trap in which the upper portion of a visible trap seal provides a water surface.

(III) Showers and tubs shall be provided with nonslip surfaces.

(IV) Water closets in patient areas shall be quiet operating types.

(V) Stools in patient toilet facilities shall be the elongated bowl type with nonreturn stops, backflow preventers and silencers. Seats shall be the split type and white in color.

(VI) Grab bars or handrails shall be provided adjacent to all bathtubs.

(VII) All lavatories shall be trimmed with valving operable without the use of hands.

C. Water supply systems.

(I) A reliable source of potable water shall be provided at the site to supply water in sufficient quantities to meet the various use demands of the hospice. The source of water shall have been tested and approved by the Missouri Department of Natural Resources.

(II) The water supply systems shall be designed to supply water at sufficient pressure to operate all fixtures and equipment during maximum demand periods.

(III) Each water service main, branch main, riser and branch to a group of fixtures shall be valved. Stop valves shall be provided at each fixture.

(IV) Reduced pressure backflow preventers shall be installed on water service entrance, hose bibbs, janitors’ sinks, bedpan-flushing attachments, and on all other fixtures to which hoses or tubing can be attached. The installation of backflow preventors shall provide safeguards against waterline expansion.

(V) The water supply system shall be designed to provide hot water at each hot water outlet at all times. The water-heating equipment shall have sufficient capacity to supply five gallons of water at 120°F per hour per bed for hospice fixtures and eight gallons per bed for kitchen and laundry. Lesser capacities may be accepted upon submission of the calculation for the anticipated demand of all fixtures and equipment in the building. Hot water at showers and bathing facilities shall not exceed 110°F. Hot water at handwashing facilities shall not exceed 120°F. Hot water circulating mains and risers shall be run from the hot storage tank to a point directly below the highest fixture at the end of each branch main.

D. Drainage systems.

(I) All fixtures and equipment shall be connected through traps to soil and waste piping and to the sewer and they shall all be properly vented to the outside.

(II) Courts, yards and drives which do not have natural drainage from the building shall have catch basins and drains to low ground, storm-water drainage system or dry wells.

(III) The building sanitary drain system shall be piped in cast iron, steel, copper or plastic.

(IV) Building sewers shall discharge into a community sewerage system when available. If such a system is not available, a facility providing sewage treatment shall conform to the rules of the Department of Natural Resources.

(V) Drainage piping shall not be installed within the ceiling or exposed in food preparation centers, food service facilities, food storage areas and clean linen storage rooms; special precautions shall be taken to protect any of these areas from possible leakage or condensation from necessary overhead drainage piping systems. These special precautions include requiring noncorrosive drip troughs with a minimum four-inch outside diameter to be installed under the drainage pipe in the direction of slope to a point where the pipe leaves the protected space and terminates at that point—usually at a wall. The trough shall be supported with noncorrosive strap hangers and screws from the pipe above. Trough joints and hanging screw penetrations shall be sealed to maintain watertight integrity throughout.

E. Natural or liquefied petroleum (LP) gas systems.

(I) Where gas-fire equipment is used, all gas piping, fittings, tanks and specialties shall be provided and installed in compliance with NFPA 54 (1992), NFPA 58 (1992), and the instructions of the gas supplier, except where more strict requirements are stated. Where liquefied petroleum gas (LPG) is used, compliance with the rules of the Missouri Department of Agriculture is also required.

(II) Where gas piping enters the building below grade, it shall have an outside vent as follows: a concrete box shall be made 18 inches by 18 inches with three-inch thick walls, of a height to rest on top of the entering gas pipe, and the top of the box to coming within six inches of top grade. The box shall be filled with coarse gravel. A one-inch upright vent line shall be to 1/2 the depth of the box and extend 12 inches above grade with a screened U-vent looking down. The vent line shall be anchored securely to the building wall.

(III) Gas outlets and gas-fired equipment shall not be installed in any patients’ bedrooms.

F. Where a piped central medical gas distribution system is installed, the oxygen piping, outlets, manifold rooms, and storage rooms shall be installed in accordance with the requirements of Chapter 4 of NFPA 99 (1993); and 9. Fire prevention and general operating requirements.

A. The hospice facility shall be maintained in a manner which provides a clean safe environment for the delivery of patient care and shall, until remodeled or renovated with the approval of the Department of Health, remain compliant with the codes and regulations under which the facility was constructed.

B. Exitways shall always be maintained free of obstructions.

C. Curtains, drapes and cubicle curtains shall be maintained in a manner which does not compromise their fire-resistant properties.

D. Smoking may be permitted in the patient’s room by the patient only, and designated smoking areas by others.

Designated smoking areas shall be ventilated as required by Table 1 of this rule. Modification of the patient room ventilation system is not required to permit occasional authorized smoking by a patient.

E. All waste containers shall be of noncombustible construction.

F. Electrical systems and medical gas systems shall be tested according to the provisions of NFPA 99 (1993) and shall be modified as necessary to comply with the operational requirements of that standard.

(5) General Design and Construction Standards for Existing Inpatient Hospice Facilities.

(A) Any inpatient hospice facility existing and in continuous operation prior to the date of October 30, 1996, will upon receipt of application for licensure, be inspected by the Department of Health to determine compliance with this rule.

Where existing physical conditions cause strict compliance to be difficult to achieve, the department may determine that the intent of the new construction rules has been satisfied through the establishment of acceptable equivalency conditions. The provision of fire alarm and detection systems, automatic extinguishment systems, building compartmentation and the presence of staff trained consistent with the facility’s disaster preparedness plan are factors which will be considered in determining fire safety compliance equivalency. The ability of the existing facility to meet the programmatic needs of the patients, their family, staff and public in an accessible and sanitary environment will be considered in determining functional equivalency. Existing inpatient hospice facilities shall provide the department evidence of compliance with all local regulations and codes as well as evidence that the existing operation is in good standing with the health facility licensure programs administered by Department of Social Services/Division of Aging. Existing inpatient hospice facilities shall be operated and licensed exclusively under the provisions of section 197.250, RSMo.

Filed Jan. 3, 2001, effective Aug. 30, 2001. Amended: Filed Sept. 11, 2007, effective March 30, 2008. *Original authority: 197.270, RSMo 1992, amended 1993.

History

authority and kept clear to provide immediate access for fire fighting equipment.
AUTHORITY: section 197.270, RSMo 2000. Original rule filed March 8, 1996, effective Oct. 30, 1996. Rescinded and readopted:

19 CSR 30-35.030 State Certification Management {#sec-19-csr-30-35.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-35.030}

PURPOSE: This rule defines the state activities related to the inspection, complaint investigation, and issuance of the certificate for state-certified hospice programs.

(1) Initial Application. When an initial application and initial fee of $500 for state hospice certification is received, the applicant shall provide the Department of Health (DOH) with sufficient evidence that the hospice has established appropriate policies and procedures for providing hospice services according to these rules. After review of these policies and procedures, and verification the hospice has the capability of providing hospice services by qualified persons, the DOH shall issue a temporary operating permit not to exceed 90 days. After the hospice has been in operation for 90 days, or sooner if possible, the DOH shall survey the hospice for compliance with these rules. The hospice shall have provided care to at least three patients for a period of at least three weeks for the purpose of the initial survey review. The DOH shall conduct the unannounced initial survey after the applicant indicates a readiness for that survey.

The DOH may extend the temporary approved certificate if the hospice can show good intent to accomplish the preparations for initial survey.

(2) The Annual Survey Inspection. The hospice management shall allow representatives of the Department of Health to survey the hospice to determine continued eligibility for hospice state certification. An annual renewal application and annual renewal fee per sliding scale must be submitted by every hospice prior to the expiration of the previous certificate.

Sliding scale annual renewal fees will be based on annual patient admissions and are as follows: 0–50 admissions, $250; 51–150 admissions, $400; 151–250 admissions, $550; and 251+ admissions, $750.

(A) The survey may include visits to the place of residence of any appropriate patient or family. After completion of the DOH survey, a written survey deficiency report shall be prepared showing the findings with respect to compliance or noncompliance with the provisions and the standards established in this chapter. The list of deficiencies found shall be served upon the hospice within 15 business days following the survey process. The list of deficiencies shall specifically state the statute or rule which the hospice is alleged to have violated. The hospice shall inform the DOH of the time necessary for compliance not to exceed 60 days from the exit date of the survey and within ten business days shall file a plan of correction with the DOH. A follow-up by the DOH to assure implementation of the plan of correction shall occur within 60 days of the hospice’s prior approved plan of correction date.

(B) Any person wishing to make a complaint against a hospice certified under the provisions of sections 197.250–197.280, RSMo, may register the complaint in writing or verbally with the DOH setting forth the details and facts supporting the complaint. The DOH shall investigate complaints received.

Any complaint related to abuse, neglect or exploitation as described in section 197.266, RSMo shall be reported according to the requirements of that section.

(C) In addition to the survey inspection required for initial certification or certification renewal the DOH may make other survey inspections and/or complaint investigations during normal business hours. Each hospice shall allow the DOH or its authorized representatives to enter upon its premises as needed for the purpose of conducting a survey inspection and/ or complaint investigation.

(3) Change of Ownership. The hospice certification shall not be transferable or assignable. If during the period in which a certificate is in effect, an operator which is a partnership, limited partnership, or corporation undergoes any of the following changes, whether by one or by more than one action, the operator shall apply for a new approved certificate not less than 30 days before any change:

(A) With respect to a limited partnership, a change in the majority interest of general partners;

(B) With respect to a limited partnership, a change in the general partner or in the majority interest of limited partners; or (C) With respect to a for-profit corporation, a change in the persons who own, hold or have the power to vote the majority of any class of stocks issued by the corporation.

(4) Multiple Offices/Counties. When the hospice consistently manages and supervises multiple offices, serving contiguous geographic areas as evidenced by indicators such as consistent meetings, chart review and other methods, and evidences the provision of patient-care services on a consistent basis throughout its geographic area of services, only one certificate shall be required. A $200 fee per each multiple office will be added to the annual renewal fee, not to exceed a total of $750.

When the hospice has multiple offices or county areas and it is evident that consistent management and supervision or consistent provision of patient-care services throughout its service area is lacking, a separate certificate shall be required for one or more of the multiple offices or through the new development of a separate certified office as determined by the DOH. Statewide certification will not be granted. Inpatient facilities shall be located within boundaries of the state of Missouri.

(5) Satellite Offices and Reciprocal Agreements with Bordering States. All agencies providing hospice services in Missouri shall have a valid Missouri Hospice Certification and shall pay the annual fee. The satellite office shall make available all records required for the survey which shall be conducted by the DOH.

(6) Certificate Not Issued. A certificate shall not be issued or renewed if the operator, owner or any principal in the operation of the hospice has ever been convicted of any offense concerning the operation of hospice or of any offense which is reasonably related to the qualification, functions, or duties of a hospice. Notwithstanding any other provisions of law, the DOH shall have access to records involving an owner or manager of a hospice applying for or renewing a certificate as provided in this chapter, where the applicant has been adjudicated and found guilty or entered a plea of guilty or nolo contendere in a prosecution under the laws of any state or of the United States for any offense reasonably related to the qualification, functions or duties of any person who manages or owns a hospice certified under sections 197.250– 197.280, RSMo. The DOH may deny, suspend, or revoke the certificate of any company whose owners or managers have been convicted of such an offense.

(7) Revocation. The DOH may refuse to issue, may suspend or may revoke or refuse to renew the certificate of any hospice for failure to comply with any provision of sections 197.250– 197.280, RSMo, or with any of these rules or standards adopted under the provisions of sections 197.250–197.280, RSMo, or for obtaining a certificate by means of fraud, misrepresentation or concealment of any material facts. Any hospice which has been refused a certificate or which has had its certificate revoked or suspended by the DOH may seek a review of the Department of Health’s action by the Administrative Hearing Commission.

There shall be a six-month waiting period for reapplication from final Department of Health action.

(8) Intermediate Sanctions. If the department determines on the basis of an inspection, or otherwise, that a statecertified hospice program is no longer in compliance with the requirements specified in these rules, and determines that the deficiencies jeopardize the health and safety of the patients of the hospice, the department shall take action to remedy the specific deficiencies through intermediate sanctions or the termination of the certification. Any action taken under this

section shall be immediately effective not-withstanding any provisions of law to the contrary. Intermediate sanctions may include:

(A) Suspension of all or part of the services provided by the hospice;

(B) Restrictions on the admission of new patients to the hospice’s program;

(C) DOH approval of the appointment of temporary management at hospice expense to oversee the operation of the hospice to protect and assure the health and safety of the individuals under the care of the hospice while improvements are made in order to bring the hospice into compliance with the requirements of these rules; and (D) These intermediate sanctions shall be designed so as to minimize the time between identification of deficiencies and imposition of these sanctions, and shall provide for the imposition of incrementally more severe sanctions for repeated or uncorrected deficiencies.

Filed Jan. 3, 2001, effective Aug. 30, 2001. *Original authority: 197.270, RSMo 1992, amended 1993.

History

AUTHORITY: section 197.270, RSMo 2000. Original rule filed March 8, 1996, effective Oct. 3, 1996. Rescinded and readopted:

Chapter 40a Comprehensive Emergency Medical Services Systems Regulations

19 CSR 30-40.005 Abbreviations and Definitions Relating to Ambulance Regulations SR 30-40.010 affing of Ambulances {#sec-19-csr-30-40.005 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.005}

(Rescinded February 28, 1999)

SR 30-40.020 Ambulance Vehicle Configuration and Equipment Requirements for 19 CSR 30-40.030 Insur ance Requirements for Ambulance Licensure SR 30-40.035 Reporting Fire and Motor Vehicle Accidents Involving Ambulances SR 30-40.047 Manda tory Notice to Emergency Response Personnel of Possible E xposure to Communicable Diseases

19 CSR 30-40.048 Training for Emergency Response Personnel and Good Samaritans on the C ommunicable Disease Reporting Regulation SR 30-40.050 Mobile Emer gency Medical Technicians SR 30-40.060 Emer gency Medical Service Personnel Application SR 30-40.070 P ublic Convenience and Necessity Hearings 19 CSR 30-40.110 Pr ocedures for EMS Course Approvals {#sec-19-csr-30-40.048 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.048}

(Rescinded February 28, 1999) ....

19 CSR 30-40.115 Requirements for Mobile Emergency Medical Technician (MEMT) {#sec-19-csr-30-40.115 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.115}

Continuing Education/Quality Improvement (CE/QI) Programs

19 CSR 30-40.120 Instructor Qualifications for EMT Courses 19 CSR 30-40.130 Use of Obtur ators by EMTs {#sec-19-csr-30-40.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.120}

(Rescinded February 28, 1999) ..............

SR 30-40.140

Cr iteria for Revocation, Suspension, Probation and/or Denial of Initial or Renewal Application for Ambulance Attendant, Attendant/Driver and Mobile Emergency Medical Technician Licenses

19 CSR 30-40.150 Restriction on Licensure Actions Without Thorough Investigation {#sec-19-csr-30-40.150 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.150}

19 CSR 30-40.152 Criminal Background Checks by Department of Health for {#sec-19-csr-30-40.152 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.152}

19 CSR 30-40.160 Physician Medical Advisor Required for All Ambulance Services SR 30-40.170 Misr epresenting the Level of Ambulance Service or Training, 19 CSR 30-40.175 Minimum T raining Level of Personnel Using Emergency Medical Equipmen t {#sec-19-csr-30-40.160 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.160}

(Rescinded February 28, 1999)

SR 30-40.180

Use of P neumatic Counter Pressure Device by EMTs SR 30-40.190 E xceptions to the Requirement for Maintenance of Voice Contact or elemetry in Regard to Mobile Emergency Medical Technician SR 30-40.195 Emer gency Medical Services (EMS) Personnel Within the Hospit al Emergency Department (Rescinded February 28, 1999)

SR 30-40.200 efinitions Relating to Air Ambulance Services

19 CSR 30-40.210 Air Ambulance Regulations for Helicopter {#sec-19-csr-30-40.210 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.210}

19 CSR 30-40.220 Air Ambulance Regulations for Fixed-Wing Aircraft {#sec-19-csr-30-40.220 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.220}

19 CSR 30-40.303 Medical Director Required for All: Ambulance Services and Emergency Medical Response Agencies That Provide Advanced Life Support S ervices, Basic Life Support Services Utilizing Medications or Providing Assistance With Patients’ Medications, or Basic Life Support Services Performing Invasive Procedures Including Invasive A irway Procedures; Dispatch Agencies Providing Pre-arrival 19 CSR 30-40.308 ation and Licensure Requirements Standards for the Licensure SR 30-40.309 ation and Licensure Requirements Standards for the Licensure and Relic ensure of Ground Ambulance Services {#sec-19-csr-30-40.303 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.303}

19 CSR 30-40.331 Application and Accreditation or Certification Requirements for raining Entities that Conduct Training for First Responders, Emergency Medical Dispatchers, Emergency Medical Technicians-Basic, Emergency Medical Technicians-Intermediate, and Emer gency Medical Technicians-Paramedic ..................... {#sec-19-csr-30-40.331 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.331}

19 CSR 30-40.333 Application and Licensure Requirements for the Licensure and Relic ensure of Emergency Medical Response Agencies That Pr ovide Advanced Life Support .................................... {#sec-19-csr-30-40.333 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.333}

SR 30-40.340

Initial Emer gency Medical Technician Licensure of Mobile Emergency Medic al Technicians, Ambulance Attendants and Ambulance At tendant-Drivers Who Have a License with an Expiration ate of August 28, 1998 or Later ...................................

SR 30-40.342 ation and Licensure Requirements for the Initial Licensure and Relic ensure of Emergency Medical Technician-Basics, Emergency Medical Technician-Intermediate, and Emergency Medical echnician-Paramedics ...........................................

19 CSR 30-40.365 Reasons and Methods the Department Can Use to Take Administrative L icensure Actions ................................................ {#sec-19-csr-30-40.365 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.365}

SR 30-40.375

Uniform D ata Collection System and Ambulance Reporting Requir ements for Ambulance Services .............................

SR 30-40.410 efinitions and Abbreviations Relating to Trauma Centers SR 30-40.440 andards for Pediatric Trauma Center Designation ..................

SR 30-40.528 Application and Licensure Requirements; Standards for SR 30-40.600 O utside the Hospital Do-Not-Resuscitate (OHDNR) ...................

19 CSR 30-40.730 andards for Stroke Center Designation ............................ {#sec-19-csr-30-40.730 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.730}

SR 30-40.740 efinitions and Abbreviations Relating to ST-Segment Elevation My ocardial Infarction (STEMI) Centers SR 30-40.750 S T-Segment Elevation Myocardial Infarction (STEMI) Center esignation Application and Review SR 30-40.760 andards for ST-Segment Elevation Myocardial Infarction (STEMI)

C enter Designation 19 CSR 30-40.770 C ommunity-based or Regional Plan for Emergency Medical Services for T rauma, ST-Segment Elevation Myocardial Infarction (STEMI), or Str oke SR 30-40.780 efinitions and Abbreviations Relating to the Transport Protocol for Str oke and the Transport Protocol for ST-Segment Elevation My ocardial Infarction (STEMI) Patients

19 CSR 30-40.790 Transport Protocol for Stroke and ST-Segment Elevation Myocardial 19 CSR 30-40.792 Adult T rauma and Pediatric Field Triage and Transport Protocol {#sec-19-csr-30-40.790 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.790}

19 CSR 30-40.800 EMT-Community Paramedic, Community Paramedic Program, and SR 30-40.810 G round Ambulance Transport of Patients to Locations That Are Not Hospit als SERVICES Services Systems Regulations {#sec-19-csr-30-40.800 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.800}

19 CSR 30-40.005 Abbreviations and Definitions Relating to Ambulance Regulations previously filed as 13 CSR 50-40.005. Original rule filed March 13, 1979, effective June 11, 1979. Amended: Filed Jan. 13, 1990, effective April 26, 1990. Rescinded: Filed Aug. 28, 1998, effective Feb. 28, {#sec-19-csr-30-40.005 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.005}

19 CSR 30-40.010 Staffing of Ambulances previously filed as 13 CS. 50-40.010. Original rule filed Aug. 22, 1974, effective Feb. 23, 1975. Amended: Filed Jan. 13, 1990, effective April 26, 1990. Rescinded: Filed Aug. 28, 1998, effective Feb. 28, {#sec-19-csr-30-40.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.010}

19 CSR 30-40.020 Ambulance Vehicle Configuration and Equipment Requirements for Licensure {#sec-19-csr-30-40.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.020}

This rule was previously filed as 13 CSR 50-40.020. Original

rule filed Aug. 22, 1974, effective Feb. 23, 1975. Amended: Filed Oct. 7, 1983, effective Jan. 13, 1984. Rescinded: Filed Aug. 28, 1998,

History

AUTHORITY: sections 190.115, RSMo 1986 and 190.185, RSMo Supp.

19 CSR 30-40.025 Ambulance Markings {#sec-19-csr-30-40.025 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.025}

Original rule filed Oct. 7, 1983, effective Jan. 13, 1984. Rescinded:

History

AUTHORITY: sections 190.115.1(4), RSMo 1986 and 190.185, RSMo Supp. 1993. This rule was previously filed as 13 CSR 50-40.025.

19 CSR 30-40.030 Insurance Requirements for Ambulance Licensure {#sec-19-csr-30-40.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.030}

Amended: Filed Nov. 14, 1989, effective Jan. 26, 1990. Rescinded:

History

AUTHORITY: sections 190.120, RSMo 1986, 190.185, RSMo Supp. 1993 and 537.610, RSMo Supp. 1989. This rule was previously filed as 13 CSR 50-40.030. Original rule filed Aug. 22, 1974, effective Feb. 23, 1975. Amended: Filed Oct. 7, 1983, effective Jan. 13, 1984.

19 CSR 30-40.035 Reporting Fire and Motor Vehicle Accidents Involving Ambulances {#sec-19-csr-30-40.035 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.035}

History

AUTHORITY: section 190.185, RSM. Supp. 1993. Original rule filed Jan. 18, 1990, effective April 26, 1990. Rescinded: Filed Aug. 28, 1998, effective Feb. 28, 1999.

19 CSR 30-40.040 Patient Care Equipment {#sec-19-csr-30-40.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.040}

Amended: Filed Aug. 26, 1993, effective April 9, 1994. Rescinded:

History

AUTHORITY: section 190.185, RSM. Supp. 1993. This rule was previously filed as 13 CSR 50-40.040. Original rule filed Aug. 22, 1974, effective Feb. 23, 1975. Amended: Filed Oct. 7, 1983, effective Jan. 13, 1984. Amended: Filed Jan. 13, 1990, effective April 26, 1990.

19 CSR 30-40.045 Communicable Disease Policy {#sec-19-csr-30-40.045 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.045}

(Rescinded: February 28, 1999)

History

AUTHORITY: section 190.185, RSMo Supp. 1993. Original rule filed Jan. 18, 1990, effective April 26, 1990. Amended: Filed Aug. 14, 1992, effective Feb. 26, 1993. Rescinded: Filed Aug. 28, 1998,

19 CSR 30-40.047 Mandatory Notice to Emergency Response Personnel of Possible Exposure to Communicable Diseases {#sec-19-csr-30-40.047 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.047}

PURPOSE: This rule establishes an inquiry and notice procedure to be followed by receiving medical facility personnel concerning the possibility of exposure to communicable diseases by emergency response personnel and good samaritans.

(1) The following definitions shall be used in the interpretation of this rule:

(A) Aerosols mean tiny invisible particles or droplet nuclei usually less than ten (10) micrometers in diameter, which float on air currents and are capable of being suspended in air for a considerable period of time and are not to be confused with droplet as defined in subsection (1)(F) of this rule;

(B) Airborne transmission means person-to-person transmission of infectious organisms through the air by means of droplet nuclei;

(C) Bloodborne transmission means person-to-person transmission of an infectious agent through contact with an infected person’s blood or other body fluids;

(D) Communicable disease means an infectious disease transmitted by a significant exposure as defined in subsections (2)(A)—(E) of this rule, and examples of likely communicable diseases for investigation for possible significant exposures are— 1. Airborne diseases—pulmonary tuberculosis (Mycobacterium tuberculosis) and measles;

Bloodborne diseases—Hepatitis B and C and human immunodeficiency virus (HIV) infection including acquired immunodeficiency syndrome (AIDS);
Droplet spread diseases—rubella, Corynebacterium diphtheriae, and Neisseria meningitides; and 4. Uncommon or rare diseases—hemorrhagic fevers including Lassa, Marburg, Ebola and Congo-Crimean; plague (Yersinia pestis); and rabies;

(E) Designated officer means a city or county health department officer, or his/her designee, appointed by the director of the Department of Health or his/her designee. The designated officer’s designee may be, at local option, a person associated with an ambulance service, fire department or other enforcement agency; the designated officer may appoint multiple designees as needed;

(F) Droplets mean large particles of moisture that rapidly settle out on horizontal surfaces and originate from talking, sneezing or coughing;

(G) Droplet spread means brief passage of an infectious agent through the air, usually within three feet (3') of the source;

(H) Emergency means a sudden or unforeseen situation or occurrence that requires immediate action to save life or to prevent suffering or disability; the determination of the existence of the emergency can be made either by the patient/ victim or by any emergency response personnel (ERP) or good samaritan on the scene;

(I) Emergency response personnel (ERP) means firefighters, law enforcement officers, paramedics, emergency medical technicians, first responders and other persons including employees of legally organized and recognized volunteer organizations—regardless of whether the individuals receive compensation—who, in the course of professional duties, respond to emergencies;

(J) Exposure or significant exposure means an ERP or good samaritan has experienced a possible risk of becoming infected with a communicable disease(s) including those identified in paragraphs (1)(D)1.–4. of this rule by a means identified in subsections (2)(A)–(E) of this rule;

(K) Good samaritans mean individuals that are not ERPs that provide emergency medical assistance or aid until ERPs arrive;

(L) Medical facility means a health care facility licensed under Chapter 197, RSMo or a state medical facility;

(M) Pathogen means any disease-producing microorganism;

(N) Patient means the victim of an emergency who has been aided by an ERP or good samaritan;

(O) Potentially life-threatening communicable disease means an infectious disease which can cause death in a susceptible host; and (P) Universal precautions means an approach to infection prevention and control that requires all human blood and certain human body fluids to be treated as if infectious for HIV, hepatitis B virus (HBV), and other bloodborne pathogens.

(2) Means of transmission of communicable diseases are— (A) Any person-to-person contact in which a commingling of respiratory secretions (saliva and sputum) between the patient and ERP or good samaritan may have taken place;

(B) Transmittal of the blood or bloody fluids of the patient onto the mucous membranes (mouth, nose or eyes) of the ERP or good samaritan or into breaks in the skin of the ERP or good samaritan;

(C) Transmittal of other body fluids (semen, vaginal secretions, amniotic fluids, feces, wound drainage or cerebral spinal fluid) onto the mucous membranes or breaks in the skin of the ERP or good samaritan;

(D) Any nonbarrier unprotected contact of the ERP or good samaritan with mucous membranes or nonintact skin of the patient; or (E) Sharing of airspace by an ERP or a good samaritan with a patient who has been determined by the treating facility to have an infectious disease caused by airborne pathogens.

(3) The designated officer shall have the following duties:

(A) Collecting, upon request, facts surrounding possible exposure of an ERP or good samaritan to a communicable disease or infection;

(B) Contacting facilities that received patients who potentially exposed ERPs or good samaritans to ascertain if a determination has been made as to whether the patient has a communicable disease or infection and to ascertain the results of that determination;

(C) Notifying the ERP or good samaritan as to whether s/he has been exposed within forty-eight (48) hours of receiving the patient’s diagnosis report, medical information or necessary test results and providing information regarding the exposure, importance of appropriate medical follow-up and confidentiality; and (D) Upon request of the receiving medical facility or coroner/ medical examiner’s office, notifying the ERP or good samaritan of potential exposure to a communicable disease.

(4) The receiving medical facility personnel shall notify the ERP or good samaritan or the appropriate designated officer as soon as there has been a determination that there may have been a significant exposure—as defined in subsection (1)(J), of this rule—to communicable diseases including those identified in paragraphs (1)(D)1.–4. of this rule, by those means identified in subsections (2)(A)–(E) of this rule, thereby creating a risk of infection from a patient transported or assisted during the possible time of communicability of the particular disease.

Information provided shall include to the extent known the type of disease in question; date, time and place of possible exposure; and recommendations regarding appropriate followup. The receiving medical facility or coroner/medical examiner’s office shall make a commitment to faithfully implement the procedures provided for by section (4) of this

rule, to assign appropriate personnel to investigate cases that appear to have involved a significant exposure as defined in subsection (1)(J) of this rule to an ERP or good samaritan and to provide the notification to the ERP or good samaritan or designated officer. If the receiving medical facility has determined that contacting the appropriate designated officer was better than notifying the ERP or good samaritan directly, then the designated officer shall employ previously developed policies and procedures governing the dissemination of information to the ERP or good samaritan and shall direct them to seek appropriate medical care. Nothing in this section shall be construed to imply that a medical facility has absolute knowledge as to the communicable disease status of all its patients at all times. Neither shall this section be construed as eliminating or reducing any preexisting duty under the common law or sections 2681–2690 of the Public Health Service Act (PHS) in 42 U.S.C.A. 300ff-81–300ff-90 to determine the communicable disease status of any patient.

(5) An ERP or good samaritan may submit a request for a determination whether s/he has had a significant exposure to a communicable disease, preferably within twenty-four (24) hours but as soon as possible.

(A) Upon receipt of a request from a designated officer, an ERP or good samaritan, the medical facility or coroner/medical examiner’s office shall evaluate the facts and determine if the ERP or good samaritan may have had a significant exposure to a communicable disease.

(B) If a determination is made of a possibly significant exposure—as defined in subsection (1)(J) of this rule—to a communicable disease(s) including those identified in paragraphs (1)(D)1.–4. of this rule, by a means identified in subsections (2)(A)–(E) of this rule, the ERP or good samaritan shall be notified as soon as possible, but not later than fortyeight (48) hours after receiving the patient’s diagnosis report.

(C) If the information provided by the ERP, good samaritan or designated officer is insufficient to make a determination, the ERP, good samaritan or designated officer shall be notified in writing, by telephone, or by electronic transmission as soon as possible but not later than forty-eight (48) hours after receiving the initial request.

(D) If the ERP, good samaritan or designated officer receives notice that insufficient information was provided, the ERP or good samaritan may request the designated officer to evaluate the request and the medical facility’s or coroner/medical examiner’s office response. The designated officer shall then evaluate the request and the medical facility’s or coroner/ medical examiner’s response and report his/her findings to the ERP or good samaritan as soon as possible but not later than forty-eight (48) hours after receiving the request.

If the designated officer finds the information provided is sufficient to make a determination of exposure, s/he shall submit the report to the medical facility or coroner/medical examiner’s office.
If the designated officer finds the information provided was insufficient to make a determination of exposure, s/ he shall contact the ERP or good samaritan to gather the additional needed information, contact the medical facility or coroner/medical examiner’s office, or both, to collect any additional available relevant information. If sufficient facts are then collected by the medical facility or coroner/medical examiner’s office, the ERP or good samaritan shall be notified of any change in status.
If there was not a significant exposure, the medical facility, coroner/medical examiner’s office or designated officer shall notify the ERP or good samaritan, or designated officer (who shall notify the ERP or good samaritan) within forty-eight (48) hours.

(6) If the ERP, good samaritan, designated officer and medical facility or coroner/medical examiner’s office are unable to achieve satisfactory resolution to questions or issues under the procedures in subsections (5)(A)–(D) of this rule, a request may be made to the Department of Health, through its director or the director’s designee, to resolve the issues or questions, preferably within seventy-two (72) hours, but as soon as possible.

(7) The Department of Health’s Com munic able Disease Exposure Report (form MO 580-1825, 4/94) shall be used by ERPs or good samaritans to notify medical facilities or coroners/medical examiner’s office or designated officer regarding suspected exposure. The ERP or good samaritan shall retain a copy of the form and shall send one (1) copy to the designated officer and one (1) copy to the receiving medical facility or coroner/ medical examiner’s office.

(8) The designated officer and the local health department shall assure that an adequate supply of reporting forms is provided to all receiving medical facilities or coroner/medical examiner’s offices within the geographic area served.

(9) The notification process established by the receiving medical facility or coroner/medical examiner’s office to deal with reported exposures to ERPs or good samaritans shall be as comprehensive as that for employees of the medical facility or coroner/medical examiner’s office.

(10) Receiving medical facilities or coroner/medical examiner’s offices and designated officers with information regarding the significant exposure—as defined in subsection (1)(J) of this rule—of an ERP or good samaritan to a communicable disease(s) including those identified in paragraphs (1)(D)1.–4. of this rule by a means identified in subsections (2)(A)–(E) of this rule, shall provide information directly to the affected ERP. In the case of a good samaritan the designated officer or his/her designee shall provide the information directly to the good samaritan. All information shall be in a manner that protects the identity and confidentiality of the possibly infected individual and the ERP or good samaritan.

(11) A sending medical facility in advance of the transfer of a patient to another medical facility or back to the patient’s residence shall notify the ambulance personnel of the existence and nature of any communicable disease(s) including those identified in paragraphs (1)(D)1.–4. of this

rule by those means identified in subsections (2)(A)–(E) of this rule and appropriate precautions and procedures to follow. If the information supplied by the sending medical facility is unclear to the ambulance personnel, the ambulance personnel may make a specific inquiry as to whether there are any known communicable disease(s) involving a possible significant exposure that might occur during the transport of the patient. Nothing in this section shall be construed to imply that a medical facility has absolute knowledge as to the communicable disease status of all its patients at all times, but neither shall this section be construed to imply that a medical facility has absolute knowledge as to the communicable disease status of all its patients at all times, but neither shall this section be construed as eliminating or reducing any preexisting duty under the common law or sections 2681–2690 of the PHS Act in 42 U.S.C.A. 300ff-81–300ff-90 to determine the communicable disease status of any patient.

History

AUTHORITY: sections 192.020, RSMo 1986 and 192.806.1, RSMo Supp. 1993. Original rule filed Feb. 2, 1994, effective Aug. 28, 1994. Original authority: 192.020, RSMo 1939, amended 1945, 1951 and 192.806, RSMo 1992, amended 1993.

19 CSR 30-40.048 Training for Emergency Response Personnel and Good Samaritans on the Communicable Disease Reporting Regulation {#sec-19-csr-30-40.048 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.048}

History

AUTHORITY: sections 192.020, RSMo 1986 and 192.806.1, RSMo Supp. 1993. Original rule filed Feb. 2, 1994, effective Aug. 28, 1994.

19 CSR 30-40.050 Mobile Emergency Medical Technicians previously filed as 13 CSR 50-40.050. Original rule filed Aug. 22, 1974, effective Feb. 23, 1975. Rescinded: Filed Aug. 28, 1998, {#sec-19-csr-30-40.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.050}

19 CSR 30-40.060 Emergency Medical Service Personnel Application {#sec-19-csr-30-40.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.060}

History

AUTHORITY: section 190.185, RSMo 1994. Original rule filed Sept. 1, 1995, effective April 30, 1996. Rescinded: Filed Aug. 28, 1998,

19 CSR 30-40.070 Public Convenience and Necessity Hearings {#sec-19-csr-30-40.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.070}

Filed March 20, 1996, effective Sept. 30, 1996. Rescinded: Filed Aug. 28, 1998, effective Feb. 28,

History

AUTHORITY: sections 190.125 and 190.185, RSMo 1994. This rule was previously filed as 13 CSR 50-40.070. Original rule filed Aug. 22, 1974, effective Feb. 23, 1975. Rescinded and readopted: Filed Nov. 16, 1987, effective Jan. 29, 1988. Amended: Filed April 14, 1992, effective Jan. 15, 1993. Emergency amendment filed May 2, 1994, effective May 14, 1994, expired Sept. 10, 1994. Amended: Filed May 2, 1994, effective Oct. 30, 1994. Amended: Filed Nov. 15, 1994, effective May 28, 1995. Amended:

19 CSR 30-40.080 Records and Forms previously filed as 13 CSR 50-40.080. Original rule filed Aug. 22, 1974, effective Feb. 23, 1975. Rescinded: Filed Aug. 28, 1998, {#sec-19-csr-30-40.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.080}

19 CSR 30-40.090 Examination Procedures {#sec-19-csr-30-40.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.090}

History

AUTHORITY: section 190.185, RSM. Supp. 1993. This rule was previously filed as 13 CSR 50-40.090. Original rule filed March 13, 1979, effective June 11, 1979. Amended: Filed April 14, 1992, effective Jan. 15. 1993. Rescinded: Filed Aug. 28, 1998, effective Feb. 28, 1999.

19 CSR 30-40.100 Relicensure Procedures previously filed as 13 CSR 50-40.100. Original rule filed March 13, 1979, effective June 11, 1979. Amended: Filed June 4, 1990, effective Oct. 31, 1990. Amended: Filed Nov. 9, 1993, effective July 10, 1994. {#sec-19-csr-30-40.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.100}

19 CSR 30-40.110 Procedures for EMS Course Approvals previously filed as 13 CSR 50-40.110. Original rule filed March {#sec-19-csr-30-40.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.110}

19 CSR 30-40.115 Requirements for Mobile Emergency Medical Technician (MEMT) Continuing Education/Quality Improvement (CE/QI) Programs {#sec-19-csr-30-40.115 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.115}

History

AUTHORITY: section 190.185, RSMo Supp. 1993. Original rule filed Nov. 9, 1993, effective July 10, 1994. Rescinded: Filed Aug. 28, 1998,

19 CSR 30-40.120 Instructor Qualifications for EMT Courses previously filed as 13 CS. 50-40.120. Original rule filed March {#sec-19-csr-30-40.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.120}

19 CSR 30-40.130 Use of Obturators by EMTs previously filed as 13 CSR 50-40.130. Original rule filed March {#sec-19-csr-30-40.130 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.130}

19 CSR 30-40.140 Criteria for Revocation, Suspension, Probation and/or Denial of Initial or Renewal Application for Ambulance At ten dant, Attendant/Driver and Mobile Emergency Medical Technician Licenses {#sec-19-csr-30-40.140 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.140}

History

AUTHORITY: section 190.185, RSMo 1994. This rule was previously filed as 13 CSR 50-40.140. Original rule filed Oct. 7, 1983, effective Jan. 13, 1984. Amended: Filed Sept. 1, 1995, effective April 30, 1996.

19 CSR 30-40.150 Restriction on Licensure Actions Without Thorough Investigation and Administrative Review {#sec-19-csr-30-40.150 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.150}

This rule was previously filed as 13 CSR 50-40.150. Original

rule filed Oct. 7, 1983, effective Jan. 13, 1984. Rescinded: Filed Aug. 28, 1998, effective Feb. 28, 1999.

History

AUTHORITY: sections 190.165, RSMo 1986 and 190.185, RSMo Supp.

19 CSR 30-40.152 Criminal Background Checks by Department of Health for Licensure and Renewal Applications {#sec-19-csr-30-40.152 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.152}

History

AUTHORITY: section 190.185, RSMo 1994. Original rule filed Sept. 1, 1995, effective April 30, 1996. Rescinded: Filed Aug. 28, 1998,

19 CSR 30-40.160 Physician Medical Advisor Required for All previously filed as 13 CSR 50-40.160. Original rule filed Oct. 7, 1983, effective Jan. 13, 1984. Amended: Filed Jan. 13, 1990, effective April 26, 1990. Amended: Filed Aug. 15, 1994, effective Feb. 26, 1995. {#sec-19-csr-30-40.160 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.160}

19 CSR 30-40.170 Misrepresenting the Level of Ambulance Service or Training, a Violation of Law {#sec-19-csr-30-40.170 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.170}

rule filed Oct. 7, 1983, effective Jan. 13, 1984. Rescinded: Filed Aug. 28, 1998, effective Feb. 28, 1999.

History

AUTHORITY: sections 190.185 RSMo Supp. 1993 and 570.160, RSMo 1986. This rule was previously filed as 13 CSR 50-40.170. Original

19 CSR 30-40.175 Minimum Training Level of Personnel Using Emergency Medical Equipment {#sec-19-csr-30-40.175 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.175}

History

AUTHORITY: section 190.185, RSMo Supp. 1993. Original rule filed Jan. 18, 1990, effective April 26, 1990. Rescinded: Filed Aug. 28, 1998, effective Feb. 28, 1999.

19 CSR 30-40.180 Use of Pneumatic Counter Pressure Device by EMTs previously filed as 13 CS. 50-40.180. Original rule filed Oct. 7, 1983, effective Jan. 13, 1984. Rescinded: Filed Aug. 28, 1998, effective Feb. 28, 1999. {#sec-19-csr-30-40.180 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.180}

19 CSR 30-40.190 Exceptions to the Requirement for Maintenance of Voice Contact or Telemetry in Regard to Mobile Emergency Medical Technician Advanced Life- Support Procedures previously filed as 13 CSR 50-40.190. Original rule filed Oct. 7, 1983, effective Jan. 13, 1984. Rescinded: Filed Aug. 28, 1998, effective Feb. 28, 1999. {#sec-19-csr-30-40.190 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.190}

19 CSR 30-40.195 Emergency Medical Service (EMS) {#sec-19-csr-30-40.195 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.195}

Personnel Within the Hospital Emergency Department

History

AUTHORITY: sections 190.140, RSMo Supp. 1987 and 190.185, RSMo Supp. 1993. Original rule filed April 14, 1992, effective Jan. 15, 1993.

19 CSR 30-40.200 Definitions Relating to Air Ambulance {#sec-19-csr-30-40.200 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.200}

Original rule filed Jan. 5, 1988, effective March 25, 1988.

History

AUTHORITY: sections 190.125, RSMo 1986 and 190.185, RSMo Supp.

19 CSR 30-40.210 Air Ambulance Regulations for Helicopter {#sec-19-csr-30-40.210 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.210}

Original rule filed Jan. 5, 1988, effective March 25, 1988. Rescinded:

History

AUTHORITY: sections 190.100(1) and 190.185, RSMo Supp. 1993.

19 CSR 30-40.220 Air Ambulance Regulations for Fixed- Wing Aircraft {#sec-19-csr-30-40.220 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.220}

Original rule filed Jan. 5, 1988, effective March 25, 1988. Rescinded:

History

AUTHORITY: sections 190.100(1) and 190.185, RSMo Supp. 1993.

19 CSR 30-40.302 Emergency Medical Services Regions and Committees {#sec-19-csr-30-40.302 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.302}

PURPOSE: This rule identifies the counties that are included in each of the six (6) emergency medical services regions and establishes the requirements for the appointment of members to each of the six (6) regional committees.

(1) The following identifies the counties that shall be included in each of the six (6) emergency medical services (EMS) regions.

(A) The Central EMS region shall include the counties of Adair, Audrain, Benton, Boone, Callaway, Camden, Chariton, Clark, Cole, Cooper, Dent, Gasconade, Howard, Knox, Lewis, Linn, Macon, Maries, Marion, Miller, Moniteau, Monroe, Montgomery, Morgan, Osage, Pettis, Phelps, Pulaski, Putnam, Ralls, Randolph, Saline, Schuyler, Scotland, Shelby, and Sullivan.

(B) The Kansas City EMS region shall include the counties of Bates, Caldwell, Carroll, Cass, Clay, Clinton, Henry, Jackson, Johnson, Lafayette, Platte, and Ray.

(C) The Northwest EMS region shall include the counties of Andrew, Atchison, Buchanan, Davies, DeKalb, Gentry, Grundy, Harrison, Holt, Livingston, Mercer, Nodaway, and Worth.

(D) The St. Louis EMS region shall include the counties of Franklin, Jefferson, Lincoln, Pike, St. Charles, St. Louis, Warren, and St. Louis City.

(E) The Southeast EMS region shall include the counties of Bollinger, Butler, Cape Girardeau, Carter, Crawford, Dunklin, Iron, Madison, Mississippi, New Madrid, Pemiscot, Perry, Reynolds, Ripley, Saint Francois, Sainte Genevieve, Scott, Stoddard, Washington, and Wayne.

(F) The Southwest EMS region shall include the counties of Barry, Barton, Cedar, Christian, Dade, Dallas, Douglas, Greene, Hickory, Howell, Jasper, Laclede, Lawrence, McDonald, Newton, Oregon, Ozark, Polk, St. Clair, Shannon, Stone, Taney, Texas, Vernon, Webster, and Wright.

(2) Each of the six (6) EMS regional committees shall consist of no more than fifteen (15) members, appointed by the director of the Department of Health.

(3) The committees should include representation from emergency medical technicians-basic, emergency medical technicians-paramedic, registered nurses with expertise in emergency medicine, firefighter/emergency medical technicians, trauma surgeons, physicians with expertise in emergency medicine, trauma nurse coordinators from designated trauma centers, emergency medical response agencies, ground ambulance service managers, EMS training entities, pediatric hospitals or physicians/registered nurses with expertise in pediatric care, emergency medical dispatchers, air ambulance services, physicians with expertise in EMS medical direction, local health departments, hospital administrators, medical examiners or coroners, and EMS consumers.

rule filed Dec. 1, 2000, effective May 30, 2001. *Original authority: 190.102, RSMo 1998; 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998.

History

AUTHORITY: sections 190.102 and 190.185, RSMo 2000. Original

19 CSR 30-40.303 Medical Director Required for All: {#sec-19-csr-30-40.303 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.303}

Ambulance Services and Emergency Medical Response Agencies That Provide Advanced Life Support Services, Basic Life Support Services Utilizing Medications or Providing Assistance With Patients’ Medications, or Basic Life Support Services Performing Invasive Procedures Including Invasive Airway Procedures; Dispatch Agencies Providing Pre-arrival Medical Instructions; and Training Entities

PURPOSE: This rule describes the qualifications and requirements related to medical directors of ambulance services, emergency medical response agencies, dispatch agencies, and training entities.

(1) As used in this rule, the following terms shall have the meanings specified:

(A) ACLS—advanced cardiac life support;

(B) ALS—advanced life support;

(D) BCLS—basic cardiac life support;

(E) BLS—basic life support;

(F) Board eligibility—a physician who has applied to a specialty board and has received a ruling that s/he has fulfilled the requirements to take the board examination and the board certification must be obtained within five (5) years of the first appointment;

(G) EMS—emergency medical services;

(H) EMT-Basic—emergency medical technician-basic;

(I) EMT-Paramedic—emergency medical technicianparamedic;

(J) PALS—pediatric advanced life support; and (K) Primary care specialty—family/general practice, internal medicine, or pediatrics.

(2) Ambulance services that provide advanced life support services, basic life support services utilizing medications (medications include, but are not limited to, activated charcoal, oral glucose and/or oxygen) or providing assistance with patients’ medications (patient medications include, but are not limited, to a prescribed inhaler, nitroglycerin and/or epinephrine), or basic life support services performing invasive procedures including invasive airway procedures (invasive airway procedures include, but are not limited to, esophageal or endotracheal intubation) shall comply with this section of the regulation.

(A) Each licensed ambulance service which provides ALS care shall have a medical director who is licensed as a doctor of medicine or a doctor of osteopathy by the Missouri State Board of Registration for the Healing Arts and who has— 1. Board certification in emergency medicine; or 2. Board certification or board eligibility in a primary care than one (1) year after initial ambulance service licensure), or documentation of equivalent education in cardiac care, trauma care and pediatric care within the past five (5) years; or 3. An active practice in the community, with current course completion or certification in ACLS and PALS (certifications shall be obtained no later than one (1) year after initial ambulance service licensure), or documented equivalent education in cardiac care and pediatric care within the past five (5) years who develops a written agreement with a physician who meets the requirements stated in (2)(A)1. or (2)(A)2. to review and approve the processes required in (2)(C), (2)(D), and (2)(E) in order to facilitate the medical direction of the ambulance service.

(B) Each licensed ambulance service which provides only BLS care shall have a medical director who is licensed as a doctor of medicine or a doctor of osteopathy by the Missouri State Board of Registration for the Healing Arts and can demonstrate current course completion or certification in ACLS and PALS (certifications must be obtained no later than one (1) year after initial ambulance service licensure), or can document equivalent education in cardiac care and pediatric care within the past five (5) years.

(C) The medical director, in cooperation with the ambulance service administrator, shall develop, implement and annually 1. Medical and treatment protocols for medical, trauma and pediatric patients;

Triage and transport protocols;
Protocols for do-not-resuscitate re-quests;
Air ambulance utilization; and 5. Medications and medical equipment to be utilized.

(D) The medical director, in cooperation with the ambulance service administrator, shall ensure that all licensed service personnel meet the education and skill competencies required for their level of license and patient care environment. The medical director shall have the authority to require additional education and training for any licensed service personnel who fail to meet this requirement and limit the patient care activities of personnel who deviate from established standards.

(E) The medical director, in cooperation with the ambulance service administrator, shall develop, implement and annually 1. Prolonged ambulance scene, response or transport times;

Incomplete run documentation;
Ambulances that are diverted from their original destinations;
Compliance with adult and pediatric triage, treatment and transport protocols (or sample thereof);
Skills performance (or sample thereof); and 6. Any other activities that the administrator or medical (3) Emergency medical response agencies that provide advanced life support services, basic life support services utilizing medications (medications include, but are not limited to, activated charcoal, oral glucose and/or oxygen) or providing assistance with patients’ medications (patient medications include, but are not limited to, a prescribed inhaler, nitroglycerin and/or epinephrine), or basic life support services performing invasive procedures including invasive airway procedures (invasive airway procedures include, but are not limited to, esophageal or endotracheal intubation) shall comply with this section of the regulation.

(A) Each emergency medical response agency which provides ALS care shall have a medical director who is licensed as a doctor of medicine or a doctor of osteopathy by the Missouri State Board of Registration for the Healing Arts and who has— 1. Board certification in emergency medicine; or 2. Board certification or board eligibility in a primary care than one (1) year after initial emergency medical response agency licensure), or documentation of equivalent education in cardiac care, trauma care and pediatric care within the past five (5) years; or 3. An active practice in the community, with current course completion or certification in ACLS and PALS (certifications shall be obtained no later than one (1) year after initial emergency medical response agency licensure), or documented equivalent education in cardiac care and pediatric care within the past five (5) years who develops a written agreement with a physician who meets the requirements stated in (3)(A)1. or (3)

(A)2. to review and approve the processes required in (3)(C), (3)

(D), and (3)(E) in order to facilitate the medical direction of the emergency medical response agency.

(B) Each emergency medical response agency which provides only BLS care shall have a medical director who is licensed as a doctor of medicine or a doctor of osteopathy by the Missouri State Board of Registration for the Healing Arts and can demonstrate current course completion or certification in ACLS and PALS, or can document equivalent education in cardiac care and pediatric care within the past five (5) years.

(C) The medical director, in cooperation with the emergency medical response agency administrator, shall develop, implement and annually review the following:

Medical and treatment protocols for medical, trauma and pediatric patients;
Triage protocols;
Protocols for do-not-resuscitate requests;
Air ambulance utilization; and 5. Medications and medical equipment to be utilized.

(D) The medical director, in cooperation with the emergency medical response agency administrator, shall ensure that all licensed agency personnel meet the education and skill competencies required for their level of license and patient care environment. The medical director shall have the authority to require additional education and training for any licensed agency personnel who fail to meet this requirement and limit the patient care activities of personnel who deviate from established standards.

(E) The medical director, in cooperation with the emergency medical response agency administrator, shall develop, implement and annually review the following:

Prolonged emergency medical response agency response times;
Incomplete run documentation;
Compliance with adult and pediatric triage and treatment protocols (or sample thereof);
Skills performance (or sample thereof); and 5. Any other activities that the administrator or medical (4) All dispatch agencies which provide pre-arrival medical instructions shall comply with this section of the regulation.

(A) Each dispatch agency shall have a medical director who is licensed as a doctor of medicine or a doctor of osteopathy by the Missouri State Board of Registration for the Healing Arts who can demonstrate current course completion or certification in ACLS, or can document equivalent education in cardiac care within the past five (5) years.

(B) The medical director, in cooperation with the dispatch agency administrator, shall develop, implement and annually 1. Medical pre-arrival instruction protocols; and 2. Standards related to the administration of those protocols.

(C) The medical director, in cooperation with the dispatch agency administrator, shall ensure that all dispatch personnel giving medical pre-arrival instructions meet the education and skill competencies required for their patient care environment.

The medical director shall have the authority to require additional education and training for any personnel who fail to meet this requirement and limit the activities related to giving medical pre-arrival instructions of personnel who deviate from established standards.

(D) The medical director, in cooperation with the dispatch agency administrator, shall develop, implement and annually 1. Prolonged ambulance or emergency medical response agency dispatch times;

Compliance with medical pre-arrival instruction protocols (or sample thereof); and 3. Any other activities that the administrator or medical (5) Training entities shall comply with this section of the

regulation.

(A) Each EMT-Paramedic training entity shall have a medical director who is licensed as a doctor of medicine or a doctor of osteopathy by the Missouri State Board of Registration for the Healing Arts and who has— 1. Board certification in emergency medicine; or 2. Board certification or board eligibility in a primary care than one (1) year after initial training entity accreditation), or documented equivalent education in cardiac care, trauma care and pediatric care within the past five (5) years; or (B) Each EMT-Basic, continuing education, first responder or emergency medical dispatch training entity shall have a medical director who is licensed as a doctor of medicine or a doctor of osteopathy by the Missouri State Board of Registration for the Healing Arts and can demonstrate current course completion or certification in ACLS and PALS (certifications must be obtained no later than one (1) year after initial training entity accreditation), or can document equivalent education in cardiac care and pediatric care within the past five (5) years.

(C) Each EMS training entity medical director shall be responsible for ensuring an accurate and thorough presentation of the medical content of the education and training program.

Ensure that the student has met the education and skill competencies based on current national standards and scope of practice for each level of licensure and/or certification.

Original rule filed Sept. 1, 1998, effective Feb. 28, 1999. Emergency rescission and rule filed July 30, 1999, effective Aug. 9, 1999, expired Feb. 3, 2000. Rescinded and readopted: Filed: July 30, 1999, effective Jan. 30, 2000. *Original authority: 190.103, RSMo 1998: 190.108, RSMo 1998; 190.109, RSMo 1998; 190.131, RSMo 1998; 190.133, RSMo 1998; 190.134, RSMo 1998; and 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998.

History

AUTHORITY: sections 190.103, 190.108, 190.109, 190.131, 190.133, 190.134 and 190.185, RSMo Supp. 1998. Emergency rule filed Aug. 28, 1998, effective Sept. 7, 1998, expired March 5, 1999.

(1) Application Requirements for Air Ambulance Service Licensure.

(A) Each applicant for an air ambulance service license or relicense shall submit an application for licensure to the Emergency Medical Services (EMS) Bureau no less than thirty (30) days or no more than one hundred twenty (120) days prior to their desired date of licensure or relicensure.

(B) An application shall include the following information: type of license applied for (rotary wing or fixed wing); trade name of air ambulance service; location of aircraft; number of aircraft to be used as an air ambulance(s); name, address, operator of air ambulance service; name, address, telephone numbers, and email address (if applicable) of manager; name, address, whether a medical doctor or doctor of osteopathy, telephone numbers, email address (if applicable), and signature of medical director and date signed; certification by the medical director that they are aware of the qualification requirements and the responsibilities of an air ambulance service medical director and agree to serve as medical director; name, address, proposed licensee of air ambulance service; name of licensee’s chief executive officer; all ambulance service licensure and related administrative licensure actions taken against the ambulance service or owner by any state agency in any state; and certification by the applicant that the application contains no misrepresentations or falsifications and that the information given by them is true and complete to the best of their knowledge and that the ambulance service has both the intention and the ability to comply with the regulations promulgated under the Comprehensive Emergency Medical Service Systems Act, Chapter 190, RSMo.

(C) Each air ambulance service that meets the requirements and standards of the statute and regulations shall be licensed and relicensed for a period of five (5) years. Air ambulances based inside or outside Missouri that do intra-Missouri transports shall be licensed in the state of Missouri and shall be held to the same standards.

(D) Air ambulance services which are currently accredited by the Commission on Accreditation of Medical Transportation Services (CAMTS) and have the required liability insurance coverage shall be considered to be compliant with the rules for air ambulance services. Accredited air ambulance services shall attach to their application evidence of accreditation and proof of their liability insurance coverage. The EMS Bureau shall conduct periodic site reviews and inspections of applicable records and medical equipment as necessary to verify compliance.

(E) Fixed wing air ambulances shall meet the requirements stated in this regulation except (8)(D), (8)(F), and (12).

(2) Air ambulance services shall meet the following operation and maintenance standards:

(A) Air ambulance services shall possess or contract for a valid Federal Aviation Administration Title 14 CFR part 135 Certificate and comply with 14 CFR section 119, a regulation from the Federal Aviation Administration and be authorized to conduct helicopter air ambulance operations in accordance with Federal Aviation Regulation part 135 and this operations specification;

(B) The air ambulance service shall ensure prompt response to all requests to that service for emergency care twentyfour (24) hours per day, each and every day of the year, and shall provide patients with medically necessary care and transportation in accordance with that air ambulance service’s protocols, scope of care, and capabilities.

If a scene request for emergency services is made to an air ambulance service which is not the recognized emergency provider, then the 911 provider or the recognized emergency provider shall be notified immediately by the air ambulance service receiving the request; and 2. Emergency transports shall not require a guarantee of payment prior to transport;

(C) Each air ambulance program shall have established information that is made available to each emergency service in the area in which they operate to include the following:

Aircraft capabilities;
Appropriate utilization of air ambulances;
Education and skills of the crew; and 4. Safety considerations;

(D) Public liability insurance or proof of self-insurance, condition to pay losses and damage caused by or resulting from the negligent operation, maintenance, or use of ambulance services under the service’s operating authority or for loss or damage to property or others. Documents submitted as proof of insurance shall specify the limits of coverage and include the ambulance service license number. Public liability coverage for air ambulance services which transport patients shall meet or exceed:

Two hundred fifty thousand dollars ($250,000) for bodily injury to, or death of, one (1) person;
Five hundred thousand dollars ($500,000) for bodily 3. One hundred thousand dollars ($100,000) for loss or cargo; and (E) The aviation crew of an air ambulance shall meet all requirements of the Federal Aviation Administration Title 14 CFR part 135, and the medical crew responding to scenes shall be able to demonstrate successful completion and maintenance of the following:
Education— A. Basic Cardiac Life Support (BCLS) which is incorporated by reference in this rule as published by the American Heart Association in 2005 and is available at the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231. This additions;

B. Advanced Cardiac Life Support (ACLS) or national equivalent. ACLS is incorporated by reference in this rule as available at the American Heart Association, 7272 Greenville subsequent amendments or additions;

C. Pediatric Advanced Life Support (PALS) or national equivalent. PALS is incorporated by reference in this rule as available at the American Heart Association, 7272 Greenville subsequent amendments or additions; and D. Trauma Nurse Core Course (TNCC) or a trauma course approved by the medical director. TNCC is incorporated by reference in this rule as published by the Emergency Nurses Association in 2007 and is available at the Emergency Nurses Association, 915 Lee Street, Des Plaines, IL 60016-9659.

This rule does not incorporate any subsequent amendments or additions. Examples of equivalent courses are, but not limited to: Pediatric Education for Pre-Hospital Professionals (PEPP); Emergency Nurse Pediatric Course (ENPC); International Trauma Life Support (ITLS); Pre-Hospital Trauma Life Support (PHTLS); and Transport Nurse Advanced Trauma Course (TNATC). PEPP is incorporated by reference in this rule as published by the American Academy of Pediatrics in 2006 and is available at the American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove, IL 60007. This rule does ENPC is incorporated by reference in this rule as published by the Emergency Nurses Association in 2004 and is available at the Emergency Nurses Association, 915 Lee Street, Des Plaines, IL 60016-9659. This rule does not incorporate any subsequent amendments or additions. ITLS is incorporated by reference in this rule as published by ITLS International in 2007 and is available at ITLS International, 1 S. 280 Summit Ave., Court B-2, Oakbrook Terrace, IL 60181. This rule does not incorporate any subsequent amendments or additions. PHTLS is incorporated by reference in this rule as published by the National Association of Emergency Medical Technicians in 2006 and is available at the National Association of Emergency Medical Technicians, PO Box 1400, Clinton, MS 39060. This rule does not incorporate any subsequent amendments or additions. TNATC is incorporated by reference in this rule as published by the Air and Surface Transport Nurse’s Association in 2006 and is available at the Air and Surface Transport Nurse’s Association, 7995 East Prentice Avenue, Suite 100, Greenwood Village, CO 80111. This rule does not incorporate any subsequent amendments or additions; and 2. Licensure/certification— A. Each medical crew member must hold a current and valid Missouri license as required for their level of practice.

(3) Each aircraft, when operated as an air ambulance, shall meet the following equipment requirements:

(A) Documentation that each aircraft is equipped with pediatric and/or adult medical supplies and equipment as required by the air ambulance service medical director for the various advanced life support procedures or protocols for the patient care activities in the out-of-hospital setting to which it will respond. Each service shall be able to produce these records for inspection during normal business hours;

(B) The aircraft will be equipped with all equipment to allow reliable communication and flight following;

(C) The air ambulance service shall have a policy and provide for the effective maintenance, storage, usage, and replacement of its medical equipment, devices, and medications;

(D) All medical equipment, except disposable items, shall be so designed, constructed, and of such material that under normal conditions and operations, it is durable and capable of withstanding repeated cleaning and being stored in a secure and protected manner; and (E) The service shall:

Comply with Occupational Safety and Health Administration (OSHA) standard 29 CFR 1910.1030 and section 191.694, RSMo; and 2. Monitor and direct the use, control, and security of drugs.

(4) Each aircraft operated as an ambulance shall be staffed by personnel selected by each air ambulance program to meet the mission and scope of that program, and at a minimum— (A) On scene flights, there shall be at least two (2) air medical crew members. The primary crew member shall be a registered nurse or physician and the secondary crew member shall be an EMT-Paramedic, registered nurse, or physician; and (B) On all transports other than scenes, there shall be at least two (2) air medical crew members, one (1) of whom will be a registered nurse or physician, and a secondary crew member who is approved by the medical director to provide critical care;

(C) A minimum of sixteen (16) hours of continuing education is required annually for each crew member to include safety, crew resource management, survival, and flight physiology;

(D) The medical flight crew members will receive training designed by the medical director and clinical registered nurse supervisor to provide knowledge and skills needed to carry out advanced life support procedures and written protocols. The unique flight and pre-hospital environment will be addressed during training.

(5) Records and forms, policies and procedures—each air ambulance service shall maintain accurate records and forms that include the following:

(A) An air ambulance report form approved by the EMS Bureau to record information on each patient transport;

(B) Disaster/multiple casualty protocols;

(D) Air ambulance service license;

(E) Licensed service personnel records;

(F) Medical director qualifications and authorized physicianordered treatment protocols and policies;

(G) Patient care records;

(H) Quality improvement program;

(I) Records required by other regulatory agencies including the Missouri Department of Health and Senior Services, Bureau of Narcotics and Dangerous Drugs (BNDD), and the Federal Drug Enforcement Administration (DEA);

(J) Safety program to include a safety committee and infection control policy as required by OSHA standard 29 CFR 1910.1030 and section 191.694, RSMo;

(K) Continuing education records; and (L) Flight response records.

(6) Each air ambulance service shall have medical control policies, procedures, and standing orders that have been approved by their medical director and clinical registered nurse supervisor— (A) The protocols will include authorization for standing orders;

(B) The written protocols will be provided to the EMS Bureau upon request; and (C) The medical director will ensure the air medical personnel are provided appropriate training to meet standards established by the program.

(7) Each air ambulance service shall have a designated medical director, working under an agreement, who is trained and meets the requirements for a medical director in accordance with 19 CSR 30-40.303(1).

(A) Medical directors for flight programs shall also demonstrate expertise in advanced trauma life support, advanced cardiac life support, and in-flight conditions unique to the air transport of patients.

(B) Medical directors for flight programs must have a current and valid license to practice medicine in the state of Missouri and shall also maintain staff privileges at a Missouri licensed hospital that regularly receives patients from the air ambulance program.

(C) An air ambulance used for transport of trauma patients must have a medical advisor who is a trauma surgeon on the staff of a designated trauma center that regularly receives patients from the air ambulance program and who will provide expertise in cooperation with the medical director in the development of policies, procedures and quality improvement for all trauma related air ambulance activities.

(D) The medical director of the flight program shall have access to consulting physicians with expertise in specialties to include, but is not limited to:

Pediatrics;
Neonatology;
Burns;
Cardiology;
Trauma; and 6. Neurology/Neurosurgery.

(E) In the event of a resignation or other occurrence, and there is no medical director for the air ambulance service, the service is only authorized to operate under strict radio communications or direct written and/or verbal orders by a physician for a period not to exceed ten (10) days before appointing a new or replacement medical director.

(F) Each air ambulance service shall notify the EMS Bureau in writing of any change in medical director within five (5) days.

(8) Communication Centers and Communication Specialists.

(A) Training shall be provided in aircraft capabilities, operational limitations, navigation, and map coordination to the communication specialists.

(B) Information pertinent to each call shall be logged in order to retrieve complete activity review reports.

(C) Communication specialists shall be responsible for flight following based on requirements of the program and Federal Aviation Administration Title 14 CFR part 135.

(D) A system shall be in place to assure emergency requests are answered, the phone calls and radio traffic are recorded, and a back-up power source is available. The system shall include means to provide the crew the ability to communicate by voice wit. hospitals and emergency agencies.

(E) The hospital emergency ambulance radio system shall not be used for flight following.

(F) Each aircraft operated as an ambulance shall have the capability to communicate by voice with hospitals and the service’s own communication center.

(G) The communication center shall:

Have a least one (1) dedicated telephone line for the

purpose of receiving requests and the coordination of the air ambulance service;

Have a system for recording all incoming and outgoing telephone and radio transmissions with time recording and playback capabilities. Recordings shall be kept for a minimum of thirty (30) days;
Have the capability to immediately contact the aviation staff, medical crew, and online medical direction (through page, radio, or telephone, etc.);
Maintain all equipment in full operating condition and in good repair;
Have a back-up emergency power source for communications or a policy delineating methods for maintaining communications during power outages and in disaster situations; and 6. Have a communications policy and procedures manual to include:

A. A pre-arranged emergency plan to cover situations in which the aircraft is overdue, communications cannot be established, or an aircraft location cannot be verified.

(H) All helicopter air ambulance services shall have flights coordinated by designated communication specialists assigned and available twenty-four (24) hours per day to receive and coordinate the request for an air ambulance.

The communication specialists must advise the requesting caller of an accurate estimated time of arrival of the responding aircraft for all flight requests.
The communication specialists shall have training commensurate with the scope of responsibility of the communications center personnel and it shall include:

A. Federal Communications Commission regulations and appropriate provisions of the certificate holder’s operations specifications and operations manual;

B. General safety rules, emergency procedures, and flight following procedures;

C. Map reading, aeronautical chart interpretation, basic navigation, and flight planning;

D. Weather terminology and procedures for flight service weather advisories;

E. Types of radio frequency bands used; and F. Annual training that includes at least a review of the program’s Post-Accident/Incident Plan (PAIP) and competency in the areas included in subsections (8)(A)–(G).

(9) There shall be an ongoing quality improvement program designed to objectively and systematically monitor, review, pursue opportunities to improve patient care, and resolve (10) A safety committee shall be established and shall meet regularly to assess and evaluate the safety aspects of the operation.

(11) Each air ambulance service shall maintain policies and procedures that include the following:

(A) Safety program, including infection control program;

(B) Communications procedures;

(D) Standards of clinical care (medical protocols);

(E) Equipment maintenance;

(F) Disaster/multiple casualty protocols; and (G) Quality improvement program.

(12) Helicopter visual flight rule programs will adhere to the ceiling and visibility standards of the Federal Aviation Administration as authorized when conducting helicopter air ambulance operations in accordance with Federal Aviation

Regulation part 135. These operations specifications will be available for inspection by the EMS Bureau during normal business hours.

(13) Each ambulance service shall display a copy of their ambulance service license in the patient care compartment of each ambulance aircraft operated by the ambulance service.

History

AUTHORITY: section 190.103, RSMo 2000, sections 190.108, 190.120, 190.160, 190.165, and 190.185, RSMo Supp. 2007 and section 190.176, HB 1790, 94th General Assembly, Second Regular Session, 2008. Emergency rule filed Aug. 28, 1998, effective Sept. 7, 1998, expired March 5, 1999. Original rule filed Sept. 1, 1998, effective Feb. 28, 1999. Amended: Filed May 19, 2008, effective Jan. 30, 2009. Original authority: 190.103, RSMo 1998; 190.120, RSMo 1973, amended 1980, 1998, 2002; 190.160, RSMo 1973, amended 1998, 2002; 190.165, RSMo 1973, amended 1978, 1998, 2002; 190.175, RSMo 1973, amended 1998, 2002; 190.176, RSMo 1998, 2008; 190.180, RSMo 1998, amended 2002; and 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002. Pursuant to Executive Orders 20-04 and 20-10, 19 CSR 30-40.308, subsections (1)(A) and (1)(C) was

(A) Each applicant for ownership of an ambulance service license or relicense shall submit an application for licensure to the Bureau of Emergency Medical Services (EMS) no less than thirty (30) days or no more than one hundred and twenty (120) days prior to their desired date of licensure or relicensure.

(B) An application shall include the following information: trade name of the ambulance service; location of vehicles; number of vehicles to be operated by the ambulance service; applicable) of operator of the ambulance service; name of manager; name, address, whether a medical doctor or doctor of osteopathy, telephone numbers, e-mail address (if applicable), and signature of medical director and date signed; certification by the medical director that they are aware of the qualification requirements and the responsibilities of an ambulance service medical director and agree to serve as medical director; applicable) of proposed licensee of the ambulance service; name of licensee’s chief executive officer; all ambulance service licensure and related administrative licensure actions taken against the ambulance service or owner by any state agency in any state; and certification by the applicant that the application contains no misrepresentations or falsifications and that the information given by them is true and complete to the best of their knowledge, and that the ambulance service has both the intention and the ability to comply with the regulations promulgated under the Comprehensive Emergency Medical Service Systems Act, Chapter 190, RSMo Supp. 1998.

(C) Each ambulance service that meets the requirements and standards of the statute and regulations shall be licensed and relicensed for a period of five (5) years.

(D) Ambulance services which are currently accredited by the Commission on Accreditation of Ambulance Services (CAAS) or the Commission on Accreditation of Medical Transportation Services (CAMTS) and have the required liability insurance coverage shall be considered to be compliant with the rules for ambulance services. Accredited ambulance services shall attach to their application evidence of accreditation and proof of their liability insurance coverage. The Bureau of EMS may conduct periodic site reviews as necessary to verify compliance.

(2) Each vehicle operated as an ambulance shall meet the following vehicle design, specification, operation, and maintenance standards:

(A) Vehicle Design and Specification Standards. In providing the transportation of patients, ambulance services shall utilize only vehicles specifically designed, manufactured, and equipped for use as an ambulance and which meet current (at date of vehicle manufacture) standards/specifications set forth by the U.S. Department of Transportation KKK-A-1822, the Commission on Accreditation of Ambulance Services Ground Vehicle Standard for Ambulances v.1.0 edition or the National Fire Protection Association 1917 Standard for Automotive Ambulances 2016 Edition. The Commission on Accreditation of Ambulance Services Ground Vehicle Standard for Ambulances v.1.0 edition is incorporated by reference in this rule as published in 2016 and is available at the Ground Vehicle Standard, 1926 Waukegan Road Suite 300, Glenview Il 60025-1770. This rule does not incorporate any subsequent amendments or additions. The National Fire Protection Association 1917 Standard for Automotive Ambulances 2016 Edition is incorporated by reference in this

rule as published in 2016 and is available at the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169-7471. This rule does not incorporate any subsequent amendments or additions. Exceptions to these standards/ specifications may include the following.

Image elements (such as paint) may be altered to the agency’s preference;
Variation of warning lights is allowed for: type and color of lens, strobe lights in lieu of halogen lights, additional warning lights beyond the U.S. Department of Transportation KKK-A-1822, National Fire Protection Association 1917 Standard for Automotive Ambulances 2016 edition or the Commission on Accreditation of Ambulance Services Ground Vehicle Standard for Ambulances v.1.0 edition specifications;
Power supply and equipment in the patient compartment may be altered to the agency’s preference; and 4. Other variations may be allowed by the Bureau of EMS;

(B) Operational Standards.

Ambulance services shall provide the quantity of ambulance vehicles, medical supplies and personnel to meet the emergency call volume which can be reasonably anticipated for their ambulance service area.
Ambulance services which are the 911 provider or the recognized emergency provider shall ensure prompt response to all requests to that service for emergency care originating from their ambulance service area twenty-four (24) hours per day, each and every day of the year, and shall provide patients with medically necessary care and transportation in accordance with that ambulance service’s protocols.
Public liability insurance or proof of self-insurance, conditioned to pay losses and damage caused by or resulting from the negligent operation, maintenance, or use of ambulance services under the service’s operating authority or for loss or damage to property of others. Documents submitted as proof of insurance shall specify the limits of coverage and include the ambulance service license number. Public liability coverage for ambulance services which transport patients in the patient compartment of a vehicle shall meet or exceed— A. Two hundred fifty thousand dollars ($250,000) for bodily injury to, or death of, one (1) person;

B. Five hundred thousand dollars ($500,000) for bodily C. One hundred thousand dollars ($100,000) for loss or cargo; and (C) Maintenance Standards. The ambulance service shall have a policy to provide for the effective maintenance of all its ambulances and maintain records that demonstrate compliance with such policy.

(3) Each vehicle operated as an ambulance shall meet the following equipment requirements:

(A) Documentation that each vehicle is equipped with pediatric and adult medical supplies and equipment as required by the ambulance service medical director for the various patient care activities in the out-of-hospital setting to which it will respond. Each service shall be able to produce these records for inspection during normal business hours; and (B) The ambulance service shall have a policy and provide for the effective maintenance, storage, usage and replacement of its medical equipment, devices and medications.

(4) Each vehicle operated as an ambulance shall meet the following staffing requirements:

(A) When transporting a patient, at least one (1) licensed EMT, registered nurse, or physician shall be in attendance with the patient in the patient compartment at all times; and (B) When an ambulance service provides advanced life support care under its protocols, the patient shall be attended by an EMT-Paramedic, registered nurse, or physician.

(5) Each ambulance service shall maintain accurate records and forms on the following:

(A) An ambulance report to record information on each emergency request for service and each ambulance run;

(B) Ground ambulance service license;

(D) Vehicle maintenance records;

(E) Vehicle driver education records;

(F) Equipment maintenance records; and (G) Records required by other regulatory agencies.

(6) Each ambulance service shall have a medical control plan that has been approved by their medical director and service manager. The medical control plan is that portion of the medical protocols which specifically addresses the transfer of patient care between agencies.

(7) Each ambulance service that provides advanced life support services, basic life support services utilizing medications (medications include activated charcoal, oral glucose and/or oxygen) or providing assistance with patients’ medications (patient medications include a prescribed inhaler, nitroglycerin and/or epinephrine), or basic life support services performing invasive procedures including invasive airway procedures (invasive airway procedures include esophageal or endotracheal intubation) shall have a designated medical director, working under an agreement, who is trained and meets the requirements for a medical director in accordance with 19 CSR 30-40.303.

(8) Each vehicle operated as an ambulance shall have the capability to communicate by voice with local hospital(s), trauma centers, and the service’s own dispatching agency.

(9) There shall be an ongoing quality improvement program designed to objectively and systematically monitor, review, pursue opportunities to improve patient care and resolve (10) Each ambulance service shall maintain policies and procedures that include the following:

(A) Safety program, including infection control program;

(B) Vehicle operations and driving procedures;

(D) Ambulance operations procedures;

(E) Standards for clinical care (medical protocols);

(F) Vehicle and equipment maintenance;

(G) Disaster/multiple casualty protocols; and (H) Quality improvement program.

(11) Each ambulance service shall display a copy of their ambulance service license in the patient care compartment of each ambulance vehicle operated by the ambulance service.

(12) Each ambulance service that held a valid ambulance vehicle license on August 28, 1998, and meets all the legislative and regulatory requirements for licensure shall be issued an initial license for a period of one to five (1–5) years. The Bureau of EMS will determine the initial licensure period for each ambulance service by randomly selecting an equal number of ambulance services for each of the five (5) periods of licensure based on the date the application is received by the Bureau of EMS.

(13) An existing ambulance service licensee may apply for and be granted by Bureau of EMS a reduction in their primary service area if they meet the following requirements:

(A) Submit a completed application for licensure, requesting a reduction of their ambulance service area and include a detailed description of the affected area that will no longer be included in their primary service area; and (B) Provide written documentation of an agreement with another licensed ambulance service, stating the service has agreed to provide ambulance service to the vacated service area through an expansion of their services, by either contract or mutual aid agreement or provide public notice to residents of the affected area.

Public notice to residents of the affected area includes:

A. Publishing notice in a newspaper of the largest general circulation, that is published in the county in the area affected by the decision to withdraw ambulance coverage, a minimum of one (1) year in advance of the proposed date of discontinuation of ambulance services. A completed affidavit of publication and an original clipping of published notice must accompany the application for licensure; and B. Providing written notice to the county commission of any county that as a whole or in part, will be affected by the discontinuation of services, a minimum of one (1) year in advance of the proposed date of discontinuation of ambulance

Amended: Filed March 16, 2017, effective Nov. 30, 2017. ** *Original authority: 190.109, RSMo 1998, amended 2001, 2002; 190.176, RSMo 1998, amended 2008, 2011; 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002; and 190.190, RSMo 1973, amended 1998. **Pursuant to Executive Orders 20-04 and 20-10, 19 CSR 30-40.309, subsection (2)(B) and section 190.243.4, RSMo was suspended from March 19, 2020 through June 15, 2020 and subsections (1)(A), (1)(C), and (1)(D) was suspended from April 29, 2020 through June 15, 2020.

History

AUTHORITY: sections 190.109, 190.176, 190.185, and 190.190, RSMo 2016. Emergency rule filed Aug. 28, 1998, effective Sept. 7, 1998, expired March 5, 1999. Original rule filed Sept. 1, 1998, effective Feb. 28, 1999. Emergency amendment filed March 31, 2003, effective April 14, 2003, expired Oct. 11, 2003. Amended: Filed March 31, 2003, effective Sept. 30, 2003. Emergency amendment filed March 16, 2017, effective March 26, 2017, expired Jan. 3, 2018.

19 CSR 30-40.331 Application and Accreditation or Certification Requirements for Training Entities that Conduct Training for First Responders, Emergency Medical Dispatchers, Emergency Medical Technicians- Basic, Emergency Medical Technicians-Intermediate, and Emergency Medical Technicians-Paramedic {#sec-19-csr-30-40.331 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.331}

PURPOSE: This rule provides the requirements for the application and accreditation or certification of training entities that conduct EMS-related training programs.

(1) General Requirements for Certification of Emergency Medical Technician-Basic (EMT-B) Training Entities, Emergency Medical Technician-Paramedic (EMT-P) Training Entities, Emergency Medical Technician-Intermediate (EMT-I) Training Entities, EMT-B Continuing Education Training Entities, and EMT-P Continuing Education Training Entities.

(A) Each applicant for certification as an emergency medical services (EMS) training entity shall make application to the EMS Bureau and undergo a review by the EMS Bureau staff to determine compliance with these rules. An application shall include, but not be limited to, the following: trade name of the training entity; training entity business address; daytime telephone number of the training entity; type of accreditation applied for; name, address, telephone number, and signature of the program director; name, address, telephone number, and signature of the medical director; and certification by the applicant that the application contains no misrepresentations or falsifications and that the information given by them is true and complete to the best of their knowledge, and that the training entity has both the intention and the ability to comply with the regulations promulgated under the Comprehensive Emergency Medical Service Systems Act, Chapter 190, RSMo.

The training entity accreditation application form, included herein, is available at the EMS Bureau office or by mailing a written request to the Missouri Department of Health and Senior Services, EMS Bureau, PO Box 570, Jefferson City, MO 65102-0570.

(B) Only certified EMS training entities shall be authorized to conduct EMS training programs. Upon receipt of an application for EMS training entity certification, the EMS Bureau shall cause an inspection of the applicant to determine compliance with these rules, and such subsequent inspection as is necessary or desirable to ensure compliance with these rules. Such inspections shall occur not less than once every five (5) years.

Training entities shall be certified to conduct the following programs:

A. EMT-P training entities shall be certified to conduct initial EMT-P; EMT-P refresher to include remedial training and National Registry bridge programs; EMT-P continuing education; initial EMT-I programs; EMT-I refresher to include remedial training; EMT-I continuing education; initial EMT-B;

EMT-B refresher to include remedial training and National Registry bridge programs; EMT-B continuing education; initial first responder; first responder refresher; and emergency medical dispatcher (EMD) courses;

B. EMT-P continuing education training entities shall be certified to conduct EMT-P continuing education courses, EMT-I continuing education courses, and EMT-B continuing education courses;

C. EMT-B training entities shall be certified to conduct initial EMT-B; EMT-B refresher to include remedial training and National Registry bridge programs; EMT-B continuing education; initial first responder; first responder refresher; and emergency medical dispatcher courses;

D. EMT-B continuing education training entities shall be certified to conduct EMT-B continuing education programs;

E. First responder training entities shall be certified to conduct only initial first responder and first responder refresher courses; and F. EMD training entities shall be certified to conduct only EMD courses.

(C) Each EMS training entity shall demonstrate an organizational structure that ensures responsibility for the organization, administration, periodic review, continued development, and effectiveness of all educational programs conducted by the EMS training entity. The EMS training entity shall have an organizational chart and job descriptions for relevant positions within the training entity and make this available to the EMS Bureau personnel on request.

(D) Each EMS training entity shall demonstrate adequate resources for the continued operation of all educational programs conducted. This shall be available to the EMS Bureau personnel on request.

(E) Each EMS training entity shall have a medical director who reviews and approves the educational content of the program and quality of medical instruction. The medical director for EMS training entities shall meet the requirements set forth in 19 CSR 30-40.303.

(F) Each EMS training entity shall demonstrate a methodology to evaluate the need for training and to ensure availability of effective training programs. The tools used to develop the methodology shall be made available for review by the EMS Bureau.

(G) Faculty Requirements.

Each EMS training entity shall have a qualified faculty.

Credentials of faculty shall be available for review by the EMS Bureau.

A. Primary faculty (those who teach twenty percent (20%) or more of classroom sessions) shall meet the EMS Bureau requirements for EMS instructors.

B. The training entity shall describe qualifications and training for laboratory instructors, where lab instructors are used.

C. The training entity shall describe qualifications and training for clinical instructors and field preceptors, where clinical instructors and field preceptors are used.

Qualifications for any adjunct instructors such as physicians, registered nurses, paramedics, clinical specialists, or expert lecturers shall be documented and available for review by the EMS Bureau.

(H) Physical Facilities.

Classrooms and laboratories shall have sufficient space to accommodate the maximum planned number of students and shall be environmentally conducive to providing a quality learning environment. The EMS Bureau may inspect classroom and laboratory facilities to determine compliance.
Equipment and supplies used in the provision of instruction shall be available and consistent with the requirements of the curriculum and adequate for the volume of students enrolled.

A. The EMS Bureau may periodically inspect such equipment and supplies to determine compliance with this requirement.

B. The EMS training entity shall describe how they will meet this requirement to the EMS Bureau.

C. The EMS training entity shall ensure that the equipment used in its training programs is in proper working order and appropriately cleaned.

Training entities that conduct initial courses of instruction shall make available to all students clearly defined and published policies and procedures. Such policies and procedures shall include the following:

A. Admission criteria;

B. Student withdrawal and refund of tuition and/or fees policies;

C. Attendance policy;

D. Grading and academic criteria;

E. Class cancellation policy;

F. Appeal and grievance procedures;

G. Examination policies;

H. Health and safety procedures;

I. Certification requirements of the National Registry of Emergency Medical Technicians and licensing requirements for the state of Missouri; and J. Recent statutes and regulations of the state of Missouri that pertain to EMS which can be obtained from the EMS Bureau. This can either be in an electronic or paper format.

(I) Program Self-Evaluation.

Each EMS training entity shall demonstrate that the programs conducted under its authority conduct program selfevaluation. Such evaluation shall include:

A. Evaluation of students shall be conducted and documented on a recurring basis and with sufficient frequency to provide both the student and program faculty with valid and timely indicators of each student’s progress toward and achievement of the competencies and objectives stated in the B. Test instruments and evaluation methods shall undergo periodic reviews by appropriate training entity staff and medical director; and C. Evaluation of the program by the students shall be documented and reviewed by the appropriate training entity staff and medical director.

(J) Record Keeping and Reporting.

Records shall be maintained for each student that demonstrate all attendance, clinical, practical, and written examination records.
Records shall be maintained for each class session that document name of instructor, title of session, beginning and ending time of each session, and attendance at the session.
Records shall be maintained for each initial course of instruction that document location of course, primary instructor, beginning enrollment, drop-out rate, course fail rate, and number of students successfully completing the course.
Lesson plans shall be maintained for each course offered.
All records shall be available for review by the EMS Bureau and kept on file for at least five (5) years.
Each EMS training entity shall submit to the EMS Bureau an annual report indicating the number, type, and location of courses offered, the pass/fail rate for each course, and the numbers of students completing training. Each annual report shall contain an affidavit that the principal officers and medical director of the training entity remain the same as the original application, or shall indicate any change.
Certificates of completion shall be issued by the training entity to students, at the request of the student, after successful completion of the appropriate criteria.

(K) EMS training entities may cooperate and develop satellite programs under their approval. In these cases, the EMS training entity remains responsible for ensuring quality EMS education and compliance with the EMS Bureau rules.

(L) Upon EMS training entity approval by the EMS Bureau, the EMS Bureau shall assign an accreditation number to each EMS training entity. The EMS training entity shall reference this accreditation number on each course completion letter or certificate issued by the EMS training entity.

(2) Specific Requirements for EMS Training Entities Offering Initial EMT-P Courses and EMT-I Courses.

(A) Only EMS training entities certified by the EMS Bureau to conduct initial EMT-P courses shall offer initial EMT-P and EMT-I courses.

(B) EMT-P and EMT-I students are only authorized to perform the skills and practice in accordance with the national standard curriculum for EMT-P and EMT-I and approved by the training entity medical director. The skills and practice performed by the student must be under the direct supervision of a clinical preceptor during scheduled clinicals at an approved site with a current clinical agreement and cannot be performed while on duty.

(C) EMS training entities offering initial EMT-P and EMT-I courses shall also be certified to conduct EMT-I, EMT-B, and/ or first responder and/or emergency medical dispatcher, and/ or EMS continuing education programs. If the training entity conducts these programs, the training entity shall also be responsible for ensuring compliance with the rules set forth for those programs.

(D) Each EMT-P training entity shall have a formal affiliation with an appropriately accredited university, senior college, community college, vocational school, technical school, or an appropriately accredited medical institution with dedication to educational endeavors. This affiliation shall include the 1. Ability for the EMT-P training program to require prerequisite post-secondary educational courses;

Responsibility by the accredited post-secondary educational institution and/or medical institution over the instructor(s) and the educational methodologies used by the EMT-P training program;
Access by the EMT-P training program into remedial education as may be necessary for the EMT-P training program;
Access by the students to financial assistance such as, but not limited to, grants and Veteran’s Benefits.

(E) Each EMT-P training program shall have a designated program director. Each EMT-P course shall have a designated primary instructor.

(F) Each EMT-P training program shall demonstrate and document that the EMT-P courses taught under its authority meet or exceed the requirements of the current national standard curriculum for EMT-P training.

(G) Training entities that provide EMT-P programs shall regularly assess the effectiveness of the training program.

(H) Clinical Requirements.

Each EMS training entity that provides EMT-P programs shall document and demonstrate a supervised clinical experience for all students. Each training entity shall approve or disapprove clinical preceptors.
Clinical affiliations shall be established and confirmed in current written affiliation agreements with institutions and agencies that provide clinical experience under appropriate medical direction and clinical supervision.
Students shall be assigned in clinical settings where experiences are clinically and educationally effective in achieving the program’s objectives.
When participating in clinicals, students shall be clearly identified by name and student status using nameplate, uniform, or other apparent means to distinguish them from other personnel.
Clinical experience shall occur only in association with an Advanced Life Support ambulance service which demonstrates medical accountability and employs preceptors who meet the training entity requirements. Each training entity shall approve or disapprove services to be used as clinic experience sites.
The EMS Bureau shall establish minimum standards for clinical experiences in accordance with current clinical recommendations of the national standard curriculum for EMT-P training.
All EMT-I students shall be currently licensed as an EMT- B.
All EMT-P students shall be currently licensed as an EMT-B or an EMT-I.

(I) Examination Requirements.

Each EMT-P training entity shall ensure that graduating training entity.
Exam scores for all students shall be maintained and be made available for review by the EMS Bureau staff.
The EMS Bureau shall review the first attempt computer adaptive test examinations results (pass rates) from each EMT-P training entity. The computer adaptive test licensure examination pass rate for first attempt candidates from each EMT-P training entity shall be no less than the national pass rate, as documented by the National Registry of EMTs for each calendar year. The EMT-P training entity with a pass rate below the national pass rate shall:

A. First year—provide the EMS Bureau with a report analyzing all aspects of the education program and identifying areas contributing to the unacceptable pass rate and a plan of action to resolve low pass rates;

B. Second consecutive year—the program manager shall be required to appear before and present to the EMS Bureau an analysis of measures taken the first year, problems identified, and plan of correction; and C. The training entity must appear before the EMS Bureau and provide the information outlined in (2)(I)3.B. until they have two (2) consecutive years of pass rates on the first attempt at the national pass rate.

(J) Training entities accredited by the Commission on Accreditation of Allied Health Education Programs (CAAHEP) and/or the Committee on Accreditation for EMS Professions (CoAEMSP) shall be considered to be compliant with the rules for training entities that conduct EMT-Paramedic programs.

CAAHEP and/or CoAEMSP accredited programs shall attach to their application evidence of accreditation. The EMS Bureau may conduct periodic site reviews as necessary to verify compliance.

(K) An EMT-P primary instructor must be present in at least eighty percent (80%) of all class sessions to ensure program continuity and to be able to identify that the students have cognitive, affective, and psychomotor skills necessary to function as an EMT-P. This primary instructor shall have attended a workshop that reviews the format, philosophy, and skills of the curriculum.

(L) Minimum EMT-P course requirements: one thousand (1,000) hours of instruction to include:

Two hundred fifty (250) hours of clinical experience in a clinical setting with a Missouri licensed ambulance service;
Five hundred (500) hours of classroom/practical lab;
Two hundred fifty (250) hours of clinical hours in a health care facility; and 4. Clinical skills as outlined in the most current EMT-P National Standard Curriculum and the National Scope of Practice for EMT-P shall be the established minimums. The EMT-P National Standard Curriculum is incorporated by reference in this rule as published in 1998 and the refresher course in 2001 by the U.S. Department of Transportation and is available at the U.S. Department of Transportation, Office of Emergency Medical published by the U.S. Department of Transportation in 2007 and (M) Minimum EMT-I course requirements: three hundred (300) hours of instruction to include:
Seventy-five (75) hours of clinical experience in a clinical setting with a Missouri licensed ambulance service;
One hundred seventy-five (175) hours of classroom/ practical lab;
Fifty (50) hours of clinical hours in a health care facility;
Clinical skills as outlined in the most current EMT-I National Standard Curriculum and the National Scope of Practice for EMT-I shall be the established minimums. The EMT-I National Standard Curriculum is incorporated by reference in this rule as published in 1999 and the refresher course in 2001 by the U.S. Department of Transportation and is available at the U.S. Department of Transportation, Office of Emergency Medical published by the U.S. Department of Transportation in 2007 and (N) United States Armed Forces Including National Guard and Reserves Option for EMT-I and EMT-P course requirements.
An EMT-B licensee that was issued a license by the EMS Bureau pursuant to 19 CSR 30-40.342(2)(A) and section (3) indicating the licensee is a current or past member of the United States Armed Forces including National Guard and Reserves and has met the EMS Bureau’s requirements for this license may present this license to a training entity certified by the EMS Bureau within two (2) years of the date of their honorable discharge if the licensee is a past member of the United States Armed Forces including National Guard and Reserves or at any time that the licensee is a current member of the United States Armed Forces including National Guard and Reserves.
The EMT-B licensee may request the training entity for the EMT-P or EMT-I programs evaluate their military training for advanced placement credit to determine which competencies have been met through their military training. The training entity shall allow the EMT-B licensee’s military training to be assessed for competencies through advanced placement if the EMT-B licensee presents an EMT-B United States Armed Forces license from the EMS Bureau indicating the licensee is a current or past member of the United States Armed Forces including National Guard and Reserves and has met the requirements in 19 CSR 30-40.342(2)(A) and section (3). Advanced placement is any process where a program formally recognizes prior learning of a student and applies that recognition toward meeting the program requirements. Advanced placement shall be applied on a case-by-case basis and allows a student to “place out” of specified program didactic, laboratory, clinical, or field requirements. This may shorten the time for completion of the program and is often thought of as an alternative pathway to program completion and eligibility for the National Registry of Emergency Medical Technicians or state examination at the paramedic level. The EMT-P and EMT-I training entities shall use the minimum training requirements for the appropriate licensure level in subsection (2)(L) above for the EMT-P program and subsection (2)(M) above for the EMT-I program to determine what the EMT-B licensee will place out of following the advanced placement review of the EMT-B licensee’s military training. The EMT-B licensee shall complete all of the minimum training requirements for the appropriate licensure level in subsection (2)(L) above for the EMT-P program and subsection (2)(M) above for the EMT-I program that the EMT-B licensee is not awarded credit for through the advanced placement assessment of the EMT-B licensee’s military training.

(3) Specific Requirements for EMS Training Entities Offering Initial EMT-B Courses.

(A) Only EMS training entities certified by the EMS Bureau to conduct initial EMT-B courses shall offer EMT-B courses.

(B) EMS training entities offering initial EMT-B courses shall also be certified to conduct first responder, emergency medical dispatcher, and EMS continuing education programs. If the training entity conducts these programs, the training entity shall also be responsible for ensuring compliance with the rules set forth for those programs.

(C) Each EMT-B training program shall have a designated program director. Each EMT-B course shall have a designated primary instructor.

(D) Each EMT-B training program shall demonstrate and document that the EMT-B courses taught under its authority meet or exceed the requirements of the national standard curriculum for EMT-B training, except for endotracheal intubation which shall not be taught.

(E) Clinical Requirements.

Each EMS training entity that provides EMT-B programs shall document and demonstrate a supervised clinical experience for all students.
Clinical affiliations shall be established and confirmed in current written affiliation agreements with institutions and agencies that provide clinical experience under appropriate medical direction and clinical supervision. Clinical supervision shall be conducted by a preceptor.
Students shall be assigned in clinical settings where experiences are clinically and educationally effective in achieving the program’s objectives.
When participating in clinicals, students shall be clearly identified by name and student status using nameplate, uniform, or other apparent means to distinguish them from other personnel.
The EMS Bureau shall establish minimum standards for clinical experiences in accordance with current clinical recommendations of the current national standard curriculum for EMT-B training.

(F) Examination Requirements.

Each EMT-B training entity shall ensure that graduating training entity. The practical examination shall include all skills designated in the National Standard Curriculum, except endotracheal intubation.
Exam scores and practical examination forms for all students shall be maintained and be made available for review by the EMS Bureau staff.
The EMS Bureau shall review the first attempt computer adaptive test examinations results (pass rates) from each EMT-B training entity. The computer adaptive test licensure examination pass rate for first attempt candidates from each EMT-B training entity shall be no less than the national pass rate, as documented by the National Registry of EMTs for each calendar year. The EMT-B training entity with a pass rate below the national pass rate shall:

B. Second consecutive year—the program manager shall be required to appear before and present to the EMS Bureau an analysis of measures taken the first year, problems identified, and plan of correction; and C. The training entity must appear before the EMS Bureau to provide the information outlined in (3)(F)3.B. until they have two (2) consecutive years of pass rates on the first attempt at the national pass rate.

(G) An EMT-B primary instructor must be present in at least eighty percent (80%) of all class sessions to ensure program continuity and to be able to identify that the students have cognitive, affective, and psychomotor skills necessary to function as an EMT-B. The primary instructor is responsible for the teaching of a specific lesson of the EMT-B course. The primary instructor shall have attended a workshop that reviews the format, philosophy, and skills of the new curriculum. The course shall use the following minimums:

Minimum of one hundred ten (110) hours of instruction;
Minimum of five (5) patient contacts in a clinical setting.

(4) Specific Requirements for EMS Training Entities Offering EMS Continuing Education for EMT-B and EMT-P.

(A) EMT-P continuing education training entities shall be certified to conduct EMT-P, EMT-I, and EMT-B continuing education. Continuing education training entities shall not conduct refresher courses, National Registry bridge programs, or remedial education. EMT-B continuing education training entities shall be certified to conduct only EMT-B continuing education courses.

(B) Each EMS continuing education training entity shall have a designated program director.

(C) In order for EMS training entities to assign continuing education unit credit for a program, the topic must be related to the appropriate national standard curriculum. Improper assignment of continuing education units may be grounds for action upon the training entity accreditation.

(D) EMS training entities that provide continuing education shall assign continuing education units according to the formula of fifty (50) minutes training time equals one (1) continuing education unit.

(E) When possible, programs shall be awarded continuing education units according to recommendations of the National Registry of EMTs or the Continuing Education Co-ordinating Board for Emergency Medical Services (CECBEMS).

(F) EMS training entities that provide continuing education may assign continuing education units for instruction of EMS programs according to the formula of fifty (50) minutes training time equals one (1) continuing education unit for programs taught at the provider’s level of licensure or higher.

(G) Accreditation of continuing education by appropriate recognized national accrediting bodies and other state EMS agencies shall constitute approval under the EMS Bureau rules.

(5) Specific Requirements for EMS Training Entities Offering Emergency Medical Dispatcher Training.

(A) Each training entity offering emergency medical dispatcher training shall demonstrate and document that the emergency medical dispatcher courses taught under its authority meet or exceed the standards set forth by the National Academy of Emergency Medical Dispatch.

(B) Each training entity shall comply with subsections (1)(A) and (1)(B).

(C) Each training entity shall ensure that graduating students meet entry level competence through the use of a final written examination administered by that training entity.

(6) Specific Requirements for EMS Training Entities Offering First Responder Training.

(A) Each training entity offering first responder training shall demonstrate and document that the first responder courses taught under its authority meet or exceed the requirements of a national standard curriculum for first responder training.

(B) Each training entity shall comply with subsections (1)(A) and (1)(B).

(C) Each training entity shall ensure that graduating training entity. The first responder in Missouri shall be taught and permitted to perform all skills including spinal motion restriction in the current First Responder National Standard Curriculum and the National Scope of Practice for First Responder shall be the established minimums. First Responder National Standard Curriculum is incorporated by reference in this rule as published in 1995 and the refresher course in 1996 by the U.S. Department of Transportation and is available at the U.S. published by the U.S. Department of Transportation in 2007 and is available at the U.S. Department of Transportation, Office of Emergency Medical Services, West Building W44-314, 1200 New Jersey Ave. SE, NTI 140, Washington, DC 20590. This additions.

(7) EMT-B, EMT-I, and EMT-P Core Continuing Education Requirements.

(A) EMS training entities may offer EMT-B and/or EMT-P core continuing education programs by offering a standalone program, by attending appropriate sessions of an initial training program, or through a continuing education format.

(B) EMT-B and/or EMT-P core continuing education programs shall include a final or modular written evaluation and, if applicable, a practical evaluation.

(C) Continuing education training entities must have a current copy of the most recent statutes and regulations of the state of Missouri that pertain to EMS which can be obtained from the EMS Bureau. These copies shall be available at all times for reference by the student and/or the training entity.

(8) Primary Instructor Qualifications.

(A) The EMS Bureau may authorize as primary instructors for EMS training programs those who can document the following:

EMT-B Instructor:

A. Current Missouri licensure, National Registry, or other state license or certification as a paramedic and at least two (2) years clinical experience as an EMT-P, EMT-B, or licensure as a registered nurse or physician with at least two (2) years clinical experience;

B. Successful completion of an instructor-training program that meets or exceeds the United States Department of Transportation EMS Instructor Curriculum which is incorporated by reference in this rule as published in 2002 by the U.S. Department of Transportation and is available at the U.S. Department of Transportation, Office of Emergency Medical Services, West Building W44-314, 1200 New Jersey Ave. SE, NTI 140, Washington, DC 20590. This rule does not incorporate any subsequent amendments or additions;

C. EMS instructional experience, which meets the (I) Documentation of instructor status as an Advanced Cardiac Life Support, Basic Cardiac Life Support, International Trauma Life Support, or Pre-Hospital Trauma Life Support.

Advanced Cardiac Life Support is incorporated by reference in this rule as published by the American Heart Association in 2005 and is available at the American Heart Association, 7272 Green-ville Avenue, Dallas, TX 75231. This rule does International Trauma Life Support is incorporated by reference in this rule as published by ITLS International in 2007 and is available at ITLS International, 1 S. 280 Summit Ave., Court B-2, Oakbrook Terrace, IL 60181. This rule does not incorporate any subsequent amendments or additions. Pre-Hospital Trauma Life Support is incorporated by reference in this rule as published by the National Association of EMTs in 2006 and is available at the National Association of EMTs, PO Box 1400, Clinton, MS 39060-1400. This rule does not incorporate any subsequent amendments or additions; or (II) Experience as a laboratory or guest instructor with an EMS training entity;

D. Continuing education in instructional topics of at least twenty (20) hours in total over the past five (5) years; and E. Competent in adult education theory and clinical skills consistent with the current EMT-B National Standard Curriculum which is incorporated by reference in this rule as published in 1994 by the U.S. Department of Transportation and not incorporate any subsequent amendments or additions;

EMT-P and EMT-I Instructor:

A. Current Missouri licensure, National Registry, or other state license or certification as a paramedic and at least two (2) years clinical experience as an EMT-P, or licensure as a registered nurse or physician with at least two (2) years clinical experience;

B. Successful completion of an instructor training program that meets or exceeds the United States Department of Transportation EMS Instructor Curriculum. The United States Department of Transportation EMS Instructor Curriculum is incorporated by reference in this rule as published in 2002 and not incorporate any subsequent amendments or additions;

C. EMS instructional experience, which meets the (I) Documentation of instructor experience in Advanced Cardiac Life Support, International Trauma Life Support, PreHospital Trauma Life Support, Pediatric Advanced Life Support, or Pediatric Education for Pre-Hospital Professionals (PEPP). Advanced Cardiac Life Support (ACLS) is incorporated by reference in this rule as published by the American Heart Association in 2005 and is available at the American Heart Association, 7272 Green-ville Avenue, Dallas, TX 75231. This rule does not incorporate any subsequent amendments or additions.

International Trauma Life Support (ITLS) is incorporated by reference in this rule as published by ITLS International in 2007 and is available at ITLS International, 1 S. 280 Summit Avenue, Court B-2, Oakbrook Terrace, IL 60181. This rule does Pre-Hospital Trauma Life Support (PHTLS) is incorporated by reference in this rule as published by the National Association of Emergency Medical Technicians in 2006 and is available at the National Association of Emergency Medical Technicians, PO Box 1400, Clinton, MS 39060-1400. This rule does not incorporate any subsequent amendments or additions. Pediatric Advanced Life Support (PALS) is incorporated by reference in this rule as available at the American Heart Association, 7272 Green-ville subsequent amendments or additions. PEPP is incorporated by reference in this rule as published by the American Academy of Pediatrics in 2006 and is available at the American Academy of Pediatrics, 141 Northwest Point Blvd., Elk Grove Village, IL 60007. This rule does not incorporate any subsequent amendments or additions; and (II) Experience as a laboratory or guest lecturer;

D. Continuing education in instructional topics of at least twenty (20) hours over the past five (5) years;

E. Competent in adult education theory and clinical skills consistent with the most current EMT-P National Standard Curriculum and the National Scope of Practice for EMT-P shall be the established minimums. The EMT-P National Standard Curriculum is incorporated by reference in this rule as published in 1998 and the refresher course in 2001 by the U.S. Department of Transportation and is available at the U.S. published by the U.S. Department of Transportation in 2007 and is available at the U.S. Department of Transportation, Office of Emergency Medical Services, West Building W44-314, 1200 New Jersey Ave. SE, NTI 140, Washington, DC 20590. This additions; and F. As of July 1, 2012, all newly employed primary instructors of initial EMT-P training entities shall possess a minimum of sixty (60) credit hours from an accredited post secondary educational institution;

First Responder Instructor:

A. The primary instructor must be a first responder, licensed EMT-B, EMT-I, EMT-P, registered nurse, or physician;

B. The primary instructor must be knowledgeable in all aspects of out-of-hospital emergency medical care, in the techniques and methods of adult education, and in managing resources and personnel;

C. The primary instructor shall have attended and successfully completed a program in EMS instruction methodology;

D. The primary instructor must be present in at least eighty percent (80%) of all class sessions to ensure program continuity and to be able to identify that the students have cognitive, affective, and psychomotor skills necessary to function as a first responder. The primary instructor is responsible for the teaching of a specific lesson of the first responder course. The primary instructor shall have attended a workshop that reviews the format, philosophy, and skills of the new curriculum.

(9) Initial licensure examination for EMT-B, EMT-Intermediate, and EMT-Paramedic.

(A) The EMS Bureau shall use the National Registry of EMTs examination process as the basis for initial licensure examinations for all levels of EMTs. The EMT-Basic exam conducted in Missouri is considered “the state approved practical examination” by the National Registry of Emergency Medical Technicians. It shall serve as the state of Missouri’s examination used for National Registry of EMT’s certification as an EMT-Basic.

Any student of an accredited Missouri EMT-Basic program shall complete the EMT-B practical examination in Missouri.
If a student from a Missouri accredited EMT-B program attempts a state approved exam outside the state of Missouri, that student shall complete all practical testing in that state and shall be ineligible from completing the Missouri EMT-B practical examination.
EMT-I and EMT-P candidates shall complete the National Registry of EMTs practical exam in Missouri or at an approved National Registry of EMTs’ Advanced Level exam site in another state.

(B) The EMS Bureau shall select providers of the practical licensure examination in the state of Missouri. The providers shall, with the EMS Bureau approval, operate all test sites and dates in accordance with the policies and procedures of the National Registry of EMTs and the EMS Bureau.

The EMS Bureau shall have oversight and review
Out-of-state applicants for EMT-B practical testing shall have their practical skills reviewed by a Missouri accredited EMT-B or EMT-P training entity. The training entity shall provide documentation to the EMS Bureau that verifies that the student is competent in all the skills listed in the National Standard Curriculum for EMT-B, except endotracheal intubation.

The EMT-B National Standard Curriculum is incorporated by reference in this rule as published in 1994 by the U.S.

Department of Transportation and is available at the U.S. 140, Washington, DC 20590. This rule does not incorporate any

Amended: Filed March 11, 2016, effective Oct. 30, 2016. ** *Original authority: 190.131, RSMo 1998, amended 2002 and 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002. **Pursuant to Executive Orders 20-04 and 20-10, 19 CSR 30-40.331, subsections (1)(A) and (1)(B) was suspended from April 29, 2020 through June 15, 2020. Pursuant to Executive Order 21-07, 19 CSR 30- 40.331, paragraphs (2)(L)1. and (2)(L)3. was suspended from August 6, 2020 through August 31, 2021.

History

authority of all EMT-B, EMT-I, and EMT-P practical and written examinations administered in the state of Missouri used to obtain licensure.
AUTHORITY: sections 190.131 and 190.185, RSMo Supp. 2013. March 5, 1999. Original rule filed Sept. 1, 1998, effective Feb. 28, 1999. Amended: Filed May 19, 2008, effective Jan. 30, 2009.

(1) Application Requirements for Emergency Medical Response Agency Licensure.

(A) Each applicant for an emergency medical response agency license or relicense shall submit an application for licensure to the Bureau of Emergency Medical Services (EMS) no less than thirty (30) days or no more than one hundred twenty (120) days prior to their desired date of licensure or relicensure.

(B) An application shall include the following information: trade name of the emergency medical response agency; location of vehicles; name, address, telephone numbers and e-mail address (if applicable) of operator of the emergency medical response agency; name of manager; name, address, whether a medical doctor or doctor of osteopathy, telephone numbers, e-mail address (if applicable), and signature of medical director and date signed; certification by the medical director that they are aware of the qualification requirements and the responsibilities of an emergency medical response agency medical director and agree to serve as medical director; applicable) of proposed licensee of the emergency medical response agency; name of licensee’s chief executive officer; all emergency medical response agency licensure and related administrative licensure actions taken against the emergency medical response agency or owner by any state agency in any state; and certification by the applicant that the application contains no misrepresentations or falsifications and that the information given by them is true and complete to the best of their knowledge, and that the emergency medical response agency has both the intention and the ability to comply with the regulations promulgated under the Comprehensive Emergency Medical Service Systems Act, Chapter 190, RSMo Supp. 1998.

(C) Each emergency medical response agency that meets the requirements and standards of the statute and regulations shall be licensed and relicensed for a period of five (5) years.

(D) A political subdivision or corporation that is licensed as an ambulance service cannot be licensed as an emergency medical response agency.

(2) Operational Standards.

(A) Emergency medical response agencies shall ensure prompt response to all requests to that service for emergency care originating from their service area, in accordance with a memorandum of understanding with the local ambulance (B) In accordance with the memorandum of understanding with local ambulance services, emergency medical response agencies shall provide services, personnel and supplies to meet the emergency call volume which can be reasonably anticipated.

(C) The emergency medical response agency shall have a policy and provide for the effective maintenance, storage, usage and replacement of its medical equipment, devices and medications.

(3) Each emergency medical response agency shall maintain accurate records and forms that include the following:

(A) A report to record information on each emergency medical call;

(B) Medical director protocol and policy authorization;

(4) Each emergency medical response agency shall have a medical control plan that has been approved by their medical director and agency manager. The medical control plan is that portion of the medical protocols which specifically addresses the transfer of patient care between agencies.

(5) Each emergency medical response agency that provides advanced life support shall have a designated medical director, working under an agreement, who is trained and meets the requirements for a medical director in accordance with 19 CSR 30-40.303.

(6) Each emergency medical response agency shall have the capability to communicate by voice with the agency’s own dispatching agency and when possible, local hospital(s), trauma centers, and local ambulance services.

(7) Each emergency medical response agency shall have a memorandum of understanding with each ambulance service that is a 911 provider or recognized emergency provider in areas not covered by 911 ambulance services in the agency’s jurisdictional boundaries and will include the following:

(A) Triage protocols;

(B) Do-not-resuscitate requests;

(D) Medical and trauma treatment protocols;

(E) Quality assurance and improvement program; and (F) Response capabilities of the emergency medical response agency.

(8) There shall be an ongoing quality improvement program designed to objectively and systematically monitor, review pursue opportunities to improve patient care and resolve (9) Each emergency medical response agency shall maintain policies and procedures that include the following:

(A) Safety program, including infection control program;

(B) Communications procedures;

(D) Equipment maintenance;

(E) Disaster/multiple casualty protocols; and (F) Quality improvement program.

rule filed Sept. 1, 1998, effective Feb. 28, 1999. ** *Original authority: 190.103 and 190.133, RSMo 1998; 190.160, RSMo 1973, amended 1998; 190.165, RSMo 1973, amended 1978, 1998; 190.175, RSMo 1973, amended 1998, 190.176, RSMo 1998; and 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998. **Pursuant to Executive Orders 20-04 and 20-10, 19 CSR 30-40.333, subsections (1)(A) and (1)(C) was

History

AUTHORITY: sections 190.103, 190.133, 190.160, 190.165, 190.175, 190.176 and 190.185, RSMo Supp. 1998. Emergency rule filed Aug. 28, 1998, effective Sept. 7, 1998, expired March 5, 1999. Original

19 CSR 30-40.340 Initial Emergency Medical Technician Licensure of Mobile Emergency Medical Technicians, Ambulance Attendants and Ambulance Attendant-Drivers Who Have a License with an Expiration Date of August 28, 1998 or Later {#sec-19-csr-30-40.340 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.340}

PURPOSE: This rule provides the requirements related to the initial emergency medical technician licensure of mobile emergency medical technicians, ambulance attendants and ambulance attendant-drivers who have a license with an expiration date of August 28, 1998 or later.

(1) Any person who has a valid mobile emergency medical technician, ambulance attendant or ambulance attendantdriver license with an expiration date of August 28, 1998, or later shall be considered as holding a valid initial license as an emergency medical technician in accordance with section 190.142, RSMo Supp. 1998, after August 28, 1998.

(2) Mobile emergency technicians shall be considered as Emergency Medical Technician-Paramedics and ambulance attendants and ambulance attendant-drivers shall be considered as Emergency Medical Technician-Basics in accordance with section 190.142, RSMo Supp. 1998 after August 28, 1998.

(3) A licensee who has a valid mobile emergency medical technician, ambulance attendant or ambulance attendantdriver license with an expiration date of August 28, 1998 or later shall be issued upon application a replacement license with an expiration date two (2) years from the date of expiration shown on that license.

(4) Each application for an emergency medical technician (EMT) replacement license and two (2)-year extension shall include the following: current Missouri Emergency Medical Services (EMS) license number and expiration date; applicant’s name, address, date of birth, sex, daytime telephone number, e-mail address (if applicable), and Social Security number; applicant’s signature; and a photocopy of the applicant’s current license.

History

AUTHORITY: sections 190.142 and 190.185, RSMo Supp. 1998. Original authority: 190.142, RSMo 1998 and 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998.

19 CSR 30-40.342 Application and Licensure Requirements for the Initial Licensure and Relicensure of Emergency Medical Technician-Basics, Emergency Medical Technician- Intermediate, and Emergency Medical Technician- Paramedics {#sec-19-csr-30-40.342 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.342}

PURPOSE: This rule provides the requirements related to the initial licensure and relicensure of EMT-Basics and EMT-Paramedics. and expensive. This material as incorporated by reference in this (1) Application Requirements for Emergency Medical Technician (EMT) Licensure.

(A) Each applicant for licensure or relicensure as an EMT- Basic, EMT-Intermediate, or EMT-Paramedic shall submit an application for licensure to the Emergency Medical Services (EMS) Bureau. An applicant for relicensure must submit their application no less than thirty (30) days or no more than one hundred twenty (120) days prior to the expiration date of their current license.

(B) An application shall include, but is not limited to, the following information: whether an initial licensure or relicensure application; if previously licensed, their license number and expiration date; type of licensure applied for (EMT- Basic (EMT-B), EMT-Intermediate (EMT-I), or EMT-Paramedic (EMT-P)); type of certification or education used for licensure or relicensure; applicant’s name, signature, address, date of birth, sex, daytime telephone number, email address (if applicable), and Social Security number; if applicable, whether or not the applicant is a past member of the United States Armed Forces including National Guard and Reserves who has been honorably discharged within the past two (2) years who requests an EMT-B United States Armed Forces license and, if applicable, attach to the application a copy of the applicant’s certificate of release or discharge from active duty (DD form 214) or an NGB-22 which verifies the applicant’s honorable discharge and discharge date; whether or not the applicant is a current member of the United States Armed Forces including National Guard and Reserves who requests an EMT-B United States Armed Forces license and, if applicable, attach to the application a copy of the applicant’s common access card; type of present primary EMS affiliation. prior administrative licensure actions taken against any license or certification in Missouri or any other state; whether they have been finally adjudicated and found guilty, or entered a plea of guilty or nolo contendere, in a criminal prosecution under the laws of any state or of the United States, whether or not they received a suspended imposition of sentence for any criminal offense; if the answer is yes to the preceding statement, they must attach to their application a certified copy of all charging documents (such as complaints, informations, or indictments), judgments and sentencing information, plea agreements and probation terms, and any other information they wish considered; certification by the applicant that they have the ability to speak, read, and write the English language; certification by the applicant that they do not have a physical or mental impairment which would substantially limit their ability to perform the essential functions of an emergency medical technician position with or without a reasonable accommodation; certification by the applicant that if relicensing using continuing education that they have successfully completed the required continuing education in accordance with state regulations, have attached a list of these continuing education units, and are in possession of documents of the required continuing education, and will make all records available to the EMS Bureau upon request under penalty of license action up to and including revocation; certification by the applicant that the application contains no misrepresentation or falsifications and that the information given by them is true and complete to the best of their knowledge; certification by the applicant that they have the intention and the ability to comply with the regulations promulgated under the Comprehensive Emergency Medical Services Systems Act, Chapter 190, RSMo; certification by the applicant that they have been a resident of Missouri for five (5) consecutive years prior to the date on their application or have attached to the application at least two (2) completed fingerprint cards.

(C) All applicants shall provide their Social Security number on their application so the Bureau of EMS can perform criminal

history checks to determine the recency and relatedness of any criminal convictions prior to the licensure or relicensure of the applicant. Criminal history checks that the EMS Bureau finds not to be relevant to the licensure or relicensure of an EMT will not be maintained in the applicant’s file.

(D) All applicants shall attach to the application a list of the qualifying continuing education used for relicensure, as applicable. This list shall include verification by the applicant’s training officer or medical director that all core requirements have been met. Receipt of this list does not constitute approval of continuing education by the EMS Bureau.

(E) An applicant shall provide all information and certification required on the EMS Bureau application for EMT licensure.

Incomplete or inaccurate information on an application shall be cause to deny or take action upon a license.

(F) An applicant shall disclose if they have ever been subject to limitation, suspension, or termination of their right to practice in a health care occupation and/or voluntarily surrendered a health care license or certification in any state.

(2) EMT-Basic (EMT-B) Licensure and Relicensure Requirements.

(A) EMT-Basic (Initial Licensure). Initial licensure requirements apply to any person who was not licensed in Missouri prior to August 28, 1998, as an attendant or attendant-driver by the EMS Bureau or whose Missouri license has expired for more than two (2) years. The applicant for initial licensure shall submit with their license application to the EMS Bureau evidence of current certification with the National Registry of EMTs as an EMT-B, EMT-I, or EMT-P. Any applicant for initial licensure as an EMT-B who is a past member of the United States Armed Forces including National Guard and Reserves who has been honorably discharged from the United States Armed Forces including National Guard and Reserves within the past two (2) years may request an EMT-B United States Armed Forces license with the EMS Bureau. The applicant shall submit to the EMS Bureau a copy of the applicant’s certificate of release or discharge from active duty (a DD form 214) or NGB-22 which verifies the applicant’s honorable discharge and discharge date in order to receive an EMT-B United States Armed Forces license from the EMS Bureau that will provide the licensee’s date of honorable military discharge. Any applicant for initial licensure as an EMT-B who is a current member of the United States Armed Forces including National Guard and Reserves may request an EMT-B United States Armed Forces license with the EMS Bureau. The applicant shall submit to the EMS Bureau a copy of the applicant’s common access card in order to receive an EMT-B United States Armed Forces license from the EMS Bureau that will provide that the applicant is currently in the United States Armed Forces including National Guard and Reserves.

(B) The EMT-B in Missouri may be permitted to perform blood glucose analysis, twelve (12) lead EKG acquisition and transmission, non-invasive airway devices not intended to be placed in the trachea, and all skills in the National Scope of Practice for Emergency Medical Technicians which is incorporated by reference in this rule as published in 2007 by the U.S. Department of Transportation and is available at U.S.

Services, West Building W 44-314, 1200 New Jersey Ave. SE, NTI 140, Washington, DC 20590. This rule does not incorporate any (C) EMT-Basic (Relicensure or Step Down from EMT-P or EMT- I).

The applicant for relicensure shall submit with their certification with the National Registry of EMTs as an EMT- Basic, EMT-Intermediate, or EMT-Paramedic; or 2. An applicant shall certify to the EMS Bureau:

A. That they have successfully completed one hundred (100) hours of continuing education which meet the EMS Bureau’s approval criteria under 19 CSR 30-40.331, forty-eight (48) hours of which cover all elements of the EMT-B core continuing education curriculum and fifty-two (52) hours of which may be elective topics from the EMT-B, EMT-I, or EMT-P B. That they are able to produce documentation of the required continuing education, and will make all records date of relicensure. Failure to obtain and retain complete and accurate documentation shall be cause for taking action upon a license; and C. That they have current basic cardiac life support training (does not count towards core continuing education curriculum).

(3) Any applicant for relicensure as an EMT-B who has been honorably discharged from the United States Armed Forces including National Guard and Reserves within the past two (2) years may request an EMT-B United States Armed Forces license with the EMS Bureau. The applicant shall submit to the EMS Bureau a copy of the applicant’s certificate of release or discharge from active duty (a DD form 214) or an NGB-22 which verifies the applicant’s honorable discharge and discharge date in order to receive an EMT-B United States Armed Forces license from the EMS Bureau that will provide the licensee’s date of honorable military discharge. Any applicant for relicensure as an EMT-B who is a current member of the United States Armed Forces including National Guard and Reserves may request an EMT-B United States Armed Forces license with the EMS Bureau.

The applicant shall submit to the EMS Bureau a copy of the applicant’s common access card in order to receive an EMT-B United States Armed Forces license from the EMS Bureau that will provide that the applicant is currently in the United States Armed Forces including National Guard and Reserves.

(4) EMT-Paramedic Licensure and Relicensure Requirements.

(A) EMT-Paramedic (Initial Licensure). Initial licensure requirements apply to any person who was not licensed in Missouri prior to August 28, 1998, as a mobile emergency medical technician by the EMS Bureau or whose Missouri license has expired for more than two (2) years. The applicant for initial licensure shall submit with their license application to the EMS Bureau evidence of current certification with the National Registry of EMTs as an EMT-P.

(B) EMT-Paramedic (Relicensure).

The applicant for relicensure shall submit with their certification with the National Registry of EMTs as an EMT-P; or 2. An applicant shall certify to the EMS Bureau— A. That they have successfully completed one hundred forty-four (144) hours of continuing education which meet the EMS Bureau’s approval criteria under 19 CSR 30-40.331, forty-eight (48) hours of which may be elective topics and the remaining ninety-six (96) hours covering all elements of the EMT-P core continuing education curriculum;

B. That they are able to produce documentation of the required continuing education and will make all records date of relicensure. Failure to obtain and retain complete and accurate documentation shall be cause for taking action upon a license; and C. That they have current advanced cardiac life support training (can be counted towards the refresher requirement).

(5) EMT-Intermediate (EMT-I) Licensure and Relicensure Requirements.

(A) EMT-I (Initial Licensure). Initial licensure requirements apply to any person applying for licensure in Missouri.

The applicant for initial licensure shall submit with their certification with the National Registry of Emergency Medical Technicians as an EMT-I. The EMT-I in Missouri may perform all the skills except intraosseous infusions in the National EMS Scope of Practice Model for Advanced EMT which is incorporated by reference in this rule as published in 2007 by the U.S. Department of Transportation and is available at U.S.

Services, West Building W 44-314, 1200 New Jersey Ave. SE, NTI 140, Washington DC 20590. This rule does not incorporate any (B) EMT-Intermediate (EMT-I) Relicensure.

The applicant for relicensure shall submit with their certification with the National Registry of EMTs as an EMT-I; or 2. An applicant shall certify to the EMS Bureau— A. That they have successfully completed one hundred forty-four (144) hours of continuing education which meet the EMS Bureau’s approval criteria under 19 CSR 30-40.331, seventytwo (72) hours of which cover all elements of the EMT-I core continuing education curriculum and seventy-two (72) hours of which may be elective topics from the EMT-B, EMT-I, or EMT-P curriculum;

B. That they are able to produce documentation of the required continuing education and shall make all records date of relicensure; and C. Applicants shall produce a copy of the front and back of a basic cardiac life support training card which confirms that the applicant has successfully completed a basic life support training course within the past two (2) years.

The applicant for relicensure shall submit with their certification with the National Registry of EMTs as an EMT-B, EMT-I, or EMT-P; or 2. An applicant shall certify to the EMS Bureau— A. That they have successfully completed one hundred (100) hours of continuing education which meet the EMS Bureau’s approval criteria under 19 CSR 30-40.331, forty-eight (48) hours of which cover all elements of the EMT-B core continuing education curriculum and fifty-two (52) hours of which may be elective topics from the EMT-B, EMT-I, or EMT-P B. That they are able to produce documentation of the required continuing education and shall make all records date of relicensure; and C. Applicants shall also have current basic cardiac life support training. This does not count towards core continuing education curriculum.

History

AUTHORITY: sections 190.142, 190.160, 190.165, and 190.185, RSMo Supp. 2013. Emergency rule filed Aug. 28, 1998, effective Sept. 7, 1998, expired March 5, 1999. Original rule filed Sept. 1, 1998, effective Feb. 28, 1999. Amended: Filed Aug. 27, 2009, effective April 30, 2010. Amended: Filed March 11, 2016, effective Oct. 30, 2016. Original authority: 190.142, RSMo 1998, amended 1999, 2002; 190.160, RSMo 1973, amended 1998, 2002; 190.165, RSMo 1973, amended 1978, 1998, 2002; and 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002. Pursuant to Executive Order 21-09, 19 CSR 30-40.342, subsection (2)(B) was suspended from October 9, 2020 through December 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 30-40.342, subsection (2)(B) was suspended from March 3, 2021 through December 31, 2021.

19 CSR 30-40.365 Reasons and Methods the Department Can Use to Take Administrative Licensure Actions {#sec-19-csr-30-40.365 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.365}

PURPOSE: This rule provides the reasons and methods the state can use to take administrative licensure actions.

(1) The department may refuse to issue or may deny renewal of any certificate, permit, or license required pursuant to the comprehensive emergency medical services systems act for failure to comply with the provisions of the comprehensive emergency medical services systems act or for any cause listed in section (2) below. The department shall notify the applicant in writing of the reasons for the refusal or denial and shall advise the applicant of his or her right to file a complaint with the Administrative Hearing Commission as provided by

Chapter 621, RSMo.

(2) The department may cause a complaint to be filed with the Administrative Hearing Commission as provided by Chapter 621, RSMo, against any holder of any certificate, permit, or license required by the comprehensive emergency medical services systems act or any person who has failed to renew or has surrendered his or her certificate, permit, or license for failure to comply with the provisions of the comprehensive emergency medical services systems act or for any of the following reasons:

(A) Use or unlawful possession of any controlled substance, as defined in Chapter 195, RSMo, or alcoholic beverage to an extent that such use impairs a person’s ability to perform the work of any activity licensed or regulated by the comprehensive emergency medical services systems act;

(B) Being finally adjudicated and found guilty, or having entered a plea of guilty or nolo contendere, in a criminal prosecution under the laws of any state or of the United States, for any offense reasonably related to the qualifications, functions or duties of any activity licensed or regulated pursuant to the comprehensive emergency medical services systems act, for any offense an essential element of which is fraud, dishonesty, or an act of violence, or for any offense involving moral turpitude, whether or not sentence is imposed;

(C) Use of fraud, deception, misrepresentation, or bribery in securing any certificate, permit, or license issued pursuant to the comprehensive emergency medical services systems act or in obtaining permission to take any examination given or required pursuant to the comprehensive emergency medical services systems act;

(D) Obtaining or attempting to obtain any fee, charge, tuition, or other compensation by fraud, deception, or misrepresentation;

(E) Incompetency, misconduct, gross negligence, fraud, misrepresentation, or dishonesty in the performance of the functions or duties of any activity licensed or regulated by the comprehensive emergency medical services systems act;

(F) Violation of, or assisting or enabling any person to violate, any provision of the comprehensive emergency medical services systems act, or of any lawful rule or regulation adopted by the department pursuant to the comprehensive emergency medical services systems act;

(G) Impersonation of any person holding a certificate, permit, or license or allowing any person to use his or her certificate, permit, license, or diploma from any school;

(H) Disciplinary action against the holder of a license or other right to practice any activity regulated by the comprehensive emergency medical services systems act granted by another state, territory, federal agency, or country upon grounds for which revocation or suspension is authorized in this state;

(I) Being finally adjudged insane or incompetent by a court of competent jurisdiction;

(J) Assisting or enabling any person to practice or offer to practice any activity licensed or regulated by the comprehensive emergency medical services systems act who is not licensed and currently eligible to practice pursuant to the comprehensive emergency medical services systems act;

(K) Issuance of a certificate, permit, or license based upon a material mistake of fact;

(L) Violation of any professional trust, confidence, or legally protected privacy rights of a patient by means of an unauthorized or unlawful disclosure;

(M) Use of any advertisement or solicitation which is false, misleading, or deceptive to the general public or persons to whom the advertisement or solicitation is primarily directed;

(N) Violation of the drug laws or rules and regulations of this state, any other state, or the federal government;

(O) Refusal of any applicant or licensee to respond to reasonable department requests for necessary information to process an application or to determine license status or license eligibility.

(P) Any conduct or practice which is or might be harmful or dangerous to the mental or physical health or safety of a patient or the public; and (Q) Repeated acts of negligence or recklessness in the performance of the functions or duties of any activity licensed or regulated by sections 190.100 to 190.245, RSMo.

(3) The Department of Health and Senior Services may suspend any certificate, permit, or license required pursuant to the comprehensive emergency medical services systems act simultaneously with the filing of the complaint with the Administrative Hearing Commission, if the department finds that there is an imminent threat to the public health. The notice of suspension shall include the basis of the suspension and notice of the right to appeal such suspension. The licensee may appeal the decision to suspend the license, certificate, or permit to the department. The appeal shall be filed within ten (10) days from the date of the filing of the complaint. A hearing shall be conducted by the department within ten (10) days from the date the appeal is filed. The suspension shall continue in effect until the conclusion of the proceedings, including review thereof, unless sooner withdrawn by the department, dissolved by a court of competent jurisdiction, or stayed by the Administrative Hearing Commission.

rule filed Jan. 14, 1999, effective Jan. 24, 1999, expired July 22, 1999.

Original rule filed Jan. 14, 1999, effective June 30, 1999. Amended:

Filed March 1, 2012, effective Sept. 30, 2012. Amended: Filed Aug. 7, 2017, effective March 30, 2018. *Original authority: 190.165, RSMo 1973, amended 1978, 1998, 2002, 2016 and 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002.

History

AUTHORITY: sections 190.165 and 190.185, RSMo 2016. Emergency

19 CSR 30-40.375 Uniform Data Collection System and Ambulance Reporting Requirements for Ambulance {#sec-19-csr-30-40.375 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.375}

PURPOSE: This rule provides the requirements for an ambulance service to report certain information on each ambulance run and to submit certain data to the department.

(1) An ambulance report or an electronic ambulance reporting system shall be used by an ambulance service to record information on each ambulance run and shall be subject to approval by the department.

(2) A copy of all emergency life threatening runs as described in

section (4) shall be sent to the department at least quarterly no later than thirty (30) days after the end of each quarter.

(3) Each ambulance service shall report to the department the total number of emergency life threatening runs, emergency urgent runs, emergency dry runs, non-emergency life threatening runs, non-emergency urgent, and non-emergency dry runs no later than thirty (30) days after the end of each calendar year.

(4) Each ambulance report shall include, but not be limited to, the following information: run report number; date of run; ambulance service number, vehicle identification number; state of pickup; county of pickup; type of run to scene; type of run from scene; times dispatched, enroute, arrive scene, depart scene, and arrive destination; place of incident; patient destination; personnel license numbers; systolic blood pressure; respiratory rate; glasgow coma score; protective equipment used; factors affecting emergency medical services (EMS); treatment authorization; trauma assessments; cause of injury; illness assessment; destination determination; patient name, address, date of birth, race, and sex; and treatment administered. The ambulance service shall keep a copy of this information for at least five (5) years.

History

AUTHORITY: sections 190.175 and 190.185, RSMo Supp. 1998. Original authority: 190.175, RSMo 1973. amended 1998 and 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998.

19 CSR 30-40.410 Definitions and Abbreviations Relating to Trauma Centers {#sec-19-csr-30-40.410 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.410}

PURPOSE: This rule defines terminology related to trauma centers.

(1) The following definitions and abbreviations shall be used in the interpretation of the rules in 19 CSR 30-40.400 to 19 CSR 30-40.450:

(A) Advanced cardiac life support (ACLS) certified means that an individual has successfully completed a course of training in advanced cardiac life-support techniques certified by the American Heart Association and that certification is maintained;

(B) Anesthesiologist assistant (AA) means a person who meets each of the following conditions:

Has graduated from an anesthesiologist assistant program accredited by the American Medical Association’s Committee on Allied Health Education and Accreditation or by its successor agency;
Has passed the certifying examination administered by the National Commission on Certification of Anesthesiologist Assistants;
Has active certification by the National Commission on Certification of Anesthesiologist Assistants;
Is currently licensed as an anesthesiologist assistant in the state of Missouri; and 5. Provides health care services delegated by a licensed anesthesiologist. For the purposes of subsection (1)(B), the licensed anesthesiologist shall be “immediately available” as this term is defined in section 334.400, RSMo;

(C) ATLS course means the advanced trauma life-support course approved by the American College of Surgeons when required, certification shall be maintained;

(D) Board-admissible means that a physician has applied to a specialty board and has received a ruling that s/he has fulfilled the requirements to take the examinations. Board certification must be obtained within five (5) years of the first appointment;

(E) Board-certified means that a physician has fulfilled all requirements, has satisfactorily completed the written and oral examinations, and has been awarded a board diploma in a specialty field;

(F) Certified registered nurse anesthetist (CRNA) means a registered nurse who has graduated from a school of nurse anesthesia accredited by the Council on Accreditation of Educational Programs of Nurse Anesthesia or its predecessor and who has been certified as a nurse anesthetist by the Council on Certification of Nurse Anesthetists;

(G) CME means continuing medical education and refers to the highest level of continuing education approved by the Missouri State Medical Association, the Missouri Association of Osteopathic Physicians and Surgeons, The American Osteopathic Association, or the Accreditation Council for Continuing Medical Education;

(H) Continuing nursing education means education approved or recognized by a national and/or state professional organization and/or trauma medical director;

(I) Core surgeon is a member of the trauma team listed on the trauma call schedule ten percent (10%) of the time or greater;

(J) Credentialed or credentialing is a hospital-specific system of documenting and recognizing the qualifications of medical staff and nurses and authorizing the performance of certain procedures and establishing clinical privileges in the hospital setting;

(K) EMS Bureau means the Missouri Department of Health and Senior Services Emergency Medical Services Bureau;

(L) Glasgow coma scale is a scoring system for assessing a patient’s level of consciousness utilizing a point system which measures eye opening, verbal response, and motor response.

The higher the total score, the better the patient’s neurological status;

(M) Immediately available (IA) means being present at bedside at the time of the patient’s arrival at the hospital when prior notification is possible and no more than twenty (20) minutes from the hospital under normal driving and weather conditions;

(N) In-house (IH) means being on the hospital premises twenty-four (24) hours a day.

(O) Liaison means one (1) physician representative from each of the following areas: Emergency Medicine, Neurosurgery, Orthopedics, and Anesthesia who is selected to attend the Performance Improvement and Patient Safety Committee and to disseminate information to the other physicians within his/ her specialty taking trauma call;

(P) Missouri trauma registry is a statewide data collection system to compile and maintain statistics on mortality and morbidity of trauma victims, using a reporting method provided by the Missouri Department of Health and Senior Services;

(Q) Multidisciplinary trauma conference means a meeting of members of the trauma team and other appropriate hospital personnel to review the care of trauma patients at the hospital;

(R) Non-core surgeon is a member of the trauma call team listed on the trauma call schedule less than ten percent (10%) of the time;

(S) PALS means pediatric advanced life support, ENPC means Emergency Nurses Pediatric Course, and APLS means Advanced Pediatrics Life Support; when required, certification shall be maintained;

(T) Physician advisory group is two (2) or more physicians who collectively assume the role of a medical advisor;

(U) Promptly available (PA) means arrival at the patient’s bedside within thirty (30) minutes after notification of a patient’s arrival at the hospital under normal driving and weather conditions;

(V) R is a symbol to indicate that a standard is a requirement for trauma center designation at a particular level;

(W) Review is the inspection of hospitals to determine compliance with the rules of this chapter. There are four (4) types of reviews: the initial review of hospitals never before designated as trauma centers or hospitals never before reviewed for compliance with the rules of this chapter or hospitals applying for a new level of trauma center designation; the verification review to evaluate the correction of any deficiencies noted in a previous review; and the validation review, which shall occur every five (5) years to assure continued compliance with the rules of this chapter, and a focus review to allow review of substantial deficiencies by a review team;

(X) Revised trauma score (RTS) is a numerical methodology for categorizing the physiological status of trauma patients;

(Y) Senior trauma surgery resident is a physician in at least the third post-graduate year of study;

(Z) Severely injured adult patient is an injured patient with a glasgow coma score (GCS) less than fourteen (14) or a systolic blood pressure less than ninety (90) millimeters of mercury or respirations less than ten (10) per minute or more than twentynine (29) per minute.

(AA) Severely injured child is defined as a patient fourteen (14) years of age or less having a GCS less than fourteen (14), shock following injury, pediatric trauma score less than eight (8), or with any of the following conditions: unable to establish or maintain an airway; ineffective respiratory effort; penetrating injury to head, neck, chest, abdomen, or extremity proximal to elbow or knee; burns greater than ten percent (10%) of the body surface area or involving inhalation injury; two (2) or more proximal long bone fractures or pelvic fracture; open or depressed skull fracture; suspected spinal cord injury and/ or paralysis; amputation proximal to wrist or ankle; facial or tracheal injury with airway compromise; pre-existing medical conditions; or respiratory or cardiopulmonary arrest after injury;

(BB) Surgical trauma call roster is a hospital-specific list of surgeons assigned to trauma care, including date(s) of coverage and back-up surgeons when indicated;

(CC) Trauma center is a hospital that has been designated in accordance with the rules in this chapter to provide systematized medical and nursing care to trauma patients.

Level I is the highest level of designation and functions as a resource center for the hospitals within that region. Level II is the next highest level of designation dealing with large volumes of serious trauma. Level III is the next level with limited resources;

(DD) Trauma medical director is a surgeon designated by the hospital who is responsible for the trauma service and performance improvement and patient safety programs related to trauma care;

(EE) Trauma nurse coordinator/trauma program manager is a registered nurse designated by the hospital with responsibility for monitoring and evaluating the care of trauma patients and the coordination of performance improvement and patient safety programs for the trauma center in conjunction with the trauma medical director;

(FF) Trauma nursing course is an education program in nursing care of trauma patients;

(GG) Trauma service is an organizational component of the hospital specializing in the care of injured patients;

(HH) Trauma team is a team consisting of the emergency physician, physicians on the surgical trauma call roster, appropriate anesthesiology staff, nursing, and other support staff as needed;

(II) Trauma team activation protocol is a hospital document outlining the criteria used to identify severely injured patients and the procedures for notification of trauma team members and indicating surgical and non-surgical specialty response times acceptable for treating major trauma patients;

(JJ) Trauma triage is an estimation of injury severity at the scene of an accident; and (KK) Virtual review means a type of review conducted through the use of secure virtual video and audio conferencing and secure file transfers in order to determine compliance with the rules of this chapter.

History

AUTHORITY: section 190.185, RSMo 2016, and section 190.241, RSMo Supp. 2022. Emergency rule filed Aug. 28, 1998, effective Sept. 7, 1998, expired March 5, 1999. Original rule filed Sept. 1, 1998, effective Feb. 28, 1999. Amended: Filed Jan. 16, 2007, effective Aug. 30, 2007. Amended: Filed May 19, 2008, effective Jan. 30, 2009. Emergency amendment filed Nov. 21, 2022, effective Dec. 7, 2022, expires June 4, 2023. Amended: Filed Nov. 21, 2022, effective June 30, 2023. Original authority: 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002, and 190.241, RSMo 1987, amended 1998, 2008, 2016, 2017, 2022.

19 CSR 30-40.420 Trauma Center Designation Requirements {#sec-19-csr-30-40.420 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.420}

PURPOSE: This rule establishes the requirements for participation in Missouri’s trauma center program.

(1) Participation in Missouri’s trauma center program is voluntary and no hospital shall be required to participate.

No hospital shall in any way indicate to the public that it is a trauma center unless that hospital has been designated as such by the Department of Health and Senior Services (the department). Hospitals desiring trauma center designation shall apply to the department either through the option outlined in section (2) or section (3). Only those hospitals found to be in compliance with the requirements of the rules in this

chapter shall be designated by the department as trauma centers.

(2) Hospitals requesting to be reviewed and designated as a trauma center by the department shall meet the following requirements:

(A) The application required for trauma center designation shall be made upon forms prepared or prescribed by the department and shall contain information the department deems necessary to make a fair determination of eligibility for review and designation in accordance with the rules of this

chapter;

(B) An application shall include the following information: designation level requested; name, address, and telephone number of hospital; name of chief executive officer, chairman/ president of board of trustees, surgeon in charge of trauma care, trauma nurse coordinator/program manager, director of emergency medicine, and director of trauma intensive care; number of emergency department trauma caseload, trauma team activations, computerized tomography scan capability, magnetic resonance imaging capability, operating rooms, intensive care unit/critical care unit beds, burn beds, rehabilitation beds, trauma surgeons, neurosurgeons, orthopedists, emergency department physicians, anesthesiologists, certified registered nurse anesthetists, pediatricians, and pediatric surgeons; date of application; and signatures of the chairman/president of board of trustees, hospital chief executive officer, surgeon in charge of trauma, and director of emergency medicine. The trauma center review and designation application form, included herein, is available at the Health Standards and Licensure (HSL) office or may be obtained by mailing a written request to Missouri Department of Health and Senior Services, HSL, PO Box 570, Jefferson City, MO 65102-0570;

(C) The department shall notify the hospital of any apparent omissions or errors in the completion of the application and shall contact the hospital to arrange a date for the review;

(D) Failure of a hospital to cooperate in arranging for a mutually suitable date for review shall constitute forfeiture of application when a hospital’s initial review is pending or suspension of designation when a hospital’s verification or validation review is pending;

(E) Hospitals designated as trauma centers under the previous designation system shall maintain their designation until a review is conducted using the rules of this chapter;

(F) The review of hospitals for trauma center designation shall include interviews with designated hospital staff, a review of the physical plant and equipment, and a review of records and documents as deemed necessary to assure compliance with the requirements of the rules of this chapter.

The department may conduct an on-site review, a virtual review, or a combination thereof on the hospitals/trauma centers. For announced reviews that are scheduled with the hospitals/trauma centers, the department will make the hospitals/trauma centers aware at least ninety (90) days prior to the scheduled review whether the department intends that the review will be conducted on-site and/or virtually.

Due to unforeseen circumstances, the department may need to change whether the review is conducted on-site and/or virtually less than ninety (90) days before the announced review. The department will contact the hospitals/trauma centers to make the hospitals/trauma centers aware of any changes about how the review will be conducted, either onsite and/or virtually, and/or when the review will be conducted with as much advance notice as possible prior to the date of the announced review. The cost of any and all site reviews shall be paid by each applicant hospital or renewing trauma center unless adequate funding is available to the department to pay for reviews. Hospitals/trauma centers shall be responsible for paying expenses related to the cost of the qualified contractors to review their respective hospitals/trauma centers during initial, validation, and focus reviews. The department shall be responsible for paying the expenses of its representative. Costs of the review to be paid by the hospital/trauma center include– 1. An honorarium shall be paid to each qualified contractor of the review team whether the review occurs on-site or virtually. Qualified contractors of the review team for levels I and II trauma center reviews shall be paid one thousand four hundred fifty dollars ($1,450) per reviewer. Qualified contractors of the review team for levels III and IV trauma center reviews shall be paid one thousand dollars ($1,000) per reviewer. This honorarium shall be paid to each qualified contractor of the review team at the time the site survey begins if on-site or prior to the beginning of the review if the review is conducted virtually.

Airfare shall be paid for each qualified contractor of the review team, if applicable;
Lodging shall be paid for each qualified contractor of the review team, unless the review is conducted virtually. The hospital/trauma center shall secure the appropriate number of hotel rooms for the qualified contractors and pay the hotel directly; and 4. Incidental expenses, if applicable, for each qualified contractor of the review team shall not exceed two hundred fifty dollars ($250) and may include the following:

A. Airport parking;

B. Checking bag charges;

C. Meals during the review; and D. Mileage to and from the review if no airfare was charged by the reviewer. If the reviewer solely participated virtually in the review and did not travel by vehicle to the review, then no mileage shall be paid. Mileage shall be paid at the federal mileage rate for business miles as set by the Internal Revenue Service (IRS). Federal mileage rates can be found at the website www.irs.gov;

(G) For the purpose of reviewing trauma centers and hospitals applying for trauma center designation, the department shall use review teams consisting of two (2) surgeons and one (1) emergency physician who are experts in trauma care and one (1) trauma nurse coordinator/trauma program manager experienced in trauma center review. The team shall be disinterested politically and financially in the hospitals to be reviewed. Out-of-state review teams shall conduct levels I and II reviews. In-state reviewers may conduct level III reviews.

In the event that out-of-state reviewers are unavailable, level II reviews may be conducted by in-state reviewers from emergency medical services (EMS) regions other than the region being reviewed with approval of the director of the Department of Health and Senior Services or his/her designee.

When utilizing in-state review teams, the level II trauma center shall have the right to refuse one (1) review team.

Any individual interested in becoming a qualified contractor to conduct reviews shall— A. Send the department a curriculum vitae (CV) or résumé that includes his or her experience and expertise in trauma care and whether an individual is in good standing with his or her licensing boards. A qualified contractor shall be in good standing with his or her respective licensing boards.

B. Provide the department evidence of his or her previous site survey experience (state and/or national designation survey process); and C. Submit a list to the department that details any ownership he or she may have in a Missouri hospital(s), whether he or she has been terminated from any Missouri hospital(s), any lawsuits he or she has currently or had in the past with any Missouri hospital(s), and any Missouri hospital(s) for which his or her hospital privileges have been revoked.

Qualified contractors for the department shall enter into a written agreement with the department indicating that, among other things, they agree to abide by Chapter 190, RSMo, and the rules in this chapter, during the review process;

(H) Any substantial deficiencies cited in the initial review or the validation review regarding patient care issues, especially those related to delivery of timely surgical intervention, shall require a focused review to be conducted. When deficiencies involve documentation or policy or equipment, the hospital’s plan of correction shall be submitted to the department and verified by department personnel;

(I) The verification review shall be conducted in the same manner and detail as initial and validation reviews. A review of the physical plant will not be necessary unless a deficiency was cited in the physical plant in the preceding initial or validation review. If deficiencies relate only to a limited number of areas of hospital operations, a focused review shall be conducted.

The review team for a focused review shall be comprised of review team members with the required expertise to evaluate corrections in the specified deficiency area;

(J) Validation reviews shall occur every three (3) years;

(K) Hospitals/Trauma centers being reviewed through a virtual survey shall do the following:

Provide a videoconferencing platform to be used for the hospital/trauma center virtual review;
Provide a live tour of the hospital;
Ensure the videoconferencing platform used during the review is compliant with state and federal laws for protected health information;
Assign an on-site visit coordinator for the review.

The on-site visit coordinator role cannot be fulfilled by the trauma program manager. This on-site visit coordinator will be responsible for the logistical aspects of the virtual review.

Responsibilities include, at least, the following:

A. Scheduling the videoconferencing meetings;

B. Sending out calendar invitations;

C. Providing electronic medical record (EMR) access to designated individuals;

D. Ensuring all required participants are on the videoconferencing line for the various parts of the review; and E. Sending separate calendar invitations for each section of the virtual review to hospital staff, qualified contractors and the department;

Assign one staff navigator per qualified contractor to help remotely navigate the EMR, the patient performance improvement patient safety (PIPS) documentation, and supporting documentation. The staff navigator role cannot be fulfilled by the trauma program manager, the trauma program medical director, the trauma program registrar, or the on-site visit coordinator for the review. The individuals designated as the staff navigators shall be familiar with navigating through the EMR.
Provide the department with requested patient care report information for the review no later than thirty (30) days prior to the virtual review;
Provide the department with requested medical records, PIPS documentation, registry report and all supporting documentation at least seven (7) days prior to the virtual visit through a method that is compliant with state and federal laws for protected health information;
Schedule a pre-review call with the qualified contractors, the department, the trauma program medical director, the trauma program manager, the staff navigators, and the on-site visit coordinator approximately one (1) week prior to the virtual review;
Test the functionality of the videoconferencing platform for the live tour of the hospital prior to the pre-review call; and 10. Provide a list of attendees for the review meeting and their roles to the review team and the department prior to the virtual review. Any changes that occur to this list may be communicated to the department during the review meeting or before the virtual review;

(L) The department may conduct an on-site review of the hospital prior to the virtual review to ensure that the hospital meets the requirements for trauma designation;

(M) Upon completion of a review, the reviewers shall submit a report of their findings to the department. The report shall state whether the specific standards for trauma center designation have or have not been met; if not met, in what way they were not met. The report shall include the patient chart audits and a narrative summary to include pre-hospital, hospital, trauma service, emergency department, operating room, recovery room, clinical lab, intensive care unit, blood bank, rehabilitation, performance improvement and patient safety programs, education, outreach, research, chart review, and interviews. The department has final authority to determine compliance with the rules of this chapter;

(N) Within thirty (30) days after receiving a review report, the department shall return a copy of the report in whole to the chief executive officer of the hospital reviewed. Included with the report shall be notification indicating that the hospital has met the criteria for trauma center designation or has failed to meet the criteria for the designation level for which it applied and options the hospital may pursue;

(O) If a verification review is required, the hospital shall be allowed a period of six (6) months to correct deficiencies. A plan of correction form shall be provided to the department and shall be completed by the hospital and returned to the department within thirty (30) days after notification of review findings;

(P) Once a review is completed, a final report shall be prepared by the department. The final report shall be public record and shall disclose the standards by which the reviews were conducted and whether the standards were met. The reports filed by the reviewers shall be held confidential and shall be disclosed only to the hospital’s chief executive officer or an authorized representative;

(Q) The department shall have the authority to put on probation, suspend, revoke, or deny trauma center designation if the department has determined that there has been a substantial failure to comply with the requirements of the rules in this chapter. Once designated as a trauma center, a hospital may voluntarily surrender the designation at any time without giving cause, by contacting the department. In these cases, the application and review process shall be completed again before the designation may be reinstated;

(R) Trauma center designation shall be valid for a period of three (3) years from the date the trauma center is designated.

Expiration of the designation shall occur unless the trauma center applies for validation review within this three- (3-) year period. Trauma center designation shall be site specific and not transferable when a trauma center changes location;

(S) The department shall investigate complaints against trauma centers. Failure of the hospital to cooperate in providing documentation and interviews with appropriate staff may result in revocation of trauma center designation.

Any hospital which takes adverse action toward an employee for cooperating with the department regarding a complaint is subject to revocation of trauma center designation; and (T) Failure of a hospital/trauma center to provide all medical records and quality improvement documentation necessary for the department to conduct a trauma review in order to determine if the requirements of 19 CSR 30-40.430 have been met shall result in the revocation of the hospital/trauma center’s designation as a trauma center.

(3) Hospitals seeking trauma center designation by the department based on their current verification as a trauma center by the American College of Surgeons shall meet the following requirements:

(A) An application for trauma center designation by the department for hospitals that have been verified as a trauma center by the American College of Surgeons shall be made upon forms prepared or prescribed by the department and shall contain information the department deems necessary to make a determination of eligibility for review and designation in accordance with the rules of this chapter. The application for trauma verified hospital designation form, included herein, is available at the Health Standards and Licensure (HSL) office, or online at the department’s website at www.health.mo.gov, or may be obtained by mailing a written request to the Missouri Department of Health and Senior Services, HSL, PO Box 570, Jefferson City, MO 65102-0570. The application for trauma center designation shall be submitted to the department no less than sixty (60) days and no more than one hundred twenty (120) days prior to the desired date of the initial designation or expiration of the current designation;

(B) The application for trauma verified hospital designation form, included herein, shall be complete before the department designates a hospital/trauma center. The department shall notify the hospital/trauma center of any apparent omissions or errors in the completion of the application for trauma verified hospital designation form. Upon receipt of a completed and approved application, the department shall designate such hospital as follows:

The department shall designate a hospital as a level I trauma center if such hospital has been verified as a level I 2. The department shall designate a hospital as a level II trauma center if such hospital has been verified as a level II 3. The department shall designate a hospital as a level III trauma center if such hospital has been verified as a level III 4. The department shall designate a hospital as a level IV trauma center if such hospital has been verified as a level IV 5. The department shall designate a hospital as a level I pediatric trauma center if such hospital has been verified as a level I pediatric trauma center (only treats children) by the American College of Surgeons;
The department shall designate a hospital as a level II pediatric trauma center if such hospital has been verified as a level II pediatric trauma center (only treats children) by the American College of Surgeons;
The department shall designate a hospital as a level I trauma center if such hospital has been verified as a level I trauma center (only treats adults) by the American College of Surgeons; and 8. The department shall designate a hospital as a level II trauma center if such hospital has been verified as a level II trauma center (only treats adults) by the American College of Surgeons.

(C) Within thirty (30) days of any changes or receipt of a verification, the hospital shall submit to the department proof of verification as a trauma center by the American College of Surgeons and the names and contact information of the medical director of the trauma center and the program manager of the trauma center. Verification as a trauma center by the American College of Surgeons shall accompany the application for trauma verified hospital designation form. A hospital shall report to the department in writing within thirty (30) days of the date the hospital no longer is verified as a trauma center by the American College of Surgeons for which the hospital used to receive its corresponding designation with the department as a trauma center, whether because the hospital voluntarily surrendered this verification or because the hospital’s verification was suspended or revoked by the American College of Surgeons or expired;

(D) Participate in local and regional emergency medical services systems for purposes of providing training, sharing clinical educational resources, and collaborating on improving patient outcomes;

(E) The designation of a hospital as a trauma center pursuant to section (3) shall continue if such hospital retains verification as a trauma center by the American College of Surgeons; and (F) The department may remove a hospital’s designation as a trauma center if requested by the hospital or if the department determines that the verification by the American College of Surgeons has been suspended or revoked. The department may also remove a hospital’s designation as a trauma center if the department determines the hospital’s verification with the American College of Surgeons has expired. Any decision made by the department to withdraw the designation of a trauma center that is based on the revocation or suspension of a verification by the American College of Surgeons shall not be subject to judicial review.

(4) Hospitals that choose to apply to the department under sections (2) and (3) above and maintain a trauma designation with both the department and the American College of Surgeons may request either of the following two (2) options:

(A) Hospitals may choose to apply to the department under

section (2) above and meet the requirements in section (2) above and 19 CSR 30-40.410 and 19 CSR 30-40.430. Hospitals may request a separate review by only the department pursuant to

section (2). Hospitals may choose to apply to the department under section (3) above and meet the requirements set by the American College of Surgeons. Hospitals may request a separate review by only the American College of Surgeons; or (B) Hospitals may choose to apply to the department under

section (2) above and meet the requirements in section (2) above and 19 CSR 30-40.410 and 19 CSR 30-40.430. Hospitals may choose to apply to the department under section (3) above and meet the requirements set by the American College of Surgeons. Hospitals may request a joint review by both the American College of Surgeons and the department. In a joint review, department personnel shall be incorporated into these reviews upon the consent of the American College of Surgeons.

During these joint reviews, the trauma review team chosen by the American College of Surgeons shall also include at least one (1) emergency department physician and at least one (1) trauma program manager (nurse). All costs for the review and review team shall be paid by the hospitals. If a hospital successfully passes the joint review by the department and the American College of Surgeons, then the hospital will be designated by the department as a trauma center under both sections (2) and (3) above.

Amended: Nov. 21, 2022, effective June 30, 2023. *Original authority: 190.176, RSMo 1998, amended 2008, 2011; 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002; and 190.241, RSMo 1987, amended 1998, 2008, 2016, 2017, 2022. **Pursuant to Executive Order 21-07, 19 CSR 30-40.420, subsection (2)(A) and section (3) was suspended from April 2, 2020 through May 1, 2021. Pursuant to Executive Order 21-09, 19 CSR 30- 40.420, subsections (2)(G) and (2)(J) and section 190.241.3, RSMo was suspended from April 2, 2020 through December 31, 2021.

History

AUTHORITY: sections 190.176 and 190.185, RSMo 2016, and section 190.241, RSMo Supp. 2022. Emergency rule filed Aug. 28, 1998, effective Sept. 7, 1998, expired March 5, 1999. Original rule filed Sept. 1, 1998, effective Feb. 28, 1999. Amended: Filed May 19, 2008, effective Jan. 30, 2009. Emergency amendment filed Feb. 2, 2018, effective Feb. 12, 2018, expired Aug. 10, 2018. Amended: Filed Feb. 2, 2018, effective Aug. 30, 2018. Emergency amendment filed Nov. 21, 2022, effective Dec. 7, 2022, expired June 4, 2023.

19 CSR 30-40.430 Standards for Trauma Center Designation {#sec-19-csr-30-40.430 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.430}

PURPOSE: This rule establishes standards for level I, II, and III trauma center designation.

EDITOR’S NOTE: I-R, II-R, or III-R after a standard indicates a requirement for level I, II, or III trauma center respectively. I-IH, II-IH, or III-IH after a standard indicates an in-house requirement for level I, II or III trauma center respectively. I-IA, II-IA, or III-IA indicates an immediately available requirement for level I, II or III trauma center respectively. I-PA, II-PA, or III-PA indicates a promptly available requirement for level I, II, or III trauma center respectively.

(1) General Standards for Trauma Center Designation.

(A) The hospital board of directors, administration, medical staff, and nursing staff shall demonstrate a commitment to quality trauma care. Methods of demonstrating the commitment shall include but not be limited to a board resolution that the hospital governing body agrees to establish policy and procedures for the maintenance of services essential for a trauma center; assure that all trauma patients will receive medical care at the level of the hospital’s designation; commit the institution’s financial, human, and physical resources as needed for the trauma program; and establish a priority admission for the trauma patient to the full services of the institution. (I-R, (B) Trauma centers shall agree to accept all trauma victims appropriate for the level of care provided at the hospital, regardless of race, sex, creed, or ability to pay. (I-R, II-R, III-R)

(C) The hospital shall demonstrate evidence of a trauma program that provides the trauma team with appropriate experience to maintain skill and proficiency in the care of trauma patients. Such evidence shall include meeting of continuing education unit requirements by all professional staff, documented regular attendance by all core trauma surgeons and liaison representation from neurosurgeons, orthopedic surgeons, emergency medicine physicians, and anesthesiologists at trauma program performance improvement and patient safety program meetings, documentation of continued experience as defined by the trauma medical director in management of sufficient numbers of severely injured patients to maintain skill levels, and outcome data on quality of patient care as defined by regional emergency medical service committees. Regular attendance shall be defined by each trauma service, but shall be not less than fifty percent (50%) of all meetings. The trauma medical director must ensure and document dissemination of information and findings from the peer review meetings to the non-core surgeons on the trauma call roster.

(D) The trauma center shall have a helicopter landing area.

(I-R, II-R, III-R)

(E) The hospital shall appoint a board-certified surgeon to serve as the trauma medical director. (I-R, II-R, III-R)

There shall be a job description and organization chart depicting the relationship between the trauma medical director and other services. (I-R, II-R, III-R)
The trauma medical director shall be a member of the surgical trauma call roster. (I-R, II-R, III-R)
The trauma medical director shall be responsible for the oversight of the education and training of the medical and nursing staff in trauma care. (I-R, II-R, III-R)
The trauma medical director shall document thirty-six (36) hours of continuing medical education (CME) in trauma care every three (3) years. (I-R, II-R, III-R)
The trauma medical director shall participate in the trauma center’s research and publication projects. (I-R)

(F) There shall be a trauma nurse coordinator/trauma program manager. (I-R, II-R, III-R)

There shall be a job description and organization chart depicting the relationship between the trauma nurse coordinator/trauma program manager and other services. (I-R, 2. The trauma nurse coordinator/trauma program manager shall document thirty-six (36) hours of continuing nursing education in trauma care every three (3) years. (I-R, II-R, III-R)

(G) By the time of the initial review, all general surgeon members of the surgical trauma call roster shall have successfully completed or be registered for a provider Advanced Trauma Life Support (ATLS) course. Current certification must then be maintained by each general surgeon on the trauma call roster. (I-R, II-R, III-R)

(H) The hospital shall demonstrate that there is a plan for adequate post-discharge follow-up on trauma patients, including rehabilitation. (I-R, II-R, III-R)

(I) A trauma registry shall be completed on each patient who sustains a traumatic injury and meets the following criteria: Includes at least one (1) code within the range of the following injury diagnostic codes as defined in the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9)-(CM) 800-959.9, which is incorporated by reference in this rule as published by the Centers for Disease Control and Prevention in 2006 and is available at National Center for Health Statistics, 1600 Clifton Road, Atlanta, GA 30333. This additions. Excludes all diagnostic codes within the following code ranges: 905–909.9 (late effects of injury), 910–924.9 (superficial injuries, including blisters, contusions, abrasions, and insect bites), 930–939.9 (foreign bodies), and must include one (1) of the following criteria: hospital admission, patient transfer out of facility, or death resulting from the traumatic injury (independent of hospital admission or hospital transfer status). Trauma centers shall enter trauma care data elements for each patient who meets these criteria. The trauma care data elements shall be those identified and defined by the National Trauma Data Standard, which is incorporated by reference in this rule as published by the American College of Surgeons in 2022 and is available at the American College of Surgeons, 633 N. St. Clair St., Chicago, IL 60611. This rule does not incorporate any subsequent amendments or additions. (I-R, II-R, III-R.

Trauma centers shall enter trauma care data elements for each patient who meets the criteria above into the following:

A. Trauma centers shall submit data into the department’s Missouri trauma registry. The data required in subsection (1)

(I) above shall be submitted electronically into the Missouri trauma registry via the department’s website at www.health. mo.gov; or (I-R, II-R, III-R)

B. Trauma centers shall submit data into a national data registry or data bank capable of being used by the trauma center to perform its ongoing performance improvement and patient safety program requirements for its trauma patients.

The trauma center shall submit data for each data element included in the national data registry or data bank’s data system. (I-R, II-R, III-R)

Electronic data shall be submitted quarterly, ninety (90) days after the quarter ends. The trauma registry must be current and complete. (I-R, II-R, III-R)
Information provided by hospitals on the trauma registry shall be subject to the same confidentiality requirements and procedures contained in section 192.067, RSMo. (I-R, II-R, III-R)

(J) A patient log of those patients entered into the trauma registry with admission date, patient name, and injuries must be available for use during the site review process. (I-R, II-R, III-R.

(K) The hospital shall have a trauma team activation protocol that establishes the criteria used to rank trauma patients according to the severity and type of injury and identifies the persons authorized to notify trauma team members when a severely injured patient is en route or has arrived at the trauma center. (I-R, II-R, III-R.

The trauma team activation protocol shall provide for immediate notification and response requirements for trauma team members when a severely injured patient is en route to the trauma center. (I-R, II-R, III-R)

(L) The hospital shall have a plan to notify an organ or tissue procurement organization and cooperate in the procurement of anatomical gifts in accordance with the provisions in section 194.233, RSMo. (I-R, II-R, III-R)

(M) There shall be no level III trauma centers designated within fifteen (15) miles of any Missouri level I or II trauma center. Hospitals which have continually been level III trauma centers since January 1, 1989, and which are within fifteen (15) miles of a Missouri level I or II trauma center may continue as level III trauma centers, provided they continue to meet standards for level III trauma centers.

(2) Hospital Organization Standards for Trauma Center (A) There shall be a delineation of privileges for the trauma service staff made by the medical staff credentialing committee.

(I-R, II-R, III-R)

(B) All members of the surgical trauma call roster shall comply with the availability and response requirements in subsection (2)(D) of this rule. If not on the hospital premises, trauma team members who are immediately available shall carry electronic communication devices at all times to permit contact by the hospital and shall respond immediately to a contact by the hospital. (I-R, II-R, III-R)

(C) Surgeons who are board-certified or board-admissible or complete an alternate pathway as documented and defined by the trauma medical director using the criteria established by the American College of Surgeons (ACS) in the current Resource for Optimal Care Document in the following specialties and who are credentialed by the hospital for trauma care shall be on the trauma center staff and/or be available to the patient as indicated. The Resource for Optimal Care Document is incorporated by reference in this rule as published by the American College of Surgeons in 2006 and is available at the American College of Surgeons, 633 N. St. Clair St., Chicago, IL 60611. This rule does not incorporate any subsequent amendments or additions.

General surgery—I-R, II-I/A, III-P/A.

A. The general surgery staffing requirement may be fulfilled by a senior surgery resident credentialed in general surgery, including trauma care, and Advanced Trauma Life Support (ATLS) certification and capable of assessing emergency situations in general surgery.

B. The trauma surgeon shall be immediately available and in attendance with the patient when a trauma surgery resident is fulfilling availability requirements.

C. In a level I or II center, call rosters providing back-up coverage will be maintained for general trauma surgeons. In a level III center, call rosters providing for back-up coverage for general trauma surgeons will be maintained or a written transfer agreement to a level I or II trauma center provided.

D. Surgeons who are board-certified or board-admissible and who are credentialed by the hospital for trauma care shall be on the trauma center staff.

Neurologic surgery—I-IH, II-IA.

A. The neurologic surgery staffing requirement may be fulfilled by a surgeon who has been approved by the chief of neurosurgery for care of patients with neural trauma.

B. The surgeon shall be capable of initiating measures toward stabilizing the patient and performing diagnostic procedures.

Cardiac/Thoracic surgery—I-R/PA, II-R/PA.
Obstetric-gynecologic surgery—I-R/PA, II-R/PA.
Ophthalmic surgery—I-R/PA, II-R/PA.
Orthopedic surgery—I-R/PA, II-R/PA.
Maxillofacial trauma surgery—I-R/PA, II-R/PA.
Otorhinolaryngolic surgery—I-R/PA, II-R/PA.
Pediatric surgery/trauma surgeon credentialed and privileged in pediatric trauma care—I-R/IA, II-R/PA; this requirement will be waived in centers that provide evaluation and care to adults only.
Plastic surgery—I-R/PA, II-R/PA.
Urologic surgery—I-R/PA, II-R/PA.
Emergency medicine—I-R/IH, II-R/IH, III-R/IH.
Cardiology—I-R/PA, II-R/PA.
Chest pulmonary medicine—I-R/PA, II-R/PA.
Gastroenterology—I-R/PA, II-R/PA.
Hematology—I-R/PA, II-R/PA.
Infectious diseases—I-R/PA, II-R/PA.
Internal medicine—I-R/PA, II-R/PA, III-R/PA.
Nephrology—I-R/PA, II-R/PA.
Pathology—I-R/PA, II-R/PA.
Pediatrics—I-R/PA, II-R/PA.
Psychiatry—I-R/PA, II-R/PA.
Radiology—I-R/PA, II-R/PA.
Anesthesiology—I-R/IH, II-R/IA, III-R/PA.

A. In a level I or II trauma center, anesthesiology staffing requirements may be fulfilled by anesthesiology residents or certified registered nurse anesthetists (CRNA) capable of assessing emergent situations in trauma patients and of providing any indicated treatment including induction of anesthesia or may be fulfilled by anesthesiologist assistants with anesthesiologist supervision in accordance with sections 334.400 to 334.430, RSMo.

B. In a level III trauma center, anesthesiology requirements may be fulfilled by a CRNA with physician supervision, or an anesthesiologist assistant with anesthesiology supervision.

(3) Standards for Special Facilities/Resources/Capabilities for Trauma Center Designation.

(A) The hospital shall meet emergency department standards for trauma center designation.

The emergency department staffing shall ensure immediate and appropriate care of the trauma patient. (I-R, II- R, III-R)

A. The physician director of the emergency department shall be board-certified or board-admissible in emergency medicine. (I-R, II-R)

B. There shall be a physician trained in the care of the critically injured as evidenced by credentialing in ATLS in the emergency department twenty-four (24) hours a day.

ATLS is incorporated by reference in this rule as published by the American College of Surgeons in 2003 and is available at American College of Surgeons, 633 N. St. Clair St., Chicago, IL 60611. This rule does not incorporate any subsequent amendments or additions. (I-R, II-R, III-R)

C. All emergency department physicians shall be certified in ATLS at least once. Physicians who are certified by boards other than emergency medicine who treat trauma patients in the emergency department are required to have current ATLS status. (I-R, II-R, III-R)

D. There shall be written protocols defining the relationship of the emergency department physicians to other physician members of the trauma team. (I-R, II-R, III-R)

E. All registered nurses assigned to the emergency department shall be credentialed in trauma nursing by the hospital within one (1) year of assignment. (I-R, II-R, III-R)

(I) Registered nurses credentialed in trauma care shall maintain current provider status in the Trauma Care After Resuscitation (TCAR), Trauma Nurse Core Curriculum (TNCC), or Advanced Trauma Care for Nurses (ATCN) and either Pediatric Care After Resuscitation (PCAR), Pediatric Advanced Life Support (PALS), Advanced Pediatric Life Support (APLS), or Emergency Nursing Pediatric Course (ENPC) within one (1) year of employment in the emergency department. The requirement for Pediatric Care After Resuscitation, Pediatric Advanced Life Support, Advanced Pediatric Life Support, or Emergency Nursing Pediatric Course may be waived in centers where policy exists diverting injured children to a pediatric trauma center and where a pediatric trauma center is adjacent and a performance improvement filter reviewing any children seen is maintained. The Trauma Nurse Core Curriculum is incorporated by reference in this rule as published in 2007 by the Emergency Nurses Association and is available at the Emergency Nurses Association, 915 Lee Street, Des Plaines, IL 60016-9659. This rule does not incorporate any subsequent amendments or additions. Advanced Trauma Care for Nurses is incorporated by reference in this rule as published in 2003 by the Society of Trauma Nurses and is available at the Society of Trauma Nurses, 1926 Waukegan Road, Suite 100, Glenview, IL 60025. This rule does not incorporate any subsequent amendments or additions. Pediatric Advanced Life Support is incorporated by reference in this rule as published in 2005 by the American Heart Association and is available at the American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231. This rule does not incorporate any subsequent amendments or additions. The Emergency Nursing Pediatric Course is incorporated by reference in this rule as published by the Emergency Nurses Association in 2004 and is available at the Emergency Nurses Association, 915 Lee Street, Des Plaines, IL 60016-9659. This rule does not incorporate any subsequent amendments or additions. Trauma Care After Resuscitation and Pediatric Care After Resuscitation are incorporated by reference in this rule as published in 2022 by TCAR Education Programs and are available at TCAR Education Programs, 33456 Havlik Drive, Scappoose, Oregon 97056. This rule does not incorporate any subsequent amendments or additions. (I-R, 2. Equipment for resuscitation and life support with age appropriate sizes for the critically or seriously injured shall include the following:

A. Airway control and ventilation equipment including laryngoscopes, endotracheal tubes, bag-mask resuscitator, sources of oxygen, and mechanical ventilator—I-R, II-R, III-R;

B. Suction devices—I-R, II-R, III-R;

C. Electrocardiograph, cardiac monitor, and D. Central line insertion equipment—I-R, II-R, III-R;

E. All standard intravenous fluids and administration devices including intravenous catheters—I-R, II-R, III-R;

F. Sterile surgical sets for procedures standard for the emergency department—I-R, II-R, III-R;

G. Gastric lavage equipment—I-R, II-R, III-R;

H. Drugs and supplies necessary for emergency care— I. Two-way radio linked with emergency medical service (EMS) vehicles—I-R, II-R, III-R;

J. End-tidal carbon dioxide monitor—I-R, II-R, III-R and mechanical ventilators—I-R, II-R;

K. Temperature control devices for patient, parenteral fluids, and blood—I-R, II-R, III-R; and L. Rapid infusion system for parenteral infusion—I-R, II-R, III-R.

There shall be documentation that all equipment is checked according to the hospital preventive maintenance schedule. (I-R, II-R, III-R)
There shall be a designated trauma resuscitation area in the emergency department. (I-R, II-R)
There shall be X-ray capability with twenty-four (24)hour coverage by technicians. (I-IH, II-IH, III-IA)
Nursing documentation for the trauma patient shall be on a trauma flow sheet approved by the trauma medical director and trauma nurse coordinator/trauma program manager. (I-R, II-R, III-R)

(B) The hospital shall meet intensive care unit (ICU) standards for trauma center designation.

There shall be a designated surgeon medical director for the ICU. (I-R, II-R, III-R)
A physician who is not the emergency department physician shall be on duty in the ICU or available in-house twenty-four (24) hours a day in a level I trauma center and shall be on call and available within twenty (20) minutes in a level II trauma center.
The minimum registered nurse/trauma patient ratio used shall be one to two (1:2). (I-R, II-R, III-R)
Registered nurses shall be credentialed in trauma care within one (1) year of assignment. (I-R, II-R, III-R)
Nursing care documentation shall be on a patient flow sheet. (I-R, II-R, III-R)
Nurses assigned to the ICU shall maintain current provider status in Advanced Cardiac Life Support (ACLS) or Advanced Life Support (ALS). ACLS is incorporated by reference in this rule as published in 2021 by the American Heart Association and is available for purchase at the American Heart Association, 7272 Greenville Ave., Dallas, TX 75231 or online at www.cpr.heart.org. This rule does not incorporate any subsequent amendments or additions. ALS is incorporated by reference in this rule as published in 2022 by the American Red Cross and is available for purchase at the American Red Cross, National Headquarters, 430 17th St. NW, Washington DC 20006 or online at www.redcross.org. This rule does not incorporate any subsequent amendments or additions. At the time of the initial review, nurses assigned to ICU shall have successfully completed or be registered for a provider ACLS or ALS course. The requirement for ACLS or ALS may be waived in pediatric centers where policy exists diverting injured adults to an adult trauma center and where an adult trauma center is adjacent to the affected pediatric facilities, and a performance improvement filter reviewing any adult trauma patients seen is maintained. (I-R, II-R, III-R)
There shall be separate pediatric and adult ICUs or a combined ICU with nurses trained in pediatric intensive care.

In ICUs providing care to children, registered nurses shall maintain credentialing in PALS, APLS, or ENPC. (I-R, II-R)

There shall be beds for trauma patients or comparable level of care provided until space is available in ICU. (I-R, II-R, III-R)
Equipment for resuscitation and to provide life support for the critically or seriously injured shall be available for the intensive care unit. In ICUs providing care for the pediatric patient, equipment with age appropriate sizes shall also be available. This equipment shall include but not be limited to – A. Airway control and ventilation equipment including laryngoscopes, endotracheal tubes, bag-mask resuscitator, and a mechanical ventilator—I-R, II-R, III-R;

B. Oxygen source with concentration controls—I-R, II-R, III-R;

C. Cardiac emergency cart, including medications—I-R, II-R, III-R;

D. Temporary transvenous pacemakers—I-R, II-R, III-R;

E. Electrocardiograph, cardiac monitor, and F. Cardiac output monitoring—I-R, II-R;

G. Electronic pressure monitoring and pulse oximetry— I-R, II-R;

H. End-tidal carbon dioxide monitor and mechanical ventilators—I-R, II-R, III-R;

I. Patient weighing devices—I-R, II-R, III-R;

J. Temperature control devices—I-R, II-R, III-R;

K. Drugs, intravenous fluids, and supplies—I-R, II-R, III- R; and L. Intracranial pressure monitoring devices—I-R, II-R.

There shall be documentation that all equipment is checked according to the hospital preventive maintenance schedule. (I-R, II-R, III-R)

Registered nurses and other essential personnel who are not on duty shall be on call and available within sixty (60) minutes. (I-R, II-R, III-R)
Equipment for resuscitation and to provide life support for the critically or seriously injured shall include but not be limited to:

A. Airway control and ventilation equipment including laryngoscopes, endotracheal tubes of all sizes, bag-mask resuscitator, sources of oxygen, and mechanical ventilator— B. Suction devices—I-R, II-R, and III-R;

C. Electrocardiograph, cardiac monitor, and D. Apparatus to establish central venous pressure monitoring—I-R, II-R;

E. All standard intravenous fluids and administration devices, including intravenous catheters—I-R, II-R, III-R;

F. Sterile surgical set for emergency procedures—I-R, II-R, and III-R;

G. Drugs and supplies necessary for emergency care— H. Temperature control devices for the patient, for parenteral fluids, and for blood—I-R, II-R, III-R;

I. Temporary pacemaker—I-R, II-R, III-R;

J. Electronic pressure monitoring—I-R, II-R; and K. Pulmonary function measuring devices—I-R, II-R, III-R.

(D) The hospital shall have acute hemodialysis capability or a written transfer agreement. (I-R, II-R, III-R)

(E) The hospital shall have a physician-directed burn unit or a written transfer agreement. (I-R, II-R, III-R)

(F) The hospital shall have injury rehabilitation and spinal cord injury rehabilitation capability or a written transfer agreement. (I-R, II-R, III-R)

(G) The hospital shall possess pediatric trauma management capability or maintain written transfer agreements. (I-R, II-R, III-R)

(H) Radiological capabilities for trauma center designation including a mechanism for timely interpretation to aid in patient management shall include:

Angiography with interventional capability available twenty-four (24) hours a day with a one- (1-) hour maximum response time from time of notification—I-R, II-R;
Sonography available twenty-four (24) hours a day with a thirty- (30-) minute maximum response time—I-R;
Resuscitation equipment available to the radiology department—I-R, II-R, III-R;
Adequate physician and nursing personnel present with monitoring equipment to fully support the trauma patient and provide documentation of care during the time the patient is physically present in the radiology department and during transportation to and from the radiology department. Nurses providing care for the trauma patients that are not accompanied by a trauma nurse while in the radiology department during initial evaluation and resuscitation shall maintain the same credentialing required of emergency department nursing personnel—I-R, II-R, III-R;
In-house computerized tomography—I-R, II-R; and 6. Computerized tomography technician—I-IH, II-IA.

(I) There shall be documentation of adequate support services in assisting the patient’s family from the time of entry into the facility to the time of discharge. (I-R, II-R, III-R)

(J) Medical surgical floors of a designated trauma center shall have the following personnel and equipment:

Registered nurses and other essential personnel on duty twenty-four (24) hours a day—I-R, II-R, III-R;
Equipment for resuscitation and to provide support for the injured patient including but not limited to:

A. Airway control and ventilation equipment including laryngoscopes, endotracheal tubes of all sizes, bag-mask resuscitator, and sources of oxygen—I-R, II-R, III-R;

B. Suction devices—I-R, II-R, III-R;

C. Electrocardiograph, cardiac monitor, and D. All standard intravenous fluids and administration devices and intravenous catheters—I-R, II-R, III-R; and E. Drugs and supplies necessary for emergency care— I-R, II-R, III-R; and 3. Documentation that all equipment is checked according to the hospital preventive maintenance schedule—I-R, II-R, III- R.

(K) The operating room personnel, equipment, and procedures of a trauma center shall include but not be limited to:

An operating room adequately staffed in-house twentyfour (24) hours a day—I-R, II-R;
Equipment including, but not limited to:

A. Operating microscope—I-R. .

B. Thermal control equipment for patient, parenteral fluids, and blood—I-R, II-R, III-R;

C. X-ray capability—I-R, II-R, III-R;

D. Endoscopic capabilities, all varieties—I-R, II-R, III-R;

E. Instruments necessary to perform an open craniotomy—I-R, II-R; and F. Monitoring equipment—I-R, II-R, III-R; and 3. Documentation that all equipment is checked according to the hospital preventive maintenance schedule—I-R, II-R, III- R;

(L) The following clinical laboratory services shall be available twenty-four (24) hours a day:

Standard analyses of blood, urine, and other body fluids—I-R, II-R, III-R;
Blood typing and cross-matching—I-R, II-R, III-R;
Coagulation studies—I-R, II-R, III-R;
Comprehensive blood bank or access to a community central blood bank and adequate hospital blood storage facilities—I-R, II-R, III-R;
Blood gases and pH determinations—I-R, II-R, III-R;
Serum and urine osmolality—I-R, II-R;
Microbiology—I-R, II-R, III-R;
Drug and alcohol screening—I-R, II-R, III-R; and 9. A written protocol that the trauma patient receives priority—I-R, II-R, III-R.

(4) Standards for Programs in Performance Improvement and Improvement Patient Safety Program, Outreach, Public Education, and Training for Trauma Center Designation.

(A) There shall be an ongoing performance improvement and patient safety program designed to objectively and systematically monitor, review, and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems. (I-R, (B) The following additional performance improvement and patient safety measures shall be required:

Regular reviews of all trauma-related deaths—I-R, II-R, III-R;
A regular morbidity and mortality review, at least quarterly—I-R, II-R, III-R;
A regular multidisciplinary trauma conference that includes representation of all members of the trauma team, with minutes of the conferences to include attendance and findings—I-R, II-R, III-R;
Regular reviews of the reports generated by the Department of Health and Senior Services from the Missouri trauma registry and the head and spinal cord injury registry— I-R, II-R, and III-R;
Regular reviews of pre-hospital trauma care including inter-facility transfers and all adult patients seen in pediatric centers—I-R, II-R, III-R;
Participation in reviews of regional systems of trauma care as established by the Department of Health and Senior Services— I-R, II-R, III-R; and 7. Trauma patients remaining greater than six (6) hours prior to transfer will be reviewed as a part of the performance improvement and patient safety program—I-R, II-R, III-R.

(C) An outreach program shall be established to assure twenty-four (24)-hour availability of telephone consultation with physicians in the outlying region. (I-R)

(D) A public education program shall be established to promote injury prevention and trauma care and to resolve problems confronting the public, medical profession, and hospitals regarding optimal care for the injured. These must address major trauma issues as identified in that program’s performance improvement and patient safety process. (I-R, II-R)

(E) The hospital shall be actively involved in local and regional emergency medical services systems by providing training and clinical resources. (I-R, II-R, III-R)

(F) There shall be a hospital-approved procedure for credentialing nurses in trauma care. (I-R, II-R, III-R)

All nurses providing care to severely injured patients and assigned to the emergency department or ICU shall complete a trauma nursing course in order to become credentialed in trauma care. (I-R, II-R, III-R)
The content and format of any trauma nursing courses developed and offered by a hospital shall be developed in cooperation with the trauma medical director. A copy of the course curriculum used shall be filed with the department’s time critical diagnosis unit. (I-R, II-R, III-R)
Trauma nursing courses offered by institutions of higher education in Missouri such as the Advanced Trauma Care for Nurses, Emergency Nursing Pediatric Course, Trauma Care After Resuscitation, Pediatric Care After Resuscitation, or the Trauma Nurse Core Curriculum may be used to fulfill this requirement.

To receive credit for this course, a nurse shall obtain advance approval for the course from the trauma medical director and trauma nurse coordinator/trauma program manager and shall present evidence of satisfactory completion of the course. (I-R, II-R, III-R).

(G) Hospital diversion information must be maintained to include date, length of time, and reason for diversion. This must be monitored as a part of the Performance Improvement and Patient Safety program, and available when the hospital is site reviewed.

(H) Each trauma center shall have a disaster plan. A copy of this disaster plan must be maintained within the trauma center policies and procedures and should document the trauma services role in planning and response.

(5) Standards for the Programs in Trauma Research for Trauma Center Designation.

(A) The hospital and its staff shall support a research program in trauma as evidenced by any of the following:

Publications in peer reviewed journals—I-R;
Reports of findings presented at regional or national meetings—I-R;
Receipt of grants for study of trauma care—I-R; and 4. Production of evidence-based reviews—I-R.

(B) The hospital shall agree to cooperate and participate with the EMS Bureau in conducting epidemiological studies and individual case studies for the purpose of developing injury control and prevention programs. (I-R, II-R, III-R)

History

AUTHORITY: section 190.185, RSMo 2016, and section 190.241, RSMo Supp. 2022. Emergency rule filed Aug. 28, 1998, effective Sept. 7, 1998, expired March 5, 1999. Original rule filed Sept. 1, 1998, effective Feb. 28, 1999. Amended: Filed Jan. 16, 2007, effective Aug. 30, 2007. Amended: Filed May 19, 2008, effective Jan. 30, 2009. Emergency amendment filed Nov. 21, 2022, effective Dec. 7, 2022, expires June 4, 2023. Amended: Filed Nov. 21, 2022, effective June 30, 2023. Original authority: 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998, 2002, and 90.241, RSMo 1987, amended 1998, 2008, 2016, 2017, 2022.

19 CSR 30-40.440 Standards for Pediatric Trauma Center Designation {#sec-19-csr-30-40.440 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.440}

PURPOSE: This rule establishes standards for pediatric trauma center designation.

(1) General Standards for Pediatric Trauma Center Designation.

(A) The pediatric trauma center shall be located in a children’s hospital or in a level I trauma center.

(B) The hospital board of directors, administration, medical staff and nursing staff shall demonstrate a commitment to quality pediatric trauma care and shall treat any pediatric trauma patient presented to the facility for care. Methods of demonstrating the commitment shall include, but not be limited to, a board resolution that the hospital governing body agrees to establish policies and procedures for the maintenance of the services essential to a pediatric trauma center; assure that all pediatric trauma patients will receive medical care that meets the standards of this rule; commit the institution’s financial, human and physical resources as needed for the trauma program; and establish a priority for the pediatric trauma patient to the full services of the institution.

(C) The hospital shall demonstrate evidence of a pediatric trauma program that provides the trauma team with appropriate experience to maintain skill and proficiency in the care of pediatric trauma patients.

(D) The hospital shall have a pediatric trauma team activation protocol that establishes the criteria used to rank trauma victims according to the severity and type of injury and identifies the persons authorized to notify trauma team members when a major pediatric trauma patient is en route or has arrived at the pediatric trauma center. That protocol shall provide for immediate notification and rapid response requirements for trauma team members.

(E) There shall be a lighted helipad on the hospital premises no more than three (3) minutes from the emergency department.

(F) The hospital shall appoint a board-certified pediatric surgeon to serve as pediatric trauma medical director.

The pediatric trauma medical director shall document a minimum average of sixteen (16) hours of trauma-related continuing medical education (CME) every year.
There shall be a job description and organizational chart depicting the relationship between the pediatric trauma program director and other services.

(G) A registered nurse shall be appointed to serve as the pediatric trauma nurse coordinator.

The pediatric trauma nurse coordinator shall document a minimum average of twenty-four (24) hours of trauma-related continuing nursing education every year.
There shall be a job description and organization chart depicting the relationship between the pediatric trauma nurse coordinator and other services.

(H) By the time of the initial review, pediatric surgeons who comprise the pediatric surgical trauma call roster shall have successfully completed or be registered for a provider advanced trauma life support (ATLS) course.

(I) All members of the pediatric surgical trauma call roster, including anesthesiology, shall document a minimum average of eight (8) hours of trauma-related CME every year.

(J) The hospital shall be able to document active involvement in local and regional emergency medical services (EMS) systems. The hospital can demonstrate involvement in the local and regional EMS programs by participating in EMS training programs and joint educational programs regarding the pediatric patient; providing appropriate clinical experience and EMS system quality assessment and quality assurance mechanisms; and assisting in the development of regional policies and procedures.

(K) The hospital shall have a plan to notify an organ or tissue procurement organization and cooperate in the procurement of anatomical gifts in accordance with the provisions in section 194.233, RSMo.

(L) All pediatric trauma centers shall support and fully participate in the Missouri trauma registry and shall belong to the Missouri poison control network.

(2) Hospital Organization Standards for Pediatric Trauma Center (A) Pediatric specialists representing the following specialties shall be on staff at the center and shall be board-certified or board-admissible and credentialed in trauma care: cardiac surgery, neurologic surgery, ophthalmic surgery, oral surgerydental, orthopedic surgery, otorhinolaryngologic surgery, pediatric surgery; plastic and maxillofacial surgery, thoracic surgery and urologic surgery. Obstetric and gynecologic surgeons shall be available on a consultant basis.

(B) The emergency department staffing shall ensure immediate and appropriate care of the pediatric trauma patient. The emergency department pediatrician shall be board certified/eligible in pediatric medicine and shall function as a designated member of the pediatric trauma team. All emergency department physicians shall have successfully completed and be current in ATLS and pediatric advanced life support (PALS) course prior to the initial review and shall document a minimum average of sixteen (16) hours of CME in trauma care every year. There shall be written protocols to clearly establish responsibilities and define the relationship between the emergency department pediatricians and other physician members of the pediatric trauma team.

(C) The pediatric trauma surgeon on call shall be physically present in-house twenty-four (24) hours a day and shall meet all major trauma patients in the emergency department at the time of the patient’s arrival. This requirement may be fulfilled by senior residents in general surgery who are ATLScertified and able to deliver surgical treatment immediately and provide control and leadership for care of the pediatric trauma patient. When senior residents are used to fulfill availability requirements, the pediatric trauma surgeon shall be immediately available.

(D) A neurosurgeon shall be available in-house and dedicated to the hospital’s pediatric trauma service. The neurosurgeon requirement may be fulfilled by a surgeon experienced in the care of pediatric patients with neural trauma and able to deliver surgical treatment immediately and provide control and leadership for the care of the pediatric patient with neural trauma.

(E) Pediatric specialists representing the following specialties shall be on call and promptly available: cardiac surgery, microsurgery, hand surgery, ophthalmic surgery, oral surgerydental, orthopedic surgery, otorhinolaryngologic surgery, pediatric surgery, plastic and maxillofacial surgery, thoracic surgery and urologic surgery.

(F) A board-certified or board-admissible pediatrician credentialed in emergency care shall be available in the emergency department twenty-four (24) hours a day. This requirement may be fulfilled by a physician who is boardcertified or board-admissible in emergency medicine who demonstrates commitment by engaging in the exclusive practice of pediatric emergency medicine a minimum of one hundred (100) hours per month or has an additional year of training in pediatric emergency medicine.

(G) A board-certified or board-admissible anesthesiologist credentialed in pediatric care shall be available in-house twenty-four (24) hours a day. Senior anesthesiology residents or anesthesiologists not credentialed in pediatric care may fulfill the in-house requirement if the credentialed pediatric anesthesiologist is on call and promptly available.

(H) A pediatric radiologist shall be promptly available twentyfour (24) hours a day.

(I) Pediatric specialists representing the following nonsurgical specialties shall be on call and available: cardiology, chest medicine, gastroenterology, hematology, infectious diseases, nephrology, neurology, pathology, psychiatry and neonatology.

(3) Standards for Special Facilities/Re-sources/Capabilities for Pediatric Trauma Center Designation.

(A) Hospitals shall meet emergency department standards for pediatric trauma center designation.

There shall be a minimum of two (2) registered nurses per shift specializing in pediatric trauma care assigned to the emergency department.

A. All registered nurses regularly assigned to pediatric care in the emergency department shall document a minimum of eight (8) hours per year of continuing nursing education on care of the pediatric trauma patient.

B. All registered nurses regularly assigned to pediatric care in the emergency department shall be PALS certified within one (1) year of assignment to the unit and shall maintain a current PALS certification.

Respiratory therapy technicians who work with pediatric trauma patients in the emergency department shall be experienced in pediatric respiratory therapy techniques.
There shall be a designated trauma resuscitation area in the emergency department equipped for pediatric patients.

Equipment to be immediately accessible for resuscitation and to provide life support for the seriously injured pediatric patient shall include, but not be limited to:

A. Airway control and ventilation equipment for all size patients, including laryngoscopes, assorted blades, airways, endotracheal tubes and bag-mask resuscitator;

B. Oxygen, air and suction devices;

C. Electrocardiograph, monitor and defibrillator to include internal and external pediatric paddles;

D. Apparatus to establish central venous pressure monitoring and arterial monitoring;

E. All standard intravenous fluids and administration F. Sterile surgical sets for standard procedures for the emergency department;

G. Gastric lavage equipment;

H. Drugs and supplies necessary for emergency care;

I. Two-way radio linked with EMS vehicles;

J. Equipment for spinal stabilization for all age groups;

K. Temperature control devices for patients, parenteral L. Blood pressure cuffs, chest tubes, nasogastric tubes and urinary drainage apparatus for the pediatric patient; and M. Patient weighing devices.

(B) The hospital shall meet radiological capabilities for pediatric trauma center designation.

There shall be X-ray capability with twenty-four (24)hour coverage by in-house technicians.
There shall be radiological capabilities promptly available, including general, peripheral and cerebrovascular angiography, sonography and nuclear scanning.
Adequate physician and nursing personnel shall be present with monitoring equipment to fully support the trauma patient and provide documentation of care during the time that the patient is physically present in the radiology department and during transportation to and from the radiology department.
There shall be in-house computerized tomography with a technician available in-house twenty-four (24) hours a day.

Mobile computerized tomography services, contracts for those services with other institutions or computerized tomography in remote areas of a hospital requiring transportation from the main hospital building shall not be considered in-house.

The pediatric trauma surgeon, neurosurgeon and emergency pediatrician shall each have the authority to initiate computerized tomography.
There shall be a continuing review of the availability of computerized tomography services for the pediatric trauma patient.
There shall be adequate resuscitation equipment available to the radiology department.

The medical director for the pediatric intensive care unit (PICU) shall be board-certified or board-eligible in pediatric critical care.
There shall be a pediatrician or senior pediatric resident on duty in the PICU twenty-four (24) hours a day or available from inside the hospital. This physician shall maintain a current PALS certification. The physician on duty in the PICU shall not be the emergency department pediatrician or the oncall trauma surgeon.
The PICU patient shall have nursing care by a registered nurse who is regularly assigned to pediatric intensive care.
The PICU shall utilize a patient classification system which defines the severity of injury and indicates the number of registered nurses needed to staff the unit. The minimum registered nurse/trauma patient ratio used shall be one to two (1:2).
All registered nurses regularly assigned to the PICU shall document a minimum of eight (8) hours per year of continuing nursing education on care of the pediatric trauma patient.
Within one (1) year of assignment, all registered nurses regularly assigned to PICU shall be PALS-certified. Registered nurses in pediatric trauma centers designated before January 1, 1989 shall have successfully completed or be registered for a PALS course by January 1, 1991.
There shall be immediate access to clinical laboratory 8. Equipment to be immediately accessible for resuscitation and life support for seriously injured pediatric patients shall include, but not be limited to:

A. Airway control and ventilation equipment for all size patients including laryngoscopes, assorted blades, endotracheal tubes, bag-mask resuscitator and mechanical ventilator;

B. Oxygen and suction devices;

C. Electrocardiograph, monitor and defibrillator, including internal and external pediatric paddles;

D. Apparatus to establish invasive hemodynamic monitoring, end tidal carbon dioxide monitoring and pulse oximetry;

E. All standard intravenous fluids and administration F. Gastric lavage equipment;

G. Drugs and supplies necessary for emergency care;

H. Temporary transvenous pacemaker;

I. Patient weighing devices;

J. Cardiac output monitoring devices;

K. Pulmonary function measuring devices;

L. Temperature control devices for the patient, parenteral M. Intracranial pressure monitoring devices;

N. Appropriate emergency surgical trays; and O. Blood pressure cuffs, chest tubes, nasogastric tubes and urinary drainage apparatus for the pediatric patient.

(D) The hospital shall meet post-anesthesia recovery room (PAR) standards for pediatric trauma center designation. Unless the hospital uses PICU to recover pediatric trauma patients, the following PAR standards apply:

The post-anesthesia recovery room shall be staffed with registered nurses regularly assigned to pediatric care and other essential personnel on call and available twenty-four (24) hours a day; and 2. Equipment to be accessible for resuscitation and life support for the seriously injured pediatric patient shall include, but not be limited to:

A. Airway control and ventilation equipment for all size patients including laryngoscopes, assorted blades, airways, endotracheal tubes and bag-mask resuscitator;

B. Oxygen and suction devices;

C. Electrocardiograph, monitor and defibrillator, including internal and external pediatric paddles;

D. Apparatus to establish and maintain hemodynamic monitoring;

E. All standard intravenous fluids and administration F. Sterile surgical sets for emergency procedures;

G. Drugs and supplies necessary for emergency care;

H. Temperature control devices for the patient, parenteral I. Temporary transvenous pacemaker; and J. Electronic pressure monitoring.

(E) The pediatric trauma center shall have hemodialysis capability.

(F) The pediatric trauma center shall have organized burn care or a written transfer agreement.

(G) The pediatric trauma center shall have spinal cord injury management capability or a written transfer agreement.

(H) There shall be documentation of adequate support services in assisting the patient’s family from the time of entry into the facility to the time of discharge.

(I) There shall be an operating room adequately staffed in-house and available twenty-four (24) hours a day with a back-up operating room staff on call and promptly available.

Equipment for resuscitation and to provide life support for the critically or seriously injured pediatric patient shall include, but not be limited to:

Cardiopulmonary bypass capability;
Operating microscope;
Thermal control equipment for patient, parenteral fluids and blood;
Endoscopes, all varieties;
Instruments necessary to perform an open craniotomy;
Invasive and noninvasive monitoring equipment;
Pediatric anesthesia equipment;
Cardiac output equipment;
Defibrillator and monitor, including internal and external pediatric paddles; and 10. Blood pressure cuffs, chest tubes, nasogastric tubes and urinary drainage apparatus for the pediatric patient.

(J) Clinical laboratory services shall be available twenty-four (24) hours a day. There shall be a comprehensive blood bank and access to a community central blood bank and adequate hospital storage facilities. There shall be provisions to provide and receive the following laboratory test results twenty-four (24) hours a day:

Microbiology;
Standard analyses of blood, urine and other body fluids;
Blood typing and cross-matching;
Coagulation studies;
Blood gases and pH determinations;
Serum and urine osmolality; and 7. Drug and alcohol screening.

(4) Standards for Programs in Quality Assurance, Outreach, Public Education and Training for Pediatric Trauma Center (A) There shall be a special audit of all trauma-related deaths.

There shall be a mechanism in place to review all deaths and identify primary admitted patients versus transferred patients.

Transferred patients shall be further identified as transferred after stabilizing treatment or direct admission after prolonged treatment.

(B) There shall be a morbidity and mortality review.

Minutes of the conference shall include attendance, individual cases reviewed and findings.

(D) There shall be a medical and nursing quality assessment program and utilization reviews and tissue reviews on a regular basis. Documentation of quality assurance shall include problem identification, analysis, action plan, documentation and location of action, implementation and reevaluation.

(E) There shall be twenty-four (24)-hour availability of telephone consultation with physicians in the outlying areas.

(F) The hospital shall demonstrate leadership in injury prevention in infants and children.

(G) The hospital and its staff shall document a research program in pediatric trauma.

(H) There shall be formal continuing education programs in pediatric trauma and rehabilitation provided by the hospital for staff physicians and nurses.

(I) The hospital shall provide programs in continuing education for the area physicians, registered nurses and emergency medical service providers concerning the treatment of the pediatric trauma patient.

(5) Standards for the Programs in Trauma Rehabilitation for Pediatric Trauma Center Designation.

(A) The hospital shall have a rehabilitation facility or a written transfer agreement with a rehabilitation center which is specifically equipped for the care of children.

(B) The pediatric trauma rehabilitation team shall develop and implement a procedure for discharge planning for the pediatric trauma patient.

(C) The pediatric trauma rehabilitation plan developed for the pediatric trauma patient shall be under the direction of a physiatrist or a physician with experience in pediatric trauma rehabilitation.

(D) The hospital shall develop a plan to document that there is adequate post-discharge follow-up on pediatric trauma patients, including rehabilitation results where applicable. This shall include identification of members of the rehabilitation team, discharge summary of trauma care to the patient’s private physician and documentation in the patient’s medical record of the post-discharge plan.

History

AUTHORITY: sections 190.185 and 190.241, RSMo Supp. 1998. Original authority: 190.185, RSMo 1973, amended 1989, 1993, 1995, 1998 and 190.241, RSMo 1987, amended 1998.

19 CSR 30-40.528 Application and Licensure Requirements; {#sec-19-csr-30-40.528 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.528}

Standards for the Licensure and Relicensure of Stretcher Van Services

PURPOSE: This rule provides the requirements and standards related to the licensure and relicensure of stretcher van services. and expensive. This material as incorporated by reference in this (1) Application requirements for stretcher van service licensure— (A) Each applicant for a stretcher van service license shall submit an application for licensure to the Emergency Medical Service. (EMS) Bureau no less than thirty (30) days or no more than one hundred twenty (120) days prior to their desired date of licensure or relicensure.

(B) An application shall include, but is not limited to, the following information: trade name of the stretcher van service; location of vehicles; number of vehicles to be operated by the stretcher van service; name, address, telephone numbers, and email address (if applicable) of manager; name, address, proposed licensee of the stretcher van service; name, address, licensee’s chief executive officer; all stretcher van service licensure and related administrative licensure actions taken against the stretcher van service or owner by any state agency in any state; and certification by the applicant that the application contains no misrepresentation or falsifications and that the information given by them is true and complete to the best of their knowledge and that the stretcher van service has both the intention and the ability to comply with the regulations promulgated under Chapter 190, RSMo. The stretcher van application form, included herein, is available at the EMS Bureau office or by mailing a written request to the Missouri Department of Health and Senior Services, EMS Bureau, PO Box 570, Jefferson City, MO 65102-0570.

(C) Each stretcher van service that meets the requirements and standards of the statutes and regulations shall be licensed for a period of five (5) years.

(2) Passengers may be transported in a stretcher van provided the passenger— (A) Needs no medical equipment (except self-administered medications, including oxygen);

(B) Needs no medical monitoring; and (C) Needs routine transportation to or from a medical appointment or service if that passenger(s) is convalescent or otherwise non-ambulatory and does not require medical monitoring, aid, care, or treatment during transport.

(3) Stretcher van services shall not transport patients currently admitted to a hospital or patients being transported to a hospital for admission or emergency treatment. A stretcher van shall not transport a patient or passenger whom— (A) Is acutely ill, wounded, or medically unstable;

(B) Is experiencing an emergency medical condition as defined in section 190.100, RSMo, an acute medical condition, an exacerbation of a chronic medical condition, or a sudden illness or injury; and (C) Was administered a medication that might prevent the person from caring for him/herself.

(4) Vehicle design and specifications for stretcher vans— (A) Delivery of each stretcher van vehicle will include documentation that the vehicle’s design and construction will afford safety, comfort, and avoid aggravation of the passenger’s(s’) present condition. The vehicle shall be complete and furnished with such modifications and attachments as may be necessary to enable the vehicle to function reliably and efficiently in sustained operation. All vehicles shall be constructed by a qualified vehicle manufacturer, designed and built to meet or exceed (at date of vehicle manufacture)

Federal Motor Vehicle Safety Standards (FMVSS) and regulations included in 49 CFR 571.1 through 571.500. Federal regulations 49 CFR 571.1 through 571.500 revised October 1, 2007, are incorporated by reference in this rule as published in the Code of Federal Regulations and are available at the United States Government Printing Office, 732 North Capitol Street NW, Washington, DC 20401, contact center via telephone at 1-866- 512-1800 or online at www.gpoaccess.gov. This rule does not incorporate any subsequent amendments or additions.

(B) Stretchers and mounting must meet or exceed KKK- A-1822 specifications or Ambulance Manufacturers Division (AMD) Standards 004 – litter retention system. The KKK-A- 1822 specifications are incorporated by reference in this rule as published in 2007 by the General Services Administration and are available at Chief, Automotive Engineering & Commodity Management Branch (QMDAA), Office of Motor Vehicle Management, General Services Administration, 2200 Crystal Drive, Suite 1006, Arlington, VA 22202. This additions. The Ambulance Manufacturers Division Standards are incorporated by reference in this rule as published in 2007 by the Ambulance Manufacturers Division and are available at Ambulance Manufacturers Division, 37400 Hills Tech Drive, Farmington Hills, MI 48331-3414. This rule does not incorporate any subsequent amendments or additions. The operation of the stretcher shall follow manufacturer’s specifications and guidelines;

(D) No “ambulance” lettering or “Star of Life” may be displayed on vehicle;

(E) Store or secure all equipment, including passengers’ own oxygen delivery system, in a readily accessible and protected manner to limit its movement during a crash; and (F) To facilitate cleaning and disinfecting, the stretcher compartment shall be impervious to soap and water, disinfectants, mildew, fire resistant, and comply with FMVSS 302; be easily cleaned/disinfected (carpeting, cloth, and fabrics are not acceptable); and all exposed surfaces shall be free of vent devices that would permit the entrapment of biological contaminates.

(5) Vehicle and equipment operation and maintenance standards— (A) Each service shall ensure that all vehicle drivers possess a valid Class E, Missouri chauffeurs driver license;

(B) Each service shall ensure that all vehicle drivers complete a driver safety education program or vehicle operations course and be able to provide documentation of completion. These records shall be available for inspection by the EMS Bureau during normal business hours;

(D) Each service shall establish a preventive maintenance program for their vehicles, and each vehicle shall receive periodic maintenance as recommended by the qualified vehicle manufacturer. The records shall be available for inspection by the EMS Bureau during normal business hours; and (E) Each service shall comply with the stretcher manufacturer’s guidelines for maintenance of the stretchers.

(6) Vehicle staffing requirements— (A) Each vehicle shall be staffed with a minimum of two (2) persons when transporting a passenger(s).

(B) At a minimum, stretcher van personnel shall have completed a nationally recognized course in cardiopulmonary resuscitation (CPR) and be certified at the community and workplace level.

(7) Vehicle communications requirements—Each service shall establish a policy for notification of 911 in an emergency and each vehicle shall be equipped to allow stretcher van personnel to communicate by voice with the service’s own dispatching agency or 911 operator.

(8) On-board equipment standards—Each vehicle shall be equipped with body substance isolation (BSI) supplies in accordance with section 191.694, RSMo.

(9) Each service shall maintain accurate records and reports on the following— (A) A passenger transport report to record information on each request for service and transportation;

(B) Stretcher van service license;

(D) Vehicle driver education records;

(E) Equipment maintenance records;

(F) Records required by other regulatory agencies; and (G) Each service shall be able to produce these records for inspection during normal business hours.

(10) Each service shall have public liability insurance or proof of self-insurance, conditioned to pay losses and damage caused by or resulting from the negligent operation, maintenance, or use of stretcher van services under the service’s operating

Documents submitted as proof of insurance shall specify the limits of coverage and include the stretcher van service license number. Liability coverage for stretcher van services shall meet or exceed— (A) Two hundred fifty thousand dollars ($250,000) for bodily injury to, or death of, one (1) person;

(B) Five hundred thousand dollars ($500,000) for bodily (C) One hundred thousand dollars ($100,000.00) for loss or cargo.

History

authority or for loss or damage to property of others.
AUTHORITY: sections 190.528 and 190.537, RSMo Supp. 2007. Original rule filed May 19, 2008, effective Jan. 30, 2009. Original authority: 190.528, RSMo 2002 and 190.537, RSMo 2002. Pursuant to Executive Orders 20-04 and 20-10, 19 CSR 30-40.528, subsections (1)(A) and (1)(C) was

19 CSR 30-40.600 Outside the Hospital Do-Not-Resuscitate (OHDNR) {#sec-19-csr-30-40.600 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-40.600}

PURPOSE: This rule establishes a procedure to be followed by personnel to comply with the outside the hospital do-not-resuscitate protocol when presented with an outside the hospital do-not-resuscitate identification or an outside the hospital do-not-resuscitate order.

(1) As used in this rule, the following terms shall mean— (A) “Attending physician”— 1. A physician licensed under Chapter 334, RSMo, selected by or assigned to a patient who has primary responsibility for treatment and care of the patient; or 2. If more than one (1) physician shares responsibility for the treatment and care of a patient, one (1) such physician who has been designated the attending physician by the patient or the patient’s representative shall serve as the attending physician;

(B) “Cardiopulmonary resuscitation” or “CPR,” emergency medical treatment administered to a patient in the event of the patient’s cardiac or respiratory arrest and shall include cardiac compression, endotracheal intubation and other advanced airway management, artificial ventilation, defibrillation, administration of cardiac resuscitation medications, and related procedures;

(D) “Emergency medical services personnel,” paid or volunteer firefighters, law enforcement officers, first responders, emergency medical technicians, advanced emergency medical technicians, paramedics, or other emergency service personnel acting within the ordinary course and scope of their professions, but excluding physicians;

(E) “Health care facility,” any institution, building, or agency or portion thereof, private or public, excluding federal facilities and hospitals, whether organized for profit or not, used, operated, or designed to provide health services, medical treatment, or nursing, rehabilitative, or preventive care to any person or persons. Health care facility includes but is not limited to ambulatory surgical facilities, health maintenance organizations, home health agencies, hospices, infirmaries, renal dialysis centers, long-term care facilities licensed under sections 198.003 to 198.186, RSMo, medical assistance facilities, mental health centers, outpatient facilities, public health centers, rehabilitation facilities, and residential treatment facilities;

(F) “Hospital,” a place devoted primarily to the maintenance and operation of facilities for the diagnosis, treatment, or care for not less than twenty-four (24) consecutive hours in any week of three (3) or more nonrelated individuals suffering from illness, disease, injury, deformity, or other abnormal physical conditions; or a place devoted primarily to provide for not less than twenty-four (24) consecutive hours in any week medical or nursing care for three (3) or more nonrelated individuals.

Hospital does not include any long-term care facility licensed under sections 198.003 to 198.186, RSMo;

(G) “Outside the hospital do-not-resuscitate (OHDNR) identification” or “outside the hospital DNR identification,” a standardized identification card, bracelet, or necklace of a single color, form, and design that signifies that the patient’s attending physician has issued an outside the hospital do-not-resuscitate order for the patient and has documented the grounds for the order in the patient’s medical file;

(H) “Outside the hospital do-not-resuscitate (OHDNR) order” or “outside the hospital DNR order,” a written physician’s order signed by the patient and the attending physician, or the patient’s representative and the attending physician, which authorizes emergency medical services personnel to withhold or withdraw cardiopulmonary resuscitation from the patient in the event of cardiac or respiratory arrest;

(I) “Outside the hospital do-not-resuscitate (OHDNR) protocol” or “outside the hospital DNR protocol,” a standardized method or procedure for the withholding or withdrawal of cardiopulmonary resuscitation by emergency medical services personnel from a patient in the event of cardiac or respiratory arrest;

(J) “Patient,” a person eighteen (18) years of age or older who is not incapacitated, as defined in section 475.010, RSMo, and who is otherwise competent to give informed consent to an OHDNR order at the time such order is issued, and who, with his or her attending physician, has executed an OHDNR order under sections 190.600 to 190.621, RSMo. A person who has a patient’s representative shall also be a patient for the purposes of sections 190.600 to 190.621, RSMo, if the person or the person’s patient’s representative has executed an OHDNR order under sections 190.600 to 190.621, RSMo. A person under eighteen (18) years of age shall also be a patient for purposes of sections 190.600 to 190.621, RSMo, if the person has had a do-not-resuscitate order issued on his or her behalf under the provisions of section 191.250, RSMo; and (K) “Patient’s representative”— 1. An attorney-in-fact designated in a durable power of attorney for health care for a patient determined to be incapacitated under sections 404.800 to 404.872, RSMo;

A guardian or limited guardian appointed under

Chapter 475, RSMo, to have responsibility for an incapacitated patient; or 3. A patient under the age of eighteen (18) years may have an OHDNR order signed by at least one (1) parent, by at least one (1) of the patient’s legal guardian(s), or by a juvenile or family court under the provisions of section 191.250, RSMo, if the patient is under juvenile court jurisdiction under section 211.031, RSMo.

(2) A properly executed OHDNR order— (A) Shall be completed on an OHDNR order form with an optional instruction form. The OHDNR order form and instruction form are included herein and available at the Emergency Medical Services Bureau office, online at www.dhss.mo.gov/ EMS, or obtained by mailing a written request to the Missouri Department of Health and Senior Services, EMS Bureau, PO Box 570, Jefferson City, MO 65102-0570. The instruction form may be photocopied on the back side of the OHDNR order form or attached as a separate page to the OHDNR order form;

(B) Shall only be effective when the patient has not been admitted to or is not being treated within a hospital or has not yet come to the emergency department as defined in the Emergency Medical Treatment and Active Labor Act (EMTALA), 42 U.S.C. section 1395dd, and the regulation 42 CFR section 489.24(a) and referenced in the Centers for Medicare & Medicaid Services State Operations Manual Appendix V – Interpretive Guideline – Responsibilities of Medicare Participating Hospitals (11/30/24) John R. Ashcroft in Emergency Cases (Rev. 1, 05-21-04);

(C) Shall be maintained as the first page of a patient’s medical record in a health care facility unless otherwise specified in the health care facility’s policies and procedures;

(D) Shall be transferred with the patient when the patient is transferred from one health care facility to another health care facility;

(E) Shall be provided to any other facility, person, or agency responsible for the medical care of the patient or to the patient or patient’s representative if the patient is transferred outside of a hospital;

(F) Shall be signed and dated by the patient or the patient’s legal representative and the patient’s attending physician. A patient’s attending physician may electronically sign his/her name to the OHDNR order form. A patient under the age of eighteen (18) years shall not sign and date an OHDNR order form for himself or herself. A patient under the age of eighteen (18) years may have an OHDNR order signed by at least one (1) parent, by at least one (1) of the patient’s legal guardian(s), or by a juvenile or family court under the provisions of section 191.250, RSMo, if the patient is under juvenile court jurisdiction under section 211.031, RSMo;

(G) Shall be printed on eight and one half inch by eleven inch (8.5" × 11") card stock that is purple in color;

(H) May be photocopied, faxed, or saved as an electronic copy, and this photocopy, electronic copy, or other complete facsimile of the original OHDNR order may be used for any

purpose for which the original OHDNR order may be used;

(I) May be revoked at any time by a patient or a patient’s representative. If a patient is under the age of eighteen (18), an OHDNR order may be revoked by the patient under the age of eighteen (18), by either parent, by the patient’s legal guardian, or by a juvenile or family court under the provisions of section 191.250, RSMo, if the patient is under juvenile court jurisdiction under section 211.031, RSMo. An OHDNR order may be revoked by— 1. Signing in the box on the OHDNR order form labeled revocation provision. The revocation provision box shall remain unsigned in order for the OHDNR order to remain in effect;

Expressing to emergency medical services personnel in any manner, before or after the onset of a cardiac or respiratory arrest, the desire to be resuscitated; or 3. Destroying a patient’s original OHDNR order form and any applicable OHDNR identification such as an identification card, bracelet, or necklace; and (J) Shall be valid and effective whether or not an instruction form is included on the back side of the OHDNR form or attached as a separate page to the OHDNR order form.

(3) Emergency medical services personnel are authorized to comply with the OHDNR protocol when presented with OHDNR identification or an OHDNR order meeting the requirements in

section (2) above. The department also authorizes emergency medical services personnel to comply with the OHDNR protocol when presented with the following forms that do not have to be purple in color, which are in compliance with the provisions of sections 190.600 to 190.621, RSMo, and are included herein— (A) Alaska Physician Orders for Life Sustaining Treatment (POLST) Form—Emergency medical services personnel and anyone listed in section 190.606, RSMo, as immune from liability are only authorized to comply with the specific do-notresuscitate section in Alaska’s POLST Form;

(B) State of Arkansas Emergency Medical Services Do-Not- Resuscitate Order;

(C) Georgia Physician Orders for Life-Sustaining Treatment (POLST) Form—Emergency medical services personnel and anyone listed in section 190.606, RSMo, as immune from liability are only authorized to comply with the specific do-notresuscitate section in Georgia’s POLST Form;

(D) State of Indiana Out of Hospital Do-Not-Resuscitate Declaration and Order Form;

(E) New Mexico Emergency Medical Services (EMS) Do-Not- Resuscitate (DNR) Form;

(F) Kansas–Missouri Transportable Physician Orders for Patient Preferences (TPOPP/POLST)—This form shall be signed in compliance with Missouri law by the patient’s attending physician as defined in subsection (1)(A) above and the patient defined in subsection (1)(J) above or the patient’s representative in subsection (1)(K) above. Emergency medical services personnel and anyone listed in section 190.606, RSMo, as immune from liability are only authorized to comply with the specific do-not-resuscitate section in the Kansas-Missouri TPOPP/POLST as long as the physician and patient or patient’s representative have signed the form in accordance with Missouri law.

(4) The OHDNR protocol includes the following standardized methods or procedures:

(A) An OHDNR order shall only be effective when the patient has not been admitted to or is not being treated within a hospital or has not yet come to the emergency department as defined in the Emergency Medical Treatment and Active Labor Act (EMTALA), 42 U.S.C. section 1395dd, and the regulation 42 CFR section 489.24(a) and referenced in the Centers for Medicare & Medicaid Services State Operations Manual Appendix V—Interpretive Guideline—Responsibilities of Medicare Participating Hospitals in Emergency Cases (Rev. 191, 07-19-19);

(B) Emergency medical services personnel shall not comply with an OHDNR order or the OHDNR protocol when the patient or patient’s representative expresses to such personnel in any manner, before or after the onset of a cardiac or respiratory arrest, the desire to be resuscitated;

(C) Emergency medical services personnel shall not comply with an OHDNR order or the OHDNR protocol when the patient under eighteen (18) years of age, either parent of such patient, the patient’s legal guardian, or the juvenile or family court if the patient is under juvenile court jurisdiction under section 211.031, RSMo, expresses to such personnel in any manner, before or after the onset of a cardiac or respiratory arrest, the desire for the patient to be resuscitated;

(D) An OHDNR order shall not be effective during such time as the patient is pregnant;

(E) A properly executed OHDNR order authorizes emergency medical services personnel to withhold or withdraw cardiopulmonary resuscitation from the patient in the event of cardiac or respiratory arrest. Emergency medical services personnel shall not withhold or withdraw other medical interventions, such as intravenous fluids, oxygen, or therapies other than cardiopulmonary resuscitation such as those to provide comfort care or alleviate pain. Nothing in this regulation shall prejudice any other lawful directives concerning such medical interventions and therapies;

(F) If any doubt exists about the validity of the OHDNR identification or an OHDNR order, resuscitation shall be initiated and medical control shall be contacted;

(G) If the OHDNR order or OHDNR identification is presented after basic or advanced life support procedures have started, the emergency medical services personnel shall honor the form and withhold or withdraw cardiopulmonary resuscitation from a patient who is suffering cardiac or respiratory arrest;

(H) After noting the properly executed OHDNR order or OHDNR identification, no cardiac monitoring is necessary and no medical control contact is necessary; and (I) Emergency medical services personnel shall document review of the OHDNR order and/or OHDNR identification in the patient care record.

(5) Single Color, Form, and Design for Additional/Optional OHDNR Identification.

(A) The OHDNR identification card— 1. Shall be signed and dated by the patient or the patient’s legal representative and the patient’s attending physician;

Shall be printed on card stock that is purple in color; and 3. Shall be three and seven-sixteenths by four and oneeighth (3 7/16 × 4 1/8) inches in size and may be folded and/or laminated.

(B) The OHDNR bracelet— 1. Shall contain a representation of the geographical shape of Missouri with the word “STOP” etched in purple, imposed over the geographical shape of Missouri on the face of the bracelet; and 2. Shall contain the inscription “MO OHDNR order” on the back of the bracelet.

(C) The OHDNR necklace— 1. Shall include a medallion containing a representation of the geographical shape of Missouri with the word “STOP” etched in purple, imposed over the geographical shape of Missouri on the face of the medallion; and 2. Shall contain the inscription “MO OHDNR order” on the back of the medallion.

(D) OHDNR bracelet and necklace vendors shall obtain approval from the department prior to manufacturing and distributing an initial OHDNR bracelet and necklace for a Missouri resident. To obtain approval from the department, OHDNR bracelet and necklace vendors shall submit to the department— 1. A document expressing an interest in manufacturing and distributing OHDNR bracelets and necklaces for Missouri residents;

A document stating that the OHDNR vendor understands and agrees to manufacture and distribute the OHDNR bracelet and necklace for each patient only after being shown an OHDNR order issued by the patient’s attending physician for the patient requesting the OHDNR bracelet or necklace. This OHDNR order must be executed by the patient or patient’s representative and the patient’s attending physician and on the form created by the department, included herein;
A document stating that the OHDNR vendor understands and agrees to send with the OHDNR bracelet or necklace a statement with the words, “Pursuant to sections 190.600– 190.621, RSMo, this OHDNR identification shall only be worn by a person who has executed an effective OHDNR order”; and 4. A prototype of the necklace and/or bracelet that meets the specifications as described herein in subsection (5)(B) or (5)

(C).

(E) After review of the required documentation and prototype from an OHDNR vendor, the department may approve the OHDNR vendor to manufacture and distribute OHDNR bracelets and necklaces. A list of approved OHDNR bracelet or necklace vendors is available at the EMS Bureau office, online at www. dhss.mo.gov/EMS or may be obtained by mailing a written request to the Missouri Department of Health and Senior Services, EMS Bureau, PO Box 570, Jefferson City, MO 65102- 0570.

(F) Department-approved OHDNR vendors shall be shown, for each patient requesting an OHDNR bracelet or necklace, an effective OHDNR order issued by the patient’s attending physician for the patient requesting the OHDNR bracelet or necklace. To be effective, this OHDNR order must be executed by the patient or patient’s representative and the patient’s attending physician and on the form created by the department, included herein.

(G) Department-approved OHDNR vendors shall send with each OHDNR necklace or bracelet manufactured and distributed to a Missouri resident a statement with the words, “Pursuant to sections 190.600–190.621, RSMo, this OHDNR identification shall only be worn by a person who has executed an effective OHDNR order.”

Chapter 41 Head and Spinal Cord Injuries

19 CSR 30-41.010 Head and Spinal Cord Injury Reporting Requirements {#sec-19-csr-30-41.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-41.010}

PURPOSE: The Department of Health is mandated by section 192.737, RSMo 1986 to establish and maintain an information registry and reporting system for the purpose of data collection and needs assessment of head and spinal cord injured persons in this state.

(1) Based on information provided by the reporting physician or his/her designee, all Missouri hospitals shall report on forms supplied by the Department of Health registry information on the following patients:

(A) Any head- or spinal cord-injured patient who is dead on arrival or dies after arriving in the emergency department;

(B) Any head- or spinal cord-injured patient who is transferred to another hospital from the emergency department; and (C) Any inpatient admitted to a hospital for the purpose of treating a head or spinal cord injury.

(2) The registry forms for patients discharged during any one (1) month shall be completed and sent to the Department of Health by the last day of the following month.

(3) The registry form shall include, but not be limited to the following items: hospital name and hospital medical record number; patient name, Social Security number, date of birth, sex and race; previous treatment for the same injury; if minor (under 18) name of parent or guardian and Social Security number; date of injury; time of injury; external cause (E code); scene of injury; place of injury; factors related to the injury such as blood alcohol content, use of all-terrain vehicle, use of restraint and use of helmet; mode of arrival; ambulance service number; ambulance report number; ambulance times; if transfer in, sending hospital; data and time of arrival in emergency department; glasgow coma score and cardiopulmonary functions at arrival in the emergency department; time intubated, sent to ct scan and sent to X-ray; time of arrival in emergency department of the trauma surgeon, orthopedic surgeon and neurosurgeon; time of discharge from emergency department; emergency department disposition; if transferred out, receiving hospital; date and time of arrival in operating room; time anesthetist arrived in operating room; operating room procedures ranked by apparent severity; final diagnoses ranked by apparent severity; date admitted; date discharged; total ICU days; disposition at discharge; degree of disability and disability related to; and expected main source of payment.

Rebecca McDowell Cook (6/30/98)

History

AUTHORITY: section 192.737, RSMo 1986. Original rule filed June 2, 1987, effective Aug. 27, 1987. Original authority 1986.

Chapter 45 Trauma Centers

19 CSR 30-45.010 Definitions and Abbreviations Relating to Trauma Centers 1987. Original rule filed Nov. 14, 1989, Aug. 28, 1998, effective Feb. 28, 1999. {#sec-19-csr-30-45.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-45.010}

19 CSR 30-45.020 Trauma Center Designation Requirements 1987. Original rule filed Nov. 14, 1989, Aug. 28, 1998, effective Feb. 28, 1999. {#sec-19-csr-30-45.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-45.020}

19 CSR 30-45.030 Standards for Trauma Center Designation 1987* Original rule filed Nov. 14, 1989, Aug. 28, 1998, effective Feb. 28, 1999. {#sec-19-csr-30-45.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-45.030}

19 CSR 30-45.040 Standards for Pediatric Trauma Center Designation 1987. Original rule filed Nov. 14, 1989, Aug. 28, 1998, effective Feb. 28, 1999. {#sec-19-csr-30-45.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-45.040}

19 CSR 30-45.050 Triage, Transportation and Treatment of Trauma Patients {#sec-19-csr-30-45.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-45.050}

(Rescinded February 25, 1999)

Original rule filed Nov. 14, 1989, Aug. 28, 1998, effective Feb. 28, 1999.

Rebecca McDowell Cook (1/29/99)

History

AUTHORITY: section 190.243, RSMo Supp.

Chapter 50SN * - moved to 19 CSR 60-50

19 CSR 30-50SN * - moved to 19 CSR 60-50 {#sec-19-csr-30-50sn omnilex-key=us-mo-regs-official--title-19--19 CSR 30-50SN}

MATTBLUNT(1/29/03)*

Rules of Department of Health and Senior Services Division 30óDivision of Health Resources SPECIAL NOTICE

Chapter 50óCertificate of Need Program On August 1, 1988, Chapter 50 of Division 30 was transferred to Division 60óMissouri Health Facilities Review Committee.

These rules may be found at 19 CSR 60. The chapter numbers are unchanged.

Chapter 60 License-Exempt Child Care Facilities

19 CSR 30-60.010 Definitions Relating to Child Care Facilities {#sec-19-csr-30-60.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-60.010}

(Moved to 5 CSR 25-300.010)

19 CSR 30-60.020 Application for Annual Fire Safety and Health and Sanitation Inspections and Inspection Procedures {#sec-19-csr-30-60.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-60.020}

(Moved to 5 CSR 25-300.020)

19 CSR 30-60.030 Local Inspections {#sec-19-csr-30-60.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-60.030}

(Moved to 5 CSR 25-300.030)

19 CSR 30-60.040 Variance Requests {#sec-19-csr-30-60.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-60.040}

(Moved to 5 CSR 25-300.120)

19 CSR 30-60.050 Staffing Requirements {#sec-19-csr-30-60.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-60.050}

(Moved to 5 CSR 25-300.040)

19 CSR 30-60.060 Health Requirements {#sec-19-csr-30-60.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-60.060}

(Moved to 5 CSR 25-300.050)

19 CSR 30-60.070 Responsibilities of Caregivers {#sec-19-csr-30-60.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-60.070}

(Moved to 5 CSR 25-300.060)

19 CSR 30-60.080 Fire Safety Requirements {#sec-19-csr-30-60.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-60.080}

(Moved to 5 CSR 25-300.070)

19 CSR 30-60.090 Sanitation Requirements {#sec-19-csr-30-60.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-60.090}

(Moved to 5 CSR 25-300.080)

19 CSR 30-60.100 Physical Plant, Space, Supplies and Equipment {#sec-19-csr-30-60.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-60.100}

(Moved to 5 CSR 25-300.090)

19 CSR 30-60.110 Transportation and Field Trip Requirements {#sec-19-csr-30-60.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-60.110}

(Moved to 5 CSR 25-300.100)

19 CSR 30-60.120 Admission Procedures and Required Reports and Records {#sec-19-csr-30-60.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-60.120}

(Moved to 5 CSR 25-300.110)

Chapter 61 Licensing Rules for Family Day Care Homes

19 CSR 30-61.085 Physical Requirements of the Family Day Care Home {#sec-19-csr-30-61.085 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.085}

19 CSR 30-61.105 The Child Care Provider and Other Child Care Personnel (9/30/21) JOHN R. ASHCROFT HEALTH AND SENIOR SERVICES Licensure Child Care Homes {#sec-19-csr-30-61.105 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.105}

19 CSR 30-61.010 Definitions {#sec-19-csr-30-61.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.010}

(Moved to 5 CSR 25-400.010)

19 CSR 30-61.015 Exemption of Day Care Facilities {#sec-19-csr-30-61.015 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.015}

(Moved to 5 CSR 25-400.015)

19 CSR 30-61.025 Organization and Administration {#sec-19-csr-30-61.025 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.025}

(Moved to 5 CSR 25-400.025)

19 CSR 30-61.045 Licensing Process {#sec-19-csr-30-61.045 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.045}

(Moved to 5 CSR 25-400.045)

19 CSR 30-61.055 Annual Requirements {#sec-19-csr-30-61.055 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.055}

(Moved to 5 CSR 25-400.055)

19 CSR 30-61.085 Physical Requirements of the Family Day Care Home {#sec-19-csr-30-61.085 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.085}

(Moved to 5 CSR 25-400.085)

19 CSR 30-61.086 Fire Safety {#sec-19-csr-30-61.086 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.086}

(Moved to 5 CSR 25-400.086)

19 CSR 30-61.090 Disaster and Emergency Preparedness {#sec-19-csr-30-61.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.090}

(Moved to 5 CSR 25-400.090)

19 CSR 30-61.095 Furniture, Equipment, and Materials {#sec-19-csr-30-61.095 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.095}

(Moved to 5 CSR 25-400.095)

19 CSR 30-61.105 The Child Care Provider and Other Child Care Personnel {#sec-19-csr-30-61.105 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.105}

(Moved to 5 CSR 25-400.105)

19 CSR 30-61.115 Day Care Family and Household {#sec-19-csr-30-61.115 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.115}

(Moved to 5 CSR 25-400.115)

19 CSR 30-61.125 Medical Examination Reports {#sec-19-csr-30-61.125 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.125}

(Moved to 5 CSR 25-400.125)

19 CSR 30-61.135 Admission Policies and Procedures {#sec-19-csr-30-61.135 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.135}

(Moved to 5 CSR 25-400.135)

19 CSR 30-61.145 Nighttime Care {#sec-19-csr-30-61.145 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.145}

(Moved to 5 CSR 25-400.145)

19 CSR 30-61.155 Overlap Care of Children {#sec-19-csr-30-61.155 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.155}

(Moved to 5 CSR 25-400.155)

19 CSR 30-61.165 Emergency School Closings {#sec-19-csr-30-61.165 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.165}

(Moved to 5 CSR 25-400.165)

19 CSR 30-61.175 Child Care Program {#sec-19-csr-30-61.175 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.175}

(Moved to 5 CSR 25-400.175)

19 CSR 30-61.185 Health Care {#sec-19-csr-30-61.185 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.185}

(Moved to 5 CSR 25-400.185)

19 CSR 30-61.190 Nutrition and Food Service {#sec-19-csr-30-61.190 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.190}

(Moved to 5 CSR 25-400.190)

19 CSR 30-61.200 Transportation and Field Trips {#sec-19-csr-30-61.200 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.200}

(Moved to 5 CSR 25-400.200)

19 CSR 30-61.210 Records and Reports {#sec-19-csr-30-61.210 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.210}

(Moved to 5 CSR 25-400.210)

19 CSR 30-61.220 Variance Request {#sec-19-csr-30-61.220 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-61.220}

(Moved to 5 CSR 25-400.220)

Chapter 62 Licensing Rules for Group Child Care Homes and Child Care Centers

19 CSR 30-62.082 Physical Requirements of Group Day Care Homes and Day Care Centers (9/30/21) JOHN R. ASHCROFT HEALTH AND SENIOR SERVICES Licensure Child Care Homes and Child Care Centers {#sec-19-csr-30-62.082 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.082}

19 CSR 30-62.010 Definitions {#sec-19-csr-30-62.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.010}

(Moved to 5 CSR 25-500.010)

19 CSR 30-62.022 Exemption of Day Care Facilities {#sec-19-csr-30-62.022 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.022}

(Moved to 5 CSR 25-500.022)

19 CSR 30-62.032 Organization and Administration {#sec-19-csr-30-62.032 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.032}

(Moved to 5 CSR 25-500.032)

19 CSR 30-62.042 Licensing Process {#sec-19-csr-30-62.042 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.042}

(Moved to 5 CSR 25-500.042)

19 CSR 30-62.052 Annual Requirements {#sec-19-csr-30-62.052 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.052}

(Moved to 5 CSR 25-500.052)

19 CSR 30-62.082 Physical Requirements of Group Day Care Homes and Day Care Centers {#sec-19-csr-30-62.082 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.082}

(Moved to 5 CSR 25-500.082)

19 CSR 30-62.087 Fire Safety {#sec-19-csr-30-62.087 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.087}

(Moved to 5 CSR 25-500.087)

19 CSR 30-62.090 Disaster and Emergency Preparedness {#sec-19-csr-30-62.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.090}

(Moved to 5 CSR 25-500.090)

19 CSR 30-62.092 Furniture, Equipment, and Materials {#sec-19-csr-30-62.092 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.092}

(Moved to 5 CSR 25-500.092)

19 CSR 30-62.102 Personnel {#sec-19-csr-30-62.102 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.102}

(Moved to 5 CSR 25-500.102)

19 CSR 30-62.112 Staff/Child Ratios {#sec-19-csr-30-62.112 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.112}

(Moved to 5 CSR 25-500.112)

19 CSR 30-62.122 Medical Examination Reports {#sec-19-csr-30-62.122 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.122}

(Moved to 5 CSR 25-500.122)

19 CSR 30-62.132 Admission Policies and Procedures {#sec-19-csr-30-62.132 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.132}

(Moved to 5 CSR 25-500.132)

19 CSR 30-62.142 Nighttime Care {#sec-19-csr-30-62.142 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.142}

(Moved to 5 CSR 25-500.142)

19 CSR 30-62.152 Hourly Care Facilities {#sec-19-csr-30-62.152 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.152}

(Moved to 5 CSR 25-500.152)

19 CSR 30-62.162 Overlap Care of Children {#sec-19-csr-30-62.162 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.162}

(Moved to 5 CSR 25-500.162)

19 CSR 30-62.172 Emergency School Closings {#sec-19-csr-30-62.172 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.172}

(Moved to 5 CSR 25-500.172)

19 CSR 30-62.182 Child Care Program {#sec-19-csr-30-62.182 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.182}

(Moved to 5 CSR 25-500.182)

19 CSR 30-62.192 Health Care {#sec-19-csr-30-62.192 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.192}

(Moved to 5 CSR 25-500.192)

19 CSR 30-62.202 Nutrition and Food Service {#sec-19-csr-30-62.202 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.202}

(Moved to 5 CSR 25-500.202)

19 CSR 30-62.212 Transportation and Field Trips {#sec-19-csr-30-62.212 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.212}

(Moved to 5 CSR 25-500.212)

19 CSR 30-62.222 Records and Reports {#sec-19-csr-30-62.222 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.222}

(Moved to 5 CSR 25-500.222)

19 CSR 30-62.230 Variance Request {#sec-19-csr-30-62.230 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-62.230}

(Moved to 5 CSR 25-500.230)

Chapter 63 Child Care Comprehensive Background Screening

19 CSR 30-63.010 Definitions {#sec-19-csr-30-63.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-63.010}

(Moved to 5 CSR 25-600.010)

19 CSR 30-63.020 General Requirements {#sec-19-csr-30-63.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-63.020}

(Moved to 5 CSR 25-600.020)

19 CSR 30-63.030 Criminal Background Screening Cost {#sec-19-csr-30-63.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-63.030}

(Moved to 5 CSR 25-600.030)

19 CSR 30-63.040 Background Screening Findings {#sec-19-csr-30-63.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-63.040}

(Moved to 5 CSR 25-600.040)

19 CSR 30-63.050 Process for Appeal Required in Section 210.1080, RSMo {#sec-19-csr-30-63.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-63.050}

(Moved to 5 CSR 25-600.050)

Chapter 70 Lead Abatement and Assessment Licensing, Training Accreditation

19 CSR 30-70.110 Definitions and Abbreviations for Lead Abatement and Assessment Licensing abbreviations to be used in the interpretation and enforcement of 19 CSR 30-70.110 through 19 CSR 30-70.200. {#sec-19-csr-30-70.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.110}

(1) EPA is the United States Environmental (2) Large-scale abatement project is a lead abatement project consisting of ten (10) or more dwellings.

(3) Occupation is one of the specific types or categories of lead-bearing substance activities identified in these regulations for which individuals may receive training from accredited training providers. This includes, but not limited to, lead inspector, risk assessor, lead and/or project designer.

(4) OLLA is the Missouri Department of Health Office of Lead Licensing and Accreditation.

(5) Passing score is a grade of seventy percent (70%) or better on the state examination for a lead occupation license.

(6) Reciprocity is an agreement between OLLA and other states who have similar licensing provisions.

(7) Refresher course is the course of instruction established by these regulations which must be periodically completed to obtain or maintain an individual’s licensure in a single (8) Renewal is the reissuance of a lead occupation license.

(9) Training course, is the course of instruction established by these regulations to prepare an individual for licensure in a single (10) Training provider is a person or entity providing training courses for the purpose of state licensure or licensure renewal in the occupations of lead inspector, risk assessor, lead abatement worker, lead abatement supervisor, and/or project designer.

Aug. 19, 1999, effective Aug. 30, 1999, Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.120 General {#sec-19-csr-30-70.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.120}

PURPOSE: This rule outlines specific responsibilities that apply to all applicants of a lead occupation license and all licensed individuals.

(1) Waiver. Applicants for licensure and/or licensees may authorize others, such as their employer, to act on their behalf regarding their license application. Such authorization shall be indicated on the application form provided by the Office of Lead Licensing and Accreditation (OLLA). If at any time the applicant and/or licensee decides to change this authorization, the applicant and/or the licensee shall notify OLLA in writing of such change.

(2) Change of Address. Licensed individuals shall notify OLLA in writing of a change of mailing address no later than thirty (30) days following the change. Licensed contractors shall notify OLLA in writing of a change of business address no later than thirty (30) days following the change. Until a change of address is received, all correspondence will be mailed to the individual’s mailing address and the contractor’s business address indicated on the most recent application form.

(3) Reciprocity. OLLA may issue a lead occupation license to any person or entity who has made application and provided proof of certification or licensure from another state, provided that OLLA has entered into a reciprocity agreement with that state, and the necessary fees have been paid.

(4) Suspension, Revocation or Restriction of a Lead Occupation License.

(A) OLLA may restrict, suspend or revoke a license issued under sections 701.300 through 701.338, RSMo, for any one or any combination of the following causes:

Providing any false information in the 2. Violations of 29 CFR part 1926.62 or 29 CFR part 1926.59;
History of citations or violations of 4. Fraud or failure to disclose facts relevant to his or her application and/or license;
Performing work requiring licensure at the job site without having proof of licensure;
Conviction of a felony under any state or federal law or having entered a plea of guilty or nolo contendere in a criminal prosecution under the laws of any state or of the United States;
Permitting the duplication or use of the individual’s own training certificate, license, or license identification by another;
Performing work requiring licensure at a job site without being licensed;
Failure to comply with any state or mulgated pursuant to these sections;
Other information which may affect the licensee’s ability to appropriately perform lead-bearing substance activities; or 11. Final disciplinary action against a (B) Prior to restricting, suspending, or revoking a license, the licensee will be given written notice of the reasons for the suspension, revocation and/or restriction. The licensee may appeal the determination of OLLA by requesting a hearing before the (5) Replacement Fee. A fifteen dollar ($15)fee will be assessed for duplicate and/or replacement license certificates or identification badges.

Aug. 19, 1999, effective Feb. 29, 2000.

ROBIN CARNAHAN (1/29/10)

19 CSR 30-70.130 Application Process and Inspectors ments to be licensed as a lead inspector. {#sec-19-csr-30-70.130 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.130}

(1) Application for a Lead Inspector License.

(A) An applicant for a lead inspector license must submit a completed application to the Office of Lead Licensing and Accreditation (OLLA) prior to consideration for license issuance. All applications for licensure must be received by OLLA at least thirty (30) days prior to the date of the state lead examination; provided, however, OLLA may waive the time for the filing of applications as particular circumstances justify. Completed applications shall be mailed to the Missouri (B) The application shall include the fol- 1. Completed lead occupation license A. The applicant’s full legal name, B. The name, address, and telephone C. The applicant’s Social Security D. The county or counties in which E. The location where the applicant F. The occupation the applicant wish- G. Licensure for lead occupations in H. Certification by the Environmental I. Type of training completed, including name of training provider, certificate identification number and dates of course completion;

J. Employment history and/or educa- K. Signature of the applicant which ulations.

A copy of the OLLA- or EPA-accredited lead inspector training program completion certificate, and any required refresher completion certificates;
Two (2) recent passport-size color 4. Documentation pursuant to pararequirements for lead inspectors; and 5. A check or money order made (C) An applicant for a lead inspector license shall apply to OLLA within one (1) year of the applicant’s successful completion of an OLLA- or EPA-accredited lead inspector training course, as indicated on the certificate of completion. Applicants failing to apply within one (1) year from the date on the training course completion certificate shall, before making application for license, successfully complete the eight (8)-hour lead inspector refresher training course accredited by OLLA or the EPA.

(D) Applicants failing to apply within three (3) years of the lead inspector training and who have not successfully completed annual plete the OLLA- or EPA-accredited lead inspector training course again before submitting application for a lead inspector license.

(2) Application for a Lead Inspector License Under Reciprocity.

(A) An applicant for a lead inspector (B) The application shall include the fol- 1. Completed lead occupation license A. The applicant’s full legal name, B. The name, address, and telephone C. The applicant’s Social Security D. The location where the applicant E. The occupation the applicant wish- F. Licensure for lead occupations in G. Certification by the EPA, includ- H. Signature of the applicant which 2. Two (2) recent passport-size color 3. A check or money order made payable to the Missouri Department of Health (3) Training, Education and Experience Requirements for Lead Inspector License.

(A) An applicant for a license as a lead inspector shall complete an OLLA- or EPAaccredited lead inspector training program (see 19 CSR 30-70.330) and pass the course examination with a score of seventy percent (70%) or more.

(B) An applicant for a license as a lead inspector shall meet minimum education lead inspector.

The minimum education and/or experience requirements for licensed lead inspector includes at least one (1) of the following:

A. A bachelor’s degree;

B. An associate’s degree and one (1) year experience in a related field such as lead, asbestos, housing repair or inspection, and/or environmental hazard remediation work; or C. A high school diploma or certificate of high school equivalency (GED) and two (2) years of experience in a related field remediation work.

The following documents will be recognized by OLLA as evidence of meeting the requirements listed in subsection (3)(B) of (1/29/10) ROBIN CARNAHAN A. Official academic transcripts or diploma as evidence of meeting the education B. Resumes, letters of reference, or documentation of work experience, which, at a minimum, includes dates (month and year) of employment, employer’s name, address and telephone number, and specific job duties, as evidence of meeting the work experience requirements; and C. Course completion certificates ing requirements.

(4) Procedure for Issuance or Denial of Lead Inspector License.

(A) OLLA will inform the applicant in 1. If an application is incomplete, the A. Within thirty (30) calendar days after the issuance date of the notice, the applicant shall submit to OLLA in writing, the information requested in the written notice.

B. Failure to submit the information (30) calendar days shall result in OLLA’s denial of the applicant’s application for a lead inspector license.

C. After receipt of the information 2. When an application for a lead inspector license is denied, the written notice of denial to the applicant will specify the reasons for the denial. OLLA may deny a lead inspector license for any one (1) or any combination of the following reasons:

A. Failure to satisfy the education B. Type and amount of training;

C. False or misleading statements in D. Failure to achieve a passing score E. Failure to submit a complete appli- F. History of citations or violations of G. Violations of 29 CFR part 1926.62 H. Fraud or failure to disclose facts I. Conviction of a felony under any J. Permitting the duplication or use by K. Other information which may perform lead inspections;

L. Failure to comply with any state or mulgated pursuant to those sections; or M . Final disciplinary action against a 3. If an application is denied, the applicant may reapply to OLLA for a lead inspector license by submitting a complete lead occupation license application form with another nonrefundable fee of one hundred dollars ($100).

If an applicant is aggrieved by a may appeal OLLA’s denial to the Administrative Hearing Commission as provided by (B) Within one hundred and eighty (180) calendar days of application approval, the applicant shall attain a passing score on the state lead inspector examination.
An applicant cannot sit for the state lead inspector examination more than three (3) times within one hundred and eighty (180) calendar days after the issuance date of the notice of an approved application.
The applicant’s failure to attain a passing score on the state lead inspector examination within the one hundred eighty (180)-day period following the notice of an approved application for a license shall result in OLLA’s denial of the applicant’s application for a license. The individual may reapply to OLLA pursuant to this regulation but only after retaking an OLLA- or EPA-accredited lead inspector training course.

(C) After the applicant passes the state lead inspector examination, OLLA will issue a two (2)-year lead inspector license certificate and photo identification badge.

(D) Restricted licenses may be issued pur- Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.140 Application Process and Requirements for the Licensure of Risk Assessors ments to be licensed as a risk assessor. {#sec-19-csr-30-70.140 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.140}

(1) Application for a Risk Assessor License.

(A) An applicant for a risk assessor license must submit a completed application to the Office of Lead Licensing and Accreditation (OLLA) prior to consideration for license issuance. All applications for licensure must be received by OLLA at least thirty (30) days prior to the date of the state lead examination; provided, however, OLLA may waive the time for the filing of applications as particular circumstances justify. Completed applications shall be mailed to the Missouri (B) The application shall include the fol- 1. Completed lead occupation license A. The applicant’s full legal name, B. The name, address, and telephone C. The applicant’s Social Security D. The county or counties in which E. The location where the applicant F. The occupation the applicant wish- G. Type of training completed, cate identification number and dates of H. Licensure for lead occupations in I. Certification by the Environmental J. Employment history and/or educa- K. Signature of the applicant which 2. A copy of the OLLA- or EPA-accredited lead inspector and risk assessor training program completion certificates and any required refresher completion certificates;

Two (2) recent passport-size color 4. Documentation pursuant to pararequirements for risk assessors; and 5. A check or money order made (C) An applicant for a risk assessor license shall apply to OLLA within one (1) year of the applicant’s successful completion of an OLLA- or EPA-accredited risk assessor training course, as indicated on the certificate of completion. Applicants failing to apply within one (1) year from the date on the training program completion certificates shall, before making application for license, successfully complete the eight (8)-hour risk assessor (D) Applicants failing to apply within three (3) years of the risk assessor training and who have not successfully completed annual plete the OLLA- or EPA-accredited risk assessor training course again before submitting application for a risk assessor license.

(2) Application for a Risk Assessor License Under Reciprocity.

(A) An applicant for a risk assessor (B) The application shall include the fol- 1. Completed lead occupation license A. The applicant’s full legal name, B. The name, address, and telephone C. The applicant’s Social Security D. The location where the applicant E. The occupation the applicant wish- F. Licensure for lead occupations in G. Certification by the EPA, includ- H. Signature of the applicant which 2. Two (2) recent passport-size color 3. A check or money order made (3) Training, Education and Experience Requirements for Risk Assessor License.

(A) An applicant for a license as a risk assessor shall complete an OLLA- or EPAaccredited lead inspector training program and an OLLA- or EPA-accredited risk assessor training program (see 19 CSR 30-70.340) and pass both of the course examinations with a score of seventy percent (70%) or more.

(B) An applicant for a license as a risk assessor shall meet minimum education risk assessor.

The minimum education and/or experience requirements for a licensed risk assessor includes at least one (1) of the following:

A. A bachelor’s degree and at least one (1) year of experience in a related field remediation work;

B. An associate’s degree and two (2) years experience in a related field such as lead, asbestos, housing repair or inspection, and/or environmental hazard remediation work;

C. Certification as an industrial hygienist, professional engineer, registered architect and/or certification in a related engineering/health/environmental field such as safety professional or environmental scientist; or D. A high school diploma or certificate of high school equivalency (GED) and three (3) years of experience in a related field remediation work.

The following documents will be recognized by OLLA as evidence of meeting the requirements listed in paragraph (3)(B)1. of A. Official academic transcripts or tion requirements;

B. Resumes, letters of reference, or C. Course completion certificates ing program, as evidence of meeting the training requirements; and D. Appropriate documentation of certifications or registrations.

(4) Procedure for Issuance or Denial of Risk Assessor License.

(A) OLLA will inform the applicant in 1. If an application is incomplete, the A. Within thirty (30) calendar days to OLLA in writing the information request- B. Failure to submit the information (30) calendar days shall result in OLLA’s denial of the applicant’s application for a risk assessor license.

C. After receipt of the information (5/31/20) JOHN R. ASHCROFT 2. When an application for a risk assessor license is denied, the written notice of denial to the applicant will specify the reasons for the denial. OLLA may deny a risk assessor license for any one (1) or any combination of the following reasons:

A. Failure to satisfy the education B. Type and amount of training;

C. False or misleading statements in D. Failure to achieve a passing score E. Failure to submit a complete F. History of citations or violations of G. Violations of 29 CFR part 1926.62 H. Fraud or failure to disclose facts I. Conviction of a felony under any J. Permitting the duplication or use K. Other information which may perform risk assessments;

L. Failure to comply with any state or M. Final disciplinary action against a 3. If an application is denied, the applicant may reapply to OLLA for a risk assessor license, by submitting a complete lead occupation license application form and another nonrefundable fee of one hundred dollars ($100).

If an applicant is aggrieved by a may appeal OLLA’s denial to the (B) Within one hundred and eighty (180) calendar days after the issuance date of application approval, the applicant shall attain a passing score on the state risk assessor examination.
An applicant cannot sit for the state risk assessor examination more than three (3) times within one hundred and eighty (180) calendar days after the issuance date of the notice of an approved application.
The applicant’s failure to attain a passing score on the state risk assessor exam within the one hundred eighty (180)-day period following the notice of an approved application for a license shall result in OLLA’s denial of the applicant’s application for a license. The individual may reapply to OLLA pursuant to this regulation but only after retaking an OLLA- or EPA-accredited risk assessor training course.

(C) After the applicant passes the state risk assessor examination, OLLA will issue a two (2)-year risk assessor license certificate and photo identification badge.

(D) Restricted licenses may be issued pur- Aug. 19, 1999, effective Feb. 29, 2000. ** **Pursuant to Executive Order 21-07, 19 CSR 30-70.140, subsection (4)(B) was suspended from April 2, 2020 through August 31, 2021.

19 CSR 30-70.150 Application Process and Abatement Workers ments to be licensed as a lead abatement worker. {#sec-19-csr-30-70.150 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.150}

(1) Application for a Lead Abatement Worker License.

(A) An applicant for a lead abatement worker license must submit a completed ation for license issuance. All applications for abatement project; provided, however, OLLA may waive the time for the filing of applications as particular circumstances justify.

Completed applications shall be mailed to the Missouri Department of Health, Attention:

Fee Receipts, P.O. Box 570, Jefferson City, MO 65102-0570.

(B) The application shall include the fol- 1. Completed lead occupation license A. The applicant’s full legal name, B. The name, address, and telephone C. The applicant’s Social Security D. The county or counties in which E. The location where the applicant F. The occupation the applicant wish- G. Licensure for lead occupations in H. Certification by the Environmental I. Type of training completed, including name of training provider, certificate identification number and dates of course completion; and J. Signature of the applicant which 2. A copy of the OLLA- or EPA-accredited lead abatement worker training program completion certificate, and any required refresher completion certificates;

Two (2) recent passport-size color 4. A check or money order made (C) An applicant for a lead abatement worker license shall apply to OLLA within one (1) year of the applicant’s successful completion of an OLLA- or EPA-accredited lead abatement worker training course, as indicated on the certificate of completion.

Applicants failing to apply within one (1) year from the date on the training program completion certificate shall, before making application for license, successfully complete the eight (8)-hour lead abatement worker (D) Applicants failing to apply within three (3) years of the lead abatement worker training and who have not successfully completed annual refresher training, shall successfully complete the OLLA- or EPA-accredited lead abatement worker training course again before submitting application for a lead abatement worker license.

(2) Application for a Lead Abatement Worker License Under Reciprocity.

(A) An applicant for a lead abatement worker license by reciprocity must submit a completed application to OLLA prior to consideration for license issuance. Completed applications shall be mailed to the Missouri (B) The application shall include the fol- 1. Completed lead occupation license A. The applicant’s full legal name, B. The name, address, and telephone C. The applicant’s Social Security D. The location where the applicant E. The occupation the applicant wish- F. Licensure for lead occupations in G. Certification by the EPA, includ- H. Signature of the applicant which 2. Two (2) recent passport-size color 3. A check or money order made (3) Training Requirements for Lead Abatement Worker License. An applicant for a license as a lead abatement worker shall complete an OLLA- or EPA-accredited lead abatement worker training program (see 19 CSR 30-70.350) and pass the course examination with a score of seventy percent (70%) or more. The document that will be recognized by OLLA as evidence of meeting the requirement is listed in subsection (1)(C) of this regulation.

(4) Procedure for Issuance or Denial of Lead Abatement Worker License.

(A) OLLA will inform the applicant in writing that the application is either approved, incomplete, or denied.

If an application is incomplete, the A. Within thirty (30) calendar days B. Failure to submit the information (30) calendar days shall result in OLLA’s denial of the applicant’s application for a lead abatement worker.

C. After receipt of the information 2. When an application for a lead abatement worker license is denied, the written a lead abatement worker license for any one (1) or any combination of the following reasons:

A. Type and amount of training;

B. False or misleading statements in C. Failure to submit a complete appli- D. History of citations or violations of existing lead abatement regulations or E. Violations of 29 CFR part 1926.62 F. Fraud or failure to disclose facts G. Conviction of a felony under any H. Permitting the duplication or use I. Other information which may affect the applicant’s ability to appropriately perform lead abatement work;

J. Failure to comply with any state or K. Final disciplinary action against a 3. If an application is denied, the appliform with another nonrefundable fee of one 4. If an applicant is aggrieved by a may appeal OLLA’s denial to the Administrative Hearing Commission as provided by (B) After notice of complete application, OLLA will issue a two (2)-year license certificate and photo identification badge.

19 CSR 30-70.160 Application Process and Abatement Supervisors ments to be licensed as a lead abatement supervisor. {#sec-19-csr-30-70.160 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.160}

(1) Application for a Lead Abatement Supervisor License.

(A) An applicant for a lead abatement supervisor license must submit a completed ation for license issuance. All applications for licensure must be received by OLLA at least thirty (30) days prior to the date of the state lead examination; provided, however, fy. Completed applications shall be mailed to (B) The application shall include the fol- 1. Completed lead occupation license A. The applicant’s full legal name, B. The name, address, and telephone C. The applicant’s Social Security D. The county or counties in which E. The location where the applicant F. The occupation the applicant wish- G. Type of training completed, cate identification number and dates of H. Licensure for lead occupations in I. Certification by the Environmental J. Employment history which meets the experience requirements in paragraph (3)(B)1. of this regulation; and K. Signature of the applicant which 2. A copy of the OLLA- or EPA-accredited lead abatement supervisor training program completion certificate, and any required refresher completion certificates;

Two (2) recent passport-size color 4. Documentation pursuant to paraof meeting the experience requirements for lead abatement supervisors; and 5. A check or money order made (C) An applicant for a lead abatement supervisor license shall apply to OLLA within one (1) year of the applicant’s successful completion of an OLLA- or EPA-accredited lead abatement supervisor training course, as indicated on the certificate of completion.

Applicants failing to apply within one (1) year from the date on the training program completion certificate shall, before making application for license, successfully complete the eight (8)-hour lead abatement supervisor (D) Applicants failing to apply within three (3) years of completing the lead abatement supervisor training and who have not successfully completed annual refresher training, shall successfully complete the OLLAor EPA-accredited lead abatement supervisor training course again before submitting application for a lead abatement supervisor license.

(2) Application for a Lead Abatement Supervisor License Under Reciprocity.

(A) An applicant for a Lead Abatement Supervisor license by reciprocity must submit a completed application to OLLA prior to consideration for license issuance. Completed applications shall be mailed to the Missouri Department of Health, Attention: Fee (B) The application shall include the fol- 1. Completed lead occupation license A. The applicant’s full legal name, B. The name, address, and telephone C. The applicant’s Social Security D. The location where the applicant E. The occupation the applicant wish- F. Licensure for lead occupations in G. Certification by the EPA, includ- H. Signature of the applicant which 2. Two (2) recent passport-size color 3. A check or money order made (3) Training and Experience Requirements for Lead Abatement Supervisor License.

(A) An applicant for a license as a lead abatement supervisor shall complete an OLLA- or EPA-accredited lead abatement supervisor training program (see 19 CSR 30- 70.360) and pass the course examination with a score of seventy percent (70%) or more.

(B) An applicant for a license as a lead abatement supervisor shall meet minimum experience requirements for a licensed lead abatement supervisor.

The minimum experience requirements for a licensed lead abatement supervisor licensure includes at least one (1) of the A. At least one (1) year of experience as a licensed lead abatement worker (by Missouri, EPA or EPA-approved state);

B. At least two (2) years of experience in asbestos abatement work or as a construction manager or superintendent; or C. At least two (2) years of experience as a manager for environmental hazard remediation projects.

The following documents shall be recognized by OLLA as evidence of meeting the requirements listed in subsection (3)(B) of A. Resumes, letters of reference, or B. Course completion certificates ing requirements; and C. A copy of the lead abatement worker certificate or identification badge as evidence of having been a licensed lead abatement worker.

(4) Procedure for Issuance or Denial of Lead Abatement Supervisor License.

(A) OLLA will inform the applicant in 1. If an application is incomplete, the A. Within thirty (30) calendar days B. Failure to submit the information for a lead abatement supervisor license.

C. After receipt of the information 2. When an application for a lead abatement supervisor license is denied, the written a lead abatement supervisor license for any one or any combination of the following reasons:

A. Failure to satisfy the experience B. Type and amount of training;

L. Failure to comply with any state or M. Final disciplinary action against a 3. If an application is denied, the appliform and another nonrefundable fee of one 4. If an applicant is aggrieved by a may appeal OLLA’s denial to the Administrative Hearing Commission as provided by (B) Within one hundred and eighty (180) calendar days after the issuance date of application approval, the applicant shall attain a passing score on the state lead abatement supervisor examination.

An applicant cannot sit for the state lead abatement supervisor examination more than three (3) times within one hundred and eighty (180) calendar days from the date of issuance of the notice of an approved applica- 2. The applicant’s failure to attain a passing score on the state lead abatement supervisor exam within the one hundred eighty (180)-day period following the notice of an approved application for a license shall result in OLLA’s denial of the applicant’s application for license. The individual may reapply to OLLA pursuant to this regulation but only after retaking an OLLA- or EPAaccredited lead abatement supervisor training (C) After the applicant passes the state lead abatement supervisor examination, OLLA will issue a two (2)-year lead abatement supervisor license certificate and photo identification badge.

(D) Restricted licenses may be issued pur- Aug. 19, 1999, effective Feb. 29, 2000. ** **Pursuant to Executive Order 21-07, 19 CSR 30-70.160, subsection (4)(B) was suspended from April 2, 2020 through August 31, 2021.

19 CSR 30-70.170 Application Process and Requirements for the Licensure of Project Designers ments to be licensed as a project designer. {#sec-19-csr-30-70.170 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.170}

(1) Application for a Project Designer License.

(A) An applicant for a project designer license must submit a completed application to the Office of Lead Licensing and Accreditation (OLLA) prior to consideration for license issuance. All applications for abatement project design; provided, however, fy. Completed applications shall be mailed to the Missouri Department of Health, (B) The application shall include the fol- 1. Completed lead occupation license A. The applicant’s full legal name, B. The name, address, and telephone C. The applicant’s Social Security D. The county or counties in which E. The location where the applicant F. The occupation the applicant wish- G. Type of training completed, cate, identification number and dates of H. Licensure for lead occupations in I. Certification by the Environmental J. Employment history and/or educa- K. Signature of the applicant which 2. A copy of the OLLA- or EPA-accredited lead abatement supervisor and project designer training program completion certificates, and any required refresher completion certificates;

Two (2) recent passport-size color 4. Documentation pursuant to pararequirements for project designers; and 5. A check or money order made (C) An applicant for a project designer license shall apply to the OLLA within one (1) year of the applicant’s successful completion of an OLLA- or EPA-accredited project designer training course, as indicated on the certificate of completion. Applicants failing to apply within one (1) year from the date on the training provider completion certificates shall, before making application for license, successfully complete the four (4)-hour project designer refresher training course accredited by OLLA or the EPA.

(D) Applicants failing to apply within three (3) years of lead abatement supervisor and project designer training and who have not successfully completed annual refresher training, shall successfully complete the OLLA- or EPA-accredited project designer training course again before submitting application for a project designer license.

(2) Application for a Project Designer License Under Reciprocity.

(A) An applicant for a project designer (B) The application shall include the fol- 1. Completed lead occupation license A. The applicant’s full legal name, B. The name, address, and telephone C. The applicant’s Social Security D. The location where the applicant E. The occupation the applicant wish- F. Licensure for lead occupations in G. Certification by the EPA, includ- H. Signature of the applicant which 2. Two (2) recent passport-size color 3. A check or money order made (3) Training, Education and Experience Requirements for Project Designer License.

(A) An applicant for a license as a project designer shall complete an OLLA- or EPAaccredited lead abatement supervisor training course and an OLLA- or EPA-accredited project designer training program (see 19 CSR 30-70.370) and pass both of the course examinations with a score of seventy percent (70%) or more.

(B) An applicant for a license as a project designer shall meet minimum education project designer.

The minimum education and/or experience requirements for a licensed project designer include at least one (1) of the A. Bachelor’s degree in engineering, architecture, or a related profession, and one (1) year of experience in building construction and design;

B. At least one (1) year of experience as a licensed lead abatement supervisor (by Missouri, EPA or an EPA-approved state) and at least two (2) years experience in building construction and design; or C. At least four (4) years of experience in building construction and design.

The following documents may be recognized by OLLA as evidence of meeting the requirements listed in paragraph (3)(B)1. of this regulation:

A. Official academic transcripts or tion requirements;

B. Resumes, letters of reference, or C. Course completion certificates ing requirements; and D. A copy of the lead abatement supervisor certificate or identification badge as evidence of having been a licensed lead abatement supervisor.

(4) Procedure for Issuance or Denial of Project Designer License.

(A) OLLA will inform the applicant in 1. If an application is incomplete, the notice shall include a list of additional infor- A. Within thirty (30) calendar days B. Failure to submit the information for a project designer license.

C. After receipt of the information 2. When an application for a project designer license is denied, the written notice of denial to the applicant will specify the reasons for the denial. OLLA may deny a project designer license for any one (1) or any combination of the following reasons:

A. Failure to satisfy the education B. Type and amount of training;

C. False or misleading statements in D. Failure to submit a complete appli- E. History of citations or violations of ROBIN CARNAHAN (1/29/10)

F. Violations of 29 CFR part 1926.62 G. Fraud or failure to disclose facts H. Conviction of a felony under any I. Permitting the duplication or use by J. Other information which may affect the applicant’s ability to appropriately perform lead abatement project design;

K. Failure to comply with any state or L. Final disciplinary action against a 3. If an application is denied, the appliform and another nonrefundable fee of one 4. If an applicant is aggrieved by a may appeal OLLA’s denial to the Administrative Hearing Commission as provided by (B) After notice of complete application, OLLA will issue a two (2)-year license certificate and photo identification badge.

19 CSR 30-70.180 Application Process and Licensure Renewal Requirements for Lead Abatement Contractors ments to be licensed and renewal requirements as a lead abatement contractor. {#sec-19-csr-30-70.180 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.180}

(1) Application for a Lead Abatement Contractor License.

(A) An applicant for a lead abatement contractor license must submit a completed ation for license issuance. All applications for abatement activity; provided, however, fy. Completed applications shall be mailed to (B) The application shall include:

A completed lead abatement contractor form provided by OLLA which shall A. The applicant’s name, address and telephone number;

B. If the applicant is a sole proprietorship, the applicant’s Social Security num- C. The county or counties in which the applicant is located;

D. Lead-bearing substance activities the applicant will be conducting (i.e., lead inspection, risk assessments, lead abatement projects, and/or project design);

If the applicant is a corporation, a copy of its registration with the Missouri secretary of state’s office. Every corporation desiring a license as a lead abatement contractor under sections 701.300 through 701.338, RSMo, must be registered and in good standing with the Missouri secretary of state’s office;
Every corporation desiring a license which conducts business under a fictitious name must have the fictitious name registered with the Missouri secretary of state’s office, and must submit a copy of its fictitious name registration with its application to OLLA;
A check or money order made for the nonrefundable fee of two hundred and fifty dollars ($250); provided, however, that lead abatement contractors who are a state, federally recognized Indian tribe, local government or nonprofit organization shall be exempt from payment of such fee.

(2) Application for a Lead Abatement Contractor License Under Reciprocity.

(A) An applicant for a lead abatement contractor license by reciprocity shall apply to OLLA. Completed applications shall be (B) The application shall include:

A completed lead abatement contractor form provided by OLLA which shall A. The applicant’s name, address and telephone number;

B. If the applicant is a sole proprietorship, the applicant’s social security num- C. The county or counties in which the applicant is located;

D. Lead-bearing substance activities the applicant will be conducting (i.e., lead inspection, risk assessments, lead abatement projects, and/or project design);

E. A certification that the lead abatement contractor shall only employ appropriately Missouri licensed individuals to conduct lead-bearing substance activities; and F. A certification that the lead abatement contractor and its employees shall comply with the Work Practice Standards 19 CSR 30-70.600 through 19 CSR 30-70.650; and 2. A check or money order made for the nonrefundable fee of two hundred and fifty dollars ($250); provided, however, that lead abatement contractors who are a state, federally recognized Indian tribe, local government or nonprofit organization shall be exempt from payment of such fee.

(3) Procedure for Issuance or Denial of a Lead Abatement Contractor License.

(A) OLLA will inform the applicant in 1. If an application is incomplete, the (1/29/10) ROBIN CARNAHAN A. Within thirty (30) calendar days B. Failure to submit the information for a lead abatement contractor license.

C. After receipt of the information 2. When an application for a lead abatement contractor license is denied, the written a lead abatement contractor license for any one (1) or any combination of the following reasons:

A. History of citations or violations of existing local, state and federal lead abatement or other environmental regulations or B. Past felony convictions under any state or federal law designed to protect human health or the environment. Any plea of guilty or nolo contendere shall be considered a conviction for the purposes of this sub-

section;

C. False or misleading statements in D. Failure to submit a complete appli- E. Other information which may perform lead-bearing substance activities;

F. Violations of 29 CFR part 1926.62 G. Fraud or failure to disclose facts relevant to the lead abatement contractor H. Failure to comply with any state or I. Final disciplinary action against a 3. When an application is denied, the applicant may reapply to OLLA by submitting a complete lead abatement contractor application form along with the applicable fee.

If an applicant is aggrieved by a may appeal OLLA’s denial to the (B) After notice of complete application, OLLA will issue a two (2)-year lead abatement contractor license.

(C) Restricted licenses may be issued pur- (4) Change of Ownership. If a licensed lead abatement contractor changes ownership, the new owner shall notify OLLA in writing no later than thirty (30) calendar days prior to the change of ownership becoming effective.

The notification shall include a new lead abatement contractor license application, the appropriate fee, and the date that the change of ownership will become effective. The new lead abatement contractor application shall be processed in the same manner pursuant to 19 CSR 30-70.180(3). The current lead abatement contractor’s license shall expire on the effective date set forth in the notification of the change of ownership.

(5) Renewal Application for Lead Abatement Contractor License. An application for lead abatement contractor license renewal shall be mailed at least sixty (60) days prior to the expiration date on the license accompanied by a nonrefundable renewal fee of two hundred and fifty dollars ($250) (provided, however, that lead abatement contractors who are a exempt from payment of such fee) with a completed application form to the 65102. If the licensee fails to apply at least sixty (60) days prior to the expiration date on the license, OLLA cannot guarantee that the license will be renewed before the end of the licensing period.

Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.190 Renewal of Lead Occupation Licenses ments for renewal licensure of lead inspector, risk assessor, lead abatement worker, lead abatement supervisor and project designer. {#sec-19-csr-30-70.190 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.190}

(1) Renewal Application for Lead Inspector, Risk Assessor, Lead Abatement Worker, Lead Abatement Supervisor and Project Designer Licenses.

(A) A completed application for renewal of license, including required supporting documentation, shall be submitted to the Missouri 65102-0570, at least sixty (60) days prior to the license expiration date indicated on the license. Failure of the licensee to submit an application at least sixty (60) days prior to the current license’s expiration date may result in the license not being renewed before the current license expires.

(B) The licensee applying for license renewal shall complete the eight (8)-hour Office of Lead Licensing Accreditation (OLLA)- or Environmental Protection Agency (EPA)-accredited refresher training course for the appropriate occupation.

A completed lead occupation renewal license application form provided by OLLA A. The licensee’s full legal name, B. The name, address, and telephone number of the licensee’s current employer;

C. The licensee’s Social Security D. The county or counties in which the licensee is employed;

E. The location where the licensee ing his or her renewal application or license;

F. The license occupation the licensee wishes to have renewed;

G. Type of refresher training completed, including name of training provider, certificate identification number and dates of course completion; and H. Signature of the licensee which is complete and true to the best of the licensee’s knowledge and that the licensee will comply with applicable state statutes and regulations;

A copy of the OLLA- or EPA-accredited refresher training course completion certificate for the appropriate occupation;
Two (2) recent passport-size color photographs of the licensee’s face without a 4. A check or money order made for the nonrefundable fee of fifty dollars ($50).

(2) Procedure for Issuance or Denial of a Renewal License.

(A) OLLA will inform the licensee in writing that the renewal application is either approved, incomplete or denied.

If a renewal application is incomplete, the notice will include a list of additional information or documentation required to complete the renewal application.

A. Within thirty (30) calendar days plete application, the licensee shall submit to OLLA the information requested in the written notice.

B. Failure to submit the information requested in the written notice to OLLA in writing shall result in OLLA’s denial of the licensee’s renewal application for the appropriate occupation.

C. After receipt of the information inform the licensee in writing that the appli- 2. When a renewal application for a lead license is denied, the written notice of denial to the applicant will specify the reasons for the denial. OLLA may deny a renewal license for any one (1) or any combination of the following reasons:

A. Type and amount of training;

B. False or misleading statements in C. Failure to submit a complete appli- D. History of citations or violations of existing lead abatement regulations or E. Violations of 29 CFR part 1926.62 F. Fraud or failure to disclose facts G. Conviction of a felony under any H. Permitting the duplication or use I. Other information which may affect the licensee’s ability to appropriately perform lead-bearing substance activities;

J. Failure to comply with any state or K. Final disciplinary action against a 3. If a renewal application is denied, the applicant may reapply to OLLA by submitting a completed lead occupation license renewal application form and another nonrefundable renewal fee of fifty dollars ($50).

If a licensee is aggrieved by a determination to deny renewal licensure, the applicant may appeal OLLA’s denial to the (B) After notice of complete renewal application, OLLA will issue a two (2)-year license certificate and photo identification badge.

(C) Restricted licenses may be issued pur- Aug. 19, 1999, effective Feb. 29, 2000. ** **Pursuant to Executive Order 21-07, 19 CSR 30-70.190, subsection (1)(B) was suspended from April 2, 2020 through May 1, 2021.

19 CSR 30-70.195 Application Process and Requirements for Reapplication after License Expiration ments for reapplication of a lead inspector, risk assessor, lead abatement worker, lead abatement supervisor and project designer after a license has expired. {#sec-19-csr-30-70.195 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.195}

(1) Unless sooner renewed or revoked, a license shall expire within two (2) years from its effective date indicated on the current license. If a licensee allows the license to expire before renewal, the licensee must reapply to the Office of Lead Licensing and Accreditation (OLLA). Completed applica- (2) The application shall include the following:

(A) A completed lead occupation license 1. The applicant’s full legal name, home 2. The name, address, and telephone 3. The applicant’s Social Security num- 4. The county or counties in which the applicant is employed;

The location where the applicant 6. The license occupation the applicant wishes to be licensed for;
Type of training completed, including name of training provider, certificate identification number and dates of course comple- 8. Licensure for lead occupations in other states including, name of other states, 9. Certification by the Environmental and a copy of the EPA certificate; and 10. Signature of the applicant which certifies that all information in the application is complete and true to the best of the appli- (B) A copy of the OLLA- or EPA-accredited refresher (and/or initial, if applicable—see 19 CSR 30-70.195(4)) training course completion certificate for the appropriate occupa- (C) Two (2) recent passport-size color photographs of the applicant’s face without a hat or sunglasses (computer generated or photocopied photographs are not acceptable); and (D) A check or money order made payable to the Missouri Department of Health for the nonrefundable fee of one hundred dollars ($100).

(3) An applicant reapplying for a lead occupation license within one (1) year from the license expiration date shall complete the appropriate eight (8)-hour refresher training course accredited by OLLA or the EPA.

(4) Applicants failing to reapply within three (3) years of the license expiration date and who have not successfully completed annual plete the appropriate OLLA- or EPA-accredited initial training course again.

(5) Any licensed lead inspector, risk assessor, or lead abatement supervisor, that allows his or her license to expire before renewal shall retake the state lead examination for the appropriate occupation.

(6) OLLA will use the procedure for issuance or denial of a license pursuant to 19 CSR 30- 70.130(4), 19 CSR 30-70.140(3), 19 CSR 30-70.150(4), 19 CSR 30-70.160(4), 19 CSR 30-70.170(4) as applicable.

Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.200 Application Process and Requirements for the Licensure of Risk Assessors Who Possessed a Valid Missouri Lead Inspector License on August 28, 1998 {#sec-19-csr-30-70.200 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.200}

(Rescinded August 30, 2018)

RSMo Supp. 1998. Emergency rule filed Aug. 19, 1999, effective Aug. 30, 1999, expired Feb. 25, 2000. Original rule filed Aug. 19, 1999, effective Feb. 29, 2000. Rescinded:

Filed Jan. 5, 2018, effective Aug. 30, 2018.

19 CSR 30-70.310 Definitions and Abbreviations for the Accreditation of Training Providers abbreviations to be used in the interpretation and enforcement of 19 CSR 30-70.310 through 19 CSR 30-70.400. {#sec-19-csr-30-70.310 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.310}

(1) Accreditation is approval by the Office of Lead Licensing and Accreditation (OLLA) of a training provider for a training course to train individuals for lead-bearing substance activities.

(2) Audit is the monitoring by OLLA of a training provider for a training course to ensure compliance with state statutes and regulations.

(3) Classroom training is training devoted to lecture, learning activities, small group activities, demonstrations, and/or evaluations.

(4) Course agenda is an outline of the key topics to be covered during a training course, including the time allotted to teach each topic.

(5) Course exam blueprint is written documentation identifying the proportion of course exam questions devoted to each major topic in the course curriculum.

(6) EPA is the United States Environmental (7) Guest instructor is an individual designated by the training manager to provide instruction specific to the lecture, hands-on training, or work practice components of a course.

(8) Hands-on skills assessment is an evaluation of the effectiveness of the hands-on training which shall test the ability of the trainees to demonstrate satisfactory performance of work practices and procedures as well as any other skills demonstrated in the course.

(9) Hands-on training is training which involves the actual practice of a procedure and/or use of equipment.

(10) Large-scale abatement project is a lead abatement project consisting of ten (10) or more dwellings.

(11) Occupation is one of the specific types or categories of lead-bearing substance activities identified in these regulations for which individuals may receive training from accredited training providers, including, but not limited to, lead inspector, risk assessor, lead and/or project designer.

(12) OLLA is the Missouri Department of Health Office of Lead Licensing and Accreditation.

(13) Oral exam is equivalent to the written exam in content, but is read to the student by the principal instructor. The student is required to provide his or her answers to the exam in writing.

(14) Principal instructor is any qualified individual designated by the training manager that has the primary responsibility for organizing and teaching a particular course.

(15) Reaccreditation is the renewal of accreditation of a training provider for a training course subsequent to initial accreditation expiration.

(16) Reciprocity is an agreement between OLLA and other states who have similar accreditation provisions.

(17) Refresher course is the course of instruction established by these regulations which must be periodically completed to obtain or maintain an individual’s licensure in a single (18) Training course is the course of instruction established by these regulations to prepare an individual for licensure in a single (19) Training provider is any person or entity providing training courses for the purpose of state licensure or licensure renewal in an (20) Training curriculum is an established set of course topics for instruction by an accredited training provider for a particular occupation designed to provide specialized knowledge and skills.

(21) Training hour is at least fifty (50) minutes of actual instruction, including but not limited to time devoted to lecture, learning activities, small group activities, demonstrations, evaluations, and/or hands-on training.

A training hour shall not include a break.

(22) Training manager is any individual responsible for administering the training courses and monitoring the performance of principal instructors and guest instructors.

Aug. 19, 1999, effective Aug. 30, 1999, Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.320 Accreditation of Training Providers for Training Courses {#sec-19-csr-30-70.320 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.320}

PURPOSE: This rule provides the procedures and requirements for the accreditation of training providers for training courses.

(1) Reciprocity. The Office of Lead Licensing and Accreditation (OLLA) may issue an accreditation certificate to any person or entity that has made application, paid the necessary fees, and provided proof of accreditation from another state, provided that OLLA has entered into a reciprocity agreement with that state.

(2) Good Standing. Every corporation desiring accreditation of the lead inspector, risk assessor, lead abatement worker, lead abatement supervisor and/or project designer training course under sections 701.300 through 701.338, RSMo, must be registered and in good standing with the Missouri secretary of state’s office.

(3) Application for Accreditation of a Training Provider for a Training Course.

(A) Completed applications shall be (B) The application shall include the fol- 1. Completed training provider course A. The training provider’s name, B. The name and date of birth of the C. The name and date of birth of the D. A list of locations at which train- E. A list of courses for which the F. A statement signed by the training 2. A copy of the student and instructor manuals;

Course agenda;
Course examination blueprint;
A copy of the quality control plan as described in subsection (6)(H) of this regula- 6. A copy of a sample course certificate as described in subsection (6)(G) of this regulation;
A description of the facilities and 8. A description of the activities and procedures that will be used for conducting the hands-on skills assessment for each 9. A check or money order for the nonrefundable fee of one thousand dollars ($1,000) per course made payable to the Missouri Department of Health; provided, however, that training providers who are a exempt from payment of such fee; and 10. Supporting documentation of the training manager’s and principal instructor’s qualifications.

(4) Application for Accreditation of a Training Provider for a Training Course Under Reciprocity.

Course examination blueprint;
A copy of the quality control plan as described in subsection (6)(H) of this regulation;
A copy of a sample course certificate as described in subsection (6)(G) of this regulation;
A description of the facilities and 7. A description of the activities and procedures that will be used for conducting the hands-on skills assessment for each 8. A check or money order for the nonrefundable fee of one thousand dollars ($1,000) per course made payable to the Missouri Department of Health; provided, however, that training providers who are a exempt from payment of such fee; and 9. Supporting documentation of the training manager’s and principal instructor’s qualifications.

(5) Procedure for Issuance or Denial of a Training Provider for a Training Course.

(A) OLLA will inform the applicant in writing that the application is either approved, incomplete, or denied.

If an application is incomplete, the notice shall include a list of additional infor- A. Within thirty (30) calendar days B. Failure to submit the information (30) calendar days shall result in denial of the application for a training course accredita- C. After the information in the written notice is received, OLLA will inform the applicant in writing that the application is either approved or denied.
If an application is approved, OLLA shall issue a two (2)-year accreditation certificate.
If an application for training course accreditation is denied, OLLA shall state in the notice of denial to the applicant the specific reasons for the denial.

A. OLLA may deny training course accreditation for any one (1) or any combination of the following reasons:

(I) Failure of the training manager and/or principal instructor to satisfy the experience requirements;

(II) History of citations or violations of existing local, state and federal regulations or standards;

(III) Persons listed in the application have been convicted of a felony under any state or federal law or have entered a plea of guilty or nolo contendere in a criminal (IV) False or misleading statements in the application;

(V) False records, instructor qualifications, or other accreditation-related information or documentation;

(VI) Failure of the applicant to submit a complete application; or (VII) Final disciplinary action against a training provider by another state, territory, federal agency or country, whether or not voluntarily agreed to by the training provider, including, but not limited to, the denial of accreditation, surrender of the accreditation, allowing the accreditation to expire or lapse, or discontinuing or restricting the accreditation while subject to investigation or while actually under investigation by another state, territory, or federal agency or country.

(B) If an application is denied, the applicant may reapply for accreditation at any time.

(C) If an applicant is aggrieved by a determination to deny accreditation, the applicant may request a hearing by the department according to Chapter 536 of the Administrative Procedures Act.

(6) Requirements for Accreditation of a Training Provider for a Training Course. For a training provider to maintain accreditation from OLLA to offer a training course, the training provider shall meet the following requirements:

(A) Training Manager. The training provider shall employ a training manager who meets the requirements in subsection (7)(A) of this regulation. The training manager shall be responsible for ensuring that the accredited training provider complies at all times with all of the requirements in these regulations. The training manager may designate guest instructors as needed to provide instruction specific to the lecture, hands-on activities, or work practice components of a (B) Principal Instructor. The training provider, in coordination with the training manager, shall designate a qualified principal instructor who meets the requirements in subsection (8)(A) of this regulation. The principal instructor shall be responsible for the organization of the course and oversight of the teaching of all course materials;

(C) The training provider shall meet the requirements set forth in subsections (6)(D) through (N) of this regulation for each course contained in the application for accreditation of a training provider for a training course;

(D) Delivery of Course. The training provider shall ensure the availability of, and provide adequate facilities for, the delivery of the lecture, course exam, hands-on training, and assessment activities. This includes providing training equipment that reflects current work practice standards set forth in 19 CSR 30-70.600 through 19 CSR 30-70.650 and maintaining or updating the course materials, equipment and facilities as needed;

(E) Course Exam. For each course offered, the training provider shall conduct a monitored, written course exam at the completion of each course. An oral exam may be administered in lieu of a written course exam for the lead abatement worker course only. If an oral examination is administered, the student is required to provide his or her answers to the exam in writing.

The course exam shall evaluate the trainee’s competency and proficiency.
All individuals must pass the course exam in order to successfully complete any course and receive a course completion certificate. Seventy percent (70%) shall be considered the passing score on the course exam.
The training provider and the training manager are responsible for maintaining the validity and integrity of the course exam to ensure that it accurately evaluates the trainees’ knowledge and retention of the course topics;

(F) Hands-On Skills Assessment. For each course offered, except for project designers, the training provider shall conduct a hands-on skills assessment. The training manager is responsible for maintaining the validity and integrity of the hands-on skills assessment to ensure that it accurately evaluates the trainees’ performance of the work practices and procedures associated with the course topics;

(G) Course Completion Certificate. The training provider shall issue unique course completion certificates to each individual who passes the training course. The course completion certificate shall include:

The name, a unique identification number, and address of the individual;
The name of the particular course that the individual completed;
Dates of course completion/exam passage; and 4. The name, address and telephone number of the training provider;

(H) Quality Control Plan. The training manager shall develop and implement a quality control plan. The plan shall be used to maintain or improve the quality of the accredited training provider over time.

This plan shall contain at least the following elements:

A. Procedures for periodic revision of training materials and the course exam to reflect innovations in the field;

B. Procedures for the training manager’s annual review of principal instructor competency; and C. A review to ensure the adequacy of the facilities and equipment.

An annual report discussing the results of the quality control plan shall be submitted to OLLA one (1) year following accreditation and at renewal;

(I) Access by OLLA. The accredited training provider shall allow OLLA to conduct audits as needed in order for OLLA to evaluate the provider’s compliance with OLLA accreditation requirements. During this audit, the provider shall make available to OLLA information necessary to complete the evaluation. At OLLA’s request, the provider shall also make documents available for photocopying;

(J) Recording Keeping. The accredited training provider shall maintain at its principal place of business, for at least five (5) years, the following records:

All documents specified in subsections (7)(B) and (8)(B) of this regulation that demonstrate the qualifications listed in sub-

section (7)(A) of this regulation for the training manager, and subsection (8)(A) of this

regulation for the principal instructor;

Curriculum/course materials and documents reflecting any changes made to these materials;
The course examination and blueprint;
Information regarding how the handson skills assessment is conducted including, but not limited to:

A. Who conducts the assessment;

B. How the skills are graded;

C. What facilities are used;

D. The pass/fail rate; and E. The quality control plan as described in subsection (6)(H) of this regulation;

Results of the students’ hands-on skills assessments and course exams, and a record of each student’s course completion certificate; and 6. Any other material not listed in paragraph (6)(J)4. of this regulation that was submitted to OLLA as part of the training provider’s application for accreditation;

(K) Course Notification. The accredited ing fourteen (14) calendar days prior to conducting an accredited training course.

The notification shall include:

A. The location of the course if it will be conducted at a location other than the provider’s training facility;

B. The dates and times of the course;

C. The name of the course; and D. The name of the principal instructor and any guest instructors conducting the 2. If the scheduled training course has been changed or canceled, the accredited ing twenty-four (24) hours prior to the scheduled training course;

(L) Changes of a Training Course. Once a training course has been accredited, any changes in any one (1) of the items listed below must be submitted in writing to OLLA for review and approval prior to the continuation of the training course:

Course curriculum;
Course examination;
Course materials;
Training manager and/or principal instructors; and/or 5. Certificate of completion.

Within sixty (60) calendar days of receipt of a change of a training course, OLLA shall inform the provider in writing that the change is either approved or disapproved. If the change is approved, the accredited training provider shall include the change in the training course. If the change is disapproved, the accredited training provider shall not include the change in the training course;

(M) Change of Ownership. If an accredited training provider changes ownership, the new owner shall notify OLLA in writing at least thirty (30) calendar days prior to the change of ownership becoming effective.

The notification shall include a new training course provider accreditation application, the appropriate fee(s), and the date that the change of ownership will become effective.

The new training course provider accreditation application shall be processed pursuant to 19 CSR 30-70.320. The current training provider’s accreditation shall expire on the effective date set forth in the notification of the change of ownership; and (N) Change of Address. The accredited ing of the accredited training provider’s new address, telephone number and description of the new training facility, and shall submit such notification to OLLA not later than thirty (30) days prior to relocating its business or transferring its records.

(7) Training, Education and Experience Requirements for the Training Manager.

(A) The education and/or experience requirements for the training manager shall include one (1) year of experience in lead or asbestos abatement, painting, carpentry, renovation, remodeling, occupational safety and health, or industrial hygiene; and at least one of the following:

A minimum of two (2) years of experience teaching or training adults;
A bachelor’s or graduate degree in building construction technology, engineering, industrial hygiene, safety, public health, business administration, education; or 3. A minimum of two (2) years experience in managing a training program specializing in environmental hazards.

(B) The following records of experience and education shall be recognized by OLLA as evidence that the individual meets or exceeds OLLA requirements for a training manager:

Resumes, letters of reference from past employers, or documentation to evidence past experience, which includes dates (month/year) of employment, employer’s name, address, telephone number, and specific job duties, as evidence of meeting the experience requirements; and 2. Official academic transcripts or tion requirements.

(8) Training, Education and Experience Requirements for the Principal Instructor.

(A) The training, education and experience requirements for the principal instructor of a training course includes all of the following:

Successfully completed at least twenty-four (24) hours of any OLLA- or Environmental Protection Agency (EPA)accredited lead-specific training;
A minimum of one (1) year of experience in teaching or training adults; and 3. A minimum of one (1) year of experience in lead or asbestos abatement, painting, carpentry, renovation, remodeling, occupational safety and health, or industrial hygiene, or an associate degree or higher from a post-secondary educational institution in building construction technology, engineering, safety, public health, or industrial hygiene; and (B) The following records of experience and education shall be recognized by OLLA as evidence that the individual meets or exceeds OLLA requirements for a principal instructor:
Course completion certificates issued by the OLLA- or EPA-accredited training provider as evidence of meeting the training requirements.
Official academic transcripts or tion requirements.
Resumes, letters of reference from past employers, or documentation to evidence past experience, which includes dates (month/year) of employment, employer’s name, address, telephone number, and specific job duties, as evidence of meeting the experience requirements.

Aug. 19, 1999, effective Aug. 30, 1999, Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.330 Requirements for a Training Provider of a Lead Inspector lum requirements for a lead inspector training course. {#sec-19-csr-30-70.330 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.330}

(1) A training provider of a lead inspector training course must ensure that their lead inspector training course curriculum includes, at a minimum, sixteen (16) training hours of classroom training and eight (8) training hours of hands-on training.

(2) A lead inspector training course shall topics. Requirements ending in an asterisk (*) indicate areas that require hands-on training as an integral component of the course.

(A) Role and responsibilities of an inspector;

(B) Background information on lead—his- (C) Health effects of lead—how lead enters and affects the body; levels of concern; and symptoms, diagnosis and treatments;

(D) Regulatory background and overview (E) Sections 701.300 to 701.338, RSMo, sure, and Missouri Work Practice Standards for Lead-Bearing Substances specific to lead inspection activities;

(F) Lead-based paint inspection methods, including selection of rooms and components for sampling or testing;* (G) Pre-inspection planning and review including: developing a schematic site plan, determining inspection criteria and locations to collect samples in single and multi-family housing;* (H) Paint, dust, and soil sampling methodologies including:* 1. Lead-based paint testing or X-ray fluorescence paint analyzer (XRF) use: types of XRF units and basic operation and interpretation of XRF results, including substrate correction;

Soil sample collection including soil sampling techniques, number and location of soil samples, and interpretation of soil sampling results; and 3. Dust sample collection techniques including number and location of wipe samples, and interpretation of test results;

(I) Quality control and assurance procedures in testing analysis;

(J) Legal liabilities and obligations;

(K) Clearance standards and testing, including random sampling;* (L) Record keeping; and (M) Preparation of the final inspection report.* Aug. 19, 1999, effective Aug. 30, 1999, Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.340 Requirements for a Training Provider of a Risk Assessor lum requirements for a risk assessor training (1) A training provider of a risk assessor training course must ensure that their risk assessor training course curriculum includes, at a minimum, twelve (12) training hours of classroom training and four (4) training hours of hands-on training. {#sec-19-csr-30-70.340 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.340}

(2) A lead risk assessor training course shall topics. Requirements ending in an asterisk (*) indicate areas that require hands-on training as an integral component of the course.

(A) Role and responsibilities of a risk assessor;

(B) Collection of background information to perform a risk assessment, including information on the age and history of the housing and occupancy by children under six (6) years of age and women of child-bearing age;

(D) Visual inspection for the purposes of identifying potential sources of lead hazards;* (E) Lead hazard screen protocol;* (F) Full risk assessment protocol;

(G) Elevated blood lead level investigations;

(H) Sampling for other sources of lead exposure, including drinking water;* (I) Interpretation of lead-based paint and other lead sampling results related to Missouri clearance standards;* (J) Sections 701.300 to 701.338, RSMo, sure, and Missouri Work Practice Standards for Lead-Bearing Substances specific to risk assessment activities;

(K) Development of hazard control options, the role of interim controls, and operations and maintenance activities to reduce lead-bearing substance hazards;

(L) Legal liabilities and obligations specific to a risk assessor; and (M) Preparation of a final risk assessment report.* Aug. 19, 1999, effective Aug. 30, 1999, Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.350 Requirements for a Training Provider of a Lead Abatement Worker Training Course lum requirements for a lead abatement worker training course. {#sec-19-csr-30-70.350 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.350}

(1) A training provider of a lead abatement worker training course must ensure that their lead abatement worker training course curriculum includes, at a minimum, sixteen (16) training hours of classroom training and eight (8) training hours of hands-on training.

(2) A lead abatement worker training course shall include, at a minimum, the following course topics. Requirements ending in an asterisk (*) indicate areas that require handson training as an integral component of the course— (A) Role and responsibilities of an abatement worker;

(B) Background information on lead—his- (C) Health effects of lead—how lead enters and affects the body; levels of concern; and symptoms, diagnosis and treatments;

(D) Regulatory background and overview (E) Personal protective equipment information, including respiratory equipment selection, air-purifying respirators, care and cleaning of respirators, respiratory program, protective clothing and equipment, and hygienic practices;* (F) Lead hazard recognition and control; site characterization, exposure measurements, medical surveillance, and engineering controls;* (G) Preabatement set-up procedures, including containments for residential and commercial building, and superstructures;* (H) Lead abatement and lead hazard reduction methods for residential and commercial buildings, and superstructures, including prohibited practices;* (I) Sections 701.300 to 701.338, RSMo, sure, Missouri Work Practice Standards for Lead-Bearing Substances specific to lead (J) Interior dust abatement methods and cleanup techniques;* (K) Soil and exterior dust abatement methods;* and (L) Waste disposal techniques.

Aug. 19, 1999, effective Aug. 30, 1999, Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.360 Requirements for a Training Provider of a Lead Abatement Supervisor Training Course lum requirements for a lead abatement supervisor training course. {#sec-19-csr-30-70.360 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.360}

(1) A training provider of a lead abatement supervisor training course must ensure that their lead abatement supervisor training course curriculum includes, at a minimum, twenty-eight (28) training hours of classroom training and twelve (12) training hours of hands-on training.

(2) A lead abatement supervisor training course shall include, at a minimum, the following course topics. Requirements ending in an asterisk (*) indicate areas that require hands-on training as an integral component of the course— (A) Role and responsibilities of a supervisor;

(B) Background information on lead—his- (C) Health effects of lead—how lead enters and affects the body, levels of concern, and symptoms, diagnosis and treatments;

(D) Regulatory background and overview (E) Liability and insurance issues relating to lead abatement;

(F) Cost estimation;* (G) Risk assessment and inspection report interpretation;* (H) Development and implementation of an occupant protection plan and preabatement work plan, including containments for residential and commercial buildings, and superstructures;* (I) Community relations process;

(J) Lead hazard recognition and control;* (K) Hazard recognition and control techniques: site characterization, exposure measurements, material identification, safety and health planning, medical surveillance, and engineering controls;

(L) Personal protective equipment information regarding respiratory equipment selection, air-purifying respirators, care and cleaning of respirators, respiratory program, protective clothing and equipment, and hygienic practices;* (M) Lead abatement and lead hazard reduction methods, including prohibited practices, for residential and commercial buildings and superstructures;* (N) Sections 701.300 to 701.338, RSMo, sure, Missouri Work Practice Standards for Lead-Bearing Substances specific to lead (O) Project management including supervisory techniques, contractor specifications; emergency response planning, and blueprint reading;* (P) Interior dust abatement and cleanup techniques;* (Q) Soil and exterior dust abatement methods;* (R) Clearance standards and testing;

(S) Cleanup and waste disposal;

(T) Record keeping; and (U) Preparation of an abatement report.* Aug. 19, 1999, effective Aug. 30, 1999, Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.370 Requirements for a Training Provider of a Project Designer lum requirements for a project designer training course. {#sec-19-csr-30-70.370 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.370}

(1) A training provider of a project designer training course must ensure that their project designer training course curriculum includes, at a minimum, eight (8) training hours of classroom training.

(2) A project designer training course shall topics:

(A) Role and responsibilities of a project designer;

(B) Development and implementation of an occupant protection plan for large-scale abatement projects;

(C) Lead abatement and lead hazard reduction methods, including prohibited practices, for large-scale abatement projects;

(D) Interior dust abatement/cleanup or lead hazard control and reduction methods for large-scale abatement projects;

(E) Soil and exterior dust abatement methods for large-scale abatement projects;

(F) Clearance standards and testing for large-scale abatement projects; and (G) Integration of lead abatement methods with modernization and rehabilitation projects for large-scale abatement projects.

Aug. 19, 1999, effective Aug. 30, 1999, Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.380 Requirements for the Accreditation of Refresher Courses {#sec-19-csr-30-70.380 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.380}

PURPOSE: This rule delineates the requirements for lead inspector, risk assessor, lead and/or project designer refresher training courses.

(1) Application for Accreditation of a Training Provider for a Refresher Training Course. A training provider may seek accreditation to offer refresher courses in any occupation. To obtain the Office of Lead Licensing and Accreditation (OLLA) accreditation to offer refresher training, a training provider must meet the following minimum requirements:

(A) Each refresher course shall review the curriculum topics of the full-length courses listed under 19 CSR 30-70.330 through 19 CSR 30-70.370 as appropriate. In addition, training providers shall ensure that their courses of study include, at a minimum, the 1. An overview of current safety practices relating to lead-bearing substance activities in general, as well as specific information pertaining to the appropriate occupation;

Current laws and regulations relating to lead-bearing substance activities in general, as well as specific information pertaining to the appropriate occupation; and 3. Current technologies relating to leadbearing substance activities in general, as well as specific information pertaining to the appropriate occupation;

(B) Each refresher course, except for the project designer course, shall last a minimum of eight (8) training hours. The project designer refresher course shall last a minimum of four (4) training hours;

(C) For each course offered, the training program shall conduct a hands-on assessment (if applicable); and (D) For each refresher course offered, the training provider shall conduct a course exam at the completion of the course.

(2) A training provider may apply for accreditation of a refresher course concurrently with its application for accreditation of the corresponding training course as described in

19 CSR 30-70.320 as appropriate. If so, OLLA shall use the procedures and requirements described in 19 CSR 30-70.320 for accreditation of the refresher course and the corresponding training course. {#sec-19-csr-30-70.320 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.320}

(3) A training provider seeking accreditation to offer refresher courses only, shall submit a written application to OLLA.

(A) Completed applications shall be (B) The application shall include the fol- 1. Completed training course accreditation application form provided by OLLA A. The training provider’s name, B. The name and date of birth of the C. The name and date of birth of the D. A list of locations at which train- E. A list of courses for which the F. A statement signed by the training 2. A copy of the student and instructor manuals;

Course agenda;
Course examination blueprint;
A copy of the quality control plan as described in 19 CSR 30-70.320(6)(H);
A copy of a sample course completion certificate as described in paragraph 19 CSR 30-70.320(6)(G);
A description of the facilities and 8. A check or money order for the nonrefundable fee of two hundred fifty dollars ($250); provided, however, that training providers who are a state, federally recognized Indian tribe, local government or nonprofit organization shall be exempt from payment of such fee; and 9. The training manager’s and principal instructor’s qualifications.

(4) The procedures for issuance or denial in 19 CSR 30-70.320(5), and the requirements for accreditation of a training provider for a training course in 19 CSR 30-70.320(6) through 19 CSR 30-70.320(8), shall apply to all training providers applying for the accreditation of refresher training courses.

(5) Application for Accreditation of a Training Provider for a Refresher Training Course Under Reciprocity. To obtain OLLA accreditation by reciprocity to offer refresher training in any occupation, a training provider shall submit a completed application to OLLA. Completed applications shall be (A) The application shall include the fol- 1. Completed training course accreditation application form provided by OLLA A. The training provider’s name, B. The name and date of birth of the C. The name and date of birth of the D. A list of locations at which train- E. A list of courses for which the F. A statement signed by the training 2. Course agenda;

Course examination blueprint;
A copy of the quality control plan as described in 19 CSR 30-70.320(6)(H);
A copy of a sample course completion certificate as described 19 CSR 30- 70.320(6)(G);
A description of the facilities and 7. A check or money order for the nonrefundable fee of two hundred fifty dollars ($250); provided, however, that training providers who are a state, federally recognized Indian tribe, local government or nonprofit organization shall be exempt from payment of such fee; and 8. The training manager’s and principal instructor’s qualifications.

(B) The procedures for issuance or denial in 19 CSR 30-70.320(5), and the requirements for accreditation of a training provider for a training course in 19 CSR 30-70.320(6) through 19 CSR 30-70.320(8), shall apply to all training providers applying for accreditation by reciprocity of refresher training courses as applicable.

Aug. 19, 1999, effective Aug. 30, 1999, Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.390 Reaccreditation of a Training Course or Refresher Course {#sec-19-csr-30-70.390 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.390}

PURPOSE: This rule provides the processes and requirements for the reaccreditation of a training course or refresher course.

(1) Unless sooner revoked, a training provider’s accreditation (including refresher training accreditation) shall expire two (2) years after the date of issuance. If a training provider meets the requirements of this section, the training provider shall be re-accredited.

(2) A training provider seeking reaccreditation shall submit an application to the Office of Lead Licensing and Accreditation (OLLA) at least sixty (60) calendar days before its accreditation expires. If a training provider does not submit its application for reaccreditation by that date, OLLA cannot guarantee that the provider will be reaccredited before the end of the accreditation period.

(3) The training provider’s application for reaccreditation shall contain— (A) Completed training provider course 1. The training provider’s name, 2. The name and date of birth of the 3. The name and date of birth of the 4. A list of locations at which training will take place;

A list of courses for which the training provider is applying for reaccreditation;
A statement signed by the training vided in the application for reaccreditation, and any additional information included with the application, is true and accurate to the best of the training manager’s knowledge and understanding, that the training provider will comply with 19 CSR 30-70.310 through 19 CSR 30-70.400, and that the training provider will only conduct lead training in those occupations in which the training provider has received accreditation;

(B) A list of courses for which it is applying for reaccreditation;

(C) A description of any changes to the training facility, equipment or course materials since its last application was approved that adversely affects the student’s ability to learn; and (D) A check or money order made payable to the Missouri Department of Health for the nonrefundable fee of one thousand dollars ($1,000) for the training course and two hundred fifty dollars ($250) for the refresher training course; provided, however that training providers who are a state, federally recognized Indian tribe, local government or nonprofit organization shall be exempt from payment of such fee.

(4) The training provider shall comply with all requirements in 19 CSR 30-70.320 through 19 CSR 30-70.380, as applicable.

(5) If the training provider has allowed its accreditation to expire, and the provider desires to be accredited, it must reapply pursuant to 19 CSR 30-70.320.

Aug. 19, 1999, effective Aug. 30, 1999, Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.400 Suspension, Revocation, and Restriction of Accredited Training Providers {#sec-19-csr-30-70.400 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.400}

PURPOSE: This rule provides the processes and reasons for suspension, revocation and restriction of an accredited training provider.

(1) The Office of Lead Licensing and Accreditation (OLLA) may restrict, suspend or revoke training provider accreditation if a training provider, training manager, or other person with supervisory authority over the training provider does any one or any combination of the following:

(A) Provides, offers to provide, or claims to provide OLLA-accredited training courses without such accreditation;

(B) Presents inaccurate information in a training course;

(D) Falsifies accreditation records, instructor qualifications, or other accreditationrelated information or documentation;

(E) Fails to comply with the training standards and requirements in 19 CSR 30- 70.320;

(F) Has history of citations or violations of existing local, state and federal regulations or (G) Has been convicted of a felony under any state or federal law or has entered a plea (H) Fails to comply with federal, state or local lead statutes or regulations;

(I) Makes false or misleading statements to OLLA in its application for accreditation or reaccreditation which OLLA relied upon in approving the application; or (J) Final disciplinary action against a training provider by another state, territory, federal agency or country, whether or not voluntarily agreed to by the training provider, including, but not limited to, the denial of accreditation, surrender of the accreditation, allowing the accreditation to expire or lapse, or discontinuing or restricting the accreditation while subject to investigation or while (2) Prior to restricting, suspending, or revoking a training provider’s accreditation, a training provider shall be given written notice of the reasons for the restriction, suspension and/or revocation. The training provider may request a hearing by the department according to Chapter 536 of Administrative Procedures Act.

Aug. 19, 1999, effective Aug. 30, 1999, Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.510 Standard of Professional Conduct {#sec-19-csr-30-70.510 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.510}

PURPOSE: This rule establishes a professional standard of conduct for licensed lead abatement workers, licensed lead abatement supervisors, licensed project designers, licensed lead inspectors, licensed risk assessors, licensed lead abatement contractors and training instructors and training managers of accredited lead training providers.

(1) In performing lead-bearing substance activities, licensees shall act with reasonable care and competence in applying the technical knowledge and skill as required by sections 701.300 through 701.338, RSMo, and

19 CSR 30-70.600 through 19 CSR 30- 70.630 for the conduct of lead-bearing substance activities. {#sec-19-csr-30-70.600 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.600}

(2) In performing lead-bearing substance activities and training, licensees and accredited entities shall be cognizant that their primary responsibility is to conduct these activities safely, reliably, and effectively to protect human health and the environment. This shall not be compromised by any self-interest of the client, licensee or accredited entity.

(3) In performing lead-bearing substance activities and training, licensees and accredited entities shall not knowingly violate any local, state or federal laws. Licensees and accredited entities shall comply with state laws and regulations governing their practice.

(4) In instances where a licensee’s or an accredited entity’s professional judgment is overruled to the extent that it may endanger the health or welfare of the public or the environment, they shall notify their employer or client, the Office of Lead Licensing and Accreditation (OLLA), and/or other authority, as may be appropriate.

(5) Licensees and accredited entities shall not misrepresent or exaggerate the scope or the

purpose for which they are licensed or accredited.

(6) Professional Responsibility.

(A) The licensee or accredited training provider shall, upon request or demand, produce to OLLA, or any of its representatives, any plan, document, book, record or copy thereof concerning a transaction covered by these regulations, and shall cooperate in the investigation of a complaint filed with OLLA.

(B) A licensee shall not use the design, plans or work of another person without that person’s knowledge and consent. After consent, the licensee shall conduct a thorough review to the extent that he or she assumes full responsibility for the use of such design, plan or work of the other person.

(7) Good Standing in Other Jurisdictions.

(A) Persons licensed to design lead abatement projects, supervise lead abatement projects, conduct lead inspections and/or lead risk assessments, perform lead abatement work and training providers accredited to provide lead training in other jurisdictions shall be in good standing in every jurisdiction where licensed, certified, or accredited and shall not have had a license, certification or accreditation suspended, revoked or surrendered in connection with a disciplinary action.

(B) Licensees and accredited lead training providers shall notify OLLA in writing no later than ten (10) days after the final disciplinary action taken by another jurisdiction against their license or certification to conduct lead-bearing substance activities or against their accreditation to provide lead training. 701.314, RSMo Supp. 1998.* Emergency rule Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.520 Public Complaint Handling and Disposition Procedure {#sec-19-csr-30-70.520 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.520}

PURPOSE: This rule establishes procedures for the handling and disposition of public complaints received by the Office of Lead Licensing and Accreditation concerning alleged violations of sections 701.300 through 701.338, RSMo.

(1) Public complaints concerning alleged violations of sections 701.300 through 701.338, RSMo, shall be handled as follows:

(A) Any person may make a complaint alleging acts or practices which may constitute a violation of any provision of sections 701.300 through 701.338, RSMo, or 19 CSR 30-70.600 through 19 CSR 30-70.630 with the Office of Lead Licensing and Accreditation (OLLA) based upon personal knowledge or upon information received from other sources. The complaint may be made against a licensed or unlicensed individual, against an accredited or non-accredited training provider or against an owner of a dwelling or child-occupied facility; and (B) Complaints may be oral or written.

Written complaints shall be mailed to:

Missouri Department of Health, Office of Lead Licensing and Accreditation, P.O. Box 570, Jefferson City, MO 65102-0570. 701.314, RSMo Supp. 1998.* Emergency rule Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.600 Definitions Pertaining to the Work Practice Standards for Conducting Lead-Bearing Substance Activities acronyms to be used in the interpretation and enforcement of 19 CSR 30-70.600 through 19 CSR 30-70.640. {#sec-19-csr-30-70.600 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.600}

(1) Adequate quality control—a plan or design which ensures the authenticity, integrity, and accuracy of samples, including dust, soil, and paint chip or paint film samples.

Adequate quality control also includes provisions for representative sampling.

(2) Authorized personnel—licensed lead workers, licensed lead risk assessors, licensed lead supervisors, licensed lead contractors, licensed project designers, representatives of the department and any persons authorized by the department to enter regulated areas.

(3) Bare soil area—any continuous three (3) square foot area or more of soil that has no or little plant growth or other covering, and that may be accessible to a child or may provide a source of airborne lead-bearing dust, including the sand in sandboxes.

(4) Clearance level—values that indicate the maximum concentration of lead allowed in surface dust, soil or water following an abatement activity.

(5) Common area—a portion of a building that is generally accessible to all occupants including, but not limited to, hallways, garages, laundry rooms, community centers, boundary fences, stairways, playgrounds and recreational rooms.

(6) Component or building component—a specific design, structural element or fixture of a building, dwelling or child-occupied facility that can be distinguished from each other by form, function and location.

(7) Containment—the structural system for protecting residents, the general public and the environment by controlling exposure to lead dust and debris created during a lead abatement project.

(8) Critical barrier containment—two (2) or more layers of six (6)-mil poly, or thicker, sealed over the entrance into a work area to prevent lead dust and debris from migrating outside of a regulated area.

(9) Disposal—the depositing or placing of lead-bearing components or a lead-bearing substance as waste.

(10) Distinct painting history—the application history, as indicated by its visual appearance or a record of application, over time, of paint or other surface coatings to a component or room.

(11) Documented methodologies—methods or protocols used to sample for the presence of lead in paint, dust, soil and water while incorporating adequate quality control.

(12) Elevated blood lead level (EBL)—an excessive absorption of lead that is a confirmed concentration of lead in whole blood of greater than or equal to ten micrograms per deciliter (³10 μg/dl) in persons under age eighteen (<18).

(13) Emergency situation—any lead abatement project that results from a sudden, unexpected event which poses an immediate threat to human health or the environment.

(14) EPA—United States Environmental (15) Hazardous waste—any waste designated as hazardous by 10 CSR 25-4.261 and/or 40 CFR 261.

(16) High efficiency particulate air (HEPA) filter—a filter capable of removing particles of 0.3 microns or larger from air at 99.97 percent or greater efficiency.

(17) HUD—United States Department of Housing and Urban Development.

(18) HUD guidelines—the most recent version of the “Guidelines for the Evaluation and Housing,” published by HUD.

(19) Industrial lead abatement—a lead abatement project performed on a structure not defined as a dwelling or child-occupied facility which includes, but is not limited to, bridges, water towers, holding tanks and other superstructures. Industrial lead abatement does not include abatement of a de minimis surface area of less than fifty (50) square feet of a lead-bearing substance per lead abatement project.

(20) Intact paint surface—any painted surface that is not chipped, chalked, peeled, flaked or otherwise separated from its substrate or that is not attached to a damaged substrate.

(21) Lead hazard screen—a risk assessment activity that involves limited paint and dust sampling as described in 19 CSR 30- 70.620(7).

(22) Living area—any area of a residential dwelling used by one (1) or more children age six (6) and under, including, but not limited to, living rooms, kitchen areas, dens, play rooms and children’s bedrooms.

(23) Multi-family dwelling—a structure that contains more than one (1) separate residential dwelling unit, which is used or occupied, or intended to be used or occupied, in whole or in part, as the home or residence of one (1) or more persons.

(24) NLLAP—National Lead Laboratory Accreditation Program.

(25) OLLA—Missouri Department of Health Office of Lead Licensing and Accreditation, or subsequent designations of such office.

(26) Permanent—an activity that is designed to eliminate exposure to lead hazards for at least twenty (20) years, under typical conditions, from the date of application.

(27) Poly—polyethylene sheeting.

(28) RCRA—Resource Conservation and Recovery Act.

(29) Regulated area—an area where a leadbearing substance activity is being conducted.

(30) Room equivalent—an identifiable part of a residence, such as a room, a house exterior, a foyer, staircase, hallway or an exterior area (i.e., play areas, painted swing sets, painted sandboxes, etc.).

(31) Structural integrity—a professional judgment as to the condition of a substrate, component or structure itself.

(32) Substrate—a surface to which a surface coating has been or may be applied.

Examples of substrates are wood, metal, plaster, gypsum, concrete and brick.

(33) Surface coating integrity—a professional judgment as to whether a surface coating is cracked, chipped, peeling, blistering, flaking or otherwise deteriorated in any way.

(34) Surface coatings—include, but are not limited to, paints, stains, lacquers, varnishes and shellacs.

(35) Target housing—a dwelling built prior to 1978.

(36) Testing combination—a unique combination of a room equivalent, building component type and substrate.

(37) TSCA—Toxic Substances Control Act.

Aug. 19, 1999, effective Aug. 30, 1999, Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.610 Work Practice Standards for a Lead Inspection {#sec-19-csr-30-70.610 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.610}

PURPOSE: This rule delineates the standards to be followed by licensed lead inspectors and licensed risk assessors to conduct lead inspections in target housing and child-occupied facilities in accordance with standards set forth in sections 701.300 through 701.338, RSMo, and 19 CSR 30-70.600 through 19 CSR 30-70.630.

(1) Licensure. All persons conducting lead inspections shall be licensed by the Office of Lead Licensing and Accreditation (OLLA) as set forth in sections 701.300 through 701.338, RSMo, and 19 CSR 30-70.110 through 19 CSR 30-70.200 as a lead inspector or risk assessor. Licensed lead inspectors and risk assessors shall present, upon request, proof of licensure in the form of the photo identification badge issued by OLLA.

(2) Conflict of Interest. OLLA recommends that licensed lead inspectors and risk assessors conducting lead inspection activities should avoid potential conflicts of interest by not being contracted, subcontracted or employed by a lead abatement contractor performing lead abatement activities on the same lead abatement project.

(3) Documented Methodologies for Conducting Lead Inspections.

(A) Licensed lead inspectors and risk assessors shall use the following documented methodologies as referenced in this regulation for conducting lead inspections:

The U.S. Department of Housing and Urban Development publication entitled, “Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing”

(HUD Guidelines); and 2. The U.S. Environmental Protection Agency publications entitled “EPA Lead- Based Paint Inspector Model Curriculum”;

“Guidance on Residential Lead-Based Paint, Lead-Contaminated Dust and Lead-Contaminated Soil”; and “Residential Sampling for Lead: Protocols for Dust and Soil Sampling.”

(B) Where a conflict exists between any of the aforementioned methodologies and any federal or state statute or regulation, or any city or county ordinance, the most stringent of these shall be adhered to by the licensed lead inspector or risk assessor.

(4) Sample Forms and Questionnaires.

Sample forms and questionnaires may be found within the documented methodologies listed in section (3) of this regulation. These sample forms and questionnaires may be used as a guide by licensed lead inspectors or risk assessors.

(5) Any paint chip, dust, or soil samples collected pursuant to these work practice standards shall be— (A) Collected by persons licensed by OLLA as a lead inspector or risk assessor;

(B) Analyzed by a laboratory recognized by EPA pursuant to section 405(b) of TSCA as being capable of performing analyses for lead compounds in paint chip, dust, and soil samples.

(6) Lead Inspection.

(A) When conducting a lead inspection, the following locations shall be selected according to the documented methodologies referenced in section (3) of this regulation and tested for the presence of lead-bearing substances:

In dwellings and child-occupied facilities, surface-by-surface sampling by paint chip collection and/or X-ray fluorescence (XRF) analysis shall be conducted on components with distinct painting histories, including those components that are stained, shellacked, varnished or covered with wallpaper; and 2. For multi-family dwellings and childoccupied facilities, the samples required in paragraph (6)(A)1. of this regulation shall be taken. In addition, surface-by-surface sampling by paint chip collection and/or XRF analysis shall be conducted in common areas on components with distinct painting histories, including those components that are stained, shellacked, varnished or covered with wallpaper.

(B) Paint and other surface coatings shall be sampled according to the documented methodologies referenced in section (3) of this regulation.

(7) Lead Inspection Report. The inspection report shall be prepared by the OLLAlicensed lead inspector or risk assessor that performed the lead inspection and shall include the following:

(A) Date of inspection;

(B) Address of dwelling or child-occupied facility;

(D) Apartment numbers (if applicable);

(E) Name, address and telephone number of the owner or owners of each residential dwelling or child-occupied facility;

(F) Name, signature and license number of each licensed inspector and/or risk assessor conducting lead inspection;

(G) Name, address and telephone number of the firm employing each inspector and/or risk assessor;

(H) XRF results including the following (if applicable):

XRF manufacturer and model;
Serial number of XRF device used during the inspection;
Calibration verification from the beginning and end of each dwelling unit;
A copy of the XRF device user’s certificate of training provided by the equipment manufacturer;
License or registration number of the instrument;
A summary that categorizes the XRF results into one (1) of three (3) categories: positive, negative or inconclusive; and 7. Recommendations for addressing inconclusive XRF results;

(I) A summary of laboratory results categorized as positive or negative and the name of each accredited laboratory that conducted the analysis (if applicable);

(J) Floor plans or sketches of the units inspected showing approximate test locations and any identifying number systems;

(K) A summary of the substrates tested including identification of component, component integrity, paint condition and color, and test identification numbers associated with the results; and (L) The results of the inspection expressed in terms appropriate to the sampling method used.

(8) Time Frame for Submission of Reports.

The inspection report shall be provided to the owner of the property within twenty (20) business days of lead inspection completion.

(9) Report Records Retention. All lead inspection reports shall be maintained by the licensed lead inspector or risk assessor who prepared the report for no fewer than three (3) years. The licensed lead inspector or risk assessor shall make copies of lead inspection reports available to OLLA upon request.

Aug. 19, 1999, effective Feb. 29, 2000.

19 CSR 30-70.620 Work Practice Standards for a Lead Risk Assessment {#sec-19-csr-30-70.620 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.620}

PURPOSE: This rule delineates the standards to be followed by licensed risk assessors to conduct risk assessments in target housing and child-occupied facilities in accordance with standards set forth in sections 701.300 through 701.338, RSMo, and 19 CSR 30- 70.600 through 19 CSR 30-70.630.

(1) Licensure. All persons conducting risk assessments shall be licensed by the Office of Lead Licensing and Accreditation (OLLA) as set forth in sections 701.300 through 701.338, RSMo, and 19 CSR 30-70.110 through 19 CSR 30-70.200. Licensed risk assessors must present, upon request, proof of licensure in the form of the photo identification badges issued by OLLA.

(2) Conflict of Interest. OLLA recommends that licensed risk assessors conducting risk assessments for dwellings or child-occupied facilities should avoid potential conflicts of interest by not being contracted, subcontracted, or employed by a lead abatement contractor performing abatement activities on the same lead abatement project.

(3) Documented Methodologies for Conducting Risk Assessments.

(A) Licensed risk assessors shall use the following documented methodologies as referenced in this regulation for conducting risk assessments:

The U.S. Department of Housing and Urban Development (HUD) publication entitled, “Guidelines for the Evaluation and Housing” (HUD Guidelines); and 2. The U.S. Environmental Protection Agency (EPA) publications entitled, “EPA Lead-Based Paint Risk Assessment Model Curriculum” (EPA Model Training); “Guidance on Residential Lead-Based Paint, Lead- Contaminated Dust and Lead-Contaminated Soil”; and “Residential Sampling for Lead:

Protocols for Dust and Soil Sampling.”

(4) Collection and Laboratory Analysis of Samples. Any paint chip, dust, or soil samples collected pursuant to these work practice standards shall be— (A) Collected by persons licensed by OLLA as a lead inspector or risk assessor;

(B) Analyzed by a laboratory recognized by EPA pursuant to section 405(b) of Toxic Substances Control Act (TSCA) as being capable of performing analyses for lead compounds in paint chip, dust, and soil samples.

(5) Sample Forms and Questionnaires.

Sample forms and questionnaires may be found within the documented methodologies referenced in section (3) of this regulation.

These samples may be used as a guide by Missouri licensed risk assessors.

(6) Lead Risk Assessment.

(A) A visual inspection for risk assessment of the dwelling or child-occupied facility shall be conducted to locate the existence of deteriorated lead-bearing substances, assess the extent and causes of the deterioration, and other potential lead hazards.

(B) Background information regarding the (6) years and under shall be collected.

(C) Each surface with deteriorated leadbearing surface coatings, which is determined using documented methodologies referenced in section (3) of this regulation, and a distinct painting history, shall be tested for the presence of lead. Each other surface determined, using documented methodologies, to be a potential lead hazard and having a distinct painting history, shall also be tested for the presence of lead.

(D) In dwellings, dust samples (either composite or single-surface samples) from the window troughs, sills, and floors near friction or impact spots or in areas with deteriorated surface coatings shall be collected in all living areas where one (1) or more children age six (6) and under is most likely to come into contact with dust (i.e., children’s playroom, kitchen, bedrooms, and bathrooms).

(E) For multi-family dwellings and childoccupied facilities, the samples required in subsection (6)(D) shall be taken. In addition, window and floor samples shall be collected in the following locations:

Common areas adjacent to the sampled residential dwelling or child-occupied facility; and 2. Other common areas in the building where the risk assessor determines that one (1) or more children age six (6) and under is likely to come into contact with dust.

(F) For child-occupied facilities, window and floor dust samples (either composite or single-surface samples) shall be collected in each room, hallway, or stairwell utilized by one (1) or more children age six (6) and under and in other common areas in the child-occupied facility where the risk assessor determines that one (1) or more children age six (6) and under is likely to come into contact with dust.

(G) Soil samples shall be collected and analyzed for lead concentrations in exterior play areas where bare soil is present and at dripline/foundation areas where bare soil is present.

(H) Any paint, dust, or soil sampling or testing shall be conducted using the documented methodologies referenced in section (3) of this regulation.

(I) The risk assessor shall prepare a risk assessment report as described in section (11)

(7) Lead Hazard Screen Risk Assessments.

(A) Background information regarding the (6) years and under shall be collected.

(B) A visual inspection of the dwelling or child-occupied facility shall be conducted to— 1. Determine if any deteriorated leadbearing substance is present; and 2. Locate at least two (2) dust sampling locations.

(C) If deteriorated paint is present, each surface with deteriorated paint and a distinct painting history shall be tested for the presence of lead.

(D) In dwellings, two (2) composite dust samples shall be collected, one from the floors and the other from the windows in rooms, hallways, or stairwells where one (1) or more children age six (6) and under is most likely to come in contact with dust.

(E) In multi-family dwellings and childoccupied facilities, in addition to the floor and window samples required in (7)(D), the risk assessor shall also collect composite dust samples from common areas where one (1) or more children age six (6) and under is most likely to come into contact with dust.

(F) Dust, paint, and soil sampling shall be conducted using the documented methodologies referenced in section (3) of this regula- (G) The risk assessor shall prepare a risk assessment report as required in section (11)

(8) Elevated Blood Lead Level (EBL)

Investigation Risk Assessments.

(A) The risk assessor shall have the parents or guardians of the EBL child fill out a questionnaire (see HUD guidelines Table 16.2) prior to sampling. Environmental testing should be linked to the child’s history and may include a prior residence or other areas frequented by the child.

(B) Background information regarding the (6) years and under shall be collected.

(C) Each surface on the dwelling itself, furniture, or play structures frequented by the child that has deteriorated surface coatings shall be tested for the presence of lead.

(D) Each chewable, impact, and friction surface shall be tested for the presence of lead-bearing substances.

(E) Dust samples from areas frequented by the child, including play areas, porches, kitchens, bedrooms, and living and dining rooms shall be collected. Dust samples shall also be collected from automobiles, work shoes, and laundry rooms if occupational lead exposure is a possibility.

(F) Soil samples shall be collected from bare soil areas of play areas, areas near the foundation of the house, and areas from the yard. If the child spends significant time at a park or other public play area, samples should be collected from these areas, unless the area has already been sampled and documented.

(G) If necessary, water samples of the firstdrawn water from the tap most commonly used for drinking water, infant formula, or food preparation shall be collected.

(H) All paint, dust, or soil collection and testing shall be conducted using the documented methodologies referenced in section (3) of this regulation.

(I) The risk assessor shall prepare a risk assessment report as required in section (11)

(9) Composite Dust Sampling. Composite dust sampling may only be conducted in the situations specified in sections (6) and (7) of this regulation. If such sampling is conducted, the following conditions shall apply:

(A) Composite dust samples shall consist of at least two (2) samples;

(B) Every component that is being tested shall be included in the sampling; and (C) Composite dust samples shall not consist of subsamples from more than one (1) type of component.

(10) Sampling Results. Analytical sampling results which are received as a result of having conducted a risk assessment, an EBL investigation risk assessment, or lead hazard screen risk assessment shall be interpreted in accordance with the following for the matrices indicated:

(A) Paint. A paint chip sample which has a lead concentration that exceeds the values indicated below is considered to be a leadbearing substance.

(B) Dust. A dust sample which has a lead concentration that exceeds the values indicated below is considered to be a lead-bearing substance.

(C) Soil. A soil sample which has a lead concentration that exceeds the values indicated below is considered to be a lead-bearing substance.

(D) Water. A water sample which has a lead concentration that exceeds the value indicated below is considered to be a leadbearing substance.

(11) Reporting and Documentation. The licensed risk assessor shall prepare a risk assessment report which shall include the following information:

(A) Date of risk assessment;

(B) Address of each dwelling or childoccupied facility;

(D) Apartment number, if applicable;

(E) Name, address, and telephone number of each owner of each dwelling or child-occupied facility;

(F) Name, signature, and license number of the licensed risk assessor conducting the Laboratory—1.0 mg/cm or 0.5% by weight (or 5,000 parts per million (PPM))

XRF—1.0 milligrams per square centimeter (mg/cm Interior Floors—10 micrograms per square foot (μg/ft Porch Floors—40 micrograms per square foot (μg/ft Interior Window Sills—100 micrograms per square foot (μg/ft Bare soil areas when children have access to the site, 400 PPM Bare soil areas when children do not have access to the site, 2,000 PPM 15 parts per billion (PPB) or 15 μg/L Window Troughs—100 micrograms per square foot (μg/ft assessment;

(G) Name, address, and telephone number of the firm employing each licensed risk assessor, if applicable;

(H) Name, address, and telephone number of each recognized laboratory conducting analysis of collected samples;

(I) Results of the visual inspection;

(J) Testing method and sampling procedure for paint analysis employed;

(K) Specific locations of each painted component tested for the presence of lead;

(L) All data collected from on-site testing, including quality control data;

(M) X-ray fluorescence (XRF) results, including the following (if applicable):

XRF manufacturer and model;
Serial number of XRF device used during the inspection;
Calibration verification from the beginning and end of each residential unit;
A copy of the XRF device user’s certificate of training provided by the equipment manufacturer;
License or registration number of the XRF instrument;
A summary that categorizes the XRF results into one (1) of three (3) categories: positive, negative, or inconclusive; and 7. Recommendations for addressing inconclusive XRF results;

(N) All results of laboratory analysis on collected paint, soil, and dust samples and the name of each accredited laboratory that conducted the analysis;

(O) Any other sampling results;

(P) Any background information collected pursuant to subsections (6)(B), (7)(A), and (8)(B) of this regulation;

(Q) To the extent that they are used as part of the lead-based paint hazard determination, the results of any previous inspections or analyses for the presence of lead-based paint, or other assessments of lead-bearing substance hazards;

(R) A description of the location, type, and severity of identified lead-bearing substance hazard and any other potential lead hazards;

(S) A description of interim controls and/or abatement options for each identified lead hazard and a suggested prioritization for addressing each hazard. If the use of an encapsulant or enclosure is recommended, the report shall recommend a maintenance and monitoring schedule for the encapsulant or enclosure.

(12) Time Frame for Submission of Reports.

The risk assessment report shall be provided to the owner of the property within twenty (20) business days of risk assessment completion.

(13) Report Records Retention. All risk assessment reports shall be kept and maintained by the risk assessor who prepared the report for no fewer than three (3) years. The licensed risk assessor shall make copies of risk assessment reports available to OLLA upon request.

Original rule filed Aug. 19, 1999, effective Feb. 29, 2000. Amended: Filed Nov. 30, 2011, effective June 30, 2012. Emergency amendment filed March 27, 2020, effective April 10, 2020, expired Oct. 6, 2020. Amended: Filed March 27, 2020, effective Sept. 30, 2020.

RSMo 1993, amended 1998, 2005, 2018.

History

AUTHORITY: section 701.301, RSMo 2016, and section 701.312, RSMo Supp. 2019. Emergency rule filed Aug. 19, 1999, effective Aug. 30, 1999, expired Feb. 25, 2000.

19 CSR 30-70.630 Lead Abatement Work Practice Standards {#sec-19-csr-30-70.630 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.630}

PURPOSE: This rule delineates the criteria for conducting lead abatement projects in target housing and child-occupied facilities in accordance with standards set forth in sections 701.300 through 701.338, RSMo, and

19 CSR 30-70.600 through 19 CSR 30- 70.630. {#sec-19-csr-30-70.600 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.600}

(1) Licensure. All persons conducting lead abatement shall be licensed as set forth in sections 701.300 through 701.338, RSMo, and 19 CSR 30-70.110 through 19 CSR 30- 70.200. Licensed lead abatement professionals must present, upon request, proof of licensure in the form of the photo identification badge issued by the Office of Lead Licensing and Accreditation (OLLA).

(2) Conflict of Interest. OLLA recommends that any person or firm conducting a lead abatement project should avoid potential conflicts of interest by not providing clearance sampling services, inspection, or risk assessment services for that same abatement pro- (3) Documented Methodologies for Conducting Lead Abatement Projects.

(A) All licensed lead abatement workers and supervisors may use the following documented methodologies, but shall, at a minimum, follow the work practice standards presented in this regulation for conducting lead abatement projects:

The U.S. Department of Housing and Urban Development (HUD) publication entitled, “Guidelines for the Evaluation and Control of Lead-based Paint Hazards in Housing” (HUD Guidelines); and 2. The U.S. Environmental Protection Agency publications entitled “Guidance on Residential Lead-Based Paint, Lead-Contaminated Dust, and Lead-Contaminated Soil” and “Residential Sampling for Lead: Protocols for Dust and Soil Sampling.”

(B) Where a conflict exists between any of the aforementioned informational resources and any federal or state statute or regulation, or any city or county ordinance, the most stringent of these shall be adhered to by licensed lead abatement workers and supervisors.

(4) Notification. Any person or lead abatement contractor conducting a lead abatement project in target housing or in any child-occupied facility shall submit a notification to the department at least ten (10) business days prior to the onset of the lead abatement pro- (A) The notification shall be mailed with a check or money order made payable to the Missouri Department of Health for the nonrefundable fee of twenty-five dollars ($25) to tion: Fee Receipts, PO Box 570, Jefferson (B) The notification form provided by the 1. The street address, city, state, zip code, and county of each location where lead 2. The name, address, and telephone 3. An indication of the type of structure being abated (i.e., single-family or multifamily dwelling and/or child-occupied facility);

The date of the onset of the abatement 5. The estimated completion date of the abatement project;
The work days and hours of operation that the abatement project will be conducted;
The name, address, telephone number, and license number of the lead abatement 8. The name and license number of each lead abatement supervisor;
The name and license number of each 10. The type(s) of abatement strategy(ies) that will be utilized (i.e., encapsulation, replacement, and/or removal); and 11. The signature of each lead abatement provided in the project notification is com- (5) Emergency Notification. If the lead abatement contractor is unable to comply with the ten- (10-) day notification period in the event of an emergency situation as defined in 19 CSR 30-70.600, the lead abatement contractor shall— (A) Notify OLLA by telephone, facsimile, or electronic mail within twenty-four (24) hours of the onset of the lead abatement project; and (B) Submit the written notification and notification fee as prescribed in section (4) of this regulation no more than five (5) business days after the onset of the lead abatement pro- (6) Renotification. A renotification shall be submitted to OLLA at least twenty-four (24) hours prior to any changes from the original (A) A renotification form shall be mailed to the Missouri Department of Health, Office of Lead Licensing and Accreditation, PO Box 570, Jefferson City, MO 65102-0570.

(B) The renotification form provided by the 1. The street address, city, state, zip code, and county of each location where 2. The name, address, and telephone 3. An indication of the type of structure being abated (i.e., single-family or multifamily dwelling and/or child-occupied facility);

The name, address, telephone number, and license number of the lead abatement 5. A list of changes to the original notification which may include the following:

A. The date of the onset of the abatement project;

B. The estimated completion date of the abatement project;

C. The work days and hours of operation that the abatement project will be conducted;

D. The name, address, telephone number, and license number of the lead abatement contractor;

E. The name and license number of each lead abatement supervisor;

F. The name and license number of each lead abatement worker; and G. The type(s) of abatement strategy(ies) that will be utilized (i.e., encapsulation, replacement, and/or removal); and 6. The signature of the lead abatement provided in the project renotification is com- (7) Occupant Protection Plan.

(A) General Scope. Occupants of dwelling units undergoing lead abatement activities shall be protected from exposure to lead hazards while lead abatement work is being performed. If occupants remain in the dwelling during a lead abatement project, the lead abatement supervisor shall ensure that occupants have safe, uncontaminated access to nonregulated areas. To ensure occupant safety, a written occupant protection plan shall be developed for all abatement projects. The occupant protection plan shall describe the measures and management procedures that will be taken during the abatement to protect the building occupants from exposure to any lead hazards. The purpose of occupant protection planning is to— 1. Evaluate the necessity of removing occupants from the residence during lead 2. Prevent uncontrolled release of dust and debris beyond the abatement work area;

Prevent entry of unlicensed individuals into the regulated area; and 4. Ensure that clearance levels have been met prior to reoccupancy by building residents.

(B) The occupant protection plan shall meet the following requirements:

Be unique to each lead abatement 2. Be developed and implemented prior to commencement of the lead abatement project;
Describe the work practices and strategies that will be taken during the lead abatement project to protect the building occupants from exposure to any lead hazards;
Be written by the licensed lead abatement supervisor responsible for the project;
Include the results of any lead inspections or risk assessments completed prior to the commencement of the lead abatement 6. The occupant protection plan shall be provided to an adult occupant of each dwelling or dwelling unit being abated, and the property owner, or property owner’s designated representative, prior to the commencement of the lead abatement project;
The occupant protection plan shall be submitted to OLLA with the lead abatement (8) Post-Abatement Project Report. A postabatement project report shall be prepared by a licensed lead abatement supervisor or licensed project designer and shall be provided to the property owner within twenty (20) business days of the abatement project completion. The licensed supervisor or project designer shall make copies of the report available to OLLA upon request. The report shall include the following information:

(A) The project location and address;

(B) The actual start and completion dates of the abatement project;

(D) The name and license number of each lead abatement supervisor and/or project designer;

(E) The name and license number of each (F) The name and license number of each lead inspector or risk assessor responsible for clearance testing;

(G) The date and the results of clearance testing, and the name of each National Lead Laboratory Accreditation Program (NLLAP)-accredited laboratory that conducted the analyses; and (H) A detailed written description of the lead abatement project, including abatement methods used, locations of rooms and/or components where abatement occurred, reason for selecting particular abatement methods for each component, and any suggested monitoring of encapsulant or enclosure.

(9) Lead Abatement Project Requirements.

(A) General.

A licensed lead abatement supervisor is required for each abatement project and shall be on-site during all work site preparation and during the post-abatement cleanup of work areas. At all other times when abatement activities are being conducted, the licensed supervisor shall be on-site or available by telephone, pager, or answering machine and able to be present at the work site in no more than two (2) hours.
The lead abatement supervisor, as well as the lead abatement contractor employing that lead abatement supervisor, shall ensure that all abatement project activities are conducted according to the requirements of these work practice standards for conducting lead-bearing substance activities (19 CSR 30- 70.600 through 19 CSR 30- 70.630) and all federal, state, and local laws, regulations, or ordinances pertaining to leadbearing substance activities.
The lead abatement supervisor shall have on-site a list of all licensed lead abatement workers, which shall include their names and license numbers, working on the current project.
All abatement project activities shall be performed by persons currently licensed by OLLA as lead abatement workers and/or lead abatement supervisors. These people shall present, upon request, proof of licensure in the form of the photo identification badge issued by OLLA.
A written occupant protection plan shall be developed prior to all abatement projects according to section (7) of this regula- 6. Access to the regulated area shall be limited to OLLA-licensed lead professionals or department-authorized persons.
All waste generated from a lead-based paint abatement project shall be disposed of in accordance with the requirements of Environmental Protection Agency (EPA), Missouri Department of Natural Resources, and any other applicable federal, state, and local laws.

(B) Prohibited Lead Abatement Project Strategies. The following lead abatement project strategies are prohibited:

Open-flame burning or torching of lead-bearing substances;
Machine sanding or grinding or abrasive blasting or sandblasting of lead-bearing substances without containment and high efficiency particulate air (HEPA)-vacuum exhaust control;
Hydroblasting or pressurized water washing of lead-bearing substances without containment and water collection and filtering;
Heat guns operating above one thousand one hundred degrees Fahrenheit (1,100 °F);
Methylene chloride based chemical strippers;
Solvents that have flashpoints below one hundred forty degrees Fahrenheit (140 °F);
Dry scraping strategies unless in conjunction with heat guns or around electrical outlets or when treating defective paint spots totaling no more than two (2) square feet in any one room, hallway, or stairwell or totaling no more than twenty (20) square feet on exterior surfaces;
Enclosure strategies where the barrier is not warranted by the manufacturer to last at least twenty (20) years under normal conditions, or where the primary barrier is not a solid barrier; and 9. Encapsulation strategies where the encapsulant is not warranted by the manufacturer to last at least twenty (20) years under normal conditions, or where the encapsulant has been improperly applied.

(C) Permissible Lead Abatement Project Strategies. Strategies that are permissible for lead abatement projects are as follows: replacement, enclosure, encapsulation, or removal. Any abatement strategy not specified herein shall be submitted to the Missouri Department of Health, Office of Lead Licensing and Accreditation, PO Box 570, Jefferson City, MO 65102-0570 for evaluation and approval prior to use.

Replacement.

A. Non-window component replacement. When conducting non-window component replacement, these minimum requirements shall be met— (I) The site shall be prepared by ers. The regulated area shall be defined to sonnel from approaching closer than twenty feet (20') to the replacement operation;

(II) Signs shall be posted at all (2") inches tall with additional language pro- (III) Any heating and cooling sys- (IV) All items shall be cleaned within the regulated area by HEPA vacuuming and/or wet wiping with a cleaning solution. Items shall then be removed from the area, or covered with six- (6-) mil poly and sealed with duct tape;

(V) At least one layer of six- (6-) floor at the base of the component and extend at least ten feet (10') beyond the perimeter of the component to be replaced;

(VI) The component, and the area immediately adjacent to the component, shall be thoroughly wetted using a garden sprayer, airless mister, or other appropriate means to reduce airborne dust;

(VII) After removal of the component, the surface behind the removed component shall be thoroughly wetted to reduce airborne dust;

(VIII) The component shall be wrapped or bagged completely in six- (6-) mil poly and sealed with duct tape to prevent loss of debris or dust; and (IX) Prior to installing a new component, the area of replacement shall be cleaned by HEPA vacuuming. After replacement is complete, the regulated area shall be cleaned by vacuuming with a HEPA vacuum, wiping down all surfaces with a cleaning solution, rinsing all surfaces, and then HEPA vacuuming the area again.

B. Window replacement. When conducting window replacement, these minimum requirements shall be met— (I) The site shall be prepared by ers. The regulated area shall be defined to sonnel from approaching closer than twenty feet (20') to the replacement operation;

(II) Signs shall be posted at all (2") inches tall with additional language pro- (III) If replacing window from the inside— (a) Critical barrier containment shall be established covering the window on the exterior;

(b) A perimeter of five feet (5') shall be established extending from the base of the interior window to be replaced;

(c) Items within the perimeter shall be removed. Items too large to remove shall be covered with poly sheeting and sealed with duct tape and left in the perimeter; and (d) At least one layer of six- (6-) mil poly, or thicker, shall be placed on the ground and extend five feet (5') out from the base of the window;

(IV) If replacing window from the exterior— (a) Critical barrier containment shall be established covering the window on the interior;

(b) A perimeter of five feet (5') shall be established extending from the base of the exterior window to be replaced;

(c) Items within the perimeter shall be removed. Items too large to remove shall be covered with poly sheeting and sealed with duct tape; and (d) At least one layer of six- (6-) mil poly, or thicker, shall be placed on the ground and extend five feet (5') out from the base of the window ensuring that all ground plants and shrubs in the perimeter are covered;

(V) The component, and the area immediately adjacent to the component, shall be thoroughly wetted using a garden sprayer, airless mister, or other appropriate means to reduce airborne dust;

(VI) After removal of the component, the surface behind the removed component shall be thoroughly wetted to reduce airborne dust;

(VII) The component shall be wrapped or bagged completely in six- (6-) mil poly and sealed with duct tape to prevent loss of debris or dust; and (VIII) Prior to installing a new component, the area of replacement shall be cleaned by HEPA vacuuming. After replacement is complete, the regulated area shall be cleaned by vacuuming with a HEPA vacuum, wiping down all surfaces with a cleaning solution, rinsing all surfaces, and then HEPA vacuuming the area again.

Enclosure. When conducting a lead abatement project using the enclosure strategy, these minimum requirements shall be met— A. The site shall be prepared by first establishing a regulated area using fencing, barrier tape, or other appropriate barriers.

The regulated area shall be defined to prevent unlicensed and/or unauthorized personnel from approaching closer than twenty feet (20') to the enclosure operation;

B. Signs shall be posted at all C. Any heating and cooling systems within the regulated area shall be shut down and the vents sealed with six- (6-) mil poly to prevent lead dust accumulation within the system;

D. All items shall be cleaned within the regulated area by HEPA vacuuming and/or wet wiping with a cleaning solution.

Items shall then be removed from the area or covered with six- (6-) mil poly and sealed E. At least one layer of six- (6-) mil, or thicker, poly shall be placed on the floor at the base of the component and extend at least ten feet (10') beyond the perimeter of the component to be enclosed;

F. The surface to be enclosed shall be labeled (behind the enclosure), horizontally and vertically, approximately every two feet (2') with a warning, “Danger: Lead-Based Paint,” in permanent ink;

G. The enclosure material shall be applied directly onto the painted surface, or a frame shall be constructed of wood or metal, using nails, staples, or screws. Glue may be used in conjunction with the aforementioned fasteners, but not alone;

H. The material used for the enclosure barrier shall be solid and rigid enough to provide adequate protection. Materials including, but not limited to, wall papers, contact paper, films, folding walls, and drapes do not meet this requirement;

I. Enclosure systems and their adhesives shall be designed to last at least twenty (20) years;

J. The substrate or building structure to which the enclosure is fastened shall be sufficient structurally to support the enclosure barrier for at least twenty (20) years.

Deterioration such as mildew, water damage, dry rot, termite damage, or any significant structural damage may impair the enclosure from remaining dust tight;

K. Preformed steel, aluminum, vinyl, or other construction material may be used for window frames, exterior siding, trim casings, column enclosures, moldings, or other similar components if they can be sealed dust tight;

L. A material equivalent to one-fourth inch (1/4") rubber or vinyl may be used to enclose stairs;

M. The seams, edges, and fastener holes shall be sealed with caulk or other sealant, providing a dust-tight system;

N. All equipment used in the regulated area shall be thoroughly cleaned with a cleaning solution and/or vacuumed with a HEPA vacuum prior to removal from the regulated area;

O. Prior to clearance, the installed enclosure and surrounding regulated area shall be cleaned by vacuuming with a HEPA vacuum, wiping down all surfaces with a cleaning solution, rinsing all surfaces, and then HEPA vacuuming the area again.

Cleaning shall begin at the end of the work area farthest from the main entrance to the area and from the top to the bottom of the regulated area; and P. It is recommended that a visual evaluation of the enclosure’s integrity be conducted and documented by the building owner or the building owner’s representative at least every year or immediately after any fire, water, or structural damage. In childoccupied facilities, it is recommended that a licensed risk assessor inspect all enclosures every three (3) years, or whenever the owner’s visual evaluation indicates a potential for increased lead hazard exposure.

Encapsulation.

A. The encapsulation strategy of lead abatement shall not be used on the following:

(I) Friction surfaces—such as window sashes and parting beads, door jambs and hinges, floors, and door thresholds;

(II) Deteriorated components— including rotten wood, rusted metal, spalled or cracked plaster, or loose masonry;

(III) Impact surfaces, such as door stops, window wells, and headers;

(IV) Deteriorated surface coatings such that the adhesion or cohesion of the surface coating is uncertain or indeterminable;

(V) Incompatible coatings.

B. When conducting a lead abatement project using the encapsulation strategy, these minimum requirements shall be met— (I) Encapsulant selection shall be limited to those that are warranted by the manufacturer to last for at least twenty (20) years and comply with fire, health, and environmental regulations;

(II) Surfaces to be encapsulated shall have sound structural integrity with no loose, chipping, peeling, or chalking paint and no dust accumulation that cannot be cleaned, and shall be prepared and applied according to the manufacturer’s recommendations;

(III) The site shall be prepared by ers. The regulated area shall be designated as to prevent unlicensed and/or unauthorized personnel from approaching closer than twenty feet (20') to the encapsulation opera- (IV) Signs shall be posted at all (V) Any heating and cooling sys- (VI) All items shall be cleaned within the regulated area by HEPA vacuuming and/or wet wiping with a cleaning solution. Items shall then be removed from the area, or covered with six- (6-) mil poly sheeting and sealed with duct tape;

(VII) At least one layer of six- (6-) ground at the base of the component and extend at least ten feet (10') beyond the perimeter of the component to be encapsulated;

(VIII) A patch test shall be conducted prior to general application to determine the adhesive and cohesive properties of the encapsulant on the surface to be encapsulated (see the HUD Guidelines for the Evaluation and Control of Lead-Based Paint Hazards in Housing, Chapter 13);

(IX) After the manufacturer’s recommended curing time, the entire encapsulated surface shall be inspected by a licensed lead abatement supervisor or a licensed project designer. Any unacceptable areas shall be evaluated to determine if a complete failure of the system is indicated, or whether the system can be patched or repaired.

Unacceptable areas are evidenced by delamination, wrinkling, blistering, cracking, cratering, and bubbling of the encapsulant;

(X) After the encapsulation is complete, the regulated area shall be cleaned by vacuuming with a HEPA vacuum, wiping down all surfaces with a cleaning solution, rinsing all surfaces, and then HEPA vacuuming the area again. Cleaning shall begin at the end of the work area farthest from the main entrance to the area and from the top to the bottom of the regulated area;

(XI) All equipment used in the regulated area shall be thoroughly cleaned with a cleaning solution and/or vacuumed with a HEPA vacuum prior to removal from the regulated area; and (XII) It is recommended that a visual evaluation of the encapsulant’s integrity be conducted and documented by the building owner or the building owner’s representative at least every year or immediately after any fire, water, or structural damage. In child-occupied facilities, it is recommended that a licensed risk assessor inspect all enscapsulations every three (3) years, or whenever the owner’s visual evaluation indicates a potential for increased lead hazard exposure.

Removal.

A. Acceptable removal strategies (I) Manual wet strategies—Manual wet scraping or manual wet sanding is acceptable for removal of lead surface coatings;

(II) Mechanical removal strategies—Power tools that are HEPA-shrouded or locally exhausted are acceptable removal strategies for lead surface coatings. HEPAshrouded or exhausted mechanical abrasion devices such as sanders, saws, drills, rotopeens, vacuum blasters, and needle guns are acceptable;

(III) Chemical removal strategies— Chemical strippers shall be used in compliance with manufacturer’s recommendations;

(IV) Soil abatement—When soil abatement is conducted, the lead-bearing soil shall be removed, tilled, or permanently covered in place as indicated in the following subparts:

(a) Removed soil shall be replaced with fill material containing no more than one hundred parts per million (100 ppm) of total lead. If the fill material exceeds one hundred (100) ppm total lead, the fill material will be acceptable only if the lead solubility is less than five (5) ppm. Soil that is removed shall not be reused as topsoil in another residential yard or child-occupied facility;

(b) If tilling is selected, soil in a child-accessible area shall be tilled to a depth which results in no more than four hundred (400) ppm total lead of the homogenized soil, or other concentrations approved by the department. Soil in an area not accessible to children shall be tilled to a depth which results in no more than two thousand (2,000) ppm total lead of the homogenized soil or other concentrations approved by the department;

(c) Permanent soil coverings include solid materials such as pavement or concrete, which separate the soil from human contact. Grass, mulch, and other landscaping materials are not considered permanent soil covering; and (d) Soil abatement shall be conducted to prevent lead contaminated soil from being blown from the site and/or from being carried away by water run-off or through percolation to groundwater.

B. Interior removal. When conducting a lead abatement project using the removal strategy on interior surfaces, these minimum requirements shall be met— (I) The site shall be prepared by ers. The regulated area shall be defined to sonnel approaching closer than twenty feet (20') to the removal operation;

(II) Signs shall be posted at all (III) Any heating and cooling sys- (IV) All items within the regulated area shall be cleaned by HEPA vacuuming and/or wet wiping with a cleaning solution.

Items shall then be removed from the area, or covered with six- (6-) mil poly and sealed (V) All windows below and within the regulated area shall be closed;

(VI) Critical barrier containment shall be constructed;

(VII) At least two (2) layers of six- (6-) mil, or thicker, poly shall be placed on the floor at the base of the component and extend at least ten feet (10') beyond the perimeter of the component being abated (removal by the chemical strategy may require chemical resistant floor cover; follow manufacturer’s recommendations);

(VIII) All equipment used in the regulated area shall be thoroughly cleaned with a cleaning solution and/or vacuumed with a HEPA vacuum prior to removal from the regulated area;

(IX) At the end of each work shift, the top layer of six- (6-) mil poly shall be removed and used to wrap and contain the debris generated by the shift. The six- (6-) mil poly shall then be sealed with duct tape and kept in a secured area until final disposal. The second layer of six- (6-) mil poly shall be HEPA vacuumed, left in place and used during the next shift. A single layer of six- (6-) mil poly shall be placed on this remaining poly before abatement resumes; and (X) After the removal is complete, the regulated area shall be cleaned by vacuuming with a HEPA vacuum, wiping down all surfaces with a cleaning solution, rinsing all surfaces, and then HEPA vacuuming the area again. Cleaning shall begin at the end of the work area farthest from the entrance to the area and from the top to the bottom of the regulated area.

C. Exterior removal. When conducting a lead abatement project using the removal strategy on exterior surfaces, these minimum requirements shall be met— (I) The site shall be prepared by ers. The regulated area shall be designated as to prevent unlicensed and/or unauthorized personnel from approaching closer than twenty feet (20') to the removal operation;

(II) Signs shall be posted at all (III) All movable items shall be moved twenty feet (20') from working surfaces. Items that cannot be readily moved twenty feet (20') from working surfaces shall be covered with six- (6-) mil poly and sealed (IV) At least one layer of six- (6-) ground and extend at least ten feet (10') from the abated surface plus another five feet (5') out for each additional ten feet (10') in sur face height over twenty feet (20'). In addition, the poly shall— (a) Be securely attached to the side of the building with cover provided to all ground plants and shrubs in the regulated area;

(b) Be protected from tearing or perforating;

(c) Contain any water, including rainfall, which may accumulate during the abatement; and (d) Be weighted down to prevent disruption by wind gusts;

(V) All windows in the regulated area and all windows below and within twenty feet (20') of working surfaces shall be closed. It is recommended that the windows of adjacent structures within twenty feet (20') also be closed;

(VI) Work shall cease if constant wind speeds are greater than ten (10) miles per hour;

(VII) Work shall cease and cleanup shall occur if rain begins;

(VIII) All equipment used in the regulated area shall be thoroughly cleaned with a cleaning solution and/or vacuumed with a HEPA vacuum prior to removal from the regulated area; and (IX) The regulated area shall be HEPA vacuumed and cleaned of lead-based paint chips, poly and other debris generated by the abatement project work at the end of each workday. Debris shall be kept in a secured area until final disposal.

(10) Post-Abatement Clearance Procedures.

The following post-abatement clearance procedures shall be performed only by a licensed lead inspector or risk assessor:

(A) Following abatement, a visual inspection shall be performed to determine if deteriorated painted surfaces and/or visible amounts of dust, debris, or residue are still present. If deteriorated painted surfaces or visible amounts of dust, debris, or residues are present, these conditions must be eliminated prior to the continuation of the clearance procedures;

(B) Following the visual inspection and any post-abatement cleanup required by subsection (10)(A) of this regulation, clearance sampling for lead-contaminated dust and/or soil shall be conducted;

(C) Dust and soil sampling shall be conducted using the documented methodologies referenced in section (3) of this regulation;

(D) Dust samples for clearance purposes shall be taken a minimum of one (1) hour after completion of final post-abatement cleanup activities;

(E) The licensed lead inspector or risk assessor shall compare the residual lead level from each dust and/or soil sample with clearance levels specified in section (11) of this

regulation for lead in dust on floors, windows, and soil;

(F) If the lead levels in a clearance dust sample exceed the clearance levels, all the components represented by the failed dust sample shall be recleaned and tested until clearance levels are met;

(G) If the lead levels in a soil clearance sample exceed the clearance levels, the soil shall be abated until a composite soil sample meets clearance levels; and (H) In a multi-family dwelling with similarly constructed and maintained residential dwellings, random sampling for the purposes of clearance may be conducted provided— 1. The licensed individuals who abate or clean the residential dwellings do not know which residential dwelling will be selected for the random sample;

A sufficient number of residential dwellings are selected for dust sampling to provide a ninety-five percent (95%) level of confidence that no more than five 5 percent (5%) or fifty (50) of the residential dwellings (whichever is smaller) in the randomly sampled population exceed the appropriate clearance levels; and 3. The randomly selected residential dwellings shall be sampled and evaluated for clearance according to the procedures found in subsections (10)(A) through (10)(G) of this

regulation.

(11) Clearance Levels. For each respective media, the following clearance levels shall be met for a lead-abatement project to be considered complete (if background lead levels are lower than the following clearance levels, clearance is not complete until background values are met):

(A) Dust samples— (B) Soil samples—

RSMo 1993, amended 1998, 2005, 2018.

History

AUTHORITY: section 701.301, RSMo 2016, and section 701.312, RSMo Supp. 2019. Emergency rule filed Aug. 19, 1999, effective Aug. 30, 1999, expired Feb. 25, 2000.

19 CSR 30-70.640 Project Notification for Industrial Lead Abatement Projects {#sec-19-csr-30-70.640 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.640}

PURPOSE: This rule delineates the procedure for filing an industrial lead abatement project notification with the Missouri Department of Health, Office of Lead Licensing and Accreditation.

(1) Notification. Any person or entity conducting an industrial lead abatement project shall submit a notification to the department at least ten (10) business days prior to the onset of the lead abatement project.

(A) The notification shall be mailed with a check or money order made payable to the Missouri Department of Health for the nonrefundable fee of twenty-five dollars ($25) to (B) The notification form provided by the 1. The street address, city, state, zip code and county of each location where 2. The name, address and telephone 3. An indication of the type of structure being abated (i.e., bridge, superstructure or other structure that is not a dwelling or childoccupied facility);

The date of the onset of the abatement 5. The estimated completion date of the abatement project;
The work days and hours of operation that the abatement project will be conducted;
The name, address, telephone number and license number of the lead abatement 0HGLD&OHDUDQFH/HYHO ,QWHULRU)ORRUV 3RUFK)ORRUV ,QWHULRUZLQGRZVLOOV :LQGRZWURXJKV Media Clearance Level Bare soil (dwelling perimeter and yard) 2,000 ppm Bare soil (small high contact areas, such as sandboxes and gardens) 400 ppm 8. The name and license number of each lead abatement supervisor;
The name and license number of each 10. The type(s) of abatement strategy(ies) that will be utilized (i.e., encapsulation, replacement, and/or removal); and 11. The signature of each lead abatement supervisor which certifies that all information provided in the project notification is complete and true to the best of the supervisor’s knowledge.

(2) Emergency Notification. If the lead abatement contractor is unable to comply with the ten (10)-day notification period in the event of an emergency situation as defined in 19 CSR 30-70.600, the lead abatement contractor shall— (A) Notify the Office of Lead Licensing and Accreditation (OLLA) by telephone, facsimile, or electronic mail within twenty-four (24) hours of the onset of the lead abatement project; and (B) Submit the written notification and notification fee as prescribed in section (1) of this regulation no more than five (5) business days after the onset of the lead abatement pro- (3) Renotification. A renotification shall be submitted to OLLA at least twenty-four (24) hours prior to any changes from the original (A) A renotification form shall be mailed to the Missouri Department of Health, Office of Lead Licensing and Accreditation, P.O.

Box 570, Jefferson City, MO 65102-0570.

(B) The renotification form provided by the 1. The street address, city, state, zip code and county of each location where 2. The name, address and telephone 3. An indication of the type of structure being abated (i.e., bridge, superstructure or other structure that is not a dwelling or childoccupied facility);

The license number of the lead abatement contractor;
A list of changes to the original notification which may include the following:

A. The date of the onset of the abatement project;

B. The estimated completion date of the abatement project;

C. The work days and hours of operation that the abatement project will be conducted;

D. The name, address, telephone number and license number of the lead abatement contractor;

E. The name and license number of each lead abatement supervisor;

History

AUTHORITY: sections 701.301, 701.309 and 701.312, RSMo Supp. 1998. Emergency rule Aug. 19, 1999, effective Feb. 29, 2000. Original authority: 701.301, RSMo 1998; 701.309, RSMo 1998; and 701.312, RSMo 1993, amended 1998.

19 CSR 30-70.650 Administrative Penalties {#sec-19-csr-30-70.650 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-70.650}

PURPOSE: This rule establishes the procedures for issuance and methods for calculation of administrative penalties by the department.

This note applies only to the reference material. The entire text of the rule is printed here.

(1) Applicability. This rule applies to any licensed lead professional who violates the provisions of 19 CSR 30-70.630, Lead Abatement Work Practice Standards.

(2) Definitions.

(A) Adjustments: Those factors related to a violator or violation, which are not reflected in the gravity-based assessment but which distinguish legitimate differences between separate violations of the same provision.

(B) Compliance: A regulated entity or individual’s meeting or conformity with applicable regulations, notifications, licensure requirements, and laws.

(D) Enforcement: A formal action taken against the regulated entity or individual for violating applicable regulations, notifications, licensure requirements, and laws. Such actions include, but are not limited to, Notice of Violation (NOV), warning letters, administrative penalties, cease and desist order, and/or licensure restriction, revocation, suspension, and/or denial.

(E) Gravity-based assessment: The degree of seriousness of a violation taking into consideration the risk to public health and/or the environment posed by the violation and considering the extent of deviation from sections 701.300–701.338, RSMo.

(F) Identified offense: A violation meeting the requirements specified in subsection (3)(B) of this rule in which administrative penalties may be assessed by the department.

(G) Lead abatement project: The replacement, encapsulation, enclosure, or removal of a lead-bearing substance on a particular component within a particular location, which will remove or remediate the lead hazard(s) for at least twenty (20) years.

(H) Multiple violation penalty: The sum of individual administrative penalties assessed when two (2) or more violations are included in the same complaint or enforcement action.

(I) Multi-day penalty: The sum of each day’s administrative penalties assessed when the same violation has occurred on or continued for two (2) or more consecutive or nonconsecutive days.

(J) Multi-day violation: A violation which has occurred on or continued for two (2) or more consecutive or nonconsecutive days.

(K) Noncompliance: Deviation from or failure to meet applicable regulations, notifications, licensure requirements, and laws.

Noncompliance can range from a single incident to chronic conduct. Noncompliance may result in a negative impact to public health and/or the environment.

(L) Notice of violation (NOV): The formal written documentation that reflects the deviation from or failure of the lead abatement contractor, supervisor, or worker to meet applicable regulations, notifications, licensure requirements, and laws. A notice of violation shall include the corrective action(s) to be performed to achieve compliance.

(M) Notification: A required package of information submitted to the department by the lead supervisor at least ten (10) days prior to the onset of a lead abatement project. The notification shall include a completed Lead Abatement Project Notification form, as required by the department; full payment of the notification fee prior to starting the lead abatement project; and disclosure of any potential lead hazards to the owners and tenants of a dwelling by the Missouri licensed risk assessor who conducted the initial risk assessment (occupant protection plan). The Lead Abatement Project Notification form, MO 580-2365 (1-05), is incorporated by reference in this rule and is available on the web at www.dhss.mo.gov or by contacting the (N) Violation: The deviation from or failure of the licensed lead professional to meet applicable regulations, notifications, licen sure requirements, and laws which require corrective action(s).

(3) General Provisions.

(A) Pursuant to section 701.317, RSMo, and in addition to any other remedy provided by law, upon determination by the department that any provision of sections 701.300– 701.338, RSMo, or a standard, limitation, order, rule, or regulation promulgated pursuant thereto, or a term or condition of any license has been violated, the department may issue an order assessing an administrative penalty upon the violator.

(B) An administrative penalty shall not be imposed until the department has issued a notice of violation pursuant to section 701.311, RSMo, to the violator regarding the same type of violation within the calendar year except a failure to provide written notification prior to the onset of a lead abatement project according to section 701.309.3, RSMo. An order assessing an administrative penalty shall state that an administrative penalty is being assessed under section 701.317, RSMo, the manner of collection and rights of appeal.

(C) An order assessing an administrative penalty shall describe the nature of the violation(s), the amount of the administrative penalty being assessed, and the basis of the penalty calculation.

(D) An order assessing an administrative penalty shall be served upon the licensee through the United States Postal Service certified mail, return receipt requested. An order assessing an administrative penalty shall be considered served if the licensee verifies receipt. A refusal to accept an order assessing an administrative penalty, or a rejection of certified mail, constitutes service of the order.

(E) The department may, at any time, withdraw without prejudice any administrative penalty order.

(4) Calculation of Penalties. The calculation of administrative penalties may include any of the following four (4) factors: gravity-based assessment, multiple violation penalties, multi-day penalties, and adjustments.

(A) Gravity-Based Assessment. The gravity-based assessment is determined by evaluating the potential for harm posed by the violation and the extent to which the violation deviates from the requirements of the law, associated rules, or licenses.

Potential for or actual harm. The potential for harm posed by a violation is based on the risk to public health, safety, or the environment and the degree that the violation undermines the purposes of or procedures for implementing the law, associated rules, or licenses.

A. The risk of exposure is dependent on both the likelihood that humans or the environment may be exposed to lead hazards and the degree of potential exposure.

Penalties will reflect the probability that the violation either did result in or could have resulted in a release of lead contamination in the environment and the harm, which either did or would have happened if the release had in fact occurred.

(I) Acute— (a) The violation poses or may pose an immediate or imminent risk to public health and/or the environment; or (b) Is a violation specified in the Enforcement Manual as Acute Noncompliance. The manual is incorporated by reference in this rule as published May 1, 2009, by the Department of Health and Senior Services and is available on the web at (II) Significant— (a) The violation poses or may pose a considerable risk to public health and/or the environment;

(b) The violation has or may have a substantial adverse effect on the purposes of or procedures for implementing sections 701.300–701.338, RSMo; or (c) Is a violation specified in the Enforcement Manual as Significant Noncompliance. The manual is incorporated by reference in this rule as published May 1, 2009, by the Department of Health and Senior Services and is available on the web at B. Violations which may or may not pose a potential threat to public health or the environment, but which have an adverse effect upon the purposes of or procedures for implementing the law, associated rules, or licenses, may warrant the assessment of penalties.

(I) Minor— (a) The violation poses a low or minimal risk to public health and/or the environment;

(b) The violation has or may have an adverse effect on the purposes of or procedures for implementing sections 701.300–701.338, RSMo; or (c) Is a violation specified in the Enforcement Manual as Minor Noncompliance. The manual is incorporated by reference in this rule as published May 1, 2009, by the Department of Health and Senior Services and is available on the web at 2. Extent of deviation. The extent of deviation may range from slight to total disregard of the requirements of the law, associated rules, or licenses. The extent of deviation shall be evaluated according to the degree of severity.

Gravity-based penalty assessment.

Administrative penalties will be assessed based on significance, acuity, and extent of deviation. The penalty range selected may be adapted to the circumstances of a particular violation.

(B) Penalties for Multiple Violations.

Penalties for multiple violations may be determined when a violation is independent of or substantially different from any other violation. The department may order a separate administrative penalty for that violation as set forth in this rule.

Penalties for multi-day violations may be determined when the department has concluded that a violation(s) has continued or occurred for more than one (1) day. Each day shall be a separate offense.

(D) Adjustments. The department may adjust the penalty after consideration of the 1. Good faith efforts to comply. The department may decrease a penalty amount if the violator has adequately documented good faith efforts taken prior to a compliance inspection and the discovery of the violation;

The amount of control the violator had over the events constituting the violation;
The foreseeability of the events constituting the violation;
Whether the violator took reasonable precautions against the events constituting the violation; and 5. History of noncompliance.

(E) Payment. Administrative penalties shall be made payable to the Missouri Department of Health and Senior Services in the form of a cashier’s check or money order and mailed to the Missouri Department of Health and Senior Services, Attention: Fee Receipts Unit, PO Box 570, Jefferson City, MO 65102. The department may negotiate a delayed payment schedule, installment plan, or penalty reduction with stipulated penalties.

(5) Penalties Assessed. The department shall only impose an administrative penalty, after a notice of violation has been issued pursuant to section 701.311, RSMo, against the violator who has conducted the same type of violation within the calendar year, except a failure to provide written notification prior to the onset of a lead abatement project according to 701.309.3, RSMo. Failure to notify the department prior to the onset of a lead abatement project shall result in a fine of two hundred fifty dollars ($250) imposed against the lead abatement contractor for the first identified offense, five hundred dollars ($500) for the second identified offense, and, thereafter, fines shall be doubled up to two thousand dollars ($2,000) for each additional identified offense within the calendar year.

(A) Acute. Acute violations shall result in a notice of violation and no administrative penalty for the first identified offense, a penalty of two hundred fifty dollars ($250) imposed against the regulated entity or individual for the second identified offense, a penalty of five hundred dollars ($500) for the third identified offense, and, thereafter, a penalty of one thousand dollars ($1,000) for each additional identified offense within the calendar year.

(B) Significant. Significant violations shall result in a notice of violation with no administrative penalty for the first identified offense, a notice of violation and administrative penalties ranging from one hundred to two hundred fifty dollars ($100–$250) imposed against the regulated entity or individual for the second identified offense, a penalty of two hundred to five hundred dollars ($200–$500) for the third identified offense, and, thereafter, a notice of violation and an administrative penalty of five hundred dollars ($500) for each additional identified offense within the calendar year.

(C) Minor. Minor violations shall result in a written warning and no administrative penalty for the first identified offense, a notice of violation and no administrative penalty for the second identified offense, a penalty of twenty-five dollars ($25) imposed against the regulated entity or individual for the third identified offense, a notice of violation and an administrative penalty of fifty dollars ($50) for the fourth identified offense, and, thereafter, a notice of violation and an administrative penalty of one hundred dollars ($100) for each additional identified offense within the calendar year.

(6) Suspended or Revoked License Penalties.

Any lead inspector, risk assessor, lead abatement supervisor, lead abatement worker, project designer, or lead abatement contractor who engages in a lead abatement project while such person’s license, issued under section 701.312, RSMo, is under suspension or revocation is guilty of a class D felony.

(7) Other Penalties. Except as otherwise provided, violation of the provisions of sections 701.309, 701.311, and 701.316, RSMo, can be referred by the department for prosecu- (8) Proceeds From Administrative Penalties.

The penalties collected pursuant to section 701.317(7), RSMo, shall be deposited in the Missouri Lead Abatement Loan Fund as established in section 701.337, RSMo. Such penalties shall not be considered charitable contributions for tax purposes.

(9) This rule may be used as guidance in assessing civil and criminal penalties.

History

AUTHORITY: sections 701.311, 701.317, and 701.337, RSMo Supp. 2008. Original rule filed July 14, 2009, effective Feb. 28, 2010. Original authority: 701.311, RSMo 1998, amended 2005; 701.317, RSMo 2005; and 701.337, RSMo 2000, amended 2005.

Chapter 80 Family Care Safety Registry

19 CSR 30-80.010 Definitions {#sec-19-csr-30-80.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-80.010}

PURPOSE: This rule provides definitions to be used in the interpretation and enforcement of 19 CSR 30-80.010 through 19 CSR 30- 80.040.

(1) “Access line,” toll-free telephone service established and maintained by the department in accordance with section 210.918, RSMo for the purpose of promoting family and community safety by allowing access to certain information recorded in the Family Care Safety Registry, as provided in section 210.921, RSMo.

(2) “Agency of record,” the state agency that has program control over maintaining or updating one or more of the sources of background information listed in section 210.909, subsection 1, subdivisions (1) through (5), RSMo.

(3) “Department,” the Missouri Department of Health.

(4) “Family Care Safety Registry workers,” a current listing of child-care and elder-care workers who have completed application for registration with the department pursuant to

section 210.906, subsections 1 through 2, RSMo, or persons who have voluntarily completed application for registration pursuant to

section 210.906, subsection 4, RSMo, including limited available information on workers’ background pursuant to section 210.909, subsection 1, subdivisions (1) through (5), RSMo.

(5) “Family Care Safety Registry providers,” a current listing of child-care and elder-care providers, pursuant to section 210.909, subsections (2) and (5), RSMo, who have been refused licensure or have experienced licensure suspension or revocation pursuant to sections 210.481 through 210.536, RSMo, sections 210.201 to 210.259, RSMo, or

Chapter 198, RSMo.

(6) “Patrol,” the Missouri State Highway Patrol.

(7) “Registrant,” any person hired on or after January 1, 2001, as a child-care or elder-care worker, or any person not required to register pursuant to the provisions of sections 210.900 to 210.936, RSMo, who voluntarily applies to the department for registration and who meets the requirements of sections 210.906 and 210.909, RSMo, including submitting to the background checks of subsection 1 of section 210.909, RSMo.

(8) “Registry,” the Family Care Safety Registry.

History

AUTHORITY: sections 210.915 and 210.924, RSMo 2000. Emergency rule filed Sept. 19, 2000, effective Jan. 1, 2001, expired June 29, 2001. Original rule filed March 30, 2001, effective Sept. 30, 2001. Original authority: 210.915, RSMo 1999; 210.924, RSMo 1999.

19 CSR 30-80.020 General {#sec-19-csr-30-80.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-80.020}

PURPOSE: This rule provides sources to contact to obtain registration forms and outlines specific responsibilities that apply to all registrants in the Family Care Safety Registry.

(1) Registration forms used for the purpose of registering in the Family Care Safety Registry may be obtained by contacting one of the following sources:

(A) The Family Care Safety Registry tollfree access line;

(B) The local Department of Health office;

(D) The local Division of Family Services office; or by (E) Accessing the Department of Health website (www.health.state.mo.us).

(2) Completed applications for registration in the Family Care Safety Registry shall be mailed to the Missouri Department of Health, Fee Receipts Unit, PO Box 570, Jefferson City, MO 65102.

(3) Change of Name. Registrants in the Family Care Safety Registry shall notify the Department of Health in writing of a change of name no later than thirty (30) days following the change. Until a change of name is received, actions required pursuant to sections 210.900 to 210.936, RSMo, may continue under the name indicated on the most recent application form.

(4) Change of Address. Registrants in the Family Care Safety Registry shall notify the Department of Health in writing of a change of mailing address no later than thirty (30) days following the change. Until a change of address is received, all correspondence will be mailed to the individual’s mailing address indicated on the most recent application form.

History

AUTHORITY: sections 210.906 and 210.924, RSMo 2000. Emergency rule filed Sept. 19, 2000, effective Jan. 1, 2001, expired June 29, 2001. Original rule filed March 30, 2001, effective Sept. 30, 2001. Original authority: 210.906, RSMo 1999; 210.924, RSMo 1999.

19 CSR 30-80.030 Child-Care and Elder- Care Worker Registration {#sec-19-csr-30-80.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-80.030}

PURPOSE: This rule establishes procedures for submitting completed applications for registration in the Family Care Safety Registry.

(1) Application for Registration.

(A) The application for registration in the Family Care Safety Registry shall include the following:

A completed Child-Care and Elder- Care Worker Registration Form, provided by the department, shall be typewritten or printed in ink. The application shall include the following:

A. Applicant’s valid Social Security number;

B. Information on applicant’s right to appeal the information contained in the registry pursuant to section 210.912, RSMo;

C. Signed consent of the applicant for the background checks pursuant to section 210.906, RSMo;

D. Signed consent of the applicant for the release of information contained in the background check for employment purposes only;

E. Worker category;

F. Applicant’s last name, first name, middle name;

G. Prior names used by applicant;

H. Applicant’s home address;

I. Applicant’s current mailing address, if different than home address;

J. Applicant’s county of residence;

K. Applicant’s date of birth;

L. Applicant’s gender;

M. Name, address and county of applicant’s current employer (if applicable); and N. Signature of the applicant and date of signature, in ink, which certifies that all information in the registration form is complete and true to the best of the applicant’s knowledge;

A photocopy of applicant’s Social Security card; and ROBINCARNAHAN(6/30/07)
A check, money order, or electronic payment for a nonrefundable fee made payable to the Missouri Department of Health and Senior Services in an amount equal to that charged by the Missouri Department of Public Safety pursuant to Chapter 43, Revised Statutes of Missouri, and Title 11 Code of State Regulations, Chapter 30 for disseminating criminal history information to noncriminal justice agencies which is currently set forth in section 43.530, RSMo, and 11 CSR 30-4.070.

(B) If the department receives an incomplete application, it will request the required information from the applicant before the application is processed. If the department does not receive the required information within sixty (60) days from the date of the certified mailing of the request, the application shall be void and another application shall be filed. If a subsequent application is filed, it shall be filed pursuant to 19 CSR 30- 80.030(1)(A)–(B).

(C) Applications for registration may be submitted to the Family Care Safety Registry by the individual applicant or their employer or prospective employer. An employer or prospective employer may submit completed registration forms using a batch processing form, provided by the department, that will also serve as a request for background screening information.

(D) A batch processing form, provided by the department, shall include the employer’s or prospective employer’s name and address, a listing of applicants for whom applications for registration are attached, and the employer’s or prospective employer’s signature that certifies the requested information is for employment purposes only and will not be used for any other purpose. Once the application process has been completed and background checks conducted the Family Care Safety Registry will notify the worker and the employer or prospective employer, whose name and signature appears on the batch processing form, of the results of the determination recorded on the registry.

rule filed Sept. 19, 2000, effective Jan. 1, 2001, expired June 29, 2001. Original rule filed March 30, 2001, effective Sept. 30, 2001. Amended: Filed Jan. 22, 2007, effective July 30, 2007. *Original authority: 210.906, RSMo 1999, amended 2001, 2002; and 210.924, RSMo 1999.

History

AUTHORITY: sections 210.906, RSMo Supp. 2006, and 210.924, RSMo 2000. Emergency

19 CSR 30-80.040 Updates and Appeals of Registry Information {#sec-19-csr-30-80.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-80.040}

PURPOSE: This rule establishes guidelines pertaining to the updating of information contained in the registry and sets forth the process for the appeal required in section 210.912, RSMo.

(1) Process for Appeal Required in Section 210.912, RSMo.

(A) After receipt of the department’s written determination of the results of a background check, conducted and entered in the Family Care Safety Registry pursuant to section 210.909, subsections 1 and 2, RSMo, registrants may appeal to the department under section 210.912, RSMo. Such appeals shall be limited only to the accuracy in the transfer of information from the agency of record to the registry and shall not include a right to appeal the accuracy of the substance of the information transferred.

Any such appeal shall be filed in writing by the registrant to the Director, Missouri Department of Health, to the attention of the Family Care Safety Registry, within thirty (30) days of the registrant’s receipt of the results of the Family Care Safety Registry’s background check.
The written appeal shall include the registrant’s full name, Social Security number, date of birth, mailing address and zip code, and telephone number, including the area code, where s/he can be reached Monday through Friday, during the hours from 8:00 a.m. through 5:00 p.m. The registrant’s written appeal shall also include a specific statement describing the information the registrant believes to have been incorrectly transferred from the agency of record to the registry.

(B) Within thirty (30) days of the filing of the appeal, an informal administrative review of the appeal will be set. The review shall be conducted by the director or by a duly authorized representative of the director.

(C) The department shall maintain a copy of its decision as long as the registrant is listed in the Family Care Safety Registry, or until such information is subsequently amended pursuant to sections 210.906 and 210.909, RSMo.

(2) Updates of the Registry.

(A) Records in the Family Care Safety Registry shall be updated when a request pursuant to section 210.921, RSMo, is made for release of registry information and, as the department deems necessary.

(B) Pursuant to section 210.912, RSMo, registrants shall be advised of updated information contained in the registry. Registrants shall also be advised of the right to appeal the accuracy in the transfer of updated information from the agency of record to the registry.

4CODE OF STATE REGULATIONS

(6/30/07) ROBINCARNAHAN

SENIOR SERVICES

History

AUTHORITY: sections 210.912, 210.915 and 210.924, RSMo 2000. Emergency rule filed Sept. 19, 2000, effective Jan. 1, 2001, expired June 29, 2001. Original rule filed March 30, 2001, effective Sept. 30, 2001. Original authority 210.912, RSMo 1999; 210.915, RSMo 1999; 210.924, RSMo 1999.

Chapter 81a Certification

19 CSR 30-81.010 General Certification Requirements {#sec-19-csr-30-81.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-81.010}

PURPOSE: This rule sets forth application procedures and general certification requirements for nursing facilities certified under the Title XIX (Medicaid) program and skilled nursing facilities under Title XVIII (Medicare), and procedures to be followed by nursing facilities when requesting a nurse staffing waiver.

This note applies only to the reference material. The entire text of the rule is printed here.

(1) Definitions.

(A) Certification shall mean the determination by the Missouri Department of Health and Senior Services, or the Centers for Medicare and Medicaid Services, that a licensed skilled nursing or intermediate care facility (SNF/ICF) licensed under Chapter 198, RSMo, or an ICF for person with mental retardation (ICF/MR), is in substantial compliance with all federal requirements and is approved to participate in the Medicaid or Medicare programs.

(B) CMS shall mean the Centers for Medicare and Medicaid Services of the U.S.

Department of Health and Human Services.

(C) Cost reporting year shall mean the facility’s twelve (12)-month fiscal reporting period covering the same twelve (12)-month period that the facility uses for its federal income tax reporting.

(D) Distinct part shall mean a portion of an institution or institutional complex that is certified to provide SNF or NF services. A distinct part must be physically distinguishable from the larger institution and must consist of all beds within the designated area. The distinct part may be a separate building, floor, wing, ward, hallway or several rooms at one end of a hall or one side of a corridor.

(E) Department shall mean the Missouri Department of Health and Senior Services.

(F) ICF/MR shall mean intermediate care facility for persons with mental retardation.

(G) Medicaid shall mean Title XIX of the federal Social Security Act.

(H) Medicare shall mean Title XVIII of the federal Social Security Act.

(I) Nursing facility (NF) shall mean an SNF or ICF licensed under Chapter 198, RSMo which has signed an agreement with the Department of Social Services to participate in the Medicaid program and which is certified by the department. As used within the contents of this rule, licensed SNFs, SNF/ICF and ICFs participating in the Medicaid program are subject to state and federal laws and regulations for participation as an NF.

(J) Section for Long Term Care (SLTC) shall mean that section of the department responsible for licensing and regulating longterm care facilities licensed under Chapter 198, RSMo.

(K) Skilled nursing facility (SNF) shall mean an SNF licensed under Chapter 198, RSMo which has a signed agreement with the CMS to participate in the Medicare program and which has been recommended for certification by the department.

(L) Title XVIII shall mean the Medicare program as provided for in the federal Social Security Act.

(M) Title XIX shall mean the Medicaid program as provided for in the federal Social Security Act.

(2) An operator of an SNF or ICF licensed by the department electing to be certified as a provider of skilled nursing services under the Title XVIII (Medicare) or NF services under the Title XIX (Medicaid) program of the Social Security Act; or an operator of a facility electing to be certified as an ICF/MR facility under Title XIX shall submit application materials to the department as required by federal law and shall comply with standards set forth in the Code of Federal Regulations (CFR) of the United States Department of Health and Human Services in 42 CFR chapter IV, part 483, subpart B for nursing homes and 42 CFR chapter IV, part 483, subpart I for ICF/MR facilities, as appropriate.

(A) For Medicaid, the application shall include:

Long Term Care Facility Application for Medicare and Medicaid, Form CMS-671 (12/02), incorporated by reference in this

rule and available through the Centers for Services, 7500 Security Boulevard, Baltimore, MD 21244-1850;

Form DA-113, Bed Classification for Licensure and Certification by Category (8- 05), incorporated by reference in this rule and available through the department’s website: www.dhss.mo.gov, or by mail at:

Department of Health and Senior Services Warehouse, Attention General Services Warehouse, PO Box 570, Jefferson City, MO 65102-0570, telephone: (573) 526-3861.

(B) For Medicare, the application shall include:

Long Term Care Facility Application for Medicare and Medicaid;
Expression of Intermediary Preference Form (8-05), incorporated by reference in this rule and avail-able through the department’s website: www.dhss.mo.gov, or by mail at: Department of Health and Senior Services Warehouse, Attention General Services Warehouse, PO Box 570, Jefferson City, MO 65102-0570, telephone: (573) 526- 3861;
Form DA-113, Bed Classification for Licensure and Certification by Category;
Three (3) copies of Health Insurance Benefit Agreement, Form CMS-1561 (07/01), incorporated by reference in this rule and available through the Centers for Services, 7500 Security Boulevard, Baltimore, MD 21244-1850;
Three (3) copies of Assurance of Compliance, Form HHS-690 (5/97), incorporated by reference in this rule and available through the Centers for http://www.cms.hhs.gov/forms, or by mail at the U.S. Department of Health and Human Services, 200 Independence Avenue, SW, Washington, DC 20201, telephone: (202) 619-0257; Toll Free: 1 (877) 696-6775.
The forms incorporated by reference in subsections (2)(A) and (B) do not include any later amendments or additions.

(C) SNFs or NFs which are newly certified or which are undergoing a change of ownership shall submit an initial certification fee in the amount up to one thousand dollars ($1,000) as stipulated by the department in writing to the operator following receipt of the properly completed application material referenced in section (2). The amount for the initial certification fee shall be the prorated portion of one thousand dollars ($1,000) with prorating based on the month of receipt of the application in relation to the beginning of the ROBIN CARNAHAN (3/31/06) next federal fiscal year. This initial certification fee shall be nonrefundable and a facility shall not be certified until the fee has been paid.

(D) All SNFs or NFs certified to participate in the Medicaid or Medicare program(s) shall submit to the department an annual certification fee of one thousand dollars ($1,000) prior to October 1 of each year. If the fee is not received by that date each year, a late fee of fifty dollars ($50) per month shall be payable to the department. If payment of any fees due is not received by the department by the time the facility license expires or by December 31 of that year, whichever is earlier, the department shall notify the Division of Medical Services and the CMS recommending termination of the Medicaid or Medicare agreement as denial of license will occur as provided in 19 CSR 30-82.010 and section 198.022, RSMo.

(3) Application material shall be signed and dated and submitted to the department’s SLTC licensure unit at least fourteen (14) working days prior to the date the facility is ready to be surveyed for compliance with federal regulations (Initial Certification Survey).

The operator or authorized representative shall notify the appropriate department regional office by letter or by phone as to the date the facility will be ready to be surveyed.

There shall be at least two (2) residents in the facility before a survey can be conducted.

The facility shall already be licensed or with licensure in process shall be in compliance with all state rules.

(4) Any facility certified for participation as an NF in the Title XIX Medicaid program electing to participate in the Title XVIII Medicare program shall submit an application signed and dated by the operator or his or her authorized representative to the department’s SLTC central office licensure unit.

The department will recommend Medicare certification to the CMS effective the date the application material is received by the department or a subsequent date if requested by the provider, provided the facility was in compliance with all federal and state regulations for SNFs at the last survey conducted by the department and provided the facility’s application is complete and has been approved by the Medicare fiscal intermediary.

(5) Any facility certified for participation in the Medicare program wishing to participate in the Medicaid program shall submit a signed and dated application to the department central office. The department will certify the facility for Medicaid participation effective the date the application is received by the department or a subsequent date requested by the provider, provided the facility was in compliance with all federal regulations at the last survey conducted by the department and the application is complete.

(6) For newly certified facilities, the facility will be certified for either Medicare or Medicaid participation effective the date the facility receives a license at the proper level or the date the facility achieves substantial compliance with the federal participation requirements, whichever is the later date. The application shall be completed. For certification in the Title XVIII (Medicare) program, the Medicare fiscal intermediary must approve the application and the CMS must concur with the department’s recommendation.

(7) The department shall conduct federal surveys in SNFs, NFs and ICF/MR facilities, utilizing regulations and procedures contained in— (A) The State Operations Manual (SOM)

(HCFA Publication 7);

(B) The Survey and Certification Regional letters received by the department from the CMS;

(C) For SNFs and NFs, federal regulation 42 CFR chapter IV, part 483, subpart B; and (D) For ICF/MR facilities, federal regulation 42 CFR chapter IV, part 483, subpart I.

(8) A facility, in its application, shall designate the number of beds to be certified and their location in the facility. A facility can be wholly or partially certified. If partially certified, the beds shall be in a distinct part of the facility and all beds shall be contiguous.

(9) If a facility certified to participate in the Title XIX (Medicaid) or Title XVIII (Medicare) program elects to change the size of its distinct part, it must submit a written request to the Licensure/Certification Unit or the ICF/MR Unit of the department, as applicable. The request shall specify the room numbers involved, the number of beds in each room and the facility cost reporting year end date. The request must include a floor diagram of the facility and a signed DA-113 form, Bed Classification for Licensure and Certification by Category. A facility is allowed two (2) changes in the size of its distinct part during the facility cost reporting year. This may be two (2) increases or one (1) increase and one (1) decrease. It may not be two (2) decreases. The first change can be done only at the beginning of the facility cost reporting year and the second change can be done effective at the beginning of a facility cost reporting quarter within that facility cost reporting year. All requests must be submitted to the Licensure/Certification Unit or the ICF/MR Unit of the department at least forty-five (45) days in advance. Any facility wishing to eliminate its distinct part to go to full certification may do so effective at the beginning of the next facility cost reporting quarter with forty-five (45) days notice. The distinct part may be reestablished only at the beginning of the next facility cost reporting year. A facility may change the location of the distinct part with thirty (30) days notice to the Licensure/Certification Unit or the ICF/MR Unit of the department.

(10) If a facility certified to participate in the Title XIX (Medicaid) or Title XVIII (Medicare) program undergoes a change of operator, the new operator shall submit an application as specified in section (2) of this

rule. The application shall be submitted within five (5) working days of the change of operator. For applications made for the Title XIX (Medicaid) program, the department shall provide the application to the Division of Medical Services of the Department of Social Services so that a provider agreement can be negotiated and signed. For applications made for the Title XVIII (Medicare) program, the department shall provide the application to the CMS. Certification status will be retained unless or until formally denied.

(11) If it is determined by the department that a facility certified to participate in Medicaid or Medicare does not comply with federal regulations at the time of a federal survey, complaint investigation or state licensure inspection, the department shall take enforcement action using the regulations and procedures contained in the following sources:

(A) 42 CFR chapter IV, part 431, subparts D, E and F;

(B) 42 CFR chapter IV, part 442;

(D) 42 U.S.C. Section 1396(r);

(E) Sections 198.026 and 198.067, RSMo;

(F) 13 CSR 70-10.015 and 13 CSR 70- 10.030.

(12) If a facility certified to participate in the Medicaid Title XIX program has been decertified as a result of noncompliance with the federal requirements, the facility can be readmitted to the Medicaid program by submitting an application for initial participation in the Medicaid program. After having received the application, the department shall conduct (3/31/06) ROBIN CARNAHAN a survey at the earliest possible date to determine if the facility is in substantial compliance with all federal participation requirements. The effective date of participation will be the date the facility is found to substantially comply with all federal requirements.

(13) If a change in the administrator or the director of nursing of a facility occurs, the facility shall provide written notice to the department’s SLTC central office licensure unit within ten (10) calendar days of the change. The notice shall show the effective date of the change, the identity of the new director of nursing or administrator and a copy of his or her license or the license number. Change of administrator information shall be submitted as a notarized statement by the operator in accordance with section 198.018, RSMo.

(14) An NF may request a waiver of nurse staffing requirements to the extent the facility is unable to meet the requirements including the areas of twenty-four (24)-hour licensed nurse coverage, the use of a registered nurse for eight (8) consecutive hours seven (7) days per week and the use of a registered nurse as director of nursing.

(A) Requests for waivers shall be made in writing to the director of the Section for Long Term Care.

(B) Requests for waivers will be considered only from facilities licensed under

Chapter 198, RSMo as ICFs which do not have a nursing pool agency that is within fifty (50) miles, within state boundaries, and which can supply the needed nursing personnel.

(C) The department shall consider each request for a waiver and shall approve or disapprove the request in writing postmarked within thirty (30) working days of receipt or, if additional information is needed, shall request from the facility the additional information or documentation within ten (10) working days of receipt of the request.

(D) Approval of a nurse waiver request shall be based on an evaluation of whether the facility has been unable, despite diligent efforts—including offering wages at the community prevailing rate for nursing facilities— to recruit the necessary personnel. Diligent effort shall mean prominently advertising for the necessary nursing personnel in a variety of local and out-of-the-area publications, including newspapers and journals within a fifty (50)-mile radius, and which are within state boundaries; contacts with nursing schools in the area; and participation in job fairs. The operator shall submit evidence of the diligent effort including:

Copies of newspapers and journal advertisements, correspondence with nursing schools and vocational programs, and any other relevant material;
If there is a nursing pool agency within fifty (50) miles which is within state boundaries and the agency cannot consistently supply the necessary personnel on a per diem basis to the facility, the operator shall submit a letter from the agency so stating;
Copies of current staffing patterns including the number and type of nursing staff on each shift and the qualifications of licensed nurses;
A current Resident Census and Condition of Residents, Form CMS-672 (10/98), incorporated by reference in this

rule and available through the Centers for Services, 7500 Security Boulevard, Baltimore, MD 21244-1850. This rule does not incorporate any subsequent amendments or additions;

Evidence that the facility has a registered nurse consultant required under 19 CSR 30-85.042 and evidence that the facility has made arrangements to assure registered nurse involvement in the coordination of the assessment process as required under 42 CFR 483.20(3);
Location of the nurses’ stations and any other pertinent physical feature information the facility chooses to provide;
Any other information deemed important by the facility including personnel procedures, promotions, staff orientation and evaluation, scheduling practices, benefit programs, utilization of supplemental agency personnel, physician-nurse collaboration, support services to nursing personnel and the like; and 8. For renewal requests, the information supplied shall show diligent efforts to recruit appropriate personnel throughout the prior waiver period. Updates of prior submitted information in other areas are acceptable.

(E) In order to meet the conditions specified in federal regulation 42 CFR 483.30, the following shall be considered in granting approval:

There is assurance that a registered nurse or physician is available to respond immediately to telephone calls from the facility for periods of time in which licensed nursing services are not available;
There is assurance that if a facility requesting a waiver has or admits after receiving a waiver any acutely ill or unstable residents requiring skilled nursing care, the skilled care shall be provided in accordance with state licensure rule 19 CSR 30-85.042;
The facility has not received a Class I notice of noncompliance in resident care within one hundred twenty (120) days of the waiver request or the department has not conducted an extended survey in the facility within one (1) year of the waiver request.

Any facility which receives a Class I notice of noncompliance in resident care or an extended survey while under waiver status will not have the waiver renewed unless the problem has been corrected and steps have been taken to prevent recurrence. If a facility received more than one (1) Class I notice of noncompliance in resident care during a waiver period, the department will consider revocation of the waiver.

(F) The facility shall cooperate with the department in providing the proper documentation. For renewal requests, the request and proper documentation shall be submitted to the department at least forty-five (45) days prior to the ending date of the current waiver period. If any changes occur during a waiver period that affect the status of the waiver, a letter shall be submitted to the deputy director of institutional services within ten (10) days of the changes. The request for a waiver or renewal of a waiver shall be denied if the facility fails to abide by these previously mentioned time frames.

(G) If a waiver request is denied, the department shall notify the facility in writing and within twenty (20) days, the facility shall submit to the department a written plan for how the facility will recruit the required personnel. If appropriate personnel are not hired within two (2) months, the department shall initiate enforcement proceedings.

Emergency rule filed Sept. 18, 1990, effective Oct. 1, 1990, expired Jan. 25, 1991. Original

rule filed Nov. 2, 1990, effective June 10, 1991. Amended: Filed June 3, 1993, effective Dec. 9, 1993. Amended: Filed Feb. 1, 1995, effective Sept. 30, 1995. Amended: Filed May 11, 1998, effective Nov. 30, 1998. Amended:

Filed Nov. 27, 2000, effective July 30, 2001.

Emergency amendment filed July 13, 2001, effective July 30, 2001, expired Feb. 28, 2002. Moved to 19 CSR 30-81.010, effective Aug. 28, 2001. Amended: Filed July 13, 2001, effective Feb. 28, 2002. Amended:

Filed Nov. 1, 2005, effective April 30, 2006. *Original authority: 660.050, RSMo 1984, amended 1988, 1992, 1993, 1994, 1995, 2001.

History

AUTHORITY: section 660.050 RSMo 2005. This rule originally filed as 13 CSR 15-9.010.

19 CSR 30-81.015 Resident Assessment Instrument {#sec-19-csr-30-81.015 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-81.015}

(Rescinded September 30, 2012)

This rule originally filed as 13 CSR 15- 9.015. Emergency rule filed Dec. 18, 1990, effective Dec. 31, 1990, expired April 29, 1991. Emergency rule filed May 7, 1991, effective May 17, 1991, expired Sept. 13, 1991. Original rule filed Dec. 18, 1990, effective June 10, 1991. Emergency amendment filed June 16, 1992, effective Aug. 1, 1992, expired Nov. 28, 1992. Amended: Filed June 16, 1992, effective Feb. 26, 1993.

Emergency amendment filed May 14, 1993, effective June 1, 1993, expired Sept. 28, 1993. Emergency amendment filed July 14, 1993, effective July 25, 1993, expired Nov. 21, 1993. Amended: Filed May 14, 1993, effective Dec. 9, 1993. Moved to 19 CSR 30- 81.015, effective Aug. 28, 2001. Rescinded:

Filed March 1, 2012, effective Sept. 30, 2012.

History

AUTHORITY: section 536.021, RSMo Supp.

19 CSR 30-81.020 Prelong-Term Care Screening {#sec-19-csr-30-81.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-81.020}

(Rescinded February 28, 2006)

Emergency rule filed March 14, 1984, effective April 12, 1984, expired Aug. 8, 1984.

Original rule filed March 14, 1984, effective Aug. 9, 1984. Amended: Filed Aug. 3, 1992, effective May 6, 1993. Moved to 19 CSR 30- 81.020, effective Aug. 28, 2001. Rescinded:

Filed Aug. 12. 2005, effective Feb. 28, 2006.

History

AUTHORITY: sections 207.020 and 208.159, RSMo 1986 and 208.153, RSMo Supp. 1991. This rule was previously filed as 13 CSR 40-81.086 and 13 CSR 15-9.020.

19 CSR 30-81.030 Evaluation and Assessment Measures for Title XIX Recipients and Applicants {#sec-19-csr-30-81.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-81.030}

PURPOSE: This rule sets the requirements for the periodic evaluation and assessments of residents in long-term care facilities in relationship to evaluation and assessment processes, level of care needed by individuals, and appropriate placement of individuals in order to receive this care. The rule also includes the algorithm utilized for the department’s Home and Community Based Services program for its level-of-care determination.

The rule includes a second level-of-care determination to be utilized from October 31, 2021, until the funding from the American Rescue Plan Act (temporary enhanced federal medical assistance percentage) has been expended.

This note applies only to the reference material. The entire text of the rule is printed here.

(1) For purposes of this rule only, the following definitions shall apply:

(A) Applicant—any resident or prospective resident of a certified long-term care facility who is seeking to receive inpatient Title XIX assistance;

(B) Certified long-term care facility—any long-term care facility which has been approved to participate in the inpatient program and receives Title XIX funding for eligible recipients;

(C) Initial assessment forms—the forms utilized to collect information necessary for a level-of-care determination pursuant to 19 CSR 30-81.030 and designated Forms DHSS- DRL-109 (10-20), Nursing Facility Level of Care Assessment and DHSS-DRL-110 (10- 20), Level One Nursing Facility Pre- Admission Screening for Mental Illness/Intellectual Disability or Related Condition, included herein;

(D) Inpatient Title XIX assistance—Title XIX payments for intermediate or skilled nursing care in a certified long-term care facility;

(E) Level-of-care assessment—the determination of level-of-care need based on an assessed point count value for each category cited in subsection (4)(B) of this rule;

(F) Level-of-care determination—the decision whether an individual qualifies for longterm care facility care;

(G) Long-term care facility—a skilled nursing facility (SNF), an intermediate care facility (ICF), or a hospital which provides skilled nursing care or intermediate nursing care in a distinct part or swing bed under

Chapter 197, RSMo;

(H) Pro re nata (PRN)—medication or treatment ordered by a physician to be administered as needed, but not regularly scheduled;

(I) Recipient—any resident in a certified long-term care facility who is receiving inpatient Title XIX assistance;

(J) Redetermination of level-of-care—the periodic assessment of the recipients’ continued eligibility and need for continuation at the previously assigned level of care. Periodic assessment includes, but is not limited to, the following:

Assessment of new admissions to a long-term care facility;
Assessment of a change in mental and/or physical status for a resident who is being readmitted to a long-term care facility after transfer to an acute care facility, and the previous DA-124 A/B or C forms do not reflect the resident’s current care needs; and 3. Assessment of DA-124 forms as requested by the Department of Social Services, Family Support Division;

(K) Reevaluation of level-of-care—the periodic assessment of the recipients’ continued eligibility and need for continuation at the previously assigned level of care. Periodic assessment includes, but is not limited to, the following:

Assessment of new admissions to a long-term care facility;
Assessment of a change in mental and/or physical status for a resident who is being readmitted to a long-term care facility after transfer to an acute care facility, and the previous DHSS-DRL-109 (10-20), Nursing Facility Level of Care Assessment or DHSS- DRL-110 (10-20), Level One Nursing Facility Pre-Admission Screening for Mental Illness/Intellectual Disability or Related Condition forms do not reflect the resident’s current care needs; and 3. Assessment of DHSS-DRL-109 (10- Assessment or DHSS-DRL-110 (10-20), Disability or Related Condition forms as requested by Department of Social Services, Family Support Division;

(L) Resident—a person seventeen (17) years or older who by reason of aging, illness, disease, or physical or mental infirmity receives or requires care and services furnished by a long-term care facility and who resides in, is cared for, treated, or accommodated in such long-term care facility for a period exceeding twenty-four (24) consecutive hours; and (M) The department—Department of Health and Senior Services.

(2) Initial Level-of-Care Determination Requirements.

(A) In accordance with 42 CFR sections 456.370 and 483.104, the department or its designated agents, or both, will conduct a review and assessment of the evaluations made by the attending physician for an applicant in or seeking admission to a long-term care facility. The review and assessment shall be conducted using the criteria in

section (5) of this rule.

(B) The initial level-of-care determination shall be completed for the following:

All applicants prior to or on admission to a long-term care facility; and 2. When an applicant or recipient has been discharged from a long-term care facility for more than sixty (60) days.

(C) A referring individual shall fill out and submit electronically using the department’s online database system available at: https://health.mo.gov/seniors/nursinghomes/pasrr.php. the required documentation contained in forms DHSS-DRL-109 (10- Assessment and DHSS-DRL-110 (10-20), Disability or Related Condition.

(D) The department shall complete the assessment within ten (10) working days of receipt of all documentation required by section (5) of this rule unless further evaluation by the State Mental Health Authority is required by 42 CFR 483.100 to 483.138.

(E) The department shall provide written notice to the individual or referring entity if Level II screening is referred to the Department of Mental Health. The referring entity shall notify the applicant or recipient of the results of the screening.

(3) Level-of-Care Reevaluation Requirements.

(A) The level-of-care reevaluation is applicable for recipients who are eligible for placement in a long-term care facility. The level-of-care reevaluation shall be completed for the following:

When a significant change has occurred in the resident’s physical, mental, or psychosocial status for a resident diagnosed with mental illness and/or intellectual disability or related condition; or 2. As requested by Department of Social Services, Family Support Division or the Department of Mental Health.

(B) A referring individual shall fill out and submit electronically using the department’s online database system available at: https://health.mo.gov/seniors/nursinghomes/pasrr.php. the required documentation contained in forms DHSS-DRL-109 (10- Assessment and DHSS-DRL-110 (10-20), Disability or Related Condition.

(C) The department shall provide written notice to the individual or referring entity if Level II screening is referred to the Department of Mental Health. The referring entity shall notify the applicant or recipient of the results of the screening.

(4) Level-of-Care Criteria for Long-Term Care Facility Care—Qualified Title XIX Recipients and Applicants.

(A) Individuals will be assessed with the ultimate goal to achieve placement for these individuals in the least restrictive environment possible, yet enable them to receive all services required by their physical/mental condition.

(B) The specific areas which will be considered when determining an individual’s ability or inability to function in the least restrictive environment are—behavioral, cognition, mobility, eating, toileting, bathing, dressing and grooming, rehabilitative services, treatments, meal preparation, medication management, and safety.

(C) To qualify for intermediate or skilled nursing care, an applicant or recipient shall exhibit physical impairment, which may be complicated by mental impairment or mental impairment which may be complicated by physical impairment, severe enough to require intermediate or skilled nursing care.

(5) Assessed Needs Point Designations Requirements.

(A) Applicants or recipients will be assessed for level-of-care by the assignment of a point count value for each category cited in subsection (4)(B) of this rule.

(B) Points will be assessed for the amount of assistance required, the complexity of the care, and the professional level of assistance necessary, based on the level-of-care criteria.

(C) For individuals seeking admission to a long-term care facility on or after July 15, 2021, the applicant or recipient will be determined as eligible for Title XIX-funded longterm care services if he or she is determined to need care with an assessed point level of eighteen (18) points or above, using the assessment procedure as required in this rule.

(D) For individuals seeking admission to a long-term care facility on or after July 15, 2021, an applicant with less than eighteen (18) points will be determined as ineligible for Title XIX-funded long-term care services, unless the applicant qualifies as otherwise provided in subsection (5)(E) of the rule.

(E) An applicant or recipient will be considered eligible for inpatient Title XIX assistance regardless of the total point count if the applicant or recipient is unable to meet physical/mental requirements for residential care facility (RCF) and assisted living facility (ALF) residency as specified by section 198.073, RSMo. In order to determine if an applicant or recipient is unable to meet RCF and ALF residency, the following criteria shall be applied:

For RCF residency an applicant or recipient shall be physically and mentally capable of negotiating a normal path to safety. In order to meet this requirement, an applicant or recipient, without staff assistance, must be able to reach and go through a required exit door to the outside building by— A. Responding to verbal direction or the sound of an alarm;

B. Being prepared to leave the facility within five (5) minutes of being alerted of the need to evacuate;

C. If using a wheelchair, the resident shall be able to transfer into the wheelchair and propel it or reach the assistive device, and open all doors without staff assistance;

D. If using another assistive device, such as a walker or cane, they shall be able to reach and utilize the assistive device without staff assistance.

For ALF residency, the applicant or recipient cannot be admitted or retained if they meet the following criteria:

A. Exhibit behaviors that present a reasonable likelihood of serious harm to himself or herself or others;

B. Require physical restraints;

C. Require chemical restraints;

D. Require skilled nursing services as defined in subsection 198.073.4, RSMo for which the facility is not licensed or able to provide;

E. Require more than one (1) person to simultaneously physically assist the resident with any activity of daily living, with the exception of bathing and transferring; or F. Is bedbound or similarly immobilized due to a debilitating or chronic condition.

(F) Points will be assigned to each category, as required by subsection (4)(B) of this

rule, in multiples of three (3) according to the following requirements:

Behavioral is defined as the applicant or recipient’s repeated behavioral challenges that affect their ability to function in the community. The applicants or recipients who exhibit uncontrolled behavior that is dangerous to themselves or others must be transferred immediately to an appropriate facility.

Determine if the applicant or recipient: receives monitoring for a mental condition, exhibits one (1) of the following mood or behavior symptoms: wandering, physical abuse, socially inappropriate or disruptive behavior, inappropriate public sexual behavior or public disrobing, resists care or exhibits one (1) of the following psychiatric conditions: abnormal thoughts, delusions, hallucinations. The applicant or recipient can receive up to nine (9) points in this category.

A. Zero (0) points if assessed with a stable mental condition and no mood or behavior symptoms observed and no reported psychiatric conditions;

B. Three (3) points if assessed with a stable mental condition monitored by a physician or licensed mental health professional at least monthly or behavior symptoms exhibited in the past, but not currently present or psychiatric conditions exhibited in the past, but not recently present;

C. Six (6) points if assessed with an unstable mental condition monitored by a physician or licensed mental health professional at least monthly, or behavior symptoms are currently exhibited, or psychiatric conditions are recently exhibited; or D. Nine (9) points if assessed with an unstable mental condition monitored by a physician or licensed mental health professional at least monthly and behavior symptoms are currently exhibited or psychiatric conditions are currently exhibited.

Cognition is defined as the applicant or recipient’s performance in remembering, making decisions, organizing daily self-care activities, as well as understanding others and making self- understood. Determine if the applicant or recipient has an issue in one (1) or more of the following areas: cognitive skills for daily decision making, memory or recall ability (short-term, procedural, situational memory), disorganized thinking/awareness, mental function varies over the course of the day, or ability to understand others or to be understood. The applicant or recipient can receive up to eighteen (18) points in this category. The applicants or recipients with “no discernable consciousness, coma” are presumed to meet nursing facility level of care. The applicant or recipient will receive— A. Zero (0) points if assessed with no issues with cognition and no issues with memory, mental function, or ability to be understood or to understand others;

B. Three (3) points if assessed as displaying difficulty making decisions in new situations or occasionally requires supervision in decision making and has issues with memory, mental function, or ability to be understood or to understand others;

C. Six (6) points if assessed as displaying consistent unsafe or poor decision making requiring reminders, cues, or supervision at all times to plan, organize, and conduct daily routines, and has issues with memory, mental function, or ability to be understood or understand others; or D. Nine (9) points if assessed as rarely or never has the capability to make decisions or displaying consistent unsafe or poor decision making or requires total supervision requiring reminders, cues, or supervision at all times to plan, organize, and conduct daily routines, and rarely or never understood by or able to understand others.

Mobility is defined as the amount of ent to move from one (1) place or position to another. Determine the applicant or recipient’s primary mode of locomotion and the amount of assistance the applicant or recipient needs with: locomotion—how one moves walking or wheeling, if wheeling how much assistance is needed once in the chair, or bed mobility—transition from lying to sitting, turning, etc. The applicant or recipient can receive up to eighteen (18) points in this category. The applicants or recipients who score in the “totally dependent on others to move or those that are bedbound” are presumed to meet nursing facility level of care. The appli- A. Zero (0) points if assessed as independently mobile, in that the applicant or recipient requires no assistance for transfers or mobility or only has set up or supervision needed;

B. Three (3) points if assessed as that the applicant or recipient performs more C. Six (6) points if assessed as requiring maximum assistance, in that the applicant or recipient needs assistance from two (2) or more individuals or more than fifty percent (50%) weight-bearing assistance or totally dependent for bed mobility.

Eating is defined as the amount of assistance needed by applicant or recipient to eat and drink, including special nutritional requirements or a specialized mode of nutrition. Determine the amount of assistance the applicant or recipient needs with eating and drinking. Includes intake of nourishment by other means [e.g. tube feeding or total parenteral nutrition (TPN)]. Determine if the participant requires a physician ordered therapeutic diet. The applicant or recipient can receive up to eighteen (18) points in this category. The applicants or recipients “totally dependent on others to eat” are presumed to meet nursing facility level of care. The appli- A. Zero (0) points if assessed as independent in dietary needs, in that the applicant or recipient requires no assistance to eat and has no physician ordered diet;

B. Three (3) points if assessed as applicant or recipient requires physician ordered therapeutic diet, or set up, supervision, or limited assistance is needed with eating;

C. Six (6) points if assessed as requiring moderate assistance with eating, in that the applicant or recipient performs more than fifty percent (50%) of tasks independently; or D. Nine (9) points if assessed as requiring maximum assistance with eating, in that the applicant or recipient requires an individual to perform more than fifty percent (50%) for assistance.

Toileting is defined as the amount of ent to complete all tasks related to toileting including the actual use of the toilet room (or commode, bedpan, urinal), transferring on/off the toilet, cleansing self, adjusting clothes, managing catheters/ostomies, and managing incontinence episodes. The applicant or recipient can receive up to nine (9) points in this category. The applicant or A. Zero (0) points if assessed as requiring no assistance, or requires only set B. Three (3) points if assessed as dently;

C. Six (6) points if assessed as requiring maximum assistance, in that applicant or recipient needs two (2) or more individuals, or more than fifty percent (50%) weightbearing assistance; or D. Nine (9) points if assessed as requiring total dependence on others.

Bathing is defined as the amount of ent to complete a full body shower or bath.

Determine the amount of assistance the applicant or recipient needs with bathing. Bathing includes: taking a full body bath/shower and the transferring in and out of the bath/shower. The applicant or recipient can receive up to six (6) points in this category. The appli- A. Zero (0) points if assessed as no assistance required, or requiring only set up or supervision needed;

B. Three (3) points if assessed as C. Six (6) points if assessed as requiring maximum assistance, in that the applicant or recipient requires two (2) or more individuals, more than fifty percent (50%) weightbearing assistance, or total dependence on others.

Dressing and grooming is defined as the amount of assistance needed by the applicant or recipient to dress, undress, and complete daily grooming tasks. Dressing may also include specialized devices such as prosthetics, orthotics, etc. The applicant or recipient can receive up to six (6) points in this category. The applicant or recipient will receive— A. Zero (0) points if assessed as requiring no assistance, or requiring only set B. Three (3) points if assessed as C. Six (6) points if assessed as requiring maximum assistance, in that applicant or recipient requires two (2) or more individuals, more than fifty percent (50%) of weightbearing assistance, or total dependence on others.
Rehabilitative services is defined as the restoration of a former or normal state of health through medically-ordered therapeutic services either directly provided by or under the supervision of a licensed qualified professional. Rehabilitative services include physical therapy, occupational therapy, speech therapy, cardiac rehabilitation, and audiology.

If ordered by the physician, each resident must have an individually planned and implemented program with written goals and response/progress documented. Points will be determined by intensity of required services and the applicant’s or recipient’s potential for rehabilitation as determined by the rehabilitation evaluation. The applicant or A. Zero (0) points if assessed as requiring no ordered rehabilitative services;

B. Three (3) points, if assessed as requiring minimal-ordered rehabilitative services of one (1) time per week;

C. Six (6) points if assessed as requiring moderate-ordered rehabilitative services of two (2) or three (3) times per week; or D. Nine (9) points if assessed as requiring maximum-ordered rehabilitative services of four (4) times per week or more.

Treatments are defined as a physician ordered medical care or management that requires additional hands on assistance. The scoring for treatments will be zero (0) or six (6). The applicant or recipient with the identified treatments will receive six (6) points.

A. Zero (0) points if no treatments are ordered by the physician; or B. Six (6) points if assessed as requiring one (1) or more of the physician ordered treatments requiring daily attention by a licensed professional. These treatments could include: catheter/ostomy care, alternate modes of nutrition (tube feeding or TPN), suctioning, ventilator/respirator, and wound care (skin must be broken).

Meal preparation is defined as the amount of assistance needed to prepare a meal based on the applicant’s or recipient’s capacity to complete the task. This includes planning, assembling ingredients, cooking, and setting out the food and utensils. The applicant or recipient can receive up to six (6) points in this category. The applicant or A. Zero (0) points if assessed as requiring no assistance, or requiring only set B. Three (3) points if assessed as than fifty percent (50%) of tasks; or C. Six (6) points if assessed as requiring maximum assistance in that the individual performs more than fifty percent (50%) of tasks for the applicant or recipient, or requires total dependence on others.
Medication management is defined as the amount of assistance needed by the applicant or recipient to safely manage their medication regimen. Assistance may be needed due to a physical or mental disability.

Determine the amount of assistance the applicant or recipient needs to safely manage their medications. The applicant or recipient can receive up to six (6) points in this category.

A. Zero (0) points if assessed as requiring no assistance;

B. Three (3) points if assessed as requiring setup help needed or supervision needed, or requires limited or moderate assistance, in that applicant or recipient performs more than fifty percent (50%) of tasks; or C. Six (6) points if assessed as requiring maximum assistance, in that the individual performs more than fifty percent (50%) of tasks for the applicant or recipient, or requires total dependence on others.

Safety is defined as the identification of a safety risk associated with vision impairment, falling, problems with balance, past institutionalization, and age. Determine if the applicant or recipient exhibits any of the following risk factors: vision impairment, falling, or problems with balance - balance is moving to standing position, turning to face the opposite direction, dizziness, or unsteady gait. The applicant or recipient can receive up to eighteen (18) points in this category. After determination of a preliminary score, institutionalization and age will be considered to determine the final score. Three (3) points can be added to the accumulated score if the applicant or recipient is aged seventy-five (75) years or older and/or has been institutionalized in the last five (5) years in a long-term care facility, mental health residence, psychiatric hospital, inpatient substance abuse, or settings for persons with intellectual disabilities and only to the specified points category listed. The applicants or recipients who score eighteen (18) points are presumed to meet nursing facility level of care. The applicant or A. Zero (0) points if assessed with no difficulty or some difficulty with vision, and no falls in the last ninety (90) days, and no recent problems with balance;

B. Three (3) points if assessed with severe difficulty with vision (sees only lights and shapes), or has fallen in the last ninety (90) days, or has current problems with balance, or has a preliminary score of zero (0) and is aged seventy-five (75) years or older or has been institutionalized;

C. Six (6) points if assessed with no vision or has fallen in the last ninety (90) days and has current problems with balance, or assessed with a preliminary score of zero (0) and is aged seventy-five (75) years or older and has been institutionalized, or assessed with a preliminary score of three (3) points and is aged seventy-five (75) years or older or has been institutionalized;

D. Nine (9) points if assessed with a preliminary score of six (6) points and has been institutionalized; or E. Eighteen (18) points if assessed with a preliminary score of six (6) points and is aged seventy-five (75) years or older or assessed with a preliminary score of three (3) points and is aged seventy-five (75) years or older and has been institutionalized.

(6) Level of Care Determination for Home and Community Based Services Program.

The department uses level of care determination for Home and Community Based Services (HCBS). The department utilizes the InterRAI Home Care Assessment System (HC), © InterRAI. Questions are scored within the InterRAI assessment using an algorithm, included herein. The HCBS assessment process is outlined in 19 CSR 15-7.021, 19 CSR 15-8.200, and 13 CSR 70-91.010.

(7) Dual level-of-care assessments to be performed to determine level-of-care need from October 31, 2021, until the date that all of the temporary enhanced federal medical assistance percentage funds from the American Rescue Plan Act of 2021 are expended.

(A) The department is eligible to receive an additional ten percent (10%) enhanced federal medical assistance percentage for home and community based services provided from April 1, 2021, through March 31, 2022, through the American Rescue Plan Act of 2021. This funding will allow the department to determine level-of-care need under the department’s previous scoring system directly prior to the department’s level-ofcare transformation which takes effect on October 31, 2021, through formal rulemaking. Therefore, if an individual does not qualify for level of care under the current level-ofcare assessment as set forth in sections (5) and (6) of this rule from October 31, 2021, until the date that all of the temporary enhanced federal medical assistance percentage funds from the American Rescue Plan Act of 2021 are expended, then individuals shall also be assessed using a level-of-care assessment as set forth in section (8) of this

rule. An individual may qualify for level-ofcare need under either of these level of care assessments from October 31, 2021, until the date that all of the temporary enhanced federal medical assistance percentage funds from the American Rescue Plan Act of 2021 are expended.

(8) Second level-of-care determination to be performed from October 31, 2021, until the date that all of the temporary enhanced federal medical assistance percentage funds from the American Rescue Plan Act of 2021 are expended.

(A) Initial determination of level-of-care needs requirements.

For the purpose of making a determination of level-of-care need and in accordance with 42 CFR sections 456.370 and 483.104, the department or its designated agents, or both, will conduct a review and assessment of the evaluations made by the attending physician for an applicant in or seeking admission to a long-term care facility. The review and assessment shall be conducted using the criteria in subsection (8)(D) of this rule.
The department shall complete the assessment within ten (10) working days of receipt of all documentation required by sub-

section (8)(D) in this rule unless further evaluation by the State Mental Health Authority is required by 42 CFR 483.100 to 483.138.

(B) Redetermination of level-of-care requirements.

Redetermination of level-of-care of individual recipients who are eligible for placement in long-term care facilities shall be conducted by the department through a review and assessment of the DA-124A/B (10-21) Initial Assessment – Social and Medical, DA-124C (10-21) Level One Nursing Facility Pre-Admission Screening for Mental Illness/Intellectual Disability or Related Condition, and DA-124C ATT (10- 21) Notice to Applicant included herein and any documentation provided by the resident’s attending physician. A referring individual shall fill out and submit the forms to the department at COMRU@health.mo.gov.

Individuals will be assessed with the ultimate goal to achieve placement for these individuals in the least restrictive environment possible, yet enable them to receive all services required by their physical/mental condition.
The specific areas which will be considered when determining an individual’s ability or inability to function in the least restrictive environment are mobility, dietary, restorative services, monitoring, medication, behavioral, treatments, personal care, and rehabilitative services.
To qualify for intermediate or skilled nursing care, an applicant or recipient shall exhibit physical impairment, which may be complicated by mental impairment or mental impairment which may be complicated by physical impairment severe enough to require intermediate or skilled nursing care.

(D) Assessed needs point designations requirements.

Applicants or recipients will be assessed for level-of-care by the assignment of a point count value for each category cited in paragraph (8)(C)2. of this rule.
Points will be assessed for the amount of assistance required, the complexity of the care, and the professional level of assistance necessary, based on the level-of-care criteria.

If the applicant’s or recipient’s records show that the applicant’s or recipient’s attending physician has ordered certain care, medication or treatments for an applicant or recipient, the department will assess points for a PRN order if the applicant or recipient has actually received or required that care, medication, or treatment within the thirty (30) days prior to review and evaluation by the department.

For individuals seeking admission to a long-term care facility on or after October, 31, 2021, the applicant or recipient will be determined to be qualified for long-term care facility care if he or she is determined to need care with an assessed point level of twentyfour (24) points or above, using the assessment procedure as required in paragraph (8)(D)7. of this rule.
For individuals seeking admission to a long-term care facility on or after October 31, 2021, an applicant with twenty-one (21) points or lower will be assessed as ineligible for Title XIX-funded long-term care in a long-term care facility, unless the applicant qualifies as otherwise provided in section (5),

section (6), or paragraphs (8)(D)5. or 6. in this rule.

Applicants or recipients may occasionally require care or services, or both, which could qualify as long-term care facility services. In these instances, a single nursing service requirement may be used as the qualifying factor, making the individual eligible for long-term care facility care regardless of the total point count. The determining factor will be the availability of professional personnel to perform or supervise the qualifying care services. Qualifying care services may include, but are not limited to:

A. Administration of levine tube or gastrostomy tube feedings;

B. Nasopharyngeal and tracheotomy aspiration;

C. Insertion of medicated or sterile irrigation and replacement catheters;

D. Administration of parenteral fluids;

E. Inhalation therapy treatments;

F. Administration of injectable medications other than insulin, if required other than on the day shift; and G. Requirement of intensive rehabilitation services by a professional therapist at least five (5) days per week.

An applicant or recipient will be considered eligible for inpatient Title XIX assistance regardless of the total point count if the applicant or recipient is unable to meet physical/mental requirements for residential care facility (RCF) or assisted living facility (ALF) residency as specified by section 198.073, RSMo.
Points will be assigned to each category, as required by paragraph (8)(C)2. in this rule, in multiples of three (3) according to the following requirements:

A. Mobility is defined as the individual’s ability to move from place to place. The (I) Zero (0) points if assessed as independently mobile, in that the applicant or recipient requires no assistance for transfers or mobility. The applicant or recipient may use assistive devices (cane, walker, wheelchair) but is consistently capable of negotiating without assistance of another individual;

(II) Three (3) points if assessed as applicant or recipient is independently mobile once the applicant or recipient receives assistance with transfers, braces, or prosthesis application or other assistive devices, or a combination of these (example, independent use of wheelchair after assistance with transfer). This category includes individuals who are not consistently independent and need assistance periodically;

(III) Six (6) points if assessed as requiring moderate assistance, in that the applicant or recipient is mobile only with direct staff assistance. The applicant or recipient must be assisted even when using canes, walker, or other assistive devices; and (IV) Nine (9) points if assessed as requiring maximum assistance, in that the applicant or recipient is totally dependent upon staff for mobility. The applicant or recipient is unable to ambulate or participate in the ambulation process, requires positioning, supportive device, application, prevention of contractures or pressure sores, and active or passive range of motion exercises;

B. Dietary is defined as the applicant’s or recipient’s nutritional requirements and need for assistance or supervision with meals. The applicant or recipient will receive— (I) Zero (0) points if assessed as independent in dietary needs, in that the applicant or recipient requires no assistance to eat. The applicant or recipient has physician’s orders for a regular diet, mechanically altered diet, or requires only minor modifications (example, limited desserts, no salt or sugar on tray);

(II) Three (3) points if assessed as applicant or recipient requires meal supervision or minimal help, such as cutting food or verbal encouragement. Calculated diets for stabilized conditions shall be included;

(III) Six (6) points if assessed as requiring moderate assistance, in that the applicant or recipient requires help, including constant supervision during meals, or actual feeding. Calculated diets for unstable conditions are included; and (IV) Nine (9) points if assessed as requiring maximum assistance, in that the applicant or recipient requires extensive assistance for special dietary needs or with eating, which could include enteral feedings or parenteral fluids;

C. Restorative services are defined as specialized services provided by trained and supervised individuals to help applicants or recipients obtain and/or maintain their optimal highest practicable functioning potential. Each applicant or recipient must have an individual overall plan of care developed by the provider with written goals and response/progress documented. Restorative services may include, but are not limited to, applicant or recipient teaching program (self-transfer, self-administration of medications, self-care), range of motion, bowel and bladder program, remotivational therapy, validation therapy, patient/family program, and individualized activity program. The applicant or recipient will receive— (I) Zero (0) points if restorative services are not required;

(II) Three (3) points if assessed as requiring minimum services in order to maintain level of functioning;

(III) Six (6) points if assessed as requiring moderate services in order to restore the individual to a higher level of functioning; and (IV) Nine (9) points if assessed as requiring maximum services in order to restore to a higher level of functioning. These are intensive services, usually requiring professional supervision or direct services;

D. Monitoring is defined as observation and assessment of the applicant’s or recipient’s physical and/or mental condition.

This monitoring could include assessment of routine laboratory work, including, but not limited to, evaluating digoxin and coumadin levels, measurement and evaluation of blood glucose levels, measurement and evaluation of intake and output of fluids the individual has received and/or excreted, weights and other routine monitoring procedures. The (I) Zero (0) points if assessed as requiring only routine monitoring, such as monthly weights, temperatures, blood pressures, and other routine vital signs and routine supervision;

(II) Three (3) points if assessed as requiring minimal monitoring, in that the applicant or recipient requires periodic assessment due to mental impairment, monitoring of mild confusion, or both, or periodic assessment of routine procedures when the recipient’s condition is stable;

(III) Six (6) points if assessed as requiring moderate monitoring, in that the applicant or recipient requires recurring assessment of routine procedures due to the applicant’s or recipient’s unstable physical or mental condition; and (IV) Nine (9) points if assessed as requiring maximum monitoring, which is intensive monitoring usually by professional personnel due to applicant’s or recipient’s unstable physical or mental condition;

E. Medication is defined as the drug regimen of all physician-ordered legend medications, and any physician-ordered nonlegend medication for which the physician has ordered monitoring due to the complexity of the medication or the condition of the applicant or recipient. The applicant or recipient will receive— (I) Zero (0) points if assessed as requiring no medication, or has not required PRN medication within the thirty (30) days prior to review and evaluation by the department;

(II) Three (3) points if assessed as requiring any regularly scheduled medication and the applicant or recipient exhibits a stable condition;

(III) Six (6) points if assessed as requiring moderate supervision of regularly scheduled medications, requiring daily monitoring by licensed personnel; and (IV) Nine (9) points if assessed as requiring maximum supervision of regularly scheduled medications, a complex medication regimen, unstable physical or mental status, or use of medications requiring professional observation and assessment, or a combination of these;

F. Behavioral is defined as an individual’s social or mental activities. The appli- (I) Zero (0) points if assessed as requiring little or no behavioral assistance.

Applicant or recipient is oriented and memory intact;

(II) Three (3) points if assessed as requiring minimal behavioral assistance in the form of supervision or guidance on a periodic basis. Applicant or recipient may display some memory lapses or occasional forgetfulness due to mental or developmental disabilities, or both. Applicant or recipient generally relates well with others (positive or neutral) but needs occasional emotional support;

(III) Six (6) points if assessed as requiring moderate behavioral assistance in the form of supervision due to disorientation, mental or developmental disabilities, or uncooperative behavior; and (IV) Nine (9) points if assessed as requiring maximum behavioral assistance in the form of extensive supervision due to psychological, developmental disabilities, or traumatic brain injuries with resultant confusion, incompetency, hyperactivity, hostility, severe depression, or other behavioral characteristics. This category includes residents who frequently exhibit bizarre behavior, are verbally or physically abusive, or both, or are incapable of self-direction. Applicants or recipients who exhibit uncontrolled behavior that is dangerous to themselves or others must be transferred immediately to an appropriate facility;

G. Treatments are defined as a systematized course of nursing procedures ordered by the attending physician. The (I) Zero (0) points if no treatments are ordered by the physician;

(II) Three (3) points if assessed as requiring minimal type-ordered treatments, including nonroutine and preventative treatments, such as whirlpool baths and other services;

(III) Six (6) points if assessed as requiring moderate type-ordered treatments requiring daily attention by licensed personnel. These treatments could include daily dressings, PRN oxygen, oral suctioning, catheter maintenance care, treatment of stasis or pressure sore ulcers, wet/moist packs, maximist, and other such services; and (IV) Nine (9) points if assessed as requiring maximum type-ordered treatments of an extensive nature requiring provision, direct supervision, or both, by professional personnel. These treatments could include intratrachial suctioning, insertion or maintenance of suprapubic catheter, continuous oxygen, new or unregulated ostomy care, dressings of deep draining lesions more than once daily, care of extensive skin disorders such as advanced pressure sore or necrotic lesions, infrared heat, and other services;

H. Personal care is defined as activities of daily living, including hygiene; personal grooming, such as dressing, bathing, oral and personal hygiene, hair and nail care, shaving; and bowel and bladder functions.

Points will be determined based on the amount of assistance required and degree of assistance involved in the activity. The appli- (I) Zero (0) points if assessed as requiring no assistance with personal care, in that the applicant or recipient is an independent, self-care individual. No assistance is required with personal grooming; the applicant or recipient has complete bowel and bladder control;

(II) Three (3) points if assessed as requiring minimal assistance with personal requires assistance with personal grooming, and/or exhibits infrequent incontinency (once a week or less);

(III) Six (6) points if assessed as requiring moderate assistance with personal requires assistance with personal grooming, requiring close supervision or exhibits frequent incontinency (incontinent of bladder daily but has some control or incontinent of bowel two (2) or three (3) times per week), or a combination of these; and (IV) Nine (9) points if assessed as requiring maximum assistance with personal requires total personal care to be performed by another individual, and/or exhibits continuous incontinency all or most of the time; and I. Rehabilitation is defined as the restoration of a former or normal state of health through medically ordered therapeutic services either directly provided by or under the supervision of a qualified professional.

Rehabilitation services include, but are not limited to, physical therapy, occupational therapy, speech therapy, and audiology. If ordered by the physician, each resident must have an individually planned and implemented program with written goals and response/progress documented. Points will be determined by intensity of required services and the applicant’s or recipient’s potential for rehabilitation as determined by the rehabilitation evaluation. The applicant or (I) Zero (0) points if assessed as requiring no ordered rehabilitation services;

(II) Three (3) points, if assessed as requiring minimal-ordered rehabilitation services of one (1) time per week;

(III) Six (6) points if assessed as requiring moderate-ordered rehabilitative services of two (2) or three (3) times per week; or (IV) Nine (9) points if assessed as requiring maximum-ordered rehabilitative services of four (4) times per week or more.

Page 1 of 4

SECTION D. ASSESSED NEEDS

Date of the last consult completed by a physician or licensed mental health professional:

Behavioral Symptoms (Check one box for each)

Withdrawn/Depressed Suspicious/Paranoid Wanders Hallucinations/Delusions Abnormal Thought Process Aggressive (Physical/Verbal)

Suicidal/Homicidal Ideation Restraints Sexually Inappropriate Controlled with Medications Stable mental condition AND no mood or behavior symptoms observed AND no reported psychiatric conditions Stable mental condition monitored by a physician or licensed mental health professional at least monthly OR behavior symptoms exhibited in past, but not currently present OR psychiatric conditions exhibited in past, but not recently present Unstable mental condition monitored by a physician or licensed mental health professional at least monthly OR behavior symptoms are currently exhibited OR psychiatric conditions are recently exhibited Unstable mental condition monitored by a physician or licensed mental health professional at least monthly AND behavior symptoms are currently exhibited OR psychiatric conditions are currently exhibited BEHAVIORAL:

• Determine if the applicant or recipient:

• Receives monitoring for mental condition • Exhibits one of the following mood or behavior symptoms - wandering, physical abuse, socially inappropriate or disruptive behavior, inappropriate public sexual behavior or public disrobing; resists care • Exhibits one of the following psychiatric conditions - abnormal thoughts, delusions, hallucinations NoneMinModMax ,1',&$7(7+(',$126(65(/(9$1772$33/,&$17·6)81&7,21$/$1'256.,//('1856,11(('6 6(&7,21&5(&(170(',&$/,1&,'(176 ,(&9$685*(5<)5$&785(+($',1-85<(7&$1'*,9('$7(6 6(&7,21%&855(17/2&$7,21352326('3/$&(0(17 REASON FOR SUBMITTING APPLICATION:

INDIVIDUAL’S CURRENT PHYSICAL LOCATION:

NAME OF PROPOSED SKILLED NURSING FACILITY: FACILITY ID NUMBER:

ADMIT DATE TO NF: DISCHARGE DATE FROM NF:

STATE OF MISSOURI

DEPARTMENT OF HEALTH AND SENIOR SERVICES 1856,1*)$&,/,7</(9(/2)&$5($66(660(17 6(&7,21$,1',9,'8$/ 6,'(17,)<,1*,1)250$7,21 NAME (LAST, FIRST, MIDDLE INITIAL, SUFFIX) DATE OF BIRTH:

DCN (MEDICAID NUMBER): SSN NUMBER:

RACE: GENDER:

See Attached All questions on this form must be answered- write N/A if not applicable. Blank areas will result in return of document and delay in payment.

Page 2 of 4 COGNITION:

• Determine if the applicant or recipient has an issues in one or more of the following areas:

• Cognitive skills for daily decision making • Memory or recall ability (short-term, procedural, situational memory)

• Disorganized thinking/awareness - mental function varies over the course of the day • Ability to understand others or to be understood Person Place Time Situation No issues with cognition AND no issues with memory, mental function, or ability to be understood/understand others Displays difficulty making decisions in new situations or occasionally requires supervision in decision making AND has issues with memory, mental function, or ability to be understood/understand others Displays consistent unsafe/poor decision making requiring reminders, cues or supervision at all times to plan, organize and conduct daily routines AND has issues with memory, mental function, or ability to be understood/understand others Rarely or never has the capability to make decisions OR displays consistent unsafe/poor decision making or requires total supervision requiring reminders, cues or supervision at all times to plan, organize and conduct daily routines AND rarely or never understood/able to understand others TRIGGER: No discernible consciousness, coma 02%,/,7< • Determine the applicant or recipient's primary mode of locomotion • Determine the amount of assistance the applicant or recipient needs with:

• Locomotion - how moves walking or wheeling, if wheeling how much assistance is needed once in the chair • Bed Mobility - transition from lying to sitting, turning, etc.

DIET ORDERED BY PHYSICIAN:

Limited or moderate assistance needed, i.e. applicant or recipient performs more than 50% of tasks independently Maximum assistance needed, i.e. applicant or recipient needs two (2) or more individuals or more than 50% weightbearing assistance OR total dependent for bed mobility TRIGGER: Applicant or recipient is bedbound OR totally dependent on the others for locomotion EATING:

• Determine the amount of assistance the applicant or recipient needs with eating and drinking.

Includes intake of nourishment by other means (e.g. tube feeding or total parenteral nutrition (TPN).

• Determine if the participant requires a physician ordered therapeutic diet.

No assistance needed AND no physician ordered diet Physician ordered therapeutic diet OR set up, supervision, or limited assistance needed with eating Moderate assistance needed with eating, i.e. applicant or recipient performs more than 50% of the task independently Maximum assistance needed with eating, i.e. applicant or recipient requires an individual to perform more than 50% for assistance TRIGGER: Totally dependent on others TOILETING:

• Determine the amount of assistance the applicant or recipient needs with toileting. Toileting includes: the actual use of the toilet room (or commode, bedpan, or urinal), transferring on/off the toilet, cleansing self, adjusting clothes, managing catheters/ ostomies, and managing incontinence episodes.

Limited or moderate assistance needed, i.e. applicant or recipient performs more than 50% of tasks independently Maximum assistance needed, i.e. applicant or recipient needs two (2) or more individuals, or more than 50% of weightbearing assistance Total dependence on others ORIENTATION: MEMORY:

LEVEL OF SUPERVISION: ABILITY TO MAKE A PATH TO SAFETY:

HEARING IMPAIRMENT: SPEECH IMPAIRMENT:

COGNITION:

• Determine if the applicant or recipient has an issues in one or more of the following areas:

• Cognitive skills for daily decision making • Memory or recall ability (short-term, procedural, situational memory)

• Disorganized thinking/awareness - mental function varies over the course of the day • Ability to understand others or to be understood Person Place Time Situation Page 3 of 4 Limited or moderate assistance needed, i.e. applicant or recipient performs more than 50% of tasks independently Maximum assistance, i.e. applicant or recipient requires two (2) or more individuals, more than 50% of weight-bearing assistance OR total dependence on others BATHING:

• Determine the amount of assistance the applicant or recipient needs with bathing.

Bathing includes: taking a full body bath/shower and the transferring in and out of the bath/shower.

Limited or moderate assistance needed, i.e. applicant or recipient performs more than 50% of tasks independently Maximum assistance, i.e. applicant or recipient requires two (2) or more individuals, more than 50% of weight-bearing assistance OR total dependence on others None of the above therapies ordered Any of the above therapies ordered 1 time per week Any of the above therapies ordered 2-3 times per week Any of the above therapies ordered 4 or more times per week TYPE OF PHYSICIAN-ORDERED REHABILITATIVE SERVICES AND FREQUENCY:

DRESSING AND GROOMING:

• Determine the amount of assistance needed by the applicant or recipient to dress, undress and complete daily grooming tasks REHABILITATIVE SERVICES:

• Determine if the applicant or recipient has the following medically ordered rehabilitative services:

Physical therapy/Occupational therapy/Speech therapy/Cardiac rehabilitation/Audiology.

None of the above treatments were ordered by the physician One or more of the above treatments was ordered by the physician requiring daily attention by a license professional Limited or moderate assistance needed, i.e. applicant or recipient performs more than 50% of tasks Maximum assistance, i.e. an individual performs more than 50% of tasks for the applicant or recipient OR total dependence on others TYPE OF PHYSICIAN-ORDERED TREATMENT/COMMENT:

TREATMENTS:

• Determine if the applicant or recipient requires any of the following treatments:

• Catheter/Ostomy care • Alternate modes of nutrition (tube feeding, TPN)

• Suctioning • Ventilator/respirator • Wound care (skin must be broken)

MEAL PREPARATION:

• Determine the amount of assistance the applicant or recipient needs to prepare a meal.

This includes planning, assembling ingredients, cooking, and setting out the food and utensils.

No assistance needed Set up help needed OR supervision needed OR limited or moderate assistance needed, i.e. applicant or recipient performs more than 50% of tasks Maximum assistance needed, i.e. an individual performs more than 50% of tasks for the applicant or recipient OR total dependence on others MEDICATION MANAGEMENT:

• Determine the amount of assistance the applicant or recipient needs to safely manage their medications. Assistance may be needed due to a physical or mental disability.

Page 4 of 4 6(&7,21(5()(55,1*,1',9,'8$/&203/(7,1*$33/,&$7,21 FIRST AND LAST NAME:

POSITION/TITLE: TYPE OF ENTITY:

NAME OF ENTITY: TELEPHONE NUMBER: EXT: FAX NUMBER:

EMAIL ADDRESS: DATE REFERRAL COMPLETED:

CHECK IF SAME AS REFERRING INDIVIDUAL OR COMPLETE CONTACT PERSON IF LEVEL II SCREENING INDICATED: TELEPHONE NUMBER: EXT:

EMAIL: FAX NUMBER:

No difficulty or some difficulty with vision AND no falls in last 90 days AND no recent problems with balance Severe difficulty with vision (sees only lights and shapes) OR has fallen in the last 90 days OR has current problems with balance OR preliminary score of 0 AND Age OR Institutionalization No vision OR has fallen in last 90 days AND has current problems with balance OR Preliminary score of 0 AND Age AND Institutionalization OR Preliminary score of 3 AND Age OR Institutionalization Preliminary score of 6 AND Institutionalization TRIGGER: Preliminary score of 6 AND Age OR Preliminary Score of 3 AND Age AND Institutionalization DATE OF LAST FALL: TYPE OF INSTITUTIONALIZATION:

TIMEFRAME OR DATE ADMITTED TO INSTITUTION: 6$)(7<

• Determine if the individual exhibits any of the following risk factors:

• Vision Impairment • Falling • Problems with balance. Balance is moving to standing position, turning to face the opposite direction, dizziness, or unsteady gait • After determination of preliminary score, history of institutionalization and age will be considered to determine final score.

• Institutionalization in the last 5 years - long-term care facility, mental health residence, psychiatric hospital, inpatient substance abuse, or settings for persons with intellectual disabilities.

• Aged - 75 years and over.

&HQWUDO2IÀFH8VH2QO\ '5/&2058

Level of Care Determination by DRL Central Office MEETS LEVEL OF CARE Yes No SIGNATURE DATE

Chapter 82 General Licensure Requirements

19 CSR 30-82.010 General Licensure Requirements {#sec-19-csr-30-82.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-82.010}

PURPOSE: This rule sets forth general licensure and application procedures and outlines the request for an exception procedure related to long-term care facility licensure.

(1) Persons wishing to operate a skilled nursing facility, intermediate care facility, assisted living facility, or residential care facility shall complete form MO 580-2631 (8-07), Application for License to Operate a Long-Term Care Facility, incorporated by reference in this rule and available through the Department of Health and Senior Services’ (department’s) website at www. dhss.mo.gov, or by mail at: Department of Health and Senior Services, Section for Long-Term Care Regulation, Licensure Unit, PO Box 570, Jefferson City, MO 65102-0570, telephone:

(573) 526-8524. This rule does not incorporate any subsequent amendments or additions. The application shall be signed by a person with the express authority to sign on behalf of the operator, who shall attest by signature that the information submitted is true and correct to the best of the applicant’s knowledge and belief and that all required documents are either included with the application or are currently on file with the department. The completed application form may be submitted by mail or electronically. If submitted electronically, send the completed application to LTCapplication@dhss. mo.gov. The application fee for application processing should be submitted by separate mail. If submitted by mail, send the application form and fee to Department of Health and Senior Services, Section for Long-Term Care Regulation, Fee Receipts, PO Box 570, 920 Wildwood, Jefferson City, MO 65102. One (1) application may be used to license multiple facilities if located on the same premises.

(A) The applicant shall submit the following documents and information as listed in the application:

Financial information demonstrating that the applicant has the financial capacity to operate the facility;
A document disclosing the location, capacity, and type of licensure and certification of any support buildings, wings, or floors housing residents on the same or adjoining premises or plots of ground;
A document disclosing the name, address, and type of license of all other long-term care facilities owned or operated by either the applicant or by the owner of the facility for which the application is being submitted;
A copy of any executed management contracts between the applicant and the manager of the facility;
A copy of any executed contract conveying the legal right to the facility premises, including, but not limited to, leases, subleases, rental agreements, contracts for deed, and any amendments to those contracts;
A copy of any contract by which the facility’s land, building, improvements, furnishings, fixtures, or accounts receivable are pledged in whole or in part as security, if the value of the asset pledged is greater than five hundred dollars ($500);
A nursing home surety bond or noncancelable escrow agreement, if the applicant holds or will hold facility residents’ personal funds in trust;
A document disclosing the name, address, title, and percentage of ownership of each affiliate of any general partnership, limited partnership, general business corporation, nonprofit corporation, limited liability company, or governmental entity which owns or operates the facility or is an affiliate of an entity which owns or operates the facility. If an affiliate is a corporation, partnership, or LLC, a list of the affiliate’s affiliates must also be submitted. As used in this rule, the word “affiliate” means:

A. With respect to a partnership, each partner thereof;

B. With respect to a limited partnership, the general partner and each limited partner with an interest of five percent (5%) or more in the limited partnership;

C. With respect to a corporation, each person who owns, holds, or has the power to vote five percent (5%) or more of any class of securities issued by the corporation, and each officer and director;

D. With respect to an LLC, the LLC managers and members with an interest of five percent (5%) or more;

If applicable, a document stating the name and nature of any additional businesses in operation on the facility premises and the document issued by the division giving its prior written approval for each business;
A list of all principals in the operation of the facility and their addresses and titles and, so that the department may verify the information disclosed pursuant to paragraphs (1)(A)11. and (1)(A)12. of this rule, the Social Security numbers or employer identification numbers of the operator and all principals in the operation of the facility. As used in this

rule, “principal” means officer, director, owner, partner, key employee, or other person with primary management or supervisory responsibilities;

Disclosure concerning whether the operator or any principals in the operation of the facility are excluded from participation in the Title XVIII (Medicare) or Title XIX (Medicaid) program of any state or territory;
Disclosure concerning whether the operator or any principals in the operation of the facility have ever been convicted of a felony in any state or federal court concerning conduct involving either management of a long-term care facility or the provision or receipt of health care services;
Emergency telephone, fax, and email contact information for the facility administrator, director of nursing, and the operator’s corporate office; and 14. Disclosure concerning whether the facility has a Department of Mental Health (DMH) license.

(B) Every facility that provides specialized Alzheimer’s or dementia care services, as defined in sections 198.500 to 198.515, RSMo, by means of an Alzheimer’s special care unit or program shall submit to the department with the licensure application or renewal, the following:

Form MO 580-2637, Alzheimer’s Special Care Services Disclosure (2-07), incorporated by reference in this rule and available through the department’s website: www.dhss.mo.gov, or by mail at: Department of Health and Senior Services,

Section for Long-Term Care Regulation, Licensure Unit, PO Box 570, Jefferson City, MO 65102-0570, telephone: (573) 526-8524.

This rule does not incorporate any subsequent amendments or additions. The form shall be completed showing how the care provided by the special care unit or program differs from care provided in the rest of the facility in the following areas:

A. The Alzheimer’s special care unit’s or program’s written statement of its overall philosophy and mission which reflects the needs of residents afflicted with dementia;

B. The process and criteria for placement in, or transfer or discharge from, the unit or program;

C. The process used for assessment and establishment of the plan of care and its implementation, including the method by which the plan of care evolves and is responsive to changes in condition;

D. Staff training and continuing education practices;

E. The physical environment and design features appropriate to support the functioning of cognitively impaired adult residents;

F. The frequency and types of resident activities;

G. The involvement of families and the availability of family support programs;

H. The costs of care and any additional fees; and I. Safety and security measures; and 2. Form Guide to Selecting an Alzheimer’s Special Care Unit (6/06) #455, incorporated by reference in this rule and available through the department’s website: at http://www.dhss.mo.gov/ Ombudsman, or by mail at: Department of Health and Senior Services, Section for Long-Term Care Regulation, Licensure Unit, PO Box 570, Jefferson City, MO 65102-0570, telephone:

(573) 526-8524 or a document of choice which contains, but is not limited to, all information on selecting an Alzheimer’s special care unit or program that is contained in the Guide to Selecting an Alzheimer’s Special Care Unit (6/06) #455. This

rule does not incorporate any subsequent amendments or additions.

(C) If, after filing an application, the operator identifies an error or if any information changes the issuance of the license, including but not limited to, a change in the administrator, board of directors, officers, level of care, number of beds, or change in the name of the operating entity, the operator 1. Submit the correction or additional information to the department’s Licensure and Certification Unit in a letter. The letter shall be signed by a person with express authority to sign on behalf of the operator attesting by signature that the 2. Submit the correction or additional information to the department’s Licensure and Certification Unit. The additional information may be submitted electronically or by mail.

Information shall be submitted using form MO 580-2623 (8-07), Corrections For Long-Term Care Facility License Application, incorporated by reference in this rule and available through the Department of Health and Senior Services’ (department’s) website at www.dhss.mo.gov, or by mail at: Department of Health and Senior Services, Section for Long-Term Care

Regulation, Licensure Unit, PO Box 570, Jefferson City, MO 65102-0570, telephone: (573) 526-8524. This rule does not incorporate any subsequent amendments or additions. The completed correction form shall be signed by a person with express authority to sign on behalf of the operator attesting by signature that the information submitted is true and correct to the best of the operator’s knowledge and belief and shall be submitted by electronic mail to LTCapplication@dhss.mo.gov, or by mail to: Department of Health and Senior Services,

Section for Long-Term Care Regulation, Fee Receipts, PO Box 570, 920 Wildwood, Jefferson City, MO 65102.

(D) If, as a result of an application review, the department requests a correction or additional information, the operator, within ten (10) working days of receipt of the written request 1. Submit the correction or additional information to the department in a letter attesting by signature that the 2. Submit the correction or additional information using form MO 580-2623 (8-07), Corrections For Long-Term Care Facility License Application referenced in paragraph (1)(C)2. of this rule.

(E) A new facility shall submit an application for an original license not less than thirty (30) days before the anticipated opening date. The department must approve the application before a licensure inspection is scheduled. Sixty (60) days after its receipt, the department shall consider any application for an original license withdrawn if it is submitted without all the required information and documents. If intending to continue with licensure, the operator shall submit a new application and fee along with all necessary documents.

(F) An operator shall submit a relicensure application thirty (30) to ninety (90) days prior to the existing license’s expiration date.

(G) If, during the license’s effective period, an operator which is a partnership, limited partnership, or corporation undergoes any of the changes described in section 198.015.4, RSMo, or a new corporation, partnership, limited partnership, limited liability company, or other entity assumes facility operation, within ten (10) working days of the effective date of that change, the operator shall submit an application for a new license.

(H) The department shall issue each license only for the premises and operator named in the application. This license shall cover the entire premises unless stipulated otherwise and shall not be transferable. If the licensed operator of a facility is replaced by another operator, the new operator shall apply for a new license before the effective date of the change. A change of operator shall include a change in form of business as well as a change of person. Upon receipt of the application and receipt of confirmation that the change of operator has taken place, the department shall grant the new operator a temporary operating permit of sufficient duration to allow the department time to evaluate the application, conduct any necessary inspection(s) to determine substantial compliance with the law and the rules, and to either issue or deny a license to the new operator. The new operator shall be subject to all the terms and conditions under which the previous operator’s license or temporary operating permit was issued. This includes any existing statement of deficiencies, plans of correction and compliance with any additional requirements imposed by the department as a result of any existing substantial noncompliance. The new operator, however, shall apply to the department for renewal in his/her/its name for any exception to the rules that had been granted the previous operator under the provisions of section (3) of this rule.

(I) The operator shall accompany each application for a license to operate a long-term care facility (skilled nursing facility, intermediate care facility, assisted living facility or residential care facility) with a license fee of one hundred dollars ($100) for those facilities which have a resident capacity of at least three (3) but less than twenty-five (25), three hundred dollars ($300) for those facilities which have a resident capacity of twenty-five through one hundred (25–100), and six hundred dollars ($600) for those facilities with a capacity of over one hundred (100+). The operator shall submit a separate fee for each facility’s license application. This fee is nonrefundable unless the facility withdraws the application within ten (10) days of receipt by the department. The department will issue a license for a period of no more than two (2) years for the premises and operator named in the application. If the license is for less than two (2) years, the department will prorate the fees accordingly.

(J) An operator may apply for licenses for two (2) or more different levels of care located on the same premises either by submitting one (1) application or by submitting a separate application for each level of care. If an operator elects to submit one (1) application for two (2) or more levels of care located on the same premises— 1. The application shall specify separately the number of beds of each level of care being applied for;

The application shall be accompanied by a license fee for each level of care applied for, as required by subsection (1)

(I) of this rule; and 3. An application for two (2) or more levels of care on the same premises shall indicate one (1) facility name only.

(K) The department shall issue a separate license for each level of care located on the same premises, whether applied for by one (1) application or more than one (1). If the operator uses one (1) application for two (2) or more levels of care on the same premises, the department shall issue licenses with one (1) expiration date. If two (2) or more levels of care have existing licenses with different expiration dates and the operator elects to apply for licenses for the levels of care by submitting one (1) relicensure application, the expiration dates of the licenses issued shall be two (2) years subsequent to the expiration date of the license of the level of care expiring earliest following receipt of the application by the department. Fees for unused portions of licenses resulting from the submission of one (1) application for two (2) or more levels of care are nonrefundable.

(L) After receiving a license application, the department shall review the application, investigate the applicant and the statements sworn to in the application for license and conduct any necessary inspections. A license shall be issued if— 1. The department has determined that the application is complete, and that all necessary documents have been filed with the application including an approved nursing home bond or noncancelable escrow agreement if personal funds of residents are held in trust;

The department has determined that the statements in the application are true and correct;
The department has determined that the facility and the operator are in substantial compliance with the provisions of sections 198.003–198.096, RSMo, and the corresponding rules;
The department has determined that the applicant has the financial capacity to operate the facility;
The department has verified that the administrator of a residential care facility that was licensed as a residential care facility II on August 27, 2006 and chooses to continue to meet all laws, rules, and regulations that were in place on August 27, 2006 for a residential care facility II, assisted living facility, an intermediate care facility, or a skilled nursing facility is currently licensed by the Missouri Board of Nursing Home Administrators under the provisions of Chapter 344, RSMo;
The department has received the fee required by subsection (1)(I) of this rule;
The applicant meets the definition of operator as defined in 19 CSR 30-83.010;
The applicant has received a Certificate of Need, if required, or has received a determination from the Certificate of Need Program that no certificate is required, has completed construction, and is in substantial compliance with the licensure rules and laws;
The department has determined that neither the operator, owner, or any principals in the operation of the facility have ever been convicted of an offense concerning the operation of a long-term care facility or other health care facility or, while acting in a management capacity, ever knowingly acted or knowingly failed to perform any duty which materially and adversely affected the health, safety, welfare, or property of a resident;
The department has determined that neither the operator, owner, or any principals in the operation of the facility are excluded from participation in the Title XVIII (Medicare) or Title XIX (Medicaid) program of any state or territory;
The department has determined that neither the operator, owner, or any principals in the operation of the facility have ever been convicted of a felony in any state or federal court concerning conduct involving either management of a long-term care facility or the provision or receipt of health care services; and 12. The department has determined that all fees due the state have been paid.

(M) If, during the period in which a license is in effect, a change occurs which causes the statements in the application to no longer be correct, including change of administrator, or if any document is executed which replaces, succeeds or amends any of the documents filed with the application, within ten (10) working days of the effective date of the change, the operator 1. Submit a letter to the department’s Licensure and Certification Unit that contains a correction of the application with notification of the effective date of the change and a copy of any new documents. The operator must ensure the letter is signed by a person with the express authority to sign on behalf of the operator, who shall attest by signature that the 2. Submit to the department a correction of the application and a copy of any new documentation and information by submitting form Corrections for Long-Term Care Facility License Application referenced in paragraph (1)(C)2. of this rule.

(N) If from an analysis of financial information submitted with the application, or if from information obtained during the term of a license, the operator appears insolvent or shows a tendency toward insolvency, the department shall have the right to request additional financial information from the operator. Within ten (10) working days after receiving a written request from the department, the operator shall— 1. Submit to the department the additional information requested in a letter accompanied by a statement attesting by signature that the information being submitted is true and correct to the best of the operator’s knowledge and belief; or 2. Submit the financial information to the department on form Corrections for Long-Term Care Facility License Application referenced in paragraph (1)(C)2. of this rule.

(O) A license applicant’s financial information, data, and records submitted to the department as required by this rule, including, but not limited to, copies of any Internal Revenue Service forms, shall be open for inspection and be released only— 1. To designated employees of the department;

To the applicant furnishing this information or to his/her representative as designated in writing;
To the director of the department or to his/her representative as designated in writing;
To the state auditor or his/her representative as designated in writing;
To appropriate committees of the General Assembly or their representatives as designated in writing;
In any judicial or administrative proceeding brought under the Omnibus Nursing Home Act; or 7. When so ordered by a court of competent jurisdiction.

(P) To obtain a license for an additional level of care on the premises, the licensed operator shall submit a written request by electronic mail to LTCapplication@dhss.mo.gov, or mail to the department for the issuance of a license for the desired level of care. The request shall indicate the level of care, the number of beds desired, the name and address of the facility, the name and address of the operator, and shall include the signature of the operator. The request shall be signed by a person with the express authority to sign on behalf of the operator, who shall attest by signature that the information submitted is true and correct to the best of the operator’s knowledge and belief.

The licensure fee shall accompany this request. Requests are subject to department approval. The operator shall submit this request no less than sixty (60) days prior to the initiation date of the new level of care. The department shall coordinate this license’s expiration date with that of the original license and the department shall prorate the license fee accordingly.

(Q) To request issuance of an amended license or temporary operating permit currently in effect, the operator shall— 1. Submit a written request to the department containing the request for amendment, the date the operator would like the amendment to be effective, and the number of the license or temporary operating permit to be amended; and 2. Submit a fee for the issuance of the amended license or temporary operating permit as required by subsection (1)(R) of this rule.

(R) If an operator initiates a request to amend a license or temporary operating permit currently in effect, the department requires the following fees:

If the request is for an increase in bed capacity, the operator shall submit a fee with the request which is the greater of— A. The amount that would have been required by subsection (1)(I) of this rule if the increase in bed capacity has been included in the application, less any amount actually paid under that subsection; or B. Fifty dollars ($50); and 2. If the request is for a decrease in resident capacity or any other change, the operator shall submit a fee of twenty-five dollars ($25) with the request.

(S) The department shall approve all requests for bed changes prior to issuance of an amended license or temporary operating permit. The effective date of the amended license or temporary operating permit shall be no earlier than the date the department approved the request for bed change.

(T) If the department issues a temporary operating permit, and then subsequently issues a regular license, the licensing period shall include the period of operation under the temporary operating permit. The licensing period shall also include any period during which the department was enjoined or stayed from revoking or denying a license or rendering the temporary operating permit null and void.

(U) Unless an operator indicates otherwise, all the rooms and space on the premises and all persons eighteen (18) years of age and over living on the premises shall be considered as

part of the facility and its licensed capacity or staff and shall be subject to compliance with all rules governing the operation of a licensed facility. If an operator, when applying or reapplying for a license, wants to exclude some portion of the premises from being licensed or wants to exclude a relative as a resident, a statement to that effect shall be filed as a separate document indicating the use which will be made of that area of the premises and who or what occupies the area, and what the relationship is of the relative(s) being excluded. The statement shall be signed by a person with the express authority to sign on behalf of the operator, who shall attest by signature that the information submitted is true and correct to the best of the operator’s knowledge and belief.

(V) The operator shall not provide care in any area on the premises to any related person who requires protective oversight unless there has been a written request to the department to consider any portion of the facility for private use and that indicates facility staff shall not be used at any time to care for the relative(s). Prior to the area being used in that manner, the operator shall submit the request for the department’s approval. The department, after investigation, shall approve or disapprove the request in writing within thirty (30) days and shall issue or reissue the license indicating clearly which portion of the premises is excluded from licensure or which specific relative(s) is/are not considered a resident(s).

(2) If a facility was licensed under Chapter 197 or 198, RSMo, and was in operation before September 28, 1979, or if an application was on file or construction plans were approved prior to September 28, 1979, the facility shall comply with construction, fire safety and physical plant rules applicable to an existing or existing licensed facility provided there has been continuous operation of the facility under a license or temporary operating permit issued by the division. If, however, there was an interruption in the operation of the facility due to license denial, license revocation, or voluntary closure, the facility may be relicensed utilizing the same fire safety, construction, and physical plant rules that were applicable prior to the license denial, license revocation, or voluntary closure provided that the facility reapplies for a license within one (1) year of the date of the denial, revocation, or voluntary closure. Regardless of licensure, application, or construction plan approval date, intermediate care facilities and skilled nursing facilities shall comply with the fire safety standards published in 19 CSR 30-85.022.

(A) If a facility changes from a skilled nursing or intermediate care facility to any other level, or if the facility changes from a an assisted living facility to a residential care facility, the facility shall comply with construction, fire safety, and physical plant rules applicable to an existing or existing licensed facility as defined in 19 CSR 30-83.010.

(B) If the facility changes from a residential care facility to any other level or if an assisted living facility changes to an intermediate care or skilled nursing facility, the facility shall comply with construction, fire safety, and physical plant rules applicable to a new or newly licensed facility as defined in 19 CSR 30-83.010.

(C) The facility shall comply with the rules applicable to a new or newly licensed facility if an application for relicensure has not been filed with the department within one (1) year of the license denial, license revocation, or voluntary closure. All such facilities seeking licensure as an assisted living facility shall also comply with the requirements of 19 CSR 30-86.047 and, if applicable, 19 CSR 30-86.045.

(3) Licensed Facility Closures.

(A) If a licensed facility discontinues operation as evidenced by the fact that no residents are in care or at any time the department is unable to freely gain entry into the facility to conduct an inspection, the facility shall be considered closed.

The department shall notify the operator in writing requesting the voluntary surrender of the license. If the department does not receive the license within thirty (30) days, it shall be void.

If the operator should choose to again license the facility, the operator shall submit a complete application. The provisions of

section (1) shall apply.

(B) If any licensed skilled nursing facility or intermediate care facility is required to temporarily close for two (2) years or less from the effective date of the temporary closure due to staffing shortages as a result of a COVID-19 vaccine mandate first issued in emergency regulation by the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services (CMS) on November 4, 2021, effective on November 5, 2021, or any amendment changes or amendments thereafter, then the skilled nursing and intermediate care facilities shall do the following:

The facility operator shall submit a closure plan to the department which is in compliance with state and federal law, including 42 CFR part 483.15(c) (detailed in federal deficiency F623 in the State Operations Manual appendix PP), 42 CFR

part 483.70(l) (detailed in federal deficiency F845 in the State Operations Manual appendix PP), and 42 CFR 483.70(m) (detailed in federal deficiency F846 in the State Operations Manual

appendix PP). The State Operations Manual appendix PP revised November 22, 2017, is incorporated by reference in this rule, as published by the Centers for Medicare and Medicaid Services and is available at www.cms.gov/Regulations-and-Guidance/ Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf. pdf or the United States Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244.

This rule does not incorporate any subsequent amendments or additions. After review of the temporary closure plan, the department shall either approve or disapprove the plan;

Facilities with approved closure plans by the department shall ensure that all residents residing at the facility are provided discharge notices in accordance with federal and state law and the facility shall assist all residents with discharge planning in accordance with federal and state law;
Facilities with approved closure plans by the department shall enter into a consent agreement with the department for a probationary license. These facilities shall agree to discharge all residents by the effective date of the temporary closure and to admit no residents while the facility is temporarily closed;
Temporary closure of facilities shall not be allowed past two (2) years from the effective date of the temporary closure.

The effective date of the temporary closure is the date the last resident left the facility;

Facilities shall be reopened within two (2) years of the effective date of the temporary closure. Prior to reopening, the department shall conduct a full survey/inspection and the facility may be approved by the department to reopen after this survey or inspection. Facilities shall not reopen until approved by the department;
Facilities shall be reopened by the facility operator which initiated the temporary closure and a change of operator may not occur during this period of temporary closure;
Facilities shall submit plans of corrections, applications, licensure, and certification fees in accordance with state law regardless of temporary closure status;
Facilities approved by the department to be temporarily closed will be noted as temporarily closed on state directories.

The department will communicate temporary closure status of these facilities approved for temporary closure to CMS; and 9. Facilities not approved for temporary closure by the department which have closed or those facilities which stayed closed longer than two (2) years from the effective date of the temporary closure shall be considered closed. The department shall notify the operator in writing requesting the voluntary surrender of the license. If the department does not receive the license within thirty (30) days, it shall be void. If the operator should choose to again license the facility, the operator shall submit a complete application. The provisions of section (1) shall apply.

(4) The department may grant exceptions for specified periods of time to any rule imposed by the department if the department has determined that the exception to the rule would not potentially jeopardize the health, safety, or welfare of any residents of a long-term care facility.

(A) The owner or operator of the facility shall make requests for exceptions in writing to the director of the department.

These requests shall contain— 1. A copy of the latest Statement of Deficiencies which shows a violation of the rule being cited, if the exception request is being made as a result of a deficiency issued during an inspection of the facility;

The section number and text of the rule being cited;
If applicable, specific reasons why compliance with the rule would impose an undue hardship on the operator, including an estimate of any additional cost that might be involved;
An explanation of any extenuating factors that may be relevant; and 5. A complete description of the individual characteristics of the facility or residents, or of any other factors that would safeguard the health, safety, and welfare of the residents if the exception were granted.

(B) With the advice of the division’s licensure inspection field staff, the department will consider any requests that contain all the information required in subsection (4)(A). The department shall notify the operator, in writing, of the decision on any request for an exception, stating the reason(s) for acceptance or denial, and, if granted, the length of time the exception is to be in effect and any additional corrective factors upon which acceptance may be conditioned.

(C) The department shall only grant exceptions to licensure requirements set out in rules imposed by the department and cannot grant exceptions to requirements established by state statute or federal regulations. Operators wishing to obtain waivers of regulations under Title XVIII or Title XIX of the Social Security Act shall follow procedures established by the Centers for Medicare and Medicaid (CMS).

(5) When the department issues a notice of noncompliance to a facility pursuant to the Omnibus Nursing Home Act (section 198.026, RSMo), the department, only after affording the facility operator a reasonable opportunity to remedy the situation, shall— (A) Make every reasonable effort to provide residents of the facility or their legally authorized representatives or designees, if any— 1. A written notice of the noncompliance;

A list of other licensed facilities appropriate to the resident’s needs; and 3. A list of agencies that will assist the resident if he/she moves from the facility; and (B) After providing the information required by subsection (5)

(A) and allowing a time period for the residents of the facility to relocate if they wish, notify the Social Security Administration in writing that a notice of noncompliance has been issued to the facility, and the effective date of the notice. If the facility achieves substantial compliance with standards and rules later, the department shall notify the Social Security Administration of the effective date of the facility’s substantial compliance.

(6) A licensed facility shall comply with the provisions of Title VI of the Civil Rights Act 1964, as amended; Section 504 of the Rehabilitation Act of 1973; Title IX of the Education Amendment of 1972; the Age Discrimination Act of 1975; the Omnibus Budget and Reconciliation Act of 1982; the Americans with Disabilities Act of 1990; and the Keyes Amendment to the Social Security Act. No person shall be denied admission to, be denied benefits of, or be subjected to discrimination under any program, activity, or service provided by the facility based on his/her race, color, national origin, sex, religion, age, or disability, including Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS). Every licensed facility shall complete and sign form MO 580-2622 (9-05), Assurance of Compliance, incorporated by reference in this

rule and available through the department’s website at www. dhss.mo.gov or by telephone at (573) 526-8505 and file the form with the application for licensure or relicensure. This rule does not incorporate any subsequent amendments or additions.

(7) The department shall make available by Internet at www. dhss.mo.gov to interested individuals or without charge a single copy of— (A) A complete set of the standards promulgated for each type of facility;

(B) An explanation of the procedures used in the state to ensure the enforcement of standards;

(C) A list of any facilities granted exception from a standard, including the justification for the exception; and (D) A list of any facilities issued notices of noncompliance, including the details of the noncompliance.

(8) Every skilled nursing facility, intermediate care facility, residential care facility, and assisted living facility issued a license or temporary operating permit by the department shall submit the required certificate of need quarterly surveys to the department on or before the fifteenth day of the first month following the previous Social Security quarter. (For example, for the Social Security quarter ending December 31, the due date is by January 15; for the Social Security quarter ending March 31, the due date is by April 15; for the Social Security quarter ending June 30, the due date is by July 15; and for the Social Security quarter ending September 30, the due date is by October 15). The information shall be submitted on the ICF/ SNF Certificate of Need Quarterly Survey form or the RCF/ALF Certificate of Need Quarterly Survey form obtained from the Missouri Certificate of Need Program, PO Box 570, Jefferson City, MO 65102.

Emergency rule filed Sept. 7, 1979, effective Sept. 28, 1979, expired Jan. 24, 1980. Original rule filed Sept. 7, 1979, effective Jan. 12, 1980. Emergency amendment filed Jan. 15, 1980, effective Jan. 25, 1980, expired May 1, 1980. Amended: Filed Jan. 15, 1980, effective May 11, 1980. Amended: Filed Dec. 10, 1980, effective May 11, 1981.

Amended: Filed Dec. 7, 1981, effective May 11, 1982. Rescinded and readopted: Filed July 13, 1983, effective Oct. 13, 1983. Emergency amendment filed Aug. 1, 1984, effective Aug. 13, 1984, expired Dec. 10, 1984. Amended: Filed Sept. 12, 1984, effective Dec. 13, 1984.

Amended: Filed June 17, 1986, effective Oct. 24, 1986. Amended:

Filed Aug. 1, 1988, effective Nov. 10, 1988. Emergency amendment filed Aug. 14, 1992, effective Aug. 28, 1992, expired Dec. 25, 1992.

Rescinded and readopted: Filed April 14, 1993, effective Oct. 10, 1993. Amended: Filed Feb. 13, 1998, effective Sept. 30, 1998. Moved to 19 CSR 30-82.010, effective Aug. 28, 2001. Amended: Filed Aug. 23, 2006, effective April 30, 2007. Amended: Filed March 13, 2008, effective Oct. 30, 2008. ** Emergency amendment filed Nov. 10, 2021, effective Nov. 29, 2021, expired May 27, 2022. Amended: Filed Nov. 10, 2021, effective May 30, 2022. *Original authority: 198.018, RSMo 1979, amended 1984, 1987, 1988, 1994, 2007, 2014; 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006, 2007; 198.076, RSMo 1979, amended 1984, 2007; and 198.079, RSMo 1979, amended 2007. **Pursuant to Executive Order 21-07, 19 CSR 30-82.010, paragraphs (4)(A)1.-3. and subsection (4)(B) was suspended from April 22, 2020 through August 31, 2021.

History

AUTHORITY: sections 198.018, 198.073, 198.076, and 198.079, RSMo 2016. This rule was originally filed as 13 CSR 15-10.010.

19 CSR 30-82.015 Long-Term Care Receiverships {#sec-19-csr-30-82.015 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-82.015}

PURPOSE: This rule establishes guidelines for the determination of qualified receivers, maintenance of the list of receivers, and the selection and removal of receivers.

(1) A person requesting to act as a receiver shall submit a completed application to the department. The application shall include the following information:

(A) Full name of the receiver, date of birth and Social Security number;

(B) Information that establishes the receiver has the necessary experience to operate a long-term care facility or the ability to contract with another party for the operation of a facility; and (C) Information that establishes the receiver has the financial capacity to operate a long-term care facility as a receiver in compliance with state laws and regulations.

(2) Based on the information submitted in the application, if the applicant has the necessary experience to operate a long-term care facility or the ability to contract with another party for the operation of a facility and the financial capacity to operate a facility, and the applicant does not have any disqualifying characteristics, the applicant will be approved to be a receiver. Disqualifying characteristics are defined as:

(A) The applicant has been convicted of a felony offense in any state or federal court arising out of conduct involving the operation or management of a long-term care facility or other health care facility or the provision or receipt of health care;

(B) The applicant has ever knowingly acted or knowingly failed to perform any duty which materially and adversely affected the health, safety, welfare or property of a resident of a long-term care facility, while acting in a management capacity; or (C) The applicant is under exclusion from participation in the Title XVIII (Medicare) or Title XIX (Medicaid) program of any state or territory.

(3) Once a completed application is received and approved, the person will be placed on the list of qualified receivers.

Receivers will be placed on the list in the order their completed application was received. If two (2) or more completed applications are received on the same day, and any two (2) or more are approved, they will be placed on the list of qualified receivers in alphabetical order according to the receivers’ last names.

(4) If any of the information in an application changes, or if a qualified receiver has any change of status, including a change in disqualifying characteristics, that could affect his/her ability to serve as a receiver, he/she must notify the department in writing within ten (10) working days. Given the additional information, the department will make a determination as to whether the receiver remains qualified to act as a receiver.

If the receiver is no longer qualified, his/her name will be removed from the list of qualified receivers. The department will notify the receiver in writing of the removal.

(5) If the department otherwise becomes aware of a change in any information in the application or a change in status of a qualified receiver that affects the receiver’s ability to serve as a receiver, the department may remove the receiver from the list of qualified receivers. The department will notify the receiver in writing of the removal.

(6) If a receiver no longer wishes to be included on the list of qualified receivers, the receiver shall notify the department in writing of his/her desire to be removed from the list and the effective date of the removal.

History

AUTHORITY: sections 198.009, RSMo 2000 and 198.105, RSMo Supp. 2003. Emergency rule filed Sept. 12, 2003, effective Sept. 22, 2003, expired March 19, 2004. Original rule filed Sept. 12, 2003, effective Feb. 29, 2004. Original authority: 198.009, RSMo 1979, amended 1993, 1995 and 198.105, RSMo 1979, amended 1984, 2003.

19 CSR 30-82.020 Classification of Rules {#sec-19-csr-30-82.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-82.020}

PURPOSE: This rule adds to the classification of the standards for long-term care facilities as cited in chapters 13 CSR 15-12, 13 CSR 15-14, 13 CSR 15-15 and 13 CSR 15-16 and as required in section 198.085.1, RSMo.

(1) All rules relating to long-term care facilities licensed by the Division of Aging, other than those rules which are informational in character, shall be followed by a notation at the end of each rule, section, subsection or pertinent part. This notation shall consist of a Roman numeral(s). These Roman numerals refer to the class (either class I, class II or class III) of standard as designated in section 198.085.1, RSMo and will be used when that rule, section, subsection or portion of a rule carrying the notation is violated by the facility.

(2) In those instances where a particular rule, section, subsection or portion of a rule is followed by a notation consisting of more than one (1) Roman numeral, the lower classification shall be applied unless the division can show that the higher classification is merited because of the extent of the violation, the violations effect on residents or the impact when combined with other deficiencies. The division, on the Statement of Deficiency, shall indicate for the operator which classification has been applied and if the higher one is used, for what reason.

(3) A violation of a class I standard is one which would present either an imminent danger to the health, safety or welfare of any resident or a substantial probability that death or serious physical harm would result. If a violation of a class I standard is not immediately corrected, or corrective action instituted, the division shall proceed as required under section 198.029, RSMo.

The division shall also take all other necessary steps to protect the health, safety or welfare of a resident which may include: initiation of license revocation action under section 198.036, RSMo; initiation of an action under section 198.067, RSMo; injunctive relief or assessment of a civil penalty, initiation of an action under section 198.070.6, RSMo; protection of residents from further abuse or neglect; initiation of an action under

section 198.105 or 198.108, RSMo for appointment of a receiver; and appointment of a monitor under section 198.103, RSMo.

(4) A violation of a class II standard is one which has a direct or immediate relationship to the health, safety or welfare of any resident, but which does not create any imminent danger.

When a violation is noted, the operator shall either correct the violation immediately or prior to the time of the reinspection or shall be correcting it in accordance with the time schedules set out in the operator’s approved plan of correction, as provided for under section 198.026.2, RSMo. If not, or the plan of correction is not approved and the violation not corrected, the violation will constitute substantial noncompliance under the Omnibus Nursing Home Act. After review by the division director or his/her designee, the division may initiate any action authorized by law, including those provided for in sections 198.026, 198.036, 198.067, 198.070.6, 198.103, 198.105 and 198.108, RSMo. Where specific standards are set out in sections 198.003–198.186, RSMo and are not otherwise classified, those standards will be treated as class II standards.

(5) A violation of a class III standard is one which has an indirect or a potential impact on the health, safety or welfare of any resident. When a violation is noted, the operator shall either correct the violation immediately or prior to the time of the reinspection, or shall be correcting it in accordance with the time schedules set out in the operator’s approved plan of correction as provided for under section 198.026, RSMo. If not, if the plan of correction is not approved and the violation not corrected, a point value of one (1) point each will be noted for violations of each distinct class III standard not corrected; however, the points will not be assessed if there are five (5) or fewer class III standards violated.

(A) If the points total twenty (20) or more points, the facility will be deemed to be in substantial noncompliance under the Omnibus Nursing Home Act and the division may initiate any action as authorized by law, including issuance of a notice of noncompliance, as provided under section 198.026, RSMo.

(B) If the points total less than twenty (20) points, the points will remain on the facility’s record until the time the violations are corrected and are noted as corrected during a reinspection. If during the reinspection a class III standard violated in the prior inspection continues to be violated, the previously assessed points will be doubled unless the operator immediately corrects the violation. If after the reinspection the points for all previously noted and left uncorrected violations of distinct class III standards total twenty (20) or more, the facility will be deemed to be in substantial noncompliance under the Omni-bus Nursing Home Act and the division may take action as provided under section 198.026, RSMo.

(C) The division shall not revoke an operator’s license to operate a long-term care facility for violations of class III standards unless— 1. The uncorrected violations taken all together present either an imminent danger to the health, safety or welfare of any resident or a substantial probability of death or serious physical harm; or 2. The operator or his/her agent knowingly acted or knowingly omitted any duty which would materially and adversely affect the health, safety, welfare or property of a resident.

(D) Points will not be assessed for class III violations if the operator can show that the violation had been corrected since it was initially noted, that the operator made a good faith effort, as judged by the division, to stay in compliance and that the violation again occurred for reasons beyond the operator’s control.

(6) The division shall not initiate any action against an operator as authorized by law, including issuance of a notice of noncompliance for uncorrected violations of class II or III standards, unless the facility’s record, the cited violations and the circumstances are reviewed by the director of the division or his/her designee.

rule was originally filed as 13 CSR 15-10.020. Original rule filed Dec. 10, 1981, effective May 13, 1982. Amended: Filed July 13, 1983, effective Oct. 13, 1983. Moved to 19 CSR 30-82.020, effective Aug. 28, 2001. *Original authority: 198.009, RSMo 1979 and 198.085, RSMo 1979, amended 1984.

History

AUTHORITY: sections 198.009 and 198.085.1, RSMo 1986. This

19 CSR 30-82.030 Assessment of Availability of Beds {#sec-19-csr-30-82.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-82.030}

(Rescinded March 30, 2020)

rule filed June 17, 1986, effective June 27, 1986, expired Oct. 24, 1986. Original rule filed June 17, 1986, effective Oct. 24, 1986.

Moved to 19 CSR 30-82.030, effective Aug. 28, 2001. Rescinded:

Filed Aug. 28, 2019, effective March 30, 2020.

History

AUTHORITY: sections 197.318, RSMo Supp. 1992 and 198.009, RSMo 1986. This rule was originally filed as 13 CSR 15-10.030. Emergency

19 CSR 30-82.050 Transfer and Discharge Procedures {#sec-19-csr-30-82.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-82.050}

PURPOSE: This rule provides instructions for persons who are discharged from a licensed long-term care facility under involuntary circumstances. When this proposed rule becomes effective it will replace 13 CSR 15-9.010(17) which will be rescinded by subsequent rulemaking. This rule also includes the provisions of section 198.088, RSMo, applicable to transfer or discharge and the notice and due process required of all licensed facilities.

(1) For the purposes of this rule, the following terms shall be defined as follows:

(A) Transfer means moving a resident from one institutional setting to another institutional setting for care and under circumstances where the releasing facility has decided that it will not readmit the resident or a legally authorized representative of the resident has not consented or agreed with the transfer. Unless indicated otherwise from the context of this rule, a transfer shall be deemed the same as a discharge;

(B) Discharge means releasing from a facility or refusing to readmit a resident from a community setting under circumstances where the resident or a legally authorized representative of the resident has not consented or agreed with the move or decision to refuse readmittance. Refusal to readmit a former resident shall not constitute a discharge if the former resident has been absent from the facility for more than ninety (90) days;

The resident or a legally authorized representative of the resident has consented to, agreed with, or requested the discharge; or 2. The resident’s treating physician has ordered the transfer and the releasing facility intends to readmit the resident if requested to do so;

(D) Consent of the resident means that the resident, with sufficient mental capacity to fully understand the effects and consequences of the transfer or discharge, consents to or agrees with the transfer or discharge; and (E) Legally authorized representative of a resident means a duly appointed guardian or an attorney-in-fact who has current and valid power to make health care decisions for the resident.

(2) The facility shall permit each resident to remain in the facility unless— (A) The transfer or discharge is appropriate because the resident’s welfare and the resident’s needs cannot be met by the facility;

(B) The transfer or discharge is appropriate because the resident’s health has improved sufficiently so the resident no longer needs the services provided by the facility;

(D) The health of individuals in the facility would otherwise be endangered;

(E) The resident has failed, after reasonable and appropriate notice, to pay for (or have paid under Medicare or Medicaid) a stay at the facility. For a resident who becomes eligible for Medicaid after admission to a facility, the facility may charge that resident only allowable charges under Medicaid; or (F) The facility ceases to operate.

(3) When the facility transfers or discharges a resident under any of the circumstances specified in subsections (2)(A)–(E), the resident’s clinical record shall be documented. The facility shall ensure that documentation for the transfer or discharge is obtained from— (A) The resident’s personal physician when transfer or discharge is necessary under subsections (2)(A)–(B); and (B) A physician when transfer or discharge is necessary under subsection (2)(D); and (C) The facility administrator or the facility director of nursing in all circumstances.

(4) Before a facility transfers or discharges a resident, the facility shall— (A) Send written notice to the resident in a language and manner reasonably calculated to be understood by the resident. The notice must also be sent to any legally authorized representative of the resident and to at least one (1) family member. In the event that there is no family member known to the facility, the facility shall send a copy of the notice to the appropriate regional coordinator of the Missouri State Ombudsman’s office;

(B) Include in the written notice the following information:

The reason for the transfer or discharge;
The effective date of transfer or discharge;
The resident’s right to appeal the transfer or discharge notice to the director of the Department of Health and Senior Services or his/her designated hearing official within thirty (30) days of the receipt of the notice;
That a request for a hearing should be sent to Department of Health and Senior Services Appeals Unit, PO Box 570, 912 Wildwood Drive 3rd floor, Jefferson City, Missouri 65102-0570, by fax to (573) 751-0247, or by email to DHSS.Appeals@health. mo.gov and the phone number for the appeals unit is (573) 522-1699;
That filing an appeal will allow a resident to remain in the facility until the hearing is held unless a hearing official finds otherwise;
The location to which the resident is being transferred or discharged;
The name, address, and telephone number of the designated regional long-term care ombudsman office;
For Medicare and Medicaid certified facility residents with developmental disabilities, the mailing address and telephone number of the Missouri Protection and Advocacy Agency, 925 South Country Club Drive, Jefferson City, MO 65109, (573) 893-3333, or the current address and telephone number of the protection advocacy agency if it has changed.

The protection and advocacy agency is responsible for the protection and advocacy of developmentally disabled individuals established under Part C of the Developmental Disabilities Assistance and Bill of Rights Act. For Medicare and Medicaid certified facility residents with mental illness, the address and telephone number of Missouri Protection and Advocacy Agency, the agency responsible for persons with mental illness under the Protection and Advocacy for Mentally Ill Individuals Act; and (C) Record and document in detail in each affected resident’s record the reason for the transfer or discharge. The recording of the reason for the transfer or discharge shall be entered into the resident’s record prior to the date the resident receives notice of the transfer or discharge, or prior to the time when the transferring or discharging facility decides to transfer or discharge the resident.

(5) The notice of transfer or discharge described in this rule shall be made by the facility no less than thirty (30) days before the resident is to be transferred or discharged. In the case of an emergency discharge, the notice shall be made as soon as practicable before the discharge when it is specifically alleged in the notice that— (A) The safety of individuals in the facility would be endangered under subsection (2)(C) of this rule and the notice contains specific facts upon which the facility has based its determination that the safety of said individuals would be so endangered;

(B) The health of individuals in the facility would be endangered under subsection (2)(D) of this rule and the notice contains specific facts upon which the facility has based its determination that the safety of said individuals would be so endangered;

(B) of this rule;

(D) An immediate transfer or discharge is required by the resident’s urgent medical needs under subsection (2)(A) of this

rule; or (E) The resident has not resided in the facility for thirty (30) days.

(6) Any resident of a facility who receives notice of discharge from the facility in which he/she resides may file an appeal of the notice with the Department of Health and Senior Services Appeals Unit, PO Box 570, 912 Wildwood Drive 3rd floor, Jefferson City, Missouri 65102-0570, by fax to (573) 751-0247, or by email to DHSS.Appeals@health.mo.gov within thirty (30) days of the date the resident received the discharge notice from the facility. The resident’s legal guardian, the resident’s attorney-in-fact appointed under sections 404.700–404.725, RSMo (Durable Power of Attorney Law of Missouri) or pursuant to sections 404.800–404.865, RSMo (Durable Power of Attorney for Health Care Act), or any other individual may file an appeal on the resident’s behalf. A Nursing Facility Transfer or Discharge Hearing Request form (MO Form 886-3245) to request a hearing may be obtained from the Department of Health and Senior Services or the regional ombudsman. However, the use of a form is not required in order to file a request for a hearing.

The request for a hearing shall be verified in writing by the resident, his/her legal guardian, attorney-in-fact, or any other party requesting a hearing on the resident’s behalf by attesting to the truth of the resident’s request for a hearing.

(7) The director of the Department of Health and Senior Services shall designate a hearing official to hear and decide the resident’s appeal.

(A) The designated hearing official shall notify the resident, the state long-term care ombudsman and the facility that the request for a hearing has been received and that a hearing has been scheduled.

(B) The hearing may be held by telephone conference call or in person at any location the designated hearing official deems reasonably appropriate to accommodate the resident’s needs.

(8) The discharge of the resident shall be stayed at the time the request for a hearing was filed unless the facility can show good cause why the resident should not remain in the facility until a written hearing decision has been issued by the designated hearing official. Good cause shall include, but is not limited to, those exceptions when the facility may notify the resident of a discharge from the facility with less than thirty (30) days notice as set forth in section (5) of this rule.

(A) The facility may show good cause for discharging the resident prior to a hearing decision being issued by the designated hearing official by filing a written Motion to Set Aside the Stay with the Department of Health and Senior Services Appeals Unit at the address, fax number, or email address in paragraph (4)(B)4. The facility must provide a copy of the Motion to Set Aside the Stay to the resident, or to the resident’s legally authorized representative and to at least one (1) family member, if one is known. In the event that a resident has no legally authorized representative and no known family members, then a copy of the Motion to Set Aside the Stay must be provided to the Missouri State Long-Term Care Ombudsman’s Office.

(B) Within five (5) days after a written Motion to Set Aside the Stay has been filed with the Department of Health and Senior Services Appeals Unit the designated hearing official shall schedule a hearing to determine whether the facility has good cause to discharge the resident prior to a written hearing decision being issued. Notice of the good cause hearing need not be in writing. All parties and representatives who received a copy of the Motion to Set Aside the Stay under subsection (8)

(A) of this rule shall also be notified of the good cause hearing.

The designated hearing official shall have the discretion to consolidate the facility’s good cause hearing with the discharge hearing requested by the resident. In the case of an emergency discharge, an expedited hearing shall be held upon the request of the resident, legally authorized representative, family member, and in a case where notice was required to be sent to the regional ombudsman, to the state long-term care ombudsman, so long as the parties waive the ten- (10-) day notice requirement specified in section (9).
Subsequent to the good cause hearing, the designated hearing official shall issue an order granting or denying the facility’s Motion to Set Aside the Stay. If the facility’s good cause hearing and the resident’s discharge hearing were consolidated, the order shall also set forth whether the facility may discharge the resident.

(9) Written notice of a hearing shall contain the date and time for the hearing and shall be mailed to the facility, the resident or the resident’s legally authorized representative, and to any and all parties in interest, including any family members who received notice of the discharge, that are known to the designated hearing official. The written notice shall be mailed to the parties at least ten (10) days prior to the hearing.

(10) If the facility’s good cause hearing and the resident’s discharge hearing were not consolidated and the designated hearing official issues an order denying the facility’s Motion to Set Aside the Stay, the designated hearing official shall schedule the discharge hearing subsequent to the date the order which denied the facility’s motion was issued. After the hearing, the designated hearing official shall issue a written decision setting forth whether the facility may discharge the resident. The written decision shall be mailed to the facility, the resident or the resident’s legally authorized representative and counsels for all parties, if any. If the state long-term care ombudsman’s office received notice of the discharge, a copy of the hearing decision shall be sent to the ombudsman’s office.

If a member of the resident’s family received notice of the discharge, a copy of the hearing decision shall be mailed to the family member upon request.

(11) The burden of showing that the facility has complied with all requirements for appropriate discharge of the resident shall be upon the facility. The resident may provide any additional evidence competent to show that the facility has not met its burden.

(12) The resident may obtain legal counsel, represent him/ herself or use a relative, a friend or other spokesperson. All natural parties, including residents, sole proprietors of a facility and a partner of a facility operated in the partnership form of business, may represent themselves in a pro se capacity on behalf of the facility. Corporate operators of a facility may only be represented by an attorney licensed to practice law in Missouri.

(13) Hearings shall be subject to the hearing procedures found in 42 CFR Chapter IV, Part 483, subpart E, and the Missouri Administrative Procedures Act, specifically sections 536.070 through 536.080, RSMo, which include, but are not limited to, oral and written evidence, witnesses, objections, official notices, affidavits, transcripts, depositions and other discovery methods, sanctions, oral arguments and written briefs. Written medical statements by a physician, psychiatrist or psychologist shall be admitted as relevant and probative evidence and shall be given due weight in consideration by the director or his/ her designated hearing official. An audiotape recording of the hearing shall be made unless it is agreed by both parties to substitute a certified transcript.

(14) If the decision is that there is no cause for discharge, the resident shall be permitted to remain in the facility. If the decision is in the facility’s favor, the resident shall be granted an additional ten (10) days after the decision is received for

purpose of relocation, and the facility shall assist the resident in making suitable arrangements for relocation. If the resident prevails and has already been discharged, the facility shall notify the resident, the qualified representative, or any other responsible party who will assure that the resident is made aware of the decision and that the resident may return to the facility. In the event that there are no beds available, the facility shall admit the resident to occupy the first available bed without regard to any waiting list maintained by the facility.

rule filed Feb. 13, 1998, effective Sept. 30, 1998. Moved to 19 CSR 30-82.050, effective Aug. 28, 2001. Amended: Filed Sept. 1, 2021, effective March 30, 2022.

Original authority: 192.2000, RSMo 1984, amended 2014; 198.009, RSMo 1979, amended 1993, 1995; and 198.088, RSMo 1997, amended 1988, 1989, 1994.

History

AUTHORITY: sections 192.2000, 198.009, and 198.088, RSMo 2016. This rule was originally filed as 13 CSR 15-10.050. Original

19 CSR 30-82.060 Hiring Restrictions—Good Cause Waiver {#sec-19-csr-30-82.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-82.060}

PURPOSE: This rule establishes the procedure by which persons with criminal convictions may seek a waiver allowing them to be employed by health care and mental health providers despite the hiring restrictions found in section 192.2495, RSMo. The waivers are to be for “good cause” as defined by that statute. This rule sets forth both the procedure for seeking waivers and the facts and circumstances to be considered by the Department of Health and Senior Services in determining “good cause.”

(1) Definitions.

(A) Applicant means a person who has been or would be rejected for employment by a provider due to the hiring restrictions found in section 192.2495, RSMo.

(B) Department means the Department of Health and Senior Services.

(C) Determination means the decision issued by the director of the Department of Health and Senior Services or the director’s designee based on the factual, procedural, or causal issues of the request for waiver.

(D) Director means the director of the Department of Health and Senior Services.

(E) Good cause waiver means a finding that is reasonable to believe that the restrictions imposed by section 192.2495, RSMo, on the employment of an applicant may be waived after an examination of the applicant’s prior work history and other relevant factors is conducted and demonstrates that such applicant does not present a risk to the health or safety of residents, patients, or clients if employed by a provider.

(F) Provider means any person, corporation or association who— 1. Is licensed as an operator pursuant to Chapter 198, RSMo;

Provides in-home services under contract with the Department of Health and Senior Services;
Employs nurses or nursing assistants for temporary or intermittent placement in health care facilities;
Is an entity licensed pursuant to Chapter 197, RSMo;
Is a public or private facility, day program, residential facility or specialized service operated, funded or licensed by the Department of Mental Health; or 6. Is a licensed adult day care provider.

(G) Reference means a written statement of character, qualification or ability issued on behalf of the applicant by a person who is not related to or residing with the applicant requesting a good cause waiver.

(H) Sponsor means the current or potential employer of the applicant, or a training program, agency, or school in which the applicant is or was a student enrolled for the purpose of earning a professional license, certification, or otherwise becoming qualified to perform the duties of an occupation.

(2) Any person who is not eligible for employment by a provider due to the hiring restrictions found in section 192.2495, RSMo, may apply to the director for a good cause waiver. If the director or the director’s designee determines that the applicant has demonstrated good cause, such restrictions prohibiting such persons from being hired by a provider shall be waived, and such persons may be so employed unless rejected for employment on other grounds. Hiring restrictions based on the Department of Health and Senior Services’ employee disqualification list are not subject to a waiver.

(3) The director, or the director’s designee, shall accept an application for a good cause waiver only if the application— (A) Is submitted in writing by the applicant on the form provided by the department;

(B) Is legible;

(D) Includes an indication of the type of waiver that is being requested;

(E) Includes a complete history of residency since the earliest disqualifying offense or incident;

(F) Includes a complete employment history since the age of eighteen (18) years;

(G) Includes an attached explanation written by the applicant as to why the applicant believes he or she no longer poses a risk to the health, safety, or welfare of residents, patients or clients;

(H) Includes an attached description written by the applicant of the events that resulted in each disqualifying offense or incident;

(I) Includes attached documentation on the applicant’s professional, vocational, or occupational licensure, certification, or registration history and current status, if any, in this state and any other state;

(J) Includes at least one (1) reference letter from a sponsor.

If the applicant is not able to obtain a sponsor, the applicant shall so state, shall identify those potential sponsors who have been approached by the applicant, and shall submit three (3) reference letters from individuals knowledgeable of the applicant’s character or work history who are not related to or residing with the applicant;

(K) Includes a criminal history record from the Missouri State Highway Patrol if requesting a waiver of disqualifying criminal offenses;

(L) Includes a certified court document for each disqualifying criminal offense. If such document is not obtainable, a written and signed statement from the court indicating that no such record exists must be submitted;

(M) Includes certified investigative reports from the Department of Social Services if requesting a waiver of child abuse or neglect findings or a waiver of foster parent license denial, revocation, or involuntary suspension;

(N) Includes certified investigative reports or other documentation of the incident(s) which resulted in the applicant’s inclusion on all other lists in the Family Care Safety Registry for which waiver is requested; and (O) If in addition to the criminal offense(s) for which the applicant is requesting a waiver the applicant has any pending felony or misdemeanor charges, includes a statement explaining the circumstances and certified copies of the charging documents for all pending criminal charges; and, in the case of an applicant seeking a position with an in-home services provider agency or home health agency, if in addition to the circumstances related to the listing on any of the background checklists of the Family Care Safety Registry for which the applicant is requesting a waiver the applicant has any pending circumstances which if established would lead to an additional listing on any of the background checklists of the Family Care Safety Registry, includes a statement explaining the circumstances and certified copies of documents relating to those circumstances.

(4) The director, or the director’s designee, will not consider any application for a good cause waiver unless it is fully completed, signed by the applicant, and contains all required attachments.

(5) Each completed application will be reviewed by a good cause waiver committee of two (2) or more employees of the department. The director shall determine the size of the committee and shall, from time to time, appoint members to serve on the committee.

(A) If the applicant seeks a good cause waiver of placement on the disqualification list maintained by the Department of Mental Health, the director shall appoint an employee of the Department of Mental Health recommended by the director of the Department of Mental Health to serve on the good cause waiver committee.

(B) A member of the good cause waiver committee shall recuse himself or herself in a good cause waiver review in which the member’s impartiality might reasonably be questioned, including but not limited to instances where the committee member has a personal bias or prejudice concerning the applicant, or personal knowledge of evidentiary facts concerning the application for good cause waiver.

(6) The department may, at any time during the application process or review thereof, request additional information from the applicant. If the applicant fails to supply any requested additional information within thirty (30) calendar days of the date of the request, unless the applicant requests and the department grants an extension, the department will consider the application for good cause waiver to be withdrawn by the applicant.

(7) The department may request that the applicant, prior to the completion of the review, appear in person to answer questions about his or her application. If the applicant is requested to appear in person, the department, in its sole discretion, shall determine the location for the appearance and may conduct any such proceedings using electronic means, including but not limited to telephonic or video conferencing. The department shall review and may investigate the information contained in each application for completeness, accuracy, and truthfulness. The burden of proof shall be on the applicant to demonstrate that he or she no longer poses a risk to the health, safety, or welfare of residents, patients, or clients. The following factors shall be considered in determining whether a good cause waiver should be granted:

(A) The applicant’s age at the time the crime was committed or at the time the incident occurred that resulted in the applicant being listed on the background checklists in the Family Care Safety Registry;

(B) The circumstances surrounding the crime or surrounding the incident that resulted in the applicant being listed on the background checklists in the Family Care Safety Registry;

(C) The length of time since the conviction or since the occurrence of the incident that resulted in the applicant being listed on the background checklists in the Family Care Safety Registry;

(D) The length of time since the applicant completed his or her sentence for the disqualifying conviction(s), whether or not the applicant was confined, conditionally released, on parole or probation;

(E) The applicant’s entire criminal history and entire history of all incidents that resulted in the applicant being listed on the background checklists in the Family Care Safety Registry, including whether that history shows a repetitive pattern of offenses or incidents;

(F) The applicant’s prior work history;

(G) Whether the applicant had been employed in good standing by a provider but subsequently became ineligible for employment due to the hiring restrictions in section 192.2495, RSMo;

(H) Whether the applicant has been convicted or found guilty of, or pled guilty or nolo contendere to any offense displaying extreme brutality or disregard for human welfare or safety;

(I) Whether the applicant has omitted a material fact or misrepresented a material fact pertaining to his or her criminal or employment history or to his or her history of incidents that resulted in his or her being listed on the background checklists in the Family Care Safety Registry;

(J) Whether the applicant has ever been listed on the Employee Disqualification List maintained by the department;

(K) Whether the applicant’s criminal offenses were committed, or the incidents that resulted in the applicant being listed on the background checklists in the Family Care Safety Registry occurred, during the time he or she was acting as a provider or as an employee for a provider;

(L) Whether the applicant has, while disqualified from employment by a provider, obtained employment by fraud, deceit, deception or misrepresentation, including misrepresentation of his or her identity;

(M) Whether the applicant has ever had a professional or occupational license, certification, or registration revoked, suspended, or otherwise disciplined;

(N) Any other information relevant to the applicant’s employment background or past actions indicating whether he or she would pose a risk to the health, safety, or welfare of residents, patients, or clients; and (O) Whether the applicant has supplied all information requested by the department.

(8) If, at the time of an application for a waiver or during the waiver consideration process, the applicant has been charged or indicted for, but not convicted of, any of the crimes covered under the provisions of section 192.2495, RSMo, the division will hold the request for waiver in abeyance while such charges are pending or until a court of competent jurisdiction enters a judgment or order disposing of the matter.

(9) Each applicant who submits a waiver application meeting the requirements of section (3) of this rule shall be notified in writing by the director, or the director’s designee, as to whether his or her application has resulted in a determination of good cause or no good cause. Such notification shall be effective if sent to the applicant’s address given on the application.

(10) Any good cause waiver granted to an applicant applies only to— (A) The specific disqualifying conviction(s), finding(s) of guilt, plea(s) of guilty or nolo contendere, as contained in the certifying copies of the court documents which are required in the application; and/or (B) The incident(s) that resulted in the applicant being listed on the background checklists in the Family Care Safety Registry, as contained in the investigative reports or other supporting documentation required in the application or subsequently requested by the department.

(11) Any good cause waiver granted to applicant applies only to those disqualifying criminal convictions on incidents that resulted in the applicant being listed on the background checklists in the Family Care Safety Registry, as covered under the provisions of section 192.2495, RSMo, and shall not apply to any other hiring restriction or exclusion imposed by any other federal or state laws or regulations.

(12) The director or the director’s designee may withdraw a good cause waiver if he or she receives information or finds that— (A) The applicant has omitted a material fact or misrepresented a material fact in seeking a good cause waiver;

(B) The applicant has been subsequently convicted or found guilty of or pled guilty or nolo contendere to any class A or B felony violation of Chapter 565, 566, or 569, RSMo, or any violation of subsection 3 of section 198.070, RSMo, or section 568.020, RSMo, in this state or any other state;

(C) Such applicant is a prospective or current employee of an in-home services provider or home health agency and has been subsequently involved in an incident that results in the applicant being listed on any of the background checklists in the Family Care Safety Registry;

(D) The applicant has omitted, misrepresented, or failed to disclose or provide any of the information required by section 192.2495, RSMo, or the provisions of this rule; or (E) There has been a material change in the circumstances upon which the good cause waiver was granted.

(13) If the good cause waiver is withdrawn by the department, the notice of such withdrawal shall be mailed by the department to the applicant’s last known address, with a copy of the notice sent to the applicant’s last known employer, if any.

(14) No applicant may be employed in a direct care or direct service position with a provider during the pendency of a request for waiver unless the applicant has been continuously employed by that provider prior to August 28, 2003. If an applicant is employed on or after August 28, 2003, he or she may be employed following submission of a completed waiver application on a conditional basis to provide in-home services or home health services to any in-home services client or home health patient during the pendency of that waiver application if— (A) The disqualifying crime is not one that would preclude employment pursuant to subsection 6 of section 192.2495, RSMo; and (B) The applicant is not listed on the Department of Health and Senior Services’ employee disqualification list.

(15) If a waiver is denied to an applicant employed on or after August 28, 2003, on a conditional basis, the conditional employment shall immediately terminate.

(16) Applicants who have been denied a good cause waiver, or who have had their good cause waivers withdrawn by the department, may reapply one (1) time every twelve (12) months, or whenever the circumstances related to the disqualifying conviction(s) have changed.

(17) Each provider shall be responsible for— (A) Requesting criminal background checks on all prospective employees, regardless of waiver status, in accordance with the provisions of sections 192.2495 and 43.540, RSMo; and (B) Contacting the department to confirm the validity of a prospective employee’s good cause waiver prior to hiring the prospective employee if the prospective employee reveals the existence of a good cause waiver or reveals the existence of an otherwise disqualifying circumstance.

(18) Each in-home services provider or home health provider shall also be responsible for— (A) Requesting Family Care Safety Registry background screenings on all prospective employees, regardless of waiver status, in accordance with the provisions of section 192.2495, RSMo; and (B) Contacting the department to confirm the validity of a prospective employee’s good cause waiver prior to hiring the prospective employee if the prospective employee reveals the existence of a good cause waiver or reveals the existence of an otherwise disqualifying circumstance.

(19) All applications for good cause waivers and related documents shall become permanent records maintained by the department.

section 192.2495, RSMo Supp. 2025.* This rule was originally filed as 13 CSR 15-10.060. Emergency rule filed March 1, 1999, effective March 30, 1999, expired Jan. 10, 2000. Original rule filed March 1, 1999, effective Sept. 30, 1999. Moved to 19 CSR 30-82.060, effective Aug. 28, 2001. Emergency amendment filed Oct. 15, 2003, effective Oct. 26, 2003, expired April 22, 2004. Amended: Filed Oct. 15, 2003, effective April 30, 2004. Amended: Filed Aug. 27, 2025, effective April 30, 2026. *Original authority: 192.006, RSMo 1993, amended 1995; 192.2000, RSMo 1984, amended 1988, 1992, 1993, 1994, 1995, 2001, 2014; and 192.2495, RSMo 1996, amended 1997, 1998, 2003, 2014, 2016, 2018.

History

AUTHORITY: sections 192.006 and 192.2000, RSMo 2016, and

19 CSR 30-82.070 Alzheimer’s Demonstration Projects {#sec-19-csr-30-82.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-82.070}

(Rescinded September 30, 2013)

History

AUTHORITY: section 198.534, RSMo Supp. 1999. This rule was originally filed as 13 CSR 15-10.070. Emergency rule filed April 14, 2000, effective April 24, 2000, expired Feb. 1, 2001. Original rule filed April 14, 2000, effective Nov. 30, 2000. Moved to 19 CSR 30- 82.070, effective Aug. 28, 2001. Rescinded: Filed March 11, 2013, effective Sept. 30, 2013.

19 CSR 30-82.080 Nursing Facility Quality of Care Improvement Program {#sec-19-csr-30-82.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-82.080}

PURPOSE: This rule explains the requirements for receiving funding from the Nursing Facility Quality of Care (NFQC) Fund to improve the quality of service the facility provides to its residents.

(1) Definitions.

(A) Qualified Facility—Any facility licensed pursuant to

Chapter 198, RSMo, that has received a Class I or Uncorrected Class II Notice of Noncompliance within the past twelve (12) months in one (1) of the following areas:

For Residential Care Facility I (RCF I) and Residential Care Facility II (RCF II):

A. Administrative, Personnel and Resident Care (19 CSR 30-86.042);

B. Dietary (19 CSR 30-86.052); or C. Resident Rights (19 CSR 30-88.010);

For Skilled Nursing Facility (SNF) and Intermediate Care Facility (ICF):

A. Administration and Resident Care (19 CSR 30-85.042)

B. Dietary (19 CSR 30-85.052); or C. Resident Rights (19 CSR 30-88.010).

(B) Quality Improvement Project for Missouri (QIPMO) consultation—Provides technical assistance and support to nursing facility staff throughout the state in order to improve the quality of care in nursing facilities using the Minimum Data Set (MDS) and on-site clinical consultation.

(2) Selection of Qualified Facilities.

(A) Qualified facilities may submit a written request to the department for funds from the Nursing Facility Quality of Care (NFQC) Fund to pay for QIPMO assistance and support. The department will provide a written response to the qualified facility’s request approving or disapproving the use of NFQC funding for QIPMO assistance. In the absence of extraordinary circumstances, a qualified facility shall receive no more than one thousand dollars ($1,000) per request. A qualified facility which wishes to receive more than one thousand dollars ($1,000) per request must separately justify reimbursement in excess of one thousand dollars ($1,000) by setting forth the extraordinary circumstances justifying reimbursement in excess of one thousand dollars ($1,000). The department may, in its sole discretion, approve reimbursement in excess of one thousand dollars ($1,000).

(B) Qualified facilities may also submit to the department proposals describing implementation of a quality improvement program, in lieu of the QIPMO Program. Such proposals shall address areas of noncompliance that have been cited in the notice of noncompliance issued in the past twelve (12) months. Upon approval of the proposal by the department, the department may use funds in the NFQC Fund that have been collected from state civil money penalties to fund the qualified facility’s proposal. In the absence of extraordinary circumstances, a qualified facility shall receive no more than one thousand dollars ($1,000) per proposal. A qualified facility which wishes to receive more than one thousand dollars ($1,000) per proposal must separately justify reimbursement in excess of one thousand dollars ($1,000) by setting forth the extraordinary circumstances justifying reimbursement in excess of one thousand dollars ($1,000). The department may, in its sole discretion, approve reimbursement in excess of one thousand dollars ($1,000).

(C) The department may impose upon a qualified facility a directed plan of correction, as set forth in section 198.066, RSMo, which includes QIPMO consultation. Funding for the QIPMO consultation may be taken from the NFQC Fund, not to exceed one thousand dollars ($1,000), unless the department, in its sole discretion, determines reimbursement in excess of one thousand dollars ($1,000) is justified by extraordinary circumstances.

(3) The qualified facility will submit to the department the paid invoice(s) for the QIPMO consultation or other quality improvement program. The department will reimburse the qualified facility for the amount granted.

rule filed Sept. 12, 2003, effective Sept. 22, 2003, expired March 19, 2004. Original rule filed Sept. 12, 2003, effective Feb. 29, 2004. *Original authority: 198.067, RSMo 1979, amended 1989, 1996, 1999, 2003.

History

AUTHORITY: section 198.067.6, RSMo Supp. 2003. Emergency

Chapter 83 Definition of Terms

19 CSR 30-83.010 Definition of Terms {#sec-19-csr-30-83.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-83.010}

PURPOSE: This rule defines terms used in the rules for long-term care facilities as set forth in chapters 19 CSR 30-85, 19 CSR 30- 86, 19 CSR 30-87, and 19 CSR 30-88.

(1) Activities of daily living (ADL)—Shall mean one (1) or more of the following:

(A) Eating;

(B) Dressing;

(D) Toileting;

(E) Transferring; and (F) Walking.

(2) Administrator—Shall mean an individual person who is in general administrative charge of a facility.

(3) Assisted living facility (ALF)—Shall mean any premises, other than a residential care facility, intermediate care facility, or skilled nursing care facility, that is utilized by its owner, operator, or manager to provide twenty-four (24) hour care and services and protective oversight to three (3) or more residents who are provided with shelter, board, and who may need and are provided with the following:

(A) Assistance with any activities of daily living and any instrumental activities of daily living;

(B) Storage, distribution or administration of medications; and (C) Supervision of health care under the direction of a licensed physician, provided that such services are consistent with a social model of care.

(D) The term “assisted living facility” does not include a facility where all of the residents are related within the fourth degree of consanguinity or affinity to the owner, operator, or manager of the facility.

(4) Automated dispensing system—Shall mean a mechanical system that performs functions that may include, but are not limited to, storing, packaging or dispensing medications, and that collects, controls and maintains all transaction information.

(5) Certified-medication technician—Shall mean a nursing assistant who has completed a course in medication administration approved by the Department of Health and Senior Services.

(6) Chemical restraint—Shall mean a psychopharmacologic medication that is used for discipline or convenience and not required to treat medical symptoms.

(7) Communicable disease—Any illness, disease or condition reportable to the Missouri Department of Health and Senior Services as required by 19 CSR 20-20.010 and 19 CSR 20-20.020 is considered, for the context of these rules, a communicable disease.

(8) Community based assessment—Shall mean documented basic information and analysis provided by appropriately trained and qualified individuals describing an individual’s abilities and needs in activities of daily living, instrumental activities of daily living, vision/hearing, nutrition, social participation and support, and cognitive functioning using an assessment tool approved by the Department of Health and Senior Services (the department), that is designed for community based services and that is not the nursing home minimum data set. The assessment tool may be one developed by the department or one used by a facility which has been approved by the department.

(9) Control of medication—Shall mean assuming responsibility by the facility for all facets of control of medication including, but not limited to, acquisition, storage, security and administration.

(10) Convenience—Shall mean any action taken by the facility to control resident behavior or maintain residents with a lesser amount of effort by the facility and not in the resident’s best interest.

(11) Dementia—Shall mean a general term for the loss of thinking, remembering, and reasoning so severe that it interferes with an individual’s daily functioning, and may cause symptoms that include changes in personality, mood, and behavior.

(12) Designee—Shall mean an individual who has been designated in writing by a resident to handle matters and receive reports related to his/her personal possessions and property.

(13) Discipline—Shall mean any action taken by the facility for the purpose of punishing or penalizing residents.

(14) Emergency medical procedure—Shall mean those written policies and procedures which describe the types and degrees of accidents and injuries, how they will be treated, by whom, in which instances the resident’s physician will be notified and how quickly.

(15) Emergency medication supply —Shall mean a limited number of dosage units of prescription medications that may be administered to a resident in an emergency situation or for initial doses of a necessary medication when a pharmacy cannot provide a prescription for a resident within a reasonable time based on the resident’s clinical needs at the time.

(16) Existing or existing licensed facility— Shall mean a long-term care facility which was licensed and in operation or one whose plans were approved prior to June 10, 1981 for a skilled or intermediate care facility or prior to November 13, 1980 for residential care facilities and assisted living facilities except as otherwise indicated in 19 CSR 30- 86.012, 19 CSR 30-86.022 and 19 CSR 30- 86.032.

(17) Exit—Shall mean a door leading to the outside or through a horizontal exit in a fire wall to a fire-safe area in the building.

(18) Facility—Shall mean any residential care facility, assisted living facility, intermediate care facility or skilled nursing facility licensed by the department.

(19) Fire-resistant construction—For intermediate care facilities and skilled nursing facilities, fire-resistant construction shall mean that a facility meets the specifications for Type II (222) or Type II (111) construction as given in the National Fire Protection Association Code 220. Fire-resistant construction for residential care facilities and assisted living facilities is defined in 19 CSR 30-86.022.

(20) Hazardous area—Shall mean furnace rooms other than electric forced air furnaces, laundries, kitchens, maintenance shops and storage rooms of over one hundred (100) square feet and any areas which contain combustible materials which will be either easily ignited, burn with an intense flame or result in the production of dense smoke and fumes.

(21) Home-like—means a self-contained long-term care setting that integrates the psychosocial, organizational and environmental qualities that are associated with being at home. Home-like may include, but is not limited, to the following:

(A) A living room and common use areas for social interactions and activities;

(B) Kitchen and family style eating area for use by the residents;

(D) A toilet room that contains a toilet, lavatory and bathing unit in each resident’s room;

(E) Resident room preferences for residents who wish to share a room, and for residents who wish to have private bedrooms;

(F) Outdoor area for outdoor activities and recreation; and (G) A place where residents can give and receive affection, explore their interests, exercise control over their environment, engage in interactions with others and have privacy, security, familiarity and a sense of belonging.

(22) Individualized service plan (ISP)—Shall mean the planning document prepared by an assisted living facility which outlines a resident’s needs and preferences, services to be provided, and the goals expected by the resident or the resident’s legal representative in partnership with the facility.

(23) Instrumental activities of daily living (IADL)—Shall mean one (1) or more of the following activities:

(A) Preparing meals;

(B) Shopping for personal items;

(D) Managing money;

(E) Using the telephone;

(F) Housework; and (G) Transportation ability.

(24) Intermediate care facility—Shall mean any premises, other than a residential care facility, assisted living facility, or skilled nursing facility, which is utilized by its owner, operator, or manager to provide twenty-four (24) hour accommodation, board, personal care, and basic health and nursing care services under the daily supervision of a licensed nurse and under the direction of a licensed physician to three (3) or more residents dependent for care and supervision and who are not related within the fourth degree of consanguinity or affinity to the owner, operator or manager of the facility.

(25) Involuntary seclusion—Shall mean separation of a resident from other residents or from her/his room or confinement to her/his room (with or without roommates) against the resident’s will, or the will of the resident’s legal representative. Emergency or short term monitored separation from other residents will not be considered involuntary seclusion and may be permitted if used for a limited period of time as a therapeutic intervention to reduce agitation until professional staff can develop a plan of care to meet the resident’s needs.

(26) Keeping residents in place—Shall mean maintaining residents in place during a fire in lieu of evacuation where a building’s occupants are not capable of evacuation, where evacuation has a low likelihood of success, or where it is recommended in writing by local fire officials as having a better likelihood of success and/or lower risk of injury.

(27) Level I medication aide—Shall mean an individual who has completed a course approved by the department in medication administration in a residential care facility or assisted living facility.

(28) Long-term care facility—Shall mean a facility that is licensed either solely or in combination as a skilled nursing facility, an intermediate care facility, a residential care facility, or assisted living facility.

(29) Long-term care services—Shall mean the assistance and support that a resident receives in a residential care facility, assisted living facility, intermediate care facility, and skilled nursing care facility, to meet the resident’s individual need for nursing care, protective oversight, monitoring, medication management, social interactions, cooking, housekeeping, laundry, and recreational activities.

(30) Major fraction thereof—Shall mean anything over fifty percent (50%) of the number of occupied beds.

(31) Major remodeling—Shall mean any remodeling of a long-term care facility which involves the addition of resident-use rooms, which affects fire safety or the structure of the building.

(32) Multistory building—Shall mean any building with more than one (1) floor entirely above the grade. A floor that is partially below grade will be counted as the first story to determine sprinkler requirements only if it contains resident sleeping rooms.

(33) New or newly licensed facility—Shall mean a long-term care facility whose plans are approved or which is licensed after June 10, 1981 for a skilled nursing or intermediate care facility or after November 13, 1980 for residential care facility or assisted living facility except as otherwise indicated in 19 CSR 30-86.012, 19 CSR 30-86.022, and 19 CSR 30-86.032.

(34) Nursing personnel—Shall include any employee, including a nurse’s aide or an orderly, who provides or assists in the provision of direct resident health care services.

(35) Operator—Shall mean any person licensed or required to be licensed under the provisions of sections 198.003–198.096, RSMo, in order to establish, conduct, or maintain a facility. The term person required to be licensed shall mean any person having the following, as determined by the department:

(A) Ultimate responsibility for making and implementing decisions regarding the operation of the facility;

(B) Ultimate financial control of the operation of a facility; and (C) Legal right to possession of the premises on which a facility is located.

(36) Person—Shall mean any individual, or any entity, including, but not limited to, a corporation, limited liability company, partnership, association, nonprofit organization, fraternal organization, church, or political subdivision of the state of Missouri.

(37) Physical restraint—Shall mean any manual method or physical or mechanical device, material or equipment attached to or adjacent to the resident’s body that the individual cannot remove easily which restricts freedom of movement or normal access to one’s body.

Physical restraints include, but are not limited to, leg restraints, arm restraints, hand mitts, soft ties or vests, lap cushions, and lap trays the resident cannot remove easily. Physical restraints also include facility practices that meet the definition of a restraint, such as the following:

(A) Using side rails that keep a resident from voluntarily getting out of bed;

(B) Tucking in or using Velcro to hold a sheet, fabric, or clothing tightly so that a resident’s movement is restricted;

(C) Using devices in conjunction with a chair, such as trays, tables, bars, or belts, that the resident cannot remove easily, that prevent the resident from rising;

(D) Placing the resident in a chair that prevents a resident from rising; and (E) Placing a chair or bed so close to a wall that the wall prevents the resident from rising out of the chair or voluntarily getting out of bed.

4CODE OF STATE REGULATIONS

(9/30/08) ROBINCARNAHAN

SENIOR SERVICES

(38) Physician—Shall mean an individual licensed to practice medicine in the state of Missouri under Chapter 334, RSMo.

(39) Premises—Shall mean any structures that are in close proximity one to the other and which are located on a single piece of property.

(40) Protective oversight—Shall mean an awareness twenty-four (24) hours a day of the location of a resident, the ability to intervene on behalf of the resident, supervision of nutrition, medication, or actual provisions of care, and the responsibility for the welfare of the resident, except where the resident is on voluntary leave.

(41) Qualified dietitian—Shall mean an individual who is registered by the American Dietetic Association or who is eligible for registration.

(42) Qualified therapist—Shall mean an individual who is either registered or is eligible for registration by the national accrediting association for that therapy or, if applicable, is licensed by the state of Missouri for the practice of the profession in which s/he is engaged.

(43) Qualified therapy assistant—Shall mean an individual who would be qualified as an occupational therapy or physical therapist assistant as outlined in 42 CFR 484.4.

(44) Residential care facility (RCF)—Shall mean any premises, other than an assisted living facility, intermediate care facility, or skilled nursing facility, which is utilized by its owner, operator, or manager to provide twenty-four (24) hour care to three (3) or more residents, who are not related within the fourth degree of consanguinity or affinity to the owner, operator, or manager of the facility and who need or are provided with shelter, board, and with protective oversight, which may include storage and distribution or administration of medications and care during short-term illness or recuperation, except that, for purposes of eligible residents of facilities formerly licensed as residential care facilities II receiving supplemental welfare assistance payments, any residential care facility that was licensed as a residential care facility II on or before August 27, 2006 that continues to meet the licensure standards for a residential care facility II in effect on August 27, 2006 shall be considered a residential care facility II for purposes of its eligible residents receiving the cash grant payment amount allocated immediately prior to August 28, 2006 for residents of a residential care facility II pursuant to section 208.030, RSMo.

(45) Responsible party—Shall mean an individual who has been designated in writing by the resident to handle matters and receive reports related to his/her general condition.

(46) Self-administration of medication—Shall mean the act of actually taking or applying medication to oneself.

(47) Self-control of medication—Shall mean assuming immediate responsibility by a resident for the storage and administration of medication for oneself while the facility retains ultimate control of medication.

(48) Skilled nursing care—Shall mean services furnished pursuant to physicians’ orders which require the skills of licensed nurses and which are provided directly by or under the on-site supervision of these personnel.

Examples of skilled nursing care may include, but are not limited to: administration of levine tube or gastrostomy tube feedings; nasopharyngeal and tracheotomy aspiration; insertion of medicated or sterile irrigation solutions and replacement of catheters; administration of parenteral fluids; inhalation therapy treatments; administration of other treatments requiring aseptic technique; and administration of injectable medication other than insulin.

(49) Skilled nursing facility—Shall mean any premises, other than a residential care facility, assisted living facility, or an intermediate care facility, which is utilized by its owner, operator, or manager to provide for twentyfour (24) hour accommodation, board and skilled nursing care and treatment services to at least three (3) residents who are not related within the fourth degree of consanguinity or affinity to the owner, operator, or manager of the facility. Skilled nursing care and treatment services are those services commonly performed by or under the supervision of a registered professional nurse for individuals requiring twenty-four (24) hours a day care by licensed nursing personnel including acts of observation, care, and counsel of the aged, ill, injured, or infirm, the administration of medications and treatments as prescribed by a licensed physician or dentist, and other nursing functions requiring substantial specialized judgment and skill.

(50) Social model of care—means long-term care services based on the abilities, desires, and functional needs of the individual delivered in a setting that is more home-like than institutional, that promote the dignity, individuality, privacy, independence, and autonomy of the individual, that respects residents’ differences and promotes residents’ choices.

(51) Voluntary leave—Shall mean an offpremises leave initiated by: a) a resident that has not been declared mentally incompetent or incapacitated by a court; or b) a legal guardian of a resident that has been declared mentally incompetent or incapacitated by a court.

(52) Vulnerable person—Shall mean any person in the custody, care, or control of the Department of Mental Health that is receiving services from an operated, funded, licensed, or certified program.

rule originally filed as 13 CSR 15-11.010.

Original rule filed Sept. 7, 1979, effective Jan. 12, 1980. Amended: Filed Dec. 10, 1980, effective June 11, 1981. Amended:

Filed Dec. 10, 1981, effective May 11, 1982.

Rescinded and readopted: Filed July 13, 1983, effective Oct. 13, 1983. Amended:

Filed Nov. 9, 1983, effective Feb. 11, 1984.

Emergency amendment filed Aug. 1, 1984, effective Aug. 13, 1984, expired Dec. 10, 1984. Amended: Filed Sept. 12, 1984, effective Dec. 13, 1984. Amended: Filed Aug. 1, 1988, effective Nov. 11, 1988. Moved to 19 CSR 30-83.010, effective Aug. 28, 2001.

Emergency amendment filed Sept. 12, 2003, effective Sept. 22, 2003, expired March 19, 2004. Amended: Filed Sept. 12, 2003, effective Feb. 29, 2004. Amended: Filed Sept. 14, 2004, effective March 30, 2005. Amended:

Filed Aug. 23, 2006, effective April 30, 2007.

Amended: Filed March 13, 2008, effective Oct. 30, 2008. *Original authority: 198.009, RSMo 1979, amended 1993, 1995 and 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006, 2007.

History

AUTHORITY: sections 198.009, RSMo 2000, and section 198.073, RSMo Supp. 2007. Emergency rule filed Sept. 7, 1979, effective Sept. 28, 1979, expired Jan. 24, 1980. This

Chapter 84 Training Program for Nursing Assistants

19 CSR 30-84.010 Nursing Assistant Training Program {#sec-19-csr-30-84.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-84.010}

PURPOSE: The Omnibus Nursing Home Act mandates in section 198.082, RSMo, that nursing assistants employed in skilled nursing and intermediate care facilities complete an approved training program. This rule gives information regarding the purpose of the training program, required objectives and curriculum content, designates what is the approved course curriculum, and indicates the training locations and testing which are required for a program to be considered approved.

(1) Definitions. For the purpose of this rule, the following definitions shall apply:

(A) Association—means the Missouri Health Care Association, the Missouri Association of Nursing Home Administrators, Leading Age Missouri, or Missouri Hospital Association;

(B) Basic course—means the seventy-five (75) hours of instructional training, the one training, and the final examination of the nursing assistant training course;

(C) Certifying agency—means an association, Career Center school, comprehensive high school, community college, or four- (4-) year institution of higher learning approved by the department;

(D) Challenge the final examination— means taking the final examination of the basic course without taking the entire basic course;

(E) Department—means the Missouri Department of Health and Senior Services;

(F) Hospital—means any licensed hospital as defined in section 197.020, RSMo;

(G) Missouri Veterans’ Home—means any facilities established and maintained as a Missouri Veterans’ Home as defined in section 42.002, RSMo;

(H) Nursing Assistant Clinical Supervisor Workshop—means the training course approved by the department and conducted by a certifying agency to prepare clinical supervisors to learn the methodology of teaching the supervised on-the-job training component of the nursing assistant training program;

(I) Nursing Assistant Instructor Workshop— means a training course approved by the department and conducted by a certifying agency to prepare instructors to learn the methodology of teaching the nursing assistant training program;

(J) Program—means the nursing assistant training program as required by section 198.082, RSMo;

(K) Registered Nurse Instructor Trainer— means a registered nurse (RN) approved by a certifying agency to teach the Nursing Assistant Instructor Workshop and the Nursing Assistant Clinical Supervisor Workshop to prepare instructors and clinical supervisors to teach the nursing assistant training program; and (L) Training agency—means an organization approved by the department which sponsors the approved nursing assistant training program.

(2) The purpose of the program shall be to prepare individuals for employment as a certified nursing assistant (CNA). The program shall be designed to teach skills in resident care which will qualify individuals to perform uncomplicated nursing procedures and to assist licensed practical nurses (LPNs) or RNs in direct resident care.

(3) All aspects of the program included in this rule (that is, qualified instructor, clinical supervisor, course curriculum, training agency, certifying agency, supervised on-the-job training, testing, and student qualifications) shall be met in order for a program to be considered as approved.

(4) Basic Course Requirements. The program shall consist of a basic course that includes, at a minimum, the following:

(A) Seventy-five (75) hours of instructional training in the curricula identified in section (5) of this rule;

(B) One hundred (100) hours of supervised on-the-job training (clinical practice) in an approved laboratory or other setting in which the student demonstrates knowledge while performing tasks on an individual under the supervision of a LPN or RN; and (C) A final examination.

(5) Curricula Content.

(A) Until August 31, 2021, a training agency identified in paragraphs (9)(A)1., (9)(A)2., and (9)(A)6. of this rule, shall teach the basic course and utilize either the content outlined in paragraphs (5)(A)1. and 2. or (5)(B)1. and 2. This basic course includes the following:

Curriculum content of the program shall include procedures and instructions on basic nursing skills in the following areas: basic hygiene techniques; bedmaking; personal care of residents; food service; charting; safety measures (including fire/safety and disaster preparedness and infection control); basic preventative and restorative care and procedures; basic observation procedures, such as weighing and measuring; communication skills; methods of handling and caring for mentally confused residents; residents’ rights; ethical and legal responsibilities; death and dying; and mental health and social needs; and 2. The course curriculum as outlined in the manual entitled The Nurse Assistant in a Long-Term Care Facility, produced by the Instructional Materials Laboratory, University of Missouri-Columbia, revised November 2001, catalogue number 50-5061- S shall be considered an approved course curriculum. Other manuals and course material may be used to supplement the curriculum.

Instructors shall use the companion instructor’s guide, catalogue number 50-5061-I.

(B) A training agency identified in paragraphs (9)(A)3.–5. of this rule, shall teach the basic course content outlined in paragraphs (5)(B)1. and 2. by August 31, 2021, a training agency identified paragraphs (9)(A)1., (9)(A)2., and (9)(A)6. of this rule, shall transition and begin teaching the basic (5)(B)1. and 2. This basic course includes the following:

The curriculum content shall include the required seventy-five (75) hours of instructional training and covers all of the following areas:

A. Communication and interpersonal skills;

B. Infection control;

C. Safety/emergency procedures, including the Heimlich maneuver;

D. Promoting residents’ independence;

E. Respecting residents’ rights;

F. Basic nursing skills including, but (I) Taking and recording vital signs;

(II) Measuring and recording height and weight;

(III) Caring for the residents’ environment;

(IV) Recognizing abnormal changes in body functioning and the importance of reporting such changes to a supervisor; and (V) Caring for residents when death is imminent;

G. Personal care skills including, but (I) Bathing;

(II) Grooming, including mouth care;

(III) Dressing;

(IV) Toileting;

(V) Assisting with eating and hydration;

(VI) Proper feeding techniques;

(VII) Skin care; and (VIII) Transfers, positioning, and turning;

H. Mental health and social service needs including, but not limited to— (I) Modifying nursing assistant’s behavior in response to resident’s behavior;

(II) Awareness of developmental tasks associated with the aging process;

(III) How to respond to resident behavior;

(IV) Allowing the residents to make personal choices, providing and reinforcing other behavior consistent with the resident’s dignity; and (V) Utilizing the resident’s family as a source of emotional support;

I. Care of cognitively impaired residents including, but not limited to— (I) Techniques for addressing the unique needs and behaviors of individuals with dementia (Alzheimer’s and others);

(II) Communicating with cognitively impaired residents;

(III) Understanding the behavior of cognitively impaired residents;

(IV) Appropriate responses to the behavior of cognitively impaired residents;

(V) Methods of reducing the effects of cognitive impairments;

J. Basic restorative services including, but not limited to— (I) Training the resident in self-care according to the resident’s abilities;

(II) The use of assistive devices in transferring, ambulation, eating, and dressing;

(III) Maintenance of range of motion;

(IV) Proper turning and positioning in bed and chair;

(V) Bowel and bladder training;

(VI) Care and use of prosthetic and orthotic devices;

K. Residents’ rights including, but (I) Providing privacy and maintenance of confidentiality;

(II) Promoting the residents’ right to make personal choices to accommodate their needs;

(III) Giving assistance in resolving grievances and disputes;

(IV) Providing needed assistance in getting to and participating in resident and family groups and other activities;

(V) Maintaining care and security of residents’ personal possessions;

(VI) Promoting the residents’ right to be free from abuse, mistreatment, and neglect and the need to report any instances of such treatment to appropriate facility staff;

(VII) Avoiding the need for restraints in accordance with current professional standards; and 2. The basic course shall be taught using current published instruction material(s) that are no more than ten (10) years old. The material(s) shall include current standards of practice for nursing assistants. Other course materials that contain current standards of practice in healthcare and are no more than ten (10) years old may be used to supplement the curriculum.

(6) Student Enrollment and Qualifications.

(A) Any individual who is employable by an intermediate care facility (ICF) or skilled nursing facility (SNF) to be involved in direct resident care shall be eligible to enroll in a training agency’s nursing assistant training program if— 1. The individual is at least eighteen (18) years of age and employable.

Employable shall mean that the individual is not listed on the department’s Employee Disqualification List (EDL) and has not been convicted or entered a plea of guilty to a misdemeanor or felony charge which includes any suspended imposition of sentence, any suspended execution of sentence or any period of probation or parole in this state or any other state which if committed in Missouri would be a class A or B felony violation of Chapters 565, 566, or 569, RSMo, or any violation of subsection 198.070.3, RSMo, or

section 568.020, RSMo, unless a good cause waiver has been granted by the department;

The individual is at least sixteen (16) years of age providing he or she is— A. Currently enrolled in a secondary school health services occupation program or a cooperative work education program of an area vocational technical school or comprehensive high school;

B. Placed for work experience in an ICF, SNF, hospital, Missouri Veterans’ hospital-based skilled nursing facility by that program;

C. Not listed on the department’s EDL and has not been convicted or entered a plea of guilty to a misdemeanor or felony charge which includes any suspended imposition of sentence, any suspended execution of sentence, or any period of probation or parole in this state or any other state which if committed in Missouri would be a class A or B felony violation of Chapters 565, 566, or 569, RSMo, or any violation of subsection 198.070.3, RSMo, or section 568.020, RSMo, unless a good cause waiver has been granted by the department; and D. Under the direct supervision of an instructor or clinical supervisor, or both, while completing the clinical portion of the (B) Prior to any direct contact with a resident, a student enrolled in the basic course in a Medicare or Medicaid certified facility shall complete sixteen (16) of the required seventy-five (75) hours of instructional training in communication and interpersonal skills; infection control; safety/emergency procedures, including the Heimlich maneuver; promoting residents’ independence; and respecting residents’ rights.

(C) If a student drops the basic course, the student may re-enroll in a course within six (6) months and make up the course material missed without retaking the entire basic course after presenting proof of attendance and materials covered in the original class.

(D) A student shall not perform any services for which the student has not been trained nor found proficient by the instructor and/or clinical supervisor.

(E) A student who received instructional training from the basic course content outlined in paragraphs (5)(B)1. and 2. of this

rule, shall register with the department approved third party test administrator upon successful completion of the seventy-five (75) training.

(7) Employees of a Long-Term Care (LTC)

Facility. Each CNA hired to work in an ICF or SNF after January 1, 1980, shall have successfully completed a nursing assistant training program approved by the department or shall enroll in and begin the first available approved training program which is scheduled to commence within ninety (90) days of the date of the CNAs employment and which shall be completed within four (4) months of employment.

(8) Final Examination Challenge.

(A) Individuals eligible to challenge the final examination, includes— 1. Individuals who were enrolled in a RN or LPN nursing education program for at least four (4) months and successfully completed a course on the fundamentals of nursing, including clinical hours within the last five (5) years;

Individuals currently enrolled in a RN or LPN nursing education program and who have successfully completed a course on the fundamentals of nursing, including clinical hours;
RN or LPN nursing licensure candidates who have failed state licensure examinations within the last five (5) years;
Individuals who have met the requirements of unlicensed assistive personnel contained in 19 CSR 30-20.125;
Individuals trained by a hospital as nursing assistants or psychiatric aides who have completed the following:

A. One hundred (100) hours of supervised on-the-job training in an ICF, SNF, hospital, Missouri Veterans’ Home, or hospitalbased nursing facility or hospital-based skilled nursing facility; and B. Instruction that covers the basic (5)(B)1. and 2. of this rule;

Any other persons whose background, education, and training in gerontology and health occupations includes components of the basic course content outlined in paragraphs (5)(B)1. and 2. may be allowed to challenge the final examination after taking those portions of the course as determined to be necessary based on evaluation of their credentials by the Section for Long-Term Care

Regulation, Health Education Unit;

A CNA who is listed as inactive for less than five (5) years on the Missouri Certified Nurse Assistant Registry and cannot provide the required employment documentation in accordance with section (18) of this

rule; and 8. Individuals who have successfully completed a nursing program outside the United States within the last five (5) years or who have obtained a nursing license outside the United States.

(B) Individuals who are certified and active on another state’s nurse aide registry shall not be required to challenge the final examination. The individual shall submit, in writing to the department, a request to be added to the Missouri Certified Nurse Assistant Registry. At a minimum, the request shall include: the individual’s legal name; Social Security number; current address; telephone number; email address, if applicable; and proof of their current certified nursing assistant certificate. The department will respond in writing, either approving or denying the request to be added to the registry.

(C) Individuals identified as eligible to challenge the final examination in paragraphs (8)(A)1.-7., shall submit a request in writing to the department and enclose, at a minimum, the following information: legal name; Social Security number; current address and telephone number; email address, as applicable; and transcripts. The department will respond in writing, either approving or denying the request to challenge the final examination. If approved, the department shall provide a list of individuals eligible to take the examination to the department approved third party test administrator.

(D) Individuals identified in paragraph (8)(A)8., shall submit a request in writing to the department to take the final examination and enclose, at a minimum, the following information: legal name; Social Security number; current address and telephone number; email address, as applicable; a copy of the out-of-country license or certificate translated to English; a copy of the school transcript translated to English; and a copy of the out-of-country criminal background check translated to English. The department will respond in writing, either approving or denying the request to challenge the final examination. If approved, the department shall provide a list of individuals eligible to take the examination to the department approved third party test administrator.

(E) Those individuals permitted to challenge shall take the final examination within one hundred twenty (120) calendar days of the department notification. Permission letters not utilized within the one hundred twenty- (120-) day period shall be considered invalid and reapplication for permission to challenge shall be made to the department.

(F) If an individual fails the final examination after one (1) attempt, he or she shall successfully complete basic course in its entirety.

(9) Training Agency Responsibilities.

(A) The following entities are eligible to apply to the department to be an approved training agency:

Career Center schools and comprehensive high schools approved by the Missouri Department of Elementary and Secondary Education (DESE) that offer health service occupation programs which have a practice classroom and equipment used in delivering health care. There shall be a signed written agreement of cooperation with one (1) or more ICFs, SNFs, hospitals, Missouri Veterans’ Homes, or hospital-based nursing facilities or hospital-based skilled nursing facilities in their vicinity for the one training component of the basic course;
Public community colleges, public colleges and universities, proprietary schools, or private agencies approved by the Missouri Department of Higher Education and Workforce Development (MDHEWD) or accredited by a recognized accrediting agency or association on the list published by the Secretary of the United States Department of Education, pursuant to the Higher Education Act of 1965, the Higher Education Opportunity Act 2008 (Public Law 110-315), and the Veterans’ Readjustment Assistance Act which have a practice laboratory with one (1) or more bed units and equipment used in delivering health care and have a signed written agreement of cooperation with one (1) or more ICFs, SNFs, hospitals, Missouri Veterans’ Homes, or hospital-based nursing facilities or hospital-based skilled nursing facilities in their vicinity for the one hundred (100) hours of supervised on-the-job training component of the basic course;
Associations as defined in section (1) of this rule. There shall be a signed written agreement of cooperation with an ICF, SNF, hospital, Missouri Veterans’ Home, or a hospital-based nursing facility or hospital-based skilled nursing facility to provide the one training;
A licensed ICF, SNF, or a hospitalbased nursing facility or hospital-based skilled nursing facility. There shall be a signed written agreement of cooperation with an ICF, SNF, hospital, Missouri Veterans’ hospital-based skilled nursing facility if the one hundred (100) hours of supervised onthe-job training is not provided on-site;
Licensed hospitals. There shall be a signed written agreement of cooperation with an ICF, SNF, hospital, Missouri Veterans’ hospital-based skilled nursing facility if the one hundred (100) hours of supervised onthe-job training is not provided on site; or 6. Missouri Veterans’ Homes. There shall be a signed written agreement of cooperation with an ICF, SNF, hospital, Missouri Veterans’ Home, or a hospital-based nursing facility or hospital-based skilled nursing facility if the one hundred (100) hours of supervised on-the-job training is not provided on site.

(B) Organizations identified in paragraphs (9)(A)1.-6. which want to be approved by the department to teach the program shall submit to the department form DHSS-DRL-2469 (08-20), Application for Approval as a Nursing Assistant Training Agency, included herein.

(C) In order to be approved, the applicant shall have a designated location which contains sufficient space, equipment, and teaching aids to meet the course objectives and accommodate the maximum number of students allowed. The instructor and each student shall be provided with the required curricula content and instructional material(s) for the basic course identified in section (5) of this (D) Any ICF or SNF which has received a Class I notice of noncompliance related to administration and resident care from the department in the two- (2-) year period prior to application for approval shall not be eligible for approval. If this notice is issued after approval, the approval shall be withdrawn by the department within ninety (90) calendar days and the certifying agencies shall be notified of the withdrawal of approval. Students already enrolled in the basic course may complete the course if a notice is issued after the basic course has begun.

(E) An ICF or SNF whose approval has been withdrawn for a Class I notice of noncompliance related to administration and resident care may request in writing to the department for an exception to train and test nursing assistants. This written request shall include, at a minimum, the following information:

The training site name, and training site number, address, telephone and fax number, and email address as applicable;
Administrator’s name and facility operator’s name and address;
Sponsoring training site name, sponsoring training site number, sponsoring training site’s instructor’s name, instructor’s Social Security number, and email address as applicable;
The exit date of the noncompliance interview for each deficiency of a Class I in the areas of administration and resident care requirements in 19 CSR 30-85.042; reason(s) for noncompliance; explanation of efforts in locating another training agency within a reasonable distance (at least one-half (½) hour travel time each way from the facility); and 5. A student roster for each class. The student roster shall include each student’s name; student’s address and telephone number; student’s Social Security number; and the student’s email address, as applicable; class begin date; number of students completed; instructor’s name and telephone number; instructor’s license number; instructor’s Social Security number; instructor’s employer; and the instructor’s email address, as applicable.

(F) The department shall make an on-site inspection of each training agency’s premises within two (2) years of approval and every two (2) years following to determine the adequacy of space; equipment and supplies; and, if clinical training is not done on-site, verify that there is a current copy of a signed written agreement of cooperation with an ICF, SNF, hospital, Missouri Veterans’ Home, or a hospital-based nursing facility or hospital-based skilled nursing facility for the clinical portion of the course.

(G) Upon receipt of the completed form DHSS-DRL-2469 (08-20), Application for Approval as a Nursing Assistant Training Agency, the department shall notify the applicant in writing within ninety (90) calendar days of approval or disapproval. If disapproved, the reasons why shall be given.

(H) Training agencies shall be approved for a two- (2-) year period and shall submit a new application for approval thirty (30) calendar days prior to the expiration of approval.

(I) The training agency shall be responsible for obtaining an approved instructor and providing training materials for each student. If an instructor is not employed by the training agency, there shall be a signed written agreement of cooperation between the training agency and the instructor.

(J) The training agency shall be responsible for obtaining an approved clinical supervisor.

If a clinical supervisor is not employed by a training agency, there shall be a signed written agreement of cooperation between the training agency and the clinical supervisor.

(K) If the training agency is not a licensed ICF or SNF, the agency shall have a signed written agreement of cooperation currently in effect with an ICF, SNF, hospital, Missouri Veterans’ Home, or a hospital-based nursing facility or hospital-based skilled nursing facility where the one hundred (100) hours of supervised on-the-job training shall be conducted.

(L) In the event that a qualified instructor for the basic course did not sign records of a student who successfully completed the program, without justification or due to resignation from his or her position, the administrator or designee of the training agency shall validate the training by signature.

(M) Evidence of successful completion of the basic course shall be documented prior to a student taking the final examination and shall include:

Class schedules and form MO 580- The 2001 Manual) Appendix A/B, included herein for training agencies using the basic (5)(A)1. and 2. of this rule; or 2. Class schedules and form DHSS- DRL-111 (08-20), Classroom and On-the-Job Training Record, included herein for training lined in paragraphs (5)(B)1. and 2. of this (N) The training agency shall ensure that all applicable portions of appropriate forms identified in paragraphs (9)(M)1. and 2. of this

rule are complete and shall provide a copy to student within seven (7) calendar days of successful completion of the seventy-five (75) training.

(O) The training agency shall maintain records for a minimum of two (2) years for basic course.

(10) Certifying Agency Responsibilities.

(A) In order for a certifying agency to be approved by the department, the agency shall have a signed written agreement of cooperation with the department which shall be renewable every five (5) years.

(B) Certifying agencies that provide the Nursing Assistant Instructor Workshop and the Nursing Assistant Clinical Supervisor Workshop shall complete the following responsibilities:

Verify eligibility requirements for the participants enrolled in the Nursing Assistant Instructor Workshop and the Nursing Assistant Clinical Supervisor Workshop;
Provide qualified Registered Nurse Instructor Trainers to teach the applicable workshop(s);
Issue the applicable workshop certificate(s) to participants upon successful completion; and 4. Within seven (7) calendar days of issuing the workshop certificate, provide a listing of approved instructors and clinical supervisors to the department that includes: the name of workshop completed; participant’s legal name, address, and telephone number; email address, as applicable; Social Security number; and date of birth.

(C) Certifying agencies that provide the four (4) hour instructor update training shall comply with the requirements in section (16) of this rule.

(D) Maintain accurate and complete records for a period of at least two (2) years.

(11) Instructor and Clinical Supervisor/Student Ratios. During the required one hundred (100) hours of supervised on-the-job training, the training agency’s instructor and clinical supervisor/student ratio shall be a maximum of one to fifteen (1:15).

(12) Qualifications of Instructors, Clinical Supervisors, and Examiners.

(A) Instructor.

An instructor shall be currently licensed as a RN in Missouri or shall hold a current temporary permit from the Missouri State Board of Nursing or shall hold a multistate or single state RN license from a jurisdiction that is party to the Nurse Licensure Compact. The licensee shall not be subject of current disciplinary action, such as censure, probation, suspension, or revocation.
An instructor shall not be listed on the department’s EDL.
An individual that has been previously disqualified as an instructor shall not function as an instructor unless he or she receives written approval from the department.
An instructor shall have had, at a minimum, two (2) years of nursing experience and at least one (1) year of experience in the provision of long-term care facility services in the last ten (10) years. Other personnel from the health professions may assist the instructor; however, they shall have at least one (1) year of experience in their field.
An instructor shall successfully complete a Nursing Assistant Instructor Workshop by a certifying agency using qualified instructors. The department shall issue a letter of approval to the qualified instructor after the individual has successfully completed the workshop. The department shall maintain a list of approved instructors.
An instructor shall be responsible to teach the seventy-five (75) hours of instructional training for the basic course and a minimum of sixteen (16) of the one hundred (100) hours of supervised on-the-job training in accordance with the requirements contained in this rule.
The instructor teaching the seventyfive (75) hours of instructional training and/or sixteen (16) of the one hundred (100) hours of supervised on-the-job training for the basic course shall complete and sign all applicable portions of either form MO 580- The 2001 Manual) Appendix A/B for training lined in paragraphs (5)(A)1. and 2. or form the-Job Training Record for training agencies using the basic course content outlined in paragraphs (5)(B)1. and 2. for each student participating in the program.
An instructor shall provide to the student within seven (7) calendar days of successful completion of the seventy-five (75) training, either completed form MO 580- The 2001 Manual) Appendix A/B for training lined in paragraphs (5)(A)1. and 2. or form the-Job Training Record for training agencies using the basic course content outlined in paragraphs (5)(B)1. and 2.
If the course is not completed, records and documentation regarding the completed portions shall be provided by the instructor to the student, if requested, and to the training agency.

(B) Clinical Supervisor (On-the-Job Supervisor).

The clinical supervisor shall be currently licensed as a RN or LPN in Missouri or hold a current temporary permit from the Missouri Board of Nursing or shall hold a multi-state or single state RN or LPN license from a jurisdiction that is party to the Nurse Licensure Compact. The licensee shall not be subject of current disciplinary action such as censure, probation, suspension, or revoca- 2. A clinical supervisor shall not be listed on the department’s EDL.
An individual that has been previously disqualified as a clinical supervisor shall not function as a clinical supervisor unless he or she receives written approval from the department.
The clinical supervisor, if not currently employed by an ICF, SNF, hospital, or Missouri Veterans’ Home, shall have at least one (1) year of licensed nursing experience.

The clinical supervisor shall be currently employed by the approved training agency facility where the students are performing their duties or by the training agency conducting the program.

A clinical supervisor shall successfully complete a Nursing Assistant Clinical Supervisor Workshop by a certifying agency using qualified instructors. The department shall issue a letter of approval to the qualified clinical supervisor after the individual has successfully completed the workshop. The department shall maintain a list of approved clinical supervisors.
The clinical supervisor shall be on the facility premises in which the students are performing their duties while the students are completing the on-the-job component of their training and shall directly assist the students in their training and observe their skills when checking their competencies.
A clinical supervisor shall be responsible to supervise eighty-four (84) of the one training in accordance with the requirements contained in this rule.
The clinical supervisor(s) shall complete and sign all applicable portions of form MO 580-2473 (12-07) Certified Nurse Assistant Competency Score Sheet (For Use Only With The 2001 Manual) Appendix A/B for training agencies using the basic course content outlined in paragraphs (5)(A)1. and 2. or form DHSS-DRL-111 (08-20), Classroom and On-the-Job Training Record for training agencies using the basic course content outlined in paragraphs (5)(B)1. and 2. for each student participating in the program.

An examiner using the department’s testing materials for the basic course content outlined in paragraphs (5)(A)1. and 2. of this

rule shall be— A. A RN currently licensed in Missouri or shall hold a current temporary permit from the Missouri State Board of Nursing, or shall hold a multi-state or single state RN license from a jurisdiction that is party to the Nurse Licensure Compact and shall not be currently subject of disciplinary action such as censure, probation, suspension, or revocation.

B. The examiner shall have taught a similar course or shall be qualified to teach a similar course; but shall not have been the instructor of the students being examined; and shall not be employed by the operator whose students are being examined. The examiner shall be specifically approved by the department to administer final examinations of the state-approved nurse assistant training curriculum and shall have signed an agreement with the department to protect and keep secure the final examinations.

Causes for Disqualification. A person shall not be allowed to be an examiner if it is found that he or she— A. Knowingly acted or omitted any duty in a manner which would materially or adversely affect the health, safety, welfare, or property of a resident;

B. Defrauded a training agency or student by taking payment and not completing a course, not administering the final examination as required, or not being on-site while students are being trained;

C. Failed to teach, examine, or clinically supervise in accordance with 19 CSR 30-84.010, or taught students from the state test, changed answers on the state test, lost test booklets, or recorded false information on test materials or test booklets of the program; or D. Failed to send documentation of a completed course to a certifying agency within thirty (30) days.

Notification of Disqualification.

A. The department shall notify the individual that he or she is no longer eligible to be an examiner.

B. The department shall notify all approved training and certifying agencies if it has been determined that an individual is no longer considered an approved examiner and that person’s name shall be removed from the lists maintained by the department of approved examiners.

C. To be reinstated as a stateapproved examiner the individual shall submit a request in writing to the department stating the reasons why reinstatement is warranted. The department shall respond in writing to the request.

(13) Instructor and Clinical Supervisor Disqualification Criteria.

(A) Causes for Disqualification. The department may disqualify an individual as an instructor or clinical supervisor if it is found the individual failed to follow the requirements in section (12) of this rule or— 1. Knowingly acted or omitted any duty in a manner which would materially or adversely affect the health, safety, welfare, or property of a resident;

Defrauded a training agency or student by taking payment and not completing a course or not being on-site while students are being trained;
Failed to teach or clinically supervise in accordance with the regulations contained in this rule, or provide false information to the department; or 4. Is disqualified as a RN Test Observer by the department approved third party test administrator.

(B) Notification of Disqualification.

The department shall notify the individual that he or she is no longer eligible to be an instructor or clinical supervisor.
The department shall notify all certifying agencies if it has been determined that an individual is no longer considered an approved instructor or clinical supervisor and that person’s name shall be removed from the lists maintained by the department of approved instructors or clinical supervisors.
To be reinstated as an approved instructor or clinical supervisor, the individual shall submit a request in writing to the department stating the reasons why reinstatement is warranted. The department shall respond in writing to the request.

(14) Training and Certifying Agency Disqualification Criteria.

(A) Causes for Disqualification. The department may disqualify a training agency or certifying agency if it is found that an agency failed to follow the requirements in

section (9) for a training agency or section (10) for a certifying agency of this rule or— 1. Defrauded a student by taking payment and not ensuring the seventy five (75) hours instructional training or on-the-job training were completed as required by this

rule; or 2. Failed to maintain approval from MDHEWD or DESE, if applicable.

(B) Notification of Disqualification.

The department shall notify the agency that he or she is no longer eligible to be a training agency or certifying agency.
To be reinstated as a training agency or certifying agency, the agency shall submit a request in writing to the department stating the reasons why reinstatement is warranted.

The department shall respond in writing to the request.

(15) Registered Nurse Instructor Trainer Responsibilities.

(A) The RN Instructor Trainer shall be currently licensed as a RN in Missouri or shall hold a current temporary permit from the Missouri State Board of Nursing or shall hold a multi-state or single state RN license from a jurisdiction that is party to the Nurse Licensure Compact. The RN Instructor Trainer shall not be subject of current disciplinary action, such as censure, probation, suspension, or revocation and shall not be listed on the department’s EDL.

(B) The RN Instructor Trainer shall also be, at a minimum, an approved nursing assistant instructor.

(C) The RN Instructor Trainer shall be employed or contracted by a certifying agency to instruct the Nursing Assistant Instructor Workshop, Nursing Assistant Clinical Supervisor Workshop, and the Instructor Update Training.

(16) Instructor Update Training.

(A) The instructor shall attend a four (4) hour update training provided by a certifying agency every five (5) years. This update training shall include, at a minimum, the following:

Instruction on how to complete form the-Job Training Record;
Instruction on the fundamentals of adult learning;
Instruction in at least one (1) area regarding standards of practice in long term care such as pressure ulcer prevention, dining practices, or resident rights issues;
Instruction on providing care for cognitively impaired residents;
Review of the Nursing Assistant Training Program regulations contained in 19 CSR 30-84.010; and 6. Review of the administration and resident care requirements contained in 19 CSR 30-85.042.

(B) The certifying agency shall provide a list of the instructors that complete the update training to the department within seven (7) calendar days of completion of the training.

(C) Any instructor who has not completed the required four (4) hour update training by August 31, 2022, and every five (5) years thereafter shall be removed from the department-approved list of instructors. If removed from the department’s list, the instructor shall attend and successfully complete the Nursing Assistant Instructor Workshop in order to be reinstated to act as an instructor.

(17) Final Examination Testing.

(A) In order to be eligible for testing, a student shall have either completed the following:

Seventy-five (75) hours of instructional training and the one hundred (100) hours of supervised on-the-job training offered by a training agency. The student shall pass a minimum of three (3) written or oral tests throughout the course with an eighty percent (80%) score or better on each test in order to be eligible to take the final examination. Each test shall consist of a minimum of fifteen (15) questions; or 2. Possess an approval letter from the department granting approval to challenge the final examination.

(B) If the course content outlined in paragraphs (5)(A)1. and 2. of this rule is used for teaching the basic course, the final examination shall be conducted by an approved examiner who may be assisted by the instructor using the following procedures:

The instructor will select an LTC resident to participate in the testing process and obtain approval for this activity from the resident;
The examiner shall verify the eligibility of the students by reviewing form MO 580-2473 (12-07) Certified Nurse Assistant The 2001 Manual) Appendix A/B to establish that the student has completed the approved training program or possesses an approval letter from the department granting approval to challenge the final examination;
The student shall successfully complete at least nine (9) procedures under the observation of the instructor or a facility licensed nurse and examiner.

A. The nine (9) procedures shall always include a type of bath, vital signs (temperature, pulse, respirations, and blood pressure), transfer techniques, feeding techniques, dressing and grooming, skin care, active or passive, range of motion to upper and lower extremities (unless contraindicated by a physician’s order), and handwashing and gloving from the standardized curriculum.

B. The remainder shall be selected according to the resident’s care needs at the time of day that testing occurs.

C. The evaluation of the student shall include communication and interaction with the resident, provision of privacy, work habits, appearance, conduct, and reporting and recording skills;

The student shall successfully answer forty (40) out of fifty (50) oral or written questions presented by the examiner based on the standardized curriculum and selected from a specific test pool of questions which are safeguarded by the department;
The examiner who uses the basic (5)(A)1. and 2. of the basic course for the final examination shall notify the department and obtain different examinations to be administered each time; and 6. The examiner who uses the basic (5)(A)1. and 2. of the basic course for the final examination shall conduct the following:

A. Complete and sign form MO 580- The 2001 Manual) Appendix A/B and the final examination score sheet which shall include scores and comments. The examiner shall advise the individual that successful completion of the evaluation will result in the addition of his/her name to the CNA Registry;

B. After scoring, the examiner shall return all test materials, test booklets, answer sheets, and any appendices to the department.

The examiner shall also provide the training agency with documentation of the student’s test scores; and C. A copy of the student’s final record sheets shall be provided to the student (except for the answer sheets). If the course is not completed, records and documentation regarding the portions completed shall be provided to the student, if requested, and to the training agency.

(C) If the basic course content outlined in paragraphs (5)(B)1. and 2. of this rule, is used to teach the course, testing shall comply with the following:

The instructor shall verify the eligibility of the students by reviewing form the-Job Training Record, to establish that the student has completed the approved program;
The final examination shall be conducted by the department approved third party test administrator and a fee will be assessed for each examination;
The student shall successfully complete an examination proctored by the department approved third party test administrator.

The student shall achieve a passing score of at least eighty percent (80%); and 4. The student shall successfully complete the skills evaluation portion of the examination proctored by the department approved third party test administrator. The student shall achieve a score of one hundred percent (100%).

(D) Any individual who fails the final examination, except those who have been permitted to challenge the examination, shall have the opportunity to retake the examination twice within ninety (90) calendar days of the initial examination. If the individual fails the final examination a third time, the entire basic course shall be retaken before another examination can be given.

(E) Any individual who is employed by a LTC facility and required by section 198.082, RSMo, to enroll in the program, but who has been permitted to challenge the final examination and who fails the examination, must immediately re-enroll in and begin study in the next available basic course. The individual shall complete the basic course within four (4) months of employment.

(18) CNA Registry.

(A) If the CNA passes the final examination, the individual’s name shall be placed on the CNA active registry.

(B) CNAs shall submit documentation (e.g., pay stubs, W-2, letter from employer, etc.) of work in nursing or nursing related services for at least one (1) day (e.g. eight (8) hours) within each twenty-four- (24-) consecutive month period to maintain active status.

Documentation shall be submitted to the department approved third party test administrator and a fee will be assessed for each renewal.

(C) A CNA who has been inactive on the registry for less than five (5) years and cannot provide documentation (e.g., pay stubs, W-2, letter from employer, etc.) of work in nursing or nursing related services for at least one (1) day (e.g. eight (8) hours) within each twentyfour- (24-) consecutive month period shall challenge the final examination in accordance with section (8) of this rule before the CNA is reinstated to the active registry.

(D) A CNA who has been inactive on the registry for more than five (5) years and cannot provide documentation (e.g., pay stubs, W-2, letter from employer, etc.) of work in nursing or nursing related services for at least one (1) day (e.g. eight (8) hours) within each twenty-four- (24-) consecutive month period is not eligible to challenge the final examination and shall successfully complete the entire basic course before the CNA is reinstated to the active registry.

1ST INSTRUCTOR SIGNATURE

2ND INSTRUCTOR SIGNATURE

ADMINISTRATOR/DON SIGNATURE - 75 HOURS

CHARGE NURSE SIGNATURE - FACILITY VERIFICATION 84 HRS OJT COMPLETED

CHARGE NURSE SIGNATURE - FACILITY VERIFICATION 16 HRS COMPETENCY EVALUATION

CLINICAL SUPERVISOR - 84 HRS OJT

CLINICAL SUPERVISOR - 16 HRS OJT

1ST EXAMINER SIGNATURE

2ND EXAMINER SIGNATURE

STUDENT NAME (PLEASE PRINT)

(LAST)

(FIRST)

(MIDDLE)

(MAIDEN)

SOCIAL SECURITY NO.

HOME PHONE NO.

PERMANENT ADDRESS (STREET)

(CITY)

(STATE)

(ZIP)

DATE OF BIRTH

WORK PHONE NO.

SITE NAME - 75 HRS CLASSROOM

COMPLETE DATE

ATTENDANCE

MAKE-UP

SITE NAME - 84 HRS/100 HRS*

COMPLETE DATE - 84 HRS/100 HRS

SITE NAME - 16 HRS COMPETENCIES

COMPLETE DATE 16 HRS.

1ST ATTEMPT

2ND ATTEMPT

3RD ATTEMPT

1ST ATTEMPT

2ND ATTEMPT

3RD ATTEMPT

MISSOURI DEPARTMENT OF HEALTH AND SENIOR SERVICESCERTIFIED NURSE ASSISTANT COMPETENCY SCORE SHEET

(FOR USE ONLY WITH 2001 MANUAL)

APPENDIX A

MO 580-2473 (12-07)

CLASS TEST SCORES1.

EACH SCORE MUST BE AT LEAST 80% (MUST BE COMPLETED BY INSTRUCTOR PRIOR TO EXAM)

APPROVED FOR

CERTIFICATION

NOT APPROVED

FOR CERTIFICATION

Evaluation of procedures includes: knowledge, safety, encouraged self-help, work habits, student-resident interaction, organiza tion, resident’s rights. Other procedures may be determined by resident’s needs. All procedures must be evaluated.

Examiner advised individual that successful completion of the evaluation will result in the addition of his/her name to the sta te nursing assistant register. If you have been determined to have committed abuse, neglect or misappropriation of goods in a certified facility, a permanent federal marker will be placed against your name on the CNA register. You will NEVER AGAIN be allowed to work in a certified facility.

STUDENT MUST INITIAL

BATH4. FEEDING TECHNIQUES7. HANDWASHING
VITAL SIGNS5. DRESSING AND GROOMING8. GLOVING
TRANSFER TECHNIQUES6. SKIN CARE9. ACTIVE OR PASSIVE FOM TO

AND EXTERMITIES

Assist resident to undress34. Apply and remove elastic stockings35. Give complete bed bath36. Give tub bath37. Give shower bath38. Make an unoccupied bed39. Make an occupied bed40. Give back rub41. Give stage 1 pressure ulcer care42. Give peri care with catheter43. Change a drainage bag44. Empty a urinary drainage bag45. Assist resident in using urinal46. Assist resident in using bedpan47. Give care of an uncomplicated established colostomy48. Move resident to head of bed (two-person assist)49. Turn resident to one side ( ⁄ turn)
Demonstrate one-person pivot transfer from bed to chair51. Demonstrate one-person pivot transfer from chair to bed 52. Demonstrate two-person pivot transfer from chair to bed (resident able to assist)
Demonstrate two-person transfer with a mechanical lift to chair54. Ambulate resident using a gait belt55. Ambulate resident using a walker56. Ambulate resident using a cane57. Give range of motion exercises to neck and shoulders58. Give range of motion exercises to elbow59. Give range of motion exercises to wrist and fingers60. Give range of motion exercises to hip and knee61. Give range of motion exercises to ankle and toes62. Measure weight of resident63. Measure height of resident64. Give post-mortem care

APPENDIX A-B –

INSTRUCTIONS

1st. Column:

List date of classroom instruction - 75 hours. 2nd Column:

Classroom instructor initials. 3rd Column:

Date the competency evaluation (16 hrs - #1-#64 below) was completed in state approved training agency. 4th Column:

Simulation must be done in white area and only if care issue NOT AILABLE in state approved training agency. 5th Column:

Clinical Supervisor/Instructor must SIGN CORRESPONDING PINK SHEET THEN initial that the Nurse Assistant is competent in this skill and that the competency evaluation was completed on a ONE TO ONE RATIO IN A STATE APPROVED TRAINING AGENCY.

DATE

EVALUATION

CS/INSTRUCTOR

DATE

EVALUATION

CS/INSTRUCTOR

Take oral temperature2. Take rectal temperature3. Take axillary temperature4. Count radial pulse5. Count apical pulse6. Count respirations7. Measure blood pressure8. Wash hands9. Put on and remove daily care non-sterile gloves 10. Put on and remove mask 11. Put on and remove non-sterile gown 12. Feed helpless resident13. Serve a food tray14. Clear airway obstruction in conscious resident15. Clear airway obstruction in unconscious resident16. Thicken liquids17. Distribute drinking water18. Measure fluid intake19. Measure fluid output20. Shave with disposable razor21. Shave with electric razor22. Assist with oral hygiene23. Administer oral hygiene to resident who is helpless/unconscious24. Provide denture care25. Give fingernail care26. Give toenail care27. Comb/brush hair28. Give shampoo during tub bath/shower bath29. Give bed shampoo30. Give perineal care to male resident31. Give perineal care to female resident32. Assist resident to dress MO 580-2473 (12-07)

PERSONAL COMPETENCY EVALUATION (PASSING SCORE REQUIRED ON ALL ITEMS PRIOR TO BEING ALLOWED TO TAKE FINAL EXAM)

Wears clean uniform, wears name tag and is free of body odor66. Observes resident rights67. Reports to work on time68. Uses facility’s procedure for absenteeism69. Completes assignments70. Communicates well with others, is courteous71. Incorporates acceptable techniques when caring for the confused resident, the mentally ill resident or the resident with unconventional behaviors.

RATER NAME

LICENSE

COMP.

Utilizes plan of care to meet resident’s needs73. Maintains a safe environment for resident/self74. Uses appropriate body mechanics75. Reports & records pertinent information to appropriate personnel76. Shows enthusiasm for learning77. Applies critical thinking during class and clinical work.78. Shows care and empathy while providing care.

RATER NAME

LICENSE

COMP.

COMMENTS

APPENDIX B

STUDENT NAME - PLEASE PRINT (LAST)

(FIRST)

(MIDDLE)

(MAIDEN)

SOCIAL SECURITY NO.

MISSOURI DEPARTMENT OF HEALTH AND SENIOR SERVICESDIVISION OF REGULATION AND LICENSURESECTION FOR LONG-TERM CARE REGULATIONCLASSROOM AND ON-THE-JOB TRAINING RECORD MO 580-3355 (9-2021)

PAGE 1 OF 3

DHSS-DRL-111 (08-20)

(12) 1ST INSTRUCTOR SIGNATURE - INSTRUCTIONAL HRS

(12A) LICENSE NO.

(12B) LAST NAME

(13) 2ND INSTRUCTOR SIGNATURE - INSTRUCTIONAL HRS

(13A) LICENSE NO.

(13B) LAST NAME

(14) ADMINISTRATOR/DIRECTOR OF NURSING (DON)/CEO SIGNATURE

(14A) LICENSE NO.

(14B) LAST NAME

(15) CHARGE NURSE SIGNATURE - FACILITY VERIFICATION 84 HRS OJT COMPLETED

(15A) LICENSE NO.

(15B) LAST NAME

(16) CHARGE NURSE SIGNATURE - FACILITY VERIFICATION 16 HRS OR 100 HRS OJT COMPLETED

(16A) LICENSE NO.

(16B) LAST NAME

(17) 1ST INSTRUCTOR SIGNATURE - 16 HRS OJT

(17A) LICENSE NO. (17B) LAST NAME

(18) 2ND INSTRUCTOR SIGNATURE - 16 HRS OJT

(18A) L

ICENSE NO. (18B) LAST NAME

(19) CLINICAL SUPERVISOR SIGNATURE - 84 HRS OJT

(19A) LICENSE NO. (19A) LAST NAME

(20) CLINICAL SUPERVISOR SIGNATURE - 84 HRS O

JT (20A) LICENSE NO. (20B) LAST NAME

(1) STUDENT NAME (LAST, FIRST, MIDDLE)

(2) FORMER NAMES USED

(3) SOCIAL SECURITY NO.

(4) STUDENT E-MAIL

(5) STUDENT PERMANENT ADDRESS (STREET, CITY, STATE, ZIP)

(6) DATE OF BIRTH

(7) STUDENT PHONE NO.

(8) APPROVED SITE NAME - 75 HRS INSTRUCTIONAL TRAINING

(8A) SITE NO.

(8B) BEGIN DATE

(8C) COMPLETION DATE

(8D) COMPLETED INSTRU

CTIONAL

TRAINING

(9) APPROVED SITE NAME - 16 HRS OR 100 HRS ON-THE-JOB-TRAINING (OJT)

(9A) SITE NO.

(9B) BEGIN DATE

(9C) COMPLETION DATE

(9D)

COMPLETED OJT HRS

(10) APPROVED SITE NAME - 84 HRS OJT

(10A) SITE NO.

(10B) BEGIN DATE

(10C) COMPLETION DATE 84 OJT HOURS

(11) CLASS TEST SCORES

Each test score must be at least 80% (must be completed prior to final exam)

(11A) APPROVED FOR FINAL EXAM

(11B) NOT APPROVED FOR FINAL EXAM 35. ive complete bed bath 36. ive tub bath 37. ive shower bath 38. ake an unoccupied bed 39. ake an occupied bed 40. ive back rub ive stage 1 pressure ulcer care & discuss prevention 42. iscuss pressure relieving devices 43. eposition for pressure relief in bed 44. eposition for pressure relief in chair 6XVSHQGUHVLGHQW·VKHHOV 46. ive perineal care with catheter 47. hange a drainage bag 48.

E mpty a urinary drainage bag 49. ssist resident in using urinal 50. ssist resident in using bedpan are of an uncomplicated established colostomy 52.

Turn resident to one side ¼ turn 53. ove resident to head of bed two person assist 54. emonstrate one person pivot transfer from bed to chair 55. emonstrate one person pivot transfer from chair to bed 56. emonstrate two person pivot transfer from chair to bed resident can assist 57. emonstrate two person transfer with a mechanical lift to chair 58. mbulate resident using a gait belt 59. mbulate resident using a walker 60. mbulate resident using a cane ange of otion (ROM) exercises neck and shoulders 62. exercises elbow 63. exercises wrist fingers 64. exercises hip knee 65. exercises ankle toes 66. easure weight of resident 67. easure height of resident 68. ive post mortem care – IO 1s List date of hours instructional training 2nd lassroom instructor initials 3rd ate the T evaluation was completed in state approved training agency 4t h imulation may be done only if care issue is no il ab in state approved training agency 5t h linical upervisor Instructor must initial the student is competent in this skill and the competency evaluation was completed on a ra ti s ra enc E An ns ruc mus vi de eas f t he LL LL DATE OJT DATE OJT OJT EVALUATION CS / INSTRUCTOR OJT EVALUATION CS / INSTRUCTOR Take oral temperature Take axillary temperature ount radial pulse ount apical pulse 5. ount respirations 6. easure blood pressure 7.

Wash hands 8. remove daily care non sterile gloves 9. remove mask 0. remove non sterile gown eed a resident that requires total assistance erve a food tray lear airway obstruction in conscious resident lear airway obstruction in unconscious resident 5.

Thicken liquids 6. istribute drinking water 7. easure fluid intake 8. easure fluid output 9. have with disposable razor 20. have with electric razor ssist with oral hygiene 22. dminister oral hygiene to resident that requires assistance 23. enture care 24. ingernail care 25.

Toenail care 26. omb brush hair 27. hampoo tub bath shower bath 28. ed shampoo 29. erineal care to male resident 30. erineal care to female resident ssist resident to dress 32. hanging a brief 33. ssist resident to undress 34. pply and remove therapeutic stockings COMMEN UDEN NAME AS RS DD E)

SOC SECUR

IT MO 580-3355

(9-202 PAGE

OF DHSS-DR

(08-20)

MO 3355 (9 2021)

PAGE 3

F 3 DHSS-DRL- 111 (08 20)

IDE TO CLASSROOM AND ON-THE-JOB TRAINING RECORD

Guide for pa agency site conducted.8A agency conducted. 8B Beginning date this date pre-date on j ob 8C 8D umber ong-term care TC)

Note: ll 100 were ity, boxes through 10C eft b ank. 9A 9B began 9C 9D umber Note: that has been denied abi ide due enforcement issues ab ide on he other ed/e igib 0A 0B began. 0C 11.

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LUVW )

LUVW 13. assisted with training, indicating he/she student. 14. dministrator, DO CE occurred. his acknow edge CNA occurred named box #9 $ LQLVWU '21R &(2 ·V $ LQLVWU '21R &(2 ·V 15. charge nurse erifying present & 16.

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T ( eft b ank if charge nurse signed ll 100 #15 6L RIÀ UVW Z SU RY LGHG XUV RI XUV 2-7 (T hese shared between more instructors. 7A , QVWUX 7B QVWUX portion 8A 8B isor ised 9A &O 9B &O isor ised portion 0A FO 0B FO Guide for $OOER[ HV R DJ P XVW E FRP HWHG [DPZ [F HSWL FRPP HQWV ER[Z KL PD\E ÀOO HG R XW SSU WH VWXGHQW All isors instructors and/or ision sign this form. extra space needed, signatures inc uded comment

section bottom page If the 75 hours of instructional training or 100 hours on-the-job hours are conducted at a different location other than at the above address - a current signed agreement shall be on file at the facility/agency. Provide the name, CNA training site number and address of the facility/ agency below:

MISSOURI DEPARTMENT OF HEALTH AND SENIOR SERVICES

DIVISION OF REGULATION AND LICENSURE

SECTION FOR LONG-TERM CARE REGULATION

APPLICATION FOR APPROVAL AS A NURSING ASSISTANT TRAINING AGENCY

MO 580-2469 (5-2021) DHSS-DRL-2469 (8-20)

DATE SUBMITTED

FACILITY/SCHOOL NAME TRAINING AGENCY NO.

LIST PREVIOUS FACILITY/SCHOOL NAMES

PHYSICAL ADDRESS (STREET, CITY, STATE, ZIP CODE) TELEPHONE

MAILING ADDRESS (STREET, CITY, STATE, ZIP CODE) FAX NUMBER

ADMINISTRATOR/DIRECTOR

DHSS APPROVED INSTRUCTOR(S) NAME LICENSE NUMBER

TRAINING AGENCY/FACILITY CONTACT EMAIL ADDRESS

PLEASE CHECK THE FOLLOWING IF APPLICABLE:

DHSS LICENSED FACILITY (ICF/SNF) NON-FACILITY BASED

HOSPITAL-BASED NF OR SNF * CAREER CENTER SCHOOL (PUBLIC) * CAREER CENTER SCHOOL (PRIVATE)

HOSPITAL * COMPREHENSIVE HIGH SCHOOL

MO VETERANS HOME * COMMUNITY OR 4-YEAR COLLEGE

ASSOCIATION * PRIVATE AGENCY *Must be approved by Department of Secondary Education or Department of Higher Education NAME(S) AND NURSE LICENSE NUMBER(S) OF DHSS APPROVED CLINICAL SUPERVISOR(S)

COMMENTS:

ADMINISTRATOR/DIRECTOR SIGNATURE DATE

The completed application form may be submitted by mail, fax to: 573-526-7656, or e-mail: cnaregistry@health.mo.gov.

Mailing address: Missouri Department of Health and Senior Services, Section for Long-Term Care Regulation, Attn: Health Education U nit, PO Box 570, Jefferson City, MO 65102-0570 NEW APPLICATION RENEWAL APPLICATION REVISED APPLICATION AGENCY/FACILITY NAMECNA SITE NO.ADDRESS (STREET, CITY, STATE, ZIP CODE)

DHSS APPROVED CERTIFYING AGENCY NAME

What portions of the course will be conducted at the above address: 75 instructional training hours 100 On-The-Job Hrs What portions of the course will not be conducted at the above address: 75 instructional training hours 100 On-The-Job Hrs

Filed March 10, 1983, effective June 11, 1983. Amended: Filed Sept. 12, 1984, effective Dec. 11, 1984. Amended: Filed Oct. 13, 1987, effective Jan. 29, 1988. Emergency amendment filed Dec. 16, 1988, effective Jan. 1, 1989, expired April 5, 1989.

Amended: Filed Jan. 19, 1989, effective April 27, 1989. Amended: Filed June 16, 1992, effective Feb. 26, 1993. Amended: Filed May 26, 1998, effective Jan. 30, 1999. Moved to 19 CSR 30-84.010, effective Aug. 28, 2001. ** Emergency amendment filed June 14, 2021, effective June 28, 2021, expired Dec. 24, 2021. Amended: Filed June 14, 2021, effective Dec. 30, 2021. *Original authority: 198.009, RSMo 2016; 198.079, RSMo 1979; and 198.082, RSMo 1979, amended 1988. **Pursuant to Executive Order 21-07, 19 CSR 30-84.010, section (4), subsections (7)(C) and (7)(D), and paragraph (10)(C)1. was suspended from April 3, 2020 through August 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 30-84.010, section (3), paragraph (5)(B)2., section (8), and paragraphs (9)(C)2., (10)(C)5., (10)(C)6., and (11)(B)4. was suspended from April 3, 2020 through December 31, 2021.

History

AUTHORITY: sections 198.009 and 198.079, RSMo 2016, and section 198.082, RSMo Supp. 2021. This rule originally filed as 13 CSR 15-13.010. Original rule filed Aug. 13, 1982, effective Jan. 13, 1983. Amended:

19 CSR 30-84.020 Certified Medication Technician Training Program {#sec-19-csr-30-84.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-84.020}

PURPOSE: Individuals who administer medications in intermediate care and skilled nursing facilities are required by rule to have successfully completed a medication administration training program approved by the Department of Health and Senior Services.

This rule sets forth the requirements for the approval of a medication technician training program designating the required course curriculum content, outlining the qualifications required of students and instructors, designating approved training facilities, outlining the testing and certification requirements, and establishing an update course.

rial. The entire text of the rule is printed (1) Definitions. For the purpose of this rule the following definitions shall apply.

(A) Cooperating agency—an intermediate care facility (ICF) or skilled nursing facility (SNF) licensed by the Department of Health and Senior Services (the department) which has entered into a written agreement with the educational training agency to provide the setting for the clinical portion of the course.

(B) Course—the sixty (60) hours of classroom training, eight (8) hours of clinical practice, and a two (2)-part final examination of the department-approved certified medication technician course curriculum.

(C) Educational training agency—an area vocational-technical school, an area career center, a comprehensive high school, a community college, or an approved four (4) year institution of higher learning that is approved by the department to conduct the Certified Medication Technician (CMT) Course. A long-term care facility cannot be a training agency.

(2) The CMT course shall be prescribed by the department in order to prepare individuals for employment as certified medication technicians in intermediate care facilities and skilled nursing facilities (ICF/SNF). The program shall be designed to teach skills in medication administration of nonparenteral medications, which will qualify students to perform this procedure to assist licensed practical nurses (LPNs) or registered nurses (RNs) in medication therapy. All aspects of the CMT course included in this rule shall be met in order for a program to be approved.

(3) If the CMT course is to be conducted in an ICF/SNF, the facility must enter into an agreement with an educational training agency which is responsible to:

(A) Provide administration of the Test of Adult Basic Education (TABE) and review of the student’s qualifications;

(B) Arrange for a department-approved instructor;

(C) Arrange for administration of the final examination; and (D) Certify the students through a department-approved certifying agency which is any one (1) of the long-term care associations or any other department-approved agency authorized to issue certificates.

(4) The objective of the CMT Training Program shall be to ensure that the medication technician will be able to do the following:

(A) Prepare, administer, and document administration of medications by all routes except those administered by the parenteral route;

(B) Observe, report, and document responses of residents to medications administered;

(D) Identify appropriate medication reference materials;

(E) Observe, report, and document responses of residents to medications;

(F) Identify lines of authority and areas of responsibility; and (G) Identify what constitutes a medication error.

(5) The course shall consist of at least sixty (60) classroom hours of instruction taught by a department-approved CMT instructor or examiner (instructor/examiner). The course shall include an additional minimum eight (8) hours of clinical practice conducted in a licensed ICF or SNF under the direct supervision of the CMT instructor/examiner or under the direct supervision of an RN employed by the cooperating agency and designated by the educational training agency in

section (9) of this rule. The instructor/examiner or the RN employed by the cooperating agency may require the student to complete more than the minimum eight (8) hours of clinical practice based on each student’s mastery of course content. A final written examination and a minimum two (2)-hour final practicum examination must be conducted in an ICF/SNF.

(A) For all courses beginning on or after the effective date of this rule, the student manual and course developed by the Department of Elementary and Secondary Education and the Missouri Center for Career Education at University of Central Missouri as outlined in the manual entitled Certified Medication Technician, (Revised 2008), incorporated by reference in this rule and available by Internet at: www.cmttest.org shall be considered the approved course curriculum. This rule does not incorporate any subsequent amendments or additions.

(B) For all courses beginning on or after the effective date of this rule, the approved course curriculum instructor’s guide shall be the companion Instructor’s Guide, (Revised 2008), incorporated by reference in this rule, and accessed by Internet: www.cmttest.org.

This rule does not incorporate any subsequent amendments or additions.

(D) The curriculum content shall include procedures and instructions in the following areas:

Basic review of body systems and medication effects on each;
Medical terminology;
Infection control;
Medication classifications;
Medication dosages, measurements, and forms;
Acquisition, storage, and security;
Problems of observations in medication therapy; and 8. Administration by oral, rectal, vaginal, otic, opthalmic, nasal, skin, topical, transdermal patches, and oral metered dose inhaler.

(E) A student shall not be allowed to independently administer medications until successfully completing the CMT course. The CMT Course Evaluation Record may be used as authorization to independently administer medications for up to sixty (60) days. After this period the student must be listed on the Missouri CNA Registry as an active CMT.

(6) Student Qualifications.

(A) Any individual employable in an ICF/SNF who will be involved in direct resident care shall be eligible to enroll as a student in the course if the following criteria are also met:

High school diploma or General Education Development (GED) Certificate;
A minimum score of 8.9 on both Vocabulary and Comprehension tests and a minimum score of 7.0 on Mathematics Concepts and Application tests on the D level of the TABE. The tests shall be administered by the educational training agency;
Six (6) months of employment as a CNA who is listed as active on the Missouri CNA Registry;
For an individual currently employed in a long-term care facility, a letter of recommendation submitted to the educational training agency by the administrator or director of nursing of the facility, or for an individual not currently employed in a long-term care facility, a letter of recommendation submitted to the educational training agency by a previous long-term care facility employer;
The individual is not listed on the department’s Employee Disqualification List (EDL) and does not have a Federal Indicator on the Missouri CNA Registry or any other state’s CNA Registry that the educational training agency has checked based on a belief that information on the individual may be included;
The individual has not been convicted of or entered a plea of guilty or nolo contendere to a crime in this state or any other state, which if committed in Missouri would be a Class A or Class B felony violation of Chapters 565, 566, or 569, RSMo, or any violation of subsection 3 of section 198.070, or section 568.020, RSMo, unless a good cause waiver has been granted by the department under the provisions of 19 CSR 30- 82.060; and 7. The individual meets the employment requirements listed in 19 CSR 30-85.042(32).

(B) Students who drop the CMT course due to illness or incapacity may reenroll within six (6) months of the date the student withdrew from the course and make up the missed course material upon presenting proof of prior attendance and materials covered if allowed by the educational training agency’s policy.

(C) Individuals seeking to challenge the CMT examination shall be listed as active on the Missouri CNA Registry and shall meet the criteria in paragraph (6)(A)6. of this rule.

If not listed as active on the Missouri CNA Registry, the individual shall first apply to challenge and successfully pass the CNA written and practicum examination. The following individuals may qualify to challenge the final written and practicum CMT examination:

A student enrolled in a professional nursing school or in a practical nursing program who has completed a medication administration course and who has a letter of endorsement from the school or program director;
An individual who successfully completed a professional or practical nursing program in the last five (5) years but who failed the professional (RN) or practical (LPN) state licensure examination;
An individual who provides evidence of successful completion of a departmentapproved CMT course while working as an aide at a facility operated by the Missouri Department of Mental Health who is listed as a CNA on the Missouri CNA Registry.

(D) An individual who provides evidence of successful completion of a Missouri Department of Mental Health (DMH)approved CMT course while working at a facility operated by the DMH but who is not listed as a CNA on the department’s Missouri CNA Registry may challenge the CMT examination. The CMT challenge may only be made after first completing the orientation module of the department’s approved Nurse Assistant Training Program and successfully challenging the final CNA examination so that the individual’s name appears on the department’s Missouri CNA Registry.

(E) An individual who has successfully completed a department-approved medication technician course in another state, who is currently listed as a CMT in good standing in that state, and who submits a letter of recommendation to the department’s Health Education Unit from an administrator or director of nursing of a facility in which the individual worked as a medication technician.

(7) Obtaining Approval to Challenge the CMT Examination.

(A) An individual wanting to challenge the written and practicum final examination shall submit a request in writing to the department’s Health Education Unit enclosing documentation required by this rule. If approved to challenge the examination, a letter so stating will be sent from the department to be presented to the educational training agency.

The educational training agency shall review and maintain a copy of the letter in the agency’s file prior to scheduling the individual for testing. Challenge approval letters shall be valid for one hundred twenty (120) days from the date of the department’s approval.

(B) An individual who has successfully completed a professional or practical nursing program and who has not yet taken or received the results of the state licensure examination may request a qualifying letter from the department’s Health Education Unit allowing the individual to administer medication in a long-term care facility. The qualifying letter allows the individual to administer medications according to this regulation in lieu of a certificate or the individual being listed on the Missouri CNA Registry as an active CMT. However, if more than ninety (90) days have lapsed since graduation or since taking the Missouri State Board Examination with no successful results confirmed, the individual shall request department approval to challenge the final examination for certification as a medication technician.

(C) An individual shall not administer medications without the instructor present until the individual has successfully completed the challenge examination and holds an authorized signed CMT Course Evaluation Record. An authorized signed CMT Course Evaluation Record is good for up to sixty (60) calendar days from the examination date pending receipt of the certificate or of listing on the Missouri CNA Registry as an active CMT.

(8) CMT Course Examiner Qualification Requirements.

(A) In order to qualify as an instructor, examiner, or both, the individual:

Shall be currently licensed to practice as an RN in Missouri or shall have a temporary permit from the Missouri State Board of Nursing. The instructor/examiner shall not be the subject of current disciplinary action, such as probation, suspension, or revocation of license;
Shall hold a current Certified Medication Technician teaching certificate from the Department of Elementary and Secondary Education, Division of Career Education;
Shall complete an instructor/examiner program workshop and be listed as a qualified CMT instructor/examiner on the department’s Instructor/Examiner Registry;
Shall sign an agreement with the department to protect and keep secure the final examination and the PIN used to electronically access the Instructor Guide/Test Bank;
May be an employee of the ICF/SNF in which training is conducted, but the ICF/SNF must have a cooperative agreement with an educational training agency;
Shall teach the course or facilitate the challenge examination only as permitted by the educational training agency; and 7. May be assisted by pharmacists as guest instructors in the areas of medication systems, regulations governing medications, medication actions, adverse reactions, medication interactions, and medication errors.

(B) CMT Instructor/Examiner Disqualification Criteria.

An individual shall not be approved to be an instructor/examiner if he or she has ever been found to have knowingly acted or omitted any duty in a manner which would materially and adversely affect the health, safety, welfare, or property of a resident.
An individual who has been approved to be an instructor/examiner shall have that status revoked if, after an investigation by the department, it is found that the individual:

A. Knowingly acted or omitted any duty in a manner which materially and adversely affected the health, safety, welfare, or property of a resident;

B. Defrauded an educational agency or student by taking payment and not completing a course or following through with certification documentation required by 19 CSR 30-84.020;

C. Failed to teach, examine, or clinically supervise in accordance with 19 CSR 30-84.020;

D. Falsified information on the CMT Course Evaluation Record or any other required documentation;

E. Failed to keep secure the automated PIN access system;

F. Failed to keep secure the CMT web-based, department-approved Instructor Guide/Test Bank;

G. Copied test questions or answer keys; or H. Prepared students directly from the exam or utilized unfair or subjective testing techniques.

Notify the individual that he or she is no longer eligible to be an instructor/examiner;
Notify all certifying agencies that the individual is no longer considered an approved instructor or examiner; and 3. Remove the individual’s name from the department’s Instructor/Examiner Registry.

(D) To be reinstated as an approved instructor/examiner the individual shall submit a request in writing to the department’s Health Education Unit stating the reasons why reinstatement is warranted. If the individual has not attended the Train-the-Trainer Program Workshop within two (2) years of the date of request, the individual shall retake the Train-the-Trainer Program Workshop.

The Section for Long-Term Care administrator or designee shall respond in writing to the request.

(9) Educational Training Agencies.

(A) The following entities are eligible to apply to the department’s Health Education Unit to be an approved educational training agency: vocational-technical schools, comprehensive high schools, community colleges or approved four (4)-year institutions of higher learning.

(B) All classrooms shall contain sufficient space, equipment and teaching aids to meet the course objectives.

(C) A school requesting approval to teach the CMT Training Course or facilitate challenging the examination shall file an application with the department’s Health Education Unit giving the names of the instructors and listing the equipment and classroom space that will be used and shall provide a copy of an agreement with the cooperating agency where the course, clinical practice, or final practicum examination of the program will be conducted and provide the names of the RNs supervising the clinical observation.

Educational training agencies shall be approved for a two (2)-year period and shall submit a new application thirty (30) days prior to the expiration date.

(D) The cooperating agency in which clinical practice and the final practicum examination are conducted shall allow students, instructors and examiners access to the medication room, supervised access to residents and access to the medication documentation area.

(E) There shall be a signed written agreement between the educational training agency and each cooperating agency which specifies the rules, responsibilities, and liabilities of each party.

(F) The educational training agency is responsible for sending the department’s Health Education Unit a copy of the most current signed agreement with the cooperating agency where any portion of the course or the entire course will be conducted. The department shall review all signed agreements of cooperation. On-site inspections of the cooperating agency or the educational training agency may be made by the department if problems occur or complaints are received. If requirements are not met, the status as an educational training agency may be revoked by the department.

(G) The classroom portion of the course may be taught in an ICF/SNF if there is an approved educational training agency as a sponsor.

(10) Certified Medication Technician Course Testing.

(A) Prior to the student’s enrollment, the TABE shall be administered by qualified examiners designated by the educational training agency. See paragraph (6)(A)2. of this rule.

(B) To be eligible for the final course examination, students shall have achieved a score of at least eighty percent (80%) on each written examination in the course curriculum.

(C) Courses beginning on or after the effective date of this rule require the instructor/examiner to administer the departmentapproved written final examination accessed through the department’s website at www.cmttest.org using a secure PIN system.

The final examination shall include fifty (50) multiple choice questions based on course objectives. A score of at least eighty percent (80%) is required for passing.

(D) The practicum examination shall include preparing and administering all nonparenteral routes and documenting administration of medications administered to residents. The practicum examination shall be conducted under the direct supervision of the department-approved instructor/examiner and the individual responsible for medication administered in the ICF/SNF. Testing on medications not available in the ICF/SNF shall be done in a simulated classroom situa- (E) The final examination may be retaken one (1) time within ninety (90) days of the first fail date without repeating the course.

(F) A challenge examination may be taken one (1) time. If failed, the entire course shall be taken.

(G) The instructor/examiner shall complete the CMT Course Evaluation Record, which includes competencies, scores, and other identifying information.

(11) Records and Certification.

(A) Records.

The educational training agency shall maintain records for at least two (2) years for CMT Course and shall submit to a department-approved certifying agency within thirty (30) calendar days from the examination date the following: the student’s legal name, Social Security number, class beginning date and completion date, whether certified by a challenge or full course, and other identifying information from the CMT Course Evaluation Record.
The educational training agency shall provide a copy of the CMT Course Evaluation Record to the certified medication technician.
The educational training agency may release a transcript with written permission from the student in accordance with the and Privacy Act, 20 U.S.C. section 1232g.

(B) Certification.

The educational training agency shall maintain the records of individuals who have been enrolled in the CMT course and shall submit to a department-approved certifying agency, the legal name, date of birth, Social Security number, certificate number, certification date, educational training agency and cooperating agency for all individuals who successfully complete the course and final examination within thirty (30) calendar days from the examination date. Upon receipt of the successful completion of the course, a department-approved certifying agency shall issue a certificate of completion to the student through the educational training agency. Any final examination documentation over sixty (60) days old shall be invalid.
Each week the certifying agency shall provide the department’s Health Education Unit with names and other identifying information of those receiving certificates.
The department shall maintain a list of certifying agencies approved to issue certificates for the CMT Training Program. In order for a certifying agency to be approved by the department, the agency shall enter into an annually renewable agreement of cooperation with the department.

(12) Requirements for Hiring an Individual as a CMT.

(A) The department shall maintain a CNA Registry, which will list the names of CMTs and other relevant and identifying informa- (B) Any individual seeking employment in an ICF/SNF as a CMT must be employable as a CNA and be listed with active status as a CNA and CMT on the department’s CNA Registry.

(C) When employing an individual as a CMT, the facility shall contact the department’s website at www.dhss.mo.gov/cnaregistry in order to verify current certification status of the individual. Current registry status must be verified even though the individual presents a CMT certificate.

Filed July 13, 1998, effective Feb. 28, 1999.

Moved to 19 CSR 30-84.020, effective Aug. 28, 2001. Amended: Filed March 13, 2008, effective Oct. 30, 2008. ** *Original authority: 198.079, RSMo 1979, amended 2007. **Pursuant to Executive Order 21-07, 19 CSR 30-84.020, subsection (9)(B) was suspended from April 9, 2020 through August 31, 2021.

Pursuant to Executive Order 21-09, 19 CSR 30-84.020, section (5), and subsections (6)(B ), (7)(A), (7)(B), (7)(C), (10)(D), and (10)(F) was suspended from April 9, 2020 through December 31, 2021.

History

AUTHORITY: section 198.079, RSMo Supp. 2007. This rule originally filed as 13 CSR 15-13.020. Original rule filed Aug. 13, 1982, effective Jan. 13, 1983. Amended: Filed Oct. 13, 1987, effective Jan. 29, 1988. Amended:

19 CSR 30-84.030 Level I Medication Aide Training Program {#sec-19-csr-30-84.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-84.030}

PURPOSE: This rule sets forth the requirements for a Level I Medication Aide (LIMA)

Training Program.

rial. The entire text of the rule is printed (1) Definitions.

(A) Certifying agency—shall mean a long term care association, area vocational technical school, career center, comprehensive high school, community college, or four- (4-) year institution of higher learning approved by the Department of Health and Senior Services (the department) to issue Level I Medication Aide (LIMA) certification.

(B) Challenge the final examination—shall mean taking the final examination of the course without enrolling in and taking the entire course.

(C) Department of Mental Health (DMH) facility—shall mean a residential setting or day program funded, licensed, operated, or certified by the Department of Mental Health to provide services to persons with developmental disabilities and/or mental illness.

(D) Level I medication aide (LIMA) instructor (instructor)—shall mean a nurse approved to instruct the LIMA course.

(E) Long term care (LTC) association— shall mean a trade association with the primary purpose of representing or advocating for long-term care providers and/or professionals.

(F) Registered nurse presenter—shall mean a registered nurse approved to teach the Train the Trainer Workshops and prepare instructors to teach the LIMA course.

(G) Simulated training setting—shall mean a combined practical and verbal process that simulates all aspects of actual medication administration, including, at a minimum, reading a medication order, setting up the medication, verbally explaining how to administer the medication to a resident, and recording the administration of the medica- (H) Train the Trainer Workshop—shall mean a training program conducted by a certifying agency to prepare instructors for the LIMA training program.

(I) Training agency—shall mean the entity that sponsors the department-approved training program.

(2) The LIMA Training Program shall be administered by the department in order to prepare individuals for employment as LIMAs in residential care facilities (RCFs) and assisted living facilities (ALFs). The program shall be designed to teach skills in medication administration by the following routes: oral, rectal, vaginal, otic, ophthalmic, nasal, topical, transdermal, buccal, sublingual, aerosol/nebulizer, and oral metered dose inhalers.

(3) The objective of the LIMA Training Program shall be to ensure that the LIMA will be able to define the role, limitations, and responsibilities of a LIMA; prepare, administer, and document administration of medications by those routes listed in section (2) of this rule; observe, report, and record unusual responses to medications; identify responsibilities associated with acquiring, storing, and securing medications; utilize appropriate medication reference materials; and identify what constitutes a medication error.

(4) The course shall include a minimum of sixteen (16) hours of integrated formal instruction and practice sessions directly supervised by an approved instructor and shall include a final written examination and a final practicum examination.

(5) Course Manual Requirements.

(A) The course manual must be approved by the department. A list of approved LIMA training manuals may be accessed through the department’s website or by telephone at (573) 526-5686.

(B) The manual content shall include procedures and instructions in the following areas: residents’ rights; fundamental human body systems; common medical terminology and abbreviations; medication classifications and their implications; observing and reporting possible medication reactions; techniques of medication administration by all routes listed in section (2) of this rule; documentation, including telephone orders, medication administration records (MARs), and leaves of absence; acquiring, storing, and securing medications; medication reference resources; and infection control.

(6) Training Agency Requirements.

(A) The following entities are eligible to be training agencies: area vocational-technical schools, career centers, comprehensive high schools, community colleges, four- (4-) year institutions of higher learning, RCFs or ALFs licensed by the department, DMH facilities, or LTC associations.

(B) The training agency is responsible for obtaining an approved instructor, providing training materials for each student, including a copy of a department-approved course manual, and presenting a class schedule for approval by an approved certifying agency.

(C) Prior to beginning the class the following information must be provided in writing to the certifying agency along with the class schedule: the approved instructor’s legal name, Social Security number, nursing license number, current address, and telephone number; each student’s legal name, address, telephone number, Social Security number, date of birth, and employer’s name and address, if applicable; the date and location of each class to be held; and the date and location of the final examination. The certifying agency which approved the class shall be notified in advance if there are any changes in dates or locations.

(D) Training locations shall contain sufficient space, equipment, and teaching aids to meet the course objectives and accommodate the number of students.

(E) If the instructor is not directly employed by the training agency, there shall be a signed written agreement between the training agency and the instructor, which specifies the roles, responsibilities, and liabilities of each party.

(F) If the training agency is not an RCF or ALF licensed by the department or a DMH facility, the agency must have a written agreement of cooperation currently in effect with the RCF, ALF, or DMH facility where the final practicum examination portion of the course will be conducted.

(G) Within thirty (30) days following the examination date, the training agency must provide in writing to the certifying agency that approved the class the following: each student’s legal name, address, date of birth, Social Security number, test booklet and test sheet, class beginning date and completion date, whether certified by a challenge or full course, and form MO 580-2531 (12/10)

LIMA Examination Score Sheet (examination score sheet), incorporated by reference in this

rule and available by mail at: Department of Health and Senior Services, Section for Long Term Care Regulation, Health Education Unit, PO Box 570, Jefferson City, MO 65102-0570 or by telephone at: (573) 526- 5686. This rule does not incorporate any subsequent amendments or additions to the materials incorporated by reference.

(H) Records Requirements.

The training agency shall maintain records for a minimum of two (2) years for LIMA course.
The training agency shall provide a copy of the examination score sheet to any individual who completes the course.
The training agency may release an examination score sheet with written permission from the student, in accordance with the and Privacy Act of 1974, 20 U.S.C. Section 1232g.

(7) Student Requirements.

(A) Any individual employable by an RCF or ALF to be involved in direct resident care shall be eligible to enroll as a student in the course. Employable shall mean an individual who is at least eighteen (18) years of age and meets the employability criteria pursuant to the provisions of 19 CSR 30-86.042, 19 CSR 30-86.043, or 19 CSR 30-86.047.

(B)

Any individual employable in a DMH facility to be involved in direct resident care shall be eligible to enroll as a student in the course. Employable shall mean an individual who meets the employability criteria pursuant to the provisions of 9 CSR 10-5.190.

(C) Individuals either enrolled in or who have been enrolled in a professional nursing school or in a practical nursing program who have completed the medication administration or pharmacology course and who have letters of endorsement from the directors of their respective programs may qualify as a LIMA by successfully challenging the final examina- 1. Those persons wanting to challenge the final examination shall submit a request in writing to the department’s Health Education Unit, enclosing documentation required by this rule. If approved to challenge the examination, a letter so stating will be sent from the department to present to an approved instructor so that arrangements can be made for testing.

Individuals requesting approval for challenging the examination shall meet the employability criteria in subsection (7)(A) or (B) of this rule.

(D) A student shall not administer medications without the instructor present until s/he successfully completes the course and obtains a copy of the examination score sheet.

(E) Biennial Training.

LIMAs shall participate in a minimum of four (4) hours of medication administration training every two (2) years in order to administer medications in an RCF or ALF via the routes set forth in section (2) of this

rule. The training shall be completed by the biennial anniversary date of the original issue of the LIMA certificate. The training shall be— A. Offered by an approved instructor as outlined in section (8) of this rule; and B. Documented on form MO 580- 2973 (12/10), LIMA Biennial Training, incorporated by reference in this rule and available through the department’s website or by mail at: Department of Health and Senior Services, Section for Long Term Care

Regulation, Health Education Unit, PO Box 570, Jefferson City, MO 65102-0570, telephone: (573) 526-5686, and kept in the employee’s personnel file. The department will also accept DMH’s Medication Aide Bi- Annual Training Form MO 650-8730 (12/00) incorporated by reference in this rule as acceptable documentation and available through the department’s website or by mail at: Department of Health and Senior Services, Section for Long Term Care

Regulation, Health Education Unit, PO Box 570, Jefferson City, MO 65102-0570, telephone: (573) 526-5686, and kept in the employee’s personnel file. This rule does not incorporate any subsequent amendments or additions to the materials incorporated by reference.

At a minimum the training shall address the following:

A. Medication ordering and storage;

B. Medication administration and documentation;

C. Use of generic drugs;

D. Infection control;

E. Observing and reporting possible medication reactions;

F. New medications and/or new procedures;

G. Medication errors;

H. Individual rights and refusal of medications and treatments;

I. Issues specific to the facility/program as indicated by the needs of the residents and the medications and treatments currently being administered; and J. Corrective actions based on identified problems.

LIMAs are responsible to ensure that the department is provided with the documentation required in subparagraph (7)(E)1.B. of this rule by the biennial anniversary date of the original LIMA certificate.

A. LIMAs who fail to submit to the department the documentation required by this rule by the biennial anniversary date of issue of their original LIMA certification will be removed from the LIMA active registry and will not be eligible to be employed as a LIMA in an RCF or ALF.

B. Any LIMA, after having been removed from the active registry for failing to provide to the department the documentation required by this rule, may be reinstated to the active registry by providing proof of a completed biennial training update at any time except any individual who has been off the active registry for more than five (5) years shall retake the course or s/he may challenge the examination if s/he meets the requirements of subsection (C) of this section.

LIMAs certified on or before September 30, 2012, shall have until September 30, 2014, to comply with the biennial training requirements required by this section.

(8) Instructor Requirements.

(A) An instructor shall be currently licensed to practice as either a registered nurse or practical nurse in Missouri, shall hold a current temporary permit from the Missouri State Board of Nursing, or shall hold a multi-state or single state registered nurse license from a jurisdiction that is party to the Nurse Licensure Compact. The licensee shall not be subject to current disciplinary action such as probation, suspension, or revocation and shall not be listed on the department’s Employee Disqualification List (EDL).

(B) In order to be qualified as an instructor, the individual shall have had one (1) year’s experience working as a nurse and shall have attended and successfully completed a “Train the Trainer” workshop to instruct the LIMA course conducted by an approved registered nurse presenter.

(C) A person who has been approved as an instructor shall have that status revoked if, after an investigation by the department or by DMH, it is found that the instructor— 1. Accepted money from a student and did not complete instruction of the class or upon successful completion of the class and final written and practicum examination did not complete the examination score sheet and provide it to the training agency;

Falsified information on the examination score sheet or any other required documentation;
Failed to administer the course in accordance with the provisions of this rule; or 4. Administered the final examination incorrectly and not in accordance with section (9) of this rule.

(D) Once an instructor’s status is revoked, only the department’s Section for Long Term Care Regulation Administrator or his/her designee may reinstate the individual and only after the individual has made a written request for reinstatement documenting new circumstances. If an instructor’s status is revoked or reinstated, the department shall make such information available to all approved certifying agencies.

(9) Testing Requirements.

(A) The final examination shall consist of a written and a practicum examination administered by an approved instructor.

A department-approved written examination which includes twenty-five (25) questions based on the course objectives shall be used.
The practicum examination shall be conducted in an RCF or ALF licensed by the department or a DMH facility and shall include the preparation, administration, and documentation of a minimum of ten (10) medications, with no more than five (5) being oral, administered to residents by routes listed in section (2) of this rule. The practicum examination shall be conducted under the direct supervision of the instructor. Testing on routes not available in the facility shall be conducted in a simulated training setting.

(B) The final examination may be retaken one (1) time within ninety (90) days of the first fail date without repeating the course. A minimum score of eighty percent (80%) for the final written examination and one hundred percent (100%) accuracy for the practicum examination is required to pass.

(C) An individual challenging the final examination who does not successfully pass the examination during the challenge process shall be required to complete the course in order to retake the examination.

(D) The instructor shall complete the examination score sheets and provide them to the training agency within fifteen (15) days of administering the examination.

(10) Registered Nurse Presenter Requirements.

(A) A registered nurse presenter shall have the following qualifications:

Registered nurse licensed in Missouri or hold a multistate or single state registered nurse license from a jurisdiction that is party to the Nurse Licensure Compact;
Approved LIMA instructor;
Has instructed at least one (1) LIMA course and conducted the final examination;
Approved by a certifying agency.

(11) Certifying Agency Requirements.

(A) In order for a certifying agency to be approved by the department, the agency shall enter into an agreement of cooperation with the department which shall be renewable annually and shall carry out the following responsibilities:

Verify eligibility requirements and approve registered nurse presenters;
Administer Train the Trainer Workshops;
Verify eligibility requirements for the Train the Trainer Workshops’ participants;
Provide instructors, who have successfully completed a Train the Trainer Workshop conducted by an approved registered nurse presenter, with a certificate documenting approval to teach the LIMA course;
Within one (1) week of issuing the LIMA instructor certificate, provide in writing to the department after each workshop held: legal names, Social Security numbers, addresses, telephone numbers, and date of birth of approved instructors. The department shall maintain a list of all instructors approved to teach the LIMA course. The list of approved instructors may be accessed through the department’s website.
Approve training agencies’ LIMA course schedules;
Verify that the instructor is listed on the department’s LIMA-approved instructor list;
Verify that the instructor’s nursing license is in good standing. A license search is available through the Missouri Division of Professional Registration website;
Review information provided by training agencies to ensure that the training program meets the requirements of the LIMA training program included in this rule;
Provide training agencies with the department-approved LIMA test booklets and test sheets prior to the final examination date for approved classes;
Issue certificates to individuals who successfully complete the LIMA course or successfully challenge the final examination;
Within one (1) week of issuing a LIMA certificate, provide in writing to the department the LIMA’s legal name, date of birth, address, telephone number, Social Security number, class beginning date and completion date, location of practicum examination, and whether certified by challenge or full course;
Issue a LIMA certificate to any DMH certified Medication Aide who applies for LIMA certification, pays the necessary fee, and provides all of the documentation and identifying information required by this A. The certifying agency shall verify with DMH that the individual is on the Medication Aide registry and has maintained current biennial training updates before issuing the certificate. Verification may be made by contacting DMH; and 14. Maintain records for a minimum of two (2) years for all requirements established in this section.

(B) The certifying agency may release an examination score sheet with written permission from the student, in accordance with the and Privacy Act of 1974, 20 U.S.C. Section 1232g.

Amended: Filed Oct. 16, 1985, effective Jan. 12, 1986. Amended: Filed May 26, 1998, effective Jan. 30, 1999. Moved to 19 CSR 30- 84.030, effective Aug. 28, 2001. Amended:

Filed Aug. 23, 2006, effective April 30, 2007.

Amended: Filed March 30, 2012, effective Nov. 30, 2012. ** *Original authority: 198.073, RSMo 1974, amended 1984, 1992, 1999, 2006 and 198.076, RSMo 1979, amended 1984. **Pursuant to Executive Order 21-07, 19 CSR 30-84.030, paragraph (1)(H)4. and subsection (7)(A) was suspended from April 9, 2020 through August 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 30-84.030, subsection (7)(C), paragraph (7)(E)1., subsection (8)(B), and paragraphs (9)(A)2., and (10)(A)1.-3. was suspended from April 9, 2020 through December 31, 2021.

History

AUTHORITY: sections 198.073 and 198.076, RSMo Supp. 2011. This rule originally filed as 13 CSR 15-13.030. Original rule filed May 14, 1985, effective Sept. 1, 1985.

19 CSR 30-84.040 Insulin Administration Training Program {#sec-19-csr-30-84.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-84.040}

PURPOSE: This rule sets forth the requirements for approval of an insulin administration training program, designates the required course curriculum content, outlines the qualifications required of students and instructors and outlines the testing and records requirements.

rial. The entire text of the rule is printed (1) The Insulin Administration Training Program shall be administered by the Department of Health and Senior Services (the department) in order to prepare medication technicians in a skilled nursing facility (SNF) or intermediate care facility (ICF), or medication aides in a residential care facility (RCF) or an assisted living facility (ALF) to administer insulin. The program shall be designed to present information on diabetes as it relates to symptoms and implications of proper or improper treatment, and to teach skills in insulin administration in order to qualify students to perform this procedure in long-term care (LTC) facilities in Missouri.

All aspects of the Insulin Administration Training course included in this rule shall be met in order for the program to be approved.

(2) The course shall consist of at least four (4) hours of classroom instruction by an approved instructor and shall include a final written and practicum examination. The practicum examination shall not be conducted in a simulated situation.

(3) The curriculum content shall include procedures and instruction in the following areas: diabetes and its treatment and complications, types of insulin, technique of insulin administration and methods of monitoring blood sugar levels.

(4) The manual entitled Insulin Administration (50-6080-S and 50-6080-I), 2001 edition, produced by the Instructional Materials Laboratory, University of Missouri-Columbia, which is incorporated by reference in this rule, and available through the Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102- 0570, shall be considered the approved course curriculum. This rule does not incorporate any subsequent amendments or additions to the materials incorporated by reference. Students and instructors shall each have a copy of the manual.

(5) A student shall not administer insulin without the instructor present until s/he has successfully completed the course.

(6) Student Qualifications.

(A) Any level I medication aide working in an RCF or ALF, who is recommended in writing for training by an administrator/manager or nurse with whom s/he has worked shall be eligible to enroll as a student in this (B) Any certified medication technician who is recommended in writing for training by the administrator or director of nursing with whom s/he has worked shall be eligible to enroll as a student in this course. The letter of recommendation shall be given to the training agency or instructor at enrollment.

(7) Instructor Qualifications. Only a registered nurse who is an approved instructor for the Level I Medication Aide Program, instructor/examiner for the Certified Nurse Assistant Program or instructor for the Certified Medication Technician Program shall be considered qualified to teach the Insulin Administration Course.

(8) Testing.

(A) The final examination shall consist of a written and practicum examination administered by an approved instructor or examiner.

The written examination shall include ten (10) questions extracted from the list in the instructor’s manual.
The practicum examination shall include the preparation, administration and recording of administration of insulin to a resident(s) under the direct supervision of the instructor/examiner.

(B) A score of eighty percent (80%) is required for passing the final written examination and one hundred percent (100%) accuracy in the performance of the steps of procedure in the practicum examination.

(C) The final examination, if not successfully passed, may be retaken one (1) time within thirty (30) days without repeating the (9) Records.

(A) The instructor shall complete the final record of the insulin administration course and shall distribute copies in the following manner:

A copy shall be provided to each individual who successfully completes the course;
A copy shall be kept in the instructor’s file; and 3. The original shall be sent to a certifying agency.

(B) Each student shall obtain a certificate from a state-approved certifying agency validating successful completion of the training program.

(D) The department shall maintain a list of approved certifying agencies to handle issuance of certificates for the Insulin Administration Program. In order for an agency to be approved by the department to be a certifying agency, it shall enter into an agreement of cooperation with the department which shall be renewable annually and the agency shall effectively carry out the following responsibilities:

Review all documents submitted by the instructor to assure that the instructor is qualified in accordance with section (7);
Assure that all program requirements have been met as set forth in these rules or as stipulated in the agreement with the department;
Issue certificates to individuals who successfully complete the course;
Provide the department with the names of those receiving certificates on at least a monthly basis; and 5. Maintain accurate and complete records for a period of at least two (2) years.

Filed Aug. 23, 2006, effective April 30, 2007. ** *Original authority: 198.005, RSMo 2006; 198.009, RSMo 1979, amended 1993, 1995; 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006 and 198.076, RSMo 1979, amended 1984. **Pursuant to Executive Order 21-07, 19 CSR 30-84.040, section (2) and subsection (6)(B) was suspended from April 15, 2020 through August 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 30-84.040, subsection (6)(A), section (7), and paragraph (8)(A)2. was suspended from April 15, 2020 through December 31, 2021.

History

AUTHORITY: sections 198.009 and 198.076, RSMo 2000 and 198.005 and 198.073, RSMo Supp. 2006. This rule originally filed 13 CSR 15-13.040. Original rule filed Oct. 15, 1990, effective March 14, 1991. Amended: Filed May 26, 1998, effective Nov. 30, 1998. Moved to 19 CSR 30- 84.040, effective Aug. 28, 2001. Amended:

Chapter 85 Intermediate Care and Skilled Nursing Facility

19 CSR 30-85.012 Construction Standards for New Intermediate Care and Skilled Nursing Facilities and Additions to and Major Remodeling of Intermediate Care {#sec-19-csr-30-85.012 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-85.012}

19 CSR 30-85.022 Fire Safety and Emergency Preparedness Standards for New and Existing {#sec-19-csr-30-85.022 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-85.022}

19 CSR 30-85.032 Physical Plant Requirements for New and Existing Intermediate Care {#sec-19-csr-30-85.032 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-85.032}

19 CSR 30-85.042 Administration and Resident Care Requirements for New and Existing {#sec-19-csr-30-85.042 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-85.042}

19 CSR 30-85.052 Dietary Requirements for New and Existing Intermediate Care and HEALTH AND SENIOR SERVICES Licensure Skilled Nursing Facility {#sec-19-csr-30-85.052 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-85.052}

19 CSR 30-85.012 Construction Standards for New Intermediate Care and Skilled Nursing Facilities and Additions to and Major Remodeling of Intermediate Care and Skilled Nursing Facilities {#sec-19-csr-30-85.012 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-85.012}

PURPOSE: This rule establishes construction standards for new intermediate care and skilled nursing facilities and additions to and remodeling of intermediate care and skilled nursing facilities.

Therefore, the material which is so incorporated is on file with the agency who filed this

PUBLISHER’S NOTE: All rules relating to long-term care facilities licensed by the Division of Aging are followed by a Roman Numeral notation which refers to the class (either class I, II or III) of standard as designated in section 198.085.1, RSMo 1986.

(1) Plans and specifications shall be prepared for the construction of all new intermediate care and skilled nursing facilities and additions to and remodeling of existing facilities.

The plans and specifications shall be prepared in conformance with Chapter 327, RSMo, by a duly registered architect or registered professional engineer. III (2) The facility may submit schematic and preliminary plans to the division showing the basic layout of the building and the general types of construction, mechanical and electrical systems. The facility may submit details before the larger and more complicated working drawings and specifications so that necessary corrections can be easily made before the final plans are submitted. The facility shall prepare and submit working drawings and specifications, complete in all respects, for approval by the division. These plans shall cover all phases of the construction project, including site preparation; paving; general construction; mechanical work, including plumbing, heating, ventilating and air conditioning; electrical work; and all built-in equipment, including elevators, kitchen equipment and cabinet work. II/III (3) Facilities shall begin construction only after the plans and specifications have received the written approval of the division.

Facilities shall then build in conformance with the approved plans and specifications.

The facility shall notify the division within five (5) days after construction begins. If construction of the project is not started within one (1) year after the date of approval of the plans and specifications are not completed within a period of three (3) years, the facility shall resubmit the plans to the division for its approval and shall amend them, if necessary, to comply with the then current rules before construction work is started or continued. II/III (4) The facility shall be located on an allweather road and have easy access for vehicular traffic. III (5) Facilities shall have access to local fire protection. III (6) The facility shall provide adequate roads and walks within the lot lines to the main entrance and service entrance. III (7) In any new addition, an existing licensed facility shall provide all required ancillary service areas, proportional to the number of new beds. However, for existing facilities, these support service areas may be reduced by the amount of existing areas that meet new facility requirements. New support areas required in this project, whether they are to serve the new beds or the existing beds, shall comply with the rules for new facilities. III (8) Facilities shall have administrative and public areas as listed: business office, administrator’s office (business office and administrator’s office may be combined); director of nurses’ office; lobby and waiting room (may be combined); public restrooms for each sex; and public telephone. III (9) The facility shall provide recreation, occupational therapy, activity and residents’ dining space at a ratio of at least thirty (30) square feet for each resident. II (10) Facilities shall provide a bulk storage area consisting of a locked room, shelving, bins and large cans for storing long-term supplies of food and other dietary materials above the floor in a dry room with adequate ventilation, cool, but not freezing. The bulk storage area shall be one (1) square foot per bed, but in no case shall it be less than one hundred (100) square feet. III (11) Facilities shall have dry short-term storage areas for daily food supplies and other dietary materials. The dry short-term storage area may include the space required for bulk storage. III (12) A facility shall provide a preparation area for wrapping removal, vegetable cleaning and peeling and meat cutting. III (13) Facilities shall provide adequate cooking and baking areas. III (14) A facility shall have a salad and sandwich preparation area for the preparation of cold foods. III (15) Facilities shall provide a tray preparation and loading area for preparing trays for residents’ food delivery and food cart loading. III (16) A facility shall provide a pot and pan washing area consisting of a three (3)-compartment sink with a double drainboard for the washing of utensils during the food preparation period. III (17) Facilities shall have a dishwashing area provided with a soiled dish receiving counter, space for scraping with a garbage grinder, prerinse sink, counter for racking dishes, dishwasher, clean dish counter, dish rack storage and an exhaust fan. II/III (18) A facility shall have a dish storage area with shelves adjacent to the tray preparation area. III (19) Facilities shall provide refrigerators of adequate capacity in all kitchens and other preparation centers where perishable foods will be stored. A minimum of two (2) separate sections or boxes shall be provided in the main kitchen; one (1) for meat and dairy products and one (1) for general storage. III (20) The refrigerators’ compressors and evaporators shall have sufficient capacity to maintain temperatures of thirty-five degrees Fahrenheit (35°F) in the meat and dairy boxes and forty degrees Fahrenheit (40°F) in the general storage boxes when the boxes are being used for those purposes. II (21) These compressors shall be automatically controlled. III (22) Compressors, piping and evaporators shall be tested for leaks and capacity. Certification of these tests shall be made available to the division. III (23) A facility shall have an office area for planning menus and food purchases next to the dietary area. III (24) Kitchen shall have handwashing sinks.

(25) A facility shall have a janitor’s area, exposed or in a closet, in or near the kitchen, that contains a floor receptor or service sink.

(26) A garbage removal area with garbage and trash cans located inconspicuously shall be easily accessible from both the kitchen and the service drive. III (27) Housekeeping areas shall be provided as listed: clean linen area, soiled linen area and laundry area. II (28) The facility shall have a designated physical therapy area large enough to give rehabilitative care to physically disabled residents.

This area shall be sized to accommodate all equipment and activities in the facility’s proposed physical therapy program. In no case shall this area be less than two hundred (200) square feet. III (29) The facility shall provide the following elements: treatment areas and equipment as dictated by the facility’s physical therapy program; a handwashing sink; an exercise area; storage for clean linen, supplies and equipment; a toilet room located in the physical therapy room or within the immediate area of the physical therapy department; and an office or sufficient space for the physical therapy director’s desk and file. The physical therapy area may be located adjacent to an occupational therapy area and share any or all of the required elements providing that the sharing of elements conforms with the facility’s therapy programs. III (30) If there is a designated occupational therapy area, it shall be large enough to accommodate all the equipment and activities in the facility’s proposed occupational therapy program. When the facility locates physical therapy and occupational therapy in the same area, there shall be a space that can be separated from the rest of the area if ceramics, sculpture, minor woodwork and light mechanical work are a part of the occupational therapy program. III (31) Facilities shall provide a maintenance room or area. II (32) A facility shall provide an employees’ dressing or locker room with separate restrooms for each sex. III (33) Facilities shall provide storage rooms as listed: general storage—ten (10) square feet per bed for the first fifty (50) beds, plus eight (8) square feet per bed for the next twentyfive (25) beds, plus five (5) square feet per bed for any additional beds over seventy-five (75). No storage room shall be less than one hundred (100) square feet of floor space. The required residents’ clothes storage room and storage for outdoor equipment may be included in the minimum area required for general storage. III (34) A continuous system of unobstructed corridors, referred to as required corridors, shall extend through the enclosed portion of each story of the building. These corridors will connect all rooms and spaces with each other and with all entrances, exit ways and elevators, with the following exceptions: work suites, such as the administrative suite and dietary area, occupied primarily by employed personnel may contain corridors or aisles as necessary, and will not be subject to the rules applicable to required corridors.

Areas may be open to this system as permitted by the 1985 edition of the Life Safety Code, for those facilities with plans approved on or before December 31, 1998. All facilities with plans submitted for approval on or after January 1, 1999, shall comply with the provisions of the 1997 Life Safety Code, incorporated by reference in this rule. II/III (35) A facility shall provide a personal care room with barber and beauty shop facilities.

(36) There shall be an oxygen storage room that is surrounded by one (1)-hour rated construction with a powered or gravity vent to the outside. II (37) Facilities shall have one (1) or more nursing units. A nursing unit shall not exceed a maximum of sixty (60) resident beds. Each nursing unit shall be a single floor continuous area which does not require resident care traffic to traverse other areas. A facility shall not locate a resident room door more than one hundred forty feet (140') from the nurses’ station and the dirty utility room. II (38) Resident room area shall be a minimum of eighty (80) square feet per bed in multiple bed resident rooms, and one hundred (100) square feet per bed in one (1)-bed resident rooms. A continuous aisle not less than three feet (3') wide shall be available around the foot and along both sides of each bed. Facilities shall locate beds to avoid drafts, excessive heat and other residents discomforts.

Typical minimum clear dimensions for the bed area in resident rooms shall be as follows: 1-Bed 10' 6" × 9' 3" 2-Bed 10' 6" × 15' 6" 3-Bed 10' 6" × 21' 9" 4-Bed 18' 0" × 15' 6"

Heating units and handwashing sinks may protrude into this required space. II (39) To provide for the isolation of a resident(s) with a communicable disease(s), each unit shall have at least two (2) private resident rooms provided with a separate room equipped with a toilet and handwashing sink to serve the isolation room only. III (40) Each resident shall have a wardrobe, locker or closet. A clothes rod and shelf shall be provided. III (41) No room shall be occupied by more than four (4) beds. III (42) No resident shall be housed in a room in which the outside grade line is more than three feet (3') above the floor level on the window side of the resident room for a distance of at least fifteen feet (15') from the outside wall of the resident room. The resident rooms shall be outside rooms with minimum window sizes as follows: 1-Bed 10 square feet 2-Bed 16 square feet 3-Bed 24 square feet 4-Bed 32 square feet These areas are for total window size including frames. III (43) Each resident, without entering the general corridor area, shall have access to a toilet room. III (44) One (1) toilet room shall serve no more than six (6) beds and no more than two (2) resident rooms. II/III (45) The toilet room shall contain a water closet and a lavatory. II (46) If each resident room contains a handwashing sink, the may omit the handwashing sink from a toilet room that serves adjacent resident rooms. When a handwashing sink is located within the same room as the toilet, the minimum area of a room shall be thirty (30) square feet. If the room contains only a toilet, the minimum area of the room shall be eighteen (18) square feet. III (47) Each nursing unit shall have a centrally located nurses’ work station with a work counter and storage space for charts. The entire counter shall have a four foot (4') distance between the wall located behind the counter and the edge of the counter nearest the wall. III (48) Facilities shall provide a medicine preparation room next to each nurses’ station that has at least sixty (60) square feet of useable floor space. Facilities shall provide a special locked medication cabinet for storage of the Class II medications inside the locked medication cabinet. If the outer cabinets are not locked, the facility must provide a closer and hardware that cannot be left unlocked on the door to the medicine room. A facility is also required to have the following in the medicine room: a work counter, handwashing sink, under cabinet storage, a medicine refrigerator, adequate lighting and provisions for proper temperature control. II/III (49) Each nursing unit shall have a clean utility room accessible directly from the nursing unit corridor and near enough to the nurses’ station to facilitate control by the nurses. The floor and walls shall have impervious surfaces. The facility shall provide this room with adequate lighting and heating, a handwashing sink and at least one (1) locking cabinet. II/III (50) Each nursing unit shall have a dirty utility room which is accessible directly from the nursing unit corridor. The floor shall have an impervious surface and the walls shall have impervious surfaces to a minimum height of five feet (5') above the floor. The room shall be provided with adequate lighting and heating, a double sink, clinic sink and at least one (1) locking cabinet. III (51) Each nursing unit shall contain one (1) training or handicapped toilet per sex, each with a floor area of at least five feet by six feet (5' × 6'). This toilet may be located in the central bath. III (52) Each nursing unit shall have a separate bathroom for each sex. II (53) Tubs shall be institutional-type, free standing with a minimum of three feet (3') clearance from the wall on each side and four feet (4') at the end. The shower shall be a minimum of four feet (4') wide and of ample length for a wheelchair resident. Thirty-inch by sixty-inch (30" × 60") Americans with Disability Act (ADA)-approved showers will be accepted. The facility may replace required institutional-type tub(s) with whirlpool tubs or other types of bathing fixtures. III (54) The aggregate number of tubs or showers or both shall not be less than one for each fifteen (1:15) beds on each floor. II/III (55) The facility shall provide a locked cabinet in or near each bathroom for the storage of cleaning supplies. III (56) Centralized bathing facilities shall have fixed partitions or fire-resistant curtains to provide a private compartment for each water closet, bathtub and shower. Curtains or doors shall be installed on access openings. III (57) Clean linen storage with adequate shelving is required in each nursing unit. III (58) Each nursing unit must have a stretcher and wheelchair parking area. III (59) Equipment and supply storage is required in each nursing unit. III (60) Required corridors shall be at least eight feet (8') wide and shall be wider at elevators and other points of traffic concentration. No

part of the area of any required corridor or aisle shall be counted as part of the required area of any space adjacent to the corridor or aisle. II/III (61) The width of stairways shall not be less than three feet eight inches (3' 8"). The width shall be measured between handrails where handrails project more than three and onehalf inches (3 1/2"). II/III (62) Doors from sleeping and treatment areas through which residents will pass shall be at least forty-four inches (44") wide. Doors to centralized toilets, bathrooms, hair care salons and small day rooms shall be at least thirty-six inches (36") wide. Doors to individual toilets adjacent to resident rooms shall be at least thirty-two inches (32") wide. II (63) Exit doors shall swing outward. Doors to rooms shall swing into the rooms they serve.

Doors to small toilet rooms may swing outward into the next room and, if they swing inward, they shall be equipped for emergency access. No doors shall swing into required corridors or aisles except doors to janitors’ closets, linen closets or doors to similar small spaces that are open only temporarily. II (64) Ceilings shall be at least eight feet (8').

Ceilings in corridors, storage rooms, toilet rooms and other minor rooms shall not be less than seven feet six inches (7' 6"). Suspended tracks, rails and pipes located in the normal traffic path shall be at least six feet eight inches (6' 8") above the floor. III (65) Drinking fountains shall be located in or near the lobby and recreation area and in each nursing unit. The fountain shall be accessible to residents in wheelchairs. III (66) Facilities with plans approved on or with the American National Standards Institute (ANSI) publication A117.1, 1971, Making Buildings and Facilities Accessible to, and Useable by, the Physically Handicapped. All new facilities whose plans were submitted to the division on or after January 1, 1999, shall comply with ANSI A117.1, 1992, Making Buildings and Facilities Accessible to, and Useable by, the Physically Handicapped, incorporated by reference in this rule. III (67) Handrails shall be provided on both sides of all corridors and aisles used by residents. Corridor handrails shall have ends return to the wall. III (68) All stairways shall have handrails on both sides. II (69) Facilities shall provide grab bars or handrails, secured in proper positions to facilitate the bodily movements of residents, next to all bathtubs, within all showers and on at least one (1) side of all toilets. II (70) Lavatories shall be positioned to be accessible to wheelchair residents and shall not have cabinets underneath or any other unnecessary obstruction to the maneuverability of wheelchairs. III (71) The facility shall provide mirrors in each resident’s room or adjoining toilet room.

Mirrors shall be at least three feet (3') high with the bottom edge located no more than three feet four inches (3' 4") above the floor or the facility may use framed tilting mirror(s). III (72) Facilities shall provide fire-resistant divider curtains attached to the ceiling or walls in all resident rooms other than private or single bedrooms. A facility shall place these divider curtains to provide complete privacy for each bed. III (73) All new facilities and additions to all areas of existing facilities which undergo major remodeling, shall be of sufficient strength in all their parts to resist all stresses imposed by dead loads, live loads and lateral or uplift forces such as wind, without exceeding, in any of the structural materials, the allowable working stresses established for these materials by generally accepted good engineering practice. II (74) The following unit live loads shall be the minimum distributed live loads acceptable for the occupancies listed:

(A) Facility bedrooms and all adjoining service rooms which compose a typical nursing unit (except solariums and corridors)— forty pounds per square foot (40 psf); II (B) Solariums, corridors in nursing units and all corridors above the first floor, examination and treatment rooms, laboratories, toilet rooms and locker rooms—sixty (60) psf;

(C) Offices, conference room, library, kitchen, corridors and other public areas on first the floor—eighty (80) psf; II (D) Stairways, laundry, large rooms used for dining, recreation or assembly areas and workshops—one hundred (100) psf; II (E) Records file room, storage and supply—one hundred twenty-five (125) psf; II (F) Mechanical equipment room—one hundred fifty (150) psf; II (G) Roofs (except use increased value where snow and ice may occur)—twenty (20) psf; and II (H) Wind—as required by local conditions but not less than fifteen (15) psf. II (75) For live loads of one hundred (100) pounds or less per square foot, the design live load on any member supporting one hundred fifty (150) square feet or more may be reduced at the rate of eight hundredths of a percent (0.08%) per square foot of area supported by the member, except that no reductions shall be made for roof live loads or for live loads of areas to be occupied as places of public assembly. The reduction shall exceed neither “R”, as determined by the following formula nor sixty percent (60%): II D + L R = 100 × _______________ 4.33 L where R = reduction in percent;

D = dead load per square foot of area supported by the member; and L = design live load per square foot of area supported by the member.

(76) For live loads exceeding one hundred (100) psf, no reduction shall be made, except that the design live loads on columns may be reduced twenty percent (20%). II (77) Floor areas where partition positions are subject to change shall be designed to support a uniformly distributed load of twenty-five (25) psf in addition to all other loads. II (78) Foundations shall rest on natural solid ground or properly compacted fill and shall be carried to a depth of not less than one foot (1') below the estimated frost line or shall rest on leveled rock or load-bearing piles when solid ground is not encountered. Footings, piers and foundation walls shall be adequately protected against deterioration from the action of groundwater. A facility shall take reasonable care to establish proper soil bearing values for the building site soil. If the bearing capacity of a soil is in question, a recognized load test may be used to determine the safe bearing value. II (79) All facilities with plans approved between June 10, 1981 and December 31, 1998, shall comply with the 1985 edition of the Life Safety Code, and all new facilities with plans approved on or after January 1, 1999, shall comply with the 1997 edition of the Life Safety Code (National Fire Protection Association NFPA 101), which are incorporated by reference in this rule. No provision of the 1997 code will be enforced if it is more restrictive than the code of original plan approval. Facilities may only use the fire safety evaluation system found in the 1995 NFPA 101A, incorporated by reference in this rule, if necessary to justify variance from the text of the Life Safety Code and not as a guide for the total design of a new facility. II (80) Facilities with plans approved on or with the fire-resistant rating of structural elements equal to those required by the 1985 Life Safety Code (NFPA 101). Facilities with plans approved on or after January 1, 1999, shall comply with the fire-resistant rating of structural elements equal to those required by the 1997 Life Safety Code (NFPA 101), incorporated by reference in this rule. All facilities shall meet the following additional requirement: exterior walls less than thirty feet (30') from an adjacent building, property line or parallel wing shall have a two (2)-hour fire-resistant rating. This distance may be reduced to fifteen feet (15') if a one (1)-hour rated wall is provided with sprinkler protection for each window. II (81) Doors between rooms and the required corridors shall not have louvres or transoms.

They shall be one and three-fourths inches (1 3/4") solid-core wood doors or metal doors with equivalent or greater fire-resistance. II (82) Laundry and trash chutes, where used, shall be of fire-resistant material and installed with a flushing ring, vent to atmosphere and floor drain in the basement. Facilities shall provide an automatic sprinkler at the top of each laundry and trash chute. Each floor shall have a self-closing one and one-half (1 1/2)hour B-label fire door that shall not open to a corridor. II (83) Hardware on toilet room doors shall be operable from both the inside and the outside.

(84) The floors of toilets, baths, bedpan rooms, pantries, utility rooms and janitors’ closets shall have smooth, waterproof surfaces which are wear-resistant. The floors of residents’ rooms shall be smooth and easily cleaned. The floors of kitchens and food preparation areas shall be waterproof, greaseproof, smooth and resistant to heavy wear.

(85) The walls of all rooms where food and drink are prepared, served or stored shall have a smooth surface with painted or equally washable finish. At the base, they shall be waterproof and free from spaces which may harbor ants and roaches. The walls of kitchens, sculleries, utility rooms, baths, showers, dishwashing rooms, janitors’ closets and spaces with sinks shall have waterproof painted, glazed or similar finishes to a point above the splash and spray line. III (86) The ceilings of all sculleries, kitchens and other rooms where food and drink are prepared shall be painted with washable paint. III (87) All floor construction shall be completely of noncombustible material regardless of the construction type of the building. II (88) All new floor covering installed and used in new and existing licensed facilities on or after January 1, 1999, shall be Class I in nonsprinklered buildings and Class II in sprinklered buildings. Class I has a critical radiant flux of zero point forty-five (0.45) or more watts per square centimeter when tested according to the 1995 NFPA 253, incorporated by reference in this rule. Class II has a critical radiant flux of zero point twenty-two (0.22) or more watts per square centimeter when tested according to the 1995 NFPA 253. Those facilities who installed new floor covering on or before December 31, 1998, shall comply with the requirements of the 1978 edition of the NFPA 253. III (89) A facility shall furnish and install the heating system, steam system, boilers and ventilation to meet all requirements of local and state codes and NFPA regulations. II/III (90) The building shall be heated by a two (2)-pipe steam system, a forced hot water system, a forced hot air system, a system of electrical heating elements or a combination of two (2) or more of these systems. No open flame space heaters or space heaters receiving combustion air from the heated space shall be used. Facilities shall not depend upon fireplaces for required heating. III (91) The heating system shall be capable of heating resident-occupied areas to a temperature of eighty degrees Fahrenheit (80°F)

(27°C) at the winter design temperature. In spaces where radiant panel heating is used, facilities may reduce the temperature as required to maintain an equivalent comfort level. III (92) The heating system shall have automatic controls adequate to provide comfortable conditions in all portions of the building at all times. III (93) Neither the heating nor the ventilating system shall require the circulation of air through openings in the required corridor partitions except for the delivery of ventilating air from corridors through each room door at a velocity of not more than two hundred fifty feet (250') per minute when the door is closed and the space under it is not over one inch (1") in height. No louvres shall be installed in doors in required corridor partitions. II/III (94) A facility with plans approved on or after January 1, 1999, shall install an air-conditioning system, or individual room air-conditioning units, that meet all the 1996 NFPA 90A requirements, incorporated by reference in this rule. The systems or units must be capable of maintaining resident-use areas at eighty-five degrees Fahrenheit (85°F)

(29.4°C) at the summer design temperature.

Those facilities with plans approved on or with the NFPA 90A requirements as referenced in the 1985 Life Safety Code. II/III (95) Ventilation requirements given in Table I—Ventilation Requirements shall be met.

TABLE I VENTILATION REQUIREMENTS

Minimum Air Pressure Changes of Outdoor Minimum Total Air All Air Exhausted Relationship to Air Per Hour Changes Per Hour Directly to Air Returned From Area Designation Adjacent Areas Supplied to Room Supplied to Room Outdoors This Room Patient Area Corridor P Optional 2 Optional Optional Physical Therapy N 2 4 Optional Optional Occupational Therapy N 2 4 Optional Optional Soiled Work Room or Soiled Holding N 2 10 Yes No *Toilet Room N Optional 6 Yes No Bathroom N Optional 6 Yes No Janitors’ Closet(s) N Optional 6 Yes No Linen and Trash Chute Room N Optional 6 Yes No Food Preparation Center E 2 6 Yes Optional Warewashing Room N Optional 6 Yes No Dietary Day Storage V Optional 2 Yes No Laundry, General V 2 6 Yes No Soiled Linen Sorting and Storage N Optional 10 Yes No P = Positive N = Negative E = Equal V = Variable *Up to 75 cubic feet per minute (cfm) of make-up air for each patient room toilet may be supplied to the corridor and need not be supplied directly to the room.

NOTE: In the interest of energy conservation, energy saving design innovations that are not in strict conformance with these requirements, which do not adversely affect direct patient care, will be acceptable if approved in writing by the Division of Aging.

(96) The entire plumbing system and its maintenance and operation shall comply with the requirements of all applicable local and state codes including the requirements set forth in this rule and with the requirements of the 1987 National Plumbing Code, which is incorporated by reference in this rule. II/III (97) Plumbing fixtures that require hot water and are resident-accessible shall be supplied with water thermostatically controlled to provide a water temperature of between one hundred twenty degrees Fahrenheit (120°F)

(49°C) and one hundred five degrees Fahrenheit (105°F) (41°C) at the fixture or faucet.

(98) The hot water heating equipment shall have sufficient capacity to supply five (5) gallons (19 l) of water at one hundred twenty degrees Fahrenheit (120°F) (49°C) per hour per bed for nursing home fixtures or faucets, and eight (8) gallons (30 l) of water at one hundred sixty degrees Fahrenheit (160°F)

(71.1°C) per hour per bed for kitchen and laundry. The division may accept lesser capacities following submission of the calculation for the anticipated demand of all fixtures and equipment in the building. II (99) Pipes shall be sized to supply water to all fixtures with a minimum pressure of fifteen pounds per square inch (15 psi) (1.02 atmospheres) at the top floor fixture during maximum demand periods. All plumbing fixtures except water closets, urinals and drinking fountains shall have both hot and cold water supplies. III (100) Facilities shall protect every supply outlet or connection to a fixture or appliance against back flow as provided by the 1987 National Plumbing Code, incorporated by reference in this rule. All faucets to which hoses can be attached, all spray fittings and all other fittings that could deliver water to points below overflow lines, shall be equipped with vacuum breakers. II/III (101) Wherever the usage of fixtures or appliances will permit, water supplied to all fixtures, open tanks and equipment shall be introduced through a suitable air gap between the water supply and the flood level of the fixture. II (102) Hot water circulating mains and risers shall be run from the hot storage tank to a point directly below the highest fixture at the end of each branch main. III (103) Where the building is higher than three (3) stories, each riser shall be circulated. III (104) Water pipe sizes shall be equal to or greater than those prescribed by the 1987 National Plumbing Code, incorporated by reference in this rule. III (105) All fixtures and equipment shall be connected through traps to soil and waste piping and to the sewer and they shall all be properly trapped and vented to the outside. II (106) Courts, yards and drives which do not have natural drainage from the building shall have catch basins and drains to low ground, storm-water system or dry wells. III (107) Facilities where gas-fired equipment is to be installed for use on or after January 1, 1999, shall provide and install all gas piping, fittings, tanks and specialties in compliance with the 1996 NFPA 54, Installation of Gas Appliances and Gas Piping, the 1995 NFPA 58, Storage and Handling of Liquefied Petroleum Gases, incorporated by reference in this rule, and the instructions of the gas supplier, except where more strict requirements are stated. Facilities which installed gas-fired equipment on or before December 31, 1998, shall ensure that the installation was in compliance with the instructions and requirements outlined in the NFPA 54 and NFPA 58 as referenced in the 1985 Life Safety Code. Where liquefied petroleum gas (LPG) is used, the Missouri Department of Agriculture also requires compliance with its rules. II (108) Where gas piping enters the building below grade, it shall have an outside vent as follows: A concrete box, eighteen inches by eighteen inches (18" × 18") with three-inch (3") thick walls, of a height to rest on top of the entering gas pipe, and top of the box to come within six inches (6") of top grade. The box shall be filled with coarse gravel. A oneinch (1") upright vent line shall be to one-half (1/2) the depth of the box and extend twelve inches (12") above top grade with a screened U-vent looking down. The vent line is to be anchored securely to the building wall. II (109) Facilities shall not install gas-fired equipment in any resident bedroom except that through-wall gas heating units may be used if vented directly to the outside, take combustion air directly from the outside and provide a complete separation of the combustion system from the atmosphere of the occupied area. II (110) In facilities where oxygen systems are installed on or after January 1, 1999, the facilities shall install the oxygen piping, outlets, manifolds, manifold rooms and storage rooms in accordance with the requirements of the 1993 NFPA 99, incorporated by reference in this rule. In facilities where oxygen systems were installed on or before December 31, 1998, facilities shall ensure that the installation was in compliance with NFPA 99 as required and referenced in the 1985 Life Safety Code. I/II (111) The building sanitary drain system may be cast iron, steel, copper or plastic if installed in compliance with the National Plumbing Code, current edition. III (112) Each main, branch main, riser and branch to a group of fixtures of the water system shall be valved. III (113) To prevent condensation, facilities shall cover cold water mains in occupied spaces with approved vapor-proof insulation. III (114) To prevent freezing, facilities shall insulate all pipes in outside walls. III (115) Facilities shall test soil, waste, vent and drain lines according to the requirements of the 1987 National Plumbing Code, incorporated by reference in this rule. The facility shall make certification of these tests available to the division. III (116) After installation and before the nursing home is operating, the facility shall disinfect the entire water distribution system, both hot and cold, and all connecting equipment by one (1) of the methods described in the 1987 National Plumbing Code, incorporated by reference in this rule. III (117) Water softeners, if used, shall be connected to the hot water supply only or connected so that water used for cooking and drinking is not softened. III (118) Facilities with plans approved on or after January 1, 1999, shall ensure that the entire electrical system and its maintenance and operation comply with the 1996 National Electrical Code, which is incorporated by reference in this rule. Facilities whose plans were approved on or before December 31, 1998, shall comply with the National Electrical Code as referenced in the 1985 Life Safety Code. II/III (119) Facilities shall adequately light all occupied areas as required by the duties performed in that space. II/III (120) Residents’ bedrooms shall have a minimum general illumination of ten (10) footcandles, a night-light and a resident’s reading light. The outlets for general illumination and night-lights shall be switched at the door. III (121) Each single-bed resident room shall have at least two (2) duplex receptacles. All multi-bed resident rooms shall have at least one (1) duplex receptacle at the head of each bed plus one (1) additional duplex receptacle.

Facilities shall not place duplex receptacles in a manner to cause an electrical shock hazard.

(122) Facilities shall furnish lighting fixtures of a type suitable for the space for all lighting outlets. III (123) If ceiling lights are used in residents’ rooms, they shall be of a type which are shaded or globed to minimize glare. III (124) Facilities shall provide an electricallypowered nurses’ call system with indicator lights at the corridor entrance of each bedroom. Audible signals and indicating panels shall be located in each nurses’ station and utility room. Facilities shall provide signal buttons at the head of each resident bed, in each toilet room and in each bathroom. III (125) Facilities shall provide night-lights in hallways, individual toilet rooms, stairways and resident rooms or adjacent toilet rooms.

(126) A qualified electrician shall test and certify the entire electrical system as being in compliance with the 1996 National Electrical Code, incorporated by reference in this rule.

In facilities whose plans were approved on or before December 31, 1998, the electrician shall test the system according to the standards of the National Electrical Code as referenced in the 1985 Life Safety Code. Facilities shall make this test certification available to the division. III (127) Facilities shall provide a complete, electrically-operated door alarm system that is audible in the nurses’ station for all resident-accessible exterior doors. III (128) A facility shall have emergency lighting for exits, stairs, corridors and nurses’ stations. Facilities may provide this emergency lighting using an emergency generator or battery-operated lights rated at least one and one-half (1 1/2) hours. In facilities with plans approved on or after January 1, 1999, an emergency generator shall supply emergency power to life support systems as required by the 1993 NFPA 99, Health Care Facilities, incorporated by reference in this

rule. In facilities where plans were approved on or before December 31, 1998, the electrical system shall comply to the standards of the National Electrical Code as referenced in the 1985 Life Safety Code. III (129) The elevator installations shall comply with all local and state codes, American Standards Association Specification A17.1, 1993 Safety Code for Elevators and Escalators, the 1996 National Electrical Code, incorporated by reference in this rule, and the minimum general standards as set forth in this rule. In facilities whose plans were approved on or before December 31, 1998, the elevators shall comply with applicable local and state codes and the requirements set forth in the ASAS A17.1, Safety Code for Elevators and Escalators, and the National Electrical Code as referenced in the 1985 Life Safety Code. II (130) Any facility with residents on one (1) or more floors above the first floor shall have at least one (1) hydraulic or electric motor driven elevator. Facilities with a bed capacity from sixty-one to two hundred (61–200) above the first floor shall not have less than two (2) elevators. II (131) Facilities with a bed capacity of from two hundred to three hundred fifty (200— 350) above the first floor shall have not less than three (3) elevators—two (2) passenger and one (1) service. II (132) Inside cab dimensions of elevators shall be not less than five feet four inches by eight feet (5' 4" × 8') with a capacity of three thousand five hundred pounds (3,500 lbs.).

Cab and shaft doors shall have no less than three feet ten inches (3' 10") clear opening.

Elevators for which operators will not be employed shall have automatic push-button controls, signal controls or dual controls for use with or without the operator. Where two (2) push-button elevators are located together and where one (1) elevator serves more than three (3) floors and basement, they shall have collective or signal control. III (133) Facilities with plans approved on or after January 1, 1999, shall have overspeed tests conducted on all elevator machines.

Elevators will be tested for speed and load, with and without loads, in both directions as covered by the 1993 Safety Code for Elevators and Escalators, incorporated by reference in this rule. Facilities whose plans were approved on or before December 31, 1998, shall conduct overspeed tests in accordance with applicable local and state codes and the requirements set forth in the ASAS A17.1, Safety Code for Elevators and Escalators, as referenced in the 1985 Life Safety Code.

Facilities shall make this test certification available to the division. III

Filed May 11, 1998, effective Dec. 30, 1998.

Emergency amendment filed May 12, 1999, effective May 22, 1999, expired Feb. 24, 2000. Amended: Filed July 13, 1999, effective Jan. 30, 2000. Moved to 19 CSR 30- 85.012, effective Aug. 28, 2001. *Original authority: 198.009, RSMo 1979, amended 1993, 1995.

History

AUTHORITY: section 198.009, RSMo Supp. 1998. This rule originally filed as 13 CSR 15-14.012. Original rule filed July 13, 1983, effective Oct. 13, 1983. Amended: Filed Aug. 1, 1988, effective Nov. 11, 1988. Amended:

19 CSR 30-85.022 Fire Safety and Emergency Preparedness Standards for New and Existing Intermediate Care and Skilled Nursing Facilities {#sec-19-csr-30-85.022 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-85.022}

PURPOSE: This rule establishes fire-safety and emergency preparedness requirements for new and existing intermediate care and skilled nursing facilities.

This note applies only to the reference material. The entire text of the rule is printed here.

AGENCY NOTE: All rules relating to longterm care facilities licensed by the Department of Health and Senior Services are followed by a Roman Numeral notation which refers to the class (either class I, II, or III) of standard as designated in section 198.085, RSMo 2000.

(1) Definitions. For the purpose of this rule, the following definitions shall apply:

(A) Accessible spaces—shall include all rooms, halls, storage areas, basements, attics, lofts, closets, elevator shafts, enclosed stairways, dumbwaiter shafts, and chutes;

(B) Area of refuge—a space located in or immediately adjacent to a path of travel leading to an exit that is protected from the effects of fire, either by means of separation from other spaces in the same building or its location, permitting a delay in evacuation. An area of refuge may be temporarily used as a staging area that provides some relative safety to its occupants while potential emergencies are assessed, decisions are made, and if applicable, evacuation has begun;

Addition of any room(s), accessible by residents, that either exceeds fifty percent (50%) of the total square footage of the facility or exceeds four thousand five hundred (4,500) square feet;
Repairs, remodeling, or renovations that involve more than fifty percent (50%) of the building;
Repairs, remodeling, or renovations that involve more than four thousand five hundred (4,500) square feet of a smoke section; or 4. If the addition is separated by two- (2-) hour fire-resistant construction, only the addition portion shall meet the requirements for an NFPA 13, 1999 edition, sprinkler system, unless the facility is otherwise required to meet NFPA 13, 1999 edition; and (D) Concealed spaces—shall include areas within the building that cannot be occupied or used for storage.

(2) General Requirements.

(A) All National Fire Protection Association (NFPA) codes and standards cited in this

rule: NFPA 10, Standard for Portable Fire Extinguishers, 1998 edition; NFPA 13, Standard for the Installation of Sprinkler Systems, 1999 edition; NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, 1998 edition;

NFPA 99, Standard for Health Care Facilities, 1999 edition; NFPA 101, The Life Safety Code, 2000 edition; NFPA 72, National Fire Alarm Code, 1999 edition; NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water-Based Fire Protection Systems, 1998 edition; NFPA 253, Standard Method of Test of Surface Burning Characteristics of Building Materials, 2000 edition;

NFPA 701, Standard Methods of Fire Tests for Flame Propagation of Textiles and Films, 1999 edition; NFPA 211, Chimneys, Fireplaces, Vents and Solid Fuel-Burning Appliances, 2000 edition; and NFPA 101A, Guide to Alternative Approaches to Life Safety, 2001 edition, are incorporated by reference in this rule and available for purchase from the National Fire Protection Agency, 1 Batterymarch Park, Quincy, MA 02269-9101; www.nfpa.org; by telephone at (617) 770- 3000 or 1-800-344-3555. This rule does not incorporate any subsequent amendments or additions to the materials listed above.

(B) This rule does not prohibit facilities from complying with standards set forth in newer editions of the incorporated by reference material listed in subsection (2)(A) of this rule if approved by the department.

(C) The department shall have the right of inspection of any portion of a building in which a licensed facility is located unless the unlicensed portion is separated by two- (2-) hour fire-resistant construction. I/II (D) Facilities shall not use space under stairways to store combustible materials. I/II (E) No section of the building shall present a fire hazard. I/II (F) All facilities shall notify the department immediately after the emergency is addressed if there is a fire in the facility or premises and shall submit a complete written fire report to the department within seven (7) days of the fire, regardless of the size of the fire or the loss involved. II/III (G) Following the discovery of any fire, the facility shall monitor the area and/or the source of the fire for a twenty-four- (24-) hour period. This monitoring shall include, at a minimum, hourly visual checks of the area.

These hourly visual checks shall be documented. I/II (H) All electrical appliances shall be Underwriters’ Laboratories (UL) or Factory Mutual (FM)-approved, shall be maintained in good repair, and no appliances or electrical equipment shall be used which emit fumes or which could in any other way present a hazard to the residents. I/II (3) All openings that could permit the passage of fire, smoke, or both, between floors shall be fire-stopped with a suitable noncombustible material. II/III (4) Hazardous areas shall be separated by construction of at least one- (1-) hour fireresistant construction. Hazardous areas may be protected by an automatic sprinkler system in lieu of a one- (1-) hour rated fire-resistant construction. When the sprinkler option is chosen, the areas shall be separated from other spaces by smoke-resistant partitions and doors. The doors shall be self-closing or automatic closing. II (5) The storage of any unnecessary combustible materials in any part of a building in which a licensed facility is located is prohibited. No section of the building shall present a fire hazard. I/II (6) Oxygen storage shall be in accordance with NFPA 99, 1999 edition. Facilities shall use permanent racks or fasteners to prevent accidental damage or dislocation of oxygen cylinders. Safety caps shall remain intact except where a cylinder is in actual use or where the regulator has been attached and the cylinder is ready for use. Individual oxygen cylinders in use or with an attached regulator shall be supported by cylinder collars or by stable cylinder carts. II/III (7) Each nursing unit may maintain only one (1) emergency-use oxygen tank in a readily accessible unit area. II (8) Fire Extinguishers.

(A) Fire extinguishers shall be provided at a minimum of one (1) per floor, so that there is no more than seventy-five feet (75') travel distance from any point on that floor to an extinguisher. I/II (B) All new or replacement portable fire extinguishers shall be ABC-rated extinguishers, in accordance with the provisions of NFPA 10, 1998 edition. A K-rated extinguisher or its equivalent shall be used in lieu of an ABC-rated extinguisher in the kitchen cooking areas. II (C) Fire extinguishers shall have a rating of at least— 1. Ten pounds (10 lbs.), ABC-rated or the equivalent, in or within fifteen feet (15') of hazardous areas as defined in 19 CSR 30- 83.010; II and 2. Five pounds (5 lbs.), ABC-rated or the equivalent, in other areas. II (D) All fire extinguishers shall bear the label of the UL or the FM Laboratories and shall be installed and maintained in accordance with NFPA 10, 1998 edition. This includes the documentation and dating of a monthly pressure check. II/III (9) Facilities shall provide every cooking range with a range hood and approved range hood extinguishing system installed, tested, and maintained in accordance with NFPA 96, 1998 edition. The range hood and its extinguishing system shall be certified at least twice annually in accordance with NFPA 96, 1998 edition. II/III (10) Complete Fire Alarm Systems.

(A) Facilities shall have a complete fire alarm system installed in accordance with (5/31/20) JOHN R. ASHCROFT NFPA 101, Section 18.3.4, 2000 edition.

The complete fire alarm system shall automatically transmit to the fire department, dispatching agency, or central monitoring company. The complete fire alarm system shall include visual signals and audible alarms that can be heard throughout the building and a main panel that interconnects all alarm-activating devices and audible signals in accordance with NFPA 72, 1999 edition. Manual pull stations shall be installed at or near each required nurse/attendant’s station and each required exit. Smoke detectors shall be interconnected to the complete fire alarm system.

Specific minimum requirements relating to the interconnected smoke detectors are found in subsections (10)(I) and (10)(J) of this rule.

(B) All facilities shall test and maintain the complete fire alarm system in accordance with NFPA 72, 1999 edition. I/II (C) All facilities shall have inspections and written certifications of the complete fire alarm system completed by an approved qualified service representative in accordance with NFPA 72, 1999 edition, at least annually. I/II (D) The complete fire alarm system shall be activated by all of the following: sprinkler system flow alarm, smoke detectors, heat detectors, manual pull stations, and activation of the range hood extinguishment system.

(E) Facilities shall test by activating the complete fire alarm system at least once a month. II/III (F) Facilities shall maintain a record of the complete fire alarm system tests, inspections and certifications required by subsections (10)(B), (10)(C), and (10)(E) of this rule. III (G) Upon discovery of a fault with the complete fire alarm system, the facility shall correct the fault. I/II (H) When a complete fire alarm system is to be out-of-service for more than four (4) hours in a twenty-four- (24-) hour period, the facility shall immediately notify the department and the local fire authority and implement an approved fire watch in accordance with NFPA 101, 2000 edition, until the fire alarm system has returned to full service. I/II (I) All facilities shall have smoke detectors interconnected to the complete fire alarm system in all corridors and spaces open to corridors. Smoke detectors shall be no more than thirty feet (30') apart with no point on the ceiling more than twenty-one feet (21') from a smoke detector. I/II (J) Facilities that have a sprinkler system exemption shall have smoke detectors interconnected to the complete fire alarm system in all accessible spaces within the facility as required by NFPA 72, 1999 edition. Smoke detectors shall be no more than thirty feet (30') apart with no point on the ceiling more than twenty-one feet (21') from a smoke detector. Smoke detectors shall not be installed in areas where environmental influences may cause nuisance alarms. Such areas include, but are not limited to, kitchens, laundries, bathrooms, mechanical air handling rooms, and attic spaces. In these areas, heat detectors interconnected to the complete fire alarm system shall be installed. Bathrooms not exceeding fifty-five (55) square feet and clothes closets, linen closets, and pantries not exceeding twenty-four (24) square feet are exempt from having any detection device if the walls and ceilings are surfaced with limited-combustible or noncombustible material as defined in NFPA 101, 2000 edition. Concealed spaces of noncombustible or limitedcombustible construction are not required to have detection devices. These spaces may have limited access but cannot be occupied or used for storage. I/II (K) For each facility not having a sprinkler system exemption, each resident room or any room designated for sleeping shall be equipped with at least one (1) battery-powered smoke alarm installed, tested, and maintained in accordance with manufacturer’s specifications. In addition, the facility shall be equipped with interconnected heat detectors installed, tested, and maintained in accordance with NFPA 72, 1999 edition, with detectors in all areas subject to nuisance alarms, including, but not limited to, kitchens, laundries, bathrooms, mechanical air handling rooms, and attic spaces. I/II 1. The facility shall maintain a written record of the monthly testing and battery changes. The written records shall be retained for one (1) year. I/II 2. Upon discovery of a fault with any detector or alarm, the facility shall correct the fault. I/II (11) Sprinkler System.

(A) All facilities shall have inspections and written certifications of the sprinkler system completed by an approved qualified service representative in accordance with NFPA 25, 1998 edition. The inspections shall be in accordance with the provisions of NFPA 25, 1998 edition, with certification at least annually by a qualified service representative. I/II (B) All facilities licensed prior to August 28, 2007, that were not required to have a complete sprinkler system in accordance with NFPA 13 shall have until December 31, 2012, to comply with NFPA 13, 1999 edition. I/II 1. Exemptions shall be granted if the facility presents evidence in writing from a certified sprinkler system representative or licensed engineer that the facility is unable to install an approved NFPA 13, 1999 edition, system due to the unavailability of the water supply. I/II (C) Facilities that have a sprinkler system installed prior to August 28, 2007, shall inspect, maintain, and test these systems in accordance with the requirements in effect for such facilities on August 27, 2007. I/II (D) Facilities licensed on or after August 28, 2007, or any section of a facility in which a major renovation has been completed on or after August 28, 2007, shall install and maintain a complete sprinkler system in accordance with NFPA 13, 1999 edition. I/II (E) When a sprinkler system is to be outof-service for more than four (4) hours in a twenty-four- (24-) hour period, the facility shall immediately notify the department and the local fire authority and implement an approved fire watch in accordance with NFPA 101, 2000 edition, until the sprinkler system has returned to full service. I/II (12) Each floor of an existing licensed facility shall have at least two (2) unobstructed exits remote from each other. One (1) of the required exits in an existing multi-story facility must be an outside stairway or an enclosed stair that is separated by one- (1-) hour construction from each floor and has an exit leading directly outside at grade level. One (1) exit may lead to a lobby with exit facilities to the ground level outside instead of leading directly to the outside. The lobby shall have at least a one- (1-) hour fire-rated separation from the remainder of the exiting floor. I/II (13) If facilities have outside stairways, they shall be substantially constructed to support residents during evacuation. These stairways shall be protected or cleared of ice and snow.

Stairways shall be of sturdy construction using at least two-inch (2") lumber and shall be continuous to ground level. All treads and risers shall be of the same height and width throughout the entire stairway, not including landings. II/III (14) Fire escapes added to existing buildings, whether interior or exterior, shall have at least a minimum thirty-six-inch (36") width, eight-inch (8") maximum risers, a nine-inch (9") minimum tread, no winders, a maximum height between landings of twelve feet (12'), minimum landing dimensions of forty-four inches (44"), landings at each exit door, and handrails on both sides. Exit(s) to fire escapes shall be at least thirty-six inches (36") wide, and the fire-escape door shall swing outward. All treads and risers shall be of the same height and width throughout the entire stairway, not including landings. II/III (15) Facilities with three (3) or more floors shall comply with the provisions of Chapter 320, RSMo, which requires that outside stairways be constructed of iron or steel. II (16) Door locks shall be of a type that can be opened from the inside by turning the knob or operating a simple device that will release the lock, or shall meet the requirements of Section 19.2 of NFPA 101, 2000 edition. Only one (1) lock will be permitted on any one (1)

door. I/II (17) All exit doors in existing licensed facilities shall be at least thirty inches (30") wide.

(18) All exit doors in new facilities shall be at least forty-four inches (44") wide. II (19) In all facilities, all exit doors and vestibule doors shall swing outward in the direction of exit travel. II (20) In all existing licensed facilities, all horizontal exit doors in fire walls and all doors in smoke barrier partitions may swing in either direction. These doors normally may be open, but shall be automatically self-closing upon activation of the fire alarm system.

They shall be capable of being manually released to self-closing action. II/III (21) Facilities shall maintain corridors to be free of obstruction, equipment, or supplies not in use. Doors to resident rooms shall not swing into the corridor. II/III (22) Facilities shall place signs bearing the word EXIT in plain, legible block letters at each required exit, except at doors directly from rooms to exit corridors or passageways.

(23) Wherever necessary, the facility shall place additional signs in corridors and passageways to indicate the exit’s direction. Letters on these signs shall be at least six inches (6") high and principle strokes three-fourths inch (3/4") wide, except that the letters of internally illuminated exit signs may be not less than four inches (4") high. III (24) Facilities shall maintain all exit and directional signs to be clearly legible and electrically illuminated at all times by acceptable means such as emergency lighting when lighting fails. II (25) Facilities shall have emergency lighting of sufficient intensity to provide for the safety of residents and other people using any exit, stairway, and corridor. The lighting shall be supplied by an emergency service, an automatic emergency generator or battery lighting system. This emergency lighting system shall be equipped with an automatic transfer switch. In an existing licensed facility, battery lights, if used, shall be wet cell units or other rechargeable-type batteries that shall be ULapproved and capable of operating the light for at least one and one-half (1 ½) hours.

Battery-operated emergency lighting shall be tested for at least thirty (30) seconds every thirty (30) days, and an annual function test shall be conducted for the full operational duration of one and one-half (1 ½) hours.

Records of these tests shall be documented and maintained for review. II (26) If existing licensed facilities have laundry chutes, dumbwaiter shafts, or other similar vertical shafts, they shall have a fire resistance rating of at least one (1) hour if serving three (3) or fewer stories. Enclosures serving four (4) or more stories shall have at least a two- (2-) hour fire-rated enclosure. These chute or shaft doors shall be self-closing or shall have any other approved device that will guarantee separation between floors. II (27) Existing licensed multistoried facilities shall provide a smoke separation barrier between the basement and the first floor and the floors of resident-use areas. At a minimum, this barrier shall consist of one-half inch (1/2") gypsum board, plaster, or equivalent. There shall be a one and three-fourths inch (1 3/4") thick solid-core wood door, or equivalent, at the top or bottom of the stairs.

If the door is glazed, it shall be glazed with wired glass. II (28) Each floor accessed by residents shall be divided into at least two (2) smoke sections with each section not exceeding one hundred fifty feet (150') in length or width. If the floor’s dimensions do not exceed seventy-five feet (75') in length or width, a division of the the floor into two (2) smoke sections will not be required. II (29) Each smoke section shall be separated by one- (1-) hour fire-rated walls that are continuous from outside wall-to-outside wall and from floor-to-floor or floor-to-roof deck. All doors in this wall shall be at least twenty- (20-) minute fire rated or its equivalent, selfclosing, and may be held open only if the door closes automatically upon activation of the fire alarm system. II (30) Existing licensed facilities shall have attached self-closing devices on all doors providing separation between floors. If the doors are to be held open, they shall have electromagnetic hold-open devices that are interconnected with either a smoke alarm or with other smoke-sensitive fire extinguishment or alarm systems in the building. II/III (31) Smoking shall be permitted only in designated areas. Areas where smoking is permitted shall be directly supervised unless the resident has been assessed by the facility and determined capable of smoking unassisted.

At least annually, the facility shall reassess those residents the facility has determined to be capable of smoking unsupervised and shall also reassess such resident when changes in his or her condition indicate the resident may no longer be capable of smoking without supervision. The facility shall document this assessment in the resident’s medical record.

(32) Designated smoking areas shall have ashtrays of noncombustible material and of safe design. The contents of ashtrays shall be disposed of properly in receptacles made of noncombustible material. II/III (33)

Fire Drills and Emergency Preparedness.

(A) All facilities shall have a written plan to meet potential emergencies or disasters and shall request consultation and assistance annually from a local fire unit for review of fire and evacuation plans. If the consultation cannot be obtained, the facility shall inform the state fire marshal in writing and request assistance in review of the plan. An up-todate copy of the facility’s entire plan shall be provided to the local jurisdiction’s emergency management director. II/III (B) The plan shall include, but is not limited to— 1. A phased response ranging from relocation of residents to an immediate area within the facility; relocation to an area of refuge, if applicable; or to total building evacuation.

This phased response part of the plan shall be consistent with the direction of the local fire unit or state fire marshal and shall be appropriate for the fire or emergency;

Written instructions for evacuation of each floor including evacuation to areas of refuge, if applicable, and floor plan showing the location of exits, fire alarm pull stations, fire extinguishers, and any areas of refuge;
Evacuating residents, if necessary, from an area of refuge to a point of safety outside the building;
The location of any additional water sources on the property such as cisterns, (5/31/20) JOHN R. ASHCROFT wells, lagoons, ponds, or creeks;
Procedures for the safety and comfort of residents evacuated;
Staffing assignments;
Instructions for staff to call the fire department or other outside emergency services;
Instructions for staff to call alternative resource(s) for housing residents, if necessary;
Administrative staff responsibilities; and 10. Designation of a staff member to be responsible for accounting for all residents’ whereabouts. II/III (C) The written plan shall be accessible at all times and an evacuation diagram shall be posted on each floor in a conspicuous place so that employees and residents can become familiar with the plan and routes to safety.

(D) A minimum of twelve (12) fire drills shall be conducted annually with at least one (1) every three (3) months on each shift. At least four (4) of the required fire drills must be unannounced to residents and staff, excluding staff who are assigned to evaluate staff and resident response to the fire drill.

The fire drills shall include a simulated resident evacuation that involves the local fire department or emergency service at least once a year. II/III (E) The fire alarm shall be activated during all fire drills unless the drill is conducted between 9 p.m. and 6 a.m., when a facilitygenerated predetermined message is acceptable in lieu of the audible and visual components of the fire alarm. II/III (F) The facility shall keep a record of all fire drills including the simulated resident evacuation. The record shall include the time, date, personnel participating, length of time to complete the fire drill, and a narrative notation of any special problems. III (34) Fire Safety Training Requirements.

(A) The facility shall ensure that fire safety training is provided to all employees:

During employee orientation;
At least every six (6) months; and 3. When training needs are identified as a result of fire drill evaluations. II/III (B) The training shall include, but is not limited to, the following:
Prevention of fire ignition, detection of fire, and control of fire development;
Confinement of the effects of fire;
Procedures for moving residents to an area of refuge, if applicable;
Use of alarms;
Transmission of alarms to the fire department;
Response to alarms;
Isolation of fire;
Evacuation of the immediate area and building;
Preparation of floors and facility for evacuation; and 10. Use of the evacuation plan required by section (33) of this rule. II/III (35) The use of wood- or gas-burning fireplaces will be permitted only if the fireplaces are built of firebrick or metal, enclosed by masonry, and have metal or tempered glass screens. The chimneys shall be of masonry construction with flue linings that have at least eight inches (8") of masonry separating the flue lining and the fireplace from any combustible material. All fireplaces shall be installed, operated, and maintained in a safe manner. Fireplaces not in compliance with these requirements may be provided if they are for decorative purposes only or if they are equipped with decorative-type electric logs or other electric heaters which bear the UL label and are constructed of electrical components complying with and installed in compliance with the National Electrical Code, incorporated by reference in this rule. Fireplaces meeting standards set forth in NFPA 211, 2000 edition, are considered in compliance with this rule. II/III (36) All electric or gas clothes dryers shall be vented to the outside and the lint trap cleaned regularly. II/III (37) In existing licensed facilities, all wall and ceiling surfaces shall be smooth and free of highly-combustible materials. II/III (38) All curtains in resident-use areas shall be rendered and maintained flame-resistant in accordance with NFPA 701, 1999 edition.

(39) All new floor covering installed in buildings that do not have a sprinkler system shall be Class I in accordance with NFPA 253, 2000 edition. II/III (40) Trash and Rubbish Disposal Requirements.

(A) Only metal or UL- or FM-approved wastebaskets shall be used for the collection of trash. II (B) The facility shall maintain the exterior premises in a manner as to provide for fire safety. II (C) Trash shall be removed from the premises as often as necessary to prevent fire hazards and public health nuisance. II (D) No trash shall be burned within fifty feet (50') of any facility except in an approved incinerator. I/II (E) Trash may be burned only in a masonry or metal container. The container shall be equipped with a metal cover with openings no larger than one-half inch (1/2") in size. II/III (41) Minimum Staffing for Safety and Protective Oversight to Residents.

(A) In a building that is of fire-resistant construction or a building with a sprinkler system, minimum staffing shall be the following:

Time Personnel Residents 7 a.m. to 3 p.m. 1 3–10* (Day) 3 p.m. to 11 p.m. 1 3–15* (Evening) 11 p.m. to 7 a.m. 1 3–20* (Night) *One (1) additional staff person for every fraction after that. I/II (B) In a building that is of nonfire-resistant construction or a building that has a sprinkler system exemption, minimum staffing shall be the following:

Time Personnel Residents 7 a.m. to 3 p.m. 1 3–10* (Day) 3 p.m. to 11 p.m. 1 3–15* (Evening) 11 p.m. to 7 a.m. 1 3–15* (Night) *One (1) additional staff person for every fraction after that. I/II

Filed Sept. 12, 1984, effective Dec. 13, 1984.

Amended: Filed Aug. 1, 1988, effective Nov. 11, 1988. Amended: Filed May 11, 1998, effective Dec. 30, 1998. Emergency amendment filed May 12, 1999, effective May 22, 1999, expired Feb. 24, 2000. Amended: Filed July 13, 1999, effective Jan. 30, 2000. Moved to 19 CSR 30-85.022, effective Aug. 28, 2001.

Emergency amendment filed Nov. 24, 2008, effective Dec. 4, 2008, expired June 1, 2009.

Amended: Filed Nov. 24, 2008, effec tive May 30, 2009. Amended: Filed March 15, 2012, effective Oct. 30, 2012. ** *Original authority: 198.074, RSMo 2007 and 198.079, RSMo 1979, amended 2007. **Pursuant to Executive Order 21-07, 19 CSR 30-85.022, sections (8) and (9) and subsections (10)(C) and (11)(A) was suspended from April 15, 2020 through May 1, 2021. Pursuant to Executive Order 21-09, 19 CSR 30-85.022, subsection (33)(D) was suspended from April 15, 2020 through December 31, 2021.

History

AUTHORITY: sections 198.074 and 198.079, RSMo Supp. 2011. This rule originally filed as 13 CSR 15-14.022. Original rule filed July 13, 1983, effective Oct. 13, 1983. Amended:

19 CSR 30-85.032 Physical Plant Requirements for New and Existing Intermediate Care and Skilled Nursing Facilities {#sec-19-csr-30-85.032 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-85.032}

PURPOSE: This rule establishes the requirements necessary in new and existing intermediate care and skilled nursing facilities.

This note applies only to the reference material. The entire text of the rule is printed here.

AGENCY NOTE: All rules relating to longterm care facilities licensed by the Division of Aging are followed by a Roman Numeral notation which refers to the class (either class I, II or III) of standard as designated in section 198.085.1, RSMo.

(1) General Requirements.

(A) All National Fire Protection Association (NFPA) codes and standards cited in this

rule: NFPA 54, National Fuel Code, 1999 edition; NFPA 58, Liquefied Petroleum Gas Code, 1999 edition; NFPA 70, National Electric Code, 1999 edition; NFPA 99, Health Care Facilities, 1999 edition; and NFPA 101, The Life Safety Code, 2000 edition, are incorporated by reference in this rule and available for purchase from the National Fire Protection Agency, 1 Batterymarch Park, Quincy, MA 02269-9101; www.nfpa.org; by telephone at (617) 770-3000 or 1-800-344- 3555. This rule does not incorporate any subsequent amendments or additions to the materials listed above.

(B) This rule does not prohibit facilities from complying with standards set forth in newer editions of the incorporated by reference material listed in subsection (1)(A) of this rule where approved by the Department of Health and Senior Services (the department).

(2) The building shall be substantially constructed and shall be maintained in good repair. New facilities shall comply with the requirements in accordance with the provisions found in 19 CSR 30-85.012. Existing licensed facilities shall meet and maintain the facility’s physical plant in accordance with the construction standards in effect at the time of initial licensing, unless there is a specific rule governing the subject cited in this

section or in 19 CSR 30-85.022, except that those facilities licensed between 1957 and 1965 shall not increase the capacity of any room or the total capacity of the facility without meeting new construction requirements.

Existing licensed facilities with plans approved after April 8, 1972 and prior to January 1, 1999, shall comply as Existing Health Care Occupancies with NFPA 101, 2000 edition. Facilities whose physical plant requirement plans are approved on or after January 1, 1999, shall comply as New Health Care Occupancies with NFPA 101, 2000 edition. II/III (3) In an existing facility licensed prior to July 1, 1965, the number of persons in any room or area used as sleeping quarters shall not exceed the proportion of one (1) adult for each sixty (60) square feet. In facilities licensed on or after July 1, 1965, adult resident rooms shall be a minimum of eighty (80) square feet per bed in multi-bed resident rooms and one hundred (100) square feet for private rooms. This square footage can include all useable floor spaces such as closets, entryways, and areas with moveable items or furniture that do not impact the safety or welfare of the resident, used for residents’ belongings or if related to their care.

Only the area of a room with a ceiling height of at least seven feet (7') can be included when calculating the square footage. II/III (4) An existing facility licensed prior to July 1, 1965 shall not use a private room less than sixty (60) square feet in size as sleeping quarters for residents under seventeen (17) years of age. In multi-bed resident rooms, the following ratios shall apply: thirty (30) square feet per bed for beds four feet (4') or less in length, forty (40) square feet per bed for beds four feet through five feet (4'–5') in length and sixty (60) square feet per bed for beds over five feet (5') in length. In facilities licensed on or after July 1, 1965, rooms shall be a minimum of thirty-five (35) square feet per bed for beds four feet (4') or less in length; forty-five (45) square feet per bed for beds four feet through five feet (4'–5') in length; eighty (80) square feet per bed over five (5) square feet in length in multiple bedrooms; and one hundred (100) square feet for private rooms. II/III (5) A facility may not house a resident in a room which has an outside grade of more than three feet (3') above the floor level on the window side of the resident’s room for a distance of at least fifteen feet (15') from the outside wall of the resident’s room. II/III (6) Facilities initially licensed after July 1, 1965 shall have no more than four (4) beds per room. II/III (7) The facility shall provide sleeping quarters, separate from resident bedrooms for the administrator or employees and their families who reside there. III (8) A facility shall conspicuously and unmistakably identify each room or ward or resident-use area with a number or room name securely fastened to, or plainly painted on the entrance of the room or ward. III (9) Each resident room shall have an outside window with an area equivalent to not less than ten percent (10%) of the required floor area. The facility shall maintain windows so that they may be readily opened and closed.

(10) Facilities shall ensure that every window in resident-use areas has shades, curtains or drapes. III (11) The facility shall make provisions for a room(s) which can be used for isolation of a resident(s) with communicable diseases.

Facilities licensed after July 1, 1965 and prior to June 11, 1981 shall have at least two (2) private rooms with a toilet room equipped with toilet and handwashing sink. Rooms designated as isolation rooms may be occupied by residents provided there is a written agreement on file indicating the resident’s willingness to relocate without prior notice if the room is needed for isolation purposes. III (12) Every facility shall provide a living room or community room for the sole use of residents. Sufficient chairs and tables shall be furnished. Under no circumstances may the living room be used as a bedroom. A living room must be well-lighted, ventilated, and easily accessible to residents. II (13) Facilities shall ensure that gas-burning equipment and appliances are approved by the American Gas Association and installed in compliance with NFPA 54, 1999 edition.

Where liquefied petroleum gas (LPG) is used, facilities shall comply with the rules of the Missouri Department of Agriculture and NFPA 58, 1999 edition. Facilities that were complying prior to the effective date of this

rule with prior editions of the NFPA 54 and NFPA 58 referenced in this rule shall be permitted to continue to comply with the earlier editions, as long as there is not an imminent danger to the health, safety, or welfare of any resident or a substantial probability that death or serious physical harm would result as determined by department. Gas-fired water heaters shall be properly vented and all water heaters shall be equipped with a temperature and pressure relief valve. II (14) Oxygen cylinders for medical use shall be labeled “Oxygen.” All facilities shall have oxygen systems, oxygen piping, outlets, manifold rooms, and storage rooms installed in accordance with the requirements of the NFPA 99, 1999 edition. I/II (15) Facilities shall provide adequate storage areas for food, supplies, linen, equipment and residents’ personal possessions. II/III (16) Toilet rooms shall be easily accessible, conveniently located, well-lighted and properly ventilated. Doors to toilet rooms which may be locked from the inside, shall be equipped with a special lock which may be opened from the outside. II/III (17) Existing licensed facilities shall provide one (1) toilet for each ten (10) residents or fraction of ten. II/III (18) The facility shall provide separate toilet facilities for each sex. Where urinals are provided for men, a facility shall provide one (1) toilet and urinal for each fifteen (15) males or fraction of fifteen. III (19) Facilities shall provide grab bars on at least one (1) side of all toilets, in proper positions to facilitate bodily movement of residents. II (20) Existing licensed facilities shall provide handwashing facilities consisting of a handwashing sink in each toilet room for each fifteen (15) residents or fraction of fifteen. The handwashing sink may be omitted from a toilet room which serves adjacent resident rooms if each room contains a handwashing sink. II/III (21) The facility shall provide one (1) shower or tub for each fifteen (15) residents or fraction of fifteen. II/III (22) Facilities shall have metal grab bars securely mounted for bathtubs, shower stalls and toilets. The facility shall also provide rubber or similar type nonskid mats or strips in tubs and showers to reduce or prevent slipping accidents and hazardous conditions. II (23) Facilities shall provide fixed partitions or curtains in bathrooms and toilet areas to ensure privacy. III (24) The facility shall ensure that plumbing fixtures that supply hot water and are accessible to the residents, shall be thermostatically controlled so the water temperature at the fixture does not exceed one hundred twenty degrees Fahrenheit (120°F) (49°C). The water shall be at a temperature range of one hundred five degrees Fahrenheit to one hundred twenty degrees Fahrenheit (105°F– 120°F) (41°C–49°C). I/II (25) Facilities shall provide adequate space and locations for the proper cleansing, disinfection, sterilization, and storage of nursing supplies and equipment. This area shall be specifically designated as a clean utility area.

There shall be a separate area designated as a dirty utility area, and neither area shall be located in or open into a kitchen, dining room, or a bathroom. The facility shall have utility areas that are easily available to personnel and located conveniently for the nursing station staff. Utility areas shall be wellventilated and well-lighted. II/III (26) The facility shall provide either a nursing station or a nurses’ work area on each floor of a multistory facility. This area shall have chart storage space on current residents.

Facilities licensed or with plans approved on or after July 1, 1965, shall have a nurses’ station for every sixty (60) beds. Handwashing facilities at or near the nurses’ station shall be available for physicians, nurses and other personnel attending residents. II/III (27) The facility shall be equipped with a call system that consists of an electrical intercommunication system, a wireless pager system, a buzzer system, or hand bells for each resident bed, toilet room, and bathroom. The call system shall be audible in the attendant’s work area and be in compliance with 19 CSR 30-85.012(124). II/III (28) The heating of the building shall be restricted to steam, hot water, permanently installed electric heating devices or warm air systems employing either central heating plants with installation so as to safeguard the inherent fire hazard or outside wall heaters with approved installation. Portable heater use is prohibited. Facilities shall provide adequate guards to safeguard residents where potential burn hazards exist. I/II (29) The facility shall heat all resident-accessible areas to ensure that the air temperature is not lower than sixty-eight degrees Fahrenheit (68°F). These areas shall be capable of being heated to not less than eighty degrees Fahrenheit (80°F). At all times the reasonable comfort needs of residents shall be met.

(30) The facility shall cool resident-accessible areas when air temperatures exceed eighty-five degrees Fahrenheit (85°F). These areas shall be capable of being cooled to at least seventy-one degrees Fahrenheit (71°F).

At all times the reasonable comfort needs of residents shall be met. I/II (31) Electrical Wiring Requirements.

(A) Electrical wiring and equipment shall be installed and maintained in accordance with the NFPA 70, 1999 edition. Facilities that were complying prior to the effective date of this rule with prior editions of the NFPA 70 referenced in this rule shall be permitted to continue to comply with the earlier editions, as long as there is not an imminent danger to the health, safety, or welfare of any resident or a substantial probability that death or serious physical harm would result as determined by the department. II/III (B) Every two (2) years, a qualified electrician will be required to certify in writing that the electrical system is being maintained and operated in accordance with the standards outlined by the NFPA 70, 1999 edition or the earlier NFPA 70 edition with which the facility was complying prior to the effective date of this rule. II/III (32) Lighting in hallways, bathrooms, recreational, dining, and all resident-use areas shall be provided with a minimum intensity of ten (10) footcandles and shall be sufficient to meet the residents’ and staff needs. III (33) Facilities shall use night-lights in hallways, resident rooms, toilet rooms or bathrooms and on stairways. II (34) The facility shall ensure that a reading light is provided for each resident who desires to read. III (35) To prevent direct glare to residents’ eyes, facilities shall ensure that lights in residentuse areas have a shade or dome. III (36) If elevators are used, their installation and maintenance shall comply with all local and state codes and NFPA 70, 1999 edition.

(37) If extension cords are used, they must be Underwriters Laboratories (UL)-approved or shall comply with other recognized electrical appliance approval standards and sized to carry the current required for the appliance used. Only one (1) appliance shall be connected to one (1) extension cord. Only two (2) appliances may be served by one (1) duplex receptacle. Extension cords shall not be placed under rugs, through doorways, or located where they are subject to physical damage. II/III (38) The facility shall maintain furniture and equipment in good condition and shall replace it if broken, torn, heavily soiled or damaged. Rooms shall be designed and furnished so that the comfort and safety of the residents are provided for at all times. II/III (39) Rooms shall be neat, orderly and cleaned daily. II/III (40) The facility shall ensure that each resident shall be provided an individual bed, single or twin, in good repair of rigid type. Beds shall be at least thirty-six inches (36") wide.

Double beds of satisfactory construction may be provided for married couples. Rollaway, metal cots or folding beds shall not be used.

(41) A minimum of three feet (3') shall be available between parallel beds. III (42) Mattresses shall be clean, in good repair, sized to fit the bed and a minimum of four inches (4") in thickness to provide comfort.

(43) The facility shall ensure that each bed has at least one (1) clean comfortable pillow.

Extra pillows shall be available to meet the needs of the residents. III (44) Multi-bed resident rooms shall have screens or curtains, either portable or permanently affixed, available and used to provide privacy as needed or as requested. III (45) Facilities shall provide each resident with an individual locker or other suitable space for storage of clothing and personal belongings. III (46) The facility shall provide residents with an individual rack for towels and washcloths unless they are provided with clean washcloths or towels for use each time needed. III (47) A comfortable chair shall be available for each resident’s use. III (48) Only activities necessary to the administration of the facility shall be contained in any building used as a long-term care facility except as follows:

(A) Related activities may be conducted in buildings subject to prior written approval of these activities by the department. Examples of these activities are home health agencies, physician’s office, pharmacy, ambulance service, child day care, food service, and outpatient therapy for the elderly or disabled in the community;

(B) Adult day care may be provided for four (4) or fewer participants without prior written approval of the department if the long-term care facility meets the following stipulations:

The operation of the adult day care business shall not interfere with the care and delivery of services to the long-term care residents;
The facility shall only accept participants in the adult day care program appropriate to the level of care of the facility and whose needs can be met;
The facility shall not change the physical layout of the facility without prior written approval of the department;
The facility shall provide a private area for adult day care participants to nap or rest;
Adult day care participants shall not be included in the census, and the number shall not be more than four (4) above the licensed capacity of the facility; and 6. The adult day care participants, while on-site, are to be included in the determination of staffing patterns for the long-term care facility; and (C) An associated adult day health care program may be operated without prior written approval if the provider of the adult day health care services is certified in accordance with 13 CSR 70-92.010. II/III

Filed Nov. 9, 1983, effective Feb. 11, 1984.

Amended: Filed Sept. 12, 1984, effective Dec. 13, 1984. Amended: Filed Aug. 1, 1988, effective Nov. 11, 1988. Amended:

Filed May 11, 1998, effective Dec. 30, 1998.

Emergency amendment filed Feb. 1, 1999, effective Feb. 11, 1999, expired Aug. 9, 1999.

Amended: Filed Feb. 1, 1999, effective July 30, 1999. Moved to 19 CSR 30-85.032, effective Aug. 28, 2001. Amended: Filed March 13, 2008, effective Oct. 30, 2008. ** *Original authority: 198.079, RSMo 1979, amended 2007. **Pursuant to Executive Order 21-07, 19 CSR 30-85.032, subsection (31)(B) was suspended from April 22, 2020 through May 1, 2021 and subsection (48)(A) was suspended from April 22, 2020 through August 31, 2021.

History

AUTHORITY: section 198.079, RSMo Supp. 2007. This rule originally filed as 13 CSR 15-14.032. Original rule filed July 13, 1983, effective Oct. 13, 1983. Emergency amendment filed Nov. 9, 1983, effective Nov. 19, 1983, expired March 18, 1984. Amended:

19 CSR 30-85.042 Administration and Resident Care Requirements for New and Existing Intermediate Care and Skilled Nursing Facilities {#sec-19-csr-30-85.042 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-85.042}

PURPOSE: This rule establishes standards for administration and resident care in an intermediate care or skilled nursing facility.

Editor’s Note: All rules relating to long-term care facilities licensed by the Department of Health and Senior Services are followed by a roman numeral notation which refers to the class (either Class I, II, or III) of standard as designated in section 198.085.1, RSMo.

(1) The operator shall designate a person as administrator who holds a current license as a nursing home administrator in Missouri. II (2) The facility shall post the administrator’s license. III (3) The operator shall be responsible to assure compliance with all applicable laws and rules. The administrator shall be fully authorized and empowered to make decisions regarding the operation of the facility and shall be held responsible for the actions of all employees. The administrator’s responsibilities shall include the oversight of residents to assure that they receive appropriate nursing and medical care. II/III (4) The administrator shall be employed in the facility and serve in that capacity on a full-time basis. An administrator cannot be listed or function as an administrator in more than one (1) licensed facility at the same time, except that one (1) administrator may serve as the administrator of more than one (1) licensed facility if all facilities are on the same premises. II/III (5) The licensed administrator shall not leave the premises without delegating the necessary

(16) All persons who have any contact with the residents in the facility shall not knowingly act or omit any duty in a manner which would materially and adversely affect the health, safety, welfare or property of a resident. I (17) Effective August 28, 1997, each facility shall, not later than two (2) working days of the date an applicant for a position to have contact with residents is hired, request a criminal background check, as provided in sections 43.530, 43.540 and 610.120, RSMo. Each facility must maintain in its record documents verifying that the background checks were requested and the nature of the response received for each such request. The facility must ensure that any applicant who discloses prior to the check of his/her criminal records that he/she has been convicted of, plead guilty or nolo contendere to, or has been found guilty of any A or B felony violation of Chapter 565, 566 or 569, RSMo, or any violation of subsection 3 of

section 198.070, RSMo, or of section 568.020, RSMo, will not be allowed to work in contact with patients or residents until and unless a check of the applicant’s criminal record shows that no such conviction occurred. II/III (18) The facility must develop and implement written policies and procedures which require that persons hired for any position which is to have contact with any patient or resident have been informed of their responsibility to disclose their prior criminal history to the facility as required by section 660.317.5, RSMo.

The facility— (A) Shall also develop and implement policies and procedures which ensure that the facility does not knowingly hire, after August 28, 1997, any person who has or may have contact with a patient or resident, who has been convicted of, plead guilty or nolo contendere to, in this state or any other state, or has been found guilty of any A or B felony violation of Chapter 565, 566 or 569, RSMo, or any violation of subsection 3 of section 198.070, RSMo, or of section 568.020, RSMo, unless the person has been granted a good cause waiver by the division;

(B) May consider for employment, in positions which have contact with resident or patients, any person who has been granted a good cause waiver by the division in accordance with the provisions of section 660.317, RSMo Supp. 1999 and 13 CSR 15-10.060; and;

(C) Shall contact the division to confirm the validity of an applicant’s good cause waiver prior to hiring the applicant. II/III (19) No person who is listed on the employee disqualification list maintained by the division as required by section 198.070, RSMo shall work or volunteer in the facility in any capacity whether or not employed by the operator. II (20) The facility shall develop and offer an in-service orientation and continuing educational program for the development and improvement of skills of all the facility’s personnel, appropriate for their job function.

Facilities shall begin providing orientation on the first day of employment for all personnel including licensed nurses and other professionals. At a minimum, this shall cover prevention and control of infection, facility policies and procedures including emergency protocol, job responsibilities and lines of

(A) All nursing assistants shall successfully complete the entire basic course (including passing the final examination) of the nursing assistant training program and be certified within four (4) months of employment. II/III (B) Nursing assistants who have not successfully completed the nursing assistant training program prior to employment may begin duties as a nursing assistant and may provide direct resident care only if under the direct supervision of a licensed nurse prior to the completion of the seventy-five (75) classroom hours of the training program. For the

purpose of this rule, direct supervision shall mean close contact whereby the licensed nurse is able to respond quickly to the needs of the resident. The nursing assistant shall not perform any care or services for which he or she has not been trained nor found proficient by a licensed nurse. II/III (C) Prior to any direct resident contact, an individual enrolled in the nursing assistant training program’s basic course in a Medicare or Medicaid certified facility shall complete at least a total of sixteen (16) of the required seventy-five (75) hours of instructional training in communication and interpersonal skills; infection control; safety/emergency procedures, including the Heimlich maneuver; promoting residents’ independence; and respecting residents’ rights. II/III (22) The facility must ensure there is a system of in-service training for nursing personnel which identifies training needs related to problems, needs, care of residents and infection control and is sufficient to ensure staff’s continuing competency. II/III (23) Facilities shall conduct at least annual in-service education for nursing personnel including training in restorative nursing. This training by a registered nurse or qualified therapist shall include: turning and positioning for the bedridden resident, range of motion (ROM) exercises, ambulation assistance, transfer procedures, bowel and bladder retraining and self-care activities of daily living. II/III (24) A registered nurse shall be responsible for the planning and then assuring the implementation of the in-service education program for nursing personnel. II (25) Facilities shall maintain records which indicate the subject of, and attendance at, all in-service sessions. III (26) All authorized personnel shall have access to the legal name of each resident, name and telephone number of physician and next of kin or responsible party of each resident to contact in the event of emergency.

(27) The facility must develop and implement policies and procedures which ensure employees are screened to identify communicable diseases and ensure that employees diagnosed with communicable diseases do not expose residents to such diseases. The facility’s policies and procedures must comply with the Missouri Department of Health’s regulations pertaining to communicable diseases, specifically 19 CSR 20-20.010 through 19 CSR 20-20.100, as amended. II (28) The administrator shall maintain on the premises an individual personnel record on each employee of the facility which shall include: the employee’s name and address;

Social Security number; date of birth; date of employment; experience and education; references, if available; the result of background checks required by section 660.317, RSMo; a copy of any good cause waiver, granted by the division, if applicable; position in the facility; record that the employee was instructed on resident’s rights; basic orientation received; and reason for termination, if applicable. Documentation shall be on file of all training received within the facility in addition to current copies of licenses, transcripts, certificates or statements evidencing competency for the position held. Facilities shall retain personnel records for at least one (1) year following termination of employment.

(29) Facilities shall maintain written documentation on the premises showing actual hours worked by each employee. III (30) All persons who have or may have contact with residents shall at all times when on duty or delivering services wear an identification badge. The badge shall give their name, title and, if applicable the status of their license or certification as any kind of health care professional. This rule shall apply to all personnel who provide services to any resident directly or indirectly. III (31) Employees other than nursing personnel shall be at least sixteen (16) years of age.II/III (32) Nursing personnel shall be at least eighteen (18) years of age except that a person between the ages of seventeen (17) years of age and eighteen (18) years of age may provide direct resident care if the individual is listed as a certified nursing assistant with an active status on the department’s certified nursing assistant registry. The individual shall work under the direct supervision of a licensed nurse and shall never be left responsible for a nursing unit. II/III (33) All nurses employed by the facility shall be currently licensed in Missouri. II (34) All facilities shall employ a director of nursing on a full-time basis who shall be responsible for the quality of patient care and supervision of personnel rendering patient care. II (35) Licensed Nursing Requirements; Skilled Nursing Facility.

(A) The director of nursing shall be a registered nurse. II (B) A registered nurse shall be on duty in the facility on the day shift. Either a licensed practical nurse (LPN) or a registered professional nurse (RN) shall be on duty in the facility on both the evening and night shifts.

(C) A registered nurse shall be on call during the time when only an LPN is on duty. II (36) Licensed Nursing Requirements; Intermediate Care Facilities.

(A) The director of nursing shall be either an RN or an LPN. II (B) When the director of nursing is an LPN, an RN shall be employed as consultant a minimum of four (4) hours per week to provide consultation to the administrator and the director of nursing in matters relating to nursing care in the facility. II (C) An LPN or RN shall be on duty and in the facility on the day shift. II (D) An LPN or RN shall be on call twenty-four (24) hours a day, seven (7) days a week. I/II (37) All facilities shall employ nursing personnel in sufficient numbers and with sufficient qualifications to provide nursing and related services which enable each resident to attain or maintain the highest practicable level of physical, mental and psychosocial well-being. Each facility shall have a licensed nurse in charge who is responsible for evaluating the needs of the residents on a daily and continuous basis to ensure there are sufficient, trained staff present to meet those needs. I/II (38) Nursing personnel shall be on duty at all times on each resident-occupied floor. II (39) Nursing personnel in any facility with more than twenty (20) residents shall not routinely perform non-nursing duties. II/III (40) Nursing personnel in facilities with twenty (20) residents or less shall perform non-nursing duties only if acceptable infection control measures are maintained. II/III (41) Each facility resident shall be under the medical supervision of a Missouri-licensed physician who has been informed of the facility’s emergency medical procedures and is kept informed of treatments or medications prescribed by any other professional lawfully authorized to prescribe medications. I/II (42) Facilities shall ensure that at the time the resident is admitted, the facility obtains from a physician the resident’s primary diagnosis along with current medical findings and the written orders for the immediate care of the resident. II/III (43) The facility shall ensure that the resident’s private physician, the physician’s designee, the facility’s supervising physician, or an alternate physician shall examine the resident at least annually, and shall examine the resident as often as necessary to ensure proper medical care. I/II (44) For each medical examination, the physician must review the resident’s care, including medications and treatments; write, sign, and date progress notes; and sign and date all orders. The facility shall establish a policy requiring the physician to sign orders and to complete all other documentation required if the physician does not visit the resident routinely. II/III (45) No medication, treatment, or diet shall be given without a written order from a person lawfully authorized to prescribe such and the order shall be followed. No restraint shall be applied except as provided in 13 CSR 15- 18.010, Resident Rights. I/II (46) There shall be a safe and effective system of medication distribution, administration, control, and use. I/II (47) Verbal and telephone orders for medication or treatment shall be given only to those individuals licensed or certified to accept orders. Orders shall be immediately reduced to writing and signed by that individual. If a telephone order is given to a certified medication technician, an initial dose of medication or treatment shall not be given until the order has been reviewed by telephone or in person by a licensed nurse or pharmacist.

The review shall be documented by the reviewer co-signing the telephone order. II (48) Medications shall be administered only by a licensed physician, a licensed nurse, or a medication technician who has successfully completed the state-approved course for medication administration. II (49) Injectable medication, other than insulin, shall be administered only by a licensed physician or a licensed nurse. Insulin injections may be administered by a certified medication technician who has successfully completed the state-approved course for insulin administration. II (50) Self-administration of medication is permitted only if approved in writing by the resident’s physician, and it is in accordance with the facility’s policy and procedures. II (51) All medication errors and adverse reactions shall be reported immediately to the nursing supervisor and the resident’s physician and, if there was a dispensing error, to the issuing pharmacist. II/III (52) At least monthly a pharmacist or a registered nurse shall review the drug regimen of each resident. Irregularities shall be reported in writing to the resident’s physician, the administrator, and the director of nurses.

There must be written documentation which indicates how the reports were acted upon.

(53) All prescription medications shall be supplied as individual prescriptions. All medications, including over-the-counter medications, shall be packaged and labeled in accordance with applicable professional pharmacy standards and state and federal drug laws and regulations. The United States Pharmacopoeia (USP) labeling shall include accessory and cautionary instructions as well as the expiration date, when applicable, and the name of the medication as specified in the physician’s order. Over-the-counter medications for individual residents shall be labeled with at least the resident’s name. II/III (54) If the resident brings medications to the facility, they shall not be used unless the contents have been examined, identified, and documented by a pharmacist or a physician.

(55) Facilities shall store all external and internal medications at appropriate temperatures in a safe, clean place and in an orderly manner apart from foodstuffs and dangerous chemicals. A facility shall secure all medications, including those refrigerated, behind at least one (1) locked door or cabinet. Facilities shall store containers of discontinued medication separately from current medications. II/III (56) Facilities shall store Schedule II medications, including those in the emergency drug supply, under double lock separately from noncontrolled medication. Schedule II medications may be stored and handled with other noncontrolled medication if the facility has a single unit dose drug distribution system in which the quantity stored is minimal and a missing dose can be readily detected. II (57) Upon discharge or transfer, a resident may be given medications with a written order from the physician. Instructions for the use of those medications will be provided to the resident or the resident’s designee. III (58) All non-unit doses and all controlled substances which have been discontinued must be destroyed on the premises within thirty (30) days. Outdated, contaminated, or deteriorated medications and non-unit dose medications of deceased residents shall be destroyed within thirty (30) days. Unit dose medications returnable to the pharmacy shall be returned within thirty (30) days. II/III (59) Medications shall be destroyed in the facility by a pharmacist and a licensed nurse or by two (2) licensed nurses. III (60) Facilities shall maintain records of medication destroyed in the facility. Records shall include: the resident’s name; the date; the name, strength, and quantity of the medication; the prescription number; and the signatures of the participating parties. III (61) The facility shall maintain records of medication released to the family or resident upon discharge or to the pharmacy. Records shall include: the resident’s name; the date; the name, strength, and quantity of the medication; the prescription number; and the signature of the persons releasing and receiving the medication. III (62) The facility must establish a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation. The system must enable the facility to determine that drug records are in order and that an account of all controlled drugs is maintained and reconciled. II/III (63) Facilities shall make available to all nursing staff up-to-date reference material on all medications in use in the facility. III (64) The facility shall develop policies to identify any emergency stock supply of prescription medications to be kept in the facility for resident use only. This emergency drug supply must be checked at least monthly by a pharmacist to ensure its safety for use and compliance with facility policy. A facility shall have the emergency drug supply readily available to medical personnel and use of medications in the emergency drug supply shall assure accountability. III (65) Each resident shall receive twenty-four- (24-) hour protective oversight and supervision. For residents departing the premises on voluntary leave, the facility shall have, at a minimum, a procedure to inquire of the resident or resident’s guardian of the resident’s departure, of the resident’s estimated length of absence from the facility, and of the resident’s whereabouts while on voluntary leave.

(66) Each resident shall receive personal attention and nursing care in accordance with his/her condition and consistent with current acceptable nursing practice. I/II (67) Each resident shall be clean, dry, and free of body and mouth odor that is offensive to others. I/II (68) Taking into consideration the resident’s preferences, residents shall be well-groomed and dressed appropriately for the time of day, the environment and any identified medical conditions. II/III (69) Residents who are physically or mentally incapable, or both, of changing their own positions shall have their positions changed at least every two (2) hours and shall be provided supportive devices to maintain good body alignment. I/II (70) The facility must provide each resident the opportunity to access sufficient fluids to maintain proper hydration in accordance with the resident’s medical condition and goals of treatment as documented in the medical record. I/II (71) All residents who require assistance at mealtimes, whether it be preparation of the food items or actual feeding, shall be provided the assistance upon delivery of the tray.

Facilities shall provide dining room supervision during meals. II/III (72) Facilities shall provide each resident, according to his/her needs, with restorative nursing to encourage independence, activity and self-help to maintain strength and mobility. Each resident shall be out of bed as desired unless medically contraindicated. II (73) Each resident shall have skin care including the application of oil, lotion, and cream as needed to prevent dryness and scaling of skin. II/III (74) Facilities shall keep residents free from avoidable pressure sores, taking measures toward prevention. If sores exist, staff shall give adequate treatment. I/II (75) Facility staff shall check residents requiring restraints every thirty (30) minutes and exercise the residents every two (2) hours. II/III (76) Facilities shall not use locked restraints.

I (77) Residents shall be cared for by using acceptable infection control procedures to prevent the spread of infection. The facility shall make a report to the division within seven (7) days if a resident is diagnosed as having a communicable disease, as determined by the Missouri Department of Health and listed in the Code of State Regulations pertaining to communicable diseases, specifically 19 CSR 20-20.020, as amended. I/II (78) In the event of accident, injury, or significant change in the resident’s condition, facility staff shall notify the resident’s physician in accordance with the facility’s emergency treatment policies which have been approved by the supervising physician. I/II (79) In the event of accident, injury, or significant change in the resident’s conditions, facility staff shall immediately notify the person designated in the resident’s record as the designee or responsible party. III (80) Staff shall inform the administrator of accidents, injuries, and unusual occurrences which adversely affect, or could adversely affect, the resident. The facility shall develop and implement responsive plans of action. III (81) Facilities shall ensure that each resident is provided individual personal care items necessary for good grooming. Items shall be stored and maintained in a clean manner within the resident’s room. III (82) Facilities shall provide equipment and nursing supplies in sufficient number to meet the needs of the residents. II/III (83) Facilities shall keep all utensils and equipment in good condition, effectively sanitized, sterilized, or both, and stored to prevent contamination. II/III (84) Staff shall ensure that bedpans, commodes, and urinals are covered after use, emptied promptly, and thoroughly cleaned after use. II/III (85) Facilities shall provide and use a sufficient supply of clean bed linen, including sheets, pillow cases, blankets, and mattress pads to assure that resident beds are kept clean, neat, dry, and odor free. II/III (86) Staff shall use moisture proof covers as necessary to keep mattresses and pillows clean, dry, and odor free. II/III (87) Facilities shall provide each resident with fresh bath towels, hand towels, and washcloths as needed for individual usage.

(88) In addition to rehabilitative or restorative nursing, all facilities shall provide or make arrangements for providing rehabilitation services to all residents according to their needs.

If a resident needs rehabilitation services, a qualified therapist shall perform an evaluation on written order of the resident’s physician.

(89) Facilities shall ensure that rehabilitation services are provided by or under the on-site supervision of a qualified therapist or a qualified therapy assistant who works under the general supervision of a qualified therapist.

(90) Staff shall include the following in documentation of rehabilitation services: physician’s written approval for proposed plan of care; progress notes at least every thirty (30) days by the therapist; daily record of the procedure(s) performed; summary of therapy when rehabilitation has been reached and, if applicable, recommendations for maintenance procedures by restorative nursing. III (91) The facility shall designate a staff member to be responsible for the facility’s social services program. The designated staff person shall be capable of identifying social and emotional needs, knowledgeable of methods or resources, or a combination of these to use to meet them and services shall be provided to residents as needed. II/III (92) The facility shall designate an employee to be responsible for the activity program.

The designated person shall be capable of identifying activity needs of residents, designing and implementing programs to maintain or increase, or both, the resident’s capability in activities of daily living. Facilities shall provide activity programs on a regular basis. Each resident shall have a planned activity program which includes individualized activities, group activities, and activities outside the facility as appropriate to his/her needs and interests. II/III (93) The facility shall provide and use adequate space and equipment within the facility for the identified activity needs of residents.

(94) The facility shall establish and maintain a program for informing all residents in advance of available activities, activity location and time. III (95) Facility staff shall include the following general information in admission records: resident’s name; prior address; age (birth date); sex; marital status; Social Security number; Medicare and Medicaid numbers; date of admission; name, address, and telephone number of responsible party; name, address, and telephone number of attending physician; height and weight on admission; inventory of resident’s personal possessions upon admission; and names of preferred dentist, pharmacist, and funeral director. II/III (96) Facility staff shall include physician entries in the medical record with the following information: admission diagnosis, admission physical and findings of subsequent examinations; progress notes; orders for all medications and treatment; orders for extent of activity; orders for restraints including type and reason for restraint; orders for diet; and discharge diagnosis or cause of death. II/III (97) Residents admitted to a facility on referral by the Department of Mental Health shall have an individualized treatment plan or individualized habilitation plan on file which is updated annually. III (98) Facilities shall ensure that the clinical record contains sufficient information to— (A) Identify the resident;

(B) Reflect the initial and ongoing assessments and interventions by each discipline involved in the care and treatment of the resident; and (C) Identify the discharge or transfer destination. II/III (99) Facilities shall ensure that the resident’s clinical record must contain progress notes that include, but are not limited to:

(A) Response to care and treatment;

(B) Change(s) in physical, mental, and psychosocial condition;

(100) The facility must safeguard clinical record information against loss, destruction, or unauthorized use. III (101) The facility must keep all information confidential that is contained in the resident’s records regardless of the form or storage method of the records, including video-, audio-, or computer-stored information. III (102) The facility must maintain clinical records on each resident in accordance with accepted professional standards and practices. These records shall be complete, accurately documented, readily accessible on each nursing unit, and systematically organized. II/III (103) Facilities must retain clinical records for the period of time required by state law or five (5) years from the date of discharge when there is no requirement in state law. III (104) Facilities shall retain all financial records related to the facility operation for seven (7) years from the end of the facility’s fiscal year. III (105) In the event the resident is transferred from the facility, the resident shall be accompanied by a copy of the medical history, transfer forms which include the physical exam report, nursing summary, and report of orders physicians prescribed. II/III

Emergency amendment filed Nov. 9, 1983, effective Nov. 19, 1983, expired March 18, 1984. Amended: Filed Nov. 9, 1983, effective Feb. 11, 1984. Amended: Filed Sept. 12, 1984, effective Dec. 13, 1984. Amended:

Filed Aug. 1, 1988, effective Nov. 10, 1988.

Amended: Filed Jan. 3, 1992, effective Aug. 6, 1992. Amended: Feb. 13, 1998, effective Sept. 30, 1998. Amended: Filed Feb. 15, 2000, effective Aug. 30, 2000. Moved to 19 CSR 30-85.042, effective Aug. 28, 2001.

Emergency amendment filed Sept. 12, 2003, effective Sept. 22, 2003, expired March 19, 2004. Amended: Filed Sept. 12, 2003, effective Feb. 29, 2004. ** Amended: Filed June 14, 2021, effective Dec. 30, 2021. *Original authority: 198.006, RSMo 1979, amended 1984, 1987, 2003; 198.009, RSMo 2016; and 198.079, RSMo 1979. **Pursuant to Executive Order 21-07, 19 CSR 30-85.042, sections (7) and (21) was suspended from April 16, 2020 through May 1, 2021 and section (27) was suspended from April 23, 2020 through August 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 30- 85.042, sections (11), (20), (33), (40), (49), and (50) was suspended from April 15, 2020 through December 31, 2021 and sections (9) and (11), subsection (35)(B), section (39), and section 198.082, RSMo was suspended from April 16, 2020 through December 31, 2021.

History

authority in writing to a responsible individual. If the administrator is absent from the facility for more than thirty (30) consecutive days, the person designated to be in administrative charge shall be a currently licensed nursing home administrator. Such thirty (30) consecutive-day absences may only occur once within any consecutive twelve (12)month period. I/II (6) The facility shall not knowingly admit or continue to care for residents whose needs cannot be met by the facility directly or in cooperation with outside resources. Facilities which retain residents needing skilled nursing care shall provide licensed nurses for these procedures. I/II (7) When outside resources are used to provide services to the resident, the facility shall enter into a written agreement with each resource. III (8) Persons under seventeen (17) years of age shall not be admitted as residents to the facility unless the facility cares primarily for residents under seventeen (17) years of age. III (9) The facility shall not care for more residents than the number for which the facility is licensed. II (10) The facility’s current license shall be readily visible in a public area within the facility. Notices provided to the facility by the Division of Aging granting exceptions to regulatory requirements shall be posted with the facility’s license. III (11) Regular daily visiting hours shall be established and posted. Relatives or guardians and clergy, if requested by the resident or family, shall be allowed to see critically ill residents at any time unless the physician orders otherwise in writing. II/III (12) A supervising physician shall be available to assist the facility in coordinating the overall program of medical care offered in the facility. II (13) The facility shall develop policies and procedures applicable to its operation to insure the residents’ health and safety and to meet the residents’ needs. At a minimum, there shall be policies covering personnel practices, admission, discharge, payment, medical emergency treatment procedures, nursing practices, pharmaceutical services, social services, activities, dietary, housekeeping, infection control, disaster and accident prevention, residents’ rights and handling residents’ property. II/III (14) A pharmacist currently licensed in Missouri shall assist in the development of written policies and procedures regarding pharmaceutical services in the facility. II/III (15) All personnel shall be fully informed of the policies of the facility and of their duties.
authority, confidentiality of resident information, and preservation of resident dignity including protection of the resident’s privacy and instruction regarding the property rights of residents. II/III (21) Nursing Assistant Training Program.
AUTHORITY: sections 198.006, 198.009, 198.079, RSMo 2016. This rule originally filed as 13 CSR 15-14.042. Original rule filed July 13, 1983, effective Oct. 13, 1983.

19 CSR 30-85.052 Dietary Requirements for New and Existing Intermediate Care and Skilled Nursing Facilities {#sec-19-csr-30-85.052 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-85.052}

PURPOSE: This rule establishes dietary requirements for new and existing intermediate care and skilled nursing facilities.

Editor’s Note: All rules relating to long-term care facilities licensed by the Division of Aging are followed by a Roman Numeral notation which refers to the class (either Class I, II or III) of standard as designated in

section 198.085.1, RSMo.

(1) Each resident shall be served nutritious food, properly prepared and appropriately seasoned, taking into consideration resident food preferences, to provide an adequate diet in accordance with the physician’s order and as recommended by the National Research Council. Nutritional needs of residents shall be met and shall be based on the individual’s circumstances, medical condition and goals of treatment as determined and justified by the physician. A qualified professional, such as a dietitian or registered nurse, shall regularly assess these needs and shall keep the physician informed of the nutritional status of the resident. I/II (2) At least three (3) substantial meals or other equivalent shall be served daily at regular hours with supplementary feedings as necessary. At least two (2) meals shall be hot.II/III (3) Foods shall be prepared and served using methods that conserve nutritive value, flavor and appearance. II/III (4) Special attention shall be given to the texture of food given to residents who have chewing difficulty. II/III (5) Provision shall be made to assure that hot food is served hot and cold food is served cold. II (6) If a resident refuses food served, appropriate substitutes of similar nutritive value shall be offered. II/III (7) Bedtime snacks of nourishing quality shall be offered to all residents unless medically contraindicated. III (8) Tray service and dining room service for residents shall be attractive and each resident shall receive appropriate table service. III (9) Each resident who is served meals in bed or in a chair not within the dining area shall be provided with either a table, an overbed table or an overbed tray of sturdy construction which is positioned so that the resident can eat comfortably. III (10) A time schedule for service of meals to residents shall be established. Meals shall be served approximately four to five (4–5) hours apart and not longer than fourteen (14) hours from a substantial evening meal to breakfast.

(11) A minimum of thirty (30) minutes shall be given for eating meals. Residents who eat slowly or who need assistance shall be given as much time to eat as necessary. II/III (12) An identification system shall be established to assure that each resident receives the diet as ordered. II/III (13) If the residents have objectionable table manners, an alternate method of meal service shall be provided. III (14) There shall be sufficient personnel properly trained in their duties to assure adequate preparation and serving of food. II (15) All facilities shall employ a food service supervisor who shall have overall supervisory responsibility for dietary services. II (16) Menus for special prescribed diets shall be reviewed and approved in writing by either a qualified dietitian, a registered nurse or a physician. II/III (17) If food preparation, service, or both, within the facility is handled through a contractual arrangement, all regulations governing sanitation (13 CSR 15-17), dietary service and contractual personnel shall be met and maintained. II/III (18) If it is determined by the Division of Aging that due to the complexity of prescribed diets or that the food service supervisor is unable to assure compliance with the dietary requirements, the facility shall be required to employ, for specified periods of time, a qualified dietitian to serve as a consultant and until the food service management improves to assure that the residents’ needs are being met. II (19) A current record of purchased food shall be kept to show the kind and amount of food purchased each month. III (20) Supplies of staple food for a minimum of a one (1)-week period and of perishable foods for a minimum of a three (3)-day period shall be maintained on the premises. II (21) Menus for all diets shall be planned at least two (2) weeks in advance. If cycle menus are used, the cycle must cover a minimum of three (3) weeks and must be different each day of the week. Menus showing the foods and amounts of food to be served each day during the current week shall be posted where seen readily as food is prepared and served. Each day’s menu shall show the date it was actually used and shall be kept on file for thirty (30) days. A list of substitutions shall be kept for thirty (30) days. III (22) A file of standardized recipes shall be used. III (23) A diet manual approved by the Division of Aging shall be readily available to attending physicians, nursing and dietary personnel. III

Filed Jan. 3, 1992, effective Aug. 6, 1992.

Moved to 19 CSR 30-85.052, effective Aug. 28, 2001. ** *Original authority: 198.009, RSMo 1979. **Pursuant to Executive Order 21-09, 19 CSR 30-85.052, sections (14), (16), and (21) was suspended from April 15, 2020 through December 31, 2021.

History

AUTHORITY: section 198.009, RSMo 1986. This rule originally filed as 13 CSR 15- 14.052. Original rule filed July 13, 1983, effective Oct. 13, 1983. Amended: Filed Aug. 1, 1988, effective Nov. 10, 1988. Amended:

Chapter 86 Residential Care Facilities and Assisted Living Facilities

19 CSR 30-86.012 Construction Standards for Assisted Living Facilities and Residential {#sec-19-csr-30-86.012 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.012}

19 CSR 30-86.022 Fire Safety and Emergency Preparedness Standards for Residential {#sec-19-csr-30-86.022 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.022}

19 CSR 30-86.032 Physical Plant Requirements for Residential Care Facilities and {#sec-19-csr-30-86.032 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.032}

19 CSR 30-86.042 Administrative, Personnel, and Resident Care Requirements for New {#sec-19-csr-30-86.042 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.042}

19 CSR 30-86.043 Administrative, Personnel, and Resident Care Requirements for Facilities Licensed as a Residential Care Facility II on August 27, 2006 {#sec-19-csr-30-86.043 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.043}

19 CSR 30-86.045 Standards and Requirements for Assisted Living Facilities Which Provide Services to Residents with a Physical, Cognitive, or Other Impairment that Prevents the Individual from Safely Evacuating the {#sec-19-csr-30-86.045 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.045}

19 CSR 30-86.047 Administrative, Personnel, and Resident Care Requirements for {#sec-19-csr-30-86.047 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.047}

19 CSR 30-86.052 Dietary Requirements for Residential Care Facilities and Assisted SERVICES Assisted Living Facilities {#sec-19-csr-30-86.052 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.052}

19 CSR 30-86.012 Construction Standards for Assisted Living Facilities and Residential Care Facilities {#sec-19-csr-30-86.012 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.012}

PURPOSE: This rule establishes construction standards for Residential Care Facilities and Assisted Living Facilities. designated in section 198.085.1, RSMo 2000.

(1) These standards apply to assisted living facilities and residential care facilities as indicated in the rule.

(2) A facility shall submit a copy of plans of proposed new construction, additions to or major remodeling of an existing facility to the Section for Long Term Care of the Department of Health and Senior Services (hereinafter—the department).

If the facility is to be licensed for more than nine (9) residents, a registered architect or registered professional engineer shall prepare the plans and specifications for new construction or additions to an existing facility in conformance with Chapter 327, RSMo. III (3) Construction of facilities shall begin only after the plans and specifications have received the written approval of the department. Facilities shall then be built in conformance with the approved plans and specifications. The facility shall notify the department when construction begins. If construction of the project is not started within one (1) year after the date of approval of the plans and specifications and completed within a period of three (3) years, the facility shall resubmit plans to the department for its approval and shall amend them, if necessary, to comply with the then current rules before construction work is started or continued. III (4) If the facility employs more than fifteen (15) people, it shall conform with section 504 of the Rehabilitation Act of 1973. Any facility that houses handicapped residents shall have the first floor rooms and living areas designed to be accessible to these residents. III (5) Facilities shall not house residents on a level where the outside grade line is more than three feet (3') above the floor level on the window side of the room. II (6) Facilities whose plans were approved after December 31, 1987, shall provide a minimum of seventy (70) square feet per resident in private and multiple occupancy bedrooms. This square footage calculation shall include the floor space used for closets and built-in furniture and equipment if these are for resident use and the closet space does not exceed five (5) square feet per resident. Private bedrooms in existing facilities that are required to comply with the requirements of 19 CSR 30-86.043 or 19 CSR 30-86.047, and multiple occupancy bedrooms in facilities licensed between November 13, 1980 and December 31, 1987, shall have a minimum of sixty (60) square feet of floor space per resident. II (7) Ceilings in bedrooms shall be a minimum of seven feet (7') in height or if a room with sloping ceiling is used, only the area where the ceiling height is at least seven feet (7') can be used to meet the required minimum square footage per resident. II (8) Facilities shall provide bedrooms with at least one (1) functional outside window with screen. Window size shall be not less than one-twentieth (1/20) or five percent (5%) of the required floor area. II (9) Facilities shall provide resident rooms with a full nonlouvered door that swings into the room. Facilities formerly licensed as residential care facilities II and existing prior to November 13, 1980, are exempt from this requirement. II (10) Facilities shall permit no more than four (4) beds per bedroom, regardless of the room size. Facilities formerly licensed as residential care facilities II and existing prior to November 13, 1980, are exempt from this requirement. II (11) One (1) tub or shower bath shall be provided for each twenty (20) residents or major fraction of twenty (20). Facilities exceeding twenty (20) residents shall have separate bathing facilities for each sex. II (12) One (1) toilet and lavatory shall be provided for each six (6) residents or major fraction of six (6). Facilities formerly licensed as residential care facilities II and in operation or whose plans were approved prior to November 13, 1980 are required to provide one (1) toilet for each ten (10) beds or major fraction of ten (10) and one (1) lavatory for every fifteen (15) residents or major fraction of fifteen (15). II (13) Separate toilet rooms shall be provided for each sex if common rooms with multi-stalls and stools are provided. II (14) Bath and toilet facilities shall be conveniently located so that residents can reach them without passing through the kitchen, another bedroom, or auxiliary service areas.

Facilities formerly licensed as residential care facilities II and in operation or whose plans were approved prior to November 13, 1980 are exempt from this requirement. III (15) Bath and toilet facilities shall be ventilated. III (16) Facilities whose plans were approved or were initially licensed after December 31, 1987, shall have a community living and dining area separate from resident bedrooms with at least twenty-five (25) square feet per resident. The community living and dining area may be combined with footage required for another long-term care facility when the facility is on the same premises as another licensed facility. Facilities that are required to comply with the requirements of 19 CSR 30-86.043 licensed prior to November 13, 1980, must have a living room area but they are exempt from minimum size requirements.

Facilities licensed between November 13, 1980 and December 31, 1987, shall have a community living area with twenty (20) square feet per resident for the first twenty (20) residents and an additional fifteen (15) square feet per resident over a census of twenty (20). II (17) Facilities shall provide the following in the dietary area: a kitchen, dishwashing, refrigeration, and garbage disposal facilities. The facility shall arrange the kitchen and equipment to efficiently and sanitarily enable the storage, preparation, cooking and serving of food and drink to residents. II (18) Residential care facilities and assisted living facilities shall provide a designated attendant’s working area which includes: a storage space for records; locked storage space for medications; a handwashing sink with hot and cold running water, a soap dispenser and paper towels; and a telephone conveniently located to the area. Facilities licensed for twelve (12) or fewer residents are exempt from a separate working area. III (19) Facilities shall have a laundry area in a separate room for storing, sorting, washing, drying and distributing linen and personal clothing. Laundry facilities of a licensed longterm care facility located on the same premises may be used.

Facilities licensed for twelve (12) or fewer residents will be exempt from having a separate room for laundry but the laundry room shall be separate from the kitchen and shall not be located in a room used by residents. III (20) All newly licensed facilities shall be of sturdy construction with permanent foundations. III (21) In buildings built prior to September 28, 1979, corridors shall have a minimum width of thirty-six inches (36"). Firstfloor resident room doors shall be a minimum of thirty-two inches (32") wide. Resident room doors of these buildings on the second floor and above shall be a minimum of thirty inches (30") wide. II/III (22) In newly licensed buildings constructed on or after September 28, 1979, all resident room doors shall be a minimum of thirty-two inches (32") wide on all floors. Corridors shall be a minimum of forty-eight inches (48") wide and interior stairs shall be at least thirty-six inches (36") wide. II/III (23) Exit doors in newly licensed facilities shall be at least thirty-six inches (36") wide, at least seventy-two inches (72") high and shall swing outward. II/III (24) Residential care facilities that accept deaf residents, shall have appropriate assistive devices to enable each deaf person to negotiate a path to safety, including, but not limited to, visual or tactile alarm systems. II/III (25) Residential care facilities and facilities formerly licensed as residential care facilities II whose plans were initially approved between December 31, 1987 and December 31, 1998, shall have at least one (1) hydraulic or electric motor-driven elevator if there are more than twenty (20) residents with bedrooms above the first floor. The elevator installation(s) shall comply with all local and state codes, American Society for Mechanical Engineers (ASME) A17.1, Safety Code for Elevators, Dumbwaiters, and Escalators, and the National Fire Protection Association’s applicable codes. All facilities with plans approved on or after January 1, 1999, shall comply with all local and state codes, ASME A17.1, 1993 Safety Code for Elevators and Escalators, and the 1996 National Electrical Code. These references are incorporated by reference in this rule and available at: American Society for Mechanical Engineers, Three Park Avenue, New York, NY 10016- 5990; and The American National Standards Institute, 11 West 42nd Street, 13th Floor, New York, NY 10036. This rule does not incorporate any additional amendments or additions. II (26) Facilities whose plans were approved or which were initially licensed after December 31, 1987, shall provide an air-conditioning system, or individual room air-conditioning units, capable of maintaining resident-use areas at eightyfive degrees Fahrenheit (85 °F) (29.4 °C) at the summer design temperature. II (27) Home-Like Requirements with Respect to Construction Standards.

(A) Any assisted living facility formerly licensed as a residential care facility shall be more home-like than institutional with respect to construction and physical plant standards. II (B) Any assisted living facility licensed as a residential care facility II prior to August 28, 2006, shall qualify as being more home-like than institutional with respect to construction and physical plant standards. II (C) Any assisted living facility that is built or has plans approved on or after August 28, 2006, shall be more home-like than institutional with respect to construction and physical plant standards. II

rule originally filed as 13 CSR 15-15.012. Original rule filed July 13, 1983, effective Oct. 13, 1983. Emergency amendment filed Aug. 1, 1984, effective Aug. 13, 1984, expired Dec. 10, 1984. Amended: Filed Sept. 12, 1984, effective Dec. 13, 1984. Amended: Filed May 13, 1987, effective Aug. 13, 1987. Amended: Filed Aug. 1, 1988, effective Nov. 10, 1988. Amended: Filed May 11, 1998, effective Dec. 30, 1998.

Moved to 19 CSR 30-86.012, effective Aug. 28, 2001. Amended:

Filed Nov. 15, 2004, effective May 30, 2005. Amended: Filed Aug. 23, 2006, effective April 30, 2007. Amended: Filed March 13, 2008, effective Oct 30, 2008. *Original authority: 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006, 2007, and

History

AUTHORITY: sections 198.073 and 198.076, RSMo Supp. 2007. This

19 CSR 30-86.022 Fire Safety and Emergency Preparedness Standards for Residential Care Facilities and Assisted Living Facilities {#sec-19-csr-30-86.022 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.022}

PURPOSE: This rule establishes fire safety and emergency preparedness standards for residential care facilities and assisted living facilities. licensed by the Department of Health and Senior Services are followed by a Roman Numeral notation which refers to the class (either class I, II, or III) of standard as designated in section 198.085, RSMo 2000.

(1) Definitions. For the purpose of this rule, the following (A) Accessible spaces—shall include all rooms, halls, storage areas, basements, attics, lofts, closets, elevator shafts, enclosed stairways, dumbwaiter shafts, and chutes;

(B) Area of refuge—a space located in or immediately other spaces in the same building or its location, permitting a delay in evacuation. An area of refuge may be temporarily used as a staging area that provides some relative safety to its occupants while potential emergencies are assessed, decisions are made, and, if applicable, evacuation has begun;

Addition of any room(s), accessible by residents, that either exceeds fifty percent (50%) of the total square footage of the facility or exceeds four thousand five hundred (4,500) square feet;
Repairs, remodeling, or renovations that involve structural changes to more than fifty percent (50%) of the building;
Repairs, remodeling, or renovations that involve structural changes to more than four thousand five hundred (4,500) square feet of a smoke section; or 4. If the addition is separated by two- (2-) hour fireresistant construction, only the addition portion shall meet the requirements for NFPA 13, 1999 edition, sprinkler system, unless the facility is otherwise required to meet NFPA 13, 1999 edition;

(D) Fire-resistant construction—type of construction in residential care and assisted living facilities in which bearing walls, columns, and floors are of noncombustible material in accordance with NFPA 101, 2000 edition. All load-bearing walls, floors, and roofs shall have a minimum of a one- (1-) hour fireresistant rating; and (E) Concealed spaces—shall include areas within the building that cannot be occupied or used for storage.

(2) General Requirements.

(A) All National Fire Protection Association (NFPA) codes and standards cited in this rule: NFPA 10, Standard for Portable Fire Extinguishers, 1998 edition; NFPA 13R, Installation of Sprinkler Systems, 1996 edition; NFPA 13, Installation of Sprinkler Systems, 1976 edition; NFPA 13 or NFPA 13R, Standard for the Installation of Sprinkler Systems in Residential Occupancies Up to and Including Four Stories in Height, 1999 edition; NFPA 13, Standard for the Installation of Sprinkler Systems, 1999 edition; NFPA 96, Standard for Ventilation Control and Fire Protection of Commercial Cooking Operations, 1998 edition; NFPA 101, The Life Safety Code, 2000 edition; NFPA 72, National Fire Alarm Code, 1999 edition; NFPA 72A, Local Protective Signaling Systems, 1975 edition; NFPA 25, Standard for the Inspection, Testing, and Maintenance of Water- Based Fire Protection Systems, 1998 edition; and NFPA 101A, Guide to Alternative Approaches to Life Safety, 2001 edition, with regard to the minimum fire safety standards for residential care facilities and assisted living facilities are incorporated by reference in this rule and available for purchase from the National Fire Protection Agency, 1 Batterymarch Park, Quincy, MA 02269-9101; www.nfpa.org; by telephone at (617) 770-3000 or 1-800-344-3555. This rule does not incorporate any subsequent amendments or additions to the materials listed above. This

rule does not prohibit facilities from complying with the standards set forth in newer editions of the incorporated by reference material listed in this subsection of this rule, if approved by the department.

(B) Facilities that were complying prior to the effective date of this rule with prior editions of the NFPA provisions referenced in this rule shall be permitted to continue to comply with the earlier editions, as long as there is not an imminent danger to the health, safety, or welfare of any resident or a substantial probability that death or serious physical harm would result as determined by the department.

(C) All facilities shall notify the department immediately after the emergency is addressed if there is a fire in the facility or premises and shall submit a complete written fire report to the department within seven (7) days of the fire, regardless of the size of the fire or the loss involved. II/III (D) The department shall have the right of inspection of any portion of a building in which a licensed facility is located unless the unlicensed portion is separated by two- (2-) hour fire-resistant construction. No section of the building shall present a fire hazard. I/II (E) Following the discovery of any fire, the facility shall monitor the area and/or the source of the fire for a twenty-four- (24-) hour period. This monitoring shall include, at a minimum, hourly visual checks of the area. These hourly visual checks shall be documented. I/II (F) The facility shall maintain the exterior premises in a manner as to provide for fire safety. II (G) Residential care facilities that accept deaf residents shall have appropriate assistive devices to enable each deaf person to negotiate a path to safety, including, but not limited to, visual or tactile alarm systems. II/III (H) Facilities shall not use space under stairways to store combustible materials. I/II (3) Fire Extinguishers.

(A) Fire extinguishers shall be provided at a minimum of one (1) per floor, so that there is no more than seventy-five feet (75') travel distance from any point on that floor to an extinguisher.

(B) All new or replacement portable fire extinguishers shall be ABC-rated extinguishers, in accordance with the provisions of NFPA 10, 1998 edition. A K-rated extinguisher or its equivalent shall be used in lieu of an ABC-rated extinguisher in the kitchen cooking areas. II (C) Fire extinguishers shall have a rating of at least:

Ten pounds (10 lbs.), ABC-rated or the equivalent, in or within fifteen feet (15') of hazardous areas as defined in 19 CSR 30-83.010; and 2. Five pounds (5 lbs.), ABC-rated or the equivalent, in other areas. II (D) All fire extinguishers shall bear the label of the Underwriters’ Laboratories (UL) or the Factory Mutual (FM)

Laboratories and shall be installed and maintained in accordance with NFPA 10, 1998 edition. This includes the documentation and dating of a monthly pressure check. II/III (4) Range Hood Extinguishing Systems.

(A) In facilities licensed on or before July 11, 1980, or in any facility with fewer than twenty-one (21) beds, the kitchen shall provide either:

An approved automatic range hood extinguishing system properly installed and maintained in accordance with NFPA 96, 1998 edition; or 2. A portable fire extinguisher of at least ten pounds (10 lbs.) ABC-rated, or the equivalent, in the kitchen area in accordance with NFPA 10, 1998 edition. II/III (B) In licensed facilities with a total of twenty-one (21) or more licensed beds and whose application was filed after July 11, 1980, and prior to October 1, 2000:
The kitchen shall be provided with a range hood and an approved automatic range hood extinguishing system unless the facility has an approved sprinkler system. Facilities with range hood systems shall continue to maintain and test these systems; and 2. The extinguishing system shall be installed, tested, and maintained in accordance with NFPA 96, 1998 edition. II/III (C) The range hood and its extinguishing system shall be certified at least twice annually in accordance with NFPA 96, 1998 edition. II/III (5) Fire Drills and Emergency Preparedness.

(A) All facilities shall have a written plan to meet potential emergencies or disasters and shall request consultation and assistance annually from a local fire unit for review of fire and evacuation plans. If the consultation cannot be obtained, the facility shall inform the state fire marshal in writing and request assistance in review of the plan. An up-to-date copy of the facility’s entire plan shall be provided to the local jurisdiction’s emergency management director. II/III (B) The plan shall include, but is not limited to, the following:

A phased response ranging from relocation of residents to an immediate area within the facility; relocation to an area of refuge, if applicable; or to total building evacuation.

This phased response part of the plan shall be consistent with the direction of the local fire unit or state fire marshal and appropriate for the fire or emergency;

Written instructions for evacuation of each floor including evacuation to areas of refuge, if applicable, and a floor plan showing the location of exits, fire alarm pull stations, fire extinguishers, and any areas of refuge;
Evacuating residents, if necessary, from an area of refuge to a point of safety outside the building;
The location of any additional water sources on the property such as cisterns, wells, lagoons, ponds, or creeks;
Procedures for the safety and comfort of residents evacuated;
Staffing assignments;
Instructions for staff to call the fire department or other outside emergency services;
Instructions for staff to call alternative resource(s) for housing residents, if necessary;
Administrative staff responsibilities; and 10. Designation of a staff member to be responsible for accounting for all residents’ whereabouts. II/III (C) The written plan shall be accessible at all times and an evacuation diagram shall be posted on each floor in a conspicuous place so that employees and residents can become familiar with the plan and routes to safety. II/III (D) A minimum of twelve (12) fire drills shall be conducted annually with at least one (1) every three (3) months on each shift. At least four (4) of the required fire drills must be unannounced to residents and staff, excluding staff who are assigned to evaluate staff and resident response to the fire drill.

The fire drills shall include a resident evacuation at least once a year. II/III (E) The facility shall keep a record of all fire drills. The record shall include the time, date, personnel participating, length of time to complete the fire drill, and a narrative notation of any special problems. III (F) The fire alarm shall be activated during all fire drills unless the drill is conducted between 9 p.m. and 6 a.m., when a facility-generated predetermined message is acceptable in lieu of the audible and visual components of the fire alarm. II/III (6) Fire Safety Training Requirements.

(A) The facility shall ensure that fire safety training is provided to all employees:

During employee orientation;
At least every six (6) months; and 3. When training needs are identified as a result of fire drill evaluations. II/III (B) The training shall include, but is not limited to, the 1. Prevention of fire ignition, detection of fire, and control of fire development;
Confinement of the effects of fire;
Procedures for moving residents to an area of refuge, if applicable;
Use of alarms;
Transmission of alarms to the fire department;
Response to alarms;
Isolation of fire;
Evacuation of immediate area and building;
Preparation of floors and facility for evacuation; and 10. Use of the evacuation plan as required by section (5) of this rule. II/III (7) Exits, Stairways, and Fire Escapes.

(A) Each floor of a facility shall have at least two (2) unobstructed exits remote from each other. I/II 1. For a facility whose plans were approved on or before December 31, 1987, or a facility licensed for twenty (20) or fewer beds, one (1) of the required exits from a multi-story facility shall be an outside stairway or an enclosed stairway that is separated by one- (1-) hour rated construction from each floor with an exit leading directly to the outside at grade level. Existing plaster or gypsum board of at least one-half inch (1/2") thickness may be considered equivalent to one- (1-) hour rated construction. The other required exit may be an interior stairway leading through corridors or passageways to outside or to a two- (2-) hour rated horizontal exit as defined by paragraph 3.3.61 of the 2000 edition NFPA 101. Neither of the required exits shall lead through a furnace or boiler room.

Neither of the required exits shall be through a resident’s bedroom, unless the bedroom door cannot be locked. I/II 2. For a facility whose plans were approved after December 31, 1987, for more than twenty (20) beds, the required exits shall be doors leading directly outside, one- (1-) hour enclosed stairs or outside stairs or a two- (2-) hour rated horizontal exit as defined by paragraph 3.3.61 of 2000 edition NFPA 101. The one- (1-) hour enclosed stairs shall exit directly outside at grade.

Access to these shall not be through a resident bedroom or a hazardous area. I/II 3. Only one (1) of the required exits may be a two- (2-) hour rated horizontal exit. I/II (B) In facilities with plans approved after December 31, 1987, doors to resident use rooms shall not be more than one hundred feet (100') from an exit. In facilities equipped with a complete sprinkler system in accordance with NFPA 13 or NFPA 13R, 1999 edition, the exit distance may be increased to one hundred fifty feet (150'). Dead-end corridors shall not exceed thirty feet (30') in length. II (C) In residential care facilities and facilities formerly licensed as residential care facilities II, floors housing residents who require the use of a walker, wheelchair, or other assistive devices or aids, or who are blind, must have two (2) accessible exits to grade or such residents must be housed near accessible exits as specified in 19 CSR 30-86.042(33) for residential care facilities and 19 CSR 30-86.043(31) for facilities formerly licensed as residential care facilities II unless otherwise prohibited by

19 CSR 30-86.045 or 19 CSR 30-86.047, facilities equipped with a complete sprinkler system, in accordance with NFPA 13 or NFPA 13R, 1999 edition, with sprinkler coverage in attics, and smoke partitions, as defined by subsection (10)(I) of this rule, may house such residents on floors that do not have accessible exits to grade if each required exit is equipped with an area of refuge as defined and described in subsections (1)(B) and (7)(D) of this rule. I/II (D) An “area of refuge” shall have— 1. An area separated by one- (1-) hour rated smoke walls, from the remainder of the building. This area must have direct access to the exit stairway or access the stair through a section of the corridor that is separated by smoke walls from the remainder of the building. This area may include no more than two (2) resident rooms; {#sec-19-csr-30-86.045 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.045}

A two- (2-) way communication or intercom system with both visible and audible signals between the area of refuge and the bottom landing of the exit stairway, attendants’ work area, or other primary location as designated in the written plan for fire drills and evacuation;
Instructions on the use of the area during emergency conditions that are located in the area of refuge and conspicuously posted adjoining the communication or intercom system;
A sign at the entrance to the room that states “AREA OF REFUGE IN CASE OF FIRE” and displays the international symbol of accessibility;
An entry or exit door that is at least a one and threefourths inch (1 3/4") solid core wood door or has a fire protection rating of not less than twenty (20) minutes with smoke seals and positive latching hardware. These doors shall not be lockable;
A sign conspicuously posted at the bottom of the exit stairway with a diagram showing each location of the areas of refuge;
Emergency lighting for the area of refuge; and 8. The total area of the areas of refuge on a floor shall equal at least twenty (20) square feet for each resident who is blind or requires the use of a wheelchair or walker housed on the floor. II (E) If it is necessary to lock exit doors, the locks shall not require the use of a key, tool, special knowledge, or effort to unlock the door from inside the building. Only one (1) lock shall be permitted on each door. Delayed egress locks complying with section 7.2.1.6.1 of the 2000 edition NFPA 101 shall be permitted, provided that not more than one (1) such device is located in any egress path. Self-locking exit doors shall be equipped with a hold-open device to permit staff to reenter the building during the evacuation. I/II (F) If it is necessary to lock resident room doors, the locks shall not require the use of a key, tool, special knowledge, or effort to unlock the door from inside the room. Only one (1) lock shall be permitted on each door. Every resident room door shall be designed to allow the door to be opened from the outside during an emergency when locked. The facility shall ensure that facility staff have the means or mechanisms necessary to open resident room doors in case of an emergency. I/II (G) All stairways and corridors shall be easily negotiable and shall be maintained free of obstructions. II (H) Outside stairways shall be constructed to support residents during evacuation and shall be continuous to the ground level. Outside stairways shall not be equipped with a counter-balanced device. They shall be protected from or cleared of ice or snow. II/III (I) Facilities with three (3) or more floors shall comply with the provisions of Chapter 320, RSMo which requires outside stairways to be constructed of iron or steel. II (J) Fire escapes constructed on or after November 13, 1980, whether interior or exterior, shall be thirty-six inches (36") wide, shall have eight-inch (8") maximum risers, nine-inch (9") minimum tread, no winders, maximum height between landings of twelve feet (12'), minimum dimensions of landings of forty-four inches (44"), landings at each exit door, and handrails on both sides and be of sturdy construction, using at least two-inch (2") lumber. Exit doors to these fire escapes shall be at least thirty-six inches (36") wide and the door shall swing outward. II/III (K) If a ramp is required to meet residents’ needs under 19 CSR 30-86.042, the ramp shall have a maximum slope of one to twelve (1:12) leading to grade. II/III (8) Exit Signs.

(A) Signs bearing the word EXIT in plain, legible letters shall be placed at each required exit, except at doors directly from rooms to exit passageways or corridors. Letters of all exit signs shall be at least six inches (6") high and principle strokes threefourths of an inch (3/4") wide, except that letters of internally illuminated exit signs shall not be less than four inches (4")

high. II (B) Directional indicators showing the direction of travel shall be placed in corridors, passageways, or other locations where the direction of travel to reach the nearest exit is not apparent. II/III (C) All required exit signs and directional indicators shall be positioned so that both normal and emergency lighting illuminates them. II/III (9) Complete Fire Alarm Systems.

(A) All facilities shall have a complete fire alarm system installed in accordance with NFPA 101, Section 18.3.4, 2000 edition. The complete fire alarm shall automatically transmit to the fire department, dispatching agency, or central monitoring company. The complete fire alarm system shall include visual signals and audible alarms that can be heard throughout the building and a main panel that interconnects all alarmactivating devices and audible signals. Manual pull stations shall be installed at or near each required attendant’s station and each required exit. I/II 1. For facilities with a sprinkler system in accordance with NFPA 13, 1999 edition, smoke detectors interconnected to the complete fire alarm system shall be installed in all corridors and spaces open to corridors. Smoke detectors shall be no more than thirty feet (30') apart with no point on the ceiling more than twenty-one feet (21') from a smoke detector. I/II A. In facilities licensed prior to November 13, 1980, 2. For facilities with a sprinkler system in accordance with NFPA 13R, 1999 edition, smoke detectors interconnected to the complete fire alarm system shall be installed in all corridors, spaces open to corridors, and in accessible spaces not protected by the sprinkler system, as required by NFPA 72, 1999 edition.

Smoke detectors shall be no more than thirty feet (30') apart with no point on the ceiling more than twenty-one feet (21') from a smoke detector. Smoke detectors shall not be installed in areas where environmental influences may cause nuisance alarms. Such areas include, but are not limited to, kitchens, laundries, bathrooms, mechanical air handling rooms, and attic spaces. In these areas, heat detectors interconnected to the complete fire alarm system shall be installed. Bathrooms not exceeding fifty-five (55) square feet and clothes closets, linen closets, and pantries not exceeding twenty-four (24) square feet are exempt from having any detection device if the walls and ceilings are surfaced with limited-combustible or non-combustible material as defined in NFPA 101, 2000 edition.

Concealed spaces of noncombustible or limited combustible construction are not required to have detection devices. These spaces may have limited access but cannot be occupied or used for storage. I/II A. In facilities licensed prior to November 13, 1980, 3. For facilities that are not required to have a sprinkler system, smoke detectors interconnected to the complete fire alarm system shall be installed in all accessible spaces, as required by NFPA 72, 1999 edition, within the facility. Smoke detectors shall be no more than thirty feet (30') apart with no point on the ceiling more than twenty-one feet (21') from a smoke detector. Smoke detectors shall not be installed in areas where environmental influences may cause nuisance alarms.

Such areas include, but are not limited to, kitchens, laundries, bathrooms, mechanical air handling rooms, and attic spaces.

In these areas, heat detectors interconnected to the fire alarm system shall be installed. Bathrooms not exceeding fifty-five (55) square feet and clothes closets, linen closets, and pantries not exceeding twenty-four (24) square feet are exempt from having any detection device if the walls and ceilings are surfaced with limited-combustible or noncombustible material as defined in NFPA 101, 2000 edition. Concealed spaces of noncombustible or limited-combustible construction are not required to have detection devices. These spaces may have limited access but cannot be occupied or used for storage. I/II A. In facilities licensed prior to November 13, 1980, (B) Facilities that are required to install a sprinkler system in accordance with section (11) of this rule shall comply with the following requirements:

Until the required sprinkler system is installed, each resident room or any room designated for sleeping shall be equipped with at least one (1) battery-powered smoke alarm installed, tested, and maintained in accordance with manufacturer’s specifications. In addition, the facility shall be equipped with interconnected heat detectors installed, tested, and maintained in accordance with NFPA 72, 1999 edition, with detectors in all areas subject to nuisance alarms, including, but not limited to, kitchens, laundries, bathrooms, mechanical air handling rooms, and attic spaces. I/II A. The facility shall maintain a written record of the monthly testing and battery changes. The written records shall be retained for one (1) year. I/II B. Upon discovery of a fault with any detector or alarm, the facility shall correct the fault. I/II (C) All facilities shall test and maintain the complete fire alarm system in accordance with NFPA 72, 1999 edition. I/II (D) All facilities shall have inspections and written certifications of the complete fire alarm system completed by an approved qualified service representative in accordance with NFPA 72, 1999 edition, at least annually. I/II (E) Facilities shall test by activating the complete fire alarm system at least once a month. I/II (F) Facilities shall maintain a record of the complete fire alarm tests, inspections, and certifications required by subsections (9)

(C) and (D) of this rule. III (G) Upon discovery of a fault with the complete fire alarm system, the facility shall correct the fault. I/II (H) When a complete fire alarm system is to be out-of-service for more than four (4) hours in a twenty-four- (24-) hour period, the facility shall immediately notify the department and the local fire authority and implement an approved fire watch in accordance with NFPA 101, 2000 edition, until the complete fire alarm system has returned to full service. I/II (I) The complete fire alarm system shall be activated by all of the following: sprinkler system flow alarm, smoke detectors, heat detectors, manual pull stations, and activation of the rangehood extinguishment system. II/III (10) Protection from Hazards.

(A) In assisted living facilities and residential care facilities licensed on or after November 13, 1980, for more than twelve (12) beds, hazardous areas shall be separated by construction of at least a one- (1-) hour fire-resistant rating. In facilities equipped with a complete fire alarm system, the one- (1-) hour fire separation is required only for furnace or boiler rooms.

Hazardous areas equipped with a complete sprinkler system are not required to have this one- (1-) hour fire separation.

Doors to hazardous areas shall be self-closing and shall be kept closed unless an electromagnetic hold-open device is used which is interconnected with the fire alarm system. When the sprinkler option is chosen, the areas shall be separated from other spaces by smoke-resistant partitions and doors. The doors shall be self-closing or automatic-closing. Facilities formerly licensed as residential care facility I or II, and existing prior to November 13, 1980, shall be exempt from this requirement. II (B) The storage of unnecessary combustible materials in any part of a building in which a licensed facility is located is prohibited. I/II (C) Electric or gas clothes dryers shall be vented to the outside. Lint traps shall be cleaned regularly to protect against fire hazard. II/III (D) In facilities that are required to comply with the requirements of 19 CSR 30-86.043 and were formerly licensed as residential care facilities II on or after November 13, 1980, each floor shall be separated by construction of at least a one- (1-) hour fire-resistant rating. Buildings equipped with a complete sprinkler system may have a nonrated smoke separation barrier between floors. Doors between floors shall be a minimum of one and three-fourths inches (1 3/4") thick and be solid core wood doors or metal doors with an equivalent fire rating. II (E) In facilities licensed prior to November 13, 1980, and multi-storied residential care facilities formerly licensed as residential care facilities I licensed on or after November 13, 1980, there shall be a smoke separation barrier between the floors of resident-use areas and any floor below the residentuse area. This shall consist of a solid core wood door or metal door with an equivalent fire rating at the top or the bottom of the stairs. There shall not be a transom above the door that would permit the passage of smoke. II (F) Atriums open between floors will be permitted if resident room corridors are separated from the atrium by one- (1-) hour rated smoke walls. These corridors must have access to at least one (1) of the required exits without traversing any space opened to the atrium. II (G) All doors providing separation between floors shall have a self-closing device attached. If the doors are to be held open, electromagnetic hold-open devices shall be used that are interconnected with either an individual smoke detector or a complete fire alarm system. II (H) All facilities shall be divided into at least two (2) smoke sections with each section not exceeding one hundred fifty feet (150') in length or width. If the floor’s dimensions do not exceed seventy-five feet (75') in length or width, a division of the floor into two (2) smoke sections will not be required. II (I) In facilities whose plans were approved or which were initially licensed after December 31, 1987, for more than twenty (20) beds and all facilities licensed after August 28, 2007, each smoke section shall be separated by one- (1-) hour fire-rated smoke partitions. The smoke partitions shall be continuous from outside wall-to-outside wall and from floor-to-floor or floor-to-roof deck. All doors in this wall shall be at least twenty- (20-) minute fire-rated or its equivalent, self-closing, and may be held open only if the door closes automatically upon activation of the complete fire alarm system. II (J) In all facilities that were initially licensed on or prior to December 31, 1987, and all facilities licensed for twenty (20) or fewer beds prior to August 28, 2007, each smoke section shall be separated by a one- (1-) hour fire-rated smoke partition that extends from the inside portion of an exterior wall to the inside portion of an exterior wall and from the floor to the underside of the floor or roof deck above, through any concealed spaces, such as those above suspended ceilings, and through interstitial structural and mechanical spaces. Smoke partitions shall be permitted to terminate at the underside of a monolithic or suspending ceiling system where the following conditions are met: The ceiling system forms a continuous membrane, a smoketight joint is provided between the top of the smoke partition and the bottom of the suspended ceiling and the space above the ceiling is not used as a plenum. Smoke partition doors shall be at least twenty- (20-) minute fire-rated or its equivalent, self-closing, and may be held open only if the door closes automatically upon activation of the complete fire alarm system. II (K) Facilities whose plans were approved or which were initially licensed after December 31, 1987, for more than twenty (20) beds which do not have a sprinkler system, shall have one- (1-) hour rated corridor walls with one and three-quarters inch (1 3/4") solid core wood doors or metal doors with an equivalent fire rating. II (L) If two (2) or more levels of long-term care or two (2) different businesses are located in the same building, the entire building shall meet either the most strict construction and fire safety standards for the combined facility or the facilities shall be separated from the other(s) by two- (2-) hour fire-resistant construction. In buildings equipped with a complete sprinkler system in accordance with NFPA 13 or NFPA 13R, 1999 edition, this separation may be rated at one (1) hour. II (11) Sprinkler Systems.

(A) Facilities licensed on or after August 28, 2007, or any

section of a facility in which a major renovation has been completed on or after August 28, 2007, shall install and maintain a complete sprinkler system in accordance with NFPA 13, 1999 edition. I/II (B) Facilities that have a sprinkler system installed prior to August 28, 2007, shall inspect, maintain, and test these systems in accordance with the requirements that were in effect for such facilities on August 27, 2007. I/II (C) All residential care facilities, and assisted living facilities that do not admit or retain a resident with a physical, cognitive, or other impairment that prevents the individual from safely evacuating the facility with minimal assistance, that were licensed prior to August 28, 2007, with more than twenty (20) residents, and do not have an approved sprinkler system in accordance with NFPA 13, 1999 edition, or NFPA 13R, 1999 edition, shall have until December 31, 2012, to install an approved sprinkler system in accordance with NFPA 13 or 13R, 1999 edition. I/II 1. The department shall grant exceptions to this requirement if the facility meets Chapter 33 of NFPA 101, 2000 edition, and the evacuation capability of the facility meets the standards required in NFPA 101A, Guide to Alternative Approaches to Life Safety, 2001 edition. I/II (D) Single-story assisted living facilities that provide care to one (1) or more residents with a physical, cognitive, or other impairment that prevents the individual from safely evacuating the facility with minimal assistance shall install and maintain an approved sprinkler system in accordance with NFPA 13R, 1999 edition. I/II (E) Multi-level assisted living facilities that provide care to one (1) or more residents with a physical, cognitive, or other impairment that prevents the individual from safely evacuating the facility with minimal assistance shall install and maintain an approved sprinkler system in accordance with NFPA 13, 1999 edition. I/II (F) All facilities shall have inspections and written certifications of the approved sprinkler system completed by an approved qualified service representative in accordance with NFPA 25, 1998 edition. The inspections shall be in accordance with the provisions of NFPA 25, 1998 edition, with certification at least annually by a qualified service representative. I/II (G) When a sprinkler system is to be out-of-service for more than four (4) hours in a twenty-four- (24-) hour period, the facility shall immediately notify the department and implement an approved fire watch in accordance with NFPA 101, 2000 edition, until the sprinkler system has been returned to full service. I/II (12) Emergency Lighting.

(A) Emergency lighting of sufficient intensity shall be provided for exits, stairs, resident corridors, and required attendants’ station. II (B) The lighting shall be supplied by an emergency service, an automatic emergency generator, or battery-operated lighting system. This emergency lighting system shall be equipped with an automatic transfer switch. II (C) If battery-powered lights are used, they shall be capable of operating the light for at least one and one-half (1 1/2) hours.

(13) Interior Finish and Furnishings.

(A) In a facility licensed on or after November 13, 1980, for more than twelve (12) beds, wall and ceiling surfaces of all occupied rooms and all exitways shall be classified either Class A or B interior finish as defined in NFPA 101, 2000 edition. II (B) In facilities licensed prior to November 13, 1980, all wall and ceiling surfaces shall be smooth and free of highly combustible materials. II (C) In facilities licensed for more than twelve (12) beds, the new or replacement floor covering and carpeting in buildings that do not have a sprinkler system shall be Class I in accordance with NFPA 253, 2000 edition. II/III (D) All curtains and drapes in a licensed facility shall be certified or treated to be flame-resistant as defined in NFPA 101, 2000 edition. II (14) Smoking.

(A) Smoking shall be permitted in designated areas only.

Areas where smoking is permitted shall be designated as such and shall be supervised either directly or by a resident informing an employee of the facility that the area is being used for smoking. II/III (B) Ashtrays shall be made of noncombustible material and safe design and shall be provided in all areas where smoking is permitted. II/III (C) The contents of ashtrays shall be disposed of properly in receptacles made of noncombustible material. II/III (15) Trash and Rubbish Disposal.

(A) Only metal or UL- or FM-fire-resistant rated wastebaskets shall be used for trash. II (B) Trash shall be removed from the premises as often as necessary to prevent fire hazards and public health nuisance. II (C) No trash shall be burned within fifty feet (50') of any facility except in an approved incinerator. I/II (D) Trash may be burned only in a masonry or metal container. II (E) The container shall be equipped with a metal cover with openings no larger than one-half inch (1/2") in size. III (16) Standards for Designated Separated Areas.

(A) When a resident resides among the entire general population of the facility, the facility shall take necessary measures to provide such residents with the opportunity to explore the facility and, if appropriate, its grounds. When a resident resides within a designated, separated area that is secured by limited access, the facility shall take necessary measures to provide such residents with the opportunity to explore the separated area and, if appropriate, its grounds. If enclosed or fenced courtyards are provided, residents shall have reasonable access to such courtyards. Enclosed or fenced courtyards that are accessible through a required exit door shall be large enough to provide an area of refuge for fire safety at least thirty feet (30') from the building. Enclosed or fenced courtyards that are accessible through a door other than a required exit shall have no size requirements. II (B) The facility shall provide freedom of movement for the residents to common areas and to their personal spaces. The facility shall not lock residents out of or inside their rooms. I/II (C) The facility may allow resident room doors to be locked providing the residents request to lock their doors. Any lock on a resident room door shall not require the use of a key, tool, special knowledge, or effort to lock or unlock the door from inside the resident’s room. Only one (1) lock shall be permitted on each door. The facility shall ensure that facility staff has the means or mechanisms necessary to open resident room doors in case of an emergency. I/II (D) The facility may provide a designated, separated area where residents, who are mentally incapable of negotiating a pathway to safety, reside and receive services and which is secured by limited access if the following conditions are met:

Dining rooms, living rooms, activity rooms, and other such common areas shall be provided within the designated, separated area. The total area for common areas within the designated, separated area shall be equal to at least forty (40) square feet per resident; II/III 2. Doors separating the designated, separated area from the remainder of the facility or building shall not be equipped with locks that require a key to open; I/II 3. If locking devices are used on exit doors egressing the facility or on doors accessing the designated, separated area, delayed egress magnetic locks shall be used. These delayed egress devices shall comply with the following:

A. The lock must unlock when the fire alarm is activated;

B. The lock must unlock when the power fails;

C. The lock must unlock within thirty (30) seconds after the release device has been pushed for at least three (3) seconds, and an alarm must sound adjacent to the door;

D. The lock must be manually reset and cannot automatically reset; and E. A sign shall be posted on the door that reads: PUSH UNTIL ALARM SOUNDS, DOOR CAN BE OPENED IN 30 SECONDS; and I/II 4. The delayed egress magnetic locks may also be released by a key pad located adjacent to the door for routine use by staff. I/II (17) Oxygen storage shall be in accordance with NFPA 99, 1999 Edition. II/III

Amended: Filed Sept. 12, 1984, effective Dec. 13, 1984. Amended:

Filed May 13, 1987, effective Aug. 13, 1987. Amended: Filed Aug. 1, 1988, effective Nov. 10, 1988. Amended: Filed Feb. 28, 2000, effective Sept. 30, 2000. Moved to 19 CSR 30-86.022, effective Aug. 28, 2001.

Amended: Filed Aug. 16, 2004, effective Feb. 28, 2005. Amended:

Filed Aug. 1, 2005, effective Jan. 30, 2006. Amended: Filed Aug. 23, 2006, effective April 30, 2007. Emergency amendment filed Nov. 24, 2008, effective Dec. 4, 2008, expired June 1, 2009. Amended:

Filed Nov. 24, 2008, effective May 30, 2009. Amended: Filed March 15, 2012, effective Oct. 30, 2012. ** *Original authority: 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006; 198.074, RSMo 2007; and 198.076, RSMo 1979, amended 1984, 2007. **Pursuant to Executive Order 21-07, 19 CSR 30-86.022, section (3), subsections (4)(A), (4)(C), (9)(C), (9)(D), (11)(D), (11)(E), and (11)(F) was suspended from April 23, 2020 through May 1, 2021. Pursuant to Executive Order 21-09, 19 CSR 30-86.022, subsection (5)(D) and section 198.074.2-4, RSMo was suspended from April 23, 2020 through December 31, 2021.

History

AUTHORITY: sections 198.073, 198.074, and 198.076, RSMo Supp. 2011. This rule originally filed as 13 CSR 15-15.022. Original rule filed July 13, 1983, effective Oct. 13, 1983. Emergency amendment filed Aug. 1, 1984, effective Aug. 13, 1984, expired Dec. 10, 1984.

19 CSR 30-86.032 Physical Plant Requirements for Residential Care Facilities and Assisted Living Facilities {#sec-19-csr-30-86.032 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.032}

PURPOSE: This rule establishes standards for the physical plant of new or existing residential care facilities I and II. designated in section 198.085.1, RSMo 2000.

(1) Definitions. For the purpose of this rule, the following (A) Adult day health care program shall mean a program operated by a provider certified to provide Medicaid-reimbursed adult day health care services to Medicaid-eligible participants in accordance with 19 CSR 70-92.010;

(B) Associated adult day health care program shall mean an adult day health care program, which is connected physically with a licensed long-term care facility but has separate designated space for an adult day health care program which is above the licensed space requirement for the long-term care residents. An associated adult day health care program may share, in part, staff, equipment, utilities, dietary and security with the connected long-term care facility. Recipients of adult day health care program may participate with the residents of the long-term care facility for some activities and programs;

(C) Home-like—means a self-contained long-term care setting that integrates the psychosocial, organizational and environmental qualities that are associated with being at home. Home-like may include, but is not limited to the 1. A living room and common use areas for social interactions and activities;

Kitchen and family style eating area for use by the residents;
Laundry area for use by residents;
A toilet room that contains a toilet, lavatory and bathing unit in each resident’s room;
Resident room preferences for residents who wish to share a room, and for residents who wish to have private bedrooms;
Outdoor area for outdoor activities and recreation; and 7. A place where residents can give and receive affection, explore their interests, exercise control over their environment, engage in interactions with others and have privacy, security, familiarity and a sense of belonging; and (D) Non-licensed adult day care program shall mean a group program designated to provide care and supervision to meet the needs of four (4) or fewer impaired adults for periods of less than twenty-four (24) hours but more than two (2) hours per day in a long-term care facility.

(2) The building shall be substantially constructed and shall be maintained in good repair and in accordance with the construction and fire safety rules in effect at the time of initial licensing. II/III (3) Only activities necessary to the administration of the facility shall be contained in any building used as a long-term care facility except as follows:

(A) Related activities may be conducted in buildings subject to prior written approval of these activities by the Department of Health and Senior Services (hereinafter—the department).

Examples of these activities are Home Health Agencies, physician’s office, pharmacy, ambulance service, child day care and food service for the elderly in the community;

(B) Adult day care may be provided for four (4) or fewer participants without prior written approval of the department if the long-term care facility meets the following stipulations:

The operation of the adult day care business shall not interfere with the care and delivery of services to the long-term care residents;
The facility shall only accept participants in the adult day care program appropriate to the level of care of the facility and whose needs can be met;
The facility shall not change the physical layout of the facility without prior written approval of the department;
The facility shall provide a private area for adult day care residents to nap or rest;
Adult day care participants shall not be included in the census, and the number of adult day care participants shall not be more than four (4) above the licensed capacity of the facility; and 6. The adult day care participants, while on-site, are to be included in the determination of staffing patterns for the longterm care facility;

(C) An associated adult day health care program may be operated without prior written approval if the provider of the adult day health care services is certified in accordance with 19 CSR 70-92.010. II/III (4) All stairways shall be equipped with permanently secured handrails on at least one (1) side. III (5) There shall be a telephone in the facility and additional telephones or extensions as necessary so that help may be summoned promptly in case of fire, accident, acute illness or other emergency. II/III (6) Bath and toilet facilities shall be provided for the convenience, privacy, comfort and safety of residents. Fixed partitions or curtains shall be provided in toilet and bathrooms to assure privacy. II/III (7) Newly licensed facilities shall have handrails and grab bars affixed in all toilet and bathing areas. Existing licensed facilities shall have handrails and grab bars available in at least one (1) bath and toilet area. The foregoing requirements are applicable to residential care facilities. All assisted living facilities shall have handrails and grab bars affixed in all toilet and bathing areas. II (8) There shall be adequate storage areas for food, supplies, linen, equipment and resident’s personal possessions. III (9) Each room or ward in which residents are housed or to which residents have reasonable access shall be capable of being heated to not less than eighty degrees Fahrenheit (80°F) under all weather conditions. Temperature shall not be lower than sixty-eight degrees Fahrenheit (68°F) and the reasonable comfort needs of individual residents shall be met. I/II (10) In newly licensed facilities or if a new heating system is installed in an existing licensed facility, the heating of the building shall be restricted to steam, hot water, permanently installed electric heating devices or a warm air system employing central heating plants with installation such as to safeguard the inherent fire hazard, or approved installation of outside wall heaters which bear the approved label of the American Gas Association or National Board of Fire Underwriters. The foregoing requirements are applicable to residential care facilities. In assisted living facilities, the heating of the building shall be restricted to steam, hot water, permanently installed electric heating devices or a warm air system employing central heating plants with installation such as to safeguard the inherent fire hazard, or approved installation of outside wall heaters which bear the approved label of the American Gas Association or National Board of Fire Underwriters. For all facilities, oil or gas heating appliances shall be properly vented to the outside and the use of portable heaters of any kind is prohibited. If approved wall heaters are used, adequate guards shall be provided to safeguard residents. I/II (11) Wood-burning stoves shall not be installed in newly licensed facilities or in existing licensed facilities that did not previously have a wood-burning stove. If wood-burning stoves are used in an existing licensed facility, or wood-burning furnaces or fireplaces are used, flues or chimneys shall be maintained in good condition and kept free of accumulation of combustible materials. The foregoing requirements are applicable to residential care facilities. Wood-burning stoves shall not be installed in assisted living facilities. II (12) Fireplaces may be used only if there is a protective screen in place; if there is direct staff supervision of residents while in use; and the fire shall not be left burning overnight. II (13) In facilities that are constructed or have plans approved after July 1, 2005, electrical wiring shall be installed and maintained in accordance with the requirements of the National Electrical Code, 1999 edition, National Fire Protection Association, Inc., incorporated by reference, in this rule and available by mail at One Batterymarch Park, Quincy, MA 02269, and local codes.

This rule does not incorporate any subsequent amendments or additions to the materials incorporated by reference. Facilities built between September 28, 1979 and July 1, 2005 shall be maintained in accordance with the requirements of the National Electrical Code, which was in effect at the time of the original plan approval and local codes. This rule does not incorporate any subsequent amendments or additions. In facilities built prior to September 28, 1979, electrical wiring shall be maintained in good repair and shall not present a safety hazard. All facilities shall have wiring inspected every two (2) years by a qualified electrician. II/III (14) Lighting is restricted to electricity. II (15) Lighting in hallways, bathrooms, recreational and dining areas and all resident-use areas shall be provided with a minimum intensity of ten (10) footcandles. All lights in residentuse areas shall be provided with a shade to prevent direct glare to the residents’ eyes. II/III (16) Night lights shall be provided for corridors, stairways and toilet areas. II (17) A reading light shall be provided for each resident desiring to read. Additional lighting shall be provided to meet the individual needs of each resident. III (18) If extension cords are used, they must be Underwriters’ Laboratory (UL)-approved or shall comply with other recognized electrical appliance approval standards and sized to carry the current required for the appliance used. Only one (1) appliance shall be connected to one (1) extension cord and only two (2) appliances may be served by one (1) duplex receptacle.

If extension cords are used, they shall not be placed under rugs, through doorways or located where they are subject to physical damage. II/III (19) If elevators are used, installation and maintenance shall comply with local and state codes and the National Electric Code. II/III (20) Air conditioning, fans or a ventilating system shall be available and used when the room temperature exceeds eighty-five degrees Fahrenheit (85°F) and the reasonable comfort needs of individual residents shall be met. I/II (21) Gas-fired water heaters shall be properly installed and vented and all water heaters shall be equipped with a temperature and pressure relief valve. II (22) Furniture and equipment shall be maintained in good condition and shall be replaced if broken, torn, heavily soiled or damaged. Rooms shall be so designed and furnished that the comfort and safety of the residents are provided for at all times. II/III (23) Rooms shall be neat, orderly and cleaned daily. II/III (24) An individual bed, in good repair and of a rigid type, shall be provided to each resident. Beds shall be at least thirty-six inches (36") wide. Double beds of satisfactory construction may be provided for married couples. Rollaway, metal cots or folding beds shall not be used. II/III (25) A minimum of three feet (3') shall be available between beds when parallel. III (26) Mattresses shall be clean, in good repair and a minimum of four inches (4") in thickness to provide comfort. II/III (27) Each bed shall be provided with at least one (1) clean, comfortable pillow. Extra pillows shall be available to meet the needs of the residents. III (28) Screens or curtains, either portable or permanently affixed, shall be available and used in multi-resident bedrooms to provide privacy as needed or if requested. III (29) Each resident shall be provided with an individual locker or other suitable space for storage of clothing and personal belongings. III (30) Each resident shall be provided with an individual rack for a towel(s) and washcloth(s) unless provided with a clean washcloth(s) or towel(s) for use each time needed. III (31) A comfortable chair shall be available for each resident’s use. III (32) Each window shall be provided with a shade, drape or curtain to restrict the amount of sunlight when necessary. III (33) All assisted living facilities and all residential care facilities whose plans are approved or which are initially licensed for more than twelve (12) residents after December 31, 1987 shall be equipped with a call system consisting of an electrical intercommunication system, a wireless pager system, buzzer system or hand bells. An acceptable mechanism for calling attendants shall be located in each toilet room and resident bedroom. Call systems for facilities whose plans are approved or which are initially licensed after December 31, 1987 shall be audible in the attendant’s work area. II/III (34) Plumbing fixtures which are accessible to residents and which supply hot water shall be thermostatically controlled so that the water temperature at the fixture does not exceed one hundred twenty degrees Fahrenheit (120°F) (49°C) and the water shall be at a temperature range between one hundred five degrees Fahrenheit (105°F) (41°C) and one hundred twenty degrees Fahrenheit (120°F) (49°C). I/II (35) Home-Like Requirements with Respect to Construction and Physical Plant Standards.

Emergency amendment filed Nov. 9, 1983, effective Nov. 19, 1983, expired March 18, 1984. Amended: Filed Nov. 9, 1983, effective Feb. 11, 1984. Emergency amendment filed Aug. 1, 1984, effective Aug. 13, 1984, expired Dec. 10, 1984. Amended: Filed Sept. 12, 1984, effective Dec. 13, 1984. Amended: Filed May 13, 1987, effective Aug. 13, 1987. Amended: Filed Aug. 1, 1988, effective Nov. 10, 1988.

Moved to 19 CSR 30-86.032, effective Aug. 28, 2001. Amended:

Filed Nov. 15, 2004, effective May 30, 2005. Amended: Filed Aug. 23, 2006, effective April 30, 2007. ** *Original authority: 198.005, RSMo 2006; 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006; and 198.076, RSMo 1979, amended 1984. **Pursuant to Executive Order 21-07, 19 CSR 30-86.032, section (13) was suspended from April 22, 2020 through May 1, 2021 and subsection (3)(A) was suspended from April 17, 2020 through August 31, 2021.

History

AUTHORITY: sections 198.076, RSMo 2000 and 198.005 and 198.073, RSMo Supp. 2006. This rule originally filed as 13 CSR 15-15.032. Original rule filed July 13, 1983, effective Oct. 13, 1983.

19 CSR 30-86.042 Administrative, Personnel, and Resident Care Requirements for New and Existing Residential Care Facilities {#sec-19-csr-30-86.042 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.042}

PURPOSE: This rule establishes standards for administration, personnel, and resident care in residential care facilities. which refers to the class (either class I, II, or III) of standard as designated in section 198.085.1, RSMo.

(1) Definitions. For the purpose of this rule, the following (A) Department—Department of Health and Senior Services;

(B) Outbreak—an occurrence in a community or region of an illness(es) similar in nature, clearly in excess of normal expectancy and derived from a common or a propagated source; and (C) Evacuate the facility—moving to an area of refuge or from one (1) smoke section to another or exiting the facility.

(2) For a residential care facility, a person shall be designated as administrator/manager who is either currently licensed as a nursing home administrator or is at least twenty-one (21) years of age, has never been convicted of an offense involving the operation of a long-term care or similar facility and who attends at least one (1) continuing education workshop within each calendar year given by or approved by the department.

When used in this chapter of rules, the term manager shall mean that person who is designated by the operator to be in general administrative charge of a residential care facility. It shall be considered synonymous to “administrator” as defined in section 198.006, RSMo and the terms administrator and manager may be used interchangeably. II/III (3) The administrator/manager of a residential care facility shall have successfully completed the state approved Level I Medication Aide course unless he or she is a physician, pharmacist, licensed nurse or a certified medication technician, or if the facility is operating in conjunction with a skilled nursing facility or intermediate care facility on the same premises, or, for an assisted living facility, if the facility employs on a fulltime basis, a licensed nurse who is available seven (7) days per week. II/III (4) The operator shall be responsible to assure compliance with all applicable laws and regulations. The administrator/manager shall be fully authorized and empowered to make decisions regarding the operation of the facility and shall be held responsible for the actions of all employees. The administrator/ manager’s responsibilities shall include oversight of residents to assure that they receive care appropriate to their needs. II/III (5) The administrator/manager shall devote sufficient time and attention to the management of the facility as is necessary for the health, safety and welfare of the residents. II (6) The administrator/manager shall designate, in writing, a staff member in charge in the administrator/manager’s absence. II/III (7) The facility shall not care for more residents than the number for which the facility is licensed. If the facility operates a non-licensed adult day care program within the licensed facility, the day care participants shall be counted in the staffing determination during the hours the day care participants are in the facility. II/III (8) The facility’s current license shall be posted in a conspicuous place and notices provided to the facility by the department granting exception(s) to regulatory requirements shall be posted alongside of the facility’s license. III (9) All personnel responsible for resident care shall have access to the legal name of each resident, name and telephone number of resident’s physician, resident’s designee or legally authorized representative in the event of emergency. II/III (10) All persons who have any contact with the residents in the which would materially and adversely affect the health, safety, the department as required by section 198.070, RSMo shall bingo, or sing-along leaders. The facility is not required to check the EDL for an individual such as a priest, minister, or congregation. However, if the minister, priest, or rabbi serves as a volunteer facility chaplain, the facility is required to check the EDL since the individual would have potential contact with all residents. I/II (11) Prior to allowing any person who has been hired in a fullany residents, the facility shall, or in the case of temporary employees hired through or contracted for an employment temporary employee to a provider— (A) Request a criminal background check for the person, as provided in section 43.540, RSMo. Each facility must maintain in its record documents verification that the background checks were requested and the nature of the response received for each such request. II 1. The facility must ensure that any applicant or person hired or retained who discloses prior to the receipt of the criminal background check that he or she has been found guilty in this state or any other state or has been found guilty of a crime, which if committed in Missouri would be a class A or B felony violation of Chapter 565, 566, or 569, RSMo, or any violation of subsection 198.070.3, RSMo, or of section 568.020, RSMo, will not have contact with residents. I/II 2. Upon receipt of the criminal background check, the facility must ensure that if the criminal background check indicates that the person hired or retained by the facility has been found guilty in this state or any other state or has been found guilty of a crime, which if committed in Missouri would be a class A or B felony violation of Chapter 565, 566, or 569, RSMo, or any violation of subsection 198.070.3, RSMo, or of section 568.020, RSMo, the person will not have contact with residents unless the facility obtains verification from the department that a good cause waiver has been granted and maintains a copy of the verification in the individual’s personnel file; I/II (B) Make an inquiry to the department, whether the person is listed on the employee disqualification list as provided in

section 192.2490, RSMo. The inquiry may be made at www. health.mo.gov/safety/edl; II/III (C) If the person has registered with the department’s Family Care Safety Registry (FCSR), the facility may utilize the Registry in order to meet the requirements of subsections (11)(A) and (11)

(B) of this rule. The FCSR is available at www.health.mo.gov/ safety/fcsr; and II/III (D) For persons for whom the facility has contracted for that will have contact with any resident, the facility must facility to reasonably ensure the safety of all residents. I/II (12) A facility shall not employ as an agent or employee who has access to controlled substances any person who has been found guilty or entered a plea of guilty or nolo contendere in a criminal prosecution under the laws of any state or of the United States for any offense related to controlled substances. II (A) A facility may apply in writing to the department for a waiver of this section for a specific employee.

(B) The department may issue a written waiver to a facility upon determination that a waiver would be consistent with the public health and safety. In making this determination, the department shall consider the duties of the employee, the circumstances surrounding the conviction, the length of time since the conviction was entered, whether a waiver has been granted by the department’s Bureau of Narcotics and Dangerous Drugs pursuant to 19 CSR 30-1.034 when the facility is registered with that agency, whether a waiver has been granted by the federal Drug Enforcement Administration (DEA) pursuant to 21 CFR 1301.76 when the facility is also registered with that agency, the security measures taken by the facility to prevent the theft and diversion of controlled substances, and any other factors consistent with public health and safety. II/III (13) The facility must develop and implement written policies position which is to have contact with any resident have been informed of their responsibility to disclose their prior criminal

history to the facility as required by section 192.2495, RSMo.

The facility must also develop and implement policies and procedures which ensure that the facility does not knowingly hire, after August 28, 1997, any person who has or may have contact with a resident who has been found guilty in this state or any other state or has been found guilty of a crime, which if committed in Missouri would be a class A or B felony subsection 198.070.3, RSMo, or of section 568.020, RSMo. II/III (14) All persons who have or may have contact with residents shall at all time when on duty or delivering services wear an (15) All personnel shall be able physically and emotionally to work in a long-term care facility. I/II (16) Personnel who have been diagnosed with a communicable approval by a physician or physician’s designee which indicates any limitations. II (17) The administrator/manager shall be responsible for preventing an employee known to be diagnosed with communicable disease from exposing residents to such disease.

The facility’s policies and procedures must comply with the department’s regulations pertaining to communicable diseases, specifically 19 CSR 20-20.010 through 19 CSR 20-20.100.

(18) The facility shall screen residents and staff for tuberculosis as required for long-term care facilities by 19 CSR 20-20.100. II (19) Prior to or on the first day that a new employee works in the facility he or she shall receive orientation of at least one (1) hour appropriate to his or her job function. This shall include at least the following:

(A) Job responsibilities;

(B) Emergency response procedures;

(D) Confidentiality of resident information;

(E) Preservation of resident dignity;

(F) Information regarding what constitutes abuse/neglect and how to report abuse/neglect to the department (1-800-392- 0210);

(G) Information regarding the Employee Disqualification List;

(H) Instruction regarding the rights of residents and protection of property; and (I) Instruction regarding working with residents with mental illness. II/III (20) In addition to the orientation training required in section (19) of this rule any facility that provides care to any resident having Alzheimer’s disease or related dementia shall provide orientation training regarding mentally confused residents such as those with Alzheimer’s disease and related dementias (A) For employees providing direct care to such persons, the orientation training shall include at least three (3) hours of training including at a minimum an overview of mentally confused residents such as those having Alzheimer’s disease and related dementias, communicating with persons with dementia, behavior management, promoting independence in activities of daily living, and understanding and dealing with family issues; II/III (B) For other employees who do not provide direct care for, but may have daily contact with, such persons, the orientation training shall include at least one (1) hour of training including at a minimum an overview of mentally confused residents such as those having dementias as well as communicating with persons with dementia; and II/III (C) For all employees involved in the care of persons with dementia, dementia-specific training shall be incorporated into ongoing in-service curricula. II/III (21) The administrator/manager shall maintain on the premises an individual personnel record on each facility employee, which shall include the following:

(A) The employee’s name and address;

(B) Social Security number;

(D) Date of employment;

(E) Documentation of experience and education including, for positions requiring licensure or certification, documentation evidencing competency for the position held, which includes copies of current licenses, transcripts when applicable, or for those individuals requiring certification, such as level I medication aides (LIMA), certified nurse aides, certified medication technicians (CMT), and insulin administration aides; printing the Web Registry search results page available at www.health.mo.gov/cnaregistry shall meet the requirements of the employer’s check regarding valid certification;

(F) References, if available;

(G) The results of background checks required by section 192.2495, RSMo, and a copy of any good cause waiver granted by the department, if applicable;

(H) Position in the facility;

(I) Documentation of the employee’s tuberculin screening status;

(J) Documentation of what the employee was instructed on during orientation training; and (K) Reason for termination if the employee was terminated due to abuse or neglect of a resident, residents’ rights issues, or resident injury. III (22) Personnel records shall be maintained for at least two (2) years following termination of employment. III (23) There shall be written documentation maintained in the (24) No one individual shall be on duty with responsibility for oversight of residents longer than eighteen (18) hours per day except in a residential care facility licensed for twelve (12) or fewer residents. I/II (25) Employees who are counted in meeting the minimum staffing ratio and employees who provide direct care to the residents shall be at least sixteen (16) years of age. III (26) One (1) employee at least eighteen (18) years of age shall be on duty at all times. I/II (27) Staffing for Residential Care Facility.

(A) The facility shall have an adequate number and type of personnel on duty at all times for the proper care of residents and upkeep of the facility. At a minimum, one (1) employee shall be on duty for every forty (40) residents to provide protective oversight to residents and for fire safety. I/II Staff Residents 1 1–40 2 41–80 3 81–120 4 121–160 (B) The required staff person shall be in the facility awake, dressed and prepared to assist residents in case of emergency, except that in a facility licensed for twelve (12) or fewer residents, this person may be asleep during the night hours.

In a facility licensed for twenty (20) or fewer residents, the required staff person may be asleep if there is a sprinkler system or if there is a complete automatic fire detection system. I/II (C) In a facility of more than one hundred (100) residents, the administrator/manager shall not be counted when determining the personnel required. II (D) If the facility is opened in conjunction with and is immediately adjacent to and contiguous to another licensed long-term care facility and if— 1. The resident bedrooms of the residential care facility are on the same floor or on the ground floor immediately below that of the other licensed facility;

There is an approved call system in each resident’s bedroom and bathroom or a patient-controlled system connected to a nursing station of the other licensed facility;
There is a complete fire alarm system in the residential care facility connected to the complete fire alarm system in the other licensed facility;
The staffing of the other licensed facility is greater than their minimum requirements; and 5. Periodic visits to the residential care facility are made by a staff person to determine the welfare of the resident in the residential care facility; then, for a facility serving twenty (20) or fewer residents, there need not be an attendant on duty during the day and evening shifts and the attendant may be asleep during the night shift; or if the facility is on the same floor as the other licensed facility, there need not be an attendant at night. If there are more than twenty (20) residents, there shall be at least one (1) staff person awake and dressed at all times for every forty (40) residents or fraction of forty (40).

(E) Those facilities which have only an asleep attendant during the night-time period and those facilities which have only the minimum staff required by subsection (27)(D) during the night-time period shall not accept residents who are blind, use assistive devices, such as walkers or wheelchairs, or who need care greater than can be provided with the staffing pattern in those facilities. Those residents who were living in a residential care facility prior to July 11, 1980, may remain in that facility with an asleep attendant even though they may be blind, deaf or use assistive devices provided they can demonstrate the ability to reach safety unassisted or with assistive devices. II (28) All residents shall be physically and mentally capable of negotiating a normal path to safety unassisted or with the use of assistive devices within five (5) minutes of being alerted of the need to evacuate the facility as defined in subsection (1)(C) of this rule. I/II (29) Residents suffering from short periods of incapacity due to illness, injury or recuperation from surgery may be allowed in or be readmitted to the facility. II/III (30) The facility shall not admit or continue to care for residents referred to appropriate outside resources or discharged from the facility. I/II (31) In the event a resident is transferred from the facility, staff shall forward a report of the resident’s current medical status, physician’s orders/prescriptions, and if applicable, a copy of the resident’s advanced directives/living will to the facility to which the resident is being transferred. If the resident is transferring to a private residence, facility staff shall provide the reports to the resident or his or her designee or legally authorized representative. II/III (32) Residents admitted to a facility on referral by the Department of Mental Health shall have an individual treatment plan or individual habilitation plan on file prepared by the Department of Mental Health, updated annually. II (33) Placement of residents in the building shall be determined by their abilities. Those residents who require the use of a walker or who are blind shall be housed on a floor which has direct exits at grade, a ramp or no more than two (2) steps to grade with a handrail unless an area of refuge as defined in 19 CSR 30-86.022 is provided. Those residents who use a wheelchair shall be able to demonstrate the ability to transfer to and from the wheelchair unassisted. They shall be housed near an exit and there shall be a direct exit at grade or a ramp or an area of refuge as defined in 19 CSR 30-86.022. II (34) Requirements for facilities which admit or retain residents with mental illness or mental retardation diagnosis and residents with assaultive or disruptive behaviors:

(A) Each resident who exhibits mental and psychosocial adjustment difficulty(ies) shall receive treatment and services to address the resident’s needs and behaviors as stated in the individual service plan; I/II (B) If specialized rehabilitative services for mental illness or mental retardation are required to enable a resident to reach and to comply with the individualized service plan, the facility must ensure the required services are provided; and II (C) The facility shall maintain in the resident’s record the most recent progress notes and personal plan developed and provided by the Department of Mental Health or designated administrative agent for each resident whose care is funded by the Department of Mental Health or designated administrative agent. III (35) The use of interventions to manage disruptive or assaultive resident behaviors shall be employed with sufficient safeguards to ensure the safety, welfare and rights of the resident and shall be in accordance with the therapeutic goals for the resident. I/II (36) Residents under sixteen (16) years of age shall not be (37) Residents admitted or readmitted to the facility shall have an admission physical examination by a licensed physician.

Documentation should be obtained prior to admission but shall be on file not later than ten (10) days after admission and shall contain information regarding the resident’s current medical status and any special orders or procedures which should be followed. If the resident is admitted directly from a hospital or another long-term care facility and is accompanied on admission by a report which reflects his/her current medical status, an admission physical will not be required. II/III (38) The facility shall follow appropriate infection control procedures. The administrator or his or her designee shall make a report to the local health authority or the department of the presence or suspected presence of any diseases or findings listed in 19 CSR 20-20.020, sections (1)–(3) according to the specified time frames as follows:

(A) Category I diseases or findings shall be reported to the local health authority or to the department within twentyfour (24) hours of first knowledge or suspicion by telephone, facsimile, or other rapid communication; I/II (B) Category II diseases or findings shall be reported to the local health authority or the department within three (3) days of first knowledge or suspicion; I/II (C) Category III. The occurrence of an outbreak or epidemic of any illness, disease or condition which may be of public health concern, including any illness in a food handler that is potentially transmissible through food. This also includes public health threats such as clusters of unusual diseases or manifestations of illness and clusters of unexplained deaths.

Such incidents shall be reported to the local authority or to the department by telephone, facsimile, or other rapid communication within twenty-four (24) hours of first knowledge or suspicion. I/II (39) Protective oversight shall be provided twenty-four (24)

(40) Residents shall receive proper care to meet their needs.

Physician orders shall be followed. I/II (41) In case of behaviors that present a reasonable likelihood of serious harm to himself or herself or others, serious illness, significant change in condition, injury or death, staff shall take appropriate action and shall promptly attempt to contact the individual listed in the resident’s record as the legally authorized representative, designee, or placement authority.

The facility shall contact the attending physician or designee and notify the local coroner or medical examiner immediately upon the death of any resident of the facility prior to transferring the deceased resident to a funeral home. II/III (42) The facility shall encourage and assist each resident based on his or her individual preferences and needs, to be clean and free of body and mouth odor. II (43) Except in the case of emergency, the resident shall not be inhibited by chemical and/or physical restraints that would limit self-care or ability to negotiate a path to safety unassisted or with assistive devices. I/II (44) If the resident brings unsealed medications to the facility, the medications shall not be used unless a pharmacist, physician or nurse examines, identifies, and determines the contents to be suitable for use. The individual performing the identification shall document his or her review. II/III (45) Self-control of prescription medication by a resident may be allowed only if approved in writing by the resident’s physician and allowed by facility policy. A resident may be permitted to control the storage and use of nonprescription medication unless there is a physician’s written order or facility policy to the contrary. Written approval for self-control of prescription medication shall be rewritten as needed but at least annually and after any period of hospitalization. II/III (46) All medication shall be safely stored at proper temperature locked door or cabinet. Medication shall be accessible only to persons authorized to administer medications. II/III (A) If access is controlled by the resident, a secured location shall mean in a locked container, a locked drawer in a bedside table or dresser or in a resident’s private room if locked in his or her absence, although this does not preclude access by a responsible employee of the facility. II/III (B) Schedule II controlled substances shall be stored in locked compartments separate from non-controlled medications, except that single doses of Schedule II controlled substances may be controlled by a resident in compliance with the requirements for self-control of medication of this rule. II/III (C) Medication that is not in current use and is not destroyed shall be stored separately from medication that is in current use. II/III (47) All prescription medications shall be supplied as individual prescriptions except where an emergency medication supply is allowed. All medications, including over-the-counter medications shall be packaged and labeled in accordance with applicable professional pharmacy standards and state and federal drug laws. Labeling shall include accessory and applicable, and the name of the medication as specified in the physician’s order. Medication labels shall not be altered by facility staff and medications shall not be repackaged by facility staff except as allowed by section (48) of this rule.

Over-the-counter medications for individual residents shall be labeled with at least the resident’s name. II/III (48) Controlled substances and other prescription and nonprescription medications for administration when a resident temporarily leaves a facility shall be provided as follows:

(A) Separate containers of medications for the leave period may be prepared by the pharmacy. The facility shall have a policy and procedure for families to provide adequate advance notice so that medications can be obtained from the pharmacy; II/III (B) Prescription medication cards or other multiple-dose prescription containers currently in use in the facility may be provided by any authorized facility medication staff member if the containers are labeled by the pharmacy with complete pharmacy prescription labeling for use. Original manufacturer containers of non-prescription medications, along with instructions for administration, may be provided by any authorized facility medication staff member; II/III (C) When medications are supplied by the pharmacy in customized patient medication packages that allow separation of individual dose containers, the required number of containers may be provided by any authorized facility medication staff member. The individual dose containers shall be placed in an outer container that is labeled with the name and address of the facility and the date; II/III (D) When multiple doses of a medication are required and it is not reasonably possible to obtain prescription medication labeled by the pharmacy, and it is not appropriate to send a container of medication currently in use in the facility, up to a twenty-four- (24-) hour supply of each prescription or nonprescription medication may be provided by a licensed nurse in United States Pharmacopeia (USP) approved containers labeled with the facility name and address, resident’s name, medication name and strength, quantity, instructions for use, date, initials of individual providing, and other appropriate information; II/III (E) When no more than a single dose of a medication is required, any authorized facility medication staff member may prepare the dose as for in-facility administration in a USP approved container labeled with the facility name and address, resident’s name, medication name and strength, quantity, instructions for use, date, initials of person providing, and other appropriate information;

(F) The facility may have a policy that limits the quantity of medication sent with a resident without prior approval of the prescriber; II/III (G) Returned containers shall be identified as having been sent with the resident, and shall not later be returned to the pharmacy for reuse; and II/III (H) The facility shall maintain accurate records of medications provided to and returned by the resident. II/III (49) Upon discharge or transfer of a resident, the facility shall release prescription medications, including controlled substances, held by the facility for the resident when the physician writes an order for each medication to be released.

Medications shall be labeled by the pharmacy with current instructions for use. Prescription medication cards or other containers may be released if the containers are labeled by the pharmacy with complete pharmacy prescription labeling. II/III (50) Injections shall be administered only by a physician or licensed nurse, except that insulin injections may be administered by a CMT or LIMA who has successfully completed the state-approved course for insulin administration, taught by a department-approved instructor. A resident who requires insulin, may administer his or her own insulin if approved in writing by the resident’s physician and trained to do so by a licensed nurse or physician. The facility is responsible to monitor the resident’s condition and continued ability for selfadministration. I/II (51) The administrator/manager shall develop and implement a safe and effective system of medication control and use, which assures that all residents’ medications are administered by personnel at least eighteen (18) years of age, in accordance with physicians’ instructions using acceptable nursing techniques.

The facility shall employ a licensed nurse eight (8) hours per week for every thirty (30) residents to monitor each resident’s condition and medication. Administration of medication shall mean delivering to a resident his or her prescription pharmacy container and placing it in a small container or applied by facility personnel if the resident is unable to do so and the resident’s physician so authorizes. All individuals who administer medication shall be trained in medication administration and, if not a physician or a licensed nurse, shall be a certified medication technician or level I medication aide.

(52) Medication Orders.

Computer identification codes shall be accessible to and used only by the individuals whose signatures they represent.

Orders that include optional doses or include pro re nata (PRN) administration frequencies shall specify a maximum frequency and the reason for administration. II/III (C) Telephone and other verbal orders shall be received only by a licensed nurse, medication technician, level I medication aide, or pharmacist and shall be immediately reduced to writing and signed by that individual. If a telephone or other verbal order is given to a medication technician or level I medication aide, an initial dosage shall not be administered until the order has been reviewed by telephone, facsimile, or in person by a licensed nurse or pharmacist. II (D) The review shall be documented by the licensed nurse’s or pharmacist’s signature within seven (7) days. III (E) The physician shall sign all telephone and other verbal orders within seven (7) days. III (F) Medication staff shall record administration of medication on a medication sheet or directly in the resident’s record. If administration of medication is recorded on a medication sheet, the medication sheet shall be made part of the resident’s medical record. The same individual who prepares and administers the medication shall record the administration.

(53) Influenza and pneumococcal polysaccharide immunizations may be administered per physician-approved facility policy after assessment for contraindications.

(A) The facility shall develop a policy that provides recommendations and assessment parameters for the administration of such immunizations. The policy shall be approved by the facility medical director for facilities having a medical director, or by each resident’s attending physician for facilities that do not have a medical director, and shall include the requirements to— 1. Provide education regarding the potential benefits and side effects of the immunization to each resident or the resident’s designee or legally authorized representative; II/III 2. Offer the immunization to the resident or obtain permission from the resident’s designee or legally authorized representative when it is medically indicated, unless the resident has already been immunized as recommended by the policy; II/III 3. Provide the opportunity to refuse the immunization; and II/III 4. Perform an assessment for contraindications. II/III (B) The assessment for contraindications and documentation of the education and opportunity to refuse the immunization shall be dated and signed by the nurse performing the assessment and placed in the medical record. II/III (C) The facility shall with the approval of each resident’s physician, access screening and immunization through outside sources, such as county or city health departments, and the facility shall document in the medical record that the requirements in subsection (53)(B) were performed by outside sources. II/III (54) Stock supplies of nonprescription medication may be kept when specific medications are approved in writing by a consulting physician, a registered nurse or a pharmacist. No stock supply of prescription medication may be kept in the facility. II/III (55) Records shall be maintained upon receipt and disposition of all controlled substances and shall be maintained separately from other records, for two (2) years.

(A) Inventories of controlled substances shall be reconciled as follows: II/III 1. Controlled Substance Schedule II medications shall be reconciled each shift; and II 2. Controlled Substance Schedule III–V medications shall be reconciled at least weekly and as needed to ensure accountability. II/III (B) Inventories of controlled substances shall be reconciled by the following:

Two (2) medication personnel, one of whom is a licensed nurse; or 2. Two (2) medication personnel, one of whom is the administrator/manager when no nurse is available on staff; or 3. Two (2) medication personnel either medication technicians or level I medication aides when neither a licensed nurse nor the administrator/manager is available. II/III (C) Receipt records shall include the date, source of supply, resident name and prescription number when applicable, medication name and strength, quantity and signature of the supplier and receiver. Administration records shall include the date, time, resident name, medication name, dose administered, and the initials of the individual administering.

The signature and initials of each medication staff documenting on the medication administration record must be signed in the signature area of the medication record. II/III (D) When self-control of medication is approved a record shall be made of all controlled substances transferred to and administered from the resident’s room. Inventory reconciliation shall include controlled substances transferred to the resident’s room. I/II (56) Documentation of the wasting of controlled substances at the time of administration shall include the reason for the waste and the signature of another medication staff member or the administrator who witnesses the waste. If no medication staff member or the administrator is available at the time of administration, the controlled substance shall be properly labeled, clearly identified as unusable, stored in a locked area, and destroyed as soon as a medication staff member or the administrator is available to witness the waste. When no medication staff member or the administrator is available and the controlled substance is contaminated by patient body fluids, the controlled substance shall be destroyed immediately and the circumstances documented. II/III (57) At least every three (3) months in a residential care facility, a pharmacist or registered nurse shall review the controlled substance recordkeeping including reconciling the inventories of controlled substances. This shall be done at the time of the drug regimen review of each resident. All discrepancies in controlled substance records shall be reported to the administrator or manager for review and investigation. The theft or loss of controlled substances shall be reported as follows: II/III (A) The facility shall notify the department’s Section for Long Term Care (SLTC) and other appropriate authorities of any theft or significant loss of any controlled substance medication written as an individual prescription for a specific resident upon the discovery of the theft or loss. The facility shall consider at least the following factors in determining if a loss is significant:

The actual quantity lost in relation to the total quantity;
The specific controlled substance lost;
Whether the loss can be associated with access by specific individuals;
Whether there is a pattern of losses, and if the losses appear to be random or not;
Whether the controlled substance is a likely candidate for diversion; and 6. Local trends and other indicators of diversion potential;

(B) If an insignificant amount of such controlled substance is lost during lawful activities, which includes but are not limited to receiving, recordkeeping, access auditing, administration, destruction and returning to the pharmacy, a description of the occurrence shall be documented in writing and maintained with the facility’s controlled substance records.

The documentation shall include the reason for determining that the loss was insignificant. II/III (58) A pharmacist or registered nurse shall review the medication regimen of each resident. This shall be done at least every three (3) months in a residential care facility. The review shall be performed in the facility and shall include but shall not be limited to indication for use, dose, possible medication interactions and medication/food interactions, contraindications, adverse reactions, and a review of the medication system utilized by the facility. Irregularities and concerns shall be reported in writing to the resident’s physician and to the administrator/manager. If after thirty (30) days, there is no action taken by a resident’s physician and significant concerns continue regarding a resident’s or residents’ medication order(s), the administrator/manager shall contact or recontact the physician to determine if he or she received the information and if there are any new instructions. II/III (59) All medication errors and adverse reactions shall be promptly documented and reported to the administrator/ manager and the resident’s physician. If the pharmacy made a dispensing error, it shall also be reported to the issuing pharmacy. II/III (60) Medications that are not in current use shall be disposed of as follows:

(A) Single doses of contaminated, refused, or otherwise unusable non-controlled substance medications may be destroyed by any authorized medication staff member at the time of administration. Single doses of unusable controlled substance medications shall be destroyed according to section (56) of this

rule;

(B) Discontinued medications may be retained up to one hundred twenty (120) days prior to other disposition if there is reason to believe, based on clinical assessment of the resident, that the medication might be reordered;

(D) After a resident has expired, medications, except for controlled substances, may be released to the resident’s legal representative upon written request of the legal representative that includes the name of the medication and the reason for the request;

(E) Medications may be returned to the pharmacy that dispensed the medications pursuant to 4 CSR 220-3.040 or returned pursuant to the Prescription Drug Repository Program, 19 CSR 20-50.020;

(F) All other medications, including all controlled substances and all expired or otherwise unusable medications, shall be destroyed within thirty (30) days as follows: II/III 1. Medications shall be destroyed within the facility by a pharmacist and a licensed nurse or by two (2) licensed nurses or when two (2) licensed nurses are not available on staff by two (2) individuals who have authority to administer medications, one (1) of whom shall be a licensed nurse or a pharmacist; and II/III 2. A record of medication destroyed shall be maintained and shall include the resident’s name, date, medication name and strength, quantity, prescription number, and signatures of the individuals destroying the medications; and II/III (G) A record of medication released or returned to the pharmacy shall be maintained and shall include the resident’s name, date, medication name and strength, quantity, prescription number, and signatures of the individuals releasing and receiving the medications. III (61) Residents shall be encouraged to be active and to participate in activities. In a residential care facility licensed for more than twelve (12) residents, a method for informing the residents in advance of what activities are available, where they will be held and at what times they will be held shall be developed, maintained and used. II/III (62) The facility shall maintain a record in the facility for each resident which shall include the following:

(A) Admission information including the resident’s name;

Medicaid numbers (if applicable); name, address, and telephone number of the resident’s physician and alternate; diagnosis; name, address, and telephone number of the resident’s legally authorized representative or designee to be notified in case of emergency; and preferred dentist, pharmacist, and funeral director; III (B) A review monthly or more frequently, if indicated, of the resident’s general condition and needs; a monthly review of medication consumption of any resident controlling his or her own medication, noting if prescription medications are being used in appropriate quantities; a daily record of administration of medication; a logging of the medication regimen review process; a monthly weight; a record of each referral of a resident for services from an outside service; and a record of any resident incidents including behaviors that present a reasonable likelihood of serious harm to himself or herself or others and accidents that potentially could result in injury or did result in injuries involving the resident; and III (C) Any Physician’s Orders. Except as allowed by section (52) of this rule, the facility shall submit to the physician written versions of any oral or telephone orders within four (4) days of the giving of the oral or telephone order. III (63) A record of the daily resident census shall be retained in the facility. III (64) Resident records shall be maintained by the operator for at least five (5) years after a resident leaves the facility or after longer and must include reason for discharge or transfer from the facility and cause of death, if applicable. III

section 198.006, RSMo Supp. 2025.* This rule originally filed as

History

AUTHORITY: sections 198.005 and 198.076, RSMo 2016, and

13 CSR 15-15.042. Original rule filed July 13, 1983, effective Oct. 13, 1983. Emergency amendment filed Aug. 1, 1984, effective Aug. 13, 1984, expired Dec. 10, 1984. Amended: Filed Sept. 12, 1984, effective Dec. 13, 1984. Amended: Filed March 14, 1985, effective June 13, 1985. Amended: Filed May 13, 1987, effective Aug. 13, 1987. {#sec-13-csr-15-15.042. omnilex-key=us-mo-regs-official--title-19--13 CSR 15-15.042.}

Amended: Filed April 17, 1990, effective June 30, 1990. Amended:

Filed Feb. 13, 1998, effective Sept. 30, 1998. Moved to 19 CSR 30- 86.042, effective Aug. 28, 2001. Emergency amendment filed Sept. 12, 2003, effective Sept. 22, 2003, expired March 19, 2004.

Amended: Filed Sept. 12, 2003, effective Feb. 29, 2004. Amended:

Filed Aug. 23, 2006, effective April 30, 2007. ** Amended: Filed Jan. 23, 2026, effective July 30, 2026. *Original authority: 198.005, RSMo 2006; 198.006, RSMo 1979, amended 1984, 1987, 2003, 2006, 2022; and 198.076, RSMo 1979, amended 1984, 2007. **Pursuant to Executive Order 21-07, 19 CSR 30-86.042, section (37) was suspended from April 17, 2020 through May 1, 2021 and sections (17) and (18) was suspended from April 17, 2020 through August 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 30-86.042, section (58) was suspended from April 17, 2020 through September 3, 2021; subsection (21)(I) and sections (50) and (51) was suspended from April 15, 2020 through December 31, 2021; and section (7) was suspended from April 17, 2020 through December 31, 2021.

19 CSR 30-86.043 Administrative, Personnel, and Resident Care Requirements for Facilities Licensed as a Residential Care Facility II on August 27, 2006 that Will Comply with Residential Care Facility II Standards {#sec-19-csr-30-86.043 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.043}

PURPOSE: This rule establishes requirements for administration, personnel and resident care requirements for facilities licensed pursuant to section 198.005, RSMo that continue to comply with residential care facilities (RCF) II standards in effect on August 27, 2006. notation which refers to the class (either Class I, II, or III) of standard as designated in section 198.085.1., RSMo.

(1) This rule contains the administrative, personnel and resident care standards in effect on August 27, 2006 for residential care facility IIs (formerly published at 19 CSR 30-86.042 (effective 12/31/05)). These standards apply to facilities that were licensed as residential care facility IIs on August 27, 2006 and that choose to be inspected under these standards rather than the standards published at 19 CSR 30-86.047.

(2) A person shall be designated to be an administrator who is currently licensed as an administrator by the Missouri Board of Nursing Home Administrators, in accordance with Chapter 344, RSMo. II (3) By January 1, 1991, the administrator of a facility shall have successfully completed the state approved Level I Medication Aide course unless s/he is a physician, pharmacist, licensed nurse or a certified medication technician, or if the facility is operating in conjunction with a skilled nursing facility or intermediate care facility on the same premises, or if the facility employs on a full-time basis, a licensed nurse who is available seven (7) days per week. II/III (4) The operator shall be responsible to assure compliance with all applicable laws and regulations. The administrator shall be fully authorized and empowered to make decisions regarding the operation of the facility and shall be held responsible for the actions of all employees. The administrator’s responsibilities shall include oversight of residents to assure that they receive appropriate care. II/III (5) The administrator shall devote sufficient time and attention to the management of the facility as is necessary for the health, safety and welfare of the residents. II (6) The administrator cannot be listed or function in more than one (1) facility at the same time unless s/he serves no more than four (4) facilities which are within a thirty (30)-mile radius and licensed to serve in total no more than one hundred (100) residents. However, one (1) administrator may serve as the administrator of more than one (1) licensed facility if all facilities are on the same premises. II/III (7) The administrator shall designate, in writing, a staff person in charge in his/her absence. If the administrator is absent for more than thirty (30) consecutive days, during which time s/ he is not readily accessible for consultation by telephone with the person in charge or if the administrator is absent from the facility for more than sixty (60) working days during the course of a calendar year the person designated to be in charge shall be an administrator currently licensed by the Missouri Board of Nursing Home Administrators, in accordance with Chapter 344, RSMo. II/III (8) The facility shall not care for more residents than the number for which the facility is licensed. II/III (9) The facility’s current license shall be posted in a conspicuous place and notices provided to the facility by the Department of Health and Senior Services (the department) granting exception(s) to regulatory requirements shall be posted alongside of the facility’s license. III (10) All personnel responsible for resident care shall have access to the legal name of each resident, name and telephone number of physician and next of kin or responsible party in the event of emergency. II/III (11) All persons who have any contact with the residents in the which would materially and adversely affect the health, safety, the department as required by section 198.070, RSMo, shall bingo leaders, or sing-along leaders. The facility is not required to check the EDL for an individual such as a priest, minister, or congregation. However, if the minister, priest, or rabbi serves as a volunteer facility chaplain, the facility is required to check the EDL since the individual would have potential contact with all residents. I/II (12) Prior to allowing any person who has been hired in a fullany resident, the facility shall, or in the case of temporary employees hired through or contracted for an employment temporary employee to a facility:

(A) Request a criminal background check for the person, as provided in section 660.317, RSMo. Each facility shall maintain documents verifying that the background checks were requested, the date of each such request, and the nature of the response received for each such request. II 1. The facility shall ensure that any person hired or retained to have contact with any resident who discloses that he or she has been convicted of, found guilty of, pled guilty to, or pled nolo contendere to a crime, in this state or any other state, which if committed in Missouri would be a class A or B felony violation of Chapter 565, 566, or 569, RSMo, or any violation of section 198.070.3., RSMo, or section 568.020, RSMo, shall not be retained in such a position. I/II 2. Upon receipt of the criminal background check, the facility shall ensure that if the criminal background check indicates that the person hired or retained by the facility has been convicted of, found guilty of, pled guilty to, or pled nolo contendere to a crime, in this state or any other state, which if committed in Missouri would be a class A or B felony

section 198.070.3., RSMo, or section 568.020, RSMo, the person shall not have contact with any resident unless and until the facility obtains verification from the department that a good cause waiver has been granted for each qualifying offense and maintains a copy of the verification in the individual’s personnel file; I/II (B) Make an inquiry to the department, as provided in section 660.315, RSMo, as to whether the person is listed on the EDL.

Each facility shall maintain documents verifying that the EDL checks were requested, the date of each such request, and the nature of the response received for each such request. The inquiry may be made through the department’s website; II/III (C) For persons for whom the facility has contracted for that will have contact with any resident, the facility shall facility to reasonably ensure the safety of all residents; and I/II (D) If the person has registered with the department’s Family Care Safety Registry (FCSR), the facility may utilize the FCSR in order to meet the requirements of subsections (12)(A) and (12)

(B) of this rule. The FCSR is available through the department’s website.

(13) The facility must develop and implement written policies position which is to have contact with any patient or resident have been informed of their responsibility to disclose their prior criminal history to the facility as required by section 660.317.5, RSMo. The facility must also develop and implement policies and procedures which ensure that the facility does not knowingly hire, after August 28, 1997, any person who has or may have contact with a patient or resident, who has been convicted of, plead guilty or nolo contendere to, in this state or any other state, or has been found guilty of any Class A or B felony violation of Chapter 565, 566 or 569, RSMo, or any violation of subsection 3 of section 198.070, RSMo, or of section 568.020, RSMo. II/III (14) All persons who have or may have contact with residents shall at all times when on duty or delivering services wear an (15) All personnel shall be able physically and emotionally to work in a long-term care facility. I/II (16) Personnel who have been diagnosed with a communicable approval by a physician or physician’s designee which indicates any limitations. II (17) The administrator shall be responsible for monitoring the health of the employees. II/III (18) Prior to or on the first day that a new employee works in the facility s/he shall receive orientation of at least one (1) hour appropriate to his/her job function. This shall include, at a minimum, job responsibilities, how to handle emergency situations, the importance of infection control and handwashing, confidentiality of resident information, preservation of resident dignity, how to report abuse/neglect to the department (1-800-392-0210), information regarding the Employee Disqualification List and instruction regarding the rights of residents and protection of property. II/III (19) The administrator shall maintain on the premises an individual personnel record on each employee of the facility which shall include: the employee’s name and address; Social Security number; date of birth; date of employment; experience and education including documentation of specialized training on medication and/or insulin administration, or both; references, if available; the results of background checks required by section 660.317, RSMo; position in the facility; written statement signed by a licensed physician or physician’s designee indicating the person can work in a long-term care facility and indicating any limitations; record that the employee was instructed on residents’ rights, facility’s policies, job duties and any other orientation and reason for termination.

Personnel records shall be maintained for at least one (1) year following termination of employment. III (20) There shall be written documentation maintained in the (21) No one individual shall be on duty with responsibility for oversight of residents longer than eighteen (18) hours per day.

(22) Employees who are counted in meeting the minimum staffing ratio and employees who provide direct care to the residents shall be at least sixteen (16) years of age. III (23) One (1) employee at least eighteen (18) years of age shall be on duty at all times. I/II (24) Staffing.

(A) The facility shall have an adequate number and type of personnel for the proper care of residents and upkeep of the (15) residents or major fraction of fifteen (15) during the day shift, one (1) person for every twenty (20) residents or major fraction of twenty (20) during the evening shift and one (1) person for every twenty-five (25) residents or major fraction of twenty-five (25) during the night shift. I/II 3 p.m. to 9 p.m. (Evening)* 1 3–20 9 p.m. to 7 a.m. (Night)* 1 3–25 (B) The required staff shall be in the facility awake, dressed (C) In a facility of more than one hundred (100) residents, the administrator shall not be counted when determining the personnel required. II (D) If the facility is operated in conjunction with and is immediately adjacent to and contiguous to another licensed long-term care facility and if the resident bedrooms of the facility are on the same floor as at least a portion of a licensed intermediate care or skilled nursing facility; there is an approved call system in each resident’s bedroom and bathroom or a patient-controlled call system; and there is a complete fire alarm system in the facility tied into the complete fire alarm system in the other licensed facility, then the following minimum staffing for oversight and care of residents, for upkeep of the facility and for fire safety shall be one (1) staff person for every eighteen (18) residents or major fraction of residents during the day shift, one (1) person for every twentyfive (25) residents or major fraction of residents during the evening shift and one (1) person for every thirty (30) residents or major fraction of residents during the night shift. I/II 7 a.m. to 3 p.m. (Day)* 1 3–18 3 p.m. to 9 p.m. (Evening)* 1 3–25 9 p.m. to 7 a.m. (Night)* 1 3–30 (E) There shall be a licensed nurse employed by the facility to work at least eight (8) hours per week at the facility for every thirty (30) residents or additional major fraction of thirty (30). The nurse’s duties shall include, but shall not be limited to, review of residents’ charts, medications and special diets or other orders, review of each resident’s adjustment to the facility and observation of each individual resident’s general physical and mental condition. The nurse shall inform the administrator of any problems noted and these shall be brought to the attention of the resident’s physician. II/III (25) All residents shall be physically and mentally capable of negotiating a normal path to safety unassisted or with the use of assistive devices. I/II (26) Residents suffering from short periods of incapacity due to illness, injury or recuperation from surgery may be allowed in or be readmitted to the facility. II/III (27) The facility shall not admit or continue to care for residents referred to appropriate outside resources or transferred to a facility providing the appropriate level of care. I/II (28) In the event a resident is transferred from the facility, a report of the resident’s current medical status shall accompany him/her. III (29) Residents admitted to a facility on referral by the Department of Mental Health shall have an individual treatment plan or individual habilitation plan on file prepared by the Department of Mental Health, updated annually. III (30) Residents under sixteen (16) years of age shall not be (31) Placement of residents in the building shall be determined by their abilities. Those residents who require the use of a walker or who are blind shall be housed on a floor which has direct exits at grade, a ramp or no more than two (2) steps to grade with a handrail. Those residents who use a wheelchair shall be able to demonstrate the ability to transfer to and from the wheelchair unassisted. They shall be housed near an exit and there shall be a direct exit at grade or a ramp. II (32) Residents admitted or readmitted to the facility shall have an admission physical examination by a licensed physician.

Documentation should be obtained prior to admission but shall be on file not later than ten (10) days after admission and shall contain information regarding the resident’s current medical status and any special orders or procedures which should be followed. If the resident is admitted directly from a hospital or another long-term care facility and is accompanied on admission by a report which reflects his/her current medical status, an admission physical will not be required. II/III (33) If at any time a resident or prospective resident is diagnosed with a communicable disease, the department shall be notified within seven (7) days and if the facility can meet the resident’s needs, the resident may be admitted or does not need to be transferred. Appropriate infection control procedures shall be followed if the resident remains in or is accepted by the facility.

(34) Protective oversight shall be provided twenty-four (24)

(35) Residents shall receive proper care to meet their needs.

Physician orders shall be followed. I/II (36) In case of serious illness, accident or death, appropriate action shall be taken and the person designated in the resident’s record as the responsible party and, if applicable, the guardian shall be immediately notified. II/III (37) Every resident shall be clean, dry and free of offensive body and mouth odor. I/II (38) Except in the case of emergency, the resident shall not be inhibited by chemical and/or physical restraints that would limit self-care or ability to negotiate a path to safety unassisted or with assistive devices. I/II (39) A supply of clean linen shall be available in the facility and provided to residents to meet their daily needs. II/III (40) Beds shall be made daily and linen changed at least weekly or more often if needed to maintain a clean, dry bed. II/III (41) The resident’s unit shall be thoroughly cleaned and disinfected following a resident’s death, discharge or transfer.

(42) Commodes and urinals, if used, shall be kept at the bedside of the residents. They shall not be left open and the container shall be emptied promptly and thoroughly cleaned after each use. III (43) Cuspidors shall be emptied and cleaned daily or disposable cartons shall be provided daily. III (44) Self-control of prescription medication by a resident may be allowed only if approved in writing by the resident’s physician and allowed by facility policy. If a resident is not taking any prescription medication, the resident may be permitted to control the storage and use of nonprescription medication unless there is a physician’s written order or facility policy to the contrary. If not permitted, all medications for that resident, including over-the-counter medications, shall be controlled by the administrator unless the physician specifies otherwise. II/III (45) Written approval for self-control of prescription medication shall be rewritten as needed but at least annually and after any period of hospitalization. III (46) All medication shall be safely stored at proper temperature locked door or cabinet. If access is controlled by the resident, a secured location shall mean in a locked container, a locked drawer in a bedside table or dresser or in a resident’s private room if locked in his/her absence, although this does not preclude access by a responsible employee of the facility. II/III (47) All prescription medications shall be supplied as individual prescriptions. All medications, including over-the-counter medications shall be packaged and labeled in accordance with applicable professional pharmacy standards, state and federal drug laws and regulations and the United States Pharmacopeia (USP). Labeling shall include accessory and applicable, and the name of the medication as specified in the physician’s order. Over-the-counter medications for individual residents shall be labeled with at least the resident’s name. II/III (48) Injections shall be administered only by a physician or licensed nurse, except that residents who require insulin, upon written order of their physician, may administer their own insulin or the insulin may be administered by a person trained to do so by a licensed nurse or physician and the resident’s condition shall be monitored by his/her physician.

After December 31, 1990, unless insulin is self-administered or it is administered only by a physician or licensed nurse, it shall be administered by a certified medication technician or a level I medication aide who has successfully completed the state-approved course for insulin administration, taught by an approved instructor and who was recommended for training by an administrator or nurse with whom he or she works.

Anyone trained prior to December 31, 1990, who completed the state-approved insulin administration course taught by an approved instructor shall be considered qualified to administer insulin in a facility. Anyone trained prior to December 31, 1990, to administer insulin by a licensed nurse or physician not using the state-approved course may qualify by challenging the final examination of the insulin administration course. I/II (49) The administrator shall develop and implement a safe and effective system of medication control and use which assures that all residents’ medications are administered or distributed by personnel at least eighteen (18) years of age, in accordance with physicians’ instructions using acceptable nursing techniques. Until January 1, 1991, those facilities administering medications shall utilize personnel trained in medication administration (a licensed nurse, certified medication technician or level I medication aide) and shall employ a licensed nurse eight (8) hours per week for every thirty (30) residents to monitor each resident’s condition. Distribution shall mean delivering to a resident his/her prescription pharmacy container and placing it in a small container or applied by facility personnel if the resident is unable to do so and the resident’s physician so authorizes. After December 31, 1990, all persons who administer or distribute medication shall be trained in medication administration and, if not a physician or a licensed nurse, shall be a certified medication technician or level I medication aide. I/II (50) Medication Orders.

(A) Physician’s instructions, as evidenced by the prescription label or by signed order of a physician, shall be accurately followed. If the physician changes the order which is designated on a prescription label, there shall be on file in the resident’s record a signed physician’s order to that effect with the amended instructions for use or until the prescription label is changed by the pharmacy to reflect the new order. II/III (B) Physician’s written and signed orders are not required, but if it is the facility’s or physician’s policy to use the orders, they shall include: name of medication, dosage and frequency of administration and the orders shall be renewed at least every three (3) months. II/III (C) Verbal and telephone orders shall be taken only by a licensed nurse, medication technician, level I medication aide or pharmacist and shall be immediately reduced to writing and signed by that individual. If a telephone order is given to a medication technician or level I medication aide, an initial dosage of a new prescription shall not be initiated until the order has been reviewed by telephone or in person by a licensed nurse or pharmacist. II (D) The review shall be documented by the nurse’s or pharmacist’s signature within seven (7) days. III (E) The physician shall sign all verbal and telephone orders within seven (7) days. III (F) The administration or distribution of medication shall be recorded on a medication sheet or directly in the resident’s record and, if recorded on a medication sheet, shall be made

part of the resident’s record. The administration or distribution shall be recorded by the same person who prepares the medication and who distributes or administers it. II/III (51) A stock supply of prescription medication may be kept in the facility. An emergency drug supply as recommended by a pharmacist or physician may be kept if approved by the department. Storage and use of medications in the emergency drug supply shall assure accountability. II/III (52) Stock supplies of nonprescription medication may be kept for pro re nata (PRN) use in facilities as long as the particular medications are approved in writing by a consulting physician, a registered nurse or a pharmacist. II/III (53) All controlled substances shall be handled according to state laws and regulations as given in and required by 19 CSR 30-1 and Chapter 195, RSMo. II/III (54) A pharmacist or registered nurse shall review the drug regimen of each resident. This shall be done at least every other month in a facility. The review shall be performed in the facility and shall include, but shall not be limited to, possible drug and food interactions, contraindications, adverse reactions and a review of the medication system utilized by the facility. Irregularities and concerns shall be reported in writing to the resident’s physician and to the administrator.

If after thirty (30) days, there is no action taken by a resident’s physician and significant concerns continue regarding a resident’s or residents’ medication order(s), the administrator shall contact or recontact the physician to determine if he or she received the information and if there are any new instructions. II/III (55) Medications controlled by the facility shall be disposed of either by destroying, returning to the pharmacy or sending with residents on discharge. The following shall be destroyed within the facility within ninety (90) days: discontinued medication not returnable to the pharmacy, all discontinued controlled substances, outdated or deteriorated medication, medication of expired residents not returnable to the pharmacy and medications not sent with the resident on discharge. II/III (56) Disposition of medication controlled by the facility shall be recorded listing the resident’s name, the date and the name, strength and quantity of the drug and the signature(s) of the person(s) involved. Medication destruction shall involve two (2) persons, one (1) of whom shall be a pharmacist, a nurse or a state inspector. III (57) Residents shall be encouraged to be active and to participate in activities. In a facility licensed for more than twelve (12) residents, a method for informing the residents in advance of what activities are available, where they will be held and at what times they will be held shall be developed, maintained and used. II/III (58) A record shall be maintained in the facility for each resident which shall include:

(A) Admission information including the resident’s name;

Medicaid number; name, address and telephone number of physician and alternate; name, address and telephone number of resident’s next of kin, legal guardian, designee or person to be notified in case of emergency; and preferred dentist, pharmacist and funeral director; and III (B) A resident’s record, including a review monthly or more frequently, if indicated, of the resident’s general condition and needs; a monthly review of medication consumption of any resident controlling his/her own medication, noting if prescription medications are being used in appropriate quantities; a daily record of distribution or administration of medication; any physician’s orders; a logging of the drug regimen review process; a monthly weight; a record of each referral of a resident for services from an outside service; and a record of any patient incidents and accidents involving the resident. III (59) A record of the resident census as well as records regarding discharge, transfer or death of residents shall be kept in the (60) Resident records shall be maintained by the operator for at least five (5) years after the resident leaves the facility or after longer. III

Filed March 1, 2012, effective Sept. 30, 2012. ** *Original authority: 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006, 2007 and **Pursuant to Executive Order 21-09, 19 CSR 30-86.043, section (54) was suspended from April 17, 2020 through September 3, 2021; sections (19), (48), and (49) was suspended from April 15, 2020 through December 31, 2021; and section (8) was suspended from April 17, 2020 through December 31, 2021.

History

AUTHORITY: sections 198.073 and 198.076, RSMo Supp. 2011. Original rule filed Aug. 23, 2006, effective April 30, 2007. Amended:

19 CSR 30-86.045 Standards and Requirements for Assisted Living Facilities Which Provide Services to Residents with a Physical, Cognitive, or Other Impairment that Prevents the Individual from Safely Evacuating the Facility with Minimal Assistance {#sec-19-csr-30-86.045 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.045}

PURPOSE: This rule establishes the additional standards for those assisted living facilities which provide services to residents with a physical, cognitive, or other impairment that prevents the individual from safely evacuating the facility with minimal assistance. notation which refers to the class (either Class I, II or III) of standard as designated in section 198.085.1, RSMo.

(1) This rule contains the additional standards for those assisted living facilities licensed pursuant to sections 198.005 and 198.073, RSMo (CCS HCS SCS SB 616, 93rd General Assembly, Second Regular Session (2006)) and complying with sections 198.073.4 and 198.073.6, RSMo (CCS HCS SCS SB 616, 93rd General Assembly, Second Regular Session (2006)) and 19 CSR 30-86.047 that choose to admit or continue to care for any individual having a physical, cognitive or other impairment that prevents the individual from safely evacuating the facility with minimal assistance.

(2) Definitions. For the purposes of this rule, the following (A) Area of refuge—A space located in or immediately other spaces in the same building or its location, permitting a delay in evacuation. An area of refuge may be temporarily used as a staging area that provides some relative safety to its occupants while potential emergencies are assessed, decisions are made, and evacuation has begun;

(B) Evacuating the facility—The act of the resident going from one (1) smoke section to another within the facility, going to an area of refuge within the facility, or going out of the (C) Individualized evacuation plan—A plan to remove the resident from the facility, to an area of refuge within the facility or from one (1) smoke section to another within the facility. The plan is specific to the resident’s needs and abilities based on the current community based assessment;

(D) Minimal assistance— 1. Is the criterion which determines whether or not staff must develop and include an individualized evacuation plan as part of the resident’s service plan;

Minimal assistance may be the verbal intervention that staff must provide for a resident to initiate evacuating the 3. Minimal assistance may be the physical intervention that staff must provide, such as turning a resident in the correct direction, for a resident to initiate evacuating the facility;
A resident needing minimal assistance is one who is able to prepare to leave and then evacuate the facility within five (5) minutes of being alerted of the need to evacuate and requires no more than one (1) physical intervention and no more than three (3) verbal interventions of staff to complete evacuation from the facility;
The following actions required of staff are considered to be more than minimal assistance:

A. Assistance to traverse down stairways;

B. Assistance to open a door; and C. Assistance to propel a wheelchair;

(E) Resident, only for the purpose of this rule, means any individual having a physical, cognitive or other impairment that prevents the individual from safely evacuating the facility with minimal assistance who is admitted to or continues to be cared for in the facility under the provisions of this rule; and (F) Smoke section—A fire-rated separation of one (1) section of the building from the rest of the building.

(3) General Requirements. I/II (A) If the facility admits or retains any individual needing more than minimal assistance due to having a physical, cognitive or other impairment that prevents the individual from safely evacuating the facility, the facility shall:

Meet the fire safety requirements of 19 CSR 30-86.022(16);
Take necessary measures to provide residents with the opportunity to explore the facility and, if appropriate, its grounds; II 3. Use a personal electronic monitoring device for any resident whose physician recommends the use of such device;
Have sufficient staff present and awake twenty-four (24) hours a day to assist in the evacuation of all residents; I/II 5. Include an individualized evacuation plan in the resident’s individual service plan; II 6. At a minimum the evacuation plan shall include the following components:

A. The responsibilities of specific staff positions in an emergency specific to the individual; II B. The fire protection interventions needed to ensure the safety of the resident; and II C. The plan shall evaluate the resident for his or her location within the facility and the proximity to exits and areas of refuge. The plan shall evaluate the resident, as applicable, for his or her risk of resistance, mobility, the need for additional staff support, consciousness, response to instructions, response to alarms, and fire drills; II 7. The resident’s evacuation plan shall be amended or revised based on the ongoing assessment of the needs of the resident; II 8. Those employees with specific responsibilities shall be instructed and informed regarding their duties and responsibilities under the resident’s evacuation plan at least every six (6) months and upon any significant change in the plan; II 9. A copy of the resident’s evacuation plan shall be readily available to all staff; and II 10. Comply with all requirements of this rule. I/II (4) Staffing Requirements.

rule filed Dec. 14, 2000, effective June 30, 2001. Moved to 19 CSR 30-86.045, effective Aug. 28, 2001. Amended: Filed Aug. 23, 2006, effective April 30, 2007. Amended: Filed March 13, 2008, effective Oct. 30, 2008. *Original authority: 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006, 2007 and

History

AUTHORITY: sections 198.073 and 198.076, RSMo Supp. 2007. This rule originally filed as 13 CSR 15-15.045. Emergency rule filed Dec. 14, 2000, effective Jan. 2, 2001, expired June 30, 2001. Original

19 CSR 30-86.047 Administrative, Personnel, and Resident Care Requirements for Assisted Living Facilities {#sec-19-csr-30-86.047 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.047}

PURPOSE: This rule establishes standards for all assisted living facilities licensed pursuant to sections 198.005 and 198.073, RSMo (CCS HCS SCS SB 616, 93rd General Assembly, Second Regular Session (2006)), and required to meet assisted living facility standards pursuant to section 198.073.3, RSMo (CCS HCS SCS SB 616, 93rd General Assembly, Second Regular Session (2006)), and

section 198.076, RSMo 2000.

PUBLISHER’S NOTE: The secretary of state has determined that publication of the entire text of the material that is incorporated notation which refers to the class (either Class I, II, or III) of standard as designated in section 198.085.1., RSMo.

(1) Facilities licensed as assisted living facilities shall be inspected pursuant to the standards outlined herein beginning April 1, 2007. An assisted living facility may request, in writing to the department, to comply with these standards prior to April 1, 2007. Upon receipt of the request, the department shall conduct an inspection to determine compliance with the standards outlined herein prior to issuing a license indicating such compliance.

(2) Consumer Education Requirements. The facility shall disclose to a prospective resident, or legal representative of the resident, information regarding the services the facility is able to provide or coordinate, the cost of such services to the resident, and the grounds for discharge or transfer as permitted or required by the Omnibus Nursing Home Act, Chapter 198, RSMo, and the department’s regulations, including the provisions set forth in section (29) of this rule. II (3) Nothing in this rule shall be construed to allow any facility that has not met the requirements of 198.073(4) and (6), RSMo (CCS HCS SCS SB 616, 93rd General Assembly, Second Regular Session (2006)), and 19 CSR 30-86.045 to care for any individual with a physical, cognitive or other impairment that prevents the individual from safely evacuating the facility with minimal assistance. I/II (4) Definitions. For the purpose of this rule, the following (A) Appropriately trained and qualified individual means an individual who is licensed or registered with the state of Missouri in a health care related field or an individual with a degree in a health care related field or an individual with a degree in a health care, social services, or human services field or an individual licensed under Chapter 344, RSMo, and who has received facility orientation training under 19 CSR 30- 86.047, and dementia training under section 192.2000, RSMo, and twenty-four (24) hours of additional training, approved by the department, consisting of definition and assessment of activities of daily living, assessment of cognitive ability, service planning, and interview skills;

(B) Area of refuge—A space located in or immediately other spaces in the same building or its location, permitting a delay in evacuation. An area of refuge may be temporarily used as a staging area that provides relative safety to its occupants while potential emergencies are assessed, decisions are made, and evacuation is begun;

(D) Chemical restraint—Is as defined in 19 CSR 30-83.010;

(E) Community based assessment—Documented basic information and analysis provided by appropriately trained and qualified individuals describing an individual’s abilities and needs in activities of daily living, instrumental activities of daily living, vision/hearing, nutrition, social participation and support, and cognitive functioning using an assessment tool approved by the department, that is designed for community based services and that is not the nursing home minimum data set. The assessment tool may be one developed by the department or one used by a facility which has been approved by the department;

(F) Evacuating the facility—For the purpose of this rule, evacuating the facility shall mean moving to an area of refuge or from one smoke section to another or exiting the facility;

(G) Home-like—Means a self-contained long-term care setting that integrates the psychosocial, organizational and environmental qualities that are associated with being at home. Home-like may include, but is not limited to the 1. A living room and common use areas for social interactions and activities;

Kitchen and family style eating area for use by the residents;
Laundry area for use by residents;
A toilet room that contains a toilet, lavatory and bathing unit in each resident’s room;
Resident room preferences for residents who wish to share a room, and for residents who wish to have private bedrooms;
Outdoor area for outdoor activities and recreation; and 7. A place where residents can give and receive affection, explore their interests, exercise control over their environment, engage in interactions with others and have privacy, security, familiarity and a sense of belonging;

(H) Individualized service plan (ISP)—Shall mean the planning document prepared by an assisted living facility, which outlines a resident’s needs and preferences, services to be provided, and the goals expected by the resident or the resident’s legal representative in partnership with the facility;

(I) Keeping residents in place—Means maintaining residents in place during a fire in lieu of evacuation where a building’s occupants are not capable of evacuation, where evacuation has a low likelihood of success, or where it is recommended in writing by local fire officials as having a better likelihood of success and/or a lower risk of injury;

(J) Minimal assistance— 1. Is the criterion which determines whether or not staff must develop and include an individualized evacuation plan as part of the resident’s service plan;

Minimal assistance may be the verbal intervention that staff must provide for a resident to initiate evacuating the 3. Minimal assistance may be the physical intervention that staff must provide, such as turning a resident in the correct direction, for a resident to initiate evacuating the facility;
A resident needing minimal assistance is one who is able to prepare to leave and then evacuate the facility within five (5) minutes of being alerted of the need to evacuate and requires no more than one (1) physical intervention and no more than three (3) verbal interventions of staff to complete evacuation from the facility;
The following actions required of staff are considered to be more than minimal assistance:

A. Assistance to traverse down stairways;

B. Assistance to open a door; and C. Assistance to propel a wheelchair;

(K) Physical restraint—Any manual method or physical or mechanical device, material, or equipment attached to or adjacent to the resident’s body that the individual cannot remove easily which restricts freedom of movement or normal access to one’s body. Physical restraints include, but are not limited to, leg restraints, arm restraints, hand mitts, soft ties or vests, lap cushions, and lap trays the resident cannot remove easily. Physical restraints also include facility practices that meet the definition of a restraint, such as the following:

Using side rails that keep a resident from voluntarily getting out of bed;
Tucking in or using Velcro to hold a sheet, fabric, or clothing tightly so that a resident’s movement is restricted;
Using devices in conjunction with a chair, such as trays, tables, bars, or belts, that the resident cannot remove easily, that prevent the resident from rising;
Placing the resident in a chair that prevents a resident from rising; and 5. Placing a chair or bed so close to a wall that the wall prevents the resident from rising out of the chair or voluntarily getting out of bed;

(L) Significant change—Means any change in the resident’s physical, emotional or psychosocial condition or behavior that will not normally resolve itself without further intervention by staff or by implementing standard disease-related clinical interventions, that has an impact on more than one (1) area of the resident’s health status, and requires interdisciplinary review or revision of the individualized service plan, or both;

(M) Skilled nursing facility—Means any premises, other than a residential care facility, assisted living facility or an intermediate care facility, which is utilized by its owner, operator or manager to provide for twenty-four (24) hour accommodation, board and skilled nursing care and treatment services to at least three (3) residents who are not related within the fourth degree of consanguinity or affinity to the owner, operator or manager of the facility. Skilled nursing care and treatment services are those services commonly performed by or under the supervision of a registered professional nurse for individuals requiring twenty-four (24)-hours-a-day care by licensed nursing personnel including acts of observation, care and counsel of the aged, ill, injured or infirm, the administration of medications and treatments as prescribed by a licensed physician or dentist, and other nursing functions requiring substantial specialized judgment and skill;

(N) Skilled nursing placement—Means placement in a skilled nursing facility as defined in subsection (4)(M) of this rule; and (O) Social model of care—Means long-term care services based on the abilities, desires, and functional needs of the individual delivered in a setting that is more home-like than institutional, that promote the dignity, individuality, privacy, independence and autonomy of the individual, that respects residents’ differences and promotes residents’ choices.

(5) The operator shall designate an individual for administrator who is currently licensed as an administrator by the Missouri Board of Nursing Home Administrators, in accordance with

Chapter 344, RSMo. II (6) The operator shall be responsible to assure compliance with all applicable laws and regulations. The administrator shall be fully authorized and empowered to make decisions regarding the operation of the facility and shall be held responsible for the actions of all employees. The administrator’s responsibilities shall include oversight of residents to assure that they receive care as defined in the individualized service plan. II/III (7) The administrator cannot be listed or function in more than one (1) licensed facility at the same time unless he or she serves no more than five (5) facilities within a thirty- (30-) mile radius and licensed to serve in total no more than one hundred (100) residents, and the administrator has an individual designated as the daily manager of each facility.

However, the administrator may serve as the administrator of more than one (1) licensed facility if all facilities are on the same premises. II (8) The administrator shall designate, in writing, a staff member in charge in the administrator’s absence. If the administrator is absent for more than thirty (30) consecutive days, during which time he or she is not readily accessible for consultation by telephone with the delegated individual, the individual designated to be in charge shall be an administrator currently licensed by the Missouri Board of Nursing Home Administrators, in accordance with Chapter 344, RSMo. Such thirty (30) consecutive day absences may only occur once within any consecutive twelve- (12-) month period. II/III (9) The facility shall not care for more residents than the number for which the facility is licensed. However, if the facility operates a non-licensed adult day care program for four (4) or fewer participants within the licensed facility, the day care participants shall not be included in the total facility census. Adult day care participants shall be counted in staffing determination during the hours the day care participants are in the facility. II/III (10) The facility shall not admit or continue to care for residents referred to appropriate outside resources or discharged from the facility. I/II (11) All personnel responsible for resident care shall have access to the legal name of each resident, name and telephone number of resident’s physician, resident’s designee or legally authorized representative in the event of emergency. II/III (12) All persons who have any contact with the residents in the that would materially and adversely affect the health, safety, the department as required by section 198.070, RSMo, shall bingo leaders, or sing-along leaders. The facility is not required to check the EDL for an individual such as a priest, minister, or congregation. However, if a minister, priest, or rabbi serves as a volunteer facility chaplain, the facility is required to check the EDL since the individual would have potential contact with all residents. I/II (13) Prior to allowing any person who has been hired in a fullany resident, the facility shall or, in the case of temporary employees hired through or contracted from an employment temporary employee to a facility— (A) Request a criminal background check for the person, as provided in section 192.2495, RSMo. Each facility shall maintain documents verifying that the background checks were requested, the date of each such request, and the nature of the response received for each such request. II 1. The facility shall ensure that any person hired or retained to have contact with any resident who discloses that he or she has been found guilty in this state or any other state or has been found guilty of a crime, which if committed in Missouri would be a class A or B felony violation of Chapter 565, 566, or 569, RSMo, or any violation of section 198.070.3., RSMo, or section 568.020, RSMo, shall not be retained in such a position. I/II 2. Upon receipt of the criminal background check, the facility shall ensure that if the criminal background check indicates that the person hired or retained by the facility has been found guilty in this state or any other state or has been found guilty of a crime, which if committed in Missouri would be a class A or B felony violation of Chapter 565, 566, or 569, RSMo, or any violation of section 198.070.3., RSMo, or section 568.020, RSMo, the person shall not have contact with any resident unless and until the facility obtains verification from the department that a good cause waiver has been granted for each qualifying offense and maintains a copy of the verification in the individual’s personnel file; I/II (B) Make an inquiry to the department, as provided in section 192.2490, RSMo, as to whether the person is listed on the EDL.

Each facility shall maintain documents verifying that the EDL checks were requested, the date of each such request, and the nature of the response received for each such request. The inquiry may be made through the department’s website at www.health.mo.gov/safety/edl; II/III (C) If the person has registered with the department’s Family Care Safety Registry (FCSR), the facility may utilize the FCSR in order to meet the requirements of subsections (13)(A) and (13)

(B) of this rule. The FCSR is available through the department’s website; and (D) For persons for whom the facility has contracted for that will have contact with any resident, the facility shall facility to reasonably ensure the safety of all residents. I/II (14) A facility shall not employ, as an agent or employee who has access to controlled substances, any person who has been found guilty or entered a plea of guilty or nolo contendere in a criminal prosecution under the laws of any state or of the United States for any offense related to controlled substances. II (A) A facility may apply in writing to the department for a waiver of this section of this rule for a specific employee.

(B) The department may issue a written waiver to a facility upon determination that a waiver would be consistent with the public health and safety. In making this determination, the department shall consider the duties of the employee, the circumstances surrounding the conviction, the length of time since the conviction was entered, whether a waiver has been granted by the department’s Bureau of Narcotics and Dangerous Drugs pursuant to 19 CSR 30-1.034 when the facility is registered with that agency, whether a waiver has been granted by the federal Drug Enforcement Administration (DEA) pursuant to 21 CFR 1301.76 when the facility is also registered with that agency, the security measures taken by the facility to prevent the theft and diversion of controlled substances, and any other factors consistent with public health and safety. II (15) The facility must develop and implement written policies position which is to have contact with any resident have been informed of their responsibility to disclose their prior criminal

history to the facility as required by section 192.2495, RSMo.

The facility must also develop and implement policies and procedures which ensure that the facility does not knowingly hire, after August 28, 1997, any person who has or may have contact with a resident who has been found guilty in this state or any other state, or has been found guilty of a crime which if committed in Missouri would be a Class A or B felony subsection 198.070.3, RSMo, or of section 568.020, RSMo. II/III (16) All persons who have or may have contact with residents shall at all times when on duty or delivering services wear an (17) Personnel who have been diagnosed with a communicable approval by a physician or physician’s designee, which indicates any limitations. II (18) The administrator shall be responsible to prevent an employee known to be diagnosed with communicable disease from exposing residents to such disease. The facility’s policies and procedures must comply with the department’s regulations pertaining to communicable diseases, specifically 19 CSR 20- 20.010 through 19 CSR 20-20.100. II/III (19) The facility shall screen residents and staff for tuberculosis as required for long-term care facilities by 19 CSR 20-20.100. II (20) The administrator shall maintain on the premises an individual personnel record on each facility employee, which shall include the following:

(A) The employee’s name and address;

(B) Social Security number;

(D) Date of employment;

(E) Documentation of experience and education including for positions requiring licensure or certification, documentation evidencing competency for the position held, which includes copies of current licenses, transcripts when applicable, or for those individuals requiring certification, such as certified medication technicians, level I medication aides and insulin administration aides; printing the Web Registry search results page available at www.health.mo.gov/cnaregistry shall meet the requirements of the employer’s check regarding valid certification;

(F) References, if available;

(G) The results of background checks required by section 192.2495, RSMo, and a copy of any good cause waiver granted by the department, if applicable;

(H) Position in the facility;

(I) Documentation of the employee’s tuberculin screening status;

(24) Employees who are counted in meeting the minimum staffing ratio and employees who provide direct care to the residents shall be at least sixteen (16) years of age. One employee at least eighteen (18) years of age shall be on duty at all times. II (25) Each facility resident shall be under the medical supervision of a physician licensed to practice in Missouri who has been informed of the facility’s emergency medical procedures and is kept informed of treatments or medications prescribed by any other professional lawfully authorized to prescribe medications. III (26) The facility shall ensure that each resident being admitted or readmitted to the facility receives an admission physical examination by a licensed physician. The facility shall request documentation of the physical examination prior to admission but must have documentation of the physical examination on file no later than ten (10) days after admission. The physical examination shall contain documentation regarding the individual’s current medical status and any special orders or procedures to be followed. If the resident is admitted directly from an acute care or another long-term care facility and is accompanied on admission by a report that reflects his or her current medical status, an admission physical shall not be required. III (27) Residents under sixteen (16) years of age shall not be (28) The facility may admit or retain an individual for residency in an assisted living facility only if the individual does not require hospitalization or skilled nursing placement as defined in this rule, and only if the facility— (A) Provides for or coordinates oversight and services to meet the needs, the social and recreational preferences in accordance with the individualized service plan of the resident as documented in a written contract signed by the resident, or legal representative of the resident; II (B) Has twenty-four (24) hour staff appropriate in numbers and with appropriate skills to provide such services; II (C) Has a written plan for the protection of all residents in the event of a disaster such as tornado, fire, bomb threat or severe weather, including— 1. Keeping residents in place;

Evacuating residents to areas of refuge;
Evacuating residents from the building if necessary; or 4. Other methods of protection based on the disaster and the individual building design; I/II (D) Completes a premove-in screening conducted as required by section 198.073.4(4), RSMo (CCS HCS SCS SB 616, 93rd General Assembly, Second Regular Session (2006)); II (E) The premove-in screening shall be completed prior to admission with the participation of the prospective resident and be designed to determine if the individual is eligible for admission to the assisted living facility and shall be based on the admission restrictions listed at section (29) of this rule; II (F) Completes a community based assessment conducted by an appropriately trained and qualified individual as defined in

section (4) of this rule:

Time frame requirements for assessment shall be— A. Within five (5) calendar days of admission; II B. At least semiannually; and II C. Whenever a significant change has occurred in the resident’s condition, which may require a change in services; II 2. The facility shall use form MO 580-2835, Assessment for Admission To Assisted Living Facilities (9-06), incorporated by reference, provided by the Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102-0570 and which is available to long-term care facilities at www.dhss.mo.gov or by telephone at (573) 526-8548. This rule does not incorporate any subsequent amendments or additions; or II 3. The facility may use another assessment form if approved in advance by the department; II (G) Develops an individualized service plan (ISP), which means the planning document prepared by an assisted living facility which outlines a resident’s needs and preferences, services to be provided, and goals expected by the resident or the resident’s legal representative in partnership with the facility; II (H) Reviews the ISP with the resident, or legal representative of the resident, at least annually or when there is a significant change in the resident’s condition which may require a change in services; II (I) Includes the signatures of an authorized representative of the facility and the resident or the resident’s legal representative in the individualized service plan to acknowledge that the service plan has been reviewed and understood by the resident or legal representative; II (J) Develops and implements a plan to protect the rights, privacy, and safety of all residents and to protect against the financial exploitation of all residents; and II (K) Complies with the dementia specific training requirements of subsection 8 of section 660.050, RSMo. II (29) The facility shall not admit or continue to care for a resident who— (A) Has exhibited behaviors that present a reasonable likelihood of serious harm to himself or herself or others; I/II (B) Requires physical restraint as defined in this rule; II (C) Requires chemical restraint as defined in this rule; II (D) Requires skilled nursing services as defined in section 198.073.4, RSMo, for which the facility is not licensed or able to provide; II (E) Requires more than one (1) person to simultaneously physically assist the resident with any activity of daily living, with the exception of bathing and transferring; or II/III (F) Is bed-bound or similarly immobilized due to a debilitating or chronic condition. II (30) The requirements of subsections (29)(D), (E), and (F) shall not apply to a resident receiving hospice care, provided the resident, his or her legally authorized representative or designee, or both, and the facility, physician and licensed hospice provider all agree that such program of care is appropriate for the resident. II (31) Programs and Services Requirements for Residents.

(A) The facility shall designate a staff member to be responsible for leisure activity coordination and for promoting the social model, multiple staff role directing all staff to provide routine care in a manner that emphasizes the opportunity for the resident and the staff member to enjoy a visit rather than simply perform a procedure. II/III (B) The facility shall make available and implement self-care, productive and leisure activity programs which maximize and encourage the resident’s optimal functional ability for residents. The facility shall provide person-centered activities appropriate to the resident’s individual needs, preferences, background and culture. Individual or group activity programs may consist of the following:

Gross motor activities, such as exercise, dancing, gardening, cooking and other routine tasks;
Self-care activities, such as dressing, grooming and personal hygiene;
Social and leisure activities, such as games, music and reminiscing;
Sensory enhancement activities, such as auditory, olfactory, visual and tactile stimulation;
Outdoor activities, such as walking and field trips;
Creative arts; or 7. Other social, leisure or therapeutic activities that encourage mental and physical stimulation or enhance the resident’s well-being. II/III (C) Staff shall inform residents in advance of any organized group activity including the time and place of the activity. II/III (32) Requirements for Facilities Providing Care to Residents Having Mental Illness or Mental Retardation Diagnosis.

(A) Each resident who exhibits mental and psychosocial adjustment difficulty(ies) shall receive treatment and services to address the resident’s needs and behaviors as stated in the individualized service plan. I/II (B) If specialized rehabilitative services for mental illness or mental retardation are required to enable a resident to reach and to comply with the individualized service plan, the facility shall ensure the required services are provided. II (C) The facility shall maintain in the resident’s record the most recent progress notes and personal plan developed and provided by the Department of Mental Health or designated administrative agent for each resident whose care is funded by the Department of Mental Health or designated administrative agent. III (33) No facility shall accept any individual with a physical, cognitive, or other impairment that prevents the individual from safely evacuating the facility with minimal assistance unless the facility meets all requirements of section 198.073, RSMo (CCS HCS SCS SB 616, 93rd General Assembly, Second Regular Session (2006)), and those standards set forth in 19 CSR 30-86.045. I/II (34) The facility shall follow appropriate infection control procedures. The administrator or his or her designee shall make a report to the local health authority or the department of the presence or suspected presence of any diseases or findings listed in 19 CSR 20-20.020, sections (1)–(3), according to the specified time frames as follows:

(B) Category II diseases or findings shall be reported to the local health authority or the department within three (3) days of first knowledge or suspicion;

(C) Category III—The occurrence of an outbreak or epidemic of any illness, disease or condition which may be of public health concern, including any illness in a food handler that is potentially transmissible through food. This also includes public health threats such as clusters of unusual diseases or manifestations of illness and clusters of unexplained deaths.

Such incidents shall be reported to the local authority or to the department by telephone, facsimile, or other rapid communication within twenty-four (24) hours of first knowledge or suspicion. I/II (35) Protective oversight shall be provided twenty-four (24)

(36) Residents shall receive proper care as defined in the individualized service plan. I/II (37) In case of behaviors that present a reasonable likelihood of serious harm to himself or herself or others, serious illness, significant change in condition, injury or death, staff shall take appropriate action and shall promptly attempt to contact the person listed in the resident’s record as the legally authorized representative, designee or placement authority. The facility shall contact the attending physician or designee and notify the local coroner or medical examiner immediately upon the death of any resident of the facility prior to transferring the deceased resident to a funeral home. I/II (38) The facility shall encourage and assist each resident based on his or her individual preferences and needs to be clean and free of body and mouth odor. II (39) If the resident brings unsealed medications to the facility, the medications shall not be used unless a pharmacist, physician or nurse examines, identifies and determines the contents to be suitable for use. The person performing the identification shall document his or her review. II/III (40) Self-control of prescription medication by a resident may be allowed only if approved in writing by the resident’s physician and included in the resident’s individualized service plan. A resident may be permitted to control the storage and use of nonprescription medication unless there is a physician’s written order or facility policy to the contrary. Written approval for self-control of prescription medication shall be rewritten as needed but at least annually and after any period of hospitalization. II/III (41) All medication shall be safely stored at proper temperature locked door or cabinet. Medication shall be accessible only to persons authorized to administer medications. II/III (A) If access is controlled by the resident, a secured location shall mean in a locked container, a locked drawer in a bedside table or dresser or in a resident’s private room if locked in his or her absence, although this does not preclude access by a responsible employee of the facility.

(B) Schedule II controlled substances shall be stored in locked compartments separate from non-controlled medications, except that single doses of Schedule II controlled substances may be controlled by a resident in compliance with the requirements for self-control of medication of this rule.

(C) Medication that is not in current use and is not destroyed shall be stored separately from medication that is in current use. II/III (42) All prescription medications shall be supplied as individual prescriptions except where an emergency medication supply is allowed. All medications, including over-the-counter medications, shall be packaged and labeled in accordance with applicable professional pharmacy standards, and state and federal drug laws. Labeling shall include accessory and applicable, and the name of the medication as specified in the physician’s order. Medication labels shall not be altered by facility staff and medications shall not be repackaged by facility staff except as allowed by section (43) of this rule.

Over-the-counter medications for individual residents shall be labeled with at least the resident’s name. II/III (43) Controlled substances and other prescription and nonprescription medications for administration when a resident temporarily leaves a facility shall be provided as follows:

(B) Prescription medication cards or other multiple-dose prescription containers currently in use in the facility may be provided by any authorized facility medication staff member if the containers are labeled by the pharmacy with complete pharmacy prescription labeling for use. Original manufacturer containers of non-prescription medications, along with instructions for administration, may be provided by any authorized facility medication staff member;

(C) When medications are supplied by the pharmacy in customized patient medication packages that allow separation of individual dose containers, the required number of containers may be provided by any authorized facility medication staff member. The individual dose containers shall be placed in an outer container that is labeled with the name and address of the facility and the date;

(D) When multiple doses of a medication are required and it is not reasonably possible to obtain prescription medication labeled by the pharmacy, and it is not appropriate to send a container of medication currently in use in the facility, up to a twenty-four- (24-) hour supply of each prescription or nonprescription medication may be provided by a licensed nurse in United States Pharmacopeia (USP) approved containers labeled with the facility name and address, resident’s name, medication name and strength, quantity, instructions for use, date, initials of individual providing, and other appropriate information;

(E) When no more than a single dose of a medication is required, any authorized facility medication staff member may prepare the dose as for in-facility administration in a USP approved container labeled with the facility name and address, resident’s name, medication name and strength, quantity, instructions for use, date, initials of person providing, and other appropriate information;

(F) The facility may have a policy that limits the quantity of medication sent with a resident without prior approval of the prescriber;

(G) Returned containers shall be identified as having been sent with the resident, and shall not later be returned to the pharmacy for reuse; and (H) The facility shall maintain accurate records of medications provided to and returned by the resident. II/III (44) Upon discharge or transfer of a resident, the facility shall release prescription medications, including controlled substances, held by the facility for the resident when the physician writes an order for each medication to be released.

Medications shall be labeled by the pharmacy with current instructions for use. Prescription medication cards or other containers may be released if the containers are labeled by the pharmacy with complete pharmacy prescription labeling. II/III (45) Injections shall be administered only by a physician or licensed nurse, except that insulin injections may also be administered by a certified medication technician or level I medication aide who has successfully completed the state-approved course for insulin administration, taught by a department-approved instructor. Anyone trained prior to December 31, 1990, who completed the state-approved insulin administration course taught by an approved instructor shall be considered qualified to administer insulin in an assisted living facility. A resident who requires insulin may administer his or her own insulin if approved in writing by the resident’s physician and trained to do so by a licensed nurse or physician.

The facility shall monitor the resident’s condition and ability to continue self-administration. I/II (46) The administrator shall develop and implement a safe and effective system of medication control and use, which assures that all residents’ medications are administered by personnel at least eighteen (18) years of age, in accordance with physicians’ instructions using acceptable nursing techniques.

The facility shall employ a licensed nurse eight (8) hours per week for every thirty (30) residents to monitor each resident’s condition and medication. Administration of medication shall mean delivering to a resident his or her prescription pharmacy container and placing it in a small cup container or applied by facility personnel if the resident is unable to do so and the resident’s physician so authorizes. All individuals who administer medication shall be trained in medication administration and, if not a physician or a licensed nurse, shall be a certified medication technician or level I medication aide.

(47) Medication Orders.

(A) No medication, treatment or diet shall be administered without an order from an individual lawfully authorized to prescribe such and the order shall be followed. II/III (B) Physician’s written and signed orders shall include: name of medication, dosage, frequency and route of administration and the orders shall be renewed at least every three (3) months.

Computer generated signatures may be used if safeguards are in place to prevent their misuse. Computer identification codes shall be accessible to and used by only the individuals whose signatures they represent. Orders that include optional doses or include pro re nata (PRN) administration frequencies shall specify a maximum frequency and the reason for administration. II/III (C) Telephone and other verbal orders shall be received only by a licensed nurse, certified medication technician, level I medication aide or pharmacist, and shall be immediately reduced to writing and signed by that individual. A certified medication technician or level I medication aide may receive a telephone or other verbal order only for a medication or treatment that the technician or level I medication aide is authorized to administer. If a telephone or other verbal order is given to a medication technician or level I medication aide, an initial dosage shall not be administered until the order has been reviewed by telephone, facsimile or in person by a licensed nurse or pharmacist. The review shall be documented by the reviewer co-signing the telephone or other verbal order.

(D) The review shall be documented by the licensed nurse’s or pharmacist’s signature within seven (7) days. III (E) The facility shall submit to the physician written versions of any oral or telephone orders within four (4) days of the giving of the oral or telephone order. III (F) Influenza and pneumococcal polysaccharide immunizations may be administered per physician-approved facility policy after assessment for contraindications— 1. The facility shall develop a policy that provides recommendations and assessment parameters for the administration of such immunizations. The policy shall be approved by the facility medical director for facilities having a medical director, or by each resident’s attending physician for facilities that do not have a medical director, and shall include the requirements to— A. Provide education to each resident or the resident’s designee or legally authorized representative regarding the potential benefits and side effects of the immunization; II/III B. Offer the immunization to the resident or obtain permission from the resident’s designee or legally authorized representative when the immunization is medically indicated unless the resident has already been immunized as recommended by the policy; II/III C. Provide the opportunity to refuse the immunization; and II/III D. Perform an assessment for contraindications; II/III 2. The assessment for contraindications and documentation of the education and opportunity to refuse the immunization shall be dated and signed by the nurse performing the assessment and placed in the medical record; or 3. The facility shall with the approval of each resident’s physician, access screening and immunization through outside sources such as county or city health departments. II/III (G) The administration of medication shall be recorded on a medication sheet or directly in the resident’s record and, if recorded on a medication sheet, shall be made part of the resident’s record. The administration shall be recorded by the same individual who prepares the medication and administers it. II/III (48) The facility may keep an emergency medication supply if approved by a pharmacist or physician. Storage and use of medications in the emergency medication supply shall assure accountability. When the emergency medication supply contains controlled substances, the facility shall be registered with the Bureau of Narcotics and Dangerous Drugs (BNDD) and shall be in compliance with 19 CSR 30-1.052 and other applicable state and federal controlled substance laws and regulations. II/III (49) Automated dispensing systems may be controlled by the facility or may be controlled on-site or remotely by a pharmacy.

(A) Automated dispensing systems may be used for an emergency medication supply.

(B) Automated dispensing systems that are controlled by a pharmacy may be used for continuing doses of controlled substance and non-controlled substance medications. When continuing doses are administered from an automated dispensing system that is controlled by a pharmacy, a pharmacist shall review and approve each new medication order prior to releasing the medication from the system. The pharmacy and the facility may have a policy and procedure to allow the release of initial doses of approved medications when a pharmacist is not available in lieu of a separate emergency medication supply. When initial doses are used when a pharmacist is not available, a pharmacist shall review and approve the order within twenty-four (24) hours of administration of the first dose.

(C) Automated dispensing systems shall be used in compliance with state and federal laws and regulations. When an automated dispensing system controlled by the facility contains controlled substances for an emergency medication supply, the facility shall be registered with the BNDD. When an automated dispensing system is controlled by a pharmacy, the facility shall use it in compliance with 20 CSR 2220-2.900. II/III (50) Stock supplies of nonprescription medication may be kept when specific medications are approved in writing by a consulting physician, a registered nurse or a pharmacist. II/III (51) Records shall be maintained upon receipt and disposition of all controlled substances and shall be maintained separately from other records, for two (2) years.

(A) Inventories of controlled substances shall be reconciled 1. Controlled Substance Schedule II medications shall be reconciled each shift; and II 2. Controlled Substance Schedule III–V medications shall be reconciled at least weekly and as needed to ensure accountability. II (B) Inventories of controlled substances shall be reconciled by the following:

Two (2) medication personnel, one of whom is a licensed nurse; or 2. Two (2) medication personnel, who are certified medication technicians or level I medication aides, when a licensed nurse is not available. II (C) Receipt records shall include the date, source of supply, resident name and prescription number when applicable, medication name and strength, quantity and signature of the supplier and receiver. Administration records shall include the date, time, resident name, medication name, dose administered and the initials of the individual administering. The signature and initials of each medication staff documenting on the medication administration record must be signed in the signature area of the medication record. II (D) When self-control of medication is approved a record shall be made of all controlled substances transferred to and administered from the resident’s room. Inventory reconciliation shall include controlled substances transferred to the resident’s room. II (52) Documentation of waste of controlled substances at the time of administration shall include the reason for the waste and the signature of another facility medication staff member who witnesses the waste. If a second medication staff member is not available at the time of administration, the controlled substance shall be properly labeled, clearly identified as unusable, stored in a locked area, and destroyed as soon as a medication staff member is available to witness the waste.

When a second medication staff member is not available and the controlled substance is contaminated by patient body fluids, the controlled substance shall be destroyed immediately and the circumstances documented. II/III (53) At least every other month, a pharmacist or registered nurse shall review the controlled substance recordkeeping including reconciling the inventories of controlled substances.

This shall be done at the time of the drug regimen review of each resident. All discrepancies in controlled substance records shall be reported to the administrator for review and investigation. The theft or loss of controlled substances shall be reported as follows:

(A) The facility shall notify the department’s Section for Long Term Care (SLTC) and other appropriate authorities of any theft or significant loss of any controlled substance medication written as an individual prescription for a specific resident upon the discovery of the theft or loss. The facility shall consider at least the following factors in determining if a loss is significant:

The actual quantity lost in relation to the total quantity;
The specific controlled substance lost;
Whether the loss can be associated with access by specific individuals;
Whether there is a pattern of losses, and if the losses appear to be random or not;
Whether the controlled substance is a likely candidate for diversion; and 6. Local trends and other indicators of diversion potential;

The documentation shall include the reason for determining that the loss was insignificant; and (C) When the facility is registered with the BNDD, the facility shall report to or document for the BNDD any loss of any stock supply controlled substance in compliance with 19 CSR 30- 1.034. II/III (54) A physician, pharmacist or registered nurse shall review the medication regimen of each resident. This shall be done at least every other month. The review shall be performed in the facility and shall include, but shall not be limited to, indication for use, dose, possible medication interactions and medication/ food interactions, contraindications, adverse reactions and a review of the medication system utilized by the facility.

Irregularities and concerns shall be reported in writing to the resident’s physician and to the administrator/manager. If after thirty (30) days there is no action taken by a resident’s physician and significant concerns continue regarding a resident’s or residents’ medication order(s), the administrator shall contact or recontact the physician to determine if he or she received the information and if there are any new instructions. II/III (55) All medication errors and adverse reactions shall be promptly documented and reported to the administrator and the resident’s physician. If the pharmacy made a dispensing error, it shall also be reported to the issuing pharmacy. II/III (56) Medications that are not in current use shall be disposed of as follows:

(A) Single doses of contaminated, refused, or otherwise unusable non-controlled substance medications may be destroyed by any authorized medication staff member at the time of administration. Single doses of unusable controlled substance medications may be destroyed according to section (52) of this rule;

(E) Medications may be returned to the pharmacy that dispensed the medications pursuant to 20 CSR 2220-3.040 or returned pursuant to the Prescription Drug Repository Program,

19 CSR 20-50.020. All other medications, including all controlled substances and all expired or otherwise unusable medications, shall be destroyed within thirty (30) days as follows: {#sec-19-csr-20-50.020. omnilex-key=us-mo-regs-official--title-19--19 CSR 20-50.020.}

Medications shall be destroyed within the facility by a pharmacist and a licensed nurse or by two (2) licensed nurses or when two (2) licensed nurses are not available on staff by two (2) individuals who have authority to administer medications, one (1) of whom shall be a licensed nurse or a pharmacist; and 2. A record of medication destroyed shall be maintained and shall include the resident’s name, date, medication name and strength, quantity, prescription number, and signatures of the individuals destroying the medications; and (F) A record of medication released or returned to the pharmacy shall be maintained and shall include the resident’s name, date, medication name and strength, quantity, prescription number, and signatures of the individuals releasing and receiving the medications. II/III (57) Residents experiencing short periods of incapacity due to illness or injury or recuperation from surgery may be allowed in or be readmitted to the facility. II (58) The facility shall maintain a record in the facility for each resident, which shall include the following:

(A) Admission information including the resident’s name;

Medicaid numbers (if applicable); name, address and telephone number of the resident’s physician and alternate; diagnosis, name, address and telephone number of the resident’s legally authorized representative or designee to be notified in case of emergency; and preferred dentist, pharmacist and funeral director; III (B) A review monthly or more frequently, if indicated, of the resident’s general condition and needs; a monthly review of medication consumption of any resident controlling his or her own medication, noting if prescription medications are being used in appropriate quantities; a daily record of administration of medication; a logging of the medication regimen review process; a monthly weight; a record of each referral of a resident for services from an outside service; and a record of any resident incidents including behaviors that present a reasonable likelihood of serious harm to himself or herself or others and accidents that potentially could result in injury or did result in injuries involving the resident; and (C) Any physician’s orders. The facility shall submit to the physician written versions of any oral or telephone orders within four (4) days of the giving of the oral or telephone order.

III (59) A record of the resident census shall be retained in the (60) Resident records shall be maintained by the operator for at least five (5) years after a resident leaves the facility or after longer and must include reason for discharge or transfer from the facility and cause of death, as applicable. III (61) Staffing Requirements.

(A) The facility shall have an adequate number and type of personnel for the proper care of residents, the residents’ social well being, protective oversight of residents and upkeep of the (15) residents or major fraction of fifteen (15) during the day shift, one (1) person for every twenty (20) residents or major fraction of twenty (20) during the evening shift and one (1) person for every twenty-five (25) residents or major fraction of twenty-five (25) during the night shift. I/II 3 p.m. to 9 p.m. (Evening)* 1 3–20 9 p.m. to 7 a.m. (Night)* 1 3–25 (B) The administrator shall count toward staffing when physically present in the facility. II (C) The required staff shall be in the facility awake, dressed (D) Meeting these minimal staffing requirements may not meet the needs of residents as outlined in the residents’ assessments and individualized service plans. I/II (E) There shall be a licensed nurse employed by the facility to work at least eight (8) hours per week at the facility for every thirty (30) residents or additional major fraction of thirty (30). The nurse’s duties shall include, but shall not be limited to, review of residents’ charts, medications, and special diets or other orders, review of each resident’s adjustment to the facility, and observation of each individual resident’s general physical and mental condition. The nurse shall inform the administrator of any problems noted, and these shall be brought to the attention of the resident’s physician. II/III (62) Prior to or on the first day that a new employee works in the facility he or she shall receive orientation of at least two (2) hours appropriate to his or her job function. This shall include at least the following:

(A) Job responsibilities;

(B) Emergency response procedures;

(D) Confidentiality of resident information;

(E) Preservation of resident dignity;

(F) Information regarding what constitutes abuse/neglect and how to report abuse/neglect to the department (1-800-392- 0210);

(G) Information regarding the Employee Disqualification List;

(H) Instruction regarding the rights of residents and protection of property;

(I) Instruction regarding working with residents with mental illness; and (J) Instruction regarding person-centered care and the concept of a social model of care, and techniques that are effective in enhancing resident choice and control over his or her own environment. II/III (63) In addition to the orientation training required in section (62) of this rule any facility that provides care to any resident having Alzheimer’s disease or related dementia shall provide orientation training regarding mentally confused residents such as those with Alzheimer’s disease and related dementias (A) For employees providing direct care to such persons, the orientation training shall include at least three (3) hours of training including at a minimum an overview of mentally confused residents such as those having Alzheimer’s disease and related dementias, communicating with persons with dementia, behavior management, promoting independence in activities of daily living, techniques for creating a safe, secure and socially oriented environment, provision of structure, stability and a sense of routine for residents based on their needs, and understanding and dealing with family issues; and (B) For other employees who do not provide direct care for, but may have daily contact with, such persons, the orientation training shall include at least one (1) hour of training including at a minimum an overview of mentally confused residents such as those having dementias as well as communicating with persons with dementia; and II/III (C) For all employees involved in the care of persons with dementia, dementia-specific training shall be incorporated into ongoing in-service curricula. II/III (64) All in-service or orientation training relating to the special needs, care and safety of residents with Alzheimer’s disease and other dementia shall be conducted, presented or provided by an individual who is qualified by education, experience or knowledge in the care of individuals with Alzheimer’s disease or other dementia. II/III (65) Requirements for training related to safely transferring residents.

(A) The facility shall ensure that all staff responsible for transferring residents are appropriately trained to transfer residents safely. Individuals authorized to provide this training include a licensed nurse, a physical therapist, a physical therapy assistant, an occupational therapist or a certified occupational therapy assistant. The individual who provides the transfer training shall observe the caregiver’s skills when checking competency in completing safe transfers, shall document the date(s) of training and competency and shall sign and maintain training documentation. Initial training shall include a minimum of two (2) classroom instruction hours in addition to the on-the-job training related to safely transferring residents who need assistance with transfers. II/III (B) The facility shall ensure that a minimum of one (1) hour of transfer training is provided by a licensed nurse annually regarding safe transfer skills. II/III

rule filed Aug. 23, 2006, effective April 30, 2007. Amended: Filed March 13, 2008, effective Oct. 30, 2008. Amended: Filed March 1, 2012, effective Sept. 30, 2012. ** Amended: Filed Nov. 3, 2025, effective May 30, 2026. *Original authority: 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006, 2007, and **Pursuant to Executive Order 21-07, 19 CSR 30-86.047, section (26) was suspended from April 17, 2020 through May 1, 2021 and sections (18) and (19) was suspended from April 17, 2020 through August 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 30-86.047, section (54) was suspended from April 17, 2020 through September 3, 2021; subsection (20)(I), sections (3), (10), (45), (46), and

section 198.073.4, RSMo was suspended from April 15, 2020 through December 31, 2021; and sections (9) and (45) was suspended from April 17, 2020 through December 31, 2021.

History

AUTHORITY: sections 198.073 and 198.076, RSMo 2016. Original

19 CSR 30-86.052 Dietary Requirements for Residential Care Facilities and Assisted Living Facilities {#sec-19-csr-30-86.052 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-86.052}

PURPOSE: This rule establishes standards for meeting dietary needs of residents in residential care facilities I and II. designated in section 198.085.1, RSMo 1986.

(1) Each resident shall be served food prepared and served under safe, sanitary conditions that is prepared consistent with the preferences of the resident and in accordance with attending physician’s orders. The nutritional needs of the residents shall be met. Balanced nutritious meals using a variety of foods shall be served. Consideration shall be given to the food habits, preferences, medical needs and physical abilities of the residents. II/III (2) Each resident shall receive and the facility shall provide at least three (3) meals daily, at regular times comparable to normal mealtimes in the community. At least two (2) meals daily shall be hot. II/III (3) There shall be no more than fourteen (14) hours between a substantial evening meal and breakfast the following day, except when a nourishing snack is provided at bedtime. Up to sixteen (16) hours may elapse between a substantial evening meal and breakfast the following day if a resident group agrees to this meal span, and a nourishing snack is served. III (4) Fresh water shall be available to the resident at all times.

(5) Dining room service for residents shall be attractive and each resident shall receive appropriate table service. III (6) Menus shall be planned in advance and shall be readily available for personnel involved in food purchase and preparation. Food shall be served as planned although substitutes of equal nutritional value and complementary to the remainder of the meal can be made if recorded. III (7) A three (3)-day supply of food shall be maintained in the (8) If a physician prescribes in writing a modified diet for a resident, the resident may be accepted or remain in the facility if— (A) The physician monitors the resident’s condition on a regular periodic basis and at least quarterly; II (B) The diet, food preparation and serving is reviewed at least quarterly by a consulting nutritionist, dietitian, registered nurse or physician and there is written documentation of the review; II/III (C) The modified diet menu is posted in the kitchen and includes portions to be served; III and (D) The facility has entered into a written agreement for dietary consultation with a nutritionist, dietitian registered nurse or physician. III (9) Nothing in this rule shall be construed as taking precedence over the resident’s right to make decisions regarding his or her eating and dining preferences.

(A) In assisted living facilities, information about the resident’s eating and dining preferences shall be incorporated in his or her individualized service plan based on an assessment that includes the resident’s culture, life-long routines, habits, patterns and preferences. III (B) In assisted living facilities, if the resident’s eating and dining preferences have a potential health risk, staff shall inform the resident or his or her legally authorized representative of the potential health risks and document this in his or her individualized service plan. III

Emergency amendment filed Aug. 1, 1984, effective Aug. 13, 1984, expired Dec. 10, 1984. Amended: Filed Sept. 12, 1984, effective Dec. 13, 1984. Amended: Filed Aug. 1, 1988, effective Nov. 10, 1988.

Moved to 19 CSR 30-86.052, effective Aug. 28, 2001. Amended: Aug. 23, 2006, effective April 30, 2007. *Original authority: 198.005, RSMo 2006; 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006; and 198.076, RSMo 1979, amended 1984.

History

AUTHORITY: sections 198.076, RSMo 2000 and 198.005 and 198.073, RSMo Supp. 2006. This rule originally filed as 13 CSR 15-15.052. Original rule filed July 13, 1983, effective Oct. 13, 1983.

Chapter 87 Sanitation Requirements for Long-Term Care Facilities

19 CSR 30-87.010 Definitions {#sec-19-csr-30-87.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-87.010}

PURPOSE: This rule defines terms used in relation to sanitation requirements for longterm care facilities.

(1) Adulterated means the condition of a food if it bears or contains any poisonous or deleterious substance in a quantity which may render it injurious to health; if it bears or contains any added poisonous or deleterious substance for which no safe tolerance has been established by rules, or in excess of tolerance if one has been established; if it consists in whole or in part of any filthy, putrid or decomposed substance, or if it is otherwise unfit for human consumption; if it has been processed, prepared, packed or held under unsanitary conditions, where it may have been rendered injurious to health; if it is in whole or in part the product of a diseased animal or an animal which has died other than by slaughter; or if its container is composed in whole or in part of any poisonous or deleterious substance which may render the contents injurious to health.

(2) Commissary means a catering establishment, restaurant or any other place in which food, containers or supplies are kept, handled, prepared, packaged or stored.

(3) Corrosion-resistant materials means those materials that maintain their original surface characteristics under prolonged influence of the food to be contacted, the normal use of cleaning compounds and bactericidal solutions and other conditions-of-use environment.

(4) Easily cleanable means that surfaces are readily accessible and made of materials and finish and so fabricated that residue may be effectively removed by normal cleaning methods.

(5) Food service employee means individuals having supervisory or management duties and any other person working in a food-service area of a long-term care facility.

(6) Equipment means stoves, ovens, ranges, hoods, slicers, mixers, meat blocks, tables, counters, refrigerators, sinks, dishwashing machines, steam tables and similar items (other than utensils) used in the operation of a food-service establishment.

(7) Food means any raw, cooked or processed edible substance, ice, beverage or ingredient used or intended for use or for sale in whole or in part for human consumption.

(8) Food-contact surface means any surface of equipment and utensils with which food normally comes in contact and any surface from which food may drain, drip or splash back onto surfaces normally in contact with food.

(9) Food-service area means any place where food is prepared and intended for individualportion service and includes the site at which individual portions are provided. The term includes any such place regardless of whether consumption is on or off the premises and regardless of whether there is a charge for the food. The term also includes delicatessentype operations that prepare sandwiches intended for individual-portion services. The term does not include private homes where food is prepared or served for individual family consumption, retail food stores, the location of food vending machines and supply vehicles.

(10) Hermetically-sealed container means a container designed and intended to be secure against the entry of microorganisms and to maintain the commercial sterility of its content after processing.

(11) Kitchenware means all multiuse utensils other than tableware.

(12) Law includes federal, state and local statutes, ordinances and regulations.

(13) Packaged means bottled, canned, cartoned or securely wrapped.

(14) Person includes any individual, partnership, corporation, association or other legal entity. Person in charge means the individual present in a food-service establishment who is the apparent supervisor of the food-service establishment at the time of inspection. If no individual is the apparent supervisor, then any employee present is the person in charge.

(15) Potentially hazardous food means any food that consists in whole or part of milk or milk products; eggs, meat, poultry, fish, shellfish, edible crustacea or other ingredients, including synthetic ingredients, in a form capable of supporting rapid and progressive growth of infectious or toxigenic microorganisms. The term does not include clean, whole, uncracked, odor-free shell eggs or foods which have a pH level of four and six-tenths (4.6) or below or a water activity (a w ) value of eighty-five hundredths (0.85) or less.

(16) Reconstituted means dehydrated food products recombined with water or liquids.

(17) Safe materials means articles manufactured from or composed of materials that may not reasonably be expected to result, directly or indirectly, in their becoming a component or otherwise affecting the characteristics of any food. All materials are safe only if they are in compliance with the state Food Drug and Cosmetic Act in sections 196.010–180, RSMo (1986) and the federal Food, Drug and Cosmetic Act and are used in conformity with all applicable regulations.

(18) Sanitization means effective bactericidal treatment by a process that provides enough accumulative heat or concentration of chemicals for sufficient time to reduce the bacterial count, including pathogens, to a safe level on utensils and equipment.

(19) Sealed means free of cracks or other openings that permit the entry or passage of moisture.

(20) Single-service articles means cups, containers, lids, closures, plates, knives, forks, spoons, stirrers, paddles, straws, napkins, wrapping materials, toothpicks and similar articles intended for one (1)-time, one (1)person use and then discarded.

(21) Tableware means multiuse eating and drinking utensils.

(22) Utensil means any implement used in the storage, preparation, transportation or service of food.

History

AUTHORITY: section 198.009, RSMo 1986. This rule originally filed as 13 CSR 15- 17.010. Original rule filed July 13, 1983, effective Oct. 13, 1983. Moved to 19 CSR 30- 87.010, effective Aug. 28, 2001. Original authority: 198.009, RSMo 1979, amended 1993, 1995.

19 CSR 30-87.020 General Sanitation Requirements for New and Existing Long- Term Care Facilities {#sec-19-csr-30-87.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-87.020}

PURPOSE: This rule establishes standards related to general sanitation and housekeeping in a long-term care facility to protect the health and safety of the residents.

Therefore, the material which is so incorporated is on file with the agency who filed this

Editor’s Note: All rules relating to long-term care facilities licensed by the department are followed by a Roman Numeral notation which refers to the class (either Class I, II or III) of standard as designated in section 198.085.1, RSMo.

(1) All parts of property used in connection with the operation of the facility shall be kept free of litter. Only articles necessary for the operation or maintenance of the facility shall be stored on the premises. III (2) The walking and driving surfaces of all exterior areas of the facility shall be surfaced with concrete or asphalt, or with gravel or similar material effectively treated to facilitate maintenance and minimize dust. These surfaces shall be graded to prevent pooling and shall be kept free of litter. III (3) There shall be present in the facility only those poisonous or toxic materials necessary for maintaining the establishment, cleaning and sanitizing equipment and utensils and controlling insects and rodents. II (4) Containers of poisonous or toxic materials shall be prominently and distinctly labeled according to law for easy identification of contents. II (5) Poisonous or toxic materials consist of the following categories: insecticides and rodenticides; disinfectants, sanitizer and related cleaning or drying agents; and caustics, acids, polishes and other chemicals. Each of these three (3) categories set forth shall be stored and physically located separate from each other. All poisonous or toxic materials shall be stored in locked cabinets or in a similar physically separate place used for no other purpose which is not accessible to residents. II (6) Bactericides, cleaning compounds or other compounds intended for use on foodcontact surfaces shall not be used in a way that leaves a toxic residue on surfaces or that constitutes a hazard to residents, employees or other persons. II (7) Poisonous or toxic materials shall not be used in a way that contaminates food, equipment or utensils, nor in a way that constitutes a hazard to residents, employees or other persons, nor in a way other than in full compliance with the manufacturer’s labeling. II (8) All rooms shall have sufficient ventilation to keep them free of excessive heat, steam, condensation, vapors, obnoxious odors, smoke and fumes. Ventilation systems shall be installed and operated according to law and, when vented to the outside, shall not create an unsightly, harmful or unlawful discharge. I/II (9) Intake and exhaust air ducts shall be maintained to prevent the entrance of dust, dirt and other contaminating materials. III (10) In new or extensively remodeled facilities, all rooms from which obnoxious odors, vapors or fumes originate shall be mechanically vented to the outside. II (11) Deodorizers or sprays shall not be used to cover up odors. Odors shall be eliminated to the source by prompt cleaning of bed pans and commodes, floors, furniture and equipment and by proper ventilation. II/III (12) All floors in the facility shall be clean and shall be maintained in good repair.

Floors and floor coverings of all food-preparation, food-storage and utensil-washing areas, and the floors of all walk-in refrigerating units, dressing rooms, locker rooms, toilet rooms and vestibules shall be constructed of smooth durable material such as sealed concrete, terrazzo, ceramic tile, durable grades of linoleum or plastic, or tight wood impregnated with plastic. Nothing in this section shall prohibit the use of antislip floor covering in areas where necessary for safety reasons. III (13) Carpeting, if used as a floor covering, shall be of closely woven construction, properly installed, easily cleanable and maintained in good repair. Carpeting is prohibited in food-preparation, equipment-washing and utensil-washing areas where it would be exposed to large amounts of grease and water, in food-storage areas and toilet room areas where urinals or toilet fixtures are located. III (14) Mats and duckboards shall be of nonabsorbent, grease-resistant materials and of that size, design and construction as to facilitate their being easily cleaned. Duckboards shall not be used as storage racks. III (15) Walls and ceilings, including doors, windows and skylights, shall be clean and maintained in good repair. III (16) Wall- and ceiling-covering materials shall be attached and sealed so as to be easily cleanable.

(17) The walls, including nonsupporting partitions, wall coverings and ceilings of walk-in refrigerating units, food-preparation areas, equipment-washing and utensil-washing areas, toilet rooms and vestibules shall be smooth, nonabsorbent and easily cleanable.

Concrete or pumice blocks used for interior wall construction in these locations shall be finished and sealed to provide an easily cleanable surface. III (18) Studs, joists and rafters, shall not be exposed in walk-in refrigerating units, foodpreparation areas, equipment-washing areas, toilet rooms and vestibules. III (19) Light fixtures, vent covers, wall-mounted fans, decorative materials and similar equipment attached to walls and ceilings shall be easily cleanable and shall be maintained clean and in good repair. III (20) Cleaning of floors and walls, except emergency cleaning of floors, shall be done during periods when the least amount of food is exposed, such as between meals. Mops used for cleaning bathrooms shall be disinfected after use and before using in other areas. III (21) In new or extensively remodeled facilities for more than twelve (12) residents at least one (1) utility sink or curbed facility with a floor drain shall be provided and used for the cleaning of mops or similar wet-floor cleaning tools and for the disposal of mop water or similar liquid wastes. The use of lavatories, utensil washing or equipment washing or food-preparation sinks for this

purpose is prohibited. III (22) Enough potable water for the needs of the facility shall be provided from a source constructed and operated according to law.

Compliance is required with sections 1401, 1411, 1414, 1431 and 1445 of the Public Service Act as amended by the Safe Drinking Water Act, Public Law 93—523 CFR 11990 4CODE OF STATE REGULATIONS as set forth in 10 CSR 60. Water shall be from a source approved by the regulating agency. I/II (23) All potable water not provided directly by pipe to the facility from the source shall be transported in a bulk water-transport system and shall be delivered to a closed-water system. Both of these systems shall be constructed and operated according to law. I/II (24) All sewage, including liquid waste, shall be disposed of by public sewage system or by a sewage disposal system constructed and operated according to law. Nonwater-carried sewage disposal facilities are prohibited. II (25) Plumbing shall be sized, installed and maintained according to the National Plumbing Code. II/III (26) There shall be no cross-connection between the potable water supply nor any source of pollution through which the potable water supply might become contaminated. II (27) A nonpotable water system is permitted only for purposes such as air conditioning and fire protection and only if the system is installed according to law and the nonpotable water does not contact, directly or indirectly, food, potable water, equipment that contacts food or utensils. The piping of any nonpotable water system shall be durably identified so that it is readily distinguishable from piping that carries potable water. II (28) The potable water system shall be installed to preclude the possibility of backflow. Devices shall be installed to protect against backflow and back siphonage at all fixtures and equipment where an air gap at least twice the diameter of the water supply inlet is not provided between the water supply inlet and the fixture’s flood level rim. A hose shall not be attached to a faucet unless a backflow prevention device is installed. II (29) Except for properly trapped open sinks, there shall be no direct connection between the sewage system and any drains originating from equipment in which food, portable equipment or utensils are placed. When a dishwashing machine is located within five feet (5') of a trapped floor drain, the dishwasher waste outlet may be connected directly on the inlet side of a properly vented floor drain trap if permitted by law. II (30) Garbage and refuse shall be kept in durable, easily-cleanable, insect-proof and rodent-proof containers that do not leak and do not absorb liquids. Plastic bags and wetstrength paper bags may be used to line these containers, and they may be used for storage inside the facility. III (31) Waste containers used in food-preparation and utensil-washing areas shall be kept covered when not in actual use. III (32) Waste containers stored outside the establishment and dumpsters, compactors and compactor systems shall be easily cleanable, shall be provided with tight-fitting lids, doors or covers and shall be kept covered when not in actual use. In containers designed with drains, drain plugs shall be in place at all times, except during cleaning. III (33) Cardboard or other packaging material not containing garbage or food wastes need not be stored in covered containers. III (34) Soiled containers shall be cleaned at a frequency to prevent insect and rodent attraction. Liquid waste from compacting or cleaning operations shall be disposed of as sewage.

(35) Garbage or refuse storage rooms, if used, shall be constructed of easily cleanable, nonabsorbent, washable materials, shall be kept clean, shall be insect-proof and rodentproof and shall be large enough to store the garbage and refuse containers that accumulate. III (36) Outside storage areas or enclosures shall be large enough to store the garbage and refuse containers that accumulate and shall be kept clean. III (37) Garbage and refuse shall be disposed of often enough to prevent the development of odor and the attraction of insects and rodents.

(38) Where refuse is burned on the premises, it shall be done in accordance with fire safety regulations. III (39) Effective measures intended to minimize the presence of rodents, flies, cockroaches and other insects on the premises shall be utilized. The premises shall be kept in such condition as to prevent the harborage or feeding of insects or rodents. II/III (40) Openings to the outside shall be effectively protected against the entrance of rodents. Outside openings shall be protected against the entrance of insects by tight-fitting, self-closing doors, closed windows, screening, control of air currents or other means.

Screen doors shall be self-closing and screens for windows, doors, skylights, transoms, intake and exhaust air ducts, and other openings to the outside shall be tight-fitting and free of breaks. Screening material shall not be less than sixteen (16) mesh to the inch. II/III (41) Toilet rooms shall be conveniently located and easily accessible to residents and employees. Toilet rooms shall be completely enclosed. Toilet fixtures shall be kept clean and in good repair. A supply of toilet tissue shall be provided at each toilet at all times.

Easily cleanable receptacles shall be provided for waste materials. Toilet rooms used by women employees shall have at least one (1) covered waste receptacle. III (42) Lavatories shall also be located in or immediately adjacent to toilet rooms or vestibules and shall be easily accessible to residents and employees. Lavatories shall be located to permit convenient use by all employees in food-preparation areas and utensil-washing areas. In new facilities, sinks used for food-preparation or for washing equipment or utensils shall not be used for handwashing. III (43) Each lavatory, bathtub or shower shall be provided with hot and cold water tempered by means of mixing valve or combination faucet.

Any self-closing, slow-closing or metering faucet used shall be designed to provide a flow of water for at least fifteen (15) seconds without the need to reactivate the faucet.

Steam-mixing valves are prohibited. III (44) A supply of hand-cleansing soap or detergent shall be available at each employeeuse lavatory. A supply of sanitary towels or a hand-drying device providing heated air shall be conveniently located near each lavatory, except that hand towels for individual use are permitted. Common towels are prohibited. If disposable towels are used, easily cleanable waste receptacles shall be conveniently located near the hand-washing facilities. III (45) Lavatories, soap dispensers, hand-drying devices and all related fixtures shall be kept clean and in good repair. III (46) If employees routinely change clothes within the facility, rooms or areas shall be designated and used for that purpose. These designated rooms or areas shall not be used for food preparation, storage or service, or for utensil washing or storage. Lockers or other suitable facilities shall be provided and used for the orderly storage of employee clothing and other belongings. Lockers or other suitable facilities may be located only in the designated dressing rooms or in foodstorage rooms or areas containing only completely packaged food or packaged single-service articles. III (47) Laundry facilities shall be so designed and procedures instituted to prevent crosscontamination of clean and dirty linen. II (48) If laundry for the facility is done commercially, either entirely or in part, space shall be provided for sorting, processing and storing soiled linen. II/III (49) Storage space shall be located to facilitate convenient pickup and delivery by commercial laundry. III (50) Equipment shall be provided to prewash linen soiled by incontinent residents before it is sent to the laundry. II/III (51) For intermediate care and skilled nursing facilities, existing assisted living facilities and new residential care facilities and assisted living facilities licensed for more than twelve (12) residents, if laundry is done in the facility entirely or partially, the laundry room shall be in a separate room from the kitchen, the residents’ room(s), the sitting or living room and the bathrooms or the nursing utility room. Adequate space shall be provided in the laundry room for storing, sorting and processing soiled linen. Table linen shall be laundered separately from bed linen, towels and clothing. Space shall be provided for storing clean linen in a separate room from the laundry. Nothing in this rule shall prohibit a facility from providing a laundry area for use by residents. II/III (52) Provision shall be made for the proper care of soiled linen and clean linen on each floor of each building. A laundry hamper, with lid, laundry chute or some other suitable arrangement shall be provided. II/III (53) Soiled clothes and linens shall be stored in nonabsorbent containers or washable laundry bags and shall be transported for laundering in tightly enclosed bags or containers.

Nothing in this rule shall require residents to use tightly enclosed bags or containers when transporting their personal laundry items to the resident laundry area referred to in section (51). III (54) Linen soiled by incontinent residents shall be washed or prewashed immediately.

(55) Clean clothes and linens shall be stored in a clean place and protected from contamination until used. III

Filed Aug. 1, 1988, effective Nov. 11, 1988.

Moved to 19 CSR 30-87.020, effective Aug. 28, 2001. Amended: Filed Aug. 23, 2006, effective April 30, 2007. *Original authority: 198.005, RSMo 2006; 198.009, RSMo 1979, amended 1993, 1995; and 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006.

History

AUTHORITY: sections 198.009, RSMo 2000 and 198.005 and 198.073, RSMo Supp. 2006. This rule originally filed as 13 CSR 15-17.020. Original rule filed July 13, 1983, effective Oct. 13, 1983. Emergency rule filed Aug. 1, 1984, effective Aug. 13, 1984, expired Dec. 10, 1984. Amended: Filed Sept. 12, 1984, effective Dec. 13, 1984. Amended:

19 CSR 30-87.030 Sanitation Requirements for Food Service {#sec-19-csr-30-87.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-87.030}

PURPOSE: This rule establishes standards related to food supplies, food protection and storage, food preparation and handling, food service, food equipment and utensils, dishwashing methods and other general requirements related to the food preparation and service area. These rules have been adapted from the 1976 recommended ordinance governing food service establishments and established by the United States Food and Drug Administration.

This note applies only to the reference material. The entire text of the rule is printed here.

(1) Employees shall maintain a high degree of personal cleanliness and shall conform to good hygienic practices during all working periods. II/III (2) Employees shall thoroughly wash their hands and the exposed portions of their arms with soap and warm water before starting work, during work as often as is necessary to keep them clean and after smoking, eating, drinking or using the toilet. Employees shall keep their fingernails clean and trimmed.

(3) The outer clothing of all employees shall be clean and employees shall use effective hair restraints to prevent the contamination of food or food-contact surfaces. III (4) Employees shall consume food only in designated dining areas. An employee dining area shall not be so designated if consuming food there may result in contamination of other food, equipment, utensils or other items needing protection. Nothing in this section shall prohibit staff from dining with residents when the facility utilizes the social model for mealtime. III (5) Employees shall not use tobacco in any form while engaged in food preparation or service, nor while in areas used for equipment or utensil washing or for food preparation. Employees shall use tobacco only in designated areas. An employee tobacco-use area shall not be designated for that purpose if the use of tobacco there may result in contamination of food, equipment, utensils or other items needing protection. III (6) The traffic of unnecessary persons through the food-preparation and utensilwashing areas is prohibited. III (7) Food preparation and storage shall not be conducted in any room used as living or sleeping quarters. In a facility licensed for more than twelve (12) residents, except in an existing residential care facility, food service operations shall be separated from living or sleeping quarters by complete partitioning and solid, self-closing doors. Nothing in this

section shall prohibit an assisted living facility from providing kitchen and family style eating areas for use by residents. III (8) Maintenance and cleaning tools such as brooms, mops, vacuum cleaners and similar equipment shall be maintained and stored in a way that does not contaminate food, utensils, equipment or linens and shall be stored in an orderly manner. III (9) Live animals, including birds and turtles shall be excluded from the food storage service and preparation areas. This exclusion does not apply to edible fish, crustacea, 6CODE OF STATE REGULATIONS shellfish or to fish in aquariums. Patrol dogs accompanying security or police officers, or service or guide dogs assisting residents or visitors shall be permitted in dining areas.

Other dogs and cats may be permitted in the dining area if food service sanitation is not compromised and residents do not object. III (10) Birds within enclosed aviaries may be in the dining area with the following stipulations:

(A) The facility ensures the aviary is cleaned at least twice a week and more often as needed to maintain a clean environment;

(B) The facility provides proper hand washing instructions to those staff having access to the birds and monitors to ensure compliance; and III (C) The facility contacts the local or county Health Department and informs that department that an aviary has been installed.

(11) Food shall be in sound condition, free from spoilage, filth or other contamination and shall be safe for human consumption.

Food shall be obtained from sources that comply with all laws relating to food and food labeling. The use of food in hermetically sealed containers that was not prepared in a food processing establishment is prohibited.

Nothing in this section shall prohibit facilities from using fresh vegetables or fruits purchased from farmers’ markets or obtained from the facility garden or residents’ family gardens. I/II (12) Fluid milk and fluid milk products used or served shall be pasteurized and shall meet the Grade A quality standards as established by law. Dry milk and dry milk products shall be made from pasteurized milk products. I/II (13) At all times, including while being stored, prepared, displayed, served or transported to or from the facility, food shall be protected from potential contamination, including dust, insects, rodents, unclean equipment and utensils, unnecessary handling, coughs and sneezes, flooding, drainage and overhead leakage or overhead drippage from condensation. The temperature of potentially hazardous food shall be forty-five degrees Fahrenheit (45°F) or below or one hundred forty degrees Fahrenheit (140°F) or above at all times, except as otherwise provided in this section. In the event of a fire, flood, power outage or similar event that might result in the contamination of food, or that might prevent potentially hazardous food from being held at required temperatures, the person in charge shall immediately contact the Department of Health and Senior Services (the department). Upon receiving notice of this occurrence, the department shall take whatever action that it deems necessary to protect the residents. II/III (14) Food, whether raw or prepared, if removed from the container or package in which it was obtained, shall be stored in a clean covered container except during necessary periods of preparation or service.

Container covers shall be impervious and nonabsorbent except that linens or napkins may be used for lining or covering bread or roll containers. III (15) Containers of food shall be stored above the floor in a manner that protects the food from splash and other contamination and that permits easy cleaning of the storage area, except that metal pressurized beverage containers, and cased food packaged in cans, glass or other waterproof containers need not be elevated when the food container is not exposed to floor moisture; and containers may be stored on dollies, racks or pallets, provided the equipment is easily movable. III (16) Food and containers of food shall be stored in a manner which protect it from contamination. The storage of food in toilet rooms or vestibules is prohibited. II/III (17) Unless its identity is unmistakable, bulk food, such as cooking oil, syrup, salt, sugar or flour not stored in the product container or package in which it was obtained, shall be stored in a container identifying the food by common name. III (18) Enough conveniently located refrigeration facilities or effectively insulated facilities shall be provided to assure the maintenance of potentially hazardous food at required temperatures during storage. Each mechanically refrigerated facility storing potentially hazardous food shall be provided with a numerically scaled indicating thermometer, accurate to plus or minus three degrees Fahrenheit (±3°F), located to measure the air temperature in the warmest part of the refrigerated facility and located to be easily readable.

Recording thermometers, accurate to plus or minus three degrees Fahrenheit (±3°F), may be used in lieu of indicating thermometers. III (19) Potentially hazardous food requiring refrigeration after preparation shall be rapidly cooled to an internal temperature of fortyfive degrees Fahrenheit (45°F) or below, utilizing such methods as shallow pans, agitation, quick chilling or water circulation external to the food container so that the cooling period shall not exceed four (4) hours.

Potentially hazardous food to be transported shall be prechilled and held at a temperature of forty-five degrees Fahrenheit (45°F) or below. I/II (20) Frozen food shall be kept frozen and should be stored at a temperature of zero degrees Fahrenheit (0°F) or below. III (21) Ice intended for human consumption shall not be used as a medium for cooling stored food, food containers or food utensils, except that such ice may be used for cooling tubes conveying beverages or beverage ingredients to a dispenser head. Ice used for cooling stored food and food containers shall not be used for human consumption. III (22) Tubing conveying beverages or beverage ingredients to dispensing heads may be in contact with stored ice provided that, the tubing is fabricated from safe materials, is grommeted at entry and exit points to preclude moisture (condensation) from entering the ice machine or the ice storage bin and is kept clean. Drainage or drainage tubes from dispensing units shall not pass through the ice machine or the ice storage bin. III (23) Enough conveniently located hot food storage facilities shall be provided to assure the maintenance of food at the required temperature during storage. Each hot food facility storing potentially hazardous food shall be provided with a numerically scaled indicating thermometer, accurate to plus or minus three degrees Fahrenheit (±3°F), located to measure the air temperature in the coolest part of the hot food storage facility and located to be easily readable. Recording thermometers, accurate to plus or minus three degrees Fahrenheit (±3°F), may be used in lieu of indicating thermometers. Where it is impractical to install thermometers on equipment such as bains-maries, steam tables, steam kettles, heat lamps, calrod units or insulated food transport carriers, a product thermometer must be available and used to check internal food temperature. III (24) The internal temperature of potentially hazardous foods requiring hot storage shall be one hundred forty degrees Fahrenheit (140°F) or above, except during periods of preparation. Potentially hazardous food to be transported shall be held at a temperature of one hundred forty degrees Fahrenheit (140°F) or above. I/II (25) Raw fruits and vegetables shall be thoroughly washed with potable water before being cooked or served. II/III (26) Potentially hazardous foods requiring cooking shall be cooked to heat all parts of the food to a temperature of at least one hundred forty degrees Fahrenheit (140°F), except that poultry, poultry stuffings, stuffed meats and stuffings containing meat shall be cooked to heat all parts of the food to at least one hundred sixty-five degrees Fahrenheit (165°F) with no interruption of the cooking process. Pork and food containing pork shall be cooked to heat all parts of the food to at least one hundred fifty degrees Fahrenheit (150°F); rare roast beef shall be cooked to an internal temperature of at least one hundred thirty degrees Fahrenheit (130°F); and rare beef steak shall be cooked to a temperature of one hundred thirty degrees Fahrenheit (130°F) unless otherwise ordered by the resident. II/III (27) Liquid, frozen, dry eggs and egg products shall be used only for cooking and baking purposes. II/III (28) Only clean whole eggs, with shell intact and without cracks or checks, or pasteurized liquid or frozen, or dry eggs or pasteurized dry egg products shall be used, except that hard-boiled, peeled eggs, commercially prepared and packaged, may be used. II (29) Potentially hazardous foods that have been cooked and then refrigerated shall be reheated rapidly to one hundred sixty-five degrees Fahrenheit (165°F) or higher throughout before being served or before being placed in a hot food-storage facility. II (30) Steam tables, bains-maries, warmers and similar hot food-holding facilities are prohibited for the rapid reheating of potentially hazardous foods. II/III (31) Nondairy creaming, whitening or whipping agents may be reconstituted on the premises only when they will be stored in sanitized, covered containers not exceeding one (1) gallon in capacity and cooled to fortyfive degrees Fahrenheit (45°F) or below within four (4) hours after preparation. II/III (32) Metal stem-type numerically scaled indicating thermometers, accurate to plus or minus two degrees Fahrenheit (±2°F), shall be provided and used to assure the attainment and maintenance of proper internal cooking, holding or refrigeration temperatures of all potentially hazardous foods. II/III (33) Potentially hazardous foods shall be thawed in refrigerated units at a temperature not to exceed forty-five degrees Fahrenheit (45°F); or under potable running water at a temperature of seventy degrees Fahrenheit (70°F) or below, with sufficient water velocity to agitate and float off loose food particles into the overflow; or in a microwave oven only when the food will be immediately transferred to conventional cooking facilities as part of a continuous cooking process or when the entire, uninterrupted cooking process takes place in the microwave oven; or as

part of the conventional cooking process.

(34) At time of service to the resident, food shall be at least one hundred twenty degrees Fahrenheit (120°F) or forty-five degrees Fahrenheit (45°F) or below. II/III (35) Milk and milk products for drinking purposes shall be provided to the resident in an unopened, commercially filled package not exceeding one (1) pint in capacity, or shall be drawn from a commercially filled container stored in a mechanically refrigerated bulk milk dispenser, or shall be poured directly into glass(es) to be used by the resident(s) from a commercially filled gallon or half-gallon container provided the container is completely emptied in the process and then discarded, or if a portion of milk remains, that no milk may be returned to that container and is immediately refrigerated. Where a bulk dispenser for milk and milk products is not available and portions of less than one-half (1/2) pint are required for mixed drinks, cereal or dessert service, milk and milk products may be poured from a commercially filled container of not more than one (1) gallon capacity and no milk may be returned to that container. II/III (36) Reconstituted dry milk and dry milk products shall not be used for drinking purposes but may be used in instant desserts and whipped products, or for cooking and baking purposes. III (37) Cream or half-and-half or nondairy creaming agents or whitening agents shall be provided in an individual service container, protected pour-type pitcher or drawn from a refrigerated dispenser designed for such service. III (38) Condiments, seasoning and dressings for self-service use shall be provided in individual packages, from dispensers or from protected containers. III (39) Condiments provided for table or counter service shall be individually portioned, except that catsup and other sauces may be served in the original container or pour-type dispenser. Sugar for consumer shall be provided in individual packages or in pour-type dispensers. III (40) Ice shall be dispensed only with scoops, tongs or other ice-dispensing utensils or through automatic self-service, ice-dispensing equipment. Ice-dispensing utensils shall be stored on a clean surface or in the ice with the dispensing utensil’s handle extended out of the ice. Between uses, ice transfer receptacles shall be stored in a way that protects them from contamination. Ice storage bins shall be drained through an air gap. III (41) To avoid unnecessary manual contact with food, suitable preparation and dispensing utensils shall be used by employees or provided to consumers who serve themselves.

Between uses, during service, dispensing utensils shall be stored in a manner which would prevent contamination. III (42) Once served to a resident, portions of leftover food shall not be served again except that packaged food, other than potentially hazardous food, that is still packaged and is still in sound condition may be re-served. III (43) Food on display shall be protected from resident contamination by the use of packaging or by the use of easily cleanable counter, serving line or salad bar protector devices, display cases or by other effective means.

Enough hot or cold food facilities shall be available to maintain the required temperature of potentially hazardous foods on display. III (44) Equipment and utensils shall be constructed and repaired with safe materials including finishing materials; shall be corrosion-resistant and nonabsorbent; and shall be smooth, easily cleanable and durable under conditions of normal use. Single-service articles shall be made from clean, sanitary, safe materials. Equipment utensils and single-service articles shall not impart odors, color or taste nor contribute to the contamination of food. III (45) Hard maple or equivalently nonabsorbent material may be used for cutting blocks, cutting boards, salad bowls and baker’s tables. The use of wood as a foodcontact surface under other circumstances is prohibited. III 8CODE OF STATE REGULATIONS (46) Safe plastic or safe rubber or safe rubber-like materials that are resistant under normal conditions of use to scratching, scoring, decomposition, crazing, chipping and distortion, that are of sufficient weight and thickness to permit cleaning and sanitizing by normal dishwashing methods, and which meet the general requirements of this rule, are permitted for repeated use. III (47) Re-use of single service articles is prohibited. III (48) Food-contact surfaces shall be easily cleanable, smooth and free of breaks, open seams, cracks, chips, pits and similar imperfections and free of difficult-to-clean internal corners and crevices. Cast iron may be used as a food-contact surface only if the surface is heated, such as in grills, griddle tops and skillets. Threads shall be designed to facilitate cleaning; ordinary “V” type threads are prohibited in food-contact surfaces, except that in equipment such as ice makers or hot oil-cooking equipment and hot oil-filtering systems, these threads shall be minimized. III (49) Equipment containing bearings and gears requiring unsafe lubricants shall be designed and constructed so that the lubricant cannot leak, drip or be forced into food or onto food-contact surfaces. Only safe lubricants shall be used on equipment designed to receive lubrication of bearings and gears on or within food-contact surfaces. III (50) All sinks and drain boards shall be selfdraining. III (51) Unless designed for in-place cleaning, food-contact surfaces shall be accessible for cleaning and inspection without being disassembled; or by disassembling without the use of tools; or by easy disassembling with the use of only simple tools such as a mallet, a screwdriver or an open-end wrench kept available near the equipment. III (52) Equipment intended for in-place cleaning shall be so designed and fabricated that cleaning and sanitizing solutions can be circulated throughout a fixed system using an effective cleaning and sanitizing regimen; cleaning and sanitizing solutions will contact all interior food-contact surfaces; and the system is self-draining or capable of being completely evacuated. III (53) Fixed equipment designed and fabricated to be cleaned and sanitized by pressure spray methods shall have sealed electrical wiring, switches and connections. III (54) Surfaces of equipment not intended for contact with food, but which are exposed to splash or food debris or which otherwise require frequent cleaning, shall be designed and fabricated to be smooth, washable, free of unnecessary ledges, projections or crevices, and readily accessible for cleaning, and shall be of such material and in a repair as to be easily maintained in a clean and sanitary condition. III (55) Ventilation hoods and devices shall be designed to prevent grease or condensation from collecting on walls and ceilings and from dripping into food or onto food-contact surfaces. Filters or other grease-extracting equipment shall be readily removable for cleaning and replacement if not designed to be cleaned in place. III (56) Equipment that was installed in an existing licensed facility and that does not fully meet all of the design and fabrication requirements shall be deemed acceptable in that establishment if it is in good repair, capable of being maintained in a sanitary condition and the food-contact surfaces are nontoxic.

Replacement equipment and new equipment shall meet the requirements for design and fabrication. III (57) Equipment that is placed on tables or counters, unless portable, shall be sealed to the table or counter or elevated on legs to provide clearance between the table or counter and equipment and shall be installed to facilitate the cleaning of the equipment adjacent areas. Equipment is portable if it is small and light enough to be moved easily by one (1) person; and it has no utility connection, or has a utility connection that disconnects quickly, or has a flexible utility connection line of sufficient length to permit the equipment to be moved for easy cleaning. III (58) Floor-mounted equipment, unless readily movable, shall be sealed to the floor; or installed on a raised platform of concrete or other smooth masonry in a way that meets all of the requirements for sealing or floor clearance; or elevated on legs to provide clearance between the floor and equipment, except that vertically-mounted floor mixers may be elevated to provide at least a four inch (4")clearance between the floor and equipment if no part of the floor under the mixer is more than six inches (6") from the cleaning access.

Equipment is easily movable if it is mounted on wheels or casters; and it has no utility connection or has a utility connection that disconnects quickly, or has a flexible utility line of sufficient length to permit the equipment to be moved for easy cleaning. III (59) Unless sufficient space is provided for easy cleaning between, behind and above each unit of fixed equipment, the space between it and adjoining equipment units and adjacent walls or ceilings shall not be more than one-thirty-second inch (1/32"); or if exposed to seepage, the equipment shall be sealed to the adjoining equipment or adjacent walls or ceilings. III (60) Aisles and working spaces between units of equipment and walls shall be unobstructed and of sufficient width to permit employees to perform their duties readily without contamination of food or food-contact surfaces by clothing or personal contact. All easily movable storage equipment such as pallets, racks and dollies shall be positioned to provide accessibility to working areas. III (61) Tableware shall be washed, rinsed and sanitized after each use. II (62) Kitchenware and food-contact surfaces of equipment shall be washed, rinsed and sanitized after each use and following any interruption of operations during which time contamination may have occurred. Water pitchers which are for individual resident use shall be sanitized daily. II/III (63) Where equipment and utensils are used for the preparation of potentially hazardous foods on a continuous or production-line

basis, utensils and the food-contact surfaces of equipment shall be washed, rinsed and sanitized at intervals throughout the day on a schedule based on food temperature, type of food and amount of food particle accumulation. III (64) The food-contact surfaces of grills, griddles and similar cooking devices and the cavities and door seals of microwave ovens shall be cleaned at least once a day, except that this shall not apply to hot oil-cooking equipment and hot oil-filtering systems. The food-contact surfaces of all cooking equipment shall be kept free of encrusted grease deposits and other accumulated soil. III (65) Nonfood-contact surfaces of equipment shall be cleaned as often as is necessary to keep the equipment free of accumulation of dust, dirt, food particles and other debris. III (66) Cloths used for wiping food spills on tableware, such as plates or bowls being served to the consumer, shall be clean, dry and used for no other purpose. III (67) Moist cloths or sponges used for wiping food spills on kitchenware and food-contact surfaces of equipment shall be clean and rinsed frequently in one (1) of the permitted sanitizing solutions and used for no other

purpose. These cloths and sponges shall be stored in the sanitizing solution between uses.

Moist cloths or sponges used for cleaning nonfood-contact surfaces of equipment such as counters, dining table tops and shelves shall be clean and rinsed and used for no other purpose. These cloths and sponges shall be stored in the sanitizing solution between uses. III (68) For manual washing, rinsing and sanitizing of utensils and equipment, a sink with not fewer than three (3) compartments shall be provided and used. Sink compartments shall be large enough to permit the accommodation of the equipment and utensils and each compartment of the sink shall be supplied with hot and cold potable running water, except that in an existing licensed facility, the use of a two (2)-vat sink and a supplementary portable container to be used for sanitization is acceptable. Fixed equipment and utensils and equipment too large to be cleaned in sink compartment shall be washed manually or cleaned through pressure spray methods. III (69) Drain boards or easily movable dish tables of adequate size shall be provided for proper handling of soiled utensils prior to washing and for cleaned utensils following sanitizing and shall be located so as not to interfere with the proper use of the dishwashing facilities. III (70) Equipment and utensils shall be preflushed or prescraped and, when necessary, presoaked to remove gross food particles and soil. III (71) Except for fixed equipment and utensils too large to be cleaned in sink compartments, manual washing, rinsing and sanitizing shall be conducted in the following sequence: sinks shall be cleaned prior to use; equipment and utensils shall be thoroughly washed in the first compartment with hot detergent solution that is kept clean; equipment and utensils shall be rinsed free of detergent and abrasives with clean water in the second compartment; and equipment and utensils shall be sanitized in the third compartment. III (72) The food-contact surfaces of all equipment and utensils shall be sanitized by immersion for at least one-half (1/2) minute in clean, hot water at a temperature of at least one hundred seventy degrees Fahrenheit (170°F); or immersion for at least one (1) minute in a clean solution containing at least fifty (50) parts per million of available chlorine as a hypochlorite and at a temperature of at least seventy-five degrees Fahrenheit (75°F); or immersion for at least one (1) minute in a clean solution containing at least twelve and one-half (12.5) parts per million of available iodine and having a pH not higher than five (5.0) and at a temperature of at least seventy-five degrees Fahrenheit (75°F); or immersion in a clean solution containing any other chemical sanitizing agent allowed under 21 CFR 178.1010 of the (Revised 2005), Food and Drug Codeof the United States Food and Drug Administration, Department of Health and Human Services, 200 Independence Avenue SW, Washington, DC 20201, Telephone: 202-619-0257, Toll Free: 1-877-696-6775, that will provide the equivalent bactericidal effect of a solution containing at least fifty (50) parts per million of available chlorine as a hypochlorite at a temperature of at least seventy-five degrees Fahrenheit (75°F); or treatment with steam, free from materials or additives other than those specified in 21 CFR 173.310 of the (Revised 2005), Food and Drug Codeof the of the United States Food and Drug Administration, Department of Health and Human Services, in the case of equipment too large to sanitize by immersion, but in which steam can be confined; or rinsing, spraying or swabbing with a chemical sanitizing solution of at least twice the strength required for that particular sanitizing solution in the case of equipment too large to sanitize by immersion. (21 CFR 178.1010 (Revised 2005) and 21 CFR 173.310 (Revised 2005) are incorporated by reference in this rule and available by Internet at: www.access.gpo.gov.

This rule does not incorporate any subsequent amendments or additions.) II/III (73) When hot water is used for sanitizing, as allowed by section (72) of this rule, the following facilities shall be provided and used: an integral heating device or fixture installed in, on or under the sanitizing compartment of the sink capable of maintaining the water at a temperature of at least one hundred seventy degrees Fahrenheit (170°F); and a numerically scaled indicating thermometer, accurate to plus or minus three degrees Fahrenheit (±3°F), convenient to the sink for frequent checks of water temperature; and dish baskets of such size and design to permit complete immersion of the tableware, kitchenware and equipment in the hot water. II/III (74) When chemicals are used for sanitization, they shall not have concentrations higher than the maximum permitted under 21 CFR 178.1010 of the (Revised 2005), Food and Drug Codeof the United States Food and Drug Administration, Department of Health and Human Services, and a test kit or other device that accurately measures the parts per million concentration of the solution shall be provided and used. III (75) Cleaning and sanitizing may be done by spray-type or immersion dishwashing machines or by any other type of machine or device if it is demonstrated that it thoroughly cleans and sanitizes equipment and utensils.

In a facility with a licensed capacity of twelve (12) or fewer beds, a home-type dishwashing machine shall be acceptable. If a new machine is purchased, it shall be one with sanitizing capabilities. In a facility licensed for a larger capacity, if a dishwasher is used, it shall meet the requirements in sections (72)–(74) of this rule. Machines and devices shall be properly installed and maintained in good repair; shall be operated in accordance with manufacturers’ instructions; and utensils and equipment placed in the machine shall be exposed to all dishwashing cycles. Automatic detergent dispensers, wetting agent dispensers and liquid sanitizer injectors, if any, shall be properly installed and maintained. II/III (76) The pressure of final rinse water supplied to spray-type dishwashing machines shall not be less than fifteen (15) nor more than twenty-five (25) pounds per square inch measured in the water line immediately adjacent to the final rinse control valve. A onefourth inch (1/4") IPS valve shall be provided immediately upstream from the final rinse control valve to permit checking the flow pressure of the final rinse water. III (77) Machine- or water line-mounted numerically scaled indicating thermometers, accurate to plus or minus three degrees Fahrenheit (±3°F), shall be provided to indicate the temperature of the water in each tank of the machine and the temperature of the final rinse water as it enters the manifold. III (78) Rinse water tanks shall be protected by baffles, curtains or other effective means of minimizing the entry of wash water into the rinse water. Conveyors in dishwashing machines shall be accurately timed to assure proper exposure times in wash and rinse cycles in accordance with manufacturers’ specifications attached to the machines. III 10CODE OF STATE REGULATIONS (79) Drain boards shall be provided and be of adequate size for the proper handling of soiled utensils prior to washing and of cleaned utensils following sanitization and shall be so located and constructed as not to interfere with the proper use of the dishwashing facilities. This does not preclude the use of easily movable dish tables for the storage of soiled utensils or the use of each movable dish table for the storage of clean utensils following sanitization. III (80) Equipment and utensils shall be flushed or scraped and, when necessary, soaked to remove gross food particles and soil prior to being washed in a dishwashing machine unless a prewash cycle is a part of the dishwashing machine operation. Equipment and utensils shall be placed in racks, trays or baskets, or on conveyors, in a way that food-contact surfaces are exposed to the unobstructed application of detergent wash and clean rinse waters and that permits free draining. III (81) Machines (single-tank, stationary-rack, door-type machines and spray-type glass washes) using chemicals for sanitization may be used provided that—the temperature of the wash water is not less than one hundred twenty degrees Fahrenheit (120°F), the wash water is kept clean, chemicals added for sanitization purposes are automatically dispensed; utensils and equipment are exposed to the final chemical sanitizing rinse in accordance with manufacturers’ specifications for time and concentration, the chemical sanitizing rinse water temperature is not less than seventy-five degrees Fahrenheit (75°F) nor less than the temperature specified by the machine’s manufacturer; chemical sanitizers used shall meet the requirements of 21 CFR 178.1010 (Revised 2005), Food and Drug Codeof the United States Food and Drug Administration, Department of Health and Human Services and a test kit or other device that accurately measures the parts per million concentration of the solution is available and is used. II/III (82) Machines using hot water for sanitizing may be used provided that they are operated in accordance with the manufacturer’s instructions and are maintained in good repair. II/III (83) All dishwashing machines shall be thoroughly cleaned at least once a day or more often when necessary to maintain them in a satisfactory operating condition. III (84) After mechanical or manual sanitization, all equipment and utensils shall be air dried.

All utensils shall be stored in a self-draining position. III (85) Cleaned and sanitized equipment and utensils shall be handled in a way that protects them from contamination. Spoons, knives and forks shall be touched only by their handles. Cups, glasses, bowls, plates and similar items shall be handled without contact with inside surfaces or surfaces that contact the user’s mouth. III (86) Cleaned and sanitized utensils and equipment shall be stored above the floor in a clean, dry location in a way that protects them from contamination by splash, dust and other means. The food-contact surfaces of fixed equipment shall also be protected from contamination. III (87) Glasses and cups shall be stored inverted. Other stored utensils shall be covered or inverted, wherever practical. Facilities for the storage of knives, forks and spoons shall be designed and used to present the handle to the employee or consumer. Unless tableware is prewrapped, holders for knives, forks and spoons at self-service locations shall protect these articles from contamination and present the handle of the utensil to the consumer. III (88) Single-service articles shall be stored above the floor in closed cartons or containers which protect them from contamination.

(89) Single-service articles shall be handled and dispensed in a manner that prevents contamination of surfaces which may come in contact with food or with the mouth of the user. III (90) Single-service knives, forks and spoons packaged in bulk shall be inserted into holders or be wrapped by a person who has washed his/her hands immediately prior to sorting or wrapping utensils. Unless singleservice knives, forks and spoons are prewrapped or prepackaged, holders shall be provided to protect these items from contamination. III (91) Prohibited Storage Area. The storage of food equipment, utensils or single-service articles in toilet rooms or vestibules is prohibited. III (92) All storage and installation of equipment under exposed sewage or water line, except for automatic fire protection sprinkler heads, is prohibited. II (93) Permanently fixed artificial light sources shall be installed to provide at least twenty (20) footcandles of light on all food preparation surfaces and at equipment or utensilwashing work levels. III (94) Permanently fixed artificial light sources shall be installed to provide, at a distance of thirty inches (30") from the floor, at least twenty (20) footcandles of light in utensil and equipment storage areas and in lavatory and toilet areas, and at least ten (10) footcandles of light in walk-in refrigerating units, dry food-storage areas and in all other areas. This shall also include dining areas during cleaning operations. III (95) Shielding to protect against broken glass falling onto food shall be provided for all artificial lighting fixtures located over, by or within food storage, preparation, service and display facilities, and facilities where utensils and equipment are cleaned and stored. III (96) Infrared or other heat lamps shall be protected against breakage by a shield surrounding and extending beyond the bulb, leaving only the face of the bulb exposed. III (97) Nothing in this rule shall prohibit a facility from hosting a resident/family picnic, carry-in dinner, fish fry or barbecue or allowing a local community or church group to sponsor such activities for residents.

Reasonable practices shall be used for maintaining sanitation and appropriate temperatures of food brought to the facility. III

rule filed July 13, 1983, effective Oct. 13, 1983. Emergency amendment filed Aug. 1, 1984, effective Aug. 13, 1984, expired Dec. 10, 1984. Amended: Filed Sept. 12, 1984, effective Dec. 13, 1984. Amended: Filed Aug. 1, 1988, effective Nov. 11, 1988. Moved to 19 CSR 30-87.030, effective Aug. 28, 2001.

Amended: Filed Aug. 23, 2006, effective April 30, 2007. *Original authority: 198.005, RSMo 2006; 198.009, RSMo 1979, amended 1993, 1995; 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006; 198.076, RSMo 1979, amended 1984; and 198.079, RSMo 1979.

History

AUTHORITY: sections 198.009, 198.076 and 198.079, RSMo 2000 and 198.005 and 198.073, RSMo Supp. 2006. This rule originally filed as 13 CSR 15-17.030. Original

Chapter 88 Resident's Rights and Handling Resident Funds and Property in Long-Term Care Facilities

19 CSR 30-88.010 Resident Rights {#sec-19-csr-30-88.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-88.010}

PURPOSE: This rule establishes requirements for protection of resident rights in all types of licensed long-term care facilities.

This note applies only to the reference material. The entire text of the rule is printed here.

AGENCY NOTE: All rules relating to longterm care facilities licensed by the department are followed by a Roman Numeral notation which refers to the class (either Class I, II or III) of standard as designated in section 198.085.1, RSMo.

(1) The facility shall retain and make available for public inspection at the facility to facility personnel, residents, their next of kin, legal representatives or designees and the general public, a list of names, addresses and occupations of all individuals who have a property interest in the facility as well as a complete copy of each official notification from the Department of Health and Senior Services (the department) of violations, deficiencies, licensure approval, disapprovals, or a combination of these, and responses. This includes, as a minimum, statements of deficiencies, copies of plan(s) of correction, acceptance or rejection notice regarding the plan(s) of corrections and revisit inspection report. II/III (2) Any notice of noncompliance shall be posted in a conspicuous location along with a copy of the most recent inspection reports, as required by section 198.026(6), RSMo. II/III (3) A copy of the most current department rules governing the facility shall be kept available and easily accessible in the facility for review by residents, their next of kin, legally authorized representatives or designees, and the public. II/III (4) Each resident admitted to the facility, or his or her next of kin, legally authorized representative or designee, shall be fully informed of the individual’s rights and responsibilities as a resident. These rights shall be reviewed annually with each resident, and/or his or her next of kin, legally authorized representative or designee, either in a group session or individually. II/III (5) All incoming and present residents, or their next of kin, legally authorized representatives or designees in a facility shall be provided statements of resident rights and a copy of any facility policies which relate to resident conduct and responsibilities. Such information shall be provided in a manner which effectively communicates, in terms the resident can reasonably be expected to understand, those rights and responsibilities. II/III (6) The facility shall document the disclosure of resident’s rights information as required in sections (4) and (5). III (7) Information regarding resident rights and facility rules shall be posted in a conspicuous location in the facility and copies shall be provided to anyone requesting this information. Informational documents which contain, but are not limited to, updated information on selecting an Alzheimer’s special care unit or program shall be given by a facility offering to provide or providing these services to any person seeking information about or placement in an Alzheimer’s special care unit or program. III (8) Prior to or at the time of admission and during his or her stay in the facility, each resident and/or his or her next of kin, legally authorized representative or designee shall be fully informed, in writing, of services available in the facility and of related charges, including any charges for services not covered by the facility’s basic per diem rate or federal or state programs. Information shall include procedures to be followed by the facility in cases of medical emergency, including transfer agreements and costs. All residents who receive treatment in an Alzheimer’s special care program or unit and their next of kin, legally authorized representatives or designees shall be given a copy of the Alzheimer’s Special Care Services Disclosure Form at the time of admission. Residents also shall be informed of services outside the facility which may reasonably be made available to the resident and of any reasonable estimate of any foreseeable costs connected with those services. II/III (9) Prior to or upon admission, each prospective resident or each resident, or his or her next of kin, legally authorized representative or designee shall be informed of the home and community based services available in this state by providing such resident a copy of Missouri’s Guide to Home and Community Based Services (Revised 4/4/05), incorporated by reference, provided by the Missouri Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102-0570 and which is available to long-term care facilities at www.ged.oa.mo.gov/PICServices/ Pamphlet/index.shtml or by telephone at 1- 800-235-5503. This rule does not incorporate any subsequent amendments or additions. III (10) Prior to or upon admission and at least annually after that, each resident or his or her next of kin, legally authorized representatives or designees shall be informed of facility policies regarding provision of emergency and life-sustaining care, of an individual’s right to make treatment decisions for himself or herself and of state laws related to advance directives for health-care decision making.

The annual discussion may be handled either on a group or on an individual basis. Residents’ next of kin, legally authorized representatives or designees shall be informed, upon request, regarding state laws related to advance directives for health-care decision making as well as the facility’s policies regarding the provision of emergency or lifesustaining medical care or treatment. If a resident has a written advance health-care directive, a copy shall be placed in the resident’s medical record and reviewed annually with the resident unless, in the interval, he or she has been determined incapacitated, in accordance with section 475.075 or 404.825, RSMo. Residents’ next of kin, legally authorized representatives or designees shall be contacted annually to assure their accessibility and understanding of the facility policies regarding emergency and life-sustaining care.

(11) A physician shall fully inform each resident of his or her health and medical condition unless medically contraindicated. If the physician determines the resident’s medical condition contraindicates the resident being fully informed of his or her diagnosis, treatment or any known prognosis, the medical record shall contain documentation and justification of this signed by the physician. If there is a legally authorized representative to ROBINCARNAHAN(9/30/08) make health-care decisions, or the resident has designated any individual to have access, that person shall be fully informed of the resident’s medical condition and shall have free access to the resident’s medical records for that purpose, subject to the limitations provided by a power of attorney, duly-executed authorization or any federal law. I/II (12) If the facility has a policy which requires that residents’ medications be bubble packed or otherwise individual dose packaged, the facility shall, prior to each resident’s admission, make such information available to the resident and/or his or her next of kin, legally authorized representatives, designees or placement authority. II/III (13) Each resident shall be afforded the opportunity to participate in the planning of his or her total care and medical treatment, to refuse treatment and to participate in experimental research only upon his or her informed written consent. If a resident refuses treatment, this refusal shall be documented in the resident’s record and the resident, his or her legally authorized representatives or designees, or both, shall be informed of possible consequences of not receiving treatment. II (14) Each resident shall have the privilege of selecting his or her own physician who will be responsible for the resident’s total care. II (15) No resident shall be transferred or discharged except in the case of an emergency discharge unless the resident, and the next of kin, or a legally authorized representative or designee, and the resident’s attending physician and the responsible agency, if any, are notified at least thirty (30) days in advance of the transfer or discharge, and casework services or other means are utilized to assure that adequate arrangements exist for meeting the resident’s needs. In the event that there is no next of kin, legally authorized representative or designee known to the facility, the facility shall notify the appropriate regional coordinator of the Missouri State Ombudsman’s office. II (16) A resident may be transferred or discharged only for medical reasons or for his or her welfare or that of other residents, or for nonpayment for his or her stay. II (17) No resident may be discharged without full and adequate notice of his or her right to a hearing before the department’s Administrative Hearings Unit and an opportunity to be heard on the issue of whether his or her discharge is necessary. Such notice shall be given in writing no less than thirty (30) days in advance of the discharge except in the case of an emergency discharge and must comply with the requirements set forth in 19 CSR 30- 82.050. II/III (18) In emergency discharge situations the facility shall submit to the resident and his or her next of kin, legally authorized representative or designee a written notice of discharge. The written notice of discharge shall be given as soon as practicable and advise the resident of the right to request an expedited hearing. In the event that there is no next of kin, legally authorized representative or designee known to the facility, the facility shall send a copy of the notice to the appropriate regional coordinator of the Missouri State Ombudsman’s office. II/III (19) A room transfer of a resident within a facility, except in an emergency situation, requires consultation with the resident as far ahead of time as possible and shall not be permitted where this transfer would result in any avoidable detriment to the resident’s physical, mental or emotional condition.

(20) Each resident shall be encouraged and assisted, throughout his or her period of stay, to exercise his or her rights as a resident and as a citizen and to this end a resident may voice grievances and recommend changes in policies and services to facility personnel or to outside representatives of his or her choice. A staff person shall be designated to receive grievances and the residents shall be free to voice their complaints and recommendations to the staff designee, an ombudsman or to any person outside the facility. Residents shall be informed of and provided a viable format for recommending changes in policy and services. The facility shall assist residents in exercising their rights to vote.

(21) The exercise of resident rights shall be free from restraint, interference, coercion, discrimination or reprisal. II/III (22) Each resident shall be free from abuse.

Abuse is the infliction of physical, sexual, or emotional injury or harm and includes verbal abuse, corporal punishment, and involuntary seclusion. I (23) The facility shall develop and implement written policies and procedures that prohibit mistreatment, neglect, and abuse of any resident and misappropriation of resident property and funds, and develop and implement policies that require a report to be made to the department for any resident or to both the department and the Department of Mental Health for any vulnerable person whom the administrator or employee has reasonable cause to believe has been abused or neglected. II/III (24) The facility shall ensure all staff are trained on the applicable laws and rules regarding reporting of suspected abuse and neglect of any resident. II (25) If the administrator or other employee of a long-term care facility has reasonable cause to believe that a resident of the facility has been abused or neglected, the administrator or employee shall immediately report or cause a report to be made to the department.

Any administrator or other employee of a long-term care facility having reasonable cause to suspect that a vulnerable person has been subjected to abuse or neglect or observes such a person being subjected to conditions or circumstances that would reasonably result in abuse or neglect shall immediately report or cause a report to be made to the department and to the Department of Mental Health. I/II (26) The resident has the right to be free from any physical or chemical restraint except as follows:

(A) When used to treat a specified medical symptom as a part of a total program of care to assist the resident to attain or maintain the highest practicable level of physical, mental, or psychosocial well-being. The use of restraints must be authorized in writing by a physician for a specified period of time; or (B) When necessary in an emergency to protect the resident from injury to himself or herself or to others, in which case restraints may be authorized by professional personnel so designated by the facility. The action taken shall be reported immediately to the resident’s physician and an order obtained which shall include the reason for the restraint, when the restraint may be removed, the type of restraint, and any other actions required.

When restraints are indicated, only devices that are the least restrictive for the resident and consistent with the resident’s total treatment program shall be used. I/II (27) In a residential care facility or an assisted living facility, if it is ever necessary to use a restraint in case of emergency, the resident shall be reevaluated immediately for appropriateness of placement and transferred if necessary. II/III 4CODE OF STATE REGULATIONS (9/30/08) ROBINCARNAHAN SENIOR SERVICES (28) All information contained in a resident’s medical, personal or financial record and information concerning source of payment shall be held confidential. Facility personnel shall not discuss aspects of the resident’s record or care in front of persons not involved in the resident’s care or in front of other residents. Written consent of the resident or his or her legally authorized representative shall be required for the release of information to persons not otherwise authorized by law to receive it. II/III (29) Each resident shall be treated with consideration, respect, and full recognition of his or her dignity and individuality, including privacy in treatment and care of his or her personal needs. All persons, other than the attending physician, the facility personnel necessary for any treatment or personal care, or the department or Department of Mental Health staff, as appropriate, shall be excluded from observing the resident during any time of examination, treatment, or care unless consent has been given by the resident.

(30) No resident shall be required to perform services for the facility. If the resident desires and it is not contraindicated by his or her physician, the resident may perform tasks or services for himself or herself or others. II/III (31) Each resident shall be permitted to communicate, associate, and meet privately with persons of his or her choice whether on the resident’s initiative or the other person’s initiative, unless to do so would infringe upon the rights of other residents. The person(s) may visit, talk with, and make personal, social, or legal services available, inform residents of their rights and entitlements by means of distributing educational materials or discussions, assisting residents in asserting their legal rights regarding claims for public assistance, medical assistance and Social Security benefits, and engaging in any other methods of assisting, advising, and representing residents so as to extend to them the full enjoyment of their rights. The facility, however, may place reasonable limitations on solicitations. II/III (32) The facility shall permit a resident to meet alone with a person or persons of his or her choice and provide an area which assures privacy. II/III (33) Telephones appropriate to the residents’ needs shall be accessible at all times. Telephones available for residents’ use shall enable all residents to make and receive calls privately. II/III (34) If the resident cannot open mail, written consent by the resident or his or her legally authorized representative shall be obtained to have all mail opened and read to the resident.

(35) Each resident shall be permitted to participate, as well as not participate, in activities of social, religious, or community groups at his/her discretion, both within the facility, as well as outside the facility, unless contraindicated for reasons documented by physician in the resident’s medical record. II/III (36) Each resident shall be permitted to retain and use personal clothing and possessions as space permits. Personal possessions may include furniture and decorations in accordance with the facility’s policies and shall not create a fire hazard. The facility shall maintain a record of any personal items accompanying the resident upon admission to the facility, or which are brought to the resident during his or her stay in the facility, which are to be returned to the resident or responsible party upon discharge, transfer, or death.

(37) Each married resident shall be assured privacy for visits by his or her spouse. II/III (38) If both husband and wife are residents, they shall be allowed the choice of sharing or not sharing a room. III (39) If siblings and/or a parent and his or her child are both residents, the facility shall allow the family members the choice of sharing or not sharing a room upon availability of room(s) appropriate to accommodate the residents. III (40) Each resident shall be allowed the option of purchasing or renting goods or services not included in the per diem or monthly rate from a supplier of his or her own choice, provided the quality of goods or services meets the reasonable standards of the facility. Each resident shall be allowed the option of purchasing his or her medications from a pharmacy of his or her choice, provided the quality of the medications and packaging meets reasonable standards of the facility.

(41) Residents shall not have their personal lives regulated or controlled beyond reasonable adherence to meal schedules and other written policies which may be necessary for the orderly management of the facility and the personal safety of the residents. II (42) All written accounts of the resident’s funds shall be brought current monthly and a written statement showing the current balance and all transactions shall be given to the resident, or his or her next of kin, legally authorized representative, or designee on a quarterly basis and upon request. The facility shall keep written receipts of all personal possessions and all funds received by or deposited with the facility and all disbursements made to or on behalf of the resident and shall disclose such receipts to the resident, and/or his or her next of kin, legally authorized representative, or designee upon request. II/III (43) The resident, or his or her next of kin, legally authorized representative, or designee shall receive an itemized bill for all goods and services actually rendered. No later than thirty (30) days after the discharge or death of a resident, the operator of the facility shall submit a final itemized bill for all goods and services rendered, showing any credit balances accruing on the date of discharge or death of the resident, and a complete account of the resident’s remaining funds with the facility, in any account, with whatever title the account(s) may be known, to the resident’s guardian, conservator, fiduciary of the resident’s estate, or the individual who was designated to receive the quarterly accounting of all financial transactions made. II/III

Filed Jan. 3, 1992, effective Aug. 6, 1992.

Amended: Feb. 13, 1998, effective Sept. 30, 1998. Moved to 19 CSR 30-88.010, effective Aug. 28, 2001. Amended: Filed March 1, 2004, effective Oct. 30, 2004. Amended:

Filed Dec. 15, 2005, effective July 30, 2006.

Amended: Filed Aug. 23, 2006, effective April 30, 2007. Amended: Filed March 13, 2008, effective Oct. 30, 2008. *Original authority: 198.009, RSMo 1979, amended 1993, 1995; 198.073, RSMo 1979, amended 1984, 1992, 1999, 2006, 2007; 198.076, RSMo 1979, amended 1984, 2007; 198.079, RSMo 1979, amended 2007; 198.088, RSMo 1979, amended 1988, 1989, 1994; and 660.050, RSMo 1984, amended 1988, 1992, 1993, 1994, 1995, 2001.

6CODE OF STATE REGULATIONS

(9/30/12) ROBINCARNAHAN

SENIOR SERVICES

History

AUTHORITY: sections 198.009 and 198.088, RSMo 2000, and sections 198.073, 198.076, 198.079, and 660.050, RSMo Supp. 2007. This rule originally filed as 13 CSR 15- 18.010. Original rule filed July 13, 1983, effective Oct. 13, 1983. Amended: Filed Sept. 12, 1984, effective Dec. 13, 1984. Amended:

19 CSR 30-88.020 Residents’ Funds and Property {#sec-19-csr-30-88.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-88.020}

PURPOSE: This rule establishes standards for protecting residents’ personal funds and property in all types of licensed long-term care facilities.

AGENCY NOTE: All rules relating to longterm care facilities licensed by the Department of Health and Senior Services are followed by a Roman Numeral notation which refers to the class (either Class I, II, or III) of standard as designated in section 198.085, RSMo.

(1) No operator is required by this rule or by

section 198.090, RSMo, to hold, manage, safeguard, or account for any personal funds or money in trust unless some other governmental agency placing residents in the facility makes this a requirement. The record keeping and other requirements of this section apply only to those personal possessions and funds which the facility accepts to hold in trust for the resident as provided in the facility’s policy.

(2) The operator or other designated person shall use the personal funds of the resident exclusively for the use of the resident and only when authorized in writing by the resident, his/her designee, guardian and conservator, or conservator. A designee shall not be the administrator or an employee of the facility. With written authorization, the operator may purchase a burial policy for the resident.

(3) When a resident is admitted, the resident, his/her designee, guardian and conservator, or conservator shall be provided with a statement explaining the facility’s policies and resident’s rights regarding personal funds. If the facility handles residents’ funds, this statement shall include an explanation of the procedure for deposit or withdrawals of funds from any source to the resident or to the resident’s account. The facility shall allow the residents access to their personal possessions and funds during regular business hours, Monday through Friday, excluding banking holidays. III (4) The separate account(s) required to be maintained by section 198.090.1.(3), RSMo, shall be maintained in a bank or savings and loan association and if any interest is accrued it shall be credited to each resident’s account at least monthly. II/III (5) A petty cash fund of up to fifty dollars ($50) for each resident for whom the facility is holding funds may be kept in the facility and shall be maintained separately from the facility's funds. II/III (6) A written account for each resident, showing receipts to and disbursements from the personal funds of each resident, shall be maintained. If the facility policy provides, or if required by another governmental agency, multiple personal funds accounts may be kept for residents. III (7) Receipt of a resident’s funds or personal possessions held in trust shall be acknowledged by a written receipt or cancelled check.

III (8) Receipts for any purchases made by the operator and paid for from the resident’s personal funds shall be kept pursuant to sections (15) and (16) of this rule and be available to the resident, his/her designee, guardian and conservator, or conservator. III (9) All written accounts of the residents’ funds shall be reconciled monthly and a written statement showing the current balance and all transactions shall be given to the resident, his/her designee, guardian and conservator, or conservator on a quarterly basis.

(10) Within five (5) calendar days of the discharge of a resident, the resident, his/her designee, guardian and conservator, or conservator shall be given an up-to-date accounting of the resident’s personal funds and the balance of the funds and all personal possessions shall be returned to the resident. This requirement shall not apply for residents discharged due to death, or for residents discharged to hospitals when those residents are expected to return to the facility. The operator shall have a receipt for all funds and possessions returned to the resident, his/her designee, guardian and conservator, or conservator. II/III (11) Upon the death of a resident, the operator shall contact the Department of Social Services (DSS), MO HealthNet Division, Third Party Liability Unit, to determine if the deceased resident is a MO HealthNet participant or has been a recipient of aid, assistance, care, services, or if the resident has had moneys expended on his/her behalf by DSS. The facility shall document the contact(s) with and response(s) from DSS. II/III (A) If the deceased resident is a MO HealthNet participant or has been a recipient of aid, assistance, care, services, or the resident has had moneys expended on his/her behalf by DSS, the operator shall provide DSS within sixty (60) days of the resident’s death, a complete account of all the resident’s remaining personal funds and the name and address of the resident’s designee, guardian and conservator, or conservator, fiduciary of the resident’s estate, or the individual who was designated to receive the quarterly accounting of all financial transactions made.

Personal funds for the purpose of this regulation shall include all the resident’s remaining funds with the facility, in any account, with whatever title the account(s) may be known.

(B) None of the resident’s personal funds shall be paid to an operator, fiduciary, guardian and conservator, conservator, or other person until the operator has fully complied with section 198.090.1., RSMo, except that funeral expenses may be paid from a resident’s personal funds held by a facility if no other funds are available to cover the cost. If funds are used for this purpose, this fact and the amount used shall be noted on the account report submitted to DSS and documentation of payment shall be attached.

(C) DSS will determine the amount of aid, care, assistance, or services paid and will notify the operator of the amount determined to have been paid on behalf of the deceased recipient within sixty (60) days of receipt of the facility operator’s accounting.

(D) The operator may make a special request for expedited response if there is a need to comply with a contractual or regulatory obligation of another governmental agency. The amount specified in the notification shall be considered as a claim upon the funds held by the operator.

(E) The operator shall pay DSS any remaining personal funds in the resident’s personal fund account up to the amount determined by DSS. Payment shall be made as instructed by DSS within sixty (60) working days of the receipt of the demand for payment. If additional funds are received by the facility after the initial claim has been filed, the operator shall immediately inform DSS.

(F) DSS will notify in writing the resident’s guardian and conservator, conservator, fiduciary of the resident’s estate, or the individual who was designated to receive the quarterly accounting of all financial transactions of the amount determined to have been paid by DSS on behalf of the deceased resident.

(12) Upon the death of a resident who has not been a recipient of aid, assistance, care, services, or who has not had moneys expended on the resident’s behalf by DSS or DSS has not made claim on the funds, the operator shall provide the fiduciary of resident’s estate, at the fiduciary’s request, a complete account of all the resident’s personal funds and possessions and deliver to the fiduciary all possessions of the resident and the balance of the resident’s funds. II/III (A) If, after one (1) year from the date of death, no fiduciary makes claim on funds or possessions, the operator shall notify the Department of Health and Senior Services (department) in writing, Attention: Licensure and Certification Unit, PO Box 570, Jefferson City, MO 65102-0570 that the funds remain unclaimed. This notice shall be sent by the operator within sixty (60) days. The notice shall include the resident’s name, Social Security number, date of death, and the amount of resident funds or possessions being held belonging to the deceased resident. II/III 1. If unclaimed funds in the resident’s fund accounts or possessions have a value of one hundred fifty dollars ($150) or less, the funds or proceeds of the sale of the possessions shall be deposited in a fund for the benefit of all residents of the facility for social and educational activities. II/III 2. If unclaimed funds in the resident’s fund accounts or possessions have a value of more than one hundred fifty dollars ($150), these funds or possessions shall be considered abandoned property under sections 447.500–447.585, RSMo. The operator shall report and return the abandoned property to the Missouri State Treasurer in accordance with sections 447.539–447.543, RSMo. II/III (B) The operator shall keep an accounting of these funds with documentation and receipts and disbursements of these funds which will be subject to inspection and audit by the department. II/III (13) Any owner, operator, manager, employee, or affiliate of an owner or operator receiving personal property or anything with a value of ten dollars ($10) or more from a resident shall make a written statement giving the date of receipt, estimated value, and the name of the person making the gift. These statements shall be retained by the operator and made available to the department or Department of Mental Health as appropriate and to the resident, his/her designee, guardian and conservator, or conservator. No owner, operator, manager, employee, or affiliate of an owner or operator shall in one (1) calendar year receive any personal property or anything of value from the residents of any facility which have a total value over one hundred dollars ($100). These requirements shall not apply to matters deemed exceptions under state law. II (14) The bond required by section 198.096, RSMo, for operators holding personal funds of residents shall be in a form approved by the department and shall provide that residents who allege that they have been wrongfully deprived of moneys held in trust may bring an action for recovery directly against the surety. The bond shall be in an amount equal to at least one and one-half (1 1/2) times the average monthly balance of the residents’ personal funds, including residents’ petty cash, or the average total of the monthly balances for the preceding twelve (12) months. The average monthly balance(s) or the average total of the monthly balance(s) shall be rounded to the nearest one thousand dollars ($1,000). One (1) bond may be used to cover the residents’ funds in more than one (1) facility operated by the same operator, if the facility is a multilicensed facility on the same premises. If not on the same premises, then one (1) bond may be used if the bond specifies the amount of coverage provided for each individual facility and the coverage for each facility is a minimum of one thousand dollars ($1,000). II/III (15) All records and receipts required to be maintained under this rule and under section 198.090, RSMo shall be maintained for at least seven (7) years from the end of the fiscal year during which the records were originally made. II/III (16) Records related to resident funds shall be maintained in the facility or shall be available for review and copying, in their entirety, within twenty-four (24) hours of a request for access by the department or its authorized representative. Records kept for the prior seven (7) years, as required in section (15) and under section 198.090, RSMo, shall be transferred to a new operator who assumes responsibility for a facility, and if not transferred in their entirety, the department shall be notified immediately by the new operator.

(17) If an operator chooses to place a cash deposit in a lending institution in lieu of a bond as referenced in section 198.096.5., RSMo, the amount must be equal to the amount of the bond required and shall be deposited with an insured lending institution pursuant to a noncancellable escrow agreement. The written agreement shall be submitted to the department and shall be approved prior to license issuance. II

Filed Sept. 12, 1984, effective Dec. 13, 1984.

Amended: Filed Aug. 1, 1988, effective Nov. 11, 1988. Amended: Filed Jan. 3, 1992, effective Aug. 6, 1992. Amended: Filed July 22, 1994, effective Feb. 26, 1995. Moved to 19 CSR 30-88.020, effective Aug. 28, 2001.

Amended: Filed March 15, 2012, effective Oct. 30, 2012. *Original authority: 198.090, RSMo 1979, amended 1982, 1989, 1992, 1993.

History

AUTHORITY: sections 198.009 and 198.090, RSMo 2000. This rule originally filed as 13 CSR 15-18.020. Original rule filed July 13, 1983, effective Oct. 13, 1983. Amended:

Chapter 89 Specialized Long-Term Care Facilities or Special Care Facilities

19 CSR 30-89.010 Pediatric Nursing Facilities {#sec-19-csr-30-89.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-89.010}

(Rescinded March 30, 2005)

History

AUTHORITY: sections 198.009 and 198.079, RSMo 1986. This rule was originally filed as

13 CSR 15-20.010. Original rule filed Nov. 2, 1990, effective April 29, 1991. Moved to 19 CSR 30-89.010, effective Aug. 28, 2001. {#sec-13-csr-15-20.010. omnilex-key=us-mo-regs-official--title-19--13 CSR 15-20.010.}

Rescinded: Filed Sept. 14, 2004, effective March 30, 2005.

Chapter 90 Adult Day Care Program Licensure

19 CSR 30-90.010 Definitions {#sec-19-csr-30-90.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-90.010}

PURPOSE: The following definitions are listed to establish understanding of these terms as applied to Chapter 90, Adult Day Care Program Licensure.

(1) Adult day care program means a group program designed to provide care and supervision to meet the needs of five (5) or more functionally impaired adults for periods of less than twenty-four (24) hours but more than two (2) hours per day in a place other than the adult’s own home.

(2) Adult day care provide means the person, corporation, partnership, association or organization legally responsible for the overall operation of the adult day care program.

(3) Adult day health care means an adult day care program certified to provide Medicaid reimbursed services to Medicaid-eligible participants in accordance with standards set forth in 19 CSR 70-92.010.

(4) Alzheimer’s special care unit or program means any adult day care program that provides a designated separated unit or program for participants with a diagnosis of probable Alzheimer’s disease or related disorder, to prevent or limit access by a participant outside the designated or separated area; or that advertises, markets or promotes the adult day care program as providing Alzheimer’s or dementia care services.

(5) Applicant means any person, corporation, partnership, association or organization which has submitted an application to operate an adult day care program, but has not yet been approved and issued a license or provisional license by the Division of Senior Services and Regulation.

(6) Associated adult day care program means an adult day care program which is located in a building also occupied by another organization established primarily to offer other services (for example: medical care, long-term care and human services) but has designated space and staff for an adult day care program which is in addition to the existing space and staffing requirements for the residents, patients or clients.

(7) Department means the Missouri Department of Health and Senior Services.

(8) Direct care staff means those staff (paid and volunteer) assigned to take care of the direct needs of participants.

(9) Division means the Division of Senior Services and Regulation of the Missouri Department of Health and Senior Services.

(10) Freestanding adult day care program means a program of adult day care services which does not share staffing or licensed space or any physical components of space, equipment, furnishings, dietary, security, maintenance or utilities utilized in the provision of services with any other organization.

(11) Functionally impaired adult. An individual aged eighteen (18) or older who, by reason of age or infirmity, requires care and supervision.

(12) Immediate danger means a situation or condition which presents a substantial likelihood of death, life-threatening injury or serious physical or mental harm to a participant.

(13) Individual plan of care means the adult day care provider’s written description of the amount, duration and scope of services to be provided to each individual participant.

(14) License means the document issued by the Division of Senior Services and Regulation in accordance with the provisions of sections 199.025 and 660.403 through 660.420, RSMo to an adult day care program which authorizes the adult day care provider to operate the program in accordance with the provisions of sections 199.025, and 660.403 to 660.420, RSMo and the applicable rules promulgated pursuant thereto.

(15) Licensed nurse means a person currently licensed under the provisions of Chapter 335, RSMo to engage in the practice of practical nursing or professional nursing.

(16) Long-term care facility means a “facility” as defined in section 198.006(6) or a “long-term care unit” as defined in 19 CSR 30-20.040.

(17) Medical care facility means a hospital, rehabilitation facility or other facility holding a valid state license to operate, issued by the Missouri Department of Health and Senior Services, as defined by 19 CSR 30-20.040.

(18) Participant means an adult who by reason of age or infirmity requires care and supervision and who is enrolled in an adult day care program.

(19) Person means any individual, firm, corporation, partnership, association, agency or any other business organization, including but not limited to limited liability companies, regardless of the name used.

(20) Program director means the individual person responsible for the on-site general administration of the adult day care program.

(21) Provisional license means the document issued by the division in accordance with the provisions of sections 199.025, RSMo and 660.403 through 660.420, RSMo to an adult day care program which is currently not meeting the requirements necessary to obtain a license.

(22) Related means any individual who is related to any of the following by reason of blood, marriage or adoption: parent, child, grandchild, brother, sister, half-brother, halfsister, stepparent, uncle, aunt, niece, nephew or first cousin.

(23) Volunteer means an individual who is utilized by the program to provide a direct care service to program participants with recurring contact whether or not supervised by other employees or volunteers. was originally filed as 13 CSR 15-8.010.

Jan. 11, 1985. Moved to 19 CSR 30-90.010, Sept. 14, 2004, effective March 30, 2005.

19 CSR 30-90.020 Licensure Requirements {#sec-19-csr-30-90.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-90.020}

PURPOSE: This rule establishes the general licensure and application procedures, fees and the rights of applicants for licensure of adult day care programs.

(1) Any person who establishes, maintains or operates an adult day care program, or advertises or holds himself or herself out as being able to perform any adult day care service, shall obtain the proper license from the division, except as provided in section (5) of this

rule.

(2) An applicant shall submit the following documents to the division for each proposed associated or freestanding adult day care program:

(A) A fully completed, properly signed and notarized Application for License to Operate an Adult Day Care Program, included herein; and (B) The required licensure fee.

(3) Every adult day care program that includes an Alzheimer’s special care unit or program as defined in section 198.505, RSMo, shall submit to the division, as part of the licensure application or renewal, the following:

(A) A completed Alzheimer’s Special Care Services Disclosure form (MO Form 886-3548), available at http://www.oa.state. mo.us/gs/form/fm_indiv.htm, stating how the care is different from the rest of the program in the following areas:

The Alzheimer’s special care unit’s or program’s written statement of its overall philosophy and mission which reflects the needs of participants afflicted with dementia;
The process and criteria for placement in, or discharge from, the program;
The process used for assessment and establishment of the plan of care and its implementation, including the method by which the plan of care evolves and is responsive to changes in condition;
Staff training and continuing education practices;
The physical environment and design features appropriate to support the functioning of cognitively impaired partici- 6. The frequency and types of participant activities;
The involvement of families and the availability of family support programs;
The costs of care and any additional fees; and 9. Safety and security measures; and (B) A document approved by the division which contains, but is not limited to, updated information on selecting an Alzheimer’s special care unit or program.

(4) A nonrefundable fee shall accompany each adult day care program application for license according to the following schedule for licensed capacity which is the number of program participants who may be present at any one time:

(A) For eight (8) participants or fewer, the fee is twenty-five dollars ($25);

(B) For nine through sixteen (9–16) participants, the fee is fifty dollars ($50);

(C) For seventeen through twenty-four (17–24) participants, the fee is seventy-five dollars ($75); and (D) For twenty-five (25) or more participants, the fee is one hundred dollars ($100).

(5) Unless the program has voluntarily submitted to licensure in accordance with section 660.409, RSMo, adult day care licensure requirements shall not apply to any:

(A) Adult day care program operated by a person in which care is offered for no more than two (2) hours per day;

(B) Adult day care program maintained or operated by the federal government except where care is provided through a management contract;

(C) Person who cares solely for persons related to the adult day care provider or who has been designated as guardian of that person;

(D) Adult day care program which cares for no more than four (4) persons who are not related to the adult day care provider as defined in 19 CSR 30-90.010;

(E) Adult day care program licensed by the Department of Mental Health under

Chapter 630, RSMo, which provides care, treatment and habilitation exclusively to adults who have a primary diagnosis of mental disorder, mental illness, mental retardation or developmental disability; or (F) Adult day care program administered or maintained by a religious not-for-profit organization serving a social or religious function if the adult day care program does not hold itself out as providing the prescription or usage of physical or medical therapeutic activities or as providing or administering medicines or drugs.

(6) The division shall review each application and investigate each applicant and adult day care program to determine if they comply with the adult day care licensure law and these regulations and to insure that the health and safety of the participants are protected.

(7) If the adult day care program and the applicant are found to be in compliance, a regular license will be issued for a period not to exceed two (2) years for the premises and persons named in the application.

(8) If an adult day care program is not currently meeting all of the requirements for licensure but demonstrates the potential capacity to meet the full requirements for licensure, a provisional license may be issued if there is no detriment to the health, safety and welfare of the participants in the program. The provisional license is nonrenewable and will be valid for a maximum of six (6) months. Any regular license issued subsequent to a provisional license will be valid for a period not to exceed two (2) years from the date that the provisional license was issued.

(9) Licensure renewal applications will be sent to adult day care providers at least sixty (60) days prior to the expiration date of the current license. Renewal applications must be accompanied by the required nonrefundable fee and be postmarked at least thirty (30) days prior to the expiration date of the current license.

(10) A regular or provisional license may be revoked or suspended for failure to comply with statutory or regulatory requirements.

The division may revoke or suspend a license in any case in which it finds that the adult day care provider:

(A) Failed to comply with any lawful request from the division to inspect the premises or investigate any complaint to determine compliance with sections 660.403 through 660.420, RSMo;

(B) Falsified documents, records or any relevant information relating to the operation of the adult day care program;

(C) Placed participants in immediate danger whether or not the adult day care program or adult day care provider corrected the situation which placed participants in immediate danger; or (D) Failed to achieve substantial compliance with statutory and regulatory requirements after being given a reasonable opportunity and period of time in which to correct the deficiencies cited by the division.

(11) If any person is refused a license, or a license is suspended or revoked, or other official action by the division is detrimental to the provider of an adult day care program, a determination from the Administrative Hearing Commission may be requested pursuant to provisions of section 621.045, RSMo et seq. This action must be taken within thirty (30) calendar days of official notification of the adverse action taken by the division.

(12) The license, or provisional license, issued to the adult day care provider, shall not be transferable when there is a change of ownership or when the program is moved to another location, building or premises.

(13) The application for an adult day care program license shall be signed by the applicant’s owner, chairman of the board or chief executive officer and shall be notarized.

(14) The division may, subject to the considerations noted below, grant exceptions for specified periods of time to any rule imposed by the division if the division determines that the exception to the rule would not potentially endanger the health, safety or welfare of any participant in the adult day care program.

(A) The owner or operator of the adult day care program shall make requests for exceptions in writing to the director of the division. The requests shall contain:

If the exception request is being made due to a deficiency being cited, a copy of the latest Letter of Notification which indicates the violation;
The section number and text of the

rule for which the exception is being requested;

Specific reasons why compliance with the rule would impose an undue hardship on the operator, including an estimate of any additional cost that might be involved;
An explanation of the relevant or extenuating factors; and 5. A complete description of the individual characteristics of the premises, program, participants or other factors that would safeguard the health, safety and welfare of the participants if the exception were granted.

(B) The division shall issue a written decision stating the reasons for approval or denial of the request for an exception. If approved, the length of time the exception will be in effect and any additional corrective factors upon which the exception is granted shall be stated in the decision.

(C) The division shall only grant exceptions to licensure requirements set out in rules imposed by the division and cannot grant exceptions to requirements established by state statutes, federal regulations or state regulations of other state agencies. was originally filed as 13 CSR 15-8.020.

Jan. 11, 1985. Moved to 19 CSR 30-90.020, Sept. 14, 2004, effective March 30, 2005.

19 CSR 30-90.030 Participants’ Rights and Program Policies {#sec-19-csr-30-90.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-90.030}

(Rescinded March 30, 2005) 1992 and 660.418, RSMo 1986. This rule originally filed as 13 CSR 15-8.030. Original

rule filed Oct. 15, 1984, effective Jan. 11, 1985. Moved to 19 CSR 30-90.030, effective Aug. 28, 2001. Rescinded: Filed Sept. 14, 2004, effective March 30, 2005.

19 CSR 30-90.040 Staffing Requirements mum requirements for adult day care program staff, ratio of numbers of staff to participants and staff training. {#sec-19-csr-30-90.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-90.040}

(1) The adult day care provider, as defined in 19 CSR 30-90.010, shall be responsible for assuring compliance with all applicable laws and rules.

(2) The adult day care program shall have a program director who is responsible for the day-to-day operation of the program. Either the program director or the program director’s designee shall be present and in charge during all hours that participants are on the premises. The program director and any such designee shall be qualified by demonstrated competence, specialized background, education or experience to manage the dayto-day operation of an adult day care program.

(3) The program director’s responsibilities shall include, but not be limited to:

(A) Managing the adult day care program as necessary for the health, safety and welfare of the participants;

(B) Complying with the laws and rules pertaining to the adult day care program;

(D) Preserving the rights of participants;

(E) Meeting staffing, record keeping, facility and fire safety requirements;

(F) Directing and supervising staff, as required, to meet the needs of the partici- (G) Conducting background checks and criminal record reviews as required and necessary to protect the health, safety and welfare of participants;

(H) Providing staff training as needed and appropriate to meet the needs of the participants; and (I) Providing direct care services when necessary to meet the needs of the participants.

(4) Direct care paid staff shall be at least eighteen (18) years of age and qualified by education, training, experience or demonstrated competence in order to perform the duties required by the written job description.

(5) Volunteer staff shall be qualified by education, training, experience or demonstrated competence to perform the duties required by the written job description.

(6) The adult day care provider shall provide a sufficient number of direct care staff on duty at all times to meet the needs of each participant and assure that participants are never left unattended. At a minimum, there shall be at least two (2) direct care staff persons when two through sixteen (2–16) participants are present and one (1) additional direct care staff person for any portion of eight (8) additional participants present. In calculating the staffing ratios:

(A) The program director shall not be counted to meet the required direct care staff ratio if serving as an administrator or manager in a long-term care facility on the same premises;

(B) The program director may be counted only when it is necessary for the program director to provide direct care in order to ensure that the needs of the participants are met;

(C) In an associated adult day care program, direct care staff shall not be counted simultaneously to meet the required staffing ratios for both the long-term care or medical care facility and the associated adult day care or any other affiliated program;

(D) Secretaries, cooks, accountants and other staff members who provide no direct care shall not be considered in calculating the staffing ratio, but such staff may be counted only if and when they are providing direct care to the participants; and (E) Trained volunteer staff at least eighteen (18) years of age may be counted in the direct care staff to participant ratio provided a written volunteer program description includes in-service training and a system for ensuring the presence of volunteer help as scheduled.

(7) All staff who have direct contact with participants shall be able to perform the assigned job duties in the adult day care program and shall be free of communicable disease in accordance with the department’s regulations pertaining to communicable diseases, specifically 19 CSR 20-20.010 through 19 CSR 20- 20.100, as amended. Persons who have been diagnosed with a communicable disease may return to duty only with written approval from a physician or the physician’s designated agent. The program director shall be responsible for monitoring the health of employees.

(8) No person shall be employed to work or allowed to volunteer, as defined in 19 CSR 30-90.010, in any capacity in the adult day care program who left or was discharged from employment with any other employer due to abuse or neglect to patients, residents or clients and the dismissal or departure has not been reversed by any tribunal or agency.

(9) Each adult day care provider shall require all new applicants for employment in positions involving contact with participants to:

(A) Disclose if he or she is listed on the Employee Disqualification List (EDL); and (B) Disclose his or her criminal history, including any conviction or a plea of guilty to a misdemeanor or felony charge and any suspended imposition of sentence, any suspended execution of sentence or any period of probation or parole; and (C) Sign a consent form authorizing a criminal record review with the Missouri Highway Patrol through:

The Missouri Highway Patrol in accordance with requirements of Chapter 43, RSMo; or 2. A private investigatory agency; or 3. The Family Care Safety Registry (FCSR), providing the applicant is registered and listed in the registry.

(10) The adult day care provider shall make periodic checks of the EDL to determine whether any current employee, contractor or volunteer has been recently added to the list.

These checks shall be made at least every ninety (90) days by contacting the FCSR once the individual is registered and listed on the registry.

(11) Prior to allowing any person who has been hired as a full-time, part-time or temporary position to have contact with participants, the adult day care provider shall, or in the case of temporary employees hired through or contracted for an employment agency, the employment agency shall prior to sending a temporary employee to a provider:

(A) Request a criminal background check for the person as provided in section 43.540, RSMo. Each adult day care provider must maintain in its records a copy of documents verifying that the background checks were requested and the nature of the response received for each such request:

The adult day care provider must ensure that any applicant or person hired or retained who discloses prior to the receipt of the criminal background check that he/she has been convicted of, pled guilty or nolo contendere to in this state or any other state, or has been found guilty of a crime, which if committed in Missouri would be a class A or B felony violation of Chapter 565, 566, or 569, RSMo, or any violation of subsection 3 of section 198.070, RSMo, or of section 568.020, RSMo, will not have contact with participants;
Upon receipt of the criminal background check, the adult day care provider must ensure that if the criminal background check indicates that the person hired or retained by the adult day care provider has been convicted of, pled guilty or nolo contendere to in this state or any other state, or has been found guilty of a crime, which if committed in Missouri would be a class A or B felony violation of Chapter 565, 566, or 569, RSMo, or any violation of subsection 3 of section 198.070, RSMo, or of section 568.020, RSMo, that person will not have contact with participants;

(B) Make an inquiry to the department whether the person is listed on the Employee Disqualification List as provided in section 660.315, RSMo; or (C) If the person has registered with the department’s Family Care Safety Registry, the adult day care provider may contact the Registry in order to meet the requirements of (11)(A) and (11)(B).

(12) All persons employed in an adult day care program shall be registered in the FCSR. Any person hired on or after the effective date of this rule, who is not listed in the Registry, shall complete a Worker Registration form (MO 580-2421), and submit it to the FCSR within fifteen (15) days of the beginning of employment pursuant to sections 210.900 through 210.936, RSMo and 19 CSR 30-80.010 through 19 CSR 30-80.040.

The Worker Registration form may be downloaded from the Department of Health and Senior Services website (http://www.dhss. mo.gov/).

(13) The adult day care program or adult day care provider shall use its business judgement in determining whether to utilize any person as an employee, independent contractor, or volunteer who is listed on the EDL.

(14) Any person who may be refused or terminated from employment based on a criminal history described in section 660.317.6, RSMo, may apply to the division for a good cause waiver under the provisions of 19 CSR 30-82.060.

(15) The adult day care provider may consider for employment any person who has been granted a good cause waiver in accordance with the provisions of section 660.317, RSMo and 19 CSR 30-82.060, in positions which have contact with participants. The adult day care provider shall be responsible for contacting the division to confirm the validity of an applicant’s good cause waiver prior to hiring the applicant.

(16) At least one (1) staff person trained and certified in first aid and cardiopulmonary resuscitation (CPR) shall be on the premises and available at all times. First aid and CPR training shall be taken from the American Red Cross or from another comparable source. Certification in first aid shall be renewed every three (3) years and certification in CPR shall be renewed annually for each staff person assigned to and performing first aid and CPR responsibilities. The program director or designee shall be responsible for ensuring that first aid supplies recommended by the American Red Cross or other comparable source are readily available.

(17) All staff, including nondirect care, direct care and volunteers, shall be given an orientation to the adult day care program, its policies, fire, safety and emergency procedures prior to performing job responsibilities. The orientation shall be sufficient in depth to enable staff to perform their assigned job responsibilities and meet the individual needs or participants.

(18) At least quarterly, or as needed based on participants’ needs, in-service training shall be provided to staff, as appropriate to their job function or participant care needs. At a minimum, in-service training shall address:

(A) Participant care needs, both general and individualized;

(B) Participants’ rights;

(C) Program policies; and (D) Specialized care needs, such as Alzheimer’s disease or related dementias, appropriate to the needs of participants, as follows:

For employees providing direct care to persons with Alzheimer’s disease or related dementia, the training shall include— A. An overview of Alzheimer’s disease and related dementia;

B. Communicating with persons with dementia;

C. Behavior management;

D. Promoting independence in activities of daily living; and E. Understanding and dealing with family issues; and 2. For employees who do not provide direct care for, but may have daily contact with, persons with Alzheimer’s disease or related dementia, the training shall include— A. An overview of dementia; and B. Communicating with persons with dementia. was originally filed as 13 CSR 15-8.040.

Jan. 11, 1985. Moved to 19 CSR 30-90.040, Sept. 14, 2004, effective March 30, 2005. ** **Pursuant to Executive Order 21-07, 19 CSR 30-90.040, sections (6), (7) and (18) was suspended from April 22, 2020 through August 31, 2021.

19 CSR 30-90.050 Program Policies and Participant Care Requirements and Rights mum requirements for operating an adult day care program and providing care to participants; establishing and preserving certain rights of participants; and requiring adult day care providers to have written program policies. {#sec-19-csr-30-90.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-90.050}

(1) The adult day care provider shall neither knowingly admit, nor continue to care for, participants whose needs cannot be met by the program directly or in cooperation with outside resources.

(2) Each adult day care provider shall have a written emergency medical plan that assures the following:

(A) Transportation to a hospital or other type of facility providing emergency or urgent care;

(B) A written agreement, signed by each participant or legal guardian, shall be on file in the facility granting permission to transport the participant in need of emergency care to the designated hospital or other type of facility;

(C) Notes in the participant’s record shall be made immediately of any accident, injury or illness and the emergency procedures taken;

(D) Emergency telephone numbers for each participant shall be available to staff at all times; and (E) At a minimum, those first-aid supplies, as recommended by the American Red Cross or other comparable source, shall be readily available on-site.

(3) The adult day care provider shall require a medical assessment by the participant’s physician or that physician’s designated agent of the participant’s medical condition to include activity needs and restrictions, dietary modifications, indicated therapies and medication as applicable prior to the first day of participation, signed by the physician or that physician’s designated agent within five (5) working days of the first day of participation.

(4) The adult day care provider shall develop a written individual plan of care for each participant within five (5) contact days following the entry of the participant into the adult day care program. The plan shall be designed to maintain the participant at, or to restore to, optimal capability for self-care. The plan shall be based on a functional assessment and information obtained from the participant, participant’s family, physician and the person or agency referring the participant. The plan shall address the participant’s physical, social and psychological needs, goals and means of accomplishing goals to the degree that the program is designed and the staff are qualified to meet these goals. The plan shall identify the positions of persons responsible for specific individualized activities provided for the participant that are not documented by the regularly scheduled plan of activities for the program. The plan of care shall identify the participant’s regularly scheduled days for attendance, including arrival and departure times. The plan of care shall be revised as frequently as warranted by the participant’s condition, but shall be reviewed at least every six (6) months and updated as necessary.

(5) The program director or program director’s designee shall maintain communication with participants and their families or other responsible persons to solve day-to-day problems which confront the participants. Referrals to other community resources should be made and services coordinated as needed.

(6) The adult day care provider or program director or an other employee of the adult day care program shall report any suspected incidents of physical or mental abuse, neglect, exploitation, or a combination of these, of its participants to the Elderly Abuse and Neglect Hotline (1-800-392-0210).

(7) The adult day care provider is required to offer at least the following services:

(A) Activities of Daily Living. This includes providing assistance and training in walking, toileting, feeding, personal care and other activities of daily living in accordance with each participant’s individual plan of care;

(B) Planned Group Activities. This includes providing planned activities during at least fifty percent (50%) of the time that the program is open for daily operation, with a maximum four (4) hours of planned activities required. Activities shall be suited to the needs and interests of participants and designed to stimulate interest, rekindle motivation and encourage physical exercise.

Activities shall be conducted individually and in small and large groups. Planned activities include meals, rest periods, exercise, recreation and social activities. Physical exercise shall be designed in relation to each individual’s needs, impairments and abilities and shall be alternated with rest periods or quiet activities;

(C) Food Service. This includes assuring the availability of meals and supplemental snacks in accordance with each participant’s individual plan of care. Meals served by the adult day care provider shall provide at least one-third (1/3) of the recommended dietary allowance of the National Research Council.

Supplemental snacks shall consist of nourishing food and beverages. Food may be prepared, stored, served, or any combination of these, on-site in compliance with the requirements of the local health department or applicable rule established by the department under the provisions of 19 CSR 20-1.010.

Food prepared away from the site shall be prepared in a food preparation facility which meets the requirements of the local health department or applicable rules established by the department under 19 CSR 20-1.010. The adult day care provider shall arrange for special diets and other diet modifications as ordered by a physician or the physician’s designated agent. Such diets shall be served as ordered by the participant’s physician or the physician’s designated agent with food preparation and service being reviewed by a qualified dietitian, physician or nurse at least every six (6) months. Modified diets shall be in effect for the specified number of days indicated in the physician’s order. If no time is specified, the period may not exceed one (1) calendar year, at which time another order from the physician shall be obtained; and (D) Observation. The health, functional and psychosocial status of each participant shall be observed and documented in the participant’s record at least monthly by the adult day care program director or other designated professional staff and the plan of care modified if necessary.

(8) The adult day care provider may offer the following services:

(A) Transportation. If transportation services are offered, directly or through a contract, they shall meet the requirements of 19 CSR 15-7.040;

(B) Counseling Services. If counseling services are offered, they shall be provided by qualified professional personnel;

(C) Rehabilitation Services. If rehabilitation services are offered, they shall be prescribed by a physician and performed by qualified therapists. Orders for the various therapies and treatments shall be in effect for the specified number of days indicated by the physician’s written order. If no time period is specified, then the time period shall not exceed sixty (60) days and a new order by the physician must be obtained. Therapy services provided shall be summarized in the participant’s record and progress noted at least monthly by the therapist;

(D) Medical Services. If medical services are offered, a licensed nurse shall be available at all times that the program is in operation.

Medical services shall be provided in accordance with the particular needs of each participant. The licensed nurse shall be the only individual authorized to receive, control and manage the medication and drug program.

The licensed nurse shall be responsible for the following:

A safe, effective system of identifying, handling and storing each participant’s medications.
A system for administering and storing medications that is reviewed not less than every ninety (90) days by a licensed nurse.
Administration of medications and treatments, including the following requirements:

A. Participants who are responsible for taking their own medication at home shall be permitted and encouraged to continue to be responsible for taking their own medication during the hours spent in the program. If (7/31/21) JOHN R. ASHCROFT a participant is unable to self-administer medication, then the adult day care provider shall assume responsibility in accordance with the applicable provisions of this rule. If a participant refuses medication, this refusal shall be documented in the participant’s record and the participant and their primary caregiver informed of the possible consequences of not receiving the medication;

B. Medications or treatments may not be administered without an order signed by a licensed physician. Physician’s phone orders may be taken only by a licensed nurse. Phone orders shall be written into the participant’s record by the licensed nurse receiving them and shall be signed by that person. The physician shall sign and date the order within five (5) working days after giving the phone order;

C. Orders concerning treatments and medications shall be in effect for a specified number of days as indicated by the physician.

If not specified, the period may not exceed sixty (60) days;

D. The licensed nurse shall communicate as indicated with the participant’s physician to report observed changes in health status, including reaction to medications and treatments. If an adverse reaction to medications, treatments or diet is observed, the licensed nurse shall promptly notify the participant’s physician. If contact cannot be made with the personal physician, emergency medical procedures shall be followed; and E. All medications, including overthe-counter medications, shall be packaged and labeled in accordance with applicable professional pharmacy standards, state and federal drug laws and regulations. Labeling shall include accessory and cautionary instructions as well as the expiration date, when applicable and the name of the medication as specified in the physician’s order.

Over-the-counter medications for individual participants shall be labeled with at least the participant’s name; and 4. Medication storage that meets the following requirements:

A. The adult day care provider shall have a safe, secure, locked place for storing medications or drugs and make them available to the participant according to the instructions of his or her personal physician;

B. Controlled substances shall be locked separately from non-controlled substance medications;

C. Medications requiring refrigeration shall be kept refrigerated in a locked room or in a separate locked refrigerator or in a locked box within the refrigerator or in a refrigerator in a locked room; and D. Nonprescription medicines may be retained in the facility for administration as ordered by the participant’s physician.

Medication records that meet the following requirements:

A. A written record of medications, including over-the-counter medications, administered shall be maintained;

B. Records shall be kept of the receipt and disposition of all controlled substances, separate from other records for two (2) years;

C. Inventories of controlled substances shall be reconciled at the time of the medication system review and as needed to ensure accountability;

D. Receipt records of controlled substances shall include the date, source of supply, resident name, prescription number, medication name and strength, quantity and signatures of the supplier and the receiver;

E. Administration records of controlled substances shall include the date, time, resident name, medication name, dose administered and signature of the person administering;

F. Documentation of waste of controlled substances at the time of administration shall include the reason for the waste and the signature of an authorized employee witness; and G. All variances of controlled substance records shall be documented and reported to the director for review and investigation. All losses of controlled substances shall be reported to the appropriate authorities.

(9) Each participant of the adult day care program shall be assured of the following rights:

(A) To be treated as an adult, with respect and dignity regardless of race, color, sex or creed;

(B) To participate in a program of services and activities which promote positive attitudes regarding one’s usefulness and capabilities;

(C) To participate in a program of services designed to encourage learning, growth and awareness of constructive ways to develop one’s interests and talents;

(D) To maintain one’s independence to the extent that conditions and circumstances permit, and to be involved in a program of services designed to promote personal independence;

(E) To be encouraged to attain self-determination within the adult day care setting, including the opportunity to participate in developing one’s plan for services;

(F) To decide whether or not to participate in any given activity and to be involved in the extent possible in program planning and operation;

(G) To be cared for in an atmosphere of sincere interest and concern in which needed support and services are provided;

(H) To have access to a telephone to make or receive calls, unless necessary restrictions are indicated in the individual’s care plan;

(I) To have privacy and confidentiality;

(J) To be free of mental or physical abuse;

(K) To be free to choose whether or not to perform services for the program;

(L) To be free of restraint, unless under physician’s order as indicated in the individual’s care plan; and (M) To be free of interference, coercion, discrimination or reprisal.

(10) Participants and their families shall be advised of participants’ rights and program policies upon admission to the adult day care program.

(11) Participants’ rights shall be posted in a conspicuous location in the adult day care facility.

(12) The adult day care provider shall have a written program description, copies of which are available to the division, participants, families and other interested agencies and individuals. The written program description shall contain at least the following:

(A) Administrative organization, including role of the advisory committee if applicable;

(B) Maximum number of participants that can be served;

(D) Days of the week and hours of operation;

(E) Services available to participants and families;

(F) Procedures and requirements for admission;

(G) Emergency arrangements for partici- (H) Criteria and procedure for discontinuing service to a participant;

(I) Participant and family procedures for resolving grievances;

(J) Confidentiality of participant information and records; and (K) A copy of the Alzheimer’s SCS form (MO FORM 886-3548) (if applicable) available at http://www.oa.state.mo.us/gs/form/ fm_indiv.htm 2003 and 660.418, RSMo 2000. This rule was originally filed as 13 CSR 15-8.050. Original

rule filed Oct. 15, 1984, effective Jan. 11, 1985. Moved to 19 CSR 30-90.050, effective Aug. 28, 2001. Amended: Filed Sept. 14, 2004, effective March 30, 2005. ** **Pursuant to Executive Order 21-07, 19 CSR 30-90.050, subparagraph (8)(D)3.C. was suspended from April 22, 2020 through May 1, 2021 and section (3) was suspended from April 22, 2020 through August 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 30- 90.050, section (4) was suspended from April 22, 2020 through December 31, 2021.

19 CSR 30-90.060 Record Keeping Requirements {#sec-19-csr-30-90.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-90.060}

PURPOSE: This rule describes the minimum requirements for administrative, participant and program records that the adult day care provider shall maintain.

(1) The adult day care provider shall maintain administrative records that include at least:

(A) Written personnel policies which address, at a minimum, the staffing requirements found in 19 CSR 30-90.040;

(B) An organizational chart depicting lines of supervision and responsibility;

(C) Individual personnel records for both paid staff and volunteer staff who are counted in the staffing ratio that include the following:

Position title and written job description of the work tasks, responsibilities and qualifications of the job duties to be performed by each person;
Name, address, home telephone number, date of birth and Social Security number;
Licensure, certification or other documentation of professional qualification; such as copies of license, certification, as applicable;
Educational background;
Employment history, documentation of references checked prior to employment including the results of the criminal background checks and, if applicable, a copy of any good cause waiver granted by the department;
Documentation of Employee Disqualification List (EDL) or Family Care Safety Registry checks;
Annual evaluation of work performance;
Documentation of orientation and inservice training received;
Record of dates and hours worked for at least the previous calendar year;
Copies of contracts with consultants, as applicable;
Documentation of any communicable disease and a physician’s or the physician’s designated agent’s written release stating that the employee or volunteer may return to work; and 12. Documentation of any current certification in first aid and cardiopulmonary resuscitation;

(D) Fiscal records that include documentation of program income and expenditures in accordance with generally accepted accounting procedures. However, either cash basis, accrual basis or modified accrual basis may be used as appropriate for the adult day care provider’s business entity and tax status;

(E) Records of orientation and in-service training provided to staff and volunteers; and (F) Inspection reports, for the past three (3) years from the local health authority, local fire authority, department, or division and any state or local inspecting authority.

(2) The adult day care provider shall maintain individual participant records that include at least:

(A) Identifying information consisting of the participant’s name; address; home telephone number; sex; date of birth; legal guardian, if applicable; the name and telephone number of the person to be notified in case of emergency and at least one (1) alternate; next of kin; travel directions between the home and program location and transportation arrangements, if applicable;

(B) Physician’s pre-admission medical report and recommendations and subsequent medical information;

(D) A chart of medications administered and any reactions noted, if applicable;

(E) Documentation of any prescribed or modified diet provided;

(F) Daily attendance log for the previous calendar year; and (G) Documentation regarding any accidents or incidents.

(3) The adult day care provider shall maintain program records that include, at a minimum, copies of:

(A) Current written program description in accordance with 19 CSR 30-90.050;

(B) Current list of participants’ rights;

(C) Schedule of daily group activities planned and record of activities actually conducted for the previous four (4) calendar months;

(D) Weekly menus of meals planned and records of actual meals served for the previous four (4) calendar months;

(E) Emergency medical plan; and (F) Fire safety plan.

(4) Records or any information regarding adult day care program participants shall be confidential and no information shall be released without a written release of information signed by the participant or legal guardian except that records shall be available to the division for investigation of any complaint, program inspection, monitoring or technical assistance purposes.

(5) Records shall be maintained for no less than five (5) years unless otherwise specified in this rule. Current records shall be kept on site within the adult day care program. Inactive records may be maintained at another central location but in no case outside the state of Missouri. Any record requested by the department or the division shall be made available within twenty-four (24) hours of the request. was originally filed as 13 CSR 15-8.060.

Jan. 11, 1985. Moved to 19 CSR 30-90.060, Sept. 14, 2004, effective March 30, 2005.

19 CSR 30-90.070 Fire Safety and Facility Physical Requirements mum physical and maintenance requirements for facilities in which adult day care programs are operated. {#sec-19-csr-30-90.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-90.070}

This note applies only to the reference material. The entire text of the rule is printed here.

(1) Facility Physical Requirements.

(A) The adult day care program building shall be safe and suitable for participants.

The building in which the program is located shall be clean, of sound construction and maintained in good repair.

(B) Minimum space requirements shall be eighty (80) square feet per participant, for up to twenty (20) participants and an additional (2/28/22) JOHN R. ASHCROFT fifty (50) square feet per each additional participant. Space requirements do not include office space, bathrooms, storage, examining rooms or dining rooms, unless the latter is also used for activities. For associated adult day care programs, the required space shall be designated and in excess of the particular facility’s required licensed space for providing long-term care or medical care. For adult day health care programs, the required space, regardless of the number of participants, shall not be less than three hundred twenty (320) square feet of space.

(C) The facility shall have a room of sufficient size to meet the needs of the participants based on minimum standards where all of the participants can gather as well as rooms or divided areas for small group activities, including a quiet area for rest, which contains at least one (1) bed for temporary use by participants when needed.

(D) Furniture shall be of a size and design so that it is easily used by persons with limited agility. It shall be sturdy and secure so that it cannot easily tip when used for support while walking or sitting. At a minimum, the following shall be provided:

One (1) chair for each participant and staff person;
Table space adequate for all participants to be served a meal at a table at the same time;
Reclining lounge chairs or other sturdy comfortable furniture, the number to be determined by the needs of the participants; and 4. At least one (1) bed with adequate privacy in a quiet area to be available for temporary use by participants as needed.

(E) Equipment and supplies shall be adequate to meet the needs of participants including items necessary for personal care and materials to encourage activities among participants. The activity materials shall be geared to the interests and backgrounds of the participants.

(F) Ventilation by natural or mechanical means shall be provided. All screen doors shall be equipped with self-closing devices and shall fit tightly. Doors and windows and other openings to the outside shall be screened when necessary to prevent entrance of insects and vermin.

(G) The heating system for adult day care facilities initially licensed prior to December 1, 2004 shall be in compliance with the applicable provisions of the 2000 Life Safety Code for existing occupancies (NFPA 101), incorporated by reference in this rule, as published by the National Fire Protection Agency, 1 Batterymarch Park, PO Box 9101, Quincy, MA 02269-9101 and all state and local codes.

This rule does not incorporate any subsequent amendments or additions. Heating systems for adult day care facilities initially licensed on or after December 1, 2004 shall be in compliance with the applicable provisions of the 2000 Life Safety Code for New Day Care Occupancies, incorporated by reference in this rule, as published by the National Fire Protection Agency, 1 Batterymarch Park, PO Box 9101, Quincy, MA 02269-9101 and all state and local codes.

This rule does not incorporate any subsequent amendments or additions. Exposed heating pipes, hot water pipes or radiators in rooms and areas used by participants shall be covered or protected, and insulated when appropriate. Portable space heaters shall not be used. Room temperatures shall be maintained between sixty-eight degrees Fahrenheit (68°F) and eighty-five degrees Fahrenheit (85°F) in all seasons. The reasonable comfort needs of individual participants shall be met.

(H) Illumination shall be adequate in all areas and commensurate with the type of activity. Glare shall be kept at a minimum by providing window coverings at all windows exposed to direct sunlight and using shaded light fixtures.

(I) All plumbing and plumbing fixtures shall conform to applicable local codes.

There shall be no cross-connection between the potable water supply and any source of pollution through which the potable water supply might become contaminated.

(J) An adequate supply of water, the source of which is approved by the state water control authority, under sufficient pressure to properly serve the facility shall be provided.

The potable water system shall be installed to preclude the possibility of backflow.

(K) Drinking water shall be easily accessible to the participants and provided by either an angle jet drinking fountain with mouth guard or by a running water supply with individual service drinking cups. Drinking facilities shall not be located in a toilet room.

(L) At least one (1) toilet and handwashing sink shall be provided for each ten (10) participants or any additional fraction thereof.

The handwashing sink shall be in close proximity to each toilet and shall have hot and cold running water. The water temperature shall be maintained between one hundred degrees Fahrenheit (100°F) and one hundred fifteen degrees Fahrenheit (115°F). The toilet room shall be within easy access of the activity areas and afford the participants privacy.

Each toilet room shall be equipped with approved natural or mechanical ventilation.

All toilets shall have grab-rails. Individual paper towels, a trash receptacle, soap and toilet paper shall be provided at all times and shall be within reach of the participants.

(M) If persons using wheelchairs or persons with other physical disabilities are accepted, or the building in which the facility is located is otherwise required to comply with the Americans with Disabilities Act (ADA), the facility shall have ramps or other means of accessibility to the adult day care facility for persons with disabilities, and shall meet the standards of the ADA Standards for Accessible Design which are available at www.usdoj.gov/crt/ada/adastd94.pdf.

(N) Stairways and hallways shall be kept free of obstructions and shall be well lighted.

All stairways and ramps shall have nonslip surface or treads. All inside and outside stairs and ramps shall have handrails.

(O) All rugs and floor coverings shall be secured to the floor. Throw rugs shall not be used. All equipment and furnishings shall be safe and maintained in good condition.

(P) The adult day care program shall provide necessary services to maintain the building or portion of the building in which the adult day care program is located in good repair and in a safe, clean, orderly and sanitary manner.

(Q) Drugs, cleaning agents, pesticides and poisonous products shall be stored apart from food, out of the reach of the participants, and shall be used in a manner which assures the safety of participants and staff.

(R) Wastebaskets and trash containers shall be made of noncombustible or fire-resistant material. Garbage and other waste shall be stored and disposed of in an appropriate manner.

(S) The facility shall be maintained free of insects and rodents. Control measures shall be implemented to prevent rodent and insect infestation.

(2) Fire Safety Requirements.

(A) Adult day care programs shall obtain annual written approval from the appropriate local fire safety officials, certifying that the facility complies with local fire codes. If there are no applicable codes, or if the department or division determines that such codes are not adequate, the department or division shall determine the adequacy of the means of egress and other measures for life safety from fire in accordance with the provisions of the Life Safety Code (NFPA 101), in order to ensure the safety of frail persons or persons with disabilities. All adult day care programs initially licensed prior to December 1, 2004 shall comply with the provisions of the 2000 Life Safety Code for existing occupancies (NFPA 101), incorporated by reference in this rule. Adult day care programs (10/31/21) JOHN R. ASHCROFT licensed on or after December 1, 2004 shall comply with the provisions of the 2000 Life Safety Code for New Day Care Occupancies (NFPA 101).

(B) The facility shall have a minimum of two (2) exits remote from each other. Exits shall be clearly marked with exit signs and shall provide egress at ground level.

(C) Each adult day care provider shall locate, install and maintain in operable condition an adequate number of smoke detectors and fire extinguishers of the appropriate type as determined in consultation with the local fire authorities or the division. Fire extinguishers shall comply with the requirements of the 1998 Standard for Portable Fire Extinguishers (NFPA 10), incorporated by reference in this rule.

(D) A written plan for assuring the safety of participants, staff and volunteers in case of fire or other disaster shall be developed in consultation with state or local fire authorities and shall include, at a minimum, the following:

A written assessment of potential fire or safety hazards present on the premises and actions and procedures to follow to minimize potential danger;
A written schedule for periodic checks for battery strength of smoke detectors and adequate pressure of fire extinguishers;
A written training plan and schedule for staff and volunteers on safety responsibilities and actions to be taken if an emergency situation occurs and documentation of the type of training provided; and 4. A written plan for conducting fire drills and other emergency preparedness procedures, including staff responsibilities and assignments to ensure orderly evacuations and participants’ safety.

(E) Fire drills shall be coordinated with local fire safety authorities and conducted at least one (1) time per month and with sufficient frequency to familiarize staff and participants with the proper evacuation procedures.

Drills may be held at unexpected times and under varying conditions to simulate the unusual conditions that occur in the case of fire. The actual evacuation of participants and staff is not necessary providing everyone involved is able to carry out actual evacuation procedures if required. Fire drills shall include suitable procedures to ensure that all affected persons actually participate in the drill exercises.

(F) The program director or other staff qualified to exercise leadership shall be responsible for planning and conducting fire drills and other emergency preparedness procedures. The program director shall ensure that staff are assigned to assist participants with disabilities or other special needs to ensure the health and safety of participants when implementing the fire and emergency preparedness procedures in evacuating the facility, or complying with written plan procedures. was originally filed as 13 CSR 15-8.070.

Jan. 11, 1985. Moved to 19 CSR 30-90.070, Sept. 14, 2004, effective March 30, 2005. ** *Original authority: 660.050, RSMo 1984, amended 1988, 1992, 1993, 1994, 1995, 2001 and 660.418, RSMo 1984, amended 1993, 1994. **Pursuant to Executive Order 21-07, 19 CSR 30-90.070, subsections (2)(A) and (2)(C) was suspended from April 22, 2020 through May 1, 2021. Pursuant to Executive Order 21-09, 19 CSR 30- 90.070, subsection (2)(E) was suspended from April 22, 2020 through September 3, 2021.

19 CSR 30-90.080 Fire Safety Requirements {#sec-19-csr-30-90.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-90.080}

(Rescinded March 30, 2005) 1992 and 660.418, RSMo 1986. This rule was originally filed as 13 CSR 15-8.080.

Jan. 11, 1985. Moved to 19 CSR 30-90.080, effective Aug. 28, 2001. Rescinded: Filed Sept. 14, 2004, effective March 30, 2005.

Chapter 91 Authorized Electronic Monitoring in Long-Term Care Facilities

19 CSR 30-91.010 Authorized Electronic Monitoring {#sec-19-csr-30-91.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-91.010}

PURPOSE: The proposed rule sets forth requirements regarding the use of an electronic monitoring device in long-term care facilities.

AGENCY NOTE: All rules relating to longterm care facilities licensed by the department are followed by a Roman Numeral notation which refers to the class (either Class I, II, or III) of standard as designated in section 198.085 RSMo.

(1) Definitions. For the purposes of this rule the following terms shall apply:

(A) Authorized electronic monitoring means the placement and use of an electronic monitoring device by a resident in his or her room in accordance with the provisions of sections 198.610 to 198.632, RSMo;

(B) Electronic monitoring device means a surveillance instrument capable of recording or transmitting audio or video footage of any activity occurring in a resident’s room;

(C) Facility or long-term care facility means any residential care facility, assisted living facility, intermediate care facility, or skilled nursing facility, as such terms are defined under section 198.006, RSMo;

(D) Guardian means the same as defined under section 475.010, RSMo; and (E) Legal representative means a person authorized under a durable power of attorney that complies with sections 404.700 to 404.737, RSMo, to act on behalf of a resident of a facility.

(2) A resident shall be permitted to place in the resident’s room an authorized electronic monitoring (AEM) device that is owned and operated by the resident or provided by the resident’s guardian or legal representative consistent with sections 198.610 to 198.632, RSMo and this regulation. II/III (3) A facility shall offer the DHSS-DRL-107 (08-20), Electronic Monitoring Device Acknowledgment and Request Form, included herein, to any resident or resident’s guardian or legal representative upon request and utilize this form to document consent and use of an electronic monitoring device. II/III (4) AEM shall not begin nor an electronic monitoring device(s) be installed until the Electronic Monitoring Device Acknowledgement and Request Form has been completed and returned to the facility. The facility at its option may disable or remove the unauthorized electronic monitoring device or may require the resident or the resident’s guardian or legal representative to remove or disable the electronic monitoring device. II/III (5) AEM shall be conducted in accordance with consent and limitations provided in the Electronic Monitoring Device Acknowledgment and Request Form. II/III (6) If AEM is being conducted in the room of a resident and another resident is moved into the room who has not yet consented to the electronic monitoring, AEM shall cease until the new resident has consented through the Electronic Monitoring Device Acknowledgment and Request Form. The facility may require the resident or the resident’s guardian or legal representative to remove or disable the electronic monitoring device. II/III (7) The placement and use of the AEM device shall be open and obvious.

(8) If a resident installs and uses an electronic monitoring device, a notice to alert and inform visitors shall be posted at the entrance of the facility and resident’s room.

(A) The facility shall post a notice at the main entrance of the facility in large, legible type and font and display the words “Electronic Monitoring” and state: “The rooms of some residents may be monitored electronically by, or on behalf of, the residents and monitoring is not necessarily open or obvious.” III (B) The facility shall require the resident to post and maintain a conspicuous notice at the entrance of the resident’s room stating: “This room is being monitored by an electronic monitoring device.” III (9) The facility shall require an electronic monitoring device to be installed as follows:

(A) In plain view;

(B) Mounted in a fixed, stationary position;

(D) Placed for maximum protection of the privacy and dignity of the resident and the roommate; and (E) In a manner that is safe for residents, employees, or visitors who may be moving about the room. II/III (10) The facility shall not refuse to admit an individual or discharge a resident because of a request to conduct AEM. II (11) The facility shall not discharge a resident because unauthorized electronic monitoring is being conducted by or on behalf of a resident. II (12) The facility shall make reasonable physical accommodation for AEM, including:

(A) Provide a reasonably secure place to mount the video surveillance camera or other electronic monitoring device; and (B) Provide access to power sources for the video surveillance camera or other electronic monitoring device. II (13) The facility shall ensure all staff are knowledgeable of the applicable laws and rules regarding AEM, sections 198.610 to 198.632, RSMo, including the consequences of hampering, obstructing, tampering with, or destroying an electronic monitoring device without the consent of the resident or resident’s guardian or legal representative. III (14) The facility shall ensure the Electronic Monitoring Device Acknowledgment and Request Form is maintained in the clinical records of the residents using AEM devices.

The roommate’s consent to the AEM device shall be maintained in his or her clinical record. These forms shall be retained for a period of five (5) years from the date of discharge. III

History

AUTHORITY: sections 198.612, 198.616, 198.620, 198.622, and 198.626, RSMo Supp. 2020. Emergency rule filed Aug. 20, 2020, effective Sept. 3, 2020, expired March 1, 2021. Original rule filed Aug. 20, 2020, effective Feb. 28, 2021. Original authority: 198.612, RSMo 2020; 198.616, RSMo 2020; 198.620, RSMo 2020; 198.622, RSMo 2020; 198.626, RSMo 2020.

Chapter 95 Medical Marijuana

19 CSR 30-95.010 Definitions {#sec-19-csr-30-95.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.010}

History

AUTHORITY: sections 1.3.(1)(b), 1.3.(2), 1.3.(3), and 1.3.(4) of Article XIV, Mo. Const. Emergency rule filed May 24, 2019, effective June

19 CSR 30-95.020 General Provisions {#sec-19-csr-30-95.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.020}

Original rule filed Dec. 14, 2018, effective June 30, 2019. Emergency rescission filed Jan. 20, 2023, effective Feb. 3, 2023, expired Aug. 1, 2023. Rescinded: Filed Jan. 20, 2023, effective July 30, 2023.

History

AUTHORITY: section 1 of Art. XVI, Mo. Const. Emergency rule filed Dec. 14, 2018, effective Dec. 24, 2018, expired June 21, 2019.

19 CSR 30-95.025 Generally Applicable Provisions Jan. 30, 2020. Emergency rescission filed Jan. 20, 2023, effective Feb. 3, 2023, expired Aug. 1, 2023. Rescinded: Filed Jan. 20, 2023, {#sec-19-csr-30-95.025 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.025}

19 CSR 30-95.028 Additional Licensing Procedures Const. Emergency rule filed Nov. 26, 2019, effective Dec. 12, 2019, expired June 8, 2020. Original rule filed Nov. 26, 2019, effective July 30, 2020. Emergency rescission filed Jan. 20, 2023, effective Feb. 3, 2023, expired Aug. 1, 2023. Rescinded: Filed Jan. 20, 2023, {#sec-19-csr-30-95.028 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.028}

19 CSR 30-95.030 Qualifying Patient/Primary Caregiver Const. Emergency rule filed May 24, 2019, effective June 3, 2019, Jan. 30, 2020. Emergency rescission filed Jan. 20, 2023, effective Feb. 3, 2023, expired Aug. 1, 2023. Rescinded: Filed Jan. 20, 2023, {#sec-19-csr-30-95.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.030}

19 CSR 30-95.040 Medical Marijuana Facilities Generally and section 195.820, RSMo Supp. 2019. Emergency rule filed May 24, 2019, effective June 3, 2019, expired Feb. 27, 2020. {#sec-19-csr-30-95.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.040}

Original rule filed May 24, 2019, effective Jan. 30, 2020. Emergency rescission filed Jan. 20, 2023, effective Feb. 3, 2023, expired Aug. 1, 2023. Rescinded: Filed Jan. 20, 2023, effective July 30, 2023.

19 CSR 30-95.050 Cultivation Facility Jan. 30, 2020. Emergency rescission filed Jan. 20, 2023, effective Feb. 3, 2023, expired Aug. 1, 2023. Rescinded: Filed Jan. 20, 2023, {#sec-19-csr-30-95.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.050}

19 CSR 30-95.060 Infused Products Manufacturing Facility {#sec-19-csr-30-95.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.060}

History

AUTHORITY: sections 1.3.(1)(b), 1.3.(2), and 1.3.(3) of Article XIV, Mo. Const. Emergency rule filed May 24, 2019, effective June

19 CSR 30-95.070 Testing Facility {#sec-19-csr-30-95.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.070}

History

AUTHORITY: sections 1.3.(1)(b), 1.3.(2), 1.3.(3), and 1.3.(4) of Article XIV, Mo. Const. Emergency rule filed May 24, 2019, effective June

19 CSR 30-95.080 Dispensary Facility Jan. 30, 2020. Emergency rescission filed Jan. 20, 2023, effective Feb. 3, 2023, expired Aug. 1, 2023. Rescinded: Filed Jan. 20, 2023, {#sec-19-csr-30-95.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.080}

19 CSR 30-95.090 Seed-to-Sale Tracking Jan. 30, 2020. Emergency rescission filed Jan. 20, 2023, effective Feb. 3, 2023, expired Aug. 1, 2023. Rescinded: Filed Jan. 20, 2023, {#sec-19-csr-30-95.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.090}

19 CSR 30-95.100 Transportation Facility (6/30/23) John R. Ashcroft AND LICENSURE SENIOR SERVICES Jan. 30, 2020. Emergency rescission filed Jan. 20, 2023, effective Feb. 3, 2023, expired Aug. 1, 2023. Rescinded: Filed Jan. 20, 2023, {#sec-19-csr-30-95.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.100}

19 CSR 30-95.110 Physicians Jan. 30, 2020. Amended: Filed May 20, 2020, effective Dec. 30, 2020. Emergency rescission filed Jan. 20, 2023, effective Feb. 3, 2023, expired Aug. 1, 2023. Rescinded: Filed Jan. 20, 2023, effective July 30, 2023. {#sec-19-csr-30-95.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-95.110}

Chapter 100 Safe Place for Newborns

19 CSR 30-100.010 Newborn Safety Incubators/Devices {#sec-19-csr-30-100.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-100.010}

PURPOSE: This rule establishes the specifications governing the installation, maintenance, and oversight of newborn safety incubators and newborn safety devices.

(1) As used in this rule, the following terms and phrases shall mean:

(A) Department shall mean the Department of Health and Senior Services;

(B) Facility shall mean the entity registered with the Department of Health and Senior Services and approved to utilize an installed newborn safety incubator/device;

(C) Newborn safety device shall mean a device which is installed in an exterior wall of a facility or structure wall in a lobby area registered with the department and which has an exterior point of access that allows a relinquishing parent to place a newborn infant inside and an interior point of access that allows individuals inside the building of the facility to safely retrieve the newborn infant. A newborn safety device used to maintain an optimal environment for the care of a newborn infant shall be designed and constructed in accordance with United States Patent Number 10,632,035 B1;

(D) Newborn safety incubator shall mean a medical device used to maintain an optimal environment for the care of a newborn infant; and (E) Relinquishing parent shall mean the biological parent or person acting on such parent’s behalf who leaves a newborn infant in a newborn safety incubator/device.

(2) Specifications for a newborn safety incubator/device.

(A) Each newborn safety incubator shall— 1. Be a medical bassinet in compliance with 21 CFR 880.5145 with the exception of bassinet wheels. Section 21 CFR 880.5145 is incorporated by reference in this rule as last amended on December 19, 2016, and published by the Office of the Federal Register, 732 N. Capitol Street NW, Washington, DC 20401 or can be found at https://govinfo.gov. This rule does not incorporate any subsequent amendments or additions. The bassinet wheels shall be removed for installation in compliance with paragraph (2)(A)2.;

Have the supporting frame of the medical bassinet physically anchored to a position that aligns the plastic basket or bed portion of the bassinet with the wall directly beneath the access portal door and prevents movement of the unit as a whole; and 3. Provide a safe sleep environment which includes:

A. A firm flat bassinet mattress;

B. A bassinet mattress sheet that fits snugly on a mattress and overlaps the mattress, so it cannot be dislodged by pulling on the corner of the sheet; and C. Is free from any bedding, including pillows, bumpers, and blankets; or (B) Each newborn safety device shall— 1. Be a device designed in accordance with United States Patent Number 10,632,035 B1;

Provide a safe sleep environment which includes:

A. A firm flat mattress;

B. A mattress sheet that fits snugly on a mattress and overlaps the mattress, so it cannot be dislodged by pulling on the corner of the sheet; and C. Is free from any bedding, including pillows, bumpers, and blankets.

(3) Installation of a newborn safety incubator.

(A) Access portal door.

The newborn safety incubator shall have an access portal door. This access portal door shall only be installed on an exterior wall or structure wall in a lobby area that ensures anonymity of the relinquishing parent and provides access to an area within the interior of the building. The newborn safety incubator access portal door shall only be installed in a manner within the interior of the building that provides unencumbered access from the exterior of the building or structure wall through the access portal door for the surrender of the child into the medical bassinet. The access portal door shall have a lock that can lock automatically upon closure by the relinquishing parent after the newborn has been placed in the newborn safety incubator. The placement of the newborn safety incubator access portal door and the medical bassinet within the interior of the building shall provide unencumbered access to the medical bassinet so a facility-trained individual can respond to an alarm notification that a child has been surrendered into the newborn safety incubator.
The access portal door shall— A. Lock automatically upon closure;

B. May only be unlocked from the interior of the building;

C. Trigger a series of alarms that, at a minimum, shall include— (I) An audible alarm triggered to a central location within the facility one (1) minute after the opening of the access portal door; and (II) An automatic call to 911 triggered from the alarm system if the alarm is not turned off from within the facility within one (1) minute of the commencement of the initial alarm.

The installation of the access portal door shall be completed by a general contractor who shall affirm in the General Contractor Attestation form, included herein, that the access portal door and the area where the newborn safety incubator is located meets the requirements of subsections (3)(A) and (3)(B). The general contractor signing the form maintains ultimate responsibility for all work performed in the process of the construction of the access portal door and the area where the newborn safety incubator is located.

(B) Interior of the building.

The interior of the building shall provide a monitored climate controlled environment, including temperature control within the range of sixty-eight (68) to seventy-five (75) degrees.
The interior of the building shall provide air circulation that is free from pollutants, exhaust, chemical fumes, and smoke.
The interior of the building shall have an automated external defibrillator (AED) within close vicinity to the newborn safety incubator.
The interior of the building shall have appropriate lighting for relinquishing parents and staff to be able to see the newborn safety incubator and signage. This lighting shall have battery backup in the event that the electricity is out.

There shall be an alarm system installed in relation to the access portal door and the location where the newborn safety incubator is located that will alert a facility-trained individual overseeing the newborn safety incubator that the access portal door has been opened, so that the facility-trained individual can then check to see if a newborn has been placed in the newborn safety incubator.
The access portal door alarm shall only be capable of being turned off from within the facility once a response is made to the newborn safety incubator.
The access portal door alarm shall be— A. Wired into the existing structure’s electrical or telecommunications system;

B. If wired into the structure’s existing electrical system— (I) Be in compliance with the NFPA 70, National Electrical Code (NEC), and NFPA 1, Fire Code if applicable. The NFPA 70, NEC, Revised 2020, and NFPA 1, Fire Code, Revised 2021, are incorporated by reference in this rule as published by the National Fire Protection Agency, 1 Batterymarch Park, Quincy, Massachusetts, 02169-7471, or can be found at www.nfpa.org.

This rule does not incorporate any subsequent amendments or additions;

(II) Be installed by a licensed electrical contractor; and (III) If the facility has a secondary or back-up power supply, then the alarm system shall be wired into the secondary or back-up power supply to ensure continued operation of the alarm system during outages of the structure’s primary power supply. If the facility does not have a secondary or back-up power supply, then the alarm system shall have battery backup; and C. Tested following installation to ensure the activation of the audible, 911, and disarming components of the system.

The installation of the alarm system shall be completed by either a licensed electrical contractor/electrician if wired into the structure’s existing electrical system and the facility’s secondary or back-up power supply if applicable or a telecommunications installation professional if wired into the structure’s existing telecommunications network. The licensed electrical contractor/electrician or telecommunications installation professional who completes the installation of the alarm system shall affirm in the Licensed Electrical Contractor/ Electrician or Telecommunications Installation Professional Attestation form, included herein, that the alarm system meets the requirements of paragraph (3)(A)2. and subsection (3)(C) in this rule. The licensed electrical contractor/electrician or the telecommunications installation professional who signs the form maintains ultimate responsibility for all work performed in the process of the installation of the alarm system.

(D) Signage.

Each location where a newborn safety incubator is installed shall post signage that clearly identifies the newborn safety incubator access portal door and provides both written and pictorial instruction to the relinquishing parents. This written signage shall be in both English, Spanish, and any other language that is commonly used in the community. The written and pictorial instruction shall depict how to do the following:

A. Open the access portal door;

B. Place the infant inside the medical bassinet; and C. Close the access portal door to engage the lock.

The written signage shall also provide contact information for the Children’s Division at the Missouri Department of Social Services, including the hotline number, in order to direct any questions the relinquishing parent(s) may have regarding the newborn after the newborn is placed in the newborn safety incubator to the Children’s Division.

(4) Installation of a newborn safety device.

(A) A newborn safety device used to maintain an optimal environment for the care of a newborn infant shall be designed and constructed in accordance with United States Patent Number 10,632,035 B1. United States Patent Number 10,632,035 B1 is incorporated by reference in this rule as published/ obtained by Safe Haven Baby Boxes on April 28, 2020, and is available at Safe Haven Baby Boxes at PO Box 185, Woodburn, Indiana or online at www.shbb.org. This rule does not incorporate any subsequent amendments or additions.

(B) The installation of the newborn safety device shall be completed by a general contractor who shall affirm in the General Contractor Attestation form, included herein, that the newborn safety device and the area where the newborn safety device is located meets the requirements of subsections (4)(A) and (4)(C). The general contractor signing the form maintains ultimate responsibility for all work performed in the process of the construction of and the area where the newborn safety device is located.

The interior of the building shall provide a monitored climate controlled environment, including temperature control within the range of sixty-eight (68) to seventy-five (75) degrees.
The interior of the building shall provide air circulation that is free from pollutants, exhaust, chemical fumes, and smoke.
The interior of the building shall have an automated external defibrillator (AED) within close vicinity to the newborn safety device.
The interior of the building shall have appropriate lighting for relinquishing parents and staff to be able to see the newborn safety device and signage. This lighting shall have battery backup in the event that the electricity is out.

(D) Alarm system.

There shall be an alarm system installed in relation to where the newborn safety device is located that will alert a facility-trained individual overseeing the newborn safety device that the newborn safety device has been opened, so that the facility-trained individual can then check to see if a newborn has been placed in the newborn safety device.
The alarm shall only be capable of being turned off from within the facility once a response is made to the newborn safety device.
The alarm shall be— A. Wired into the existing structure’s electrical or telecommunications system;

This rule does not incorporate any subsequent amendments or additions;

The installation of the alarm system shall be completed by either a licensed electrical contractor/electrician if wired into the structure’s existing electrical system and the facility’s secondary or back-up power supply if applicable or a telecommunications installation professional if wired into the structure’s existing telecommunications network. The licensed electrical contractor/electrician or telecommunications installation professional who completes the installation of the alarm system shall affirm in the Licensed Electrical Contractor/ Electrician or Telecommunications Installation Professional Attestation form, included herein, that the alarm system meets the requirements of subsections (4)(A) and (4)(D) in this rule. The licensed electrical contractor/electrician or the telecommunications installation professional who signs the form maintains ultimate responsibility for all work performed in the process of the installation of the alarm system.

(E) Signage.

Each location where a newborn safety device is installed shall post signage that clearly identifies the newborn safety device front opening in which the newborn should be placed and provides both written and pictorial instruction to the relinquishing parents. This written signage shall be in both English, Spanish, and any other language that is commonly used in the community. The written and pictorial instruction shall depict how to do the following:

A. Open the newborn safety device;

B. Place the infant inside the newborn safety device; and C. Close the newborn safety device to engage the lock.

The written signage shall also provide contact information for the Children’s Division at the Missouri Department of Social Services, including the hotline number, in order to direct any questions the relinquishing parent(s) may have regarding the newborn after the newborn is placed in the newborn safety device to the Children’s Division.

(5) Maintenance/staff.

(A) Each registered facility shall have a medical contact in order to obtain the required newborn safety incubator. The newborn safety incubator is a prescription device per 21 CFR 880.5145.

(B) Each registered facility shall have at least one (1) individual trained and on duty at all times, twenty four (24) hours a day, seven (7) days a week to take possession of a newborn placed in the newborn safety incubator/device. If a trained individual is on duty, but may at times be away from the facility, then the facility shall submit a back-up plan to the department for approval detailing who will respond, how the individual(s) will respond if the alarm goes off in the facility and/or an automatic call to 911 is placed by the alarm system, including gaining access to the newborn safety incubator/device and the training that the individual(s) has received. Training shall occur before the individual is initially placed on duty with the facility and as needed as issues/problems arise. Training shall consist of compliance with this rule including at least what to do when taking possession of a newborn from a newborn safety incubator/device— 1. How to care for the newborn before the newborn is transferred to the hospital;

Who to call for immediate transportation of the newborn to the nearest hospital;
How to test the alarm system, how to recognize the alarm, how to silence the alarm, how to check the newborn safety incubator/device twice a day for debris;
How to clean and sanitize the newborn safety incubator/ device;
How to access the newborn safety incubator/device from the interior of the building;
How to complete required paperwork; and 7. Who to contact if there are any problems related to the relinquishment of a newborn.

(C) Staff shall also be current in cardiopulmonary resuscitation (CPR) and automated external defibrillator (AED) certification which includes CPR and AED use specifically for infants. The facility shall complete documentation of the required training and maintain a list of individuals trained to be on duty. The facility shall also complete documentation regarding the individuals on duty each day. This documentation shall be maintained onsite and current as long as the newborn Documentation of the required training, the list of trained individuals and which individuals were on duty shall be made available to the department upon the department’s request.

This documentation shall be maintained for a period of five (5)

(D) Upon taking possession of a newborn from a newborn safety incubator/device, facility staff shall arrange for the immediate transportation of the child to the nearest hospital licensed pursuant to Chapter 197, RSMo.

(E) The facility shall test the alarm system a minimum of once a week to ensure the activation of the audible, 911, and disarming components of the system are properly working. The facility shall complete documentation of this required testing of the alarm system. This documentation shall be maintained onsite and current as long as the newborn safety incubator/ device is registered at that facility’s location. Documentation of the required testing shall be made available to the department upon the department’s request. This documentation shall be maintained for a period of five (5) years.

(F) The facility shall test the access portal door/the opening where the newborn is placed locking system at least once a week to ensure the activation of the automatic locking system.

The facility shall complete documentation of this required testing of the locking system for the access portal door/ opening where the newborn is placed. This documentation shall be maintained onsite and current as long as the newborn Documentation of the required testing shall be made available to the department upon the department’s request. This documentation shall be maintained for a period of five (5)

(G) The newborn safety incubator/device shall be checked a minimum of twice daily for debris. The facility shall complete documentation of this twice daily check for debris. This documentation shall be maintained onsite and current as long as the newborn safety incubator/device is registered at that facility’s location. Documentation of the required twice daily check for debris shall be made available to the department upon the department’s request. This documentation shall be maintained for a period of five (5) years.

(H) The newborn safety incubator/device shall be cleaned at least weekly and after any child surrender. The cleaning of the bassinet shall include:

An inspection for breaks in integrity that would impair either cleaning or disinfection/sterilization;
Sanitization of the basket or bed portion of the bassinet with an EPA-registered hospital disinfectant (e.g., phenolics) using the label’s safety precautions and directions. The surfaces of the bassinet shall be rinsed with water after sanitizing and then dried before being returned to use; and 3. The facility shall complete documentation of this required cleaning and sanitization. This documentation shall be maintained onsite and current as long as the newborn Documentation of the required cleaning and sanitization shall be made available to the department upon the department’s request. This documentation shall be maintained for a period of five (5) years.

(I) The facility shall keep track of the number of newborns placed into the newborn safety incubator/device at its facility.

This documentation shall be maintained onsite and current as long as the newborn safety incubator/device is registered at that facility’s location. This documentation shall be made available to the department upon the department’s request.

This documentation shall be maintained for a period of five (5)

(6) Oversight.

(A) Prior to utilizing an installed newborn safety incubator/ device, each facility that has a newborn safety incubator/device installed at a location shall register with the department. This registration shall include— 1. A completed Newborn Safety Incubator/Device – Location, Contact Information and Attestation of Compliance registration form, included herein;

A completed General Contractor Attestation form, included herein, completed by the general contractor; and 3. A completed Licensed Electrical Contractor/Electrician or Telecommunications Installation Professional Attestation form, included herein, completed by the licensed electrical contractor/electrician or telecommunications installation professional.

(B) After receiving a completed registration packet, the department shall complete an inspection of the facility to confirm compliance with this rule. If the department finds any deficiencies during the inspection that do not conform with this rule, the department will provide the facility written notice of all deficiencies. The facility shall send the department a plan of corrections within ten (10) calendar days to demonstrate how the facility has corrected or is planning to correct the deficiencies set forth by the department.

(C) Once all deficiencies have been corrected by the facility and approved by the department, then the facility may begin utilizing the installed newborn safety incubator/device at the location and area of the facility that was reviewed and approved by the department. If the facility changes the location of the newborn safety incubator/device, then the facility shall immediately contact the department within twenty-four (24) hours and shall not use the newborn safety incubator/device until the department has inspected and approved the new location. The facility shall complete new registration forms set forth in subsection (6)(A) and send to the department prior to the department inspecting and approving of the new location.

(D) The department will post the location of approved facilities on its website at www.health.mo.gov.

(E) The facility shall make the department aware of any change(s) in the contact or contact information listed on the Newborn Safety Incubator/Device—Location, Contact Information and Attestation of Compliance registration form within ten (10) days of any change(s) occurring by completing a new Newborn Safety Incubator/Device—Location, Contact Information and Attestation of Compliance registration form and submitting it to the department.

(F) The facility shall annually complete a Newborn Safety Incubator/Device—Location, Contact Information and Attestation of Compliance registration form and submit this completed form to the department within thirty (30) days of the anniversary of the initial or previous renewal registration date.

(G) The department may, at any time, request additional information that the department determines to be necessary to assess compliance with the applicable criteria, standards, and requirements established by this rule. The facility shall submit any additional information requested by the department within thirty (30) days of the department’s request. The department may require any additional information requested to be submitted in less than thirty (30) days if health or safety is of concern.

(H) Any facility that has a newborn safety incubator/device registered with the department may choose to voluntarily terminate their registration by doing the following:

Removing the newborn safety incubator/device from use by locking the access portal door/the opening where the newborn is placed and removing all signage for the newborn safety incubator/device; and 2. Notifying the department within seven (7) days of removing the newborn safety incubator/device from use, so the department can close out the registration and remove the facility’s name and location from the department’s website.

(I) The department may inspect the facility at any time to determine compliance with the requirements of this rule. If the department finds any deficiencies during the inspection that do not conform with this rule, the department will provide the facility written notice of all deficiencies. The facility shall send the department a written plan of corrections within ten (10) calendar days to demonstrate how the facility has corrected or is planning to correct the deficiencies set forth by the department. The plan of corrections shall include the date and time the facility plans to resume normal operation of the newborn safety incubator/device and what measures will be taken to mitigate any risk identified by cited deficiencies until the deficiency or deficiencies are corrected. Failure of the facility to be in compliance with the requirements of this rule may result in legal action against the facility by the department.

Original rule filed July 29, 2022, effective Jan. 30, 2023. *Original authority: 210.950, RSMo 2002, amended 2005, 2013, 2014, 2021.

History

AUTHORITY: section 210.950, RSMo Supp. 2022. Emergency rule filed July 29, 2022, effective Aug. 12, 2022, expired Feb. 23, 2023.

Chapter 105 Supplemental Health Care Services Agency

19 CSR 30-105.030 Procedures and Requirements for Registration of a Supplemental SERVICES {#sec-19-csr-30-105.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-105.030}

19 CSR 30-105.010 Definitions {#sec-19-csr-30-105.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-105.010}

PURPOSE: This rule defines terms as set forth in this chapter and sections 198.640 through 198.648, RSMo.

(1) Addresses shall mean, for legal entities and individuals, the physical address from which the disclosing entity operates its Missouri business and mailing address if different from the physical address.

(2) Articles shall mean a legal entity’s articles of incorporation, articles of association, articles of organization, or articles of partnership.

(3) Average amount charged shall mean the average hourly rates or set pricing charged to a health care facility by an agency for each applicable individual health care personnel.

(4) Average amount paid shall mean the average hourly rates or set pricing paid by the agency to each applicable individual health care personnel.

(5) Controlling person shall mean a business entity, officer, program administrator, or director whose responsibilities include the direction of the management or policies of a supplemental health care services agency. The term controlling person shall also mean an individual who, directly or indirectly, beneficially owns an interest in a corporation, partnership, or other business association that is a controlling person.

(6) Department shall mean the Missouri Department of Health and Senior Services.

(7) Digital website shall mean an online webpage or technology platform operated by an agency that maintains data of health care personnel or independent contractors submitted to the agency online, for referral or provisioning engagement of the healthcare personnel to a health care facility.

(8) Digital smart phone application shall mean a computer program or software application operated by an agency that maintains data of health care personnel or independent contractors or provisioning engagement of the healthcare personnel to a health care facility.

(9) Employment opportunities shall mean either part time or full-time employment with any health care facility.

(10) Health care facility shall mean a licensed hospital as defined under section 197.020, RSMo, or a licensed assisted living facility, intermediate care facility, residential care facility, or skilled nursing facility as defined under section 198.006, RSMo.

(11) Health care personnel or personnel shall mean any individual licensed, accredited, or certified by the state of Missouri to perform specified health services consistent with state law.

(12) Immediately available shall mean made available to the department or its agent within two (2) business days following written requests made by means of email, fax, or in-person delivery, or within (1) hour of requests made during inspection visits.

(13) Independent contractor shall mean a self-employed worker licensed, accredited, or certified by the state of Missouri to perform specified health services consistent with state law, who is contracted, referred, or provisioned for engagement by a supplemental health care services agency to fulfill specified health services in a health care facility.

(14) Operator shall mean any person who establishes, conducts, or maintains an agency, or any person licensed or required to be licensed to establish, maintain, or conduct an agency.

(15) Owner shall mean any person with an ownership interest of five percent (5%) or more in the agency.

(16) Ownership interest shall mean a percentage of ownership of each person of any general partnership, limited partnership, general business corporation, nonprofit corporation, limited liability company, or governmental entity which owns or operates the agency.

(17) Person shall mean an individual, firm, corporation, partnership, association, or other legal entity.

(18) Referral shall mean the act of sending or directing health care personnel to a health care facility to work at the request of or for the benefit of the facility.

(19) Specified health service shall mean services provided by any individual health care personnel or independent contractor in a health care facility.

(20) Supplemental health care services agency or agency shall mean a person, firm, corporation, partnership, or association engaged for hire in the business of providing or procuring temporary employment in health care facilities for health care personnel, including a temporary nursing staffing agency as defined in section 383.130, RSMo, or that operates a digital website or digital smartphone application that facilitates the provision of the engagement of health care personnel and accepts requests for health care personnel through its digital website or digital smartphone application. The term shall not include an individual who engages only on his or her own behalf, or to provide the individual’s services on a temporary

basis to health care facilities or a home health agency licensed under section 197.415, RSMo, and shall not include a person, firm, corporation, partnership, or association engaged in the provision of contracted specialty services by a practitioner as defined under subdivision (4) of section 376.1575, RSMo, to a hospital as defined under section 197.020, RSMo, or to other individuals or entities providing health care that are not health care facilities.

(21) Temporary employment shall mean health care personnel placed by a supplemental health care services agency in a health care facility for an initial term of less than twenty-four (24) months to support or supplement the facilities’ workforce for any purpose.

19 CSR 30-105.020 Registration Fees {#sec-19-csr-30-105.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-105.020}

PURPOSE: This rule establishes registration fees authorized by

section 198.642, RSMo.

(1) The following fees are required by the Supplemental Health Care Services Agency program:

(A) Initial annual registration fee $830 (B) Renewal annual registration fee $700 (2) Fees must be payable to the Department of Health and Senior Services in the form of a cashier’s check, personal or certified check, company check, money order, or through the online payment system by credit card or e-check. A registrant may mail their fee to the Department of Health and Senior Services, Fee Receipt Unit, PO Box 570, Jefferson City, MO 65102- 0570. Payments made using the online payment system may include an additional processing fee.

(3) All fees are nonrefundable and are not proratable.

(4) Notwithstanding any other provision in this rule to the contrary, if an agency fails to provide sufficient registration fee(s), the department shall reject the application and return the fee(s). An agency may then resubmit an application with the correct registration fee(s).

19 CSR 30-105.030 Procedures and Requirements for Registration of a Supplemental Health Care Services Agency {#sec-19-csr-30-105.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-105.030}

PURPOSE: This rule specifies the minimum requirements for registration and renewal of a supplemental health care services agency in Missouri.

(1) No person shall establish, conduct, or maintain a supplemental health care services agency in this state without a valid registration issued by the department.

(2) Each supplemental health care services agency providing, procuring, or engaging health care personnel or independent contractors for temporary employment in Missouri health care facilities must submit a registration application and fee. The Application for Registration to Operate a Supplemental Health Care Service Agency (“Application”), included herein, shall be completed and submitted to the department via mail or electronically online with the fee required by 19 CSR 30-105.020. Information provided in the application shall be attested by signature to be true and correct to the best of the applicant’s knowledge and belief.

(3) Each separate business location from which the agency operates in Missouri shall have a separate application.

(4) The application shall include— (A) Agency information, including— 1. The agency’s legal or registered fictitious name, addresses, telephone number, fax number, email address, and responsible contact person;

Indication of whether the application is the result of a new registered agency or renewal of an existing agency’s registration; and 3. The agency’s days and hours of operation;

(B) Owner information, including— 1. Owner name(s), federal employer identification number(s) or social security number(s), state tax identification number, mailing address, and contact information. The owner shall be registered to do business with Missouri Secretary of State;

Type of owner’s legal entity;
All controlling persons in the ownership of the agency, including each individual or entity name, title or position, personal or primary address, telephone number, federal employer identification number or Social Security number, and percentage of ownership;
If the owner is a legal entity, include copies of the articles and current bylaws, together with the names and addresses of officers, managers, members, or directors;

(C) Operator information, including— 1. Operator name, mailing address, and contact information. The operator shall be registered to do business with Missouri Secretary of State;

Type of operator’s legal entity;
All controlling persons in the operation of the agency, including each individual or entity name, title or position, personal or primary address, telephone number, federal employer identification number or Social Security number, and percentage of ownership;
List any other supplemental health care services agencies in which the operator owns or operates and provide the agency’s name, address, type of registration, and registration number;

(D) Financial information, including— 1. Proof of financial responsibility through one (1) of the following methods documenting at least four weeks of back wages per employee:

A. Establishing and maintaining an escrow account consisting of cash or assets eligible for deposit; or B. Obtaining and maintaining an unexpired irrevocable letter of credit established. Such letters of credit shall be nontransferable and nonassignable and shall be issued by any bank or savings association organized and existing under the laws of this state or the United States;

Name and address of the bank, savings bank, or savings association in which the agency will deposit the agency’s employee’s income tax withholdings. If the agency is not responsible for employee income tax withholding, the agency shall provide the name and address of each personnel for whom income taxes will not be withheld; and 3. Additional proof of stable or satisfactory financial condition, as specifically requested by the department. This additional documentation shall be submitted within ten (10) business days of receipt of the written request;

(E) Other information, including— 1. Proof that the agency or health care personnel, including independent contractors, has medical malpractice insurance (professional liability insurance is acceptable), as required by section 198.644.1(4), RSMo;

Proof of current worker’s compensation coverage as required by Missouri law and Chapter 287, RSMo or, if the personnel are independent contractors, proof of occupational accident insurance; and (F) Affidavit, including the following attestations— 1. That the individual or operating entity has adequate financial resources to properly operate the agency referred to in the application;
That the agency is familiar with the requirements of a supplemental health care services agency as set out in Chapter 198, RSMo, and the regulations of the Department of Health and Senior Services promulgated thereunder;
That the agency does not restrict in any manner the employment opportunities of health care personnel and independent contractors;
That the agency refrains in any contract with any health care personnel, including independent contractors, or health care facility from requiring the payment of liquidated damages, employment fees, or other compensation should the health care personnel be hired as a permanent employee of a health care facility;
That all health care personnel, including independent contractors, meet all licensing or certification requirements and all training and continuing education standards for the position in which the personnel would be working; and 6. That each health care personnel and independent contractor complies with requirements related to background checks in sections 192.2490 and 192.2495, RSMo.

(5) An agency’s registration is valid for one (1) year and shall expire on the annual anniversary of the date the registration was originally issued. If renewed, an agency’s registration is valid for one (1) year and shall expire on the annual anniversary of the date the registration was last renewed.

(6) An agency’s renewal application must be received at least sixty (60) days prior to the expiration of the current registration.

(7) An agency’s registration is valid only for the entity and/ or person identified on the registration issued at the address shown thereon and is not subject to sale, assignment, or other transfer.

(8) An agency must send a copy of its current registration to any member of the general public upon request.

MO 580-3424 (08/23) Page 1 of 5 MISSOURI DEPARTMENT OF HEALTH AND SENIOR SERVICES DIVISION OF REGULATION AND LICENSURE APPLICATION FOR REGISTRATION TO OPERATE A (One application per registered agency location)

Applications must be received at least 60 days prior to the expiration of the current registration. Applications will not be considered for review until payment has been received.

Agency Information 1. AGENCY INFORMATION – The name of the Agency must be indicated exactly as you want it to appear on the registration. Include the mailing address of the Agency, if different from the street address.

Name of Agency/Doing business as (D.B.A)

Agency Physical Address City County State Zip Agency Telephone Number Fax Number Mailing Address or Same as above City County State Zip Agency E-mail Address Agency Website (optional)

Responsible Person Responsible Person Email and Phone Number (if different from Agency)

Indicate if this application is a result of a new registered agency or renewal:

New Agency ($830 fee) Renewal ($700 fee)

Each application for registration must be accompanied by a registration fee outlined above. Attach a cashier’s check, personal or certified check, company check, or money order payable to the Department of Health and Senior Services. If fee is submitted online, attach fee receipt. This fee is nonrefundable and not proratable.

Check box if submitting payment online Check box if mailing payment; add check number here:

List the days and hours of regular operation. (NOTE: Inspections by the department will occur during the business hours submitted.) Section not applicable to agencies that operate 24 hours a day and 7 days a week.

Check box if agency operates 24 hours a day and 7 days a week DAY OF THE WEEK OPENING TIME (indicate A.M. or P.M.) CLOSING TIME (indicate A.M. or P.M.)

Sunday Monday Tuesday Wednesday Thursday Friday Saturday DO NOT WRITE IN THIS SPACE AGENCY REGISTRATION NUMBER RENEWAL NEW AGENCY EXPIRATION DATE DATE FEE REC’D CHECK NO/ JET PAY NO AMOUNT $ MO 580-3424 (08/23) Page 2 of 5 2.OWNER INFORMATION – Please complete the following for each of the agency’s owner(s). Attach multiple copies of this page if necessary.

Owner Name(s) The name of the owner must be the exact legal name. If the owner is any entity other than a sole proprietor, the owner name must match the Missouri Secretary of State filing. The owner name should not be the name of any individual stockholder, partner, or member.

Federal Employer Identification Number (EIN) State Tax ID # Mailing Address or Same as Agency Mailing Address City State Zip Contact Name Contact Telephone Number Contact E-mail Address Description of Owner (check one):

Corporation Limited Liability Company Limited Partnership Individual Sole Proprietor Other-explain A.Individual and/or Entity Ownership of Owner as listed in section 2 above – Provide the information for each controlling person. Attach additional sheets if necessary.

FULL NAME of INDIVIDUAL or ENTITY TITLE OR POSITION PERSONAL/PRIMARY ADDRESS EIN (or SSN if sole proprietor)

% OWNERSHIP

B.Board Members and Officers of Owner – If the owner is a legal entity, provide the information for each individual or entity that serves as an officer or is on the board of directors of the owner, if applicable. Do not include voluntary board members.

TITLE FULL NAME PERSONAL/PRIMARY ADDRESS

C.Articles – If the owner is a legal entity, attach copies of the owner’s articles and current bylaws to this application. 3.OPERATOR INFORMATION – Please complete the following for the entity(s) operating the agency.

MO 580-3424 (08/23) Page 3 of 5 Check mark this box if the operating entity(s) is the same as the owner. If checked, skip ahead to #1 below.

Operator Name(s) The name of the operator must be the exact legal name. If the operator is any entity other than a sole proprietor, the operator name must match the Missouri Secretary of State filing. The operator name should not be the name of any individual stockholder, partner, or member.

Mailing Address or Same as above City State Zip Contact Name Contact Telephone Number Contact E-mail Address Description of Operator (check one):

Corporation Limited Liability Company Limited Partnership Individual Sole Proprietor Other-explain A.Individual and/or Entity Ownership of Operator as listed in section 3 above – Provide the information for each controlling person. Attach additional sheets if necessary.

FULL NAME of INDIVIDUAL or ENTITY TITLE OR POSITION PERSONAL/PRIMARY ADDRESS EIN (or SSN if sole proprietor)

% OWNERSHIP

B. Board Members and Officers of Operator – Provide the information for each individual or entity (corporation, partnership, association) that serves as an officer or is on the board of directors.

TITLE FULL NAME PERSONAL/PRIMARY ADDRESS TELEPHONE NUMBER

Does the operator currently operate or own any other Supplemental Health Care Services Agencies?

Yes No If the operator currently operates or owns any other supplemental health care services agencies, then list below or attach a list of such agency or agencies, including their names, address(es), type of registrations and registration number.

Attached Previously submitted; no amendment or change MO 580-3424 (08/23) Page 4 of 5 Each registrant must submit financial information demonstrating that the operator has the financial capacity to operate an agency.

Other Information 1.Provide proof that the agency or that the health care personnel has medical malpractice insurance (professional liability insurance is acceptable); 2.Provide proof of current worker’s compensation coverage as required by Missouri Statutes, Chapter 287 RSMo, or if any personnel are independent contractors, provide proof of occupational accident insurance.

Acceptable forms of worker’s compensation coverage include: a certificate of insurance supplied by an authorized Worker’s Compensation insurance carrier pursuant to Chapter 287, RSMo. The certificate shall include the name of the registrant, the name of the corporation legally responsible for the registrant, or the name the registrant is doing business as. The certificate must be effective prior to the issuance of an initial registration or have an effective date on or after the effective date of a renewal registration. OR provide approval from the MO Department of Labor to be self-insured.

You cannot be issued a registration and may not operate as a supplemental health care services agency unless acceptable evidence of compliance with workers’ compensation coverage provisions is provided.

Each agency must provide proof of financial responsibility through one of the following methods documenting at least four weeks of back wages per employee:

Enter number of all temporary health care personnel or independent contractor employees: •Establishing and maintaining an escrow account consisting of cash or assets eligible for deposit; •Obtaining and maintaining an unexpired irrevocable letter of credit established. Such letters of credit shall be nontransferable and nonassignable and shall be issued by any bank or savings association organized and existing under the laws of this state or the United States.

AND Provide the name and address of the bank, savings bank, or savings association in which the agency will deposit the agency’s employee’s income tax withholdings.

If the agency is not responsible for employee income tax withholding, the agency shall provide the name and address of each personnel for whom income taxes will not be withheld.

Attached Previously submitted; no amendment or change Financial Information MO 580-3424 (08/23) Page 5 of 5 I attest that I as an individual, or that the operating entity for which I sign, have/has adequate financial resources to properly operate the Agency referred to in this application.

I further attest I am familiar with the requirements of a supplemental health care services agency as set out in Chapter 198 of the Missouri Revised Statutes and the regulations of the Department of Health and Senior Services promulgated thereunder.

I further attest to refrain in any contract with any health care personnel or health care facility from requiring the payment of liquidated damages, employment fees, or other compensation should the health care personnel be hired as a permanent employee of a health care facility;

I further attest that the agency does not restrict in any manner the employment opportunities of its health care personnel;

I further attest that each health care personnel meets all licensing or certification requirements and all training and continuing education standards for the position in which the personnel would be working;

I further attest that each health care personnel complies with requirements related to background checks in sections 192.2490 and 192.2495.

I further attest that all documents and information required by the Department of Health and Senior Services to be provided pursuant to this application are true and correct to the best of my knowledge and belief, that the statements contained in this application and any attached information are true and correct to the best of my knowledge and belief, and that all required documents are either included with the application or are currently on file with the Department of Health and Senior Services. I understand that if it is determined by the Department of Health and Senior Services that the statements contained herein are not true and correct, the application may be denied and any registration issued based on the application may be revoked.

I further attest that I have the express authority to sign this application on behalf of the owner and operator.

My signature attests to the truth and accuracy of the foregoing attestations.

Authorized Signature of Agency Telephone Number Printed or Typed Name and title of Signatory Telephone Number Affidavit

19 CSR 30-105.040 Requirements for Changes to a Registered {#sec-19-csr-30-105.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-105.040}

PURPOSE: This rule outlines requirements for changes to an issued registration of a supplemental health care services agency in Missouri.

(1) A registered agency shall notify the department of any change in ownership or operator within thirty (30) days of the change. This includes the addition or removal of any owners, operators, or controlling persons. The registration shall be void and the new owner and/or operator shall apply for a new registration and pay the required fee. The date issued on the new registration shall be the effective date when the change of ownership or operator occurred.

(A) A registered agency which is a partnership, limited partnership, limited liability company, or corporation that undergoes any of the following changes, or a new corporation, partnership, limited partnership, limited liability company, or other entity assumes operation of an agency whether by one (1) or by more than one (1) action shall apply for a new registration:

With respect to a partnership, a change in the majority interest of general partners;
With respect to a limited partnership, a change in the general partner or in the majority interest of limited partners;
With respect to a limited liability company, a change in any manager or in the majority interest of members or parent company; and 4. With respect to a corporation, a change in the persons who own, hold, or have the power to vote the majority of any class of securities issued by the corporation.

(2) An agency shall notify the department of any change in agency name, address, phone number, fax number, email address, and/or responsible contact person information by completing and submitting a Changes to a Registered Agency form, included herein, to the department. Any change of owner or operator will require a new initial application and payment of the required fee.

MISSOURI DEPARTMENT OF HEALTH AND SENIOR SERVICES

DIVISION OF REGULATION AND LICENSURE

CHANGES TO A REGISTERED AGENCY FORM

Only fill out sections related to the necessary agency changes.

AGENCY REGISTRATION NUMBER

CURRENT REGISTERED AGENCY NAME

NEW REGISTERED AGENCY NAME (if changing name)

CURRENT REGISTERED BUSINESS PHYSICAL ADDRESS

NEW BUSINESS PHYSICAL ADDRESS (if changing address) *Additional documentation and information may be required CURRENT REGISTERED BUSINESS MAILING ADDRESS Same as physical address NEW BUSINESS MAILING ADDRESS (if changing address)

Same as physical address NEW AGENCY TELEPHONE NUMBER (if changing number) NEW AGENCY FAX NUMBER (if changing fax number)

NEW OR ADDITIONAL AGENCY EMAIL ADDRESS (if changing or adding an email address. Also, indicate if a current email address should be removed)

NEW RESPONSIBLE CONTACT PERSON (if changing contact person) NEW RESPONSIBLE CONTACT PERSON EMAIL AND PHONE NUMBER (if different from registered Agency)

REASON FOR CHANGES LISTED ABOVE:

RESPONSIBLE CONTACT PERSON NAME

SIGNATURE

DATE

MO 580-3425 (08/23)

19 CSR 30-105.050 Inspections {#sec-19-csr-30-105.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-105.050}

PURPOSE: This rule outlines inspections, complaints, and requirements of a supplemental health care services agency.

(1) The department may conduct unannounced in-person or virtual registration or complaint inspection visits to an agency’s office or records repository.

(2) An agency shall be available during the agency’s regular operating hours and shall maintain and make immediately available the following business records for inspection by the department— (A) Copies of articles and bylaws, if applicable;

(B) An individual file or account information for each health care personnel, including independent contractors, including— 1. Personnel’s name and address, Social Security number, and date of birth;

Documentation of each personnel’s or independent contractor’s employment history, health, and medical records.

A. Personnel and independent contractors must have received the necessary testing and immunizations required or requested by each health care facility.

B. Drug screening of personnel and including independent contractors must be performed before referral by the agency to a health care facility, if the health care facility requires drug screening of facility employees;

Evidence of the personnel’s or independent contractor’s skills, qualifications, education, and training to demonstrate compliance with the provisions of section 198.644.1, RSMo;
Current copies of licenses, transcripts, certificates, or statements evidencing competency for the position held;
Two (2) or more references and documentation of two (2) or more reference checks of each personnel or independent contractor, completed before referral by the agency;
Documentation of submission for background screening and background screening results pursuant to sections 192.2490 and 192.2495, RSMo; and 7. Copy of any good cause waiver, granted by the department, if applicable;

(C) Documentation of any complaints known to the agency involving any of its health care personnel or independent contractors, and any follow-up action taken with respect to such complaints;

(D) Records documenting the work performed by each health care personnel or including independent contractor, including date of personnel referral by the agency or request by an independent contractor and the dates and locations of each personnel and independent contractor placement. Copies of time records or invoices identifying the services provided are acceptable documentation for this requirement;

(E) Copies of any written employment contracts or other agreements entered into between the agency and each health care personnel or independent contractor. Such contract or agreement shall specifically and clearly advise if the personnel is an employee of the agency or is an independent contractor referred by the agency. If the personnel is retained as an independent contractor, the contract or agreement shall specifically state that the independent contractor is responsible for paying federal income taxes. Prior to placement in a health care facility, the agency shall provide a document to each health care personnel or independent contractor, for his or her signature or digital acceptance, which states that the personnel understands his or her relationship with the agency, either as an employee or independent contractor. The signed or accepted document shall be filed in each personnel’s file or account;

(F) Copies of records required by the United States Internal Revenue Services to be prepared by the agency for each personnel or independent contractor;

(G) Documentation to verify each personnel’s or independent contractor’s employment eligibility in compliance with the immigration laws of the United States;

(H) Copies of contracts, if any, between an agency and a health care facility setting forth terms and conditions under which the agency will provide specific health services staff to the facility. Such contracts shall state whether the staff provided by the agency are referred as employees of the agency or as independent contractors;

(I) Most recently released annual or quarterly financial reports;

(J) Evidence of medical malpractice insurance (professional liability insurance is acceptable); and (K) Evidence of current worker’s compensation coverage as required by Chapter 287, RSMo, or if the personnel provided are independent contractors, maintain evidence of occupational accident insurance.

(3) Agencies shall retain personnel records for at least ten (10) years following termination of employment or independent contractor relationship from the agency.

(4) The agency shall make all records requested by the department immediately available.

(5) Personnel and independent contractors of an agency who report potential violations by an agency to the department may not be subjected to retaliation of any kind, including termination, demotion, or other adverse employment action as a result of their report.

(6) If statutory or regulatory violations are identified by the department during an inspection or investigation, the department shall provide a report of findings and violation(s) to the agency.

(A) The agency shall then submit to the department a plan of correction for the identified violations within thirty (30) days of the receipt of the report of findings and violation(s), unless an alternative time frame is required or approved by the department in writing.

(B) Upon the department’s acceptance of the agency’s plan of correction, the department may conduct an unannounced follow-up inspection or off-site review to verify correction of deficiencies at any time.

(C) If the violations are not corrected within the required time frame, the department may suspend or revoke the agency’s registration.

19 CSR 30-105.060 Denial, Suspension, or Revocation of Registration {#sec-19-csr-30-105.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-105.060}

PURPOSE: This rule specifies the process of denial or revocation of a registration of a supplemental health care services agency in Missouri.

(1) Any agency whose registration has been denied, suspended, or revoked by the department may seek a review of the department’s actions by the Administrative Hearing Commission.

(2) If an agency is notified of a registration denial or revocation due to noncompliance with sections 198.640 to 198.648, RSMo, the owner and operator shall not be eligible to apply for or receive a registration for five (5) years following the date of denial or revocation.

(3) For contracts entered into on or after August 28, 2022, if the contract between an agency and health care personnel or a health care facility requires the payment of liquidated damages, employment fees, or other compensation should the health care personnel be hired as a permanent employee of a health care facility, the agency’s registration shall be subject to revocation or nonrenewal of its registration.

(4) If an agency fails to provide any of the items required in

section four (4) of 19 CSR 30-105.030 within ten (10) business days of the department’s written request, the department shall immediately suspend or refuse to issue the agency’s registration.

(5) If the department revokes, fails to renew, or immediately suspends an agency’s registration, the agency shall— (A) Immediately stop referring personnel to health care facilities; and (B) Notify health care facilities where personnel are currently referred or contracted that the agency no longer has a valid operating registration.

19 CSR 30-105.070 Quarterly Rate and Charge Reporting Requirements {#sec-19-csr-30-105.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-105.070}

PURPOSE: This rule specifies the quarterly rate and charge reporting requirements of a supplemental health care services agency in Missouri.

(1) Any registered supplemental health care services agency that contracts with a health care facility that participates in Medicare or Medicaid shall submit the following report every quarter to the department:

(A) A detailed list of each health care facility participating in Medicare or Medicaid with whom the agency has contracted over the prior quarter;

(B) A detailed list of the average amount charged by the agency to the health care facility over the prior quarter, broken down by health care facility and each individual health care personnel within each job classification (including but not limited to nursing, therapy, dietary/nutrition, lab, and radiology); and (C) A detailed list of the average amount paid by the agency to health care personnel over the prior quarter, broken down by health care facility and each individual health care personnel within each job classification, including but not limited to nursing, therapy, dietary/nutrition, lab, and radiology.

(2) The required submission dates shall be as follows:

(A) The quarterly report containing data from January 1 through March 31 shall be submitted no later than April 30;

(B) The quarterly report containing data from April 1 through June 30 shall be submitted no later than July 31;

(C) The quarterly report containing data from July 1 through September 30 shall be submitted no later than October 31; and (D) The quarterly report containing data from October 1 through December 31 shall be submitted no later than January 31.

(3) Health care personnel to be reported shall include all positions that are licensed, accredited, or certified by the state of Missouri to perform specified health services consistent with state law.

(4) Failure of the agency to provide any of this information to the department shall result in revocation or nonrenewal of its registration.

History

AUTHORITY: section 198.648, RSMo Supp. 2022 Original rule filed Feb. 8, 2023, effective Sept. 30, 2023.

Chapter 110 Prescribed Pediatric Extended Care Facilities

19 CSR 30-110.010 Prescribed Pediatric Extended Care Facilities Definitions {#sec-19-csr-30-110.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-110.010}

PURPOSE: This rule defines terms as set forth in this chapter and sections 192.2550 through 192.2560, RSMo.

(1) An allowed practitioner is a physician or advanced practice registered nurse licensed in the state of Missouri.

(2) The center director is an adult who is responsible for planning, monitoring, and managing the licensed child care facility’s daily program.

(3) A child is an individual who is under the age of seventeen (17).

(4) Child care staff member shall have the same meaning as defined in 5 CSR 25-500.010.

(5) Clinical records are medical records maintained in accordance with accepted professional standards and practices.

(6) Department is the Missouri Department of Health and Senior Services.

(7) DESE is the Missouri Department of Elementary and Secondary Education.

(8) Direct care personnel is a Certified Nursing Assistant or Certified Medical Technician certified by the department under section 198.082, RSMo.

(9) The director of nursing is a registered nurse, approved by the department, responsible for the medical oversight of eligible children admitted to the facility.

(10) An eligible child is an individual who is under the age of six (6) years admitted to a prescribed pediatric extended care facility that has complex medical needs requiring continuous skilled nursing intervention of at least four (4) hours per day, as ordered by a physician.

(11) A licensed practical nurse (LPN) is a person licensed under

Chapter 335, RSMo, to engage in the practice of practical (12) Life support equipment is equipment which if stopped could result in loss of human life or serious injury.

(13) A multidisciplinary group is a group with a representative from each of the healthcare disciplines provided to the eligible child.

(14) NFPA 99 is the NFPA 99, Health Care Facilities Code (2024), published October 2024.

(15) An occupational therapist is a person licensed under

Chapter 324, RSMo, to practice occupational therapy.

(16) A person is any individual, firm, corporation, partnership, association, agency, incorporated or unincorporated organization, or other legal entity, regardless of the name used.

(17) A physician is a person licensed by the State Board of Registration for the Healing Arts pursuant to Chapter 334, RSMo, to practice in this state as a physician and surgeon.

(18) A physical therapist is a person who is licensed to practice physical therapy under Chapter 334, RSMo.

(19) A plan of care is a comprehensive plan approved by a physician to direct prescribed pediatric extended care (PPEC) staff members in care and treatment of eligible children that contains nutrition orders, medication orders, treatment orders, equipment orders, and interventions for developmental goals.

(20) A PPEC staff member is a child care staff member who has medical training and credentials as required by this chapter and is assigned to care for eligible children.

(21) A prescribed pediatric extended care facility (PPEC or facility or PPEC facility) is a facility providing medically necessary multidisciplinary services to eligible children no more than twelve (12) hours within a twenty-four- (24-) hour period. The facility must be licensed by DESE under Chapter 210, RSMo. The facility must offer multidisciplinary services to include skilled nursing and personal care and speech, physical, and occupational therapy services, as ordered by a physician.

(22) A prescribed pediatric extended care provider (provider) is the person or persons licensed or required to be licensed under sections 192.2550 to 192.2560, RSMo, to establish, conduct, or maintain a PPEC facility.

(23) A registered nurse (RN) is a person licensed under Chapter 335, RSMo, to engage in the practice of professional nursing.

(24) Skilled nursing includes those services which are required to be provided by a registered nurse or a licensed practical nurse.

(25) Speech therapy is therapy provided by a person licensed under section 345.075, RSMo, as a speech-language pathologist.

19 CSR 30-110.020 Prescribed Pediatric Extended Care Facilities Licensure Management {#sec-19-csr-30-110.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-110.020}

PURPOSE: This rule describes the licensure, inspection, plan of correction, and variance processes.

(1) Initial Application for License.

(A) Persons desiring to receive a license to operate a prescribed pediatric extended care (PPEC) facility in the state of Missouri shall file a written Application to Operate a Prescribed Pediatric Extended Care Facility, included herein.

(B) If the applicant has an active License to Operate a Group Child Care Home or Child Care Center for the location that the applicant is applying for PPEC licensure, the applicant shall include— 1. A copy of the License to Operate a Group Child Care Home or Child Care Center;

The most recent fire inspection report;
The most recent sanitation inspection report;
The terms of any discipline applicable to the License to Operate a Group Child Care Home or Child Care Center; and 5. Copies of any variances granted by Department of Elementary and Secondary Education (DESE) to regulations under 5 CSR 25.

(C) If the applicant does not have an active License to Operate a Group Child Care Home or Child Care Center, the applicant shall include evidence of a pending application for said license.

(D) The applicant shall include a chart or description of the lines of administrative authority.

(E) The application shall include confirmation that the applicant can provide multidisciplinary services to include skilled nursing and personal care and speech, physical, and occupational therapy services.

(F) Upon receipt of a complete application, the department will initiate the initial licensure process.

(G) If the applicant does not complete the initial licensure process within six (6) months, the application shall be void and another application may be filed.

(H) No license shall be granted until the applicant has provided proof of compliance with all rules within this chapter.

(I) Once granted, the PPEC facility license shall be posted in a public area of the facility.

(J) The license shall not be transferable and shall apply only to the person and address shown on the license.

(K) The department will not accept an application for PPEC facility licensure for a period of twelve (12) months after revocation or denial of the facility license.

(L) The department will not accept an application for PPEC licensure from a provider whose License to Operate a Group Child Care Home or Child Care Center is suspended or pending proposed revocation.

(2) Limitations on Facility Location and Operation.

(A) The PPEC shall be located within thirty (30) minutes or twenty (20) miles, whichever is less, from a licensed hospital with an emergency department.

(B) The PPEC shall be located on the ground floor of any multi-level building.

(D) The PPEC facility shall not be located in a residence.

(E) There shall be no nighttime care of eligible children in the PPEC facility. For the purposes of this rule, night shall have the same meaning as defined in 5 CSR 25-500.010.

(3) Post Licensing Requirements.

(A) Thirty (30) days after either initial licensing or beginning to care for eligible children, whichever is later, the provider shall obtain a sanitation inspection.

(B) The provider shall notify the department of any new or changed variances granted by DESE to regulations under 5 CSR 25.

(C) Providers shall provide to the department annual proof of compliance with fire safety and sanitation requirements set by DESE.

Compliance with fire safety requirements shall be proven with an inspection by the Department of Public Safety, Division of Fire Safety, showing the facility to be in full compliance.
Compliance with sanitation requirements shall be proven with an inspection by the Department of Health and Senior Services showing the facility to be in full compliance.

(4) Inspection and Plan of Correction Process.

(A) The PPEC facility provider and staff shall allow representatives of the department to survey the facility.

(B) After completion of each department survey, the department shall prepare a written report of the findings with respect to compliance or noncompliance with the provisions of sections 192.2550 – 192.2560, RSMo, and the regulations within this chapter, as well as a list of deficiencies.

(C) The provider or designee shall have ten (10) calendar days following receipt of the written survey report to provide the department with a written plan of correction for the identified deficiencies.

(D) Upon receipt of the required plan of correction for achieving license compliance, the department shall review the plan to determine the appropriateness of the corrective action and respond to the facility. If the plan is not acceptable, the department shall notify the provider or designee and indicate the reasons why the plan was not acceptable. A revised plan of correction shall be provided to the department within seven (7) calendar days of this notice.

(E) Upon expiration of the completion date for correction of deficiencies specified in the approved plan of correction, the department shall determine if the required corrective measures have been acceptably accomplished. If the department finds the facility to still be noncompliant, the department may request another plan of correction or may take action to discipline the license.

(F) The department may proceed with the immediate suspension and proposed revocation of a license prior to receiving a plan of correction if there is an imminent threat of bodily harm to the children in care.

(G) The department will not accept a plan of correction and will proceed with the immediate suspension and proposed revocation of a license if DESE immediately suspends the provider’s child care license, or if DESE revokes the provider’s child care license.

(5) Variance Request Process.

(A) Any provider may request a variance from a rule in this chapter. The request for a variance shall be submitted in writing to the department and shall include the rule(s) for which a variance is requested and the reason(s) the provider requests the variance.

(B) The department may grant variances for specified periods of time to any rule imposed by the department in this chapter if the department has determined that the variance to the rule would not potentially jeopardize the health, safety, or welfare of any children in the PPEC facility. The department shall notify the provider, in writing, of the decision on any request for variance, stating the reason(s) for acceptance or denial, and, if granted, the length of time the variance is to be in effect and any additional corrective factors upon which variance may be conditioned. The determination is subject to review under

Chapter 536, RSMo.

(12-2024)

APPLICATION TO OPERATE A PRESCRIBED PEDIATRIC EXTENDED CARE FACILITY (PPEC )

INITIAL APPLICATION APPLICATION /CHANGE UPDATE CHANGE OF OWNERSHIP

In accordance with the requirements of the Missouri State Agency, Licensing Authority (192.2550-192.2560, RSMo), application is hereby made for a license to conduct and maintain a Prescribed Pediatric Extended Care Facility to operate in accordance with 192.2550- 192.2560, RSMo, 19 CSR 30-110.010, 19 CSR 30-110.020 and 19 CSR 30-110.030.

THIS INFORMATION WITHOUT FURTHER VERIFICATION, WILL BE PROVIDED TO THE MEDICAID OFFICE AND

WILL BE USED TO UPDATE THE STATE AGENCY DIRECTORY.

LEGAL NAME OF FACILITY

DOING BUSINESS AS NAME (IF APPLICABLE) TELEPHONE NO

OPERATING ADDRESS (STREET, CITY, STATE, ZIP)

COUNTY

MAILING ADDRESS

CENTER DIRECTOR NAME

CENTER DIRECTOR EMAIL ADDRESS DIRECTOR OF NURSING NAME

OWNERSHIP AND MANAGEMENT (CHECK ONLY ONE)

GOVERNMENTAL

COUNTY

CITY-COUNTY

CITY

DISTRICT

NON-GOVERNMENTAL

NON-PROFIT PROPRIETARY

CORPORATION INDIVIDUAL LLC

OTHER (EXPLAIN) PARTNERSHIP

LLC CORPORATION

IF OPERATED BY MANAGEMENT CONSULTANT, NAME OF FIRM

PLEASE NOTE: THE PPEC MUST HAVE CURRENT LICENSURE BY THE MISSOURI DEPARTMENT OF ELEMENTARY AND SECONDARY

EDUCATION (DESE)

NAME OF CHILD CARE CENTER UNDER WHICH PPEC OPERATES IN ACCORDANCE WITH 5 CSR 25-500.010

DESE DVN #

PPEC DAYS AND HOURS OF OPERATION

PPEC (ANTICIPATED) CAPACITY

FLOOR OF BUILDING USED FOR PPEC ELIGIBLE CHILDREN

PLEASE CHECK EACH MULTI-DISCIPLINARY SERVICE BELOW TO CONFIRM THE PPEC CAN PROVIDE THE SERVICE IF

REQUIRED FOR THE ELIGIBLE CHILD

SKILLED NURSING PERSONAL CARE

NUTRITIONAL ASSESSMENT DEVELOPMENTAL ASSESSMENT

SPEECH THERAPY PHYSICAL THERAPY

OCCUPATIONAL THERAPY

Attestation The Center Director acknowledges they have read the foregoing application and that the statements contained therein are correct and true to the best of their knowledge; and further gives assurance of the ability and intention of the facility to comply with the regulations promulgated under the Missouri PPEC law 192.2550-192.2560, 19 CSR 30-110.010, 19 CSR 30-110.020 and 19 CSR 30-110.030.

It is further agreed the facility will comply with all recommendations for correction and/or improvements as contained in the most recent Licensing Survey Report prepared by the Department of Health and Senior Services and submitted to said facility.

(12-2024)

Signature of Center Director Date Additional documentation to be submitted with this application:  A copy of the License to Operate a Group Child Care Home or Child Care Center;  A chart or description of the lines of administrative authority,  Current copy of registration with Missouri Secretary of State Office;  The most recent fire inspection report;  The most recent sanitation inspection report; and, if applicable:

The terms of any discipline applicable to the License to Operate a Group Child Home or Child Care Center; and - Copies of any variances granted by DESE to regulations under 5 CSR 25.

If the applicant does not have an active license to operate a Group Child Care Home or Child Care Center, the applicant shall include evidence of a pending application for said license.

RETURN THIS COMPLETED FORM (WITH ADDITIONAL REQUIRED DOCUMENTATION) TO:

MISSOURI DEPARMENT OF HEALTH AND SENIOR SERVICES

ATTN: BUREAU OF HOME CARE AND REHABILITATIVE STANDARDS

PO BOX 570

JEFFERSON CITY, MO 65102

19 CSR 30-110.030 Prescribed Pediatric Extended Care Facilities Operations {#sec-19-csr-30-110.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 30-110.030}

PURPOSE: This rule defines the minimum requirements for the provision of care in licensed Prescribed Pediatric Extended Care (PPEC) facilities.

(1) Providers must comply with all regulations under this

chapter and all relevant regulations under 5 CSR 25-500, 5 CSR 25-600, and all other relevant state and federal laws.

(A) Providers shall notify the department of any discipline proposed by Department of Elementary and Secondary Education (DESE) against the provider’s license to operate a child care facility. This notice shall be sent to the department within one (1) business day of receipt of the notice of proposed discipline.

(B) The provider must have an active license to operate a child care facility for the same location as the PPEC facility license.

(2) Organization and Administration.

(A) The facility must immediately notify the department of any personnel changes of the center director or director of (B) The facility must immediately notify the department of changes in the facility contact information.

(C) The director of nursing is responsible for PPEC staff member assignments; coordinating medical care of eligible children; assuring that the needs of eligible children are continually assessed; and assuring the development, implementation, and updates of the individualized plan of care.

(D) The center director and director of nursing positions shall not be held by the same individual.

(E) When the director of nursing is not available, a qualified designee approved in writing by the department shall assume the same responsibilities and obligations as the director of (F) The director of nursing or an approved qualified designee shall be available on-site during all operating hours.

(3) Policies.

(A) Each PPEC facility must develop, implement, and maintain written policies and procedures governing the following at a minimum:

Medical, nutritional, and developmental assessments of eligible children;
Admission, transfer, and discharge;
Multidisciplinary medical staff, direct care staff supervision;
Child abuse and neglect;
Infection control program;
Infection control isolation procedures;
Medical equipment;
The plan of care;
Medication storage and administration;
Clinical records;
Quality assurance program;
Complaints;
Emergency preparedness and medical response; and 14. Staff training and competency evaluation.

(B) Policies and procedures must be developed, maintained, and implemented by a group of professional PPEC staff members comprised of at least the center director, the director of nursing, and a representative of each multidisciplinary service offered. Policies and procedures shall be developed in conjunction with a physician consultant.

rule.

(4) Medical, Nutritional, and Developmental Assessments.

The facility shall conduct the following initial assessments to ensure that the PPEC facility is equipped and staffed to meet the needs of an eligible child prior to admission:

(A) Prior to admission to the facility, a registered nurse or physician shall conduct and document an initial assessment to assess the eligible child’s immediate physical and medical equipment needs prior to admission to the facility. The assessment shall be completed as often as required to meet the needs of the eligible child;

(B) Prior to admission to the facility, a registered nurse, registered dietician, nutritionist, physician assistant, or physician shall conduct and document an initial nutritional assessment to assess the eligible child’s immediate nutritional and equipment needs prior to admission to the facility. The assessment shall be completed as often as required to meet the needs of the eligible child;

(C) Prior to admission to the facility, a registered nurse, physical therapist, occupational therapist, speech therapist, physician assistant, or physician shall conduct and document an initial developmental assessment to assess the eligible child’s immediate developmental needs. Further assessments shall be completed as often as required to meet the needs of the eligible child; and (D) Initial assessments shall be conducted in person and may take place at either the eligible child’s home, the facility, or other medical facility.

(5) Admission, Transfer, and Discharge.

(A) The admission of each eligible child to a PPEC facility must be under the supervision of the director of nursing in collaboration with the center director and must be in accordance with facility policies and procedures.

(B) Each eligible child admitted to a PPEC facility must be admitted upon written orders by a licensed physician and must remain under the care of a physician for the duration of the child’s admittance in the facility.

(C) The facility must ensure that all medical equipment and medical staff necessary to meet the needs of the eligible child will be available in the facility before admission of the eligible child.

(D) Each eligible child admitted for service to a PPEC facility must meet at least the following criteria:

Eligible children considered for admission to the PPEC facility will be those who are medically or technologically dependent and require continuous skilled nursing intervention of at least four (4) hours per day;
The eligible children must not, immediately prior to admission, present significant risk of infection to other children or child care staff members. The director of nursing must review, on a case-by-case basis, any eligible child with a suspected infectious disease to determine appropriateness of admission;
The eligible child must be medically stabilized, require skilled nursing care or other interventions, and be appropriate for outpatient care; and 4. If the eligible child meets the preceding criteria, the director of nursing must implement a pre-admission plan which delineates services to be provided and appropriate sources for such services.

A. If the eligible child is hospitalized at the time of referral, pre-admission planning will include the parents or guardians and relevant hospital medical, nursing, social services, and developmental staff to assure that the hospital discharge plans will be implemented upon admission to the PPEC.

B. A consent form outlining the purpose of a PPEC admission, family responsibilities, authorized treatment, liability release, and emergency disposition plans must be signed by the parents or guardians and witnessed prior to admission to the PPEC. The parents or guardians must be provided a copy of the consent form. A copy of the signed consent form must be maintained in the eligible child’s medical record.

C. Confidentiality of the PPEC records must be maintained in accordance with facility policies and applicable state and federal laws.

(E) If an eligible child requires emergency medical treatment, the facility shall immediately provide the accepting clinician, emergency medical services, or healthcare provider verbally and in writing the necessary medical information regarding immediate medical needs and the eligible child’s relevant

history.

(F) If an eligible child transfers to another PPEC facility, the facility shall provide to the receiving facility a verbal report and pertinent written information, which shall include at a minimum— 1. Current medication profile;

Problems that require intervention or follow-up; and 3. Current plan of care.

(G) The name and contact information of the center director and director of nursing, including the telephone numbers, shall be provided to the eligible child’s parent or guardian upon admission and upon any changes to the contact information.

The facility shall explain to the child’s parent or guardian when the director of nursing should be contacted for discussion about services provided to the child.

(H) A discharge summary must be sent to the primary care practitioner or other healthcare professional who will be responsible for providing care and services to the eligible child after discharge from the facility within five (5) business days of the date of the order for discharge from the responsible physician.

(I) Discharge for cause. Notwithstanding other provisions of this rule, a PPEC facility may discharge an eligible child without a discharge order from the responsible physician for cause.

Discharge for cause shall only be allowed in situations involving— A. Parent or guardian non-compliance with plan of care;

B. Non-payment; or C. Discharge is required to prevent a threat of imminent harm to children in care or child care staff members.

The PPEC facility shall provide the eligible child’s parent or guardian with a minimum of fourteen (14) days’ notice except in situations where the director of nursing or center director determines that such discharge is required to prevent a threat of imminent harm to children in care or child care staff members.
The PPEC facility shall notify the department in writing within forty-eight (48) hours of the decision to discharge an eligible child for cause.

(6) Facility Staffing.

(A) Director of nursing.

The director of nursing shall have a pre-designated approved qualified individual to act in his/her absence. This individual shall meet the minimum qualifications of the director of nursing.
Only individuals approved by the department shall serve as director of nursing or as a qualified individual in the director of nursing’s absence.
The director of nursing shall meet the following minimum qualifications:

A. Be a registered nurse with an unencumbered license;

B. Hold current certifications in basic life support (BLS) appropriate to the ages of eligible children for which the PPEC facility is licensed to provide care; and C. Have a minimum of three (3) years acute pediatric nursing experience.

To request approval of a director of nursing or predesignated qualified individual, the provider shall submit a written request to the department including proof that the individual meets the minimum qualifications listed above.
Director of nursing approval shall be on file at the facility for the director of nursing and any pre-designated qualified individuals.
The duties and responsibilities of the director of nursing and any pre-designated qualified individual(s) shall be clearly defined in writing.

(B) Skilled nursing services.

Minimum qualifications for skilled nursing personnel shall be as follows:

A. Be a registered nurse or licensed practical nurse with an unencumbered license;

B. Hold current certifications in BLS appropriate to the ages of eligible children for which the facility is licensed to provide care;

C. Have a minimum of one (1) year of nursing experience; and D. Will be trained by the director of nursing in the care of eligible children per facility policy. The training and competency evaluation must be documented in the employee file.

Skilled nursing services shall be provided in accordance with recognized standards of practice.
The duties and responsibilities of skilled nursing staff shall be clearly defined in writing.
The ongoing assessment, planning, and provision of nursing services shall be the overall responsibility of a registered nurse.
When skilled nursing services are delegated to a licensed practical nurse, the licensed practical nurse shall be supervised by a registered nurse present during the hours that the licensed practical nurse is providing services.
A registered nurse must provide nursing interventions; educational services to increase the parent’s or guardian’s confidence and competence in caring for the child with special needs; assistance to facilitate coping with the effects of chronic illness on the child and family and support effective relationships among siblings and the ill child; and interventions to foster normal development and psychosocial adaptation.

Minimum qualifications for direct care personnel shall be as follows:

A. Be a certified nursing assistant or certified medical technician; and B. Hold current certifications in BLS appropriate to the ages of eligible children for which the facility is licensed to provide care.

The duties and responsibilities of direct care personnel shall be defined clearly in writing.
Direct care personnel must work under the supervision of the registered nurse and be responsible for providing direct care to eligible children.
Prior to care responsibilities being assigned to direct care personnel, said personnel must be trained by a facility registered nurse on the specific care, equipment, and medical precautions for care of eligible children. This training shall be documented and recorded in an employee file.

(D) Multidisciplinary staffing.

The facility may have a written agreement for the provision of multidisciplinary services. The agreement shall include the following:

A. Identification of the services to be provided in accordance with the plan of care;

B. Delineation of the role(s) of the PPEC facility and the contracted services;

C. Assurance that the contracted staff shall be appropriately licensed; and D. Assurance of current certifications in BLS appropriate to the ages of eligible children for which the facility is licensed to provide care by all individuals providing multidisciplinary services.

If multidisciplinary services are provided without supervision of PPEC staff members, providers of multidisciplinary services must have evidence of being eligible for employment or presence in a child care facility, as determined by DESE.

(E) Employee files.

The facility shall maintain employee files for all PPEC staff members, which shall be available to state agencies upon request. The employee files shall contain at a minimum— A. Evidence of the active professional registration, license, or certification;

B. Evidence of minimum required experience;

C. Evidence of training on medical emergencies and specialized medical equipment;

D. Training on PPEC specific policies and procedures;

E. A current job description for each PPEC staff member;

F. Evidence of initial and annual child abuse and neglect training; and G. Orientation of the PPEC staff member with the philosophy, organization, program, practices, and goals of the PPEC facility.

(F) Additional staffing requirements.

Nursing services must be provided by direct employees (those employees issued a form W-2) of the licensed provider.
All PPEC staff members, including contracted staff, shall be considered child care staff members and must be eligible for employment or presence in a child care facility, as determined by DESE in accordance with 5 CSR 25-600.
Nursing services shall be staffed to ensure that the needs of each eligible child are met, including at least the staff members required by this rule and any additional staff necessary to meet the needs of all eligible children in care.
The facility shall have staffing which is sufficient to meet the complete needs of all eligible children in care in accordance with the eligible childrens’ respective plans of care.
Oversight of all contracted medical staff is the overall responsibility of the director of nursing.
A registered nurse shall be on duty at all times when an eligible child is present in the facility.
The facility shall have trained PPEC staff members in sufficient numbers to evacuate the children from the facility in case of emergency.
The PPEC staffing schedule shall be readily available to inspectors for the previous forty-five- (45-) day period.

(7) Eligible Children in Care.

(A) The facility shall maintain a daily attendance record, which indicates the names of children currently receiving services at the facility and the times each child arrived at and departed from the facility each day.

(B) There shall be no more than thirty-six (36) eligible children in care at any licensed facility.

Eligible Children Total PPEC Staff RNRN or LPN Direct Care Personnel 2-6211 7-93111 10-124112 13-155212 16-186213 19-217223 22-248224 25-279324 28-3010325 31-3311335 34-3612336 (8) In-Service Training for Staff, Parents, and Guardians.

(A) Each PPEC facility must develop a staff training program.

(B) In addition to the training required by 5 CSR 25-500.102, PPEC staff training must include, at a minimum, the following:

Staff development programs appropriate to the category of personnel. For the purposes of this rule, staff development programs must consist of a minimum of twelve (12) hours of training per year. Training topics shall include, but need not be limited to, standards of practice, equipment, medication, infection control, and communicating with and educating parents and guardians regarding the eligible child’s plan of care;
Documentation of all staff development programs and required participation in an employee file; and 3. Current BLS certification for all PPEC staff.

(C) In addition to orientation required by 5 CSR 25-500.102, each new PPEC staff member will participate in orientation to acquaint the PPEC staff member with the philosophy, organization, program, practices, and goals of the PPEC facility.

This orientation shall occur prior to providing unsupervised care to eligible children and be documented in an employee file.

(D) A comprehensive orientation to acquaint the parent or guardian with the philosophy and services will be provided at the time of the eligible child’s admission to the PPEC facility.

(E) In addition to the training requirements set forth in 5 CSR 25-500.102, each PPEC staff member shall be trained on child abuse and neglect recognition, definition, reporting, and the facility policy. The training shall be completed on hire before any unsupervised child contact, and annually.

(9) Infection Control.

(A) In addition to infection control measures required by 5 CSR 25-500, facilities must maintain infection control requirements that include at least the following:

All cribs and beds must be labeled with the individual eligible child’s name. Linens must be removed from the crib for laundering purposes only;
Bed linens must be changed when soiled and as necessary, but not less than twice weekly;
Laundry facilities shall be so designed, and procedures instituted, to prevent cross-contamination of clean and dirty linens;
Adequate space shall be provided in the laundry room for storing, sorting, and processing soiled linen. Space shall be provided for storing clean linen in a separate room from the laundry;
Soiled clothes and linens shall be stored in nonabsorbent containers or washable laundry bags and shall be transported for laundering in tightly enclosed bags or containers;
Clean clothes and linens shall be stored in a clean place and protected from contamination until used;
Handwashing sinks shall be in or immediately adjacent to toilet rooms or vestibules and shall be easily accessible to employees in areas where eligible children may be present;
Antimicrobial soap and disposable paper towels must be at each handwashing sink;
Sinks used for food preparation or for washing equipment or utensils shall not be used for handwashing;
Portable sinks are not permitted;
PPEC staff members shall thoroughly wash their hands and exposed portions of their arms with antimicrobial soap and water after direct contact with bodily fluids, before and after performing any type of procedures with a child, before starting work, during work as often as is necessary to keep them clean and after eating, drinking, using the toilet, and between care of eligible children using appropriate handwashing techniques to prevent the spread of infection from one child to another;
Alcohol-based hand rub (ABHR) may be used for handwashing in lieu of antimicrobial soap and water except when there has been direct exposure to bodily fluids. ABHR must have a minimum alcohol content of sixty percent (60%);
PPEC staff members shall keep their fingernails clean and trimmed;
A supply of sanitary towels or a hand-drying device providing heated air shall be conveniently located near each lavatory, except that hand towels for individual use are permitted. Common towels are prohibited. If disposable towels are used, easily cleanable waste receptacles shall be conveniently located near the hand-washing facilities;
Lavatories, soap dispensers, hand-drying devices, and all related fixtures shall be kept clean and in good repair;
Eligible children suspected of having a communicable disease, which may be transmitted through casual contact, as determined by the facility director of nursing, must be isolated; the parents or guardians must be notified of the condition; and the child must be removed from the PPEC facility as soon as possible. The child may not return to the PPEC facility until deemed non-infectious, as evidenced by a written physician’s statement;
The PPEC facility must have an isolation room with the ability to monitor any eligible child requiring isolation under these rules;
PPEC staff members suspected of having a communicable disease must leave and may return to work based on the facility’s policy;
The facility shall have rigid, leak-proof, and punctureresistant containers for the safe storage of disposed medical sharps readily available for nursing staff;
The facility shall have containers identified for the storage of biohazardous waste;
The facility shall dispose of biohazardous waste in a manner consistent with standards of professional practice;
The facility shall have an area designated for sterile medical procedures that limits traffic of unnecessary staff and limits the movement of airborne microbes. This area shall not be used to store soiled linens, trash, or any other contaminated materials that may lead to an increased risk of infection; and 23. The facility shall have a potable water management plan.

(10) General Sanitation Requirements.

(A) There shall be present in the facility only those poisonous or toxic materials necessary for maintaining the establishment, cleaning and sanitizing equipment and utensils, and controlling insects and rodents.

(B) Facility ventilation intake and exhaust air ducts shall be maintained to prevent the entrance of dust, dirt, and other contaminating material into the facility.

(C) Cleaning of floors and walls, except emergency cleaning of floors, shall be done during periods when the least amount of food is exposed, such as between meals. Mops used for cleaning bathrooms shall be disinfected after use and before using in other areas.

(D) Garbage and refuse shall be kept in durable, easily cleanable, insect-proof and rodent-proof containers that do not leak and do not absorb liquids. Plastic bags and wet-strength paper bags may be used to line these containers, and they may be used for storage inside the facility.

(E) Garbage or refuse storage rooms, if used, shall be constructed of easily cleanable, nonabsorbent, washable materials, shall be kept clean, shall be insect-proof and rodentproof, and shall be large enough to store the garbage and refuse containers that accumulate.

(F) Effective measures intended to minimize the presence of rodents, flies, cockroaches, and other insects on the premises shall be utilized. The premises shall be kept in such condition as to prevent the harborage or feeding of insects or rodents.

(G) Maintenance and cleaning tools such as brooms, mops, vacuum cleaners, and similar equipment shall be maintained and stored in a way that does not contaminate food, utensils, equipment or linens and shall be stored in an orderly manner.

(H) Food shall be secured and stored in accordance with 19 CSR 20-1.025.

(11) Equipment.

(A) The facility shall provide education to PPEC staff members on the safe use of any specialized medical equipment. This education shall be documented in an employee file.

(B) The facility shall maintain written evidence that all medical equipment available for use in care of eligible children has been inspected and maintained on an annual basis and in accordance with the manufacturer’s specifications.

(C) The facility shall have policies and procedures for cleaning, storing, accessing, and distributing any facilityowned equipment.

(D) Oxygen and oxygen safety.

The facility shall maintain an alternate emergency oxygen source for oxygen dependent eligible children.
There shall be an oxygen storage room that is surrounded by one- (1-) hour fire-rated construction with a powered or gravity vented door.
Oxygen storage shall be in accordance with NFPA 99, Health Care Facilities Code (2024), published October 2024, which is incorporated by reference in this rule as published by the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169-7471, and available online at https:// www.nfpa.org/product/nfpa-99-code/p0099code#2024edition-details. This rule does not incorporate any subsequent amendments or additions. The facility shall use permanent racks or fasteners to prevent accidental damage or dislocation of compressed oxygen cylinders. Safety caps remain intact except where a cylinder is in actual use or where the regulator has been attached and the cylinder is ready for use. Individual oxygen cylinders in use or with an attached regulator shall be supported by cylinder collars or by stable cylinder carts.

(12) Plan of Care.

(A) The facility shall have written policies regarding development and revising the eligible child’s plan of care. The plan of care shall be reviewed and signed every sixty (60) days at a minimum, or as frequently as medically necessary, by a physician. The plan of care shall include, at a minimum, the following:

Identification of all allowed practitioners involved in the care of the child;
A medication list that includes the medication name, dose, frequency, and route of administration;
The medical equipment and emergency equipment necessary to care for the child;
The diet, nutrition, and developmental requirements for the child;
The frequency of treatment for skilled nursing, speech, physical, and occupational therapy; and 6. Treatments required by the child.

(B) The facility must notify the eligible child’s physician when the plan of care cannot be followed or when there is a change in the child’s condition that would indicate a change to the plan of care is necessary.

(C) The individualized plan of care must be reviewed and revised by the physician who is responsible for the plan of care as frequently as the eligible child’s condition or needs require, but no less frequently than every sixty (60) days, beginning with the admission date to the facility.

(D) The physician who initiated PPEC care is responsible for the ongoing plan of care; however, in order to assure the development and implementation of a coordinated plan of care, the facility shall communicate with all physicians involved in the child’s care as often as medically necessary.

(E) The director of nursing is responsible for integrating orders from all relevant physicians involved in the plan of care to ensure the orders are approved by the responsible physician.

(13) Medications.

(A) The facility shall develop policies and procedures for the safe and effective administration of medications, in accordance with accepted professional standards.

(B) The facility shall maintain safe storage and control of medications.

(D) Multi-use medications must be labeled with the date opened and expiration date.

(E) Medications or parenteral fluids that require refrigeration shall be appropriately labeled and stored in a temperaturecontrolled refrigerator that is tested daily. The refrigerator shall be always maintained between thirty-five to forty-six degrees Fahrenheit (35-46 F°). The daily refrigerator temperature tests shall be documented.

(14) Clinical Records.

(A) Clinical records and health information must be maintained in accordance with the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

(B) The facility shall have written policies for clinical records, including timeliness of data entry.

(C) The facility shall establish and maintain a clinical record for every eligible child receiving care and services from admission to discharge.

(D) An entry by the licensed nurse shall be documented as often as medically necessary to reflect care and services provided according to the plan of care, at a minimum daily.

(E) The record shall be complete, legible, readily accessible, and accurate.

(F) Each clinical record shall be a compilation of information for all services provided.

(G) Clinical entries shall include time and date of the entry identified by the person providing the services.

(H) The clinical record shall include the plan of care, physician orders, medication administration, multidisciplinary assessments, pertinent medical history, precautions, allergies, immunization records, and communication with coordinating healthcare providers.

(I) Verbal orders must be authenticated and dated by the physician or allowed practitioner in accordance with the facility policy, no longer than thirty (30) days from the verbal order.

(J) Documentation of nutritional management and special diets, as appropriate.

(K) The facility shall safeguard the clinical record against loss, destruction, and unauthorized use.

(L) A discharge order written by the primary physician will be documented and entered in the eligible child’s record. A discharge summary, which includes the reason for discharge, shall be included.

(M) Medical records must be secured after discharge according to applicable state law.

(15) Quality Assurance.

(A) All PPEC facilities must have a quality assurance program with quarterly meetings that focus on indicators related to improved outcomes, including the use of emergent care services, hospital admissions, and re-admissions; and takes actions that address the facility’s performance across the spectrum of care, including the prevention and reduction of medical errors. The meeting at a minimum shall review staffing, emergency care, medical record audits, complaints, emergency preparedness exercises, and infection control reports. The facility must implement quality improvement projects to correct any issues identified in the program.

(B) The quality assurance committee shall conduct quarterly random medical record audits for at least three (3) eligible children, or twenty-five percent (25%) of the daily average census, whichever is greater.

(C) The quality assurance committee shall have a minimum of three (3) representatives including the center director, director of nursing, and a professional multidisciplinary team member.

(D) The quarterly quality assurance review will be conducted by the quality assurance committee, which shall generate a written report including any recommendations for quality improvement projects.

(E) At least yearly, the quality assurance committee will include a physician or allowed practitioner to review care issues and conduct a review of the policies and procedures and provide updates as necessary.

(F) The director of nursing maintains overall responsibility to ensure that an ongoing program for quality improvement and patient safety is defined, implemented, and maintained.

(16) Multidisciplinary Meetings.

(A) A multidisciplinary group, representative of the services provided for the eligible child, shall conduct at a minimum a monthly meeting to review each eligible child’s plan of care for appropriateness considering any changes in the child’s condition or needs.

(B) The multidisciplinary group shall coordinate immediately for any changes in the eligible child’s immediate medical needs.

(C) The team shall notify the eligible child’s physician of any recommendations regarding the eligible child’s plan of care and request physician orders as appropriate. The meeting attendees and any recommendations shall be documented.

(D) The director of nursing is responsible for coordination of the multidisciplinary meetings.

(E) The director of nursing is responsible to coordinate with and educate the parent or guardian regarding the multidisciplinary plan of care meetings and resulting recommendations.

(17) Fire Safety and Emergency Procedures.

(A) All PPEC facilities must conform to state standards of the State Fire Marshal. A copy of the current annual fire inspection report must be on file at the PPEC facility. Documentation of a satisfactory fire safety inspection shall be provided annually or when requested by the department.

(B) If a facility accepts any eligible child that requires electrical life support equipment, an emergency backup electrical system with an automatic transfer switch shall be installed.

The system shall be sized and installed by a qualified installer to provide power for the maximum number of allowed life support systems for a minimum of two (2) hours. The system shall be installed by a qualified installer, tested, and maintained in accordance with manufacturer’s specifications.

(D) Emergency transportation must be performed by a licensed ambulance service, with PPEC medical staff coordinating the emergent transfer.

(E) The PPEC facility must have a child-specific emergency medical kit available for each eligible child in care.

(F) PPEC staff shall be trained on the use of emergency medical equipment for eligible children. The training shall be documented in the employee file.

(G) The facility shall have an emergency preparedness program that considers the specific needs of eligible children.

(H) The facility shall ensure that there is adequate space around eligible children and their life support equipment to allow unencumbered access for evacuation and provision of emergency care.

(18) The emergency preparedness program shall include at a minimum— (A) A written communication procedure plan considering special needs of eligible children;

(B) A written emergency evacuation plan considering special needs of the eligible children, which must be reviewed and accepted by the department;

(C) Annual documented training of PPEC staff on the emergency preparedness program for the PPEC care facility; and (D) Annual simulated exercises to test the emergency plan involving all PPEC staff. The exercise procedure and outcomes shall be documented. Simulations shall include pseudopatients in lieu of eligible children so as not to risk harm to children during the exercise.

(19) Transportation. Child care staff members shall not transport eligible children in their capacity as a child care staff member unless the child care staff member is the eligible child’s parent or guardian.

Division 40 Division of Maternal, Child and Family Health

Chapter 1 Crippled Children's Service (CCS)

19 CSR 40-1.010 Definitions Relating to the Crippled Childrenís Service (CCS) {#sec-19-csr-40-1.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-1.010}

PURPOSE: This rule defines terminology used throughout this chapter.

(1) Administrator means the administrator of CCS as designated in section 201.050, RSMo (1986).

(2) Advisory committee means the general advisory committee, as defined in section 201.110, RSMo 1986. This committee shall be comprised of a majority of physicians, as licensed under Chapter 334, RSMo 1986, and the remainder of consumers, other health care personnel and interested parties. It shall meet at least once a year and shall select a chairperson among its members to voice the committeeís collective advice.

(3) Care means specialized treatment services and does not include general medical care, which remains the responsibility of the client or the clientís family and the referring health provider. Care does not include education or domiciliary care.

(4) Case finding means a method of locating children who can benefit from CCS. This shall be accomplished through close cooperation of local physicians, hospitals, other health providers, schools, official and voluntary agencies, parents and other interested individuals.

(5) Case management means management of resources across agency and professional lines to develop and attain the clientís care plan with optimal participation of the client or the clientís family or both.

(6) Central office means that portion of the CCS which has the responsibility and authority to administer the statewide program.

(7) Diagnostic services means services which include, but are not limited to, medical, social, psychological and other services necessary to identify the presence of a handicapping disability, its cause and complications and to determine the extent to which the disability limits or is likely to limit an individualís daily living and work activities.

(8) District and subdistrict office means that portion of CCS which includes case managers and personnel who interact directly with individual clients and providers of care.

(9) Financial eligibility means eligibility for those health services offered by CCS, based on the financial status of the client or the clientís family or the clientís guardians. Categories of financial eligibility have been established by CCS in 19 CSR 40-1.040.

(10) Habilitation means the continuous development of skills and abilities.

(11) Individual care plan (ICP) means a written statement developed by a provider of care, interdisciplinary team, case manager, parents or guardians and the child, if possible, which analyzes the childís achievement level, lists short-range and annual goals, describes specific services needed to meet those goals and develops a schedule for monitoring progress.

(12) Interdisciplinary team means a team of professionals representing a variety of disciplines which provides services to persons with physical handicaps.

(13) Services means services in hospitals, convalescent homes and clinics by physicians, chiropractors, dentists, nurses, medical social workers, nutritionists, dietitians, physical therapists, occupational therapists, speech pathologists and audiologists, technicians and other personnel whose services are needed in the CCS programs.

(14) Medical eligibility means eligibility for those health services offered by CCS as based on medical condition. Categories of medical conditions acceptable for services have been established in 19 CSR 40-1.030.

(15) Crippled Childrenís Service or CCS is the agency of the Department of Health for facilitating the early identification of physically handicapped children and of individuals who have the potential of producing physically handicapped children; the provision of preventive, diagnostic and treatment services, including case management services, for the restoration of optimum health for physically handicapped children; the development, strengthening and improvement of standards and techniques relating to the provision of those services; the training of personnel engaged in the provision of those services or the strengthening and improvement of services; and the necessary administration to provide services to physically handicapped children and individuals at risk of having physically handicapped children.

(16) Physically handicapped child means an individual below the age of twenty-one (21) years who has a disease, defect or condition which may hinder the achievement of normal physical growth and development.

(17) Pre-authorization means written permission obtained from CCS in advance of an action which would result in either the obligation or expenditure of funds or the performance of an activity.

(18) Program administrator means the person responsible for planning, developing, implementing and monitoring the program of special health services on a statewide basis for handicapped children.

(19) Program coordinator means the person responsible for coordinating a segment of the CCS and the duties assigned to that segment.

(20) Provider of care means an individual who is regulated under Chapters 331, 332, 334ñ338 and 344ñ346, RSMo Supp. 1988; or an organization licensed under Chapter 197, RSMo Supp. 1988 or approved by the Joint Commission on Accreditation of Hospitals or the American Osteopathic Association.

(21) Rehabilitation means the process of improving or reestablishing an individualís skill or level of adjustment by increasing the ability to maintain an optimum level of independent functioning.

(22) Third-party payer means any person, corporation, trust, association, the state of Missouri, any governmental subdivision or agency or any other legal entity which pays directly or indirectly for health care services provided to another person or reimburses or pays a benefit to or on behalf of another person for health care services in conformance to a contract, plan, employee benefit or member benefit. ously filed as 13 CSR 50-160.010. Emergency 13, 1987. Amended: Filed Jan. 18, 1989, effective April 27, 1989.

19 CSR 40-1.020 Program Eligibility {#sec-19-csr-40-1.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-1.020}

PURPOSE: This rule establishes the criteria by which CCS accepts clients for service.

(1) Conditions of eligibility for Crippled Childrenís Service (CCS) services include:

(A) A client must be under twenty-one (21) years of age. All expenditures by CCS on behalf of a child must be for services received prior to his/her twenty-first birthday;

(B) A client must be a resident of Missouri;

(D) A client must be medically eligible for CCS;

(E) Marital status is not a condition of eligibility; and (F) Each client shall have a parent or an appointed guardian as a condition of eligibility, unless the client is legally emancipated and may sign on his/her own behalf.

(2) To qualify medically for services under the auspices of CCS, a client must meet the definition of a physically-handicapped child in 19 CSR 40-1.010(16) and have a medical condition which is included in 19 CSR 40- 1.030.

(A) The following factors shall be considered in establishing categories of conditions eligible under CCS: severity; complexity; extent of significant dysfunction or disability that is present or expected; duration of the disorder; potential for habilitation or rehabilitation and also a reasonable expected longevity; amenability to limited standard medical intervention; and a strong likelihood the treatment will have a major impact upon the physically handicapping condition(s).

There must be reasonable expectation or improvement to be eligible for CCS coverage.

(B) CCS may assist any child under twenty-one (21) years of age who resides in Missouri in obtaining a diagnostic evaluation if that child is possibly afflicted with a CCS-eligible condition.

(C) The medically-eligible client will be treated only for the eligible condition and for directly related conditions necessary to prepare the client for treatment of the eligible condition and to preserve the benefits derived from the treatment. An unrelated medical condition which is ineligible does not become eligible when the client is accepted for treatment of an eligible condition.

(D) On emergency cases that need to be referred to CCS but not previously known to the agency, it will be the responsibility of the attending physician or the hospital to contact CCS within seventy-two (72) hours for tentative oral approval for treatment at an approved CCS hospital. Final approval will be given only upon receipt of an official CCS application form and the medical report for establishing eligibility. The application process must be initiated no later than seven (7) calendar days after the time of admission.

(E) The clientís medical condition shall be reviewed on a periodic basis by CCS to insure the continuing CCS eligibility.

(3) To receive medical or surgical services, the client must be medically eligible and the clientís family must meet the current financial eligibility criteria which are included in

(A) CCS is the last resource after all other available sources of payment have been exhausted.

(B) The financial situation of the client and of his/her family shall be reviewed on a periodic basis by CCS to insure the continuing CCS eligibility. ously filed 13 CSR 50-160.020. Emergency

19 CSR 40-1.030 Categories of Care {#sec-19-csr-40-1.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-1.030}

PURPOSE: This rule defines the medical conditions for which MCCS will provide service and funding.

(1) Category I shall include those eligible applicants whose medical conditions require immediate life-saving medical treatment. The conditions include, but are not necessarily limited to:

(A) Burn careóany burns requiring seven (7) days or more inpatient care and burns requiring skin grafting;

(B) Cardiac careócongenital heart disease requiring surgical intervention or presenting with congestive heart failure; and acute rheumatic fever with congestive heart failure or requiring cardiac surgery;

(D) Genito-urinary (GU) careóbladder extrophy, vesico-ureteral reflux and ureteropelvic junction obstruction;

(E) Myelomeningocele care (spina bifida)ósurgical closure of myelocele;

(F) Neurology careódepressed skull fracture, subdural hematoma and uncontrolled seizures;

(G) Neurosurgery careóshunting procedures;

(H) Orthopedic careóacquired amputations, fractures and fracture dislocations of the vertebral column with or without associated spinal cord injury except for closed coccygeal fractures, open fractures, osteogenesis imperfecta, osteomyelitis or pyarthrosis presenting with sepsis; and (I) Pediatric surgery careódiaphragmatic hernia with accompanying respiratory distress; Hirschsprungís disease; multiple surgically-staged imperforate anus; duodenal atresia; jejunal atresia; tracheoesophageal fistula; gastroschisis; omphalocele; intestinal obstruction in neonates; lacerated tendons; electrical burns to the mouth; surgical procedures for subglottic stenosis; laryngeal webs; choanal atresia; and ingestion burns; and (J) The following are not covered under Category I: arthritis care; cerebral palsy care; ear; nose and throat (ENT)/hearing care;

ENT/surgical care; and physical, medical and rehabilitation (PM&R) care.

(2) Category II shall include those medical conditions which, if not treated, could grow worse or cause a crippling disability. A limited term of hospitalization and a good prognosis should be expected. The conditions may include, but are not necessarily limited to:

(A) Arthritis careóacute juvenile rheumatoid arthritis;

(B) Burn careófollow-up and rehabilitation services;

(C) Cardiac careócongenital heart disease (CHD) not requiring immediate surgical intervention and CHD not presenting with congestive heart failure;

(D) Cerebral palsy careósurgical procedures and bracing;

(E) Cleft lip and palate careósurgical procedures;

(F) Ear, nose and throat (ENT) surgical careósurgical procedures for chronic otitis media, tympanic membrane perforation, cholesteatoma and other otologic conditions requiring specialty care;

(G) Genito-urinary careóbladder exstrophy, vesicoureteral reflux, utreteropelvic junction obstruction, hypospadias and ambiguous genitalia;

(H) Myelomeningocele care (spinal bifida)ófollow-up and rehabilitation services:

4CODE OF STATE REGULATIONS

(I) Neurology careóresiduals of meningitis, Guillain-Barre syndrome, Reyeís syndrome, poliomyelitis, seizure disorders and stalic encephalopathies;

(J) Neurosurgery careóhydrocephanlus, diastematomyelia, enecephalocele and vascular lesions affecting the central nervous system;

(K) Orthopedic careócongenital deformities; arthrogryposis congenital dysplasia of the hip; complicated fractures of the limbs, pelvis and shoulder girdle; scoliosis and kyphosis; surgical treatment of late effects of epiphyseal injury; osteomyelitis; closed spinal fracture without neurologic deficit, excluding coccygeal fractures; rickets; Legg- Calve-Perthes disease; club feet; nonmalignant bone tumors and acquired injury to limbs;

(L) Pediatric surgery careóbenign tumors, hemangiomas, lymphangiomas and neurofibromas which cause functional impairment or disfigurement and surgical correction of laryngeal papillomas;

(M) Physical, medical and rehabilitation (PM&R) careórehabilitation for spinal cord injuries; and (N) The following are not covered under Category II: ear, nose and throat (ENT)/hearing care.

(3) Category III shall include those eligible applicants whose conditions may require prolonged outpatient care and may require hospitalization at some time. The conditions have a fair prognosis if treated and may include, but are not necessarily limited to:

(A) Arthritis careójuvenile sheumatoid arthritis follow-up as needed;

(B) Burn careócovered under Category I and II;

(D) Cerebral palsy careórehabilitation services;

(E) Cleft lip and palate careósurgical revisions, dental care and speech therapy;

(F) Ear, nose and throat (ENT)/hearing careóall eligible services;

(G) Ear, nose and throat (ENT)/surgical careósurgical care follow-up;

(H) Genito-urinary careófollow-up care as needed;

(I) Myelomeningocele careócovered under Categories I and II;

(J) Neurology careóresiduals of meningitis, seizure disorders, Guillain-Barre syndrome, Reyeís syndrome, poliomyelitis and stalic encephalopathies;

(K) Neurosurgery careóhydrocephalus, diastematomyelia, encephalocele and vascular lesions affecting the central nervous system;

(L) Orthopedic careóclaw foot, calcaneovalgus and other acquired congenital deformities and rehabilitation services;

(M) Pediatric surgery careófollow-up care as needed; and (N) Physical, medical and rehabilitation (PM&R) careócovered under Category II.

(4) Category IV shall include those eligible applicants whose medical conditions have a poor to fair prognosis or uncertain restoration to a useful or productive life regardless of the treatment provided. The conditions are considered to be maintained by the services that are provided for them and thus are put in this category of maintenance. This is primarily a category of case management and covers the entire spectrum of CCS-eligible conditions.

(5) Category V shall include all those eligible applicants whose medical conditions have variable prognosis; enhancement allows improvements in activities of daily living (ADL), physical appearance for psychological reasons, with plastic surgical procedures, etc. This also includes exotic conditions such as craniofacial anomalies which are not ordinarily eligible for CCS services due to budgetary limitations; if funding allows, these conditions would be included under this category. Cosmesis, inborn errors of metabolism, exotic drugs and special counseling are some of the miscellaneous items that would be funded in this category.

(6) The categories in sections (1)ñ(5) of this

rule may have funding ceilings or limitations imposed on them or may be categorically suspended, as stipulated in 19 CSR 40- 1.060(1)(B). ously filed 13 CSR 50-160.030. Emergency Emergency amendment filed Feb. 20, 1985, effective March 2, 1985, expired June 30, 1985. Emergency amendment filed April 11, 1985, effective April 21, 1985, expired June 30, 1985. Amended: Filed June 2, 1987, effective Aug. 13, 1987.

19 CSR 40-1.040 CCS Financial Eligibility {#sec-19-csr-40-1.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-1.040}

PURPOSE: This rule establishes guidelines for determining financial eligibility for enrollment in Crippled Childrenís Service.

(1) Financial eligibility guidelines for enrollment in Crippled Childrenís Services (CCS) shall be based upon the Poverty Income Guidelines in section (2) of this rule, as established by the United States Department of Health and Human Services. The determination of individual client eligibility shall be based upon the following factors:

(A) Total adjusted gross income shall not exceed one hundred eighty-five percent (185%) of the federal poverty income guideline for the family size;

(B) Size of family unit shall be the number of persons in the household, including the responsible party(ies) and dependents allowable by the Internal Revenue Service as federal income tax exemptions. If there is more than one (1) eligible CCS client in the household, the total family size shall be increased by one (1) unit for each additional client; and (C) Families or individuals whose income exceeds the one hundred eighty-five percent (185%) poverty level shall be given consideration if the medical cost of an eligible condition, regardless of third-party payment, would bring the income below the one hundred eighty-five percent (185%) poverty level.

(2) Poverty Income Guidelines. 1990 Poverty Income Guidelines for All States (Except Alaska and Hawaii) and the District of Columbia Size of FamilyPoverty UnitGuidelines 1$ 6,280 2$ 8,420 3$10,560 4$12,700 5$14,840 6$16,980 7$19,120 8$21,260 ously filed as 13 CSR 50-160.040. Emergency rule filed Dec. 12, 1984, effective Dec. 22, 13, 1987. Rescinded and readopted: Filed Nov. 2, 1990, effective April 29, 1991.

19 CSR 40-1.050 Client Responsibilities {#sec-19-csr-40-1.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-1.050}

PURPOSE: This rule establishes the way in which clients maintain their program eligibility.

(1) Clients and their families are responsible for providing Crippled Childrenís Service (CCS) with accurate information concerning their financial status.

(2) The client or the clientís family shall use all available health insurance benefits, Medicaid or other third-party payment mechanismóincluding recoveries specifically awarded for medical expenses from thirdparty insurance sources through settlement of personal injury claims attributable to the condition being treatedófor payment toward medical expenses.

(3) The client or the clientís family shall enroll in any state or other public programs for which they are eligible in order to provide maximum comprehensive services.

(4) The client or the clientís family shall report any major changes in income, household composition, insurance, Medicaid coverage or address within ten (10) working days after the date the client or the clientís family becomes aware of the change.

(5) The client or the clientís family shall keep the CCS case manager updated on the medical progress of the clientís individual care plan.

(6) The client or the clientís family shall take the clientís CCS service authorization to all diagnostic and therapeutic appointments being covered by CCS.

(7) To maintain eligibility, an applicant shall complete and have approved another application at the end of the eligibility period. An eligibility period shall be the year following the anniversary date of original application or the year following the date of the filing of a new 1040 tax form.

(8) Provisions of sections (1)ñ(7) of this rule are considered mandatory, and if not followed by the client or the clientís family, CCS may discontinue services.

(9) An applicant who is determined ineligible for CCS may reapply when s/he feels there have been changes which may make the applicant eligible.

(10) When an application is denied, the applicant shall be informed of his/her right to appeal.

(11) Information shall be released by CCS only upon receipt of a release of information form signed by the client or the clientís parent or appointed guardian indicating the clientís approval of the release of information to the party seeking the information. Information shall not be released to the client unless the client requests the information from CCS. 201.120, RSMo 1986.* This rule was previously filed 13 CSR 50-160.050. Emergency *Original authority: 192.005, RSMo 1985 and 201.120,

19 CSR 40-1.060 Organization and Management {#sec-19-csr-40-1.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-1.060}

PURPOSE: This rule establishes the components of CCS. It also delineates central office and district and subdistrict office roles in the components of the program.

(1) Central Office Role.

(A) The Department of Health shall see that Crippled Childrenís Service (CCS) is administered strictly within the statesí fiscal guidelines.

The line of authority by which the Department of Health administers CCS shall be through the Division of Personal Health Services.
The program administrator shall be held accountable to the division director, who in turn shall be held accountable to the director of the Department of Health.
The program administrator shall work with the CCS advisory committee, informing committee members of issues pertinent to the operation of the program and giving due consideration to the committeeís collective advice.

(B) Central office may administratively revise limitations on CCS programs. CCS, for budgetary reasons, may suspend one (1) or more of the categories of care in 19 CSR 40-1.030(1)ñ(5) or impose or revise funding ceilings for services throughout the state.

(C) Central office may develop and implement demonstration or special projects to provide services to groups in special need.

The development of the projects shall include development of policies, standards and criteria applicable to provision of the services and to the selection of groups in special need.

Special funds may be set aside for these projects and shall be limited to no more than ten percent (10%) of the general service budget.

(D) Central office shall attempt to formulate written agreements with any other governmental agencies and their respective departments in order to carry out the mandates stipulated in section 201.030, RSMo 1986.

(E) Central office shall consult with the district and subdistrict staff on complicated individual care plans and shall monitor the case management function of the staff.

(F) Central office shall maintain statistics of children in Missouri who have congenital anomalies, birth defects and physically-handicapping conditions.

(G) Central office shall review the qualifications of CCS-approved providers. Notification of any changes of status or revisions will be sent to the district and subdistrict offices.

(2) District and Subdistrict Office Role.

(A) Case finding is a primary function of the CCS staff at the district and subdistrict level. The staff, in conjunction with providers of care and other public and private agencies and concerned individuals, shall actively seek out children and families who may be eligible for CCS services.

(B) Services shall be initiated at the district and subdistrict level.

The staff shall monitor requests for diagnostic services from all providers of care and other public and private agencies and concerned individuals who may refer a child or family for the services.
The staff shall reject or bring up for further review with the central CCS office any referrals and requests for services for children with conditions not included in 19 CSR 40-1.030(1)ñ(5).
Referral from district and subdistrict staff to an appropriate provider of care and other public and private agencies and concerned individuals shall be made for all children or families referred to CCS.

(C) Case management shall be a primary function at the district and subdistrict level. It includes all activities related to the monitoring of the clientís medical progress and the individual care plan (ICP) outlined for the client by the provider(s) of service, case manager, clientís parents and the client.

6CODE OF STATE REGULATIONS

The staff shall provide feedback on the client to service providers and shall work with providers and other community resources to create an appropriate ICP for CCS clients.
The staff shall also work together as an interdisciplinary team when necessary to review and implement complicated ICPs and, when necessary, to see that ICPs are periodically being reviewed by the providers of care.
The staff shall provide feedback on the clientís CCS status within twenty (20) working days after the client or clientís family reports any major changes in income, household composition, insurance, Medicaid coverage, medical condition or the clientís care plan; and work with the client and the clientís family to insure the clientís ICP is appropriate. ously filed 13 CSR 50-160.060. Emergency

19 CSR 40-1.070 Service Providers {#sec-19-csr-40-1.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-1.070}

PURPOSE: This rule establishes the responsibilities of service providers and outlines the framework of who is eligible to provide care; this includes hospitals and clinics, as well as individual providers of care.

(1) Provider Specifications.

(A) Eligible children may be approved for hospitalization by contractual agreement in treatment centers.

Treatment centers shall have a pediatric unit which meets the requirements of 19 CSR 30-20.021(4)(F)1.ñ7.
Treatment centers shall have open heart surgical facilities and facilities for cardiac catheterization.
Treatment centers shall have the capacity for dealing appropriately with neurosurgical conditions requiring emergency services.
Treatment centers shall have the capacity for dealing appropriately with all pediatric surgical procedures.
Treatment centers shall have the capacity to be designated as pediatric trauma centers.
Treatment centers shall have the capacity to provide pediatric specialty outpatient clinics.
Treatment centers shall be approved by the Joint Commission on the Accreditation of Hospitals (JCAH) or the American Osteopathic Association (AOA).

(B) Special condition centers (SCC) include pediatric rehabilitation units, burn units, orthopedic units, dental units, plastic surgery units and otolaryngologic units and other pediatric facilities which do not have the full capacity of a treatment center, but have the capacity to provide limited or specialized services for Crippled Childrenís Service (CCS)-eligible clients.

SCCs shall be limited in number, based on geographic and demographic considerations of any given part of Missouri.
Eligible children may be approved for hospitalization or outpatient care by contractual agreement for those specific conditions for which the SCCs provide services.
Emergency hospital admissions shall be handled as required by 19 CSR 40- 1.020(2)(D). In the event that the SCC is not able to provide adequate hospitalization, the patient shall be stabilized and subsequently transferred to a treatment center which is more fully equipped to deal with the emergency.
SCCs shall be approved by JCAH or AOA.

(C) CCS-approved physicians shall be certified by or eligible for certification by a specialty or subspecialty practice board recognized by and affiliated with the American Medical Association (AMA) or the AOA.

Chiropractors shall be certified by or eligible for certification by a specialty or subspecialty practice board recognized by and affiliated with the Council of Chiropractic Education, the American Chiropractic Association or the International Chiropractic Association.

Physicians or chiropractors who are boardeligible shall have two (2) years from the time they are approved to obtain board certification before being discontinued from the CCS list of approved physicians or chiropractors.

For certain conditions, the physician or chiropractor is expected to act as an integral part of an interdisciplinary team of physicians or chiropractors and other health professionals to deal with the medical aspects of the condition. These conditions include spina bifida, cleft lip and palate, severe and extensive burns, spinal cord injuries and head trauma with loss of consciousness for more than twenty-four (24) hours. Services shall be provided or supervised by a CCS-approved physician or chiropractor who is a specialist in the condition for which the child is CCSapproved.

(D) Therapists include speech therapists, physical therapists and occupational therapists.

Therapy must be approved in advance by CCS. When therapy is recommended by the attending physician or interdisciplinary team, CCS authorization is necessary for therapy services not covered by another agency.
Therapy services are provided by a CCS-approved therapist.
Therapy personnel shall be licensed by their respective boards in Missouri.

(E) General dental services are not approved by CCS, except as specified in 19 CSR 40-1.020(2)(C). Specialized dental services are approved for cleft lip and palate and gengevectomy for patients receiving dilantin therapy. CCS-approved specialty dentists must be board-certified or board-eligible and licensed to practice in their specialty areas under section 332.171, RSMo 1986. Dentists who are board-eligible shall have two (2) years from the time they are approved to obtain board certification before being discontinued from the CCS list of approved dentists.

(F) Appliances, prostheses and equipment that are approved by CCS are provided by contractual agreement with direct service vendors; approved repairs and replacements are also provided by contractual agreement with direct service vendors. Appliances, prostheses and equipment authorized by CCS include artificial limbs, artificial stock eyes, braces, catheterization supplies, communication devices, dental appliances within orthondontic and prosthodontic limitations, ear molds, hearing aids, ostomy supplies and feeding tubes, respirator equipment, shoes for specific diagnostic criteria, tracheostomy tubes and supplies, wheelchairs, walkers, ambulatory aids and universal cuffs and splints.

(G) Outpatient x-ray and laboratory services are authorized if they are directly related to the medical condition the client has been enrolled under. They may be requested by the patientís attending physician, chiropractor, dentist or interdisciplinary team.

Whenever possible, they should be included in the clientís individual care plan (ICP).

(H) All outpatient drugs, supplies and equipment costing more than three hundred dollars ($300) must be pre-authorized by CCS. Medication, nutritional formulas and supplies necessary for the treatment of a disease or condition may be provided.

(I) Payment for medical services shall be limited to those services available in Missouri, except when a client develops specialized needs which cannot be treated in Missouri and must be referred out-of-state.

(2) Any person or facility wishing to provide health care for CCS shall complete a provider application. CCS shall notify providers of application approval and make contractual agreements with facilities approved to provide health care.

(A) Approved providers shall agree to accept as payments in full, the amounts established by CCS.

If a provider receives payment from a source other than CCS which is equal to or exceeds the amount of the program fee schedule for the authorized services rendered, the provider may not seek any additional amount from either the client or the program.
Approved providers shall submit bills on forms prescribed by CCS and within the billing time limits negotiated between CCS and its providers. Unless the provider receives a waiver of the time limit from the program administrator or designee, failure to comply with time limits may result in denial of the claim.

(B) Approved providers shall submit to the case manager legible and complete medical or chiropractic reports for each service or set of related services authorized by CCS. Failure to submit medical reports may result in termination of provider agreement.

Medical reports submitted to CCS are the property of CCS. CCS shall not release the reports except under the following circumstances:

A. Reports shall be given to other providers when necessary to assure continuity of treatment or provision of services to the client, if the client consents to the release; and B. Reports shall be used by CCS as necessary to collect for services paid for by CCS from liable third parties.

For a client to receive and continue receiving services, the clientís CCS-approved physician or chiropractor shall initiate a proposal for services to be incorporated into the ICP.

(C) CCS shall reimburse for diagnostic evaluations or treatment services only if a prior written authorization has been provided.

Emergency authorization of reimbursement for treatment service(s) shall be provided by CCS in situations which are determined by the CCS program administrator or designee to have the potential for irrevocable damage, injury or long-term consequences if treatment is not provided immediately. In these instances, CCS shall be notified by the attending physician or hospital within seventy-two (72) hours after admission to a CCS-approved hospital. Eligibility for further authorization shall be determined according to criteria in 19 CSR 40- 1.020(2)(D).
Purchase of services related to psychosocial disturbances are excluded, except when attributable to a medical condition for which the client is enrolled. Requests for these services are subject to review by the program administrator or designee.
Purchase of services related to educational activities or educational disabilities are excluded.
Out-of-state providers are subject to the same fee schedule, time limitations, standards and requirements as in-state providers.

Emergency rule filed Dec. 12, 1984, effective Dec. 22, 1984, expired April 20, 1985. Original rule filed Dec. 12, 1984, effective April 11, 1985. Amended: Filed June 2, 1987, effective Aug. 13, 1987. Amended: Filed Jan. 18, 1989, effective April 27, 1989. *Original authority: 192.005, RSMo 1985; 201.060, RSMo 1959; 201.100, RSMo 1959 and 201.120, RSMo 1959.

History

AUTHORITY: sections 192.005.2, 201.060, 201.100 and 201.120, RSMo 1986. This rule was previously filed as 13 CSR 50-160.070.

19 CSR 40-1.080 Sanctions {#sec-19-csr-40-1.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-1.080}

PURPOSE: This rule establishes the violations for which providers and clients will be penalized and those actions which will be taken against them.

(1) Sanctions will be imposed by Crippled Childrenís Service (CCS) against a provider for any one (1) or more of the following reasons:

(A) The provider knowingly and willfully makes or causes to be made any false statement or misrepresentation of a material fact by presenting or causing to be presented for payment under CCS any false or fraudulent claim for services or merchandise; submitting or causing to be submitted false information for the purpose of obtaining greater compensation than that which the provider is legally entitled; submitting or causing to be submitted false information for the purpose of meeting prior approval status; or submitting a false or fraudulent application for provider status;

(B) The provider fails to provide and maintain quality services which meet professionally recognized standards of care;

(C) The provider breaks the terms of the provider agreement or fails to comply with the terms of the provider certification on the CCS claim form;

(D) The provider is convicted of a criminal offense relating to performance of a provider agreement with the state or for negligent or abusive practice resulting in the death or injury of a client;

(E) The provider fails to meet licensure or certification standards for participation as a given type of provider;

(F) The provider solicits, charges or receives payments from recipients for services for which the provider has billed CCS;

(G) The provider is suspended or terminated from participation in another governmental medical program such as, but not limited to, Workersí Compensation, Medicaid and Medicare;

(H) The provider is indicted for fraudulent billing practices or for negligent practice resulting in physical, emotional or psychological injury or death to the providerís client; or (I) The provider fails to repay or to make arrangements for the repayment of identified overpayments or otherwise erroneous payments.

(2) One (1) or more of the following sanctions may be invoked against a provider for any violation listed in section (1) of this rule: termination from participation in CCS; suspension from participation in CCS; suspension or withholding of payments; or referral for investigation to the State Board of Registration for the Healing Arts or other appropriate state licensing agency.

(3) A client may be dismissed or an application cancelled for any of the following reasons: financial ineligibility; medical ineligibility; death of registrant; failure to keep scheduled appointments; failure to reply to CCS correspondence; residency established out-of-state; return appointment more than twelve (12) months away; no treatment recommended; unable to locate; age twenty-one (21) reached; failure to supply requested information; unwillingness to follow medical recommendations; medical recommendations indicate care needed is below current acceptable minimum to meet eligibility criteria for the diagnosis; or failure to properly use thirdparty coverage benefits.

(4) In cases where CCS intends to discontinue, terminate, suspend or reduce benefits to clients, providers or applicants, the program must give written notice that the proposed action will occur no sooner than fourteen (14) calendar days after the notice is dated.

The notice must include a statement of what 8CODE OF STATE REGULATIONS action the program intends to take; the reasons for the intended action; and a statement of the right to appeal. Further information is available by contacting the nearest district or subdistrict office or the CCS central office.

(5) An opportunity for a hearing is granted upon request toóan applicant whose application is denied; a client who is aggrieved by any CCS decision resulting in suspension, reduction, discontinuance or termination of benefits; or a provider who is aggrieved by any program decision resulting in suspension, reduction, discontinuance or termination of benefits.

(A) A hearing shall be conducted at a reasonable time, date and place. The notice of the time, date and place of a hearing shall be mailed to the requesting applicant, client or provider at least twenty (20) days prior to the hearing.

(B) An officer appointed by the director of the Department of Health shall preside at the hearing. The officer shall not have been involved in the initial determination of the action in question. The hearing officer shall prepare a report consisting of a statement of issues, findings of fact, conclusions and recommendations.

(C) The appellant shall have adequate opportunity to record the hearing proceedings, examine the contents of his/her case file, bring witnesses, establish all pertinent facts, advance arguments without undue interference and question or refute any testimony or evidence.

(D) The final decision shall be made by the director of the Department of Health, based upon the evidence and other material introduced at the hearing and the hearing officerís report. This decision shall be mailed to the appellant within ninety (90) calendar days after the hearing date.

(6) Any person who has exhausted all administrative remedies provided by law and sections (4) and (5) and subsections (5)(A) and (B) of this rule and who is aggrieved by a final decision in a contested case, whether this decision is affirmative or negative, shall be entitled to judicial review as provided in sections 536.100ñ536.140, RSMo 1986. ously filed 13 CSR 50-160.080. Emergency

Chapter 2 Chronic Diseases

19 CSR 40-2.010 Requirements for Participating in the Hemophilia Program {#sec-19-csr-40-2.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-2.010}

PURPOSE: This rule establishes the requirements for participation in the Missouri Hemophilia Program as a patient and as a provider of diagnosis, treatment or blood products for patients in the program.

Therefore, the material which is so incorporated is on file with the agency who filed this

(1) To be eligible to receive assistance from the Missouri Hemophilia Program ó (A) The individual must be diagnosed as having a hereditary disorder of blood coagulation;

(B) The individual shall have on file with the Missouri Hemophilia Program a completed application and verification of his/her own income or, if the individual is under twentyone (21) years of age, the income of his/her parents or guardian. An Internal Revenue Service Form 1040 or a valid substitute shall be submitted upon request of the program administrator;

(C) The individual shall show that all benefits of insurance coverage and other assistance programs have been exhausted, as required in section 191.335, RSMo 1986; and (D) The individual may be required to make payments for charges after insurance and other assistance. These charges are determined by a sliding percentage scale matched against the individualís income.

(2) Providers of diagnoses, treatment or blood products to persons participating in the Missouri Hemophilia Program shall be under contract with the Department of Health. Any facility under contract with the Department of Health to provide comprehensive treatment shall meet the criteria of a hemophilia treatment center as established by the Department of Health with the counsel of the Hemophilia Advisory Committee in Hemophilia Diagnostic and Treatment Center Criteria.

Original rule filed Nov. 8, 1984, effective Feb. 11, 1985. *Original authority: 191.335, RSMo 1979; 191.340, RSMo 1979.

MATTBLUNT(1/29/03)

Chapter 2óChronic Diseases19 CSR 40-2

History

AUTHORITY: sections 191.330, 191.335, 191.340 and 191.420, RSMo 1986. This rule was previously filed as 13 CSR 50-156.010.

Chapter 3 The Sudden Infant Death Syndrome (SIDS) Program

19 CSR 40-3.010 Administration of the SIDS Program {#sec-19-csr-40-3.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-3.010}

PURPOSE: State law mandates—an autopsy at state expense on any infant who dies suddenly when in apparent good health, the use of Sudden Infant Death Syndrome as cause of death on death certificates when autopsy results confirm this, prompt notification of autopsy results and provision of information regarding Sudden Infant Death Syndrome to the parent(s) or guardian(s). This rule provides procedures for meeting these requirements.

(1) In the event of the sudden and unexplained death of any infant one (1) week to one (1) year of age— (A) The coroner or medical examiner shall advise the parent(s) or guardian(s) of the deceased infant that an autopsy shall be performed at state expense for the purpose of confirming Sudden Infant Death Syndrome (SIDS). For a SIDS autopsy, the coroner or medical examiner shall notify the nearest child death pathologist who has been certified by the Missouri Department of Health and shall arrange for an autopsy. Pathologists certified by, and following the protocols of, the Department of Social Services State Technical Assistance Team shall be deemed certified by the Department of Health;

(B) The pathologist who performs this autopsy shall report in writing the preliminary results to the coroner or medical examiner who authorized the autopsy. The pathologist or coroner/medical examiner shall comply with the reporting requirements of the State Technical Assistance Team, Child Fatality Review Program;

(C) The certified child death pathologist shall ensure that a tangible summary of the autopsy results is provided to the parents or guardian of the child and shall provide informational material on the subject of Sudden Infant Death Syndrome to the family within one week after the autopsy is performed.

Performed is defined as the completion of the autopsy including, but not limited to, laboratory results and any other testing, as indicated. The certified child death pathologist shall, upon request by the parents or guardian, release the full autopsy results to the parents, guardian, or family physician in cases of suspected Sudden Infant Death Syndrome within thirty (30) days of such request. The tangible summary and full autopsy report shall be provided at no cost to the parents or guardian.

The Department of Health will develop a form letter which shall include a statement informing the parents or guardians of the right to receive the full autopsy results in cases of suspected Sudden Infant Death Syndrome and such letter shall be used by the child death pathologist to communicate this information to the parents or guardians. A copy of the child death pathologist’s letter shall be sent to the Department of Health, Bureau of Family Health. The Department of Health shall provide the required informational material to be included with the form letter to the child death pathologists at no charge;

(D) The Missouri Department of Health shall pay for non-Medicaid SIDS autopsies at the same rate as that paid for SIDS autopsies covered by Medicaid, The Missouri Department of Health shall pay for transportation of the body to and from the nearest facility utilized by the pathologist at the actual cost of said transportation up to but not to exceed a maximum of one hundred fifty dollars ($150). Any additional fee charged by the pathologist shall not be paid by the family; and (E) The medical examiner or coroner shall notify the medical certifier of the autopsy finding. The medical certifier, by affidavit, shall authorize a correction on the death certificate within ten (10) days of notification from the medical examiner or coroner.

(2) The Missouri Department of Health, coroners and medical examiners, within their current limits of confidentiality, without revealing the identity of the family of the autopsied infant, may release to qualified investigators medical information gained from autopsies to be utilized in scientific research.

Filed June 4, 1990, effective March 9, 1992.

Amended: Filed April 14, 1992, effective Dec. 3, 1992. Emergency amendment filed Oct. 15, 1992, effective Oct. 25, 1992, expired Feb. 21, 1993. Emergency amendment filed Feb. 11, 1993, effective Feb. 22, 1993, expired June 21, 1993. Amended: Filed Oct. 15, 1992, effective May 6, 1993. Emergency amendment filed Aug. 26, 1993, effective Sept. 4, 1993, expired Jan. 1, 1994.

Amended: Filed Aug. 26, 1993, effective April 9, 1994. Amended: Filed Nov. 13, 1998, effective May 30, 1999. Amended:

Filed Feb. 15, 2000, effective Sept. 30, 2000. *Original authority: 194.117, RSMo 1978, amended 1991, 1993, 1999.

Rebecca McDowell Cook (8/31/00)

History

AUTHORITY: section 194.117, RSMo Supp. 1999. This rule was previously filed as 13 CSR 50-155.010. Original rule filed April 12, 1979, effective Sept. 14, 1979. Amended:

Chapter 4 Early Periodic Screening, Diagnosis and Treatment (EPSDT)

19 CSR 40-4.010 Basis for Provisions of EPSDT {#sec-19-csr-40-4.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-4.010}

(Rescinded October 30, 2020)

History

AUTHORITY: sections 191.420 and 192.020, RSMo 1986. This rule was previously filed as

13 CSR 50-157.010. Original rule filed Dec. 30, 1975, effective Jan. 9, 1976. Amended: {#sec-13-csr-50-157.010. omnilex-key=us-mo-regs-official--title-19--13 CSR 50-157.010.}

Filed May 10, 1978, effective Aug. 11, 1978.

Emergency amendment filed Aug. 16, 1979, effective Oct. 1, 1979, expired Nov. 10, 1979.

Amended: Filed Aug. 16, 1979, effective Nov. 11, 1979. Amended: Filed Jan. 15, 1985, effective April 11, 1985. Rescinded: Filed April 23, 2020, effective Oct. 30, 2020.

Chapter 5 Food and Nutrition Programs

19 CSR 40-5.010 Special Supplemental Food Program for Women, Infants and Children (WIC) {#sec-19-csr-40-5.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-5.010}

(Moved to 19 CSR 45-5.010)

19 CSR 40-5.020 State Funding for Extended Hours of the Special Supplemental Food Program for Women, Infants and Children (WIC) Clinics {#sec-19-csr-40-5.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-5.020}

(Moved to 19 CSR 45-5.020)

19 CSR 40-5.050 Child and Adult Care Food Program (CACFP) {#sec-19-csr-40-5.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-5.050}

(Moved to 19 CSR 45-5.050)

19 CSR 40-5.060 Summer Food Service Program (SFSP) for Children {#sec-19-csr-40-5.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-5.060}

(Moved to 19 CSR 45-5.060)

MATTBLUNT(5/31/03)

Chapter 5óFood and Nutrition Programs19 CSR 40-5

Chapter 6 Perinatal Substance Abuse

19 CSR 40-6.010 Perinatal Substance Abuse Forms for Health Care Providers {#sec-19-csr-40-6.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-6.010}

PURPOSE: This rule establishes the forms and protocol to be used by health care providers to implement the perinatal substance abuse legislation in sections 191.725, 191.741 and 191.743, RSMo.

(1) All licensed health care providers who provide obstetrical and gynecological care to pregnant women shall use the Department of Health form MCFH-4, the protocol required by section 191.741, RSMo, in Appendix A of this rule or any other assessment form which documents the substance abuse risk status of each patient. The medical record shall show documentation of this assessment.

(2) The health care providers designated in

section (1) of this rule shall have all patients sign the Department of Health form MCFH- 3 in Appendix B of this rule, or any form which is signed and dated by the patient and which states the substances discussed.

(3) To document the offer of service coordination for each pregnant woman at high risk for substance abuse, the health care providers designated in section (1) of this rule shall use the Department of Health form MCFH-2 in

Appendix C of this rule and retain it in the medical record, or have documentation of the offer for service coordination and the womanís response in the medical record. The health care provider shall make the referral for service coordination to the Department of Health by telephone or in writing.

4CODE OF STATE REGULATIONS

6CODE OF STATE REGULATIONS

8CODE OF STATE REGULATIONS

History

AUTHORITY: sections 191.725, 191.741 and 191.743, RSMo Supp. 1991. Original rule filed Feb. 2, 1994, effective July 30, 1994. Original authority: 191.725, RSMo 1991; 191.741, RSMo 1991 and 191.743, RSMo 1991.

Chapter 7 Metabolic Formula Program

19 CSR 40-7.010 Definitions RSMo (1994 and Supp. 1995). Emergency {#sec-19-csr-40-7.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-7.010}

rule filed Aug. 19, 1996, effective Aug. 29, 1996, expired Feb. 24, 1997. Original rule Oct. 30, 2020.

19 CSR 40-7.020 Program Eligibility RSMo (1994 and Supp. 1995). Original rule Oct. 30, 2020. {#sec-19-csr-40-7.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-7.020}

19 CSR 40-7.030 Client Responsibilities RSMo (1994 and Supp. 1995). Emergency {#sec-19-csr-40-7.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-7.030}

rule filed Aug. 19, 1996, effective Aug. 29, 1996, expired Feb. 24, 1997. Original rule Oct. 30, 2020.

19 CSR 40-7.040 Definitions {#sec-19-csr-40-7.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-7.040}

PURPOSE: This rule defines the terms used in this chapter.

(1) Client is a person who meets eligibility requirements as defined by 19 CSR 40-7.050 Program Eligibility, and is approved for participation in the Metabolic Formula Program (MFP).

(2) Department is the Missouri Department of Health and Senior Services.

(3) The Metabolic Formula Program is a program of the department through which lowprotein formula, a special dietary product, is provided to individuals diagnosed as having phenylketonuria (PKU), maple syrup urine disease (MSUD) and other metabolic conditions as approved by the Newborn Screening Standing Committee. The Newborn Screening Standing Committee, a subcommittee of the Missouri Genetic Advisory Committee, makes recommendations on newborn screening issues.

(4) Maple syrup urine disease (MSUD) is a metabolic disorder due to a defect in the enzyme that is responsible for the metabolism of the essential branched-chain amino acids isoleucine, leucine and valine.

(5) Metabolic treatment center is a medical facility with the capacity to diagnose metabolic conditions and to provide comprehensive medical management.

(6) Phenylketonuria (PKU) is a hereditary disorder of phenylalanine metabolism characterized by brain damage and mental retardation due to accumulation of toxic metabolic products.

(7) Resident is an individual having a domicile in Missouri with the intention to live in Missouri on a permanent basis.

(8) Sliding fee scale is the tool utilized to determine the monthly premium to be paid for the MFP program services.

Supp. 2007.* Emergency rule filed Sept. 7,

19 CSR 40-7.050 Program Eligibility {#sec-19-csr-40-7.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-7.050}

PURPOSE: The Department of Health and Senior Services (DHSS) provides low-protein formula, a special dietary product, to individuals diagnosed as having phenylketonuria (PKU), maple syrup urine disease (MSUD) and other metabolic conditions as approved by the Newborn Screening Standing Committee, a subcommittee of the Missouri Genetic Advisory Committee which makes recommendations to the department on newborn screening issues. This rule establishes the criteria by which the Metabolic Formula Program accepts clients for service.

(1) Conditions of eligibility for the Metabolic Formula Program (MFP) include:

(A) An applicant must be diagnosed as having phenylketonuria (PKU), maple syrup urine disease (MSUD) or other metabolic conditions as approved by the Newborn Screening Standing Committee and recommended to the department. The diagnosis must be made by a physician who practices at a metabolic treatment center;

(B) An applicant must be a resident of Missouri and cannot reside in a state facility.

Proof of residency will consist of submitting a copy of the previous month’s utility bill with the applicant’s home address clearly printed;

A letter requesting the applicant be placed on the MFP;
The name and address of the applicant; and 3. A prescription, signed by the treating physician, stating the name of the low-protein formula, a special dietary product the individual will be using; and (D) Financial eligibility guidelines for enrollment in the MFP shall be based upon the Poverty Income Guidelines as established by the United States Department of Health and Human Services. Determination of individual applicant eligibility shall be based upon the following:
Applicants five (5) years or under shall have no income qualification requirements;
Applicants six (6) through eighteen (18) years whose family income is below three hundred percent (300%) of the federal poverty level shall be eligible for enrollment in the MFP;
Applicants six (6) through eighteen (18) years whose family income is at three hundred percent (300%) of the federal poverty level or above shall be eligible based on a sliding fee scale for enrollment in the MFP;
Applicants nineteen (19) years and above whose income does not exceed one hundred eighty-five percent (185%) of the federal poverty level shall be eligible for enrollment in the MFP;
Size of family unit shall be the number of persons in the household, including the responsible party(ies) and dependents allowable by the Internal Revenue Service as federal income tax exemptions. The family size may be increased by two (2) additional family members per affected individual nineteen (19) years and above for the cost of low-protein formula; and 6. Funding to eligible applicants may be adjusted by the department based on available funding.

(2) A sliding fee scale shall be used to determine the amount of monthly premium and assistance to be provided by the department (9/30/20) JOHN R. ASHCROFT SENIOR SERVICES for those individuals six (6) through eighteen (18) years having no insurance, Medicaid or Medicare and whose adjusted gross income places the family at three hundred percent (300%) of the federal poverty level or above.

The sliding fee scale shall be updated based on changes in the federal poverty guidelines.

The adjusted gross income line from Internal Revenue Service recognized tax forms shall be the income used to determine financial eligibility with adjustments for child support received or paid. The table for establishing a sliding scale fee of premiums is provided below. *Based upon DHSS cost of formula and subject to available funding for the program.

(3) Approved applicants having no insurance coverage for metabolic formula, Medicaid benefits or other third party payor will have formula provided as prescribed by the person’s genetic disease physician or a general physician in consultation with the genetic disease physician at the metabolic treatment center.

Supp. 2007.* Emergency rule filed Sept. 7,

19 CSR 40-7.060 Application Process {#sec-19-csr-40-7.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-7.060}

PURPOSE: This rule establishes how individuals apply for participation in the Metabolic Formula Program.

(1) Application for participation in the Metabolic Formula Program (MFP) shall be made on forms designated by the Department of Health and Senior Services. Application forms may be requested from the Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102-0570.

(2) The applicant, or if the applicant is a minor or incapacitated, the applicant’s parent(s) or legal guardian, shall:

(A) Submit a copy of their most current federal 1040 tax form and complete a Metabolic Formula Program application that includes: the applicant’s last name, first, middle initial; date of birth; gender; race; marital status; Social Security number; address (street, city, state, zip); county of residence; home telephone number; cell telephone number; work telephone number; responsible party (last, first, middle initial), relationship and phone number; a copy of any applicable court appointed guardian/custodian document; dependents claimed on federal income tax filing (last, first, middle initial), relationship to the applicant and social security number of the dependents; alternate contact (last, first, middle initial), relationship to the applicant and phone number; MO HealthNet number (if applicable); amount of MO HealthNet spend down per month (if applicable); copy of the front and back on any third party payors (if applicable); other proof of income if the most recent federal income tax filing is not reflective of the current financial status; yearly amount of child support received; and yearly amount of child support paid.

(B) Submit a copy of the previous month’s utility bill with the applicant’s home address clearly printed as proof of residency.

(C) Report any major changes in income, household composition, insurance, MO HealthNet coverage or address within ten (10) working days after the date the applicant or the applicant’s parent(s) or legal guardian becomes aware of the change.

(3) When the applicant is eligible, payments shall be made for such services through MO HealthNet or other insurance benefits available to the applicant to the fullest possible extent. The benefits available under the provisions of section 191.331, RSMo Supp. 2007 shall not replace those provided under other federal or state law or under other contractual or legal entitlements of the persons receiving them.

(4) The applicant is responsible for paying for any amount of debt incurred above the program amount paid by the department based on the established sliding fee scale in 19 CSR 40-7.050.

(5) The applicant or the applicant’s parent(s) or legal guardian shall provide the department with complete and accurate information concerning their financial status.

(6) To maintain eligibility, an applicant shall submit a new application prior to the end of the eligibility period. The eligibility period shall be the state fiscal year, July 1 through June 30. Each new application submitted must meet the eligibility requirements and the most recent federal 1040 tax form must be submitted with the application. Applications may be accepted any time during the fiscal year.

(7) If the applicant or the applicant’s parent(s) or legal guardian does not meet the requirements of sections (1)–(3) of this rule, the MFP shall discontinue services. The applicant may retain eligibility for service coordination services if the applicant’s income exceeds income eligibility guidelines.

(8) Any applicant determined ineligible for the MFP may reapply based on changes, which may make them eligible.

Supp. 2007.* Emergency rule filed Sept. 7, Table: Sliding Fee Scale for those Applicants Age 6 through 18 Years Based on Family Adjusted Gross Income Adjusted Gross Income is:Approximate Family Monthly Premium for Formula* 299% of poverty or below0 300% – 399% of poverty25% 400 – 499% of poverty40% 500% of poverty and above50%

Chapter 8 Missouri Genetics Disease Program

19 CSR 40-8.010 Definitions {#sec-19-csr-40-8.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-8.010}

PURPOSE: This rule defines the terms used in this chapter.

(1) The “Missouri Genetics Disease Program” is the program of the Department of Health authorized by the provisions of statute sections 191.300 to 191.331, 191.340, and 191.365 to 191.380, RSMo.

(2) “Department” is the Missouri Department of Health.

(3) “Tertiary genetic centers” means the permanent genetic divisions in university medical schools that provide comprehensive genetic diagnostic, treatment and counseling services.

(4) “Outreach clinics” are the medical clinics which provide genetic diagnosis and counseling at sites away from the tertiary genetic centers.

(5) “Genetic counseling” is the provision and interpretation of medical information based on expanding knowledge of human genetics.

(6) “Genetic disorders” are those abnormalities of structure, function, or body metabolism which may be inherited or may result from damage to the fetus.

(7) “Genetic screening” refers to the search through testing for persons with genetic disorders.

History

AUTHORITY: section 191.315, RSMo Supp. 1997. Original rule filed Oct. 6, 1998, effective May 30, 1999. Original authority 1985, amended 1993, 1995.

19 CSR 40-8.020 Tertiary Genetic Center Responsibilities {#sec-19-csr-40-8.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-8.020}

PURPOSE: The Department of Health administers the Missouri Genetics Disease Program to provide genetic diagnostic and counseling services. The department may contract with qualifying tertiary genetic centers to provide genetic services for residents of Missouri. This rule sets forth the requirements for becoming a contractor and the reimbursement criteria to receive funding for tertiary genetic centers awarded contracts pursuant to this program.

(1) The requirements for a tertiary genetic center to participate in the Missouri Genetics Disease Program are that the center— (A) Maintains staff, facilities, resources and equipment which have the capability to provide up-to-date and comprehensive genetic services;

(B) Staff must have clinical expertise in syndrome identification. The center must provide a minimum of two (2) personnel, one (1) of which shall be a medical geneticist and the other shall be a genetic associate. The center’s staff shall additionally include a nurse, a social worker, a cytogeneticist, a psychologist, and clerical staff;

(C) Provide existing access to the following specialists: audiologist, ear, nose and throat specialist, pediatric neurologist, pediatric cardiologist, orthopedic specialist, neonatologist, perinatologist, and prenatal ultrasonography specialist;

(D) Be capable of providing pedigree analyses, full diagnosis, referral for patient evaluation and lab work, and multidisciplinary consultation; and (E) Be equipped with a cytogenetic laboratory, a biochemical genetics laboratory, and a cell culture laboratory with full diagnostic capabilities. If the center has only one (1) laboratory, it must have all of the above described specific laboratory capabilities.

(2) Tertiary genetic centers under contract with the Department of Health, pursuant to the Missouri Genetics Disease Program, must satisfy the following criteria in order to receive reimbursement:

(A) Perform service community networking which establishes and maintains appropriate and effective coordination with other related health services and genetic diseaserelated programs in the area. To facilitate and carry out contractual activities, the contractor shall permit expansion of less-developed programs to strengthen limited activities and develop new programs in an area in which no current program exists, for example, establishment of a teratogen hotline;

(B) Provide genetic evaluations for individuals and their families who are at risk for genetic or genetic-related conditions;

(C) Provide genetic counseling and upon completion of the diagnosis give a complete explanation of the findings to the individual and their family;

(D) Conduct genetic outreach activities; the delivery of genetic diagnosis, counseling, and education services at outreach clinic sites;

(E) Provide professional education programs for physicians, nurses, scientists, technicians, therapists, and other allied health professionals regarding the causes, methods of treatment, prevention and cure of genetic diseases;

(F) Provide educational activities to the general public regarding the various types of genetic disorders and their modes of inheritance; the impact of genetic disorders in Missouri; and genetic services that are available in Missouri; and (G) Collect demographic and other patient data as identified by the Missouri Genetics Disease Program and report information according to current reporting requirements established through the Genetic Automated Office System (GOAS).

Original rule filed Oct. 6, 1998, effective May 30, 1999. *Original authority 1985, amended 1993, 1995.

Rebecca McDowell Cook (4/30/99)

History

AUTHORITY: section 191.315, RSMo Supp.

Chapter 9 Universal Newborn Hearing Screening Program

19 CSR 40-9.010 Definitions {#sec-19-csr-40-9.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-9.010}

PURPOSE: This section defines the terms used in this chapter.

(1) Acceptable refer rates means the department has determined the facilityís percentage of newborns referred for rescreening or diagnostic evaluation is acceptable, based on factors including but not limited to type of equipment; methodology; population screened; and facility staff.

(2) Audiologist is a person who is licensed in the state of Missouri according to Chapter 345, RSMo to provide audiological services.

(3) Automated screening equipment is equipment used for newborn hearing screening which automatically provides a pass/refer outcome.

(4) Automated pass/refer criteria is the interpretive criteria incorporated into hearing screening equipment that automatically provides a pass/refer outcome.

(5) Birth admission is the hospitalization during which the newborn is delivered.

(6) Diagnostic audiological assessment is the required audiometric testing used to determine the presence, type and severity of hearing loss.

(7) Department is the Missouri Department of Health.

(8) Department-designee is a person acting on behalf of the department in assessing, tracking and/or surveillance of hearing screening information.

(9) Facility is a hospital or ambulatory surgical center licensed by the state of Missouri, Department of Health.

(10) Food and Drug Administration (FDA)approved equipment is hearing screening equipment that is designed specifically for use with newborns, and has met approved standards of operation set forth by the U.S.

Food and Drug Administration.

(11) Hearing loss is a dysfunction of the auditory system of any type or degree that is sufficient to interfere with the acquisition and development of speech and language skills.

(12) Hearing screening is the completion of an objective, physiological test or battery of tests using recommended guidelines to identify newborns that need further audiological assessment.

(13) Infant is any child at least thirty (30) days of age, and less than twelve (12) months of age.

(14) Initial hearing screening is the first hearing screening performed on a newborn preferably prior to discharge from the facility where the birth occurred.

(15) Lost to follow-up is a newborn who cannot be located through tracking, and who may not have completed the screening and/or referral process.

(16) Missed is any newborn that did not have a hearing screening prior to discharge from the birthing facility.

(17) Newborn is any child twenty-nine (29) days of age or less.

(18) Non-audiologic personnel means any person that is not licensed as an audiologist in the state of Missouri according to Chapter 345, RSMo.

(19) One-stage newborn hearing screening program is designed so that newborns who do not pass the initial hearing screening are referred for diagnostic audiological assessment.

(20) Parent is a biological parent, stepparent, adoptive parent, legal guardian or other legal custodian of a newborn.

(21) Pass is the result obtained by automated hearing screening equipment, with preset interpretive criteria based upon a specific scientific rationale, which requires no further screening or testing.

(22) Primary care provider is a physician or person who professionally undertakes the pediatric care of the newborn, and is licensed in the state of Missouri as appropriate.

(23) Program manager is the person designated as being responsible for the newborn hearing screening program at a facility.

(24) Reasonable effort is demonstrated when the department has documentation of at least two (2) attempts to contact the newborn/infantís parent(s) by mail or phone, and at least one (1) attempt to contact the newborn/infantís primary care provider.

(25) Refer is the result obtained by hearing screening equipment, with preset interpretive criteria based upon a specific scientific rationale, that requires further screening or confirmatory testing.

(26) Referral is the process of sending a newborn that receives a ìreferî screening result for additional audiological, educational, medical, or social assessment or evaluation.

(27) Rescreening is a repeat hearing screening performed on a newborn or infant, typically in an outpatient setting and preferably within thirty (30) days of the initial hearing screening.

(28) Third party payer is any person, corporation, trust, association, the state of Missouri, any governmental subdivision or agency or any other legal entity which pays directly or indirectly for health care services provided to another person or reimburses or pays a benefit to or on behalf of another person for health care services in conformance to a contract, plan, employee benefit or member benefit.

(29) Tracking is the process of reviewing information concerning the newbornís hearing screening status, to ensure the hearing screening and referral process is completed in a timely manner.

(30) Two-stage newborn hearing screening program is designed so that newborns who do not pass the initial hearing screening are referred for a rescreening exam. If the newborn does not pass the rescreening exam, the newborn/infant is referred for diagnostic audiological assessment.

Jan. 30, 2002.

19 CSR 40-9.020 Screening Methodologies and Procedures {#sec-19-csr-40-9.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-9.020}

PURPOSE: This rule establishes the screening methodologies and procedures that a facility, audiologist, and/or other person that performs hearing screenings outside of a facility must use to operate a newborn hearing screening program and/or perform diagnostic audiological assessments.

Chapter 9óUniversal Newborn Hearing Screening Program19 CSR 40-9 (1) Each facility shall designate a person responsible for carrying out the newborn hearing screening program at their facility, referred to as the program manager.

(2) By February 1, 2002, each facility shall notify the department, electronically or in writing, of the name, business address and telephone number of the program manager.

Changes to the facilityís program manager and/or changes in the business contact information shall be reported to the department within thirty (30) calendar days.

(3) Each facility operating a newborn hearing screening program shall establish written policies and procedures. These policies and procedures shall include, but are not limited to:

(A) The type of newborn hearing screening program (one or two stage) to be operated;

(B) The type of Food and Drug Administration (FDA)-approved hearing screening equipment being used, and screening methods, including the facility location(s) where the screenings will be completed;

(C) Specific duties for all persons participating in the newborn hearing screening program, including minimum training/experience requirements for persons performing the screenings;

(D) A written plan for initial training for all persons participating in the newborn hearing screening program;

(E) A method of evaluating and documenting the competency of each newborn hearing screenerís performance upon completion of the initial training and at least annually thereafter;

(F) A plan for ensuring accuracy of newborn hearing screening results. The plan shall address the importance of attaining and maintaining acceptable referral rates;

(G) A plan to notify the parent(s) and primary care provider of the hearing screening results;

(H) Designation of facility personnel responsible for reporting newborn hearing screening results to the department;

(I) Distribution of the prescreening pamphlet to all families of newborns;

(J) Distribution of the audiologist resource guide;

(K) A method of referral for newborns who ìmissedî the birth admission hearing screening, or require rescreening and/or diagnostic audiological assessment; and (L) Documentation of screenings refused by the family.

(4) A facility using non-audiologic personnel to perform the newborn hearing screening shall use FDA-approved screening equipment that provides automated pass/refer criteria.

(5) A facility shall provide to the department or department-designee, a copy of their written policies and procedures upon request.

(6) The facility shall provide each newbornís parent(s) with information about newborn hearing screening in English or other language or alternate method as appropriate.

The department shall provide information to facilities in other languages upon request.

(7) A facility or person(s) performing hearing screenings outside a facility shall notify parent(s) and the primary care provider of the hearing screening results within seven (7) calendar days of the screening.

(8) A facility or person that performs a hearing screening outside a facility, shall give the parent(s) of a newborn receiving unilateral or bilateral ìreferî result(s), a list (developed by the department) of audiological services. Parent(s) shall be instructed to contact the primary care provider and any third-party payers to determine the appropriate referral process prior to obtaining audiological services.

(9) Rescreening shall be performed by an audiologist, physician, and/or facility personnel trained in the newborn hearing screening program.

(10) Rescreening shall be completed within thirty (30) calendar days of the initial newborn hearing screening. Infants requiring continuous acute care following birth shall have their rescreening completed within thirty (30) calendar days of the acute care discharge.

(11) Diagnostic audiological assessments shall be performed by audiologists.

(12) Diagnostic audiological assessments shall be completed within thirty (30) calendar days of the rescreening, or initial screening if applicable. Infants requiring continuous acute care following birth shall have their diagnostic audiological assessment completed within three (3) months of the acute care discharge.

(13) The audiologist shall notify the parent(s) and primary care provider of the diagnostic audiological assessment results no later than seven (7) calendar days following the completion of the assessment.

(14) The department shall make reasonable efforts to assure that all newborns have a hearing screening by three (3) months of age (or within three (3) months of discharge from an acute facility for infants requiring continuous acute care following birth).

(15) The department shall make reasonable efforts to assure that all newborns with a confirmed hearing loss are referred to the appropriate point of contact for the Part C of the Individuals with Disabilities Education Act (IDEA) system of early intervention services (First Steps) by six (6) months of age (or within six (6) months of discharge from an acute care facility for infants requiring continuous acute care following birth).

Jan. 31, 2002. Amended: Filed Jan. 31, 2003, effective July 30, 2003.

19 CSR 40-9.040 Information to be Reported to the Department of Health {#sec-19-csr-40-9.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-9.040}

PURPOSE: This rule establishes the information management, reporting and tracking system used by facilities, primary care providers, and audiologists to report newborn hearing screening data to the department.

Timely reporting is necessary to assure the provision of early diagnostic and intervention services.

(1) Each facility, physician, or primary care provider shall report all newborn hearing screening results, including missed screenings, via either the departmentís web-based reporting system or manually on the departmentís newborn hearing reporting form. This newborn hearing reporting form shall be developed and made available by the department. The results shall be reported to the department within seven (7) calendar days of completion of the hearing screening.

(2) Each facility, or person designated to perform repeat hearing screenings, shall report information for tracking newborns who receive ìreferî results or missed the birth admission hearing screening. The information shall be reported to the department via either the web-based reporting system or manually on the departmentís newborn hearing tracking form, within seven (7) calendar days of completion of the hearing screening.

(3) The facility or person designated to perform the missed hearing screening, the rescreening, and/or the diagnostic audiological assessment, shall notify the department if 4CODE OF STATE REGULATIONS (6/30/03) MATTBLUNT Division 40óDivision of Maternal, 19 CSR 40-9óDEPARTMENT OF HEALTH AND SENIOR SERVICES Child and Family Health the scheduled appointment was not kept. This information shall be reported to the department via either the departmentís web-based reporting system or manually on the departmentís newborn hearing tracking form, within seven (7) calendar days of the date of discharge or scheduled appointment date.

(4) The audiologist shall report all diagnostic audiological assessment results to the department, via either the web-based reporting system or manually on the departmentís newborn hearing tracking form, within seven (7) calendar days of completion of the assessment.

(5) Each facility or primary care provider shall provide to the department, upon request, information from the newbornís medical record relevant to the newbornís hearing status.

(6) Each facility, physician, primary care provider, or audiologist shall document all parental refusals for newborn hearing screening, and report the refusal to the department via either the web-based reporting system or manually on the departmentís newborn hearing screening tracking form within seven (7) calendar days of refusal.

Jan. 30, 2002.

Chapter 9óUniversal Newborn Hearing Screening Program19 CSR 40-9

Chapter 10 Forensic Examinations for Sexual Assault

19 CSR 40-10.010 Payments for Sexual Assault Forensic Examinations HEALTH AND SENIOR SERVICES and Family Health Sexual Assault {#sec-19-csr-40-10.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-10.010}

19 CSR 40-10.010 Payments for Sexual Assault Forensic Examinations {#sec-19-csr-40-10.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-10.010}

(Rescinded August 30, 2018)

Emergency rule filed Sept. 6, 2007, effective Sept. 16, 2007, terminated Nov. 3, 2007. Emergency rule filed Oct. 24, 2007, effective Nov. 3, 2007, expired March 13, 2008. Original rule filed Nov. 1, 2007, effective May 30, 2008. Rescinded: Filed Jan. 5, 2018, effective Aug. 30, 2018.

JOHNR. ASHCROFT(7/31/18)

History

AUTHORITY: section 191.225, RSMo Supp.

Chapter 11 * - moved to 13 CSR 40-91

19 CSR 40-11.010 Payments for Vision Examinations {#sec-19-csr-40-11.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-11.010}

(Moved to 13 CSR 40-91.040)

ROBINCARNAHAN(2/28/11)

Chapter 12 Critical Congenital Heart Disease

19 CSR 40-12.010 Critical Congenital Heart Disease Screening for Newborns {#sec-19-csr-40-12.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-12.010}

PURPOSE: This rule defines the terms used and establishes the screening guidelines and information reporting required to assure the provision of critical congenital heart disease screening (CCHD).

This note applies only to the reference material. The entire text of the rule is printed here.

(1) Definitions for purposes of this rule— (A) “Facility” is an ambulatory surgical center, birthing center, or hospital that is responsible under section 191.334, RSMo, for performing a Critical Congenital Heart Disease (CCHD) screening prior to the discharge of a newborn; and (B) “Individual” is the person responsible for performing the CCHD screening under

section 191.334, RSMo, when the delivery of a newborn takes place outside a facility.

(2) Screening for CCHD required by section 191.334, RSMo, shall be conducted by pulse oximetry in accordance with the guidelines in the journal article “Strategies for Implementing Screening for Critical Congenital Heart Disease” published in Pediatrics® Official Journal of the American Academy of Pediatrics, Volume 128, No. 5 on November 1, 2011, which is incorporated by reference in this rule and is available at www.health.mo.gov/cchd or by contacting the Missouri Department of Health and Senior Services (DHSS) at 800-877-6246.

This rule does not incorporate any subsequent amendments or additions.

(3) Each facility or individual shall report all screening results and screening refusals utilizing either the Missouri Electronic Vital Records (MoEVR) system or the department’s Critical Congenital Heart Disease Reporting Form. The Missouri Electronic Vital Records Critical Congenital Heart Disease Screening Results User Manualpublished September 2016, and the Critical Congenital Heart Disease Reporting Form published April 2016, are incorporated by reference in this rule and are available at www.health.mo.gov/cchd or by contacting the Missouri Department of Health and Senior Services (DHSS) at 800-877-6246.

This rule does not incorporate any subsequent amendments or additions.

(4) The screening results shall be reported to the department within thirty (30) calendar days of completion of the CCHD screening.

JOHNR. ASHCROFT(10/31/17)

History

AUTHORITY: sections 191.334 and 192.006, RSMo 2016. Original rule filed March 16, 2017, effective Nov. 30, 2017. Original authority: 191.334, RSMo 2013 and 192.006, RSMo 1993, amended 1995.

Chapter 13 * - moved to 19 CSR 20-43

19 CSR 40-13.010 Definitions {#sec-19-csr-40-13.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-13.010}

(Moved to 19 CSR 20-43.010)

19 CSR 40-13.020 Administration of the HIV/AIDS Medications Program {#sec-19-csr-40-13.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-13.020}

(Moved to 19 CSR 20-43.020)

19 CSR 40-13.030 Eligibility for the HIV/AIDS Medications Program {#sec-19-csr-40-13.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-13.030}

(Moved to 19 CSR 20-43.030)

19 CSR 40-13.040 Service Provider Requirements {#sec-19-csr-40-13.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-13.040}

(Rescinded August 30, 1999)

Rescinded: Filed Jan. 14, 1999, effective Aug. 30, 1999.

Rebecca McDowell Cook (7/31/99)

History

AUTHORITY: sections 191.650–191.698, 192.006, 192.020, 192.025 and Chapter 213, RSMo 1994 and Supp. 1996. Emergency rule filed Nov. 21, 1996, effective Dec. 1, 1996, expired May 29, 1997. Original rule filed Dec. 10, 1996, effective May 30, 1997.

Chapter 60 * - moved to 19 CSR 30-60

19 CSR 40-60.010 Definitions Relating to Child Care Facilities {#sec-19-csr-40-60.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-60.010}

(Moved to 19 CSR 30-60.010)

19 CSR 40-60.020 Application for Annual Fire Safety and Health and Sanitation Inspections and Inspection Procedures {#sec-19-csr-40-60.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-60.020}

(Moved to 19 CSR 30-60.020)

19 CSR 40-60.030 Local Inspections {#sec-19-csr-40-60.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-60.030}

(Moved to 19 CSR 30-60.030)

19 CSR 40-60.040 Variance Requests {#sec-19-csr-40-60.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-60.040}

(Moved to 19 CSR 30-60.040)

19 CSR 40-60.050 Staffing Requirements {#sec-19-csr-40-60.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-60.050}

(Moved to 19 CSR 30-60.050)

19 CSR 40-60.060 Health Requirements {#sec-19-csr-40-60.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-60.060}

(Moved to 19 CSR 30-60.060)

19 CSR 40-60.070 Responsibilities of Caregivers {#sec-19-csr-40-60.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-60.070}

(Moved to 19 CSR 30-60.070)

19 CSR 40-60.080 Fire Safety Requirements {#sec-19-csr-40-60.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-60.080}

(Moved to 19 CSR 30-60.080)

19 CSR 40-60.090 Sanitation Requirements {#sec-19-csr-40-60.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-60.090}

(Moved to 19 CSR 30-60.090)

19 CSR 40-60.100 Physical Plant, Space, Supplies and Equipment {#sec-19-csr-40-60.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-60.100}

(Moved to 19 CSR 30-60.100)

19 CSR 40-60.110 Transportation and Field Trip Requirements {#sec-19-csr-40-60.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-60.110}

(Moved to 19 CSR 30-60.110)

19 CSR 40-60.120 Admission Procedures and Required Reports and Records {#sec-19-csr-40-60.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-60.120}

(Moved to 19 CSR 30-60.120)

Rebecca McDowell Cook (6/30/98)

Chapter 61 * - moved to 19 CSR 30-61

19 CSR 40-61.085 Physical Requirements of the Family Day Care Home {#sec-19-csr-40-61.085 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.085}

19 CSR 40-61.105 The Day Care Provider and Other Day Care Personnel 2CODE OF STATE REGULATIONS (6/30/98) Rebecca McDowell Cook {#sec-19-csr-40-61.105 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.105}

19 CSR 40-61.230 Review and Appeal Process for Licensed Facilities itle 19—DEPARTMENT OF HEALTH and Family Health Day Care Homes {#sec-19-csr-40-61.230 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.230}

19 CSR 40-61.010 Definitions {#sec-19-csr-40-61.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.010}

(Moved to 19 CSR 30-61.010)

19 CSR 40-61.015 Exemption of Day Care Facilities {#sec-19-csr-40-61.015 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.015}

(Moved to 19 CSR 30-61.015)

19 CSR 40-61.025 Organization and Administration {#sec-19-csr-40-61.025 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.025}

(Moved to 19 CSR 30-61.025)

19 CSR 40-61.045 Initial Licensing Information {#sec-19-csr-40-61.045 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.045}

(Moved to 19 CSR 30-61.045)

19 CSR 40-61.055 License Renewal {#sec-19-csr-40-61.055 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.055}

(Moved to 19 CSR 30-61.055)

19 CSR 40-61.085 Physical Requirements of the Family Day Care Home {#sec-19-csr-40-61.085 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.085}

(Moved to 19 CSR 30-61.085)

19 CSR 40-61.095 Furniture, Equipment and Materials {#sec-19-csr-40-61.095 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.095}

(Moved to 19 CSR 30-61.095)

19 CSR 40-61.105 The Day Care Provider and Other Day Care Personnel {#sec-19-csr-40-61.105 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.105}

(Moved to 19 CSR 30-61.105)

19 CSR 40-61.115 Day Care Family and Household {#sec-19-csr-40-61.115 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.115}

(Moved to 19 CSR 30-61.115)

19 CSR 40-61.125 Medical Examination Reports {#sec-19-csr-40-61.125 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.125}

(Moved to 19 CSR 30-61.125)

19 CSR 40-61.135 Admission Policies and Procedures {#sec-19-csr-40-61.135 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.135}

(Moved to 19 CSR 30-61.135)

19 CSR 40-61.145 Nighttime Care {#sec-19-csr-40-61.145 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.145}

(Moved to 19 CSR 30-61.145)

19 CSR 40-61.155 Overlap Care of Children {#sec-19-csr-40-61.155 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.155}

(Moved to 19 CSR 30-61.155)

19 CSR 40-61.165 Emergency School Closings {#sec-19-csr-40-61.165 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.165}

(Moved to 19 CSR 30-61.165)

19 CSR 40-61.175 Child Care Program {#sec-19-csr-40-61.175 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.175}

(Moved to 19 CSR 30-61.175)

19 CSR 40-61.185 Health Care {#sec-19-csr-40-61.185 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.185}

(Moved to 19 CSR 30-61.185)

19 CSR 40-61.190 Nutrition and Food Service {#sec-19-csr-40-61.190 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.190}

(Moved to 19 CSR 30-61.190)

19 CSR 40-61.200 Transportation and Field Trips {#sec-19-csr-40-61.200 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.200}

(Moved to 19 CSR 30-61.200)

19 CSR 40-61.210 Records and Reports {#sec-19-csr-40-61.210 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.210}

(Moved to 19 CSR 30-61.210)

19 CSR 40-61.220 Variance Request {#sec-19-csr-40-61.220 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-61.220}

(Moved to 19 CSR 30-61.220)

9 CSR 40-61.230 Review and Appeal Process for Licensed Facilities {#sec-9-csr-40-61.230 omnilex-key=us-mo-regs-official--title-19--9 CSR 40-61.230}

(Rescinded March 30, 1996)

Original rule filed Aug. 27, 1993, effective April 9, 1994. Emergency rule filed Jan. 4, 1994, effective Jan. 14, 1994, expired May 13, 1994. Rescinded: Filed Sept. 12, 1994, effective March 30, 1996.

Rebecca McDowell Cook (6/30/98)

History

AUTHORITY: section 210.221.1(3), RSMo Supp. 1993. Empergency rule filed Aug. 27, 1993, effective Sept. 5, 1993, expired Jan. 2, 1994. Emergency rule filed Aug. 27, 1993, effective Sept. 5, 1993, expired Jan. 2, 1994.

Chapter 62 * - moved to 19 CSR 30-62

19 CSR 40-62.082 Physical Requirements of Group Day Care Homes and 2CODE OF STATE REGULATIONS (6/30/98)* MATTBLUNT Title 19óDEPARTMENT OF HEALTH Division 40óDivision of Maternal, Child and Family Health {#sec-19-csr-40-62.082 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.082}

Chapter 62óLicensing Rules for Group Day Care Homes and Child Day Care Centers

19 CSR 40-62.010 Definitions {#sec-19-csr-40-62.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.010}

(Moved to 19 CSR 30-62.010)

19 CSR 40-62.022 Exemption of Day Care Facilities {#sec-19-csr-40-62.022 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.022}

(Moved to 19 CSR 30-62.022)

19 CSR 40-62.032 Organization and Administration {#sec-19-csr-40-62.032 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.032}

(Moved to 19 CSR 30-62.032)

19 CSR 40-62.042 Initial Licensing Information {#sec-19-csr-40-62.042 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.042}

(Moved to 19 CSR 30-62.042)

19 CSR 40-62.052 License Renewal {#sec-19-csr-40-62.052 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.052}

(Moved to 19 CSR 30-62.052)

19 CSR 40-62.082 Physical Requirements of Group Day Care Homes and Day Care Centers {#sec-19-csr-40-62.082 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.082}

(Moved to 19 CSR 30-62.082)

19 CSR 40-62.092 Furniture, Equipment and Materials {#sec-19-csr-40-62.092 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.092}

(Moved to 19 CSR 30-62.092)

19 CSR 40-62.102 Personnel {#sec-19-csr-40-62.102 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.102}

(Moved to 19 CSR 30-62.102)

19 CSR 40-62.112 Staff/Child Ratios {#sec-19-csr-40-62.112 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.112}

(Moved to 19 CSR 30-62.112)

19 CSR 40-62.122 Medical Examination Reports {#sec-19-csr-40-62.122 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.122}

(Moved to 19 CSR 30-62.122)

19 CSR 40-62.132 Admission Policies and Procedures {#sec-19-csr-40-62.132 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.132}

(Moved to 19 CSR 30-62.132)

19 CSR 40-62.142 Nighttime Care {#sec-19-csr-40-62.142 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.142}

(Moved to 19 CSR 30-62.142)

19 CSR 40-62.152 Hourly Care Facilities {#sec-19-csr-40-62.152 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.152}

(Moved to 19 CSR 30-62.152)

19 CSR 40-62.162 Overlap Care of Children {#sec-19-csr-40-62.162 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.162}

(Moved to 19 CSR 30-62.162)

19 CSR 40-62.172 Emergency School Closings {#sec-19-csr-40-62.172 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.172}

(Moved to 19 CSR 30-62.172)

19 CSR 40-62.182 Child Care Program {#sec-19-csr-40-62.182 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.182}

(Moved to 19 CSR 30-62.182)

19 CSR 40-62.192 Health Care {#sec-19-csr-40-62.192 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.192}

(Moved to 19 CSR 30-62.192)

19 CSR 40-62.202 Nutrition and Food Service {#sec-19-csr-40-62.202 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.202}

(Moved to 19 CSR 30-62.202)

19 CSR 40-62.212 Transportation and Field Trips {#sec-19-csr-40-62.212 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.212}

(Moved to 19 CSR 30-62.212)

19 CSR 40-62.222 Records and Reports {#sec-19-csr-40-62.222 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.222}

(Moved to 19 CSR 30-62.222)

19 CSR 40-62.230 Variance Request {#sec-19-csr-40-62.230 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.230}

(Moved to 19 CSR 30-62.230)

19 CSR 40-62.240 Review and Appeal Process for Licensed Facilities {#sec-19-csr-40-62.240 omnilex-key=us-mo-regs-official--title-19--19 CSR 40-62.240}

(Rescinded March 30, 1996)

MATTBLUNT(6/30/98)*

Chapter 62óLicensing Rules for Group Day Care Homes and Child Day Care Centers19 CSR 40-62

History

AUTHORITY: section 210.221.1(3), RSMo Supp. 1993. Emergency rule filed Aug. 27, 1993, effective Sept. 5, 1993, expired Jan. 2, 1994. Emergency rule filed Jan. 4, 1994, effective Jan. 14, 1994, expired May 13, 1994. Original rule filed Aug. 27, 1993, effective April 9, 1994. Rescinded: Filed Sept. 12, 1995, effective March 30, 1996.

Division 45 Division of Nutritional Health and Services

Chapter 5 Food and Nutrition Programs

19 CSR 45-5.010 Special Supplemental Food Program for Women, Infants and Children (WIC) ments for agencies participating in the Special Supplemental Food Program for Women, Infants and Children. {#sec-19-csr-45-5.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 45-5.010}

(1) Each Women, Infants and Children (WIC) program shall provide supplemental food, nutrition education and health care referral to eligible pregnant, breastfeeding and postpartum women, eligible infants and children up to five (5) years of age. Eligibility shall be based on inadequacy of income using the guidelines in 19 CSR 40-1.040(2) and assessed nutritional risk.

(2) Each WIC program shall follow the requirements of 7 CFR 246.1ñ246.28 in administering the program.

History

AUTHORITY: section 192.005.2, RSMo 1986. This rule was previously filed as 19 CSR 40-5.010. Original rule filed Jan. 14, 1993, effective July 8, 1993. Moved to 19 CSR 45-5.010, effective May 1, 2003. Original authority: 192.005.2, RSMo 1985.

19 CSR 45-5.020 State Funding for Extended Hours of the Special Supplemental Food Program for Women, Infants and Children (WIC) Clinics {#sec-19-csr-45-5.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 45-5.020}

PURPOSE: This rule establishes the procedures to be used by the Department of Health to award grants to local health units for extending clinic hours.

(1) The following definitions shall be used in the interpretation and enforcement of this

rule:

(A) County health unit means any entity approved by Department of Health to provide Women, Infants and Children (WIC) services in a given service area;

(B) County poverty level means the economic level of a county as determined by use of the most recent United States census and the poverty income guidelines of 19 CSR 40- 1.040(2).

(C) Participation means the sum of the number of pregnant and postpartum women, infants and children up to five (5) years of age who have received WIC supplemental food vouchers and the number of exclusively breastfed infants in the program during the reporting period.

(2) The following procedures shall be used by the Department of Health when determining which county health units will receive grants authorized by section 191.807, RSMo:

(A) All grants shall be awarded October 1 each year;

(B) County health units desiring to apply for a grant shall request an application from the Department of Healthís WIC bureau;

(D) Grants shall be evaluated by a committee of three (3) persons appointed by the director of the Department of Healthís Division of Maternal, Child and Family Health;

(E) There shall be a maximum of ten thousand dollars ($10,000) for each grant; and (F) Applicants shall be chosen based on the county poverty level and the percent of eligible women and children not served in the county.

History

AUTHORITY: section 191.807, RSMo Supp. 1992. This rule was previously filed as 19 CSR 40-5.020. Original rule filed Jan. 14, 1993, effective July 8, 1993. Moved to 19 CSR 45-5.020, effective May 1, 2003. Original authority: 191.807, RSMo 1992.

19 CSR 45-5.050 Child and Adult Care Food Program (CACFP) ments for agencies participating in the Child and Adult Care Food Program. Through this program nutritious food service is provided to children and adult participants in nonresidential institutions that provide care. {#sec-19-csr-45-5.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 45-5.050}

(1) Sponsoring organizations of day care homes can request all, part, or no administrative advance payment when they submit an annual application for participation in the Child and Adult Care Food Program (CACFP).

(2) Section 708(f) of Public Law 104-193, the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) states that it is beyond the authority of the United States Department of Agriculture (USDA) to require state agencies to continue to make advances to CACFP institutions, including administrative advances to sponsoring organizations of day care homes. Instead, state agencies are now given the option to issue advances. This rule outlines criteria that will be used by the Missouri Department of Health (MDOH) to issue administrative advances for sponsoring organizations of day care homes.

(3) The MDOH will review and approve advance payments for those sponsoring organizations that can demonstrate good program performance which includes, but is not limited to, financial accountability and meal quality with emphasis on proper fund management.

(A) If approved, the advance payment will be issued as specified in 7 CFR 226.6(b)(10), which is hereby incorporated by reference and made a part of this rule.

(B) If the request for advance payment is denied, the sponsoring organization will be provided with a written explanation and will be given an opportunity to appeal as specified in 7 CFR 226.6(k), which is hereby incorporated by reference and made a part of this

rule.

(4) Sponsoring organization means a public or nonprofit private organization which is MATTBLUNT(5/31/03)*

Chapter 5óFood and Nutrition Programs19 CSR 45-5 4CODE OF STATE REGULATIONS (5/31/03)* MATTBLUNT 19 CSR 45-5óDEPARTMENT OF HEALTH AND SENIOR SERVICES Division 45óDivision of Nutritional Health and Services approved by MDOH for administering the CACFP in one (1) or more day care homes.

(5) Each Child and Adult Care Food Program shall follow all other requirements which can be found in 7 CFR 226.1ñ226.27, which is hereby incorporated by reference and made a

part of this rule.

Original rule filed Jan. 14, 1993, effective July 8, 1993. Rescinded and readopted: Filed April 16, 1999, effective Oct. 30, 1999.

Amended: Filed: April 14, 2000, effective Oct. 30, 2000. Moved to 19 CSR 45-5.050, effective May 1, 2003. *Original authority: 192.006, RSMo 1993, amended 1995; and 192.025, RSMo 1951.

History

AUTHORITY: sections 192.006, RSMo Supp. 1999 and 192.025, RSMo 1994. This rule was previously filed as 19 CSR 40-5.050.

19 CSR 45-5.060 Summer Food Service Program (SFSP) for Children ments for agencies participating in the Summer Food Service Program. Through this program nutritious food service is provided to children from needy areas during periods when area schools are closed for the summer months and at other approved times. {#sec-19-csr-45-5.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 45-5.060}

(1) Each Summer Food Service Program (SFSP) shall follow the requirements of 7 CFR 225.1ñ225.20 for administering the program.

(2) Service institutions, as defined in section 191.810, RSMo, that want to participate in the SFSP shall apply to the Department of Health. Applications received will be processed in accordance with the standards in 7 CFR 225.6.

(3) School food authorities in needy areas, as defined in section 191.810, RSMo, who do not wish to sponsor the SFSP and are in areas where no other service institution is offering the SFSP, shall apply for a waiver as required in 5 CSR 30-680.070.

History

AUTHORITY: section 191.810, RSMo Supp. 1992. This rule was previously filed as 19 CSR 40-5.060. Original rule filed Jan. 14, 1993, effective July 8, 1993, Moved to 19 CSR 45-5.060, effective May 1, 2003. Original authority: 191.810, RSMo 1992.

Division 50 Division of Injury Prevention, Head Injury Rehabilitation and Local Health Services

Chapter 1 * - moved to 19 CSR 10-3

19 CSR 50-1.010 Loan Program for Medical Students {#sec-19-csr-50-1.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-1.010}

(Moved to 19 CSR 10-3.010)

19 CSR 50-1.020 Funding of the Programs to Increase General and Family Physician Training Opportunities {#sec-19-csr-50-1.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-1.020}

(Moved to 19 CSR 10-3.020)

19 CSR 50-1.030 Medical School Loan Repayment Program {#sec-19-csr-50-1.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-1.030}

(Moved to 19 CSR 10-3.030)

Rebecca McDowell Cook (6/30/98)

Chapter 2 * - moved to 19 CSR 10-6

19 CSR 50-2.010 Nurse Loan and Nurse Loan Repayment Programs {#sec-19-csr-50-2.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-2.010}

(Moved to 19 CSR 10-6.010)

Rebecca McDowell Cook (7/31/98)

Chapter 3 Legal Expense Fund Coverage

19 CSR 50-3.010 Volunteer Health Care Workers in a School {#sec-19-csr-50-3.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-3.010}

19 CSR 50-3.020 Volunteer Health Care Workers in a Health Department AND SENIOR SERVICES LOCAL HEALTH SERVICES SERVICES Injury Rehabilitation and Local Health Services {#sec-19-csr-50-3.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-3.020}

19 CSR 50-3.010 Volunteer Health Care Workers in a School {#sec-19-csr-50-3.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-3.010}

(Rescinded August 30, 2018)

History

AUTHORITY: section 105.711, RSMo Supp. 1993. Original rule filed May 2, 1994, effective Oct. 30, 1994. Rescinded: Filed Jan. 5, 2018, effective Aug. 30, 2018.

19 CSR 50-3.020 Volunteer Health Care Workers in a Health Department {#sec-19-csr-50-3.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-3.020}

(Rescinded August 30, 2023)

History

AUTHORITY: section 105.711, RSMo Supp. 1993. Original rule filed May 2, 1994, effective Oct. 30, 1994. Rescinded: Filed Jan. 23, 2023, effective Aug. 30, 2023.

19 CSR 50-3.030 Legal Expense Fund Coverage {#sec-19-csr-50-3.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-3.030}

PURPOSE: This rule defines terms, prescribes contract procedures, and procedures for documentation of care provided under paragraphs (b), (c), (d), (e), and (f) of subdivision (3) of subsection 2 of section 105.711, RSMo.

(1) Definitions. The following definitions shall be used in the interpretation and enforcement of this rule:

(A) Child care means all physician child health services provided to a child for a condition or conditions that occurred or arose out of pregnancy or childbirth;

(B) Community health clinic means a nonprofit community health center qualified as exempt from federal taxation under Section 501(c)(3) of the Internal Revenue Code of 1987, as amended, that provides primary care and preventive health services to people without health insurance coverage;

(D) Federally funded community health center means a federally funded community health center organized under

Section 315, 329, 330, or 340 of the Public Health Services Act (42 U.S.C. Section 216, 254c);

(E) Health care provider refers to any nurse, physician assistant, dental hygienist, dentist, or other health care professional licensed or registered under Chapter 330, 331, 332, 334, 335, 336, 337, or 338, RSMo, who provides health care services within the scope of his or her license or registration;

(F) Health care refers to any health or dental care provided by any physician or health care provider within the scope of his or her license or registration;

(G) Health department refers to a city or county health department organized under Chapter 192, RSMo, or Chapter 205, RSMo, or a city health department operating under a city charter, or a combined city-county health department;

(H) Nonprofit community health center means a nonprofit community health center qualified as exempt from federal taxation under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended;

(I) Physician refers to any physician licensed to practice medicine in the state of Missouri under the provisions of

Chapter 334, RSMo, who provides care within the scope of his or her license;

(J) Pregnancy means all medical care given by a physician during the course of pregnancy for any condition related to pregnancy including the postpartum period sixty (60) days, including all medical care for any pregnancy-related condition for which treatment was begun during that pregnancy and postpartum period until resolution of that condition is reached;

(K) Primary care and preventive health care services means any essential health or dental care of a noninvasive nature except that injections, the suturing of minor lacerations and incisions of boils or superficial abscesses are permitted.

Obstetrical care and other specialized care or treatment are not included;

(L) School includes public, private, or parochial elementary or secondary school;

(M) State Legal Expense Fund refers to the fund created by

section 105.711, RSMo; and (N) Summer camp means a summer camp as defined by

section 210.201, RSMo.

(2) Scope of Coverage. This regulation applies to payment of any claim or any amount required by any final judgment rendered by a court of competent jurisdiction against individuals qualifying for State Legal Expense Fund Coverage under section 105.711.2(3)(b)-(f), RSMo.

(3) Contract Procedures. A physician or health care provider who provides services as described in this rule shall enter into a written agreement with the health department, federally funded community health center, nonprofit entity, nonprofit community health center, community health clinic, school, or summer camp through which the physician or health care provider is employed, contracted, affiliated or associated with, receives referrals, or otherwise provides services described in this rule. This agreement shall include, at a minimum:

(A) The physician’s or health care provider’s name, address, place of employment, if any, daytime telephone number, and professional license or registration number or similar identifier;

(B) The physician or health care professional is assigned or referred patients under procedures adopted by the health department, federally funded community health center, nonprofit entity, nonprofit community health center, community health clinic, school, or summer camp;

(C) The physician or health care provider has no preexisting caregiver patient relationship with any patient under which a fee has been collected or contracted for;

(D) The patient is informed in writing, at the outset of any care that no fee will be charged, sought, or accepted for care regardless of the outcome of care, except as otherwise allowed by section 105.711, RSMo;

(E) The physician or health care provider does not discriminate in providing health care on the basis of race, sex, religion, national origin, or ethnic background;

(F) Neither the physician or health care provider or the health department, federally funded community health center, nonprofit entity, nonprofit community health center, community health clinic, school, or summer camp receives, or contracts for the receipt of a fee, donation or contribution of money, goods, services or any other thing of value in any way related to the health care provided, except as otherwise allowed by section 105.711, RSMo;

(G) No other individual or entity, other than the patient and his or her heirs or assigns and beneficiaries, receives anything of value in any way related to the health care services provided at or through the health department, federally (7/31/23) John R. Ashcroft HEAD INJURY REHABILITATION AND 19 CSR 50-3—DEPARTMENT OF HEALTH LOCAL HEALTH SERVICES AND SENIOR SERVICES funded community health center, nonprofit entity, nonprofit community health center, community health clinic, school, or summer camp;

(H) No health care services shall be provided to a child under the age of eighteen (18) years old without the express written permission of the child’s parent or legal guardian.

(4) Documentation of Care Provided.

(A) Each physician or health care provider who provides care as described in this rule shall annually during the month of June provide to the department— 1. The physician or health care provider’s name, address, and day-time telephone number;

A copy of the physician or health care provider’s license, registration, or authority to act or other evidence that the physician or health care provider may lawfully practice in Missouri;
A copy of any contract(s) or agreement(s) as described in section (2) of this rule to which the physician or health care provider is a party;
If services described in this rule are provided without compensation through a nonprofit community health center, a copy of the nonprofit community health center’s federal tax exemption letter or other verification of tax-exempt status under Section 501(c)(3) of the Internal Revenue Code; and 5. An approximate breakdown of the hours per year of health care services provided, as described in this rule, including:

A. The entities through which the health care services were provided during the previous twelve (12) months;

B. The inclusive dates of service provided through each entity; and C. The approximate number of hours and approximate number of patients for whom services were provided through each entity during the previous twelve (12) months.

(B) Physicians and health care providers providing health care services as described in this rule shall maintain records of the care provided in a manner consistent with relevant state and federal laws and regulations.

History

AUTHORITY: section 105.711, RSMo 2016. Original rule filed Jan. 23, 2023, effective Aug. 30, 2023. Original authority: 105.711, RSMo 1983, amended 1987, 1989, 1990, 1993, 1995, 1999, 2004, 2005, 2007, 2008, 2009, 2013, 2014.

19 CSR 50-3.040 Voluntary Health Services {#sec-19-csr-50-3.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-3.040}

PURPOSE: This rule explains how health care providers and sponsoring organizations may register with the department for liability coverage under the Voluntary Health Services Act. This

rule also explains the procedure for the department to revoke a registration.

(1) Definitions. The following definitions shall be used in the interpretation and enforcement of this rule:

(A) Department refers to the Department of Health and Senior Services;

(B) Health care provider or provider refers to any physician, surgeon, dentist, nurse, optometrist, mental health professional licensed under Chapter 337, RSMo, veterinarian, or other practitioner of a health care discipline, the professional practice of which requires licensure or certification under Missouri law or under comparable law of another state, territory, district, or possession of the United States;

(C) Sponsoring organization refers to any organization that organizes or arranges for the voluntary provision of health care services and registers with the department as a sponsoring organization in accordance with this rule and section 191.1106, RSMo; and (D) Voluntary provision of health care services refers to the providing of professional health care services by a health care provider without charge to a recipient of the services or a third party. The provision of such health care services shall be the provider’s professional practice area in which the provider is licensed or certified.

(2) Duties of Sponsoring Organizations.

(A) Annual Registration. Before providing volunteer health services in Missouri, a sponsoring organization shall register with the department and pay the annual registration fee.

The sponsoring organization shall submit annually the Registration Form for Sponsoring Organizations, Revised 2023, which is incorporated by reference in this rule as published by the Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102-0570 and available by the department at https://health.mo.gov/atoz/volunteerhealthservices/pdf/ AnnualRegistrationForm.pdf. This rule does not incorporate any subsequent amendment or additions.
Upon any change in the information required by the Registration Form for Sponsoring Organizations, the sponsoring organization shall notify the department in writing of such change within thirty (30) days of occurrence.
The sponsoring organizations shall submit the registration fee annually with the Registration Form for Sponsoring Organizations. The registration fee shall be fifty dollars ($50). This amount does not include any additional fees which may be charged for use of electronic payment services.
The sponsoring organization’s registration begins upon the date the department acknowledges receipt of the completed Registration Form for Sponsoring Organizations and registration fee. The registration is valid for one (1) year.
A sponsoring organization that wishes to voluntarily terminate its registration may do so by notifying the department in writing. Unless otherwise stated in the request, the sponsoring organization’s registration will be terminated effective the date the written request is received by the department. The sponsoring organization’s annual fee will not be prorated or refunded in any manner as a result of voluntary termination.

(B) Quarterly Reports.

The sponsoring organization shall submit quarterly a Quarterly Report Form for Sponsoring Organizations, Revised 2022, which is incorporated by reference in this rule as published by the Department of Health and Senior Services, PO Box 570, Jefferson City, MO 65102-0570 and available by the department at https://health.mo.gov/atoz/volunteerhealthservices/pdf/ SponsoringOrganizationQuarterlyReport.pdf. This rule does not incorporate any subsequent amendment or additions.

AND SENIOR SERVICES LOCAL HEALTH SERVICES

Information submitted on the Quarterly Report Form shall correspond to one of the following quarters: January– March, April – June, July–September, or October–December.

For a period of at least five (5) years following the provision of health care services, the sponsoring organization shall maintain on file – A. Information, including the date, place, and type of services provided; and B. A list of health care providers associated with its provision of voluntary health care services. For each such health care provider, the sponsoring organization shall maintain a copy of a current license, certificate, or statement of exemption from licensure or certification, or in the event that the health care provider is currently licensed in the state of Missouri, a copy of the health care provider’s license verification obtained from a state-sponsored website, if available. For the purposes of this paragraph, “current” shall be interpreted to mean current at the time services were provided.
Records shall be furnished upon request to any regulatory board of healing arts profession established under state law.

(4) Revocation of Registration. The department may revoke the registration of any sponsoring organization that fails to comply with the requirements of this rule.

(A) If the department proposes to revoke the registration of a sponsoring organization, the department shall provide the organization with written notice of the proposed revocation, including the specific reason why the revocation is being revoked.

(B) The sponsoring organization may appeal the proposed revocation. Such appeal shall be submitted in writing to the department no later than fifteen (15) days from the date of the notice of proposed revocation. The appeal shall include any information and/or documentation that the sponsoring organization would like the department to consider in making its final determination.

(C) The department shall notify the sponsoring organization of its final decision regarding the proposed revocation in writing no later than thirty (30) days from the date of the notice of proposed revocation. This determination shall be a final agency decision.

(D) The sponsoring organization’s annual fee will not be prorated or refunded in any manner as a result of revocation.

History

AUTHORITY: section 191.1106, RSMo 2016. Original rule filed Jan. 23, 2023, effective Aug. 30, 2023. Original authority: 191.1106, RSMo 2013.

Chapter 4 * - moved to 19 CSR 10-4

19 CSR 50-4.010 Primary Care Resource Initiative for Missouri (PRIMO) Program {#sec-19-csr-50-4.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-4.010}

(Moved to 19 CSR 10-4.010)

19 CSR 50-4.020 J-1 Visa Waiver Program {#sec-19-csr-50-4.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-4.020}

(Moved to 19 CSR 10-4.020)

Rebecca McDowell Cook (6/30/98)

Chapter 10 Missouri Rehabilitation Center (rescinded)

19 CSR 50-10.010 Standard Means Test for Patients {#sec-19-csr-50-10.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-10.010}

(Rescinded August 30, 2018)

Filed Jan. 5, 2018, effective Aug. 30, 2018.

History

AUTHORITY: section 192.005.2., RSMo 1986. Original rule filed Oct. 3, 1986, effective Dec. 26, 1986. Amended: Filed Nov. 26, 1991, effective April 9, 1992. Rescinded:

19 CSR 50-10.020 Patient Rights Regarding Health Care Decisions {#sec-19-csr-50-10.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-10.020}

(Rescinded August 30, 2018)

JOHNR. ASHCROFT(7/31/18)

History

AUTHORITY: section 192.005.2., RSMo 1986. Original rule filed Jan. 15, 1993, effective July 8, 1993. Rescinded: Filed Jan. 5, 2018, effective Aug. 30, 2018.

Chapter 20 Head Injury Program

19 CSR 50-20.010 Service Providers {#sec-19-csr-50-20.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 50-20.010}

PURPOSE: This rule establishes the eligibility requirements and responsibilities of head injury service providers.

Therefore, the material which is so incorporated is on file with the agency who filed this

(1) Any person, organization or agency wishing to provide services shall apply to the Office of Head Injury Services (OHIS).

Interested individuals or facilities shall meet eligibility criteria outlined in the Provider Manual published by the Missouri Department of Health, Head Injury Program, June 1993. OHIS shall notify providers of application approval or disapproval and shall make contractual agreements with facilities approved to provide services.

(2) Approved providers shall agree to accept the amounts established by OHIS as payments in full.

(A) If a provider receives payment from any source other than the OHIS which is equal to or exceeds the amount of the program fee schedule for the authorized services rendered, the provider shall not accept any additional amount from either the client or the program. Claims shall be submitted to any third-party payer (see 19 CSR 40- 1.010(22)) before submitting a claim to the OHIS.

(B) Approved providers shall submit bills on forms prescribed by the OHIS and within the billing time limits stated in the Provider Manual. Unless the provider receives a waiver of the time limit from the program administrator or designee, failure to comply with the time limits may result in denial of the claim.

(C) The OHIS shall reimburse for services only if a prior written authorization request has been approved. That request completed by the provider shall include a plan of care and assurance that the client/family participated in the plan and agree.

(3) Sanctions shall be imposed by the OHIS against a provider for any one (1) or more of the following reasons:

(A) The provider knowingly and willfully makes or causes to be made any false statement or misrepresentation of a material fact by presenting or causing to be presented for payment under OHIS any false or fraudulent claim of services or merchandise; submits or causes to be submitted false information for the purpose of obtaining compensation greater than that for which the provider is legally entitled; submits or causes to be submitted false information for the purpose of meeting prior approval status; or submits a false or fraudulent application for provider status;

(B) The provider fails to provide and maintain quality services which meet professionally recognized standards of care;

(D) The provider is convicted of a criminal offense relating to performance of a provider agreement with the state or for a negligent or abusive practice resulting in the death or injury of a client;

(E) The provider fails to meet licensure or certification standards for participation as a given type of provider;

(F) The provider solicits, charges or receives payments for services for which the provider has billed OHIS;

(G) The provider is indicted for fraudulent billing practices or for negligent practice resulting in physical, emotional or psychological injury or death to the providerís client; or (H) The provider fails to repay or to make arrangements for the repayment of identified overpayments or other erroneous payments.

(4) One (1) or more of the following sanctions may be invoked against a provider for any violation listed in section (3) of this rule: termination from participation in OHIS; suspension from participation in OHIS; suspension or withholding of payments; or referral for investigation to the State Board of Registration for the Healing Arts or other appropriate state licensing agency.

Chapter 20óHead Injury Program19 CSR 50-20 4CODE OF STATE REGULATIONS (1/29/03) MATTBLUNT 19 CSR 50-20óDEPARTMENT OF HEALTH ANDDivision 50óDivision of Injury Prevention, Head Injury Rehabilitation SENIOR SERVICESand Local Health Services

Chapter 20óHead Injury Program19 CSR 50-20 6CODE OF STATE REGULATIONS (1/29/03) MATTBLUNT 19 CSR 50-20óDEPARTMENT OF HEALTH AND Division 50óDivision of Injury Prevention, Head Injury Rehabilitation SENIOR SERVICESand Local Health Services

History

AUTHORITY: sections 199.001 and 199.003, RSMo Supp. 1991 and 199.009, RSMo Supp. 1993. Original rule filed Feb. 2, 1994, effective July 30, 1994. Original authority: 199.001 and 199.003, RSMo 1991 and 199.009, RSMo 1991, amended 1993.

Division 60 Missouri Health Facilities Review Committee

Chapter 50 Certificate of Need Program

19 CSR 60-50.010 State Health Planning and Development Agency (SHPDA) {#sec-19-csr-60-50.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.010}

19 CSR 60-50.020 Missouri Health Facilities Review Committee {#sec-19-csr-60-50.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.020}

19 CSR 60-50.030 Review of Health Projects Under SSA-1122 Program {#sec-19-csr-60-50.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.030}

19 CSR 60-50.040 Definitions Relating to Certificate of Need {#sec-19-csr-60-50.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.040}

19 CSR 60-50.041 Information Added to CN Application {#sec-19-csr-60-50.041 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.041}

(Rescinded November 30, 1994) .. 3

19 CSR 60-50.100 Public Hearings, Reconsideration Hearings {#sec-19-csr-60-50.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.100}

19 CSR 60-50.150 Criteria and Written Findings for Review of Certificate of Need SERVICES Committee {#sec-19-csr-60-50.150 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.150}

19 CSR 60-50.010 State Health Planning and Development Agency (SHPDA) {#sec-19-csr-60-50.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.010}

Rescinded: Filed July 3, 1989, effective Jan. 12, 1990.

History

AUTHORITY: section 197.310, RSMo 1986. This rule previously filed as 13 CSR 60-1.010 and 19 CSR 30-50.010. Emergency rule filed Nov. filed Sept. 11, 1980, effective April 2, 1981. Emergency rescission filed July 3, 1989, effective July 13, 1989, expired Nov. 9, 1989.

19 CSR 60-50.011 Certificate of Need (CN) Definitions {#sec-19-csr-60-50.011 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.011}

Rescinded: Filed June 2, 1994, effective Nov. 30, 1994.

History

AUTHORITY: sections 197.318, RSMo Supp. 1992 and 197.320, RSMo 1986. Emergency rule filed July 3, 1989, effective July 13, 1989, expired Nov. 9, 1989. Original rule filed July 3, 1989, effective Jan. 12, 1990. Amended: Filed Feb. 4, 1993, effective July 8, 1993.

19 CSR 60-50.020 Missouri Health Facilities Review Committee {#sec-19-csr-60-50.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.020}

Emergency rescission filed July 3, 1989, effective July 13, Jan. 12, 1990.

History

AUTHORITY: sections 197.310 and 197.320, RSMo 1986. This rule was previously filed as 13 CSR 60-1.020 and 19 CSR 30-50.020.

19 CSR 60-50.021 CN Program Administration {#sec-19-csr-60-50.021 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.021}

rule filed July 3, 1989, effective Jan. 12, 1990. Amended: Filed Nov. 16, 1990, effective June 10, 1991. Amended: Filed April 6, 1992, effective Sept. 6, 1992. Emergency amendment filed July 30, 1992, effective Aug. 9, 1992, expired Dec. 6, 1992. Amended: Filed July 30, 1992, effective April 8, 1993. Amended: Filed April 14, 1993, effective Oct. 10, 1993. Rescinded: Filed June 2, 1994, effective Nov. 30, 1994.

19 CSR 60-50.030 Review of Health Projects Under SSA-1122 Program {#sec-19-csr-60-50.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.030}

rule was previously filed as 13 CSR 60-2.010 and 19 CSR 30-50.030.

Emergency rescission filed July 3, 1989, effective July 13, Jan. 12, 1990.

History

AUTHORITY: sections 197.305(2), 197.310(1)6, 197.320 and 536.043, RSMo 1986, P.L. 9-603, 42 U.S.C. 1320a-1; 42 CFR 100; 42 CFR 122, 42 CFR 123 and section 1122 of the Federal Social Security Act. This

19 CSR 60-50.031 Certificate of Need (CN) Applications {#sec-19-csr-60-50.031 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.031}

rule filed July 3, 1989, effective Jan. 12, 1990. Amended: Filed Jan. 3, 1990, effective March 26, 1990. Amended: Filed Nov. 16, 1990, effective July 8, 1991. Emergency amendment filed July 30, 1992, effective Aug. 9, 1992, expired Dec. 6, 1992. Amended: Filed July 14, 1992, effective April 8, 1993. Amended: Filed July 30, 1992, effective April 8, 1993. Amended: Filed Feb. 4, 1993, effective July 8, 1993.

Rescinded: Filed June 2, 1994, effective Nov. 30, 1994.

19 CSR 60-50.040 Definitions Relating to Certificate of Need {#sec-19-csr-60-50.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.040}

April 1, 1981. Original rule filed Sept. 11, 1980, effective April 2, 1981.

Amended: Filed: Oct. 19, 1983, effective May 11, 1984. Emergency 1989. Rescinded: Filed July 3, 1989, effective Jan. 12, 1990.

History

AUTHORITY: sections 197.305 and 197.320, RSMo 1986. This rule was previously filed as 13 CSR 60-3.010 and 19 CSR 30-50.040.

19 CSR 60-50.041 Information Added to CN Application filed July 3, 1989, effective Jan. 12, 1990. Emergency amendment filed July 30, 1992, effective Aug. 9, 1992, expired Dec. 6, 1992. {#sec-19-csr-60-50.041 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.041}

Amended: Filed July 30, 1992, effective April 8, 1993. Rescinded:

Filed June 2, 1994, effective Nov. 30, 1994.

19 CSR 60-50.050 Certificate of Need Necessary {#sec-19-csr-60-50.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.050}

Emergency rescission filed July 3, 1989, effective July 13, 1989, expired Nov. 9, 1989. Rescinded: Filed July 3, 1989, effective Jan. 12, 1990.

History

AUTHORITY: sections 197.315.1, 197.315.7, 197.315.12, 197.315.14, 197.320 and 197.340, RSMo 1986. This rule was previously filed as 13 CSR 60-3.020 and 19 CSR 30-50.050. Emergency rule Nov. filed Sept. 11, 1980, effective April 2, 1981. Emergency amendment filed Feb. 9, 1983, effective March 1, 1983, expired June 28, 1983.

19 CSR 60-50.051 Information on MHFRC Meetings {#sec-19-csr-60-50.051 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.051}

rule filed July 3, 1989, effective Jan. 12, 1990. Amended: Filed Nov. 16, 1990, effective June 10, 1991. Emergency amendment filed July 30, 1992, effective Aug. 9, 1992, expired Dec. 6, 1992. Amended:

(10/31/24) John R. Ashcroft Filed July 30, 1992, effective April 8, 1993. Rescinded: Filed June 2, 1994, effective Nov. 30, 1994.

19 CSR 60-50.060 Waiver of Certificate of Need {#sec-19-csr-60-50.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.060}

Emergency rescission filed July 3, 1989, effective July 13, Jan. 12, 1990.

History

AUTHORITY sections 197.320 and 197.330(9), RSMo 1986. This rule was previously filed as 13 CSR 60-3.030 and 19 CSR 30-50.060.

19 CSR 60-50.061 Certificate of Need Decisions filed July 3, 1989, effective Jan. 12, 1990. Amended: Filed Nov. 16, 1990, effective June 10, 1991. Emergency amendment filed July 30, 1992, effective Aug. 9, 1992, expired Dec. 6, 1992. Amended: Filed July 14, 1992, effective April 8, 1993. Amended: Filed July 30, 1992, effective April 8, 1993. Rescinded: Filed June 2, 1994, effective Nov. 30, 1994. {#sec-19-csr-60-50.061 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.061}

19 CSR 60-50.070 Issuance and Penalties {#sec-19-csr-60-50.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.070}

History

AUTHORITY: sections 197.315.2, 197.315.3, 197.315.4, 197.315.5, 197.315.6 and 197.320, RSMo 1986. This rule was previously filed as

13 CSR 60-3.040 and 19 CSR 30-50.070. Emergency rule filed Nov. filed Sept. 11, 1980, effective April 2, 1981. Emergency rescission filed July 3, 1989, effective July 13, 1989, expired Nov. 9, 1989. {#sec-13-csr-60-3.040 omnilex-key=us-mo-regs-official--title-19--13 CSR 60-3.040}

Rescinded: Filed July 3, 1989, effective Jan. 12, 1990.

19 CSR 60-50.071 Post-Decision Review filed July 3, 1989, effective Jan. 12, 1990. Amended: Filed Nov. 16, 1990, effective June 10, 1991. Amended: Filed Feb. 4, 1993, effective July 8, 1993. Rescinded: Filed June 2, 1994, effective Nov. 30, 1994. {#sec-19-csr-60-50.071 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.071}

19 CSR 60-50.080 Certificate of Need Application Process {#sec-19-csr-60-50.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.080}

History

AUTHORITY: sections 197.315.8, 197.315.10, 197.320, 197.325, 197.330(1), 197.330(3), 197.330.4, 197.330.5 and 197.330.6, RSMo 1986. This rule was previously filed as 13 CSR 60-3.050 and 19 CSR 30-50.080. Emergency rule filed Nov. 20, 1980, effective Dec. 1, 1980, expired April 1, 1981. Original rule filed Sept. 11, 1980, effective April 2, 1981. Emergency rescission filed July 3, 1989, effective July 13, 1989, expired Nov. 9, 1989. Rescinded: Filed July 3, 1989, effective Jan. 12, 1990.

19 CSR 60-50.081 Criteria and Standards filed July 3, 1989, effective Jan. 12, 1990. Amended: Filed March 16, 1990, effective June 28, 1990. Amended: Filed July 17, 1990, effective Dec. 31, 1990. Amended: Filed Nov. 16, 1990, effective June 10, 1991. Amended: Filed April 6, 1992, effective Sept. 6, 1992. Emergency amendment filed July 30, 1992, effective Aug. 9, 1992, expired Dec. 6, 1992. Amended: Filed July 14, 1992, effective April 8, 1993. Amended: Filed July 30, 1992, effective April 8, 1993. {#sec-19-csr-60-50.081 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.081}

Amended: Filed April 14, 1993, effective Oct. 10, 1993. Rescinded:

Filed June 2, 1984, effective Nov. 30, 1994.

19 CSR 60-50.090 Nonsubstantive Review {#sec-19-csr-60-50.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.090}

Emergency rescission filed July 3, 1989, effective July 13, Jan. 12, 1990.

History

AUTHORITY: sections 197.320 and 197.330(3), RSMo 1986. This rule was previously filed as 13 CSR 60-3.060 and 19 CSR 30-50.090.

19 CSR 60-50.100 Public Hearings, Reconsideration Hearings {#sec-19-csr-60-50.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.100}

rule was previously filed as 13 CSR 60-3.070 and 19 CSR 30-50.100.

Emergency rescission filed July 3, 1989, effective July 13, Jan. 12, 1990.

History

AUTHORITY: sections 197.320 and 197.330(3), RSMo 1986. This

19 CSR 60-50.110 Appeals {#sec-19-csr-60-50.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.110}

Emergency rescission filed July 3, 1989, effective July 13, Jan. 12, 1990.

History

AUTHORITY sections 197.320 and 197.335, RSMo 1986. This rule was previously filed as 13 CSR 60-3.080 and 19 CSR 30-50.110.

19 CSR 60-50.120 Annual Report, Public Access {#sec-19-csr-60-50.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.120}

Original rule filed Sept. 11, 1980, effective April 2, 1981. Emergency 1989. Rescinded: Filed July 3, 1989, effective Jan. 12, 1990.

History

AUTHORITY: section 197.320, RSMo 1986. This rule was previously filed as 13 CSR 60-3.090 and 19 CSR 30-50.120. Emergency rule filed Nov. 20, 1980, effective Dec. 1, 1980, expired April 1, 1981.

19 CSR 60-50.130 Forfeiture of Certificate {#sec-19-csr-60-50.130 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.130}

Emergency rescission filed July 3, 1989, effective July 13, Jan. 12, 1990.

History

AUTHORITY: sections 197.315.9 and 197.320, RSMo 1986. This rule was previously filed as 13 CSR 60-3.100 and 19 CSR 30-50.130.

19 CSR 60-50.140 Adoption of Criteria {#sec-19-csr-60-50.140 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.140}

This rule was previously filed as 13 CSR 60-3.100 and 19 CSR 30- 50.140. Emergency rule filed Nov. 20, 1980, effective Dec. 1, 1980, expired April 1, 1981. Original rule filed Sept. 11, 1980, effective April 2, 1981. Emergency rescission filed July 3, 1989, effective July 13, 1989, expired Nov. 9, 1989. Rescinded: Filed July 3, 1989, effective Jan. 12, 1990.

History

AUTHORITY: sections 197.300–197.365 and 536.043, RSMo 1986.

19 CSR 60-50.150 Criteria and Written Findings for Review of Certificate of Need Applications {#sec-19-csr-60-50.150 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.150}

April 1, 1981. Original rule filed Sept. 11, 1980, effective April 2, 1981.

Amended: Filed May 3, 1988, effective Aug. 11, 1988. Emergency 1989. Rescinded: Filed July 3, 1989, effective Jan. 12, 1990.

History

AUTHORITY: sections 197.315 and 197.320, RSMo 1986. This rule was previously filed as 13 CSR 60-4.010 and 19 CSR 30-50.150.

19 CSR 60-50.200 Purpose and Structure {#sec-19-csr-60-50.200 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.200}

PURPOSE: This rule describes the purpose of the Certificate of Need (CON) statute and the structure of the Missouri Health Facilities Review Committee.

(1) The Certificate of Need (CON) statute, sections 197.300– 197.366, RSMo, became effective September 28, 1979, except those sections which were not effective until October 1, 1980 or later. CON had its origin in the federal Public Law 93-641, 1974, and was initially intended to address issues of need, cost, and distribution of health services, as well as other factors which impact the health of the population.

(2) The purpose of the CON statute is to achieve the highest level of health for Missourians through cost containment, reasonable access, and public accountability. The goals are to— (A) Review proposed health care services;

(B) Contain health costs;

(D) Evaluate competing interests;

(E) Prevent unnecessary duplication; and (F) Disseminate health-related information to affected parties.

(3) The CON statute is administered by the nine (9)-member Missouri Health Facilities Review Committee (committee). Five (5) members are appointed by the governor, two (2) by the president pro tem of the senate, and two (2) by the speaker of the house, each serving two (2)-year terms or until replaced.

(4) On behalf of the committee, the CON Program provides technical and administrative services as shown in rule 19 CSR 60-50.900.

History

AUTHORITY: section 197.320, RSMo 2000. Original rule filed June 1998. Emergency rescission and rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Amended: Filed Oct. 1, 2010, effective May 30, 2011.

19 CSR 60-50.300 Definitions for the Certificate of Need Process {#sec-19-csr-60-50.300 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.300}

PURPOSE: This rule defines the terms used in the Certificate of Need (CON) review process.

(1) Affiliate means an organization— (A) That owns five percent (5%) or more of the ownership interests in the operator; or (B) In which the operator owns five percent (5%) or more of the ownership interests. Affiliates include, without limitation, a parent organization, joint venture, partner, or general partner.

(2) Applicant means all owner(s) and operator(s) of any new institutional health service.

(3) By or on behalf of a health care facility includes any expenditures made by the facility itself as well as capital expenditures made by other persons that assist the facility in offering services to its patients/residents.

(4) Cost means— (A) Price paid or to be paid by the applicant for a new institutional health service to acquire, purchase, or develop a health care facility or major medical equipment; or (B) Fair market value of the health care facility or major medical equipment as determined by the current selling price at the date of the application as quoted by builders or architects for similar facilities, or normal suppliers of the requested equipment; or (C) Fair market value of the existing land(s) and building(s) to be converted as determined by the current selling price at the date of the application or a current appraisal.

(5) Construction of a new hospital means the establishment of a newly licensed facility at a specific location under the Hospital Licensing Law, section 197.020.2, RSMo, as the result of building, renovation, modernization, and/or conversion of any structure not licensed as a hospital.

(6) Expedited application means a shorter than full application and review period as defined in 19 CSR 60-50.420 and 19 CSR 60- 50.430 for any long-term care replacement as defined in section 197.318, RSMo, long-term care renovation and modernization, or the replacement of any major medical equipment as defined in section (13) of this rule.

(7) Full review means the complete analytical period for applications as described in 19 CSR 60-50.420 and 19 CSR 60-50.430 for the development of health care facilities and acquisition of major medical equipment.

(8) Generally accepted accounting principles pertaining to capital expenditures include, but are not limited to— (A) Expenditures related to acquisition or construction of capital assets;

(B) Capital assets are investments in property, plant, and equipment used for the production of other goods and services approved by the committee; and (C) Land is not considered a capital asset until actually converted for that purpose with commencement of aboveground construction approved by the committee.

(9) Health care facility means those described in section 197.366, RSMo.

(10) Health care facility expenditure includes the capital value of new construction or renovation costs, architectural/ engineering fees, equipment not in the construction contract, land acquisition costs, consultants’/legal fees, interest during construction, predevelopment costs as defined in section 197.305(12), RSMo, in excess of one hundred fifty thousand dollars ($150,000), any existing land and building converted to the applicant’s medical use for the first time, and any other capitalizable costs incurred over a twelve- (12-) month period as listed on the “Proposed Project Budget” (Form MO 580-1863), included herein.

(11) LTC bed expansion review means a facility licensed pursuant to Chapter 198, RSMo, may increase its licensed bed capacity by submitting a Letter of Intent documenting the expansion, certification from the Department of Health and Senior Services and health facilities review committee that the requesting facility has had no patient care class I deficiencies within the last eighteen (18) months, and has maintained a ninety-percent (90%) average occupancy rate for the previous six (6) quarters as shown by CON’s most recent Six-Quarter Occupancy of Intermediate Care and Skilled Nursing Facility (or Residential Care and Assisted Living Facility) Licensed Beds only report published on the CON website.

(12) Health maintenance organizations means entities as defined in section 354.400(10), RSMo, except for activities directly related to the provision of insurance only.

(13) Major medical equipment means any piece of equipment and collection of functionally related devices acquired to operate the equipment and additional related costs such as software, shielding, and installation acquired over a twelve- (12-) month period with an aggregate cost of one (1) million dollars or more, when the equipment is intended to provide the following diagnostic or treatment services and related variations, including but not limited to— (A) Cardiac catheterization;

(B) Computed tomography;

(D) Lithotripsy;

(E) Magnetic resonance imaging;

(F) Linear accelerator;

(G) Positron emission tomography/computed tomography; or (H) Evolving technology.

(14) Major medical equipment to be replaced shall mean a piece of existing and operational equipment, if applicable. If the existing equipment to be replaced has not operated in over twelve (12) months, a CON application for new equipment must be made if the project cost is one (1) million dollars or more.

(15) Non-applicability review means a Letter of Intent process to document that a CON is not needed for a proposal when the capital expenditure is less than the expenditure minimum in section 197.305(6), RSMo; the proposal is to increase the number of beds by ten (10) or ten percent (10%) of total bed capacity, whichever is less, over a two- (2-) year period since any long-term care beds were last licensed, the facility has had no resident care class I deficiencies within the last eighteen (18) months and has maintained at least an eighty-five percent (85%) average occupancy rate for the previous six (6) quarters as shown by CON’s most recent Six-Quarter Occupancy of Intermediate Care and Skilled Nursing Facility (or Residential Care and Assisted Living Facility) Licensed Beds report published on the CON website, and the capital expenditure is less than the expenditure minimum in section 197.305(6), RSMo; an exemption or exception is found in accordance with

section 197.312, RSMo; or the proposal meets the definition of a non-substantive project.

(16) Nonsubstantive project includes but is not limited to at least one (1) of the following situations:

(A) An expenditure which is required solely to meet federal or state requirements or involves predevelopment costs or the development of a health maintenance organization;

(B) The construction or modification of nonpatient care services, including parking facilities, sprinkler systems, heating or air-conditioning equipment, fire doors, food service equipment, building maintenance, administrative equipment, telephone systems, energy conservation measures, land acquisition, medical office buildings, and other projects or functions of a similar nature; or (C) Expenditures for construction, equipment, or both, due to an act of God or a normal consequence of maintenance, but not replacement, of health care facilities, beds, or equipment.

(17) Offer, when used in connection with health services, means that the applicant asserts having the capability and the means to provide and operate the specified health services.

(18) Predevelopment costs mean expenditures as defined in

section 197.305(12), RSMo, including consulting, legal, architectural, engineering, financial, and other activities directly related to the proposed project, but excluding the application fee for submission of the application for the proposed project.

(19) “Request to relicense,” a health care facility licensed under

Chapter 197 or Chapter 198 that ceases offering health services may seek verification to relicense the facility within twelve (12) months from the date of closure under the same general licensure conditions at the time the facility ceased offering health services. Beds must be relicensed in the same category of care at the time of closure and cannot exceed the licensed bed capacity at the time of closure.

(20) For new hospitals or major medical equipment projects, service area means a geographic region made up of an area such as a county or contiguous areas such as a set of contiguous counties or zip codes, appropriate to the proposed service, documented by the applicant and approved by the committee. For long-term care projects, the fifteen- (15-) mile radius calculation must be used.

Emergency amendment filed Oct. 20, 1998, effective Oct. 30, 1998, expired April 27, 1999. Amended: Filed Oct. 20, 1998, effective April 30, 1999. Amended: Filed Jan. 4, 2000, effective July 30, 2000. Emergency rescission and rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Emergency rescission and rule filed Dec. 16, 2002, effective Jan. 1, 2003, expired June 29, 2003. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Amended: Filed April 12, 2004, effective Nov. 30, 2004.

Emergency amendment filed Aug. 14, 2006, effective Aug. 28, 2006, expired Feb. 23, 2007. Amended: Filed Aug. 14, 2006, effective March 30, 2007. Amended: Filed Oct. 1, 2010, effective May 30, 2011. Amended: Filed Aug. 9, 2019, effective March 30, 2020.

Amended: Filed June 29, 2022, effective Jan. 30, 2023. Amended:

Filed Aug. 19, 2025, effective April 30, 2026.

19 CSR 60-50.310 Guidelines for Specific Health Services {#sec-19-csr-60-50.310 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.310}

(Rescinded June 30, 2002)

Amended: Filed Oct. 19, 1999, effective May 30, 2000. Emergency rescission filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded: Filed Dec. 14, 2001, effective June 30, 2002.

History

AUTHORITY: section 197.320, RSMo Supp. 1999. Emergency rule filed Aug. 29, 1997, effective Sept. 8, 1997, expired March 6, 1998. Original rule filed Aug. 29, 1997, effective March 30, 1998.

19 CSR 60-50.400 Letter of Intent Process {#sec-19-csr-60-50.400 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.400}

PURPOSE: This rule delineates the process for submitting a Letter of Intent to begin the Certificate of Need (CON) review process and outlines the projects subject to CON review.

(1) Applicants shall submit by mail, fax, or email a Letter of Intent (LOI) to begin the Certificate of Need (CON) review process so that it is received at the CON office at least thirty (30) days prior to the submission of the CON application and will remain valid for six (6) months.

(2) Once filed, a LOI may be amended, except for project address, not later than ten (10) days in advance of the CON application filing, or it may be withdrawn at any time without prejudice.

(3) A long-term care (LTC) bed replacement sought pursuant to section 197.318, RSMo, requires a CON application if the capital expenditure for such bed replacement exceeds six hundred thousand dollars ($600,000) but allows for shortened information requirements and review time frames.

(4) The Certificate of Need Program (CONP) staff, as an agent of the Missouri Health Facilities Review Committee (committee), will review LOIs according to the following provisions:

(A) Major medical equipment is reviewed as an expenditure on the basis of cost, regardless of owners or operators, or location (mobile or stationary);

(B) The CONP staff shall test the LOI for applicability in accordance with statutory provisions for expenditure minimums, exemptions, and exceptions;

(C) If the test verifies that a statutory exception or exemption is met on a proposed project, or the proposed cost is below all applicable expenditure minimums, the committee chair may issue a Non-Applicability CON letter indicating the application review process is complete; otherwise, the CONP staff shall add the proposal to a list of Non-Applicability proposals to be considered at the next regularly scheduled committee meeting;

(D) If an exception or exemption is not verified, and if the proposal is above any applicable expenditure minimum, then a CON application will be required for the proposed project;

(E) A Non-Applicability CON letter will be valid subject to the following conditions:

Any change in the project scope, including change in type of service, cost, operator, ownership, or site, could void the effectiveness of the letter and require a new review; and 2. Final project costs with third-party verification must be provided on a Periodic Progress Report (Form MO 580-1871), included herein; and (F) A CON application must be made if— 1. The project involves the development of a new hospital costing one (1) million dollars or more, except for a facility licensed under Chapter 197, RSMo, meeting the requirements described in 42 CFR, section 412.23(e);
The project involves the acquisition or replacement of major medical equipment in any setting not licensed under

Chapter 198, RSMo, costing one (1) million dollars or more;

The project involves the acquisition or replacement of major medical equipment for a health care facility licensed under Chapter 198, RSMo, costing four hundred thousand dollars ($400,000) or more;
The project involves the acquisition of any equipment or beds in a long-term care hospital meeting the requirements found in 42 CFR section 412.23(e) at any cost;
The project involves a capital expenditure for renovation or modernization, but not additional beds, by or on behalf of an existing health care facility licensed under Chapter 198, RSMo, costing six hundred thousand dollars ($600,000) or more;
The project involves additional LTC (licensed or certified residential care facility, assisted living facility, intermediate care facility, or skilled nursing facility) beds licensed under

Chapter 198, RSMo, that either— A. Costs six hundred thousand dollars ($600,000) or more; or B. Exceeds ten (10) beds or ten percent (10%) of that facility’s existing licensed bed capacity, whichever is less.

The project involves the development of a new LTC facility (licensed or certified residential care facility, assisted living facility, intermediate care facility, or skilled nursing facility) licensed under Chapter 198, RSMo, costing six hundred thousand dollars ($600,000) or more.

(5) Nonsubstantive projects are waived from review by the authority of section 197.330.1(8), RSMo, and any applicant seeking such a determination shall submit information through the LOI process. A project meeting the definition of a nonsubstantive project shall be posted for review on the CON website at least twenty (20) days in advance of the committee meeting when the project is scheduled to be confirmed by the committee.

Amended: Filed Nov. 15, 1995, effective April 30, 1996. Emergency amendment filed Nov. 26, 1996, effective Dec. 6, 1996, expired June 3, 1997. Emergency rescission filed Aug. 29, 1997, effective Sept. 8, 1997, expired March 6, 1998. Emergency rule filed Aug. 29, 1997, effective Sept. 8, 1997, terminated Sept. 21, 1997. Emergency rule filed Sept. 11, 1997, effective Sept. 21, 1997, expired March 19, 1998.

Emergency rescission and rule filed June 29, 1999, effective July 9, 1999, expired Jan. 5, 2000. Rescinded and readopted: Filed June 29, 1999, effective Jan. 30, 2000. Emergency rescission and

rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Emergency amendment filed Dec. 16, 2002, effective Jan. 1, 2003, expired June 29, 2003. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Amended: Filed April 12, 2004, effective Nov. 30, 2004. Emergency amendment filed Aug.

Oct. 1, 2010, effective May 30, 2011. Amended: Filed Aug. 9, 2019, Jan. 30, 2023. Amended: Filed Aug. 19, 2025, effective April 30, 2026.

History

AUTHORITY: section 197.320, RSMo 2016. Original rule filed June 2, 1994, effective Nov. 30, 1994. Emergency amendment filed Nov. 16, 1995, effective Nov. 26, 1995, expired May 23, 1996.

19 CSR 60-50.410 Letter of Intent Package {#sec-19-csr-60-50.410 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.410}

PURPOSE: This rule provides the information requirements and the details for how to complete the Letter of Intent package to begin the Certificate of Need (CON) review process.

(1) The Letter of Intent (LOI) (Form MO 580-1860), included herein, shall be completed as follows:

(A) Project Information: sufficient information to identify the intended service, such as the name of the existing or proposed facility, whichever is applicable, and address or if address is unknown or not yet established, a specific description or the latitude and longitude identifying a specific site rather than a general area (county designation alone is not sufficient);

(B) Applicant Identification: the full legal name of all owner(s) and operator(s) which compose the applicant who, singly or jointly, propose to develop, offer, lease, or operate a new institutional health service within Missouri; provide the corporate entity, not individual names, of the corporate board of directors or the facility administrator;

(C) Type of Review: the applicant shall indicate if the review is for a full review, expedited review, non-applicability review, or a long-term care (LTC) bed expansion review pursuant to

section 197.318, RSMo;

(D) Project Description: information which provides details of the number and type of beds to be added, removed, or replaced, square footage of new construction and/or renovation, services affected, and equipment to be acquired. If a replacement project, information which provides details of the facilities or equipment to be replaced, including name, location, distance from the current site, and its final disposition. If replacing equipment previously approved, provide the CON project number of existing equipment;

(E) Estimated Project Cost: total proposed expenditures necessary to achieve the application’s objectives—not required for LTC bed expansions pursuant to section 197.318, RSMo;

(F) Authorized Contact Person Identification: the full name, title, address (including association), telephone number, email, fax number, signature, and date of signature; and (G) Applicability: page 2 of the LOI must be filled out by applicants requesting a non-applicability review or LTC bed expansion pursuant to section 197.318, RSMo, to provide the reason and rationale for the non-applicability or LTC bed expansion review request.

(2) If a non-applicability review is sought, the applicant shall submit the following additional information:

(A) Proposed Expenditures (Form MO 580-2375), included herein;

(B) Information which details all methods and assumptions used to estimate project costs. Documentation of costs may be requested;

(D) Evidence of submission of architectural plans to the Division of Regulation and Licensure Engineering Consultation Unit, Department of Health and Senior Services, for long-term care projects and other facilities; and (E) In addition to the above information, for exceptions or exemptions, documentation of other provisions in compliance with the Certificate of Need (CON) statute, as described in sections (7) through (8) below of this rule.

(3) If a LTC bed expansion review is sought pursuant to

section 197.318, RSMo, the applicant shall submit the following additional information:

(A) Purchase Agreement (Form MO 580-2352 included herein); and (B) Schematic drawings and evidence of site control, with appropriate documentation.

(4) When an LOI for a LTC bed expansion review pursuant to

section 197.318, RSMo, is filed, the Certificate of Need Program (CONP) staff shall immediately review that facility’s average licensed bed occupancy for the most recent six (6) consecutive calendar quarters, and request certification that the requesting facility had no patient care Class I deficiencies within the last eighteen (18) months from the Division of Regulation and Licensure (DRL), Department of Health and Senior Services, through a LTC Facility Expansion Certification (Form MO 580- 2351, included herein), to verify compliance with occupancy and deficiency requirements pursuant to section 197.318.4(1), RSMo. Occupancy data shall be taken from the CON’s most recent Six-Quarter Occupancy of Intermediate Care and Skilled Nursing Facility (or Residential Care and Assisted Living Facility) Licensed Beds only report published on the CON website.

(5) For a LTC bed expansion review pursuant to section 197.318, RSMo, the sellers and purchasers shall be defined as the owner(s) and operator(s) of the respective facilities, which includes building, land, and license. On the Purchase Agreement (Form MO 580-2352 included herein), both the owner(s) and operator(s) of the purchasing and selling facilities shall sign.

(6) Upon staff verification that the statutory requirements described in sections (3) through (5) above in this rule are satisfied, staff will notify the applicant and request the applicant to submit either— (A) If an agreement is reached by the selling and purchasing entities, a copy of the selling facility’s reissued license verifying surrender of beds sold; or (B) If no agreement is reached by the selling and purchasing entities and effort(s) to purchase have been unsuccessful, Purchase Agreement Form(s) (MO 580-2352 included herein), and additional documentation verifying unsuccessful effort(s) to purchase.

(7) If an exemption is sought for a residential care or assisted living facility (RCF/ALF) pursuant to section 197.312, RSMo, the applicant shall submit documentation that this facility had previously been owned or operated for or on behalf of St. Louis C ity.

(8) The LOI must have an original signature for the contact person, which can be an electronic signature.

LETTER OF INTENT

Project Information (Attach additional pages as necessary to identify multiple project sites.)

Title of Proposed Project (Name of existing or proposed facility) County Project Address (Street/City/State/Zip Code or Latitude and Longitude with City/State/Zip Code if no assigned address)

Applicant Identification (Attach additional pages as necessary to lis t all owners and operators.)

List Al l Owner(s): (Li st corporate entity.) Address (Street/City/State/Zip Code) Telephone Number List Al l Operator(s): (List entity to be licensed or certified.) Address (Street/City/State/Zip Code) Telephone Number 3. Type of Review 4. Project Description (Information should be brief but sufficient to understand scope of project.)

Full Review:

New Hospital New/Add LTC Beds* New/Add LTCH Beds/Eqpt.

New/ Additional Equipment Expedited Review: 6-mile RCF/ALF Replacement 15-mile LTC Replacement 30-mile LTC Replacement LTC Renov./Modernization Equipment Replacement previously approved Non-Applicability Review:

(See 7. Applicability next page)

LTC Bed Expansion Review (See 8. LTC Bed Expansion next page)

Include the number and type of long-term care beds to be added (RCF/ALF/ICF/SNF/LTCH), replaced, removed, or purchased, square footage of new construction and/or renovation, services affected, and major medical equipment to be acquired or replaced. If replacing equipment previously approved, provide the CON project number of th e existing equipment. If replacing or purchasing long-term care beds, include the facility name the beds are being replaced or purchased from. If requesting a non-applicability or LTC bed expansion CON letter, also complete the ne xt page of this form.

Key: LTC = Long-Term Care; LTCH = Long-Term Care Hospital; RCF/ALF = Residential Care Facility/Assisted Living Facility SNF/ICF = Skilled Nursing Facility/Intermediate Care Facility 5. Estimated Project Cost: $ 6. Authorized Contact Person Identification (List only one person who would be the main contact person for the project)

Name of Contact Person Title Contact Person Address (Company/Street/City/State/Zip Code)

Telephone Number Fax Number E-mail Address Signature of Contact Person Date of Signature MO 580-1860 (03/2026)

LETTER OF INTENT

Applicability (Check the box below to indicate th e rationale for the exemption or waiver being sought.)

A Proposed Expenditure form (MO 580-2375) is required even if the project cost is “$0”.

If proposed expenditures are less than the minimums in §197.305(6), attach supporting documentation to illustrate how each of those amounts were determined, such as schematic drawings, equipment quotes, and contractor estimates. §197.305(9)(e) for additional long te rm care beds in the same category (certified as RCF/ALF, IC F or SNF) in a RCF/ALF, nursing home, or acute care hospital costing less th an $600,000, and are 10 beds or 10% of th at facility’s existing capacity, whichever is less. The facility must have had no patient care class I deficiencies within the last 18 months and has maintained at least an 85% average occupancy rate for the previous 6 quarters.

If the proposal meets one of the exemptions or exceptions below, then check the appropriate box, and attach detailed documentation substantiating compliance with the statutory provisions as set out in

Rule 19 CSR 60-50.410: §197.312 for an RCF/ALF previously owned and operated by the city of St . Louis; or If the proposal meets the definition of “nonsubstantive projects” in §197.305(10) and 19 CSR 60-50.300(13) for a waiver from review, complete both pages of this form as the first step in the process, and provide the rationale as to why the proposal should be deemed to be “nonsubstantive” in the space below.

If the proposal meets th e definition of “purchase” or “replacement” in §197.318(4) and 19 CSR 60-50.450(4) for an exception from review, complete both pages of this form, and provide the rationale in the space below, including attached schematics and other documentation as to why the proposal should be deemed to be “nonapplicable”.

LTC Bed Expansion (Provide the items outlined below.)

If a LTC bed expansion review is sought pursuant to section §197.318, RSMo, the applicant shall submit the following additional information:

(A) Purchase Agreement (Form MO 580-2352);

(B) Schematic drawings and evidence of site control, with appropriate documentation.

Upon CON staff verification that the statutory requirements are met described in section 197.318, RSMo, CON staff will notify the applicant and request the applicant to submit either:

(A) If an agreement is reached by the selling and purchasing entities, provide a copy of the selling facility’s reissued license verifying surrender of beds sold; or (B) If no agreement is reached by the selling and purchasing entities and effort(s) to purchase have been unsuccessful, provide Purchase Agreement Form(s) (MO 580-2352), and additional documentation verifying unsuccessful effort(s) to purchase.

MO 580-1860 (03/2026)

LTC Facility Expansion CERTIFICATION by the Division of Regulation and Licensure (DRL)

Part I: Facility Information (check RCF/ALF for residential care and assisted living facility Number and Type of Beds: or ICF/SNF for intermediate care and skilled nursing facility)

Project Number:

Part II : Quarterly RCF/ALF/ICF/SNF Bed Occupancy Rate Occupancy statistics for this facility for the most recent si x consecutive calendar quarters prior to the LOI da te shown above:

(circle appropriate quarter, insert the Calendar Year (CY), and complete information below)

Qtr 1 2 3 4 CY_____: % Qtr 1 2 3 4 CY: % Qtr 1 2 3 4 CY: % Qtr 1 2 3 4 CY: % Qtr 1 2 3 4 CY: % Qtr 1 2 3 4 CY: % Six-quarter average:__ % For expansion through the purchase of beds, based on the DRL Quarterly Survey Data, the 90% bed occupancy requirement has been met.

For expansion through the addition of beds, ba sed on the DRL’s Quarterly Survey Data, the 92% bed occupancy requirement has been met for under 40 LTC beds, or 93% for 40 bed or more LTC beds (see above).

Part III : Deficiencies For expansion through the purchase or addition of beds, ba sed on the DRL’s annual facility survey, the above-named facility has not had any final Class I patient care deficiencies during the past 18 months.

Part IV: Certification of Information Statement: The above information is an accurate representation of the findings by the DRL in accordance with appropriate CON rules.

Signature:

MO 580-2351 (07/09) ∆

PURCHASE AGREEMENT

Part 1: Purchasing Facility Information Number/Type of Licensed Beds:

(Check RCF/ALF for residential care and assisted living facility or ICF/SNF for intermediate care and skilled nursing facility.)

Part II: Selling Facility Information Number/Type Licensed Beds:

(Check RCF/ALF for residential care and assisted living facility or ICF/SNF for intermediate care and skilled nursing facility.)

Part III: Value of Consideration Monetary Value of Purchase: $ No./Type Beds:

Terms of Purchase:

(Add more pages as necessary to describe the sale.)

Part IV: Certification of Information Yes No The above Purchaser and Seller have agreed to these purchase terms.

Purchaser Signature:

Seller(s) Signature(s):

MO 580‐2352 (05/12)

Aug. 29, 1997, effective Sept. 8, 1997, expired March 6, 1998.

Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Emergency rescission and rule filed Dec. 16, 2002, effective Jan. 1, 2003, expired June 29, 2003. Amended: Filed June 9, 2003, effective Nov. 30, 2003. Emergency amendment filed Aug. 14, 2006, effective Aug. 28, 2006, expired Feb. 23, 2007. Amended: Filed Aug. 14, 2006, effective March 30, 2007. Amended: Filed Oct. 1, 2010, effective May 30, 2011. Amended: Filed March 10, 2014, effective Oct. 30, 2014. Amended: Filed Aug. 9, 2019, effective March 30, 2020. Amended: Filed June 29, 2022, effective Jan. 30, 2023.

Amended: Filed Aug. 19, 2025, effective April 30, 2026.

19 CSR 60-50.420 Review Process {#sec-19-csr-60-50.420 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.420}

PURPOSE: This rule delineates the process for submitting a Certificate of Need (CON) application for a CON review.

(1) The Certificate of Need (CON) filing deadlines are as follows:

(A) For full applications, at least seventy-one (71) days but not more than one hundred (100) days prior to each Missouri Health Facilities Review Committee (committee) meeting;

(B) For expedited applications, the tenth day of each month, or the next business day thereafter if that day is a holiday or weekend;

(2) A CON application filing that does not substantially conform with the LOI, including any change in owner(s), operator(s), or scope of services, shall not be considered a CON application and shall be subject to the following provisions:

(A) The Certificate of Need Program (CONP) staff shall return any nonconforming submission; or (B) The committee may issue an automatic denial unless the applicant withdraws the attempted application.

(3) All filings must be received at the principal office of the committee during regular business hours. The CONP staff, as an agent of the committee, shall provide notification of applications received through publication of the Application Review Schedule (schedule) as follows:

(A) For full and expedited applications, the schedule shall include the filing date of the application, a brief description of the proposed service, the time and place for filing comments and requests for a public hearing, and the tentative date of the meeting at which the application is scheduled for review.

Publication of the schedule shall occur within two (2) business days after the filing deadline. The publication of the schedule is conducted through the following actions:

The schedule shall be submitted to the secretary of state’s office for publication in the next regularly scheduled Missouri Register;
The schedule shall be posted on the CON website; and 3. The schedule shall be emailed to all affected persons who have registered with the CONP staff as having an interest in such CON applications; and (B) For non-applicability reviews, the listing of nonapplicability letters to be confirmed shall be posted on the CON website at least twenty (20) days prior to each scheduled meeting of the committee where confirmation is to take place.

(4) The CONP staff shall review CON applications relative to the Criteria and Standards in the order filed. If a full application has met all Criteria and Standards, and is not contested within thirty (30) days after filing, then its review may be conducted according to the expedited application process.

(5) If an application is incomplete, the CONP staff shall notify the applicant in writing or by email within fifteen (15) calendar days of filing a full application or within five (5) working days of filing an expedited application.

(6) Verbal information or testimony shall not be considered

part of the application.

(7) Subject to statutory time constraints, the CONP staff shall post its written analysis on the CON website and immediately notify the committee of the posting by mail or email as follows:

(A) For full CON applications, the CONP staff shall post the analysis and immediately notify the committee at least twenty (20) days in advance of the first committee meeting following the seventieth day after the CON application is filed. The written analysis of the CONP staff shall be sent to the applicant no less than fifteen (15) days before the meeting;

(B) For expedited applications which meet all statutory and rules requirements and which have no opposition, the CONP staff shall send its written analysis to the committee and the applicant within two (2) working days following the expiration of the thirty- (30-) day public notice waiting period or the date upon which any required additional information is received, whichever is later; and (C) Expedited applications which do not meet all statutory and rules requirements or those which have opposition will be considered at the earliest scheduled committee meeting where the written analysis by the CONP staff can be sent to the committee and the applicant at least seven (7) days in advance.

(8) See rule 19 CSR 60-50.600 for a description of the CON decision process which shall apply to all face-to-face, videographic, telephonic, computerized, and other meeting venues.

(9) An applicant may withdraw an application without prejudice by written notice by mail or email at any time prior to the committee’s decision. Later submission of the same application or an amended application shall be handled as a new application with a new fee.

(10) In addition to using the Community Need Criteria and Standards as guidelines, the committee may also consider other factors to include, but not be limited to, the needs of residents based upon religious considerations, residents with HIV/AIDS, or mental health diagnoses, and special exceptions to the Community Need Criteria and Standards.

Aug. 29, 1997, effective Sept. 8, 1997, expired March 6, 1998.

Emergency amendment filed Dec. 16, 2002, effective Jan. 1, 2003, expired Jan. 29, 2003. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Amended: Filed Oct. 1, 2010, effective May 30, 2011. Amended: Filed March 10, 2014, effective Oct. 30, 2014. Amended: Filed Aug. 9, 2019, effective March 30, 2020.

Amended: Filed June 29, 2022, effective Jan. 30, 2023.

19 CSR 60-50.430 Application Package {#sec-19-csr-60-50.430 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.430}

PURPOSE: This rule provides the information requirements and the application format for how to complete a Certificate of Need (CON) application for a CON review.

(1) A Certificate of Need (CON) application package shall be accompanied by an application fee which shall be a nonrefundable minimum amount of one thousand dollars ($1,000) or one-tenth of one percent (0.1%), which may be rounded up to the nearest dollar, of the total project cost, whichever is greater, made payable to the “Missouri Health Facilities Review Committee.”

(2) A written application package consisting of an electronic file in PDF format or a paper original shall be prepared and organized as follows:

(A) The CON Applicant’s Completeness Checklists and Table of Contents shall be used as follows:

Include at the front of the application;
Check the appropriate “done” boxes to assure completeness of the application;
Number all pages of the application sequentially and indicate the page numbers in the appropriate blanks;
Check the appropriate “N/A” box if an item in the Review Criteria is “not applicable” to the proposal type; and 5. Restate the Review Criteria (preferably in bold type) and answer all Review Criteria items;

(B) The application package shall be based on one (1) of the following CON Applicant’s Completeness Checklists and Table of Contents appropriate to the proposed project type, as 1. New Hospital Application (Form MO 580-2501 included herein). Use this for a new or replacement hospital project;

New or Additional Long-Term Care (LTC) Bed Application (Form MO 580-2502 included herein). Use this form for a Residential Care Facility project, Assisted Living Facility project, Intermediate Care Facility project, or Skilled Nursing Facility project or Long-Term Care Hospital project;
New or Additional Long-Term Care Hospital (LTCH) Bed Application (also use Form MO 580-2502 included herein);
New or Additional Equipment Application (Form MO 580-2503 included herein);
Expedited LTC Bed Replacement Application (Form MO 580-2504 included herein);
Expedited LTC Renovation/Modernization Application (Form MO 580-2505 included herein); or 7. Equipment Replacement Application (Form MO 580- 2506 included herein);

Divider I. Application Summary;
Divider II. Proposal Description;
Divider III. Service-Specific Criteria and Standards; and 4. Divider IV. Financial Feasibility (only required for full applications or expedited replacement equipment applications which do not currently hold a valid CON);

(D) Support information shall be included at the end of each

section to which it pertains, and shall be referenced in the

section narrative. For applicants anticipating having multiple applications in a year, master file copies of such things as maps, population data (if applicable), board memberships, IRS Form 990, or audited financial statements may be submitted once, and then referred to in subsequent applications, as long as the information remains current;

(E) The application package shall document the need or meet the additional information requirements in 19 CSR 60- 50.450(4)–(5) for the proposal by addressing the applicable Community Need Criteria and Standards using the standards in 19 CSR 60-50.440 through 19 CSR 60-50.460 plus providing additional documentation to substantiate why any proposed alternative Criteria and Standards should be used.

(3) An Application Summary shall be composed of the completed forms in the following order:

(A) Applicant Identification and Certification (Form MO 580- 1861 included herein). Additional specific information about board membership may be requested, if needed.

Provide documentation from the Missouri Secretary of State that the proposed owner(s) and proposed operator(s) are registered to do business in Missouri.
For new or additional long-term care bed and new hospital projects— A. State if the license of the proposed operator or any previous five (5) years;

B. If the license of the proposed operator or any affiliate of the proposed operator has been revoked within the previous five (5) years, provide the name and address of the facility whose license was revoked;

C. State if the Medicare and/or Medicaid certification of any facility owned or operated by the proposed operator or any previous five (5) years; and D. If the Medicare and/or Medicaid certification of any facility owned or operated by the proposed operator or any affiliate of the proposed operator has been revoked within the previous five (5) years, provide the name and address of the facility whose Medicare and/or Medicaid certification was revoked;

(B) A completed Representative Registration (Form MO 580- 1869 included herein), for the contact person and any others as required by section 197.326.1, RSMo;

(C) A detailed Proposed Project Budget (Form MO 580-1863 included herein); and (D) An attachment which details how each line item was determined, including all methods and assumptions used. If a third-party vendor or contractor was used to determine costs, provide documentation of costs.

(4) The Proposal Description shall include documents which— (A) Provide a complete detailed description and scope of the project, and identify all institutional services or programs which will be directly affected by this proposal;

(B) Describe the developmental details including— 1. A timeline of anticipated events for the proposal from the time of the CON application review through project completion, including the commencement and completion of new construction or renovation, or purchase and installation of equipment;

A legible street or road map showing the exact location of the facility or health service, and a copy of the site plan showing the relation of the project to existing structures and boundaries;
Preliminary schematics for the project on an eight and one-half inch by eleven inch (8 1/2" × 11") format (not required for replacement equipment projects). The function for each space, including the location of each existing and proposed bed before and after construction or renovation, shall be clearly identified and all space shall be assigned;
Evidence of submission of architectural plans to the Division of Regulation and Licensure, Department of Health and Senior Services, for long-term care projects and other facilities (not required for equipment projects);
For long-term care proposals, existing and proposed gross square footage for the entire facility and for each institutional service or program directly affected by the project.

If the project involves relocation, identify what will go into vacated space;

Documentation that the proposed owner owns the project site, or that the proposed owner has an executed option to purchase or lease the site; and 7. Proposals which include major medical equipment shall include an equipment list with prices and also documentation in the form of bid quotes, purchase orders, catalog prices, or other sources to substantiate the proposed equipment costs;

(C) Proposals for new, additional, and replacement major medical equipment must define the community to be served and geographic service area;

(D) Proposals for new hospitals or new or additional longterm care (LTC) beds must define the community to be served— 1. Describe the service area(s) population using projected year populations provided by th e Bureau of Health Care Analysis and Data Dissemination (BHCADD), which can be obtained by contacting— Chief, Bureau of Health Care Analysis and Data Dissemination (BHCADD)

Department of Health and Senior Services PO Box 570, Jefferson City, MO 65102 Telephone: (573) 751-6272 There will be a charge for any of the information requested, and seven to fourteen (7–14) days should be allowed for a response from BHCADD. Information requests should be made to BHCADD such that the response is received at least two (2) weeks before it is needed for incorporation into the CON application;

Use the maps and population data received from BHCADD with the CON Applicant’s Population Determination Method to determine the estimated population for LTC projects, as follows:

A. Utilize all of the population for zip codes entirely within the fifteen- (15-) mile radius for LTC beds or geographic service area for hospitals and major medical equipment;

B. Reference a state highway map (or a map of greater detail) to verify population centers (see BHCADD) within each zip code overlapped by the fifteen- (15-) mile radius or geographic service area;

C. Categorize population centers as either “in” or “out” of the fifteen- (15-) mile radius or geographic service area and remove the population data from each affected zip code categorized as “out”;

D. Estimate, to the nearest five percent (5%), the portion of the zip code area that is within the fifteen- (15-) mile radius or geographic service area by “eyeballing” the portion of the area in the radius (if less than five percent (5%), exclude the entire zip code);

E. Multiply the remaining zip code population (total population less the population centers) by the percentage determined in subparagraph (4)(D)2.D. (Due to numerous complexities, population centers will not be utilized to adjust overlapped zip code populations in Jackson, Clay, St. Louis, and St. Charles counties or St. Louis City; instead, the total population within the zip code will be considered uniform and multiplied by the percentage determined in subparagraph (4)

(D)2.D.);

F. Add back the population center(s) “inside” the radius or region for zip codes overlapped; and G. The sum of the estimated zip codes, plus those entirely within the radius, will equal the total population within the fifteen- (15-) mile radius or geographic service area;

Provide other statistics, such as studies, patient origin, or discharge data, Hospital Industry Data Institute’s information, or consultants’ reports, to document the size and validity of any proposed user-defined “geographic service area”;

(E) Identify specific community problems or unmet needs which the proposed or expanded service is designed to remedy or meet;

(F) Provide historical utilization for each existing service affected by the proposal for each of the past three (3) full years;

(G) Provide utilization projections through at least three (3) full years beyond the completion of the project for all proposed and existing services directly affected by the project;

(H) If an alternative methodology is added, specify the method used to make need forecasts and describe in detail whether projected utilizations will vary from past trends; and (I) Provide the current and proposed number of licensed beds by type for projects which would result in a change in the licensed bed complement of the LTC facility.

(5) Document that consumer needs and preferences have been included in planning this project. Describe how consumers have had an opportunity to provide input into this specific project, and include in this section all petitions, letters of acknowledgement, support or opposition received.

(6) Document that providers of similar health services in the proposed service area have been notified of the application by a public notice in the local newspaper of general circulation before it was filed with the CON Program from the applicant.

The public notice shall include a contact person’s name and phone number and/or email for the project.

(7) For proposed full or expedited CON applications, excluding equipment replacement applications, document that administrators or directors of all affected facilities in the proposed fifteen- (15-) mile radius or service area were addressed letters regarding the application.

(8) In addition to using the Community Need Criteria and Standards as guidelines, the committee may also consider other factors to include, but not be limited to, the needs of residents based upon religious considerations, residents with HIV/AIDS, or mental health diagnoses, and special exceptions to the Community Need Criteria and Standards.

NEW HOSPITAL APPLICATION

Project Description: __ ________ __ 1. Applicant Identification and Certification (Form MO 580-1861) __ ________ __ 2. Representative Registration (From MO 580-1869) __ ________ __ 3. Proposed Project budget (Form MO 580-1863) and detail sheet with documentation of costs. __ ________ __ 4. Provide documentation from MO Secretary of State that the proposed owner(s) and operator(s) are registered to do business in MO. __ ________ __ 5. State if the license of the proposed operator or any affiliate of the proposed operator has been revoked within the _ _ ________ __ 6. If the license of the proposed operator or any affiliate of the proposed operator has been revoked within the previous 5 years, provide the name and address of the facility whose license was revoked. _ _ ________ __ 7. State if the Medicare and/or Medicaid certification of any facility owned or operated by the proposed operator or any affiliate of the proposed operator has been revoked within the previous 5 years. _ _ ________ __ 8 . If the Medicare and/or Medicaid certification of any facility owned or operated by the proposed operator or any affiliate of the proposed operator has been revoked within the previous 5 years, provide the name and address of the facility whose Medicare and/or Medicaid certification was revoked. __ ________ __ 1. Provide a complete detailed project description. __ ________ __ 2. Provide the proposed number of licensed beds by medical specialty. __ ________ __ 3. Provide a timeline of events for the project, from CON issuance through project competition. __ ________ __ 4. Provide a legible city or county map showing the exact location of the proposed facility. __ ________ __ 5 . Provide a site plan for the proposed project. __ ________ __ 6. Provide preliminary schematic drawings for the proposed project. __ ________ __ 7. Provide evidence that architectural plans have been submitted to the Department of Health and Senior Services. __ ________ __ 8. Provide the proposed square footage. __ ________ __ 9. Document ownership of the project site or provide an option to purchase. __ ________ __ 10 . Define the community to be served (service area: projected population, ar ea, rationale). __ ________ __ 11. Provide utilization projections through the first three (3) FULL years of operation of the new beds __ ________ __ 12. Identify specific community problems or unmet needs the proposal would address. __ ________ __ 13. Provide the methods and assumptions used to project utilization. __ ________ __ 14. Document that consumer needs and preferences have been included in planning this project and describe how consumers had an opportunity to provide input. __ ________ __ 15. Provide copies of any petitions, letters of support or opposition received. __ ________ __ 16. Document that providers of similar health services in the proposed service area have been notified of the application by a public notice in the local newspaper. __ ________ __ 17. Document that providers of all affected facilities in the proposed 15-mile radius were addressed letters regarding the application.

Divider III. Service Specific Criteria and Standards: __ ________ __ 1. Document the methodology utilized to determine the need for the proposed hospital. __ ________ __ 2. Provide the most recent three (3) FULL years of evidence that the average occupancy of the same type(s) of beds at each other hospital in the proposed service area exceeds eighty percent (80%). __ ________ __ 3. Discuss the impact the proposed hospital would have on utilization of other hospitals in the geographic service area. __ ________ __ 4. Document the unmet need in the geographic service area for each type of bed being proposed according to the population-based need formula Divider IV. Financial Feasibility Review Criteria and Standards: __ ________ __ 1. Document that the proposed costs per square foot are reasonable when compared to the latest “RS Means Construction Cost data” __ ________ __ 2. Document that sufficient financing is available by providing a letter from a financial institution or an auditor’s statement indicating that sufficient funds are available. __ ________ __ 3. Provide Service-Specific Revenues and Expenses (Form MO 580-1865) for the latest three (3) years, and projected through three (3) FULL years beyond project completion. __ ________ __ 4. Document how patient charges ar e derived. __ ________ __ 5. Document responsiveness to the needs of the medically indigent.

MO 580-2501 (03/26)

NEW OR ADDITIONAL LONG TERM CARE BED APPLICATION (Use for RCF/ALF, ICF/SNF and LTCH beds)

Project Name:________________________________________________________ Project No:_____________________________ Project Description:_______________________________________________________________________________________________ __ _______ __ 1. Applicant Identification and Certification (Form MO 580-1861) __ ________ __ 2. Representative Registration (From MO 580-1869) __ ________ __ 3. Proposed Project budget (Form MO 580-1863) and detail sheet with documentation of costs. __ ________ __ 4. Provide documentation from MO Secretary of State that the proposed owner(s) and operator(s) are registered to do business in MO. __ ________ __ 5. State if the license of the proposed operator or any affiliate of the proposed operator has been revoked within the __ ________ __ 6. If the license of the proposed operator or any affiliate of the proposed operator has been revoked within the previous 5 years, provide the name and address of the facility whose license was revoked. __ ________ __ 7. State if the Medicare and/or Medicaid certification of any facility owned or operated by the proposed operator or any affiliate of the proposed operator has been revoked within the previous 5 years. __ ________ __ 8. If the Medicare and/or Medicaid certification of any facility owned or operated by the proposed operator or any affiliate of the proposed operator has been revoked within the previous 5 years, provide the name and address of the facility whose Medicare and/or Medicaid certification was revoked. __ ________ __ 1. Provide a complete detailed project description. __ ________ __ 2. Provide a timeline of events for the project, from CON issuance through project competition. __ ________ __ 3. Provide a legible city or county map showing the exact location of the proposed facility. __ ________ __ 4. Provide a site plan for the proposed project. __ ________ __ 5. Provide preliminary schematic drawings for the proposed project. __ ________ __ 6. Provide evidence that architectural plans have been submitted to the Department of Health and Senior Services. __ ________ __ 7. Provide the proposed square footage. __ ________ __ 8. Document ownership of the project site, or provide an option to purchase. __ ________ __ 9. Define the community to be served. __ ________ __ 10. Provide projected population projections for the 15-mile radius service area. __ ________ __ 11. Identify specific community problems or unmet needs the proposal would address. __ ________ __ 12. Provide historical utilization for each of the past three (3) years and utilization projections through the first three (3)

FULL years of operation of the new LTC beds. __ ________ __ 13. Provide the methods and assumptions used to project utilization. __ ________ __ 14. Document that consumer needs and preferences have been included in planning this project and describe how consumers had an opportunity to provide input. __ ________ __ 15. Provide copies of any petitions, letters of support or opposition received. __ ________ __ 16. Document that providers of similar health services in the proposed service area have been notified of the application by a public notice in the local newspaper. __ ________ __ 17. Document that providers of all affected facilities in the proposed 15-mile radius were addressed letters regarding the application.

Divider III. Service Specific Criteria and Standards: __ ________ __ 1. For ICF/SNF beds, address the population-based bed need methodology of fifty-three (53) beds per one thousand (1,000) population age sixty-five (65) and older. __ ________ __ 2. For RCF/ALF beds, address the population-based bed need methodology of twenty-five (25) beds per one thousand (1,000) population age sixty-five (65) and older. __ ________ __ 3. For LTCH beds, address the population-based bed need methodology of one-tenth (0.1) bed per one thousand (1,000) population. __ ________ __ 4. Document any alternate need methodology used to determine the need for additional beds such as Alzheimer’s, mental health or other specialty beds. __ ________ __ 5. For any proposed facility which is designed and operated exclusively for persons with acquired human immunodeficiency syndrome (AIDS) provide information to justify the need for the type of beds being proposed. __ ________ __ 6. If the project is to add beds to an existing facility, has the facility received a Notice of Noncompliance within the last 18 months as a result of a survey, inspection or complaint investigation? If the answer is yes, explain.

Divider IV. Financial Feasibility Review Criteria and Standards: __ ________ __ 1. Document that the proposed costs per square foot are reasonable when compared to the latest “RS Means Construction Cost data” __ ________ __ 2. Document that sufficient financing is available by providing a letter from a financial institution or an auditor’s statement indicating that sufficient funds are available. __ ________ __ 3. Provide Service-Specific Revenues and Expenses (Form MO 580-1865) for the latest three (3) years, and projected through three (3) FULL years beyond project completion. __ ________ __ 4. Document how patient charges are derived. __ ________ __ 5. Document responsiveness to the needs of the medically indigent. __ ________ __ 6. For a proposed new skilled nursing or intermediate care facility, what percentage of your admissions would be Medicaid eligible on the first day of admission or become Medicaid eligible within 90 days of admission? __ ________ __ 7. For an existing skilled nursing or intermediate care facility, what percentage of your admissions are Medicaid eligible on the first day of admission or becomes Medicaid eligible within 90 days of admission.

MO 580-2502 (10/24)

Project Description:

Done Pa ge N/A Description � � 1. Applicant Identification and Certification (Form MO 580-1861). � � 2. Representative Registration (Form MO 580-1869). � � 3. Proposed Project Budget (Form MO 580-1863) and detail sheet with documentation of costs. � � 1. Provide a complete detailed project description. � � 2. Provide a timeline of events for the project, from the issuance of the CON through project completion. � � 3. Provide preliminary schematic drawings for the proposed project. � � 4. Prove the existing and proposed gross square footage. � � 5. Document ownership of the project site.

Divider III. Community Need Criteria and Standards:

If the proposal is to relocate RCF/ALF beds within 6-mile radius in accordance with §197.318.4(4) provide the following: � � - Documentation that all facilities involved are under the same licensure ownership or control; � � - Documentation that all facilities involved are within the 6-mile limit; and � � - Documentation that all owners and operators of the facility from which the beds are being transferred are aware of the proposal and consent to it.
If the proposal is to replace one-half of a qualifying licensed facility’s beds within a 30-mile radius in accordance with §197.318.5 provide the following: � � - Documentation that the facility has only been operating 50% of its licensed capacity with every resident residing in a private room and all vacant beds have been reported to the Division of

Regulation and Licensure as unavailable for occupancy for at least the most recent four consecutive calendar quarters; � � - Documentation that the replacement beds shall be built to private room specifications and only used for single occupancy; and � � - Documentation that the existing and proposed facilities have the same owner or owners, and that the owner or owners stipulate that the beds to be replaced shall not be used later for long term care; if the existing facility is being operated under a lease, both the lessee and owner shall stipulate the same.

If the proposal is to replace a facility in its entirety at a single site within a 15-mile radius in accordance with §197.318.6 provide the following: � � - Documentation that all facilities involved are within the 15-mile limit; and � � - Documentation that the existing facility and the proposed facility have the same owner or owners with a written stipulation that the facility to be replaced will not be used later for a long term care.

MO 580-2504 (03/26)

EXPEDITED LTC BED REPLACEMENT APPLICATION

EQUIPMENT REPLACEMENT APPLICATION

Project Description: _ Divider I.

Application Summary:

Applicant Identification and Certification (Form MO 580-1861)
Representative Registration (From MO 580-1869)
Proposed Project Budget (Form MO 580-1863) and detail sh eet with documentation of costs.
Provide a complete detailed project description, CON project number of the existing equipment (if prev. CON approved), and include the type/brand of both the existing equipment and the replacement equipment.
Provide a listing with itemized costs of the medical equipment to be acquired and bid quotes.
Provide a timeline of events for the project, from CON issuance through project completion.

Divider III . Service Specific Criteria and Standards:

Describe the financial rationale for the proposed replacement equipment.
Document if the existing equipment has exceeded its useful life.
Describe the eff ect the replacement unit would have on quality of care.
Document if the existing equipment is in constant need of repair.
Document if the lease on the current unit has expired.
Describe the technological advances provided by the new unit.
Describe how patient satisfaction would be improved.
Describe how patient outcomes would be improved.
Describe what impact the new unit would have on utilization.
Describe any new capabilities that the new unit would provide.
By what percent will this replacement increase patient charges.

(If replacement equipment was not previously approved, also complete Divider IV below.)

Divider IV .

Financial Feasibility Review Criteria and Standards:

Document th at sufficient financing is available by providing a letter from a financial institution or an auditor's statement indicating th at sufficient funds are available.
Provide Service-Specific Revenues and Expenses (Form MO 580-1865) projected through three (3) FULL ye ars beyond project completion.
Document how patient charges are derived.
Document responsiveness to the needs of the medically indigent.

MO 580-2506 (11/22)

Aug. 29, 1997, effective Sept. 8, 1997, expired March 6, 1998.

Filed Aug. 14, 2006, effective March 30, 2007. Amended: Filed Oct. 1, 2010, effective May 30, 2011. Amended: Filed March 10, 2014, effective Oct. 30, 2014. Amended: Filed Aug. 9, 2019, effective March 30, 2020. Amended: Filed June 29, 2022, effective Jan. 30, 2023. Amended: Filed April 22, 2024, effective Nov. 30, 2024.

Amended: Filed Aug. 19, 2025, effective April 30, 2026.

19 CSR 60-50.440 Criteria and Standards for Equipment and New Hospitals {#sec-19-csr-60-50.440 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.440}

PURPOSE: This rule lists the service-specific criteria and standards used in the Certificate of Need (CON) review process.

(1) For new units or services in the service area, use the following:

(A) Provide the minimum annual utilization for each of the other providers in the service area for the most recent three (3) full years, if applicable. The provider(s) should achieve at least the following community need rates as follows by the final year:

Magnetic resonance imaging procedures: 2,000 2. Positron emission tomography/computed tomography procedures: 1,000 3. Lithotripsy treatments: 1,000 4. Linear accelerator treatments: 3,500 5. Cardiac catheterization procedures (include coronary angioplasties): 500 6. Gamma knife treatments: 200 7. Computed tomography: 3,500 8. Robotic surgery system: 240 (B) For long-term care hospitals (such as a hospital-withina-hospital or long-term acute care hospital), the applicant should comply with the standards as described in 42 CFR,

section 412.23(e), and the bed need should meet the applicable population-based bed need methodology in 19 CSR 60-50.450;

(2) For additional units or services, provide the applicant’s annual utilization for the most recent three (3) full years, if applicable. The applicant should achieve at least the following community need rates as follows, by the final year:

(A) Magnetic resonance imaging procedures: 3,000 (B) Positron emission tomography/computed tomography procedures: 1,000 (C) Lithotripsy treatments: 1,000 (D) Linear accelerator treatments: 6,000 (E) Cardiac catheterization procedures: 750 (F) Gamma knife treatments: 200 (G) Computed tomography: 4,000 (H) Robotic surgery system: 240 (3) For replacement equipment, utilization standards are not used, but rather the following questions shall be answered:

(A) What is the financial rationale for the replacement?

(B) How has the existing unit exceeded its useful life in accordance with American Hospital Association guidelines?

(C) How does the replacement unit affect quality of care, utilization, and operational efficiencies compared to th e existing unit?

(D) Is the existing unit in constant need of repair?

(E) Has the current lease on the existing unit expired?

(F) What technological advances and capabilities will the new unit include?

(G) How will patient satisfaction be improved?

(H) How will the new unit improve outcomes and/or clinical improvements?

(I) By what percentage will this replacement increase patient charges?

(4) For the construction of a new hospital, the following questions shall be answered:

(A) What methodology was utilized to determine the need for the proposed hospital?

(B) Provide the most recent three (3) full years of evidence that the average occupancy of the same type(s) of beds at each other hospital in the proposed service area exceeds eighty percent (80%).

(D) What is the unmet need according to the following population-based bed need formula using (Unmet Need = (R × P) – U), where— P = Projected year population in the service area;

U = Number of licensed and approved beds in the service area; and R = Community need rate of one (1) bed per population in the service area as follows:

Medical/surgical bed: 570 2. Pediatric bed: 8,330 3. Psychiatric bed: 2,080 4. Substance abuse/chemical dependency bed: 20,000 5. Inpatient rehabilitation bed: 9,090 6. Obstetric bed: 5,880 Aug. 29, 1997, effective Sept. 8, 1997, expired March 6, 1998.

Emergency rescission and rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Amended: Filed Oct. 1, 2010, effective May 30, 2011. Amended: Filed March 10, 2014, effective Oct. 30, 2014. Amended: Filed Aug. 9, 2019, effective March 30, 2020. Amended: Filed June 29, 2022, effective Jan. 30, 2023.

Amended: Filed April 22, 2024, effective Nov. 30, 2024.

19 CSR 60-50.450 Criteria and Standards for Long-Term Care which a project involving a long-term care facility would be evaluated in a Certificate of Need (CON) review. {#sec-19-csr-60-50.450 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.450}

(1) The following population-based long-term care bed need methodology for the fifteen- (15-) mile radius shall be used to determine the need:

(A) Approval of additional intermediate care facility/skilled nursing facility (ICF/SNF) beds will be based on— 1. A service area need determined to be fifty-three (53) beds per one thousand (1,000) projected year population age sixty-five (65) and older minus the current supply of ICF/SNF beds shown in the most recent Six-Quarter Occupancy of Hospital and Nursing Home Licensed and Available Beds report as provided by the Certificate of Need Program (CONP), which includes licensed and Certificate of Need (CON)-approved beds;

(B) Approval of additional residential care facilities/assisted living facilities (RCF/ALF) beds will be based on— 1. A service area need determined to be twenty-five (25) beds per one thousand (1,000) projected year population age sixty-five (65) and older minus the current supply of RCF/ ALF beds shown in the most recent Six-Quarter Occupancy of Residential Care and Assisted Living Facility Licensed and Available Beds as provided by the CONP which includes licensed and CON-approved beds;

(C) Approval for Long-Term Care Hospital (LTCH) beds, as described in 42 CFR, section 412.23(e), will be based on a service area need determined to be one-tenth (0.1) bed per one thousand (1,000) projected year population minus the current supply of LTCH beds shown in the most recent Six-Quarter Occupancy of Long-Term Care Hospital Facility Licensed and Available Beds as provided by the CONP, which includes licensed beds and CON-approved beds; and (D) If the project is to add beds to an existing long-term care facility, the applicant shall state whether or not the facility received any resident care Class I deficiencies within the last eighteen (18) months as a result of a survey, inspection, or complaint investigation and the reason for and status of the deficiencies.

(2) Replacement Chapter 198 beds may qualify for an exception to the LTC bed minimum occupancy requirements (MOR) plus shortened information requirements and review time frames if an applicant proposes to— (A) Relocate RCF/ALF beds within a six- (6-) mile radius pursuant to section 197.318.4(4), RSMo;

(B) Replace one-half (1/2) of its licensed beds within a thirty- (30-) mile radius pursuant to section 197.318.5, RSMo; or (C) Replace a facility in its entirety within a fifteen- (15-) mile radius pursuant to section 197.318.6, RSMo, under the following conditions:

The existing facility’s beds shall be replaced at only one (1) site;
The existing facility and the proposed facility shall have the same owner(s), regardless of corporate structure; and 3. The owner(s) shall stipulate in writing that the existing facility’s beds to be replaced will not be used later to provide long-term care services by any person or entity; or if the facility is operated under a lease, both the lessee and the owner of the existing facility shall stipulate the same in writing.

(3) An exception to the CON application filing fee will be recognized for any proposed facility which is designed and operated exclusively for persons with acquired human immunodeficiency syndrome (AIDS).

(4) For LTC renovation or modernization projects which do not include increasing the number of beds, the applicant shall document the following, if applicable:

(A) The proposed project is needed to comply with current facility code local, state, or federal government requirements for licensure, certification, or accreditation;

(B) Operational efficiencies will be attained through reconfiguration of space and functions;

(C) The methodologies used for determining need and the reallocation of space and functions; and (D) The benefits to the facility because of its age or condition.

Aug. 29, 1997, effective Sept. 8, 1997, expired March 6, 1998.

Emergency amendment filed Dec. 16, 2002, effective Jan. 1, 2003, expired June 29, 2003. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Emergency amendment filed Aug. 14, 2006, effective Aug. 28, 2006, expired Feb. 23, 2007. Amended Oct. 1, 2010, effective May 30, 2011. Amended: Filed Aug. 9, 2019, Jan. 30, 2023. Amended: Filed April 22, 2024, effective Nov. 30, 2024. Amended: Filed Aug. 19, 2025, effective April 30, 2026.

19 CSR 60-50.460 Criteria and Standards for Evolving Technology which a project involving new technology would be evaluated in a Certificate of Need (CON) review. {#sec-19-csr-60-50.460 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.460}

(1) For evolving technology not currently available in the state or not in general usage in the state, the following shall be documented:

(A) The medical effects shall be described and documented in published scientific literature;

(B) The degree to which the objectives of the technology have been met in practice;

(D) The relationships, if any, to existing preventive, diagnostic, therapeutic or management technologies and the effects on the existing technologies;

(E) Food and Drug Administration approval;

(F) The need methodology used by this proposal in order to assess efficacy and cost impact of the proposal; and (G) Explain the degree of partnership, if any, with other institutions for the joint use of and financing of the evolving technology.

Emergency rescission and rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002.

History

AUTHORITY: section 197.320, RSMo 2000. Emergency rule filed Aug. 29, 1997, effective Sept. 8, 1997, expired March 6, 1998.

19 CSR 60-50.470 Criteria and Standards for Financial Feasibility which a project involving a health care facility would be evaluated relative to the financial feasibility of the project in a Certificate of Need (CON) review. {#sec-19-csr-60-50.470 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.470}

(1) Proposals for any new hospital, skilled nursing facility, intermediate care facility, residential care facility, or assisted living facility construction must include documentation that the proposed costs per square foot are reasonable when compared to the latest RS Means Cost Data Percentile Limit Total New Construction Project Costs (Form MO 580-1866 included herein), available from the Certificate of Need Program (CONP).

Any proposal with costs in excess of the three-fourths (3/4) percentile must include justification for the higher costs.

(2) Proposals must document that sufficient financing will be available to assure completion of the project by providing a letter from a financial institution saying it is willing to finance the project including the amount necessary for financing, or an auditor’s statement that unrestricted funds are available for the project.

(3) Document financial feasibility by including— (A) The Service-Specific Revenues and Expenses (Form MO 580-1865 included herein), as a financial pro forma for each revenue generating service affected by the project for the past three (3) full years projected through three (3) full years beyond project completion; and (B) For existing services, a copy of the latest available audited financial statements or the most recent Internal Revenue Service (IRS) 990 Form or similar IRS filing for facilities not having individual audited financial statements.

(4) Show how the proposed service will be affordable to the population in the proposed service area:

(A ) Document how th e proposal would impact current patient charges, and disclose the method for deriving charges for this service, including both direct and indirect components of the charge; and (B) Demonstrate that the proposed service will be responsive to the needs of the medically indigent through such mechanisms as fee waivers, reduced charges, sliding fee scales, or structured payments.

(5) If the proposal is for a new skilled nursing or intermediate care facility, provide the percentage of the admissions that would be Medicaid eligible on the first day of admission or become Medicaid eligible within ninety (90) days of admission.

(6) If the proposal is to add new long-term beds to an existing skilled nursing or intermediate care facility, provide the percentage of the admissions that is Medicaid eligible on the first day of admission or becomes Medicaid eligible within ninety (90) days of admission.

Aug. 29, 1997, effective Sept. 8, 1997, expired March 6, 1998.

Amended: Filed Oct. 19, 1999, effective April 30, 2000. Emergency rescission and rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Emergency amendment filed Aug.

Oct. 1, 2010, effective May 30, 2011. Amended: Filed Aug. 9, 2019, Jan. 30, 2023. Amended: Filed Aug. 19, 2025, effective April 30, 2026.

19 CSR 60-50.480 Criteria and Standards for Alternatives {#sec-19-csr-60-50.480 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.480}

(Rescinded June 30, 2002)

Emergency rescission filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded: Filed Dec. 14, 2001, effective June 30, 2002.

History

AUTHORITY: section 197.320, RSMo Supp. 1997. Emergency rule filed Aug. 29, 1997, effective Sept. 8, 1997, expired March 6, 1998. Original rule filed Aug. 29, 1997, effective March 30, 1998.

19 CSR 60-50.500 Additional Information {#sec-19-csr-60-50.500 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.500}

PURPOSE: This rule describes the process for submitting additional information and for requesting a public hearing on Certificate of Need (CON) applications in the CON review process.

(1) Additional information requested by the Missouri Health Facilities Review Committee (committee) shall be submitted within the time frame specified by the committee.

(2) If an application is determined to be incomplete, the applicant shall be notified within twenty (20) calendar days after filing a full or expedited application. The applicant’s written response shall be received within ten (10) calendar days after receipt of notification.

(3) Support, neutral, and opposing information submitted by affected persons shall be received at the committee’s principal office at least five (5) full business days before the scheduled meeting of the committee.

(4) Copies of any additional information sent directly to the committee by applicants or affected persons shall also be sent to the Certificate of Need Program (CONP) for file copies.

(5) When a request in writing or email is filed by any affected person within thirty (30) calendar days from the date of publication of the Application Review Schedule, the committee or CONP staff shall hold a public hearing on any application under the following conditions:

(A) The hearing may be conducted in the city of the proposed project if monetarily feasible;

(B) The CONP staff will present the introductions and orientation for the public hearing;

(D) Any person may present written testimony and up to five (5) minutes of verbal testimony at the public hearing; and (E) The testimony shall become a part of the record of the review.

Emergency rescission and rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded and readopted:

Filed Dec. 14, 2001, effective June 30, 2002. Amended: Filed Oct. 1, 2010, effective May 30, 2011. Amended: Filed Aug. 9, 2019, effective March 30, 2020. Amended: Filed June 29, 2022, effective Jan. 30, 2023. Amended: Filed Aug. 19, 2025, effective April 30, 2026.

19 CSR 60-50.600 Certificate of Need Decisions {#sec-19-csr-60-50.600 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.600}

PURPOSE: This rule describes the process for making decisions on Certificate of Need (CON) applications in the CON review process.

(1) Decisions on full Certificate of Need (CON) applications and contested expedited applications shall be subject to the following:

(A) Parliamentary procedures for all face-to-face, videographic, telephonic, and computerized meetings shall follow Robert’s Rules of Order, incorporated by reference, newly revised edition, 10th edition, published October 2000, Perseus Publishing, 11 Cambridge Center, Cambridge, MA 02142. This

rule does not include any later amendments or additions;

(B) The CON Program’s analysis becomes the findings of fact for the Missouri Health Facilities Review Committee (committee) decision except to the extent that it is expressly rejected, amended, or replaced by the committee in which case the minutes of the committee will contain the changes and become the amended findings of fact of the committee.

The committee’s final vote becomes conclusion of law; and (C) A final decision is rendered on any application after each committee member present is given the opportunity to vote and the chair announces the passage or defeat of the motion on the floor. The chair or acting chair shall vote only in case of a tie.

(2) Decisions on expedited CON applications shall be subject to the following:

(A) In the case of qualifying expedited review applications, committee members will receive a ballot in addition to the written analysis. Members may vote either to approve the application or to have it placed on the next formal meeting agenda for consideration;

(B) Ballots may be returned to the CON office by either mail, email, or fax, but must be received within seven (7) business days from the date they were emailed to committee members; and (C) A final decision to approve the application will be rendered if all ballots received by the cut-off date (at least five (5) ballots are required) signify a vote to approve the project. If the vote is not unanimous, the application will be subject to the provisions of section (1) of this rule.

(3) The committee shall make a decision on an application within one hundred thirty (130) calendar days after the date the application is filed and subsequently notify the applicant by providing either a legal certificate or denial letter by mail and email.

Emergency rescission and rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Emergency amendment Filed Oct. 1, 2010, effective May 30, 2011. Amended: Filed Aug. 9, 2019, effective March 30, 2020.

19 CSR 60-50.700 Post-Decision Activity {#sec-19-csr-60-50.700 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.700}

PURPOSE: This rule describes the procedure for filing Periodic Progress Reports after approval of Certificate of Need (CON) applications, CONs subject to forfeiture, and the procedure for requesting a cost overrun.

(1) Applicants who have been granted a Certificate of Need (CON) or a Non-Applicability CON letter shall file reports by mail or email with the Missouri Health Facilities Review Committee (committee), using Periodic Progress Report (Form MO 580-1871), included herein. A report shall be filed within ten (10) days following the end of each six- (6-) month period after CON approval, or issuance of a Non-Applicability CON letter, until the project is complete which includes the licensing of all new beds, installation of equipment, and/or completion of renovations. All Periodic Progress Reports must contain a complete and accurate accounting of all expenditures for the report period. Final project costs with third-party verification must be provided on a Periodic Progress Report (Form MO 580- 1871), included herein.

(2) Applicants who have been granted a CON and fail to incur a capital expenditure within six (6) months may request an extension of six (6) months by submitting a written request to the committee outlining the reasons for the failure, with a listing of the actions to be taken within the requested extension period to insure compliance. The Certificate of Need Program (CONP) staff on behalf of the committee will analyze the request and grant an extension, if appropriate. Applicants may request additional extensions by submitting a completed Request for Extension (Form MO 580-1872), included herein, and must provide financial information plus other documentation describing delays.

(3) A Non-Applicability CON letter is valid for six (6) months from the date of issuance. Failure to incur a capital expenditure or purchase the proposed equipment within that time frame shall result in the Non-Applicability CON letter becoming null and void. The applicant may request one (1) six (6)-month extension unless otherwise constrained by statutory changes.

Failure to file the required Periodic Progress Report shall result in the Non-Applicability CON letter becoming null and void.

(4) A CON shall be subject to forfeiture for failure to— (A) Incur a project-specific capital expenditure within twelve (12) months after the date the CON was issued through initiation of project aboveground construction by any of the following: installation of structural support; installation of structural steel; installation of framing; establishing foundations and a wall or lease/purchase of the proposed equipment since a capital expenditure, according to generally accepted accounting principles, must be applied to a capital asset; or (B) File the required Periodic Progress Report.

(5) If the CONP staff finds that a CON may be subject to forfeiture— (A) Not less than thirty (30) calendar days prior to a committee meeting, the CONP shall notify the applicant in writing of the possible forfeiture, the reasons for it, and its placement on the committee agenda for action; and (B) After receipt of the notice of possible forfeiture, the applicant may submit information to the committee within ten (10) calendar days to show compliance with this rule or other good cause as to why the CON shall not be forfeited.

(6) If the committee forfeits a CON, or a Non-Applicability CON letter becomes null and void, CONP staff shall notify all affected state agencies of this action.

(7) Cost overrun review procedures implement the CON statute

section 197.315.7, RSMo. Immediately upon discovery that a project’s actual costs would exceed approved project costs by more than ten percent (10%), the applicant shall apply for approval of the cost variance. A nonrefundable fee in the amount of one-tenth of one percent (0.1%) of the additional project cost above the approved amount made payable to “Missouri Health Facilities Review Committee” shall be required. The information requirements for a cost overrun review are required as follows:

(A) Amount and justification for cost overrun shall document— 1. Why and how the approved project costs would be exceeded, including a detailed listing of the areas involved;

Any changes that have occurred in the scope of the project as originally approved; and 3. The alternatives to incurring this overrun that were considered and why this particular approach was selected; and (B) Provide a Proposed Project Budget (Form MO 580-1863), included herein, and budget detail including all methods and assumptions used. Documentation of costs may be requested.

(8) Applicants may request a project owner change. The information requirements for an owner change review are as (A) Reason for owner change;

(B) Statement as to whether or not the proposed owner is an affiliate of the current owner, and explanation of relationship;

This can be a statement or a contract;

(D) Documentation that the proposed owner owns the site, or has an executed option to purchase or lease the real property;

(E) Documentation that the proposed owner(s) is registered to do business in Missouri;

(F) Documentation that sufficient financing would be available to assure completion of the project; and (G) Provide a complete and signed Applicant Identification the proposed owner listed.

(9) Applicants may request a project operator change. The information requirements for an operator change review are as follows:

(A) Reason for operator change;

(B) Statement as to whether or not the proposed operator is an affiliate of the current operator, and explanation of relationship;

This can be a statement or a contract;

(D) Documentation that the proposed operator(s) is registered to do business in Missouri;

(E) The proposed operator must provide a brief explanation of their ability and experience operating a long-term care facility.

State if the license of the proposed operator or any 2. If the license of the proposed operator or any affiliate of the proposed operator has been revoked within the previous five (5) years, provide the name and address of the facility whose license was revoked.
State if the Medicare and/or Medicaid certification of any facility owned or operated by the proposed operator or any 4. If the Medicare and/or Medicaid certification of any facility owned or operated by the proposed operator or any affiliate of the proposed operator has been revoked within the previous five (5) years, provide the name and address of the facility whose Medicare and/or Medicaid certification was revoked; and (F) Provide a complete and signed Applicant Identification the proposed operator listed.

(10) Applicants may request a project site change. The information requirements for a site change review are as (A) Reason for site change;

(B) Documentation the proposed site is within fifteen (15) miles as the crow flies of the existing site;

(D) Documentation of the cost of the proposed site;

(E) A legible street or road map showing the exact location of the facility or health service, and a copy of the site plan showing the relation of the project to existing structures and boundaries;

(F) Statement as to whether or not the project cost would change. If the project cost would change, submit a revised proposed budget and fee if applicable;

(G) Provide the population-based long-term care bed need methodology for the fifteen- (15-) mile radius of the proposed site;

(H) Provide a complete and signed Applicant Identification the proposed site listed;

(I) List of any additional changes to the project as originally presented to the committee, such as— 1. Decrease in the number of beds. If a decrease, how many beds would be licensed;

Change to the building structure(s). If there would be a change, a description of the change(s), the total square footage, and revised schematics of the proposed building(s) with all use of space marked; and 3. The timeline of events for the project, from site change approval through project completion;

(J) Statement of how consumers were made aware of the proposed site change. All feedback received from consumers regarding the proposed site; and (K) Documentation that sufficient financing would be available to assure completion of the project.

(11) Any applicant who requests an owner, operator or site change or cost overrun must still comply with sections (1) and (2) of this rule.

(12) At any time during the process from Letter of Intent to project completion, the applicant is responsible for notifying the committee of any change in the designated contact person.

If a change is necessary, the applicant must file a Contact Person Correction (Form MO 580-1870), included herein.

Rescinded and readopted: Filed Aug. 29, 1997, effective March 30, 1998. Amended: Filed Oct. 19, 1999, effective April 30, 2000.

Emergency rescission and rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Emergency rescission and rule filed Dec. 16, 2002, effective Jan. 1, 2003, expired June 29, 2003.

Amended: Filed June 9, 2003, effective Nov. 30, 2003. Emergency amendment filed Aug. 14, 2006, effective Aug. 28, 2006, expired Feb. 23, 2007. Amended: Filed Aug. 14, 2006, effective March 30, 2007. Amended: Filed Oct. 1, 2010, effective May 30, 2011.

Amended: Filed Aug. 9, 2019, effective March 30, 2020. Amended:

Filed June 29, 2022, effective Jan. 30, 2023.

19 CSR 60-50.800 Meeting Procedures {#sec-19-csr-60-50.800 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.800}

PURPOSE: This rule describes the meeting format and protocol in a Certificate of Need (CON) review meeting.

(1) The regular meetings of the Missouri Health Facilities Review Committee (committee) to consider Certificate of Need (CON) applications shall be held approximately every eight (8) weeks according to a schedule adopted by the committee before the beginning of each calendar year and modified periodically to reflect changes. A copy of this calendar may be obtained from the CON Program (CONP) staff or CON website.

(2) All new information not previously in the application shall be received by the CONP staff at least thirty (30) calendar days before the scheduled meeting with one (1) exception.

An applicant shall have no less than three (3) business days to respond to the findings of the staff and adverse information received from other parties. An applicant shall respond in writing to an inquiry from a committee member. The response shall be provided to the committee for consideration and a copy shall be sent to the CON office.

(3) Requests for the addition of agenda items including CON modification and extension requests shall be received by the CONP staff at least thirty-five (35) calendar days before the scheduled meeting.

(4) Any committee member may request that an item be added to the agenda up to forty-eight (48) hours before the scheduled meeting, exclusive of weekends and holidays when the principal office is closed.

(5) The tentative agenda for each committee meeting shall be released at least twenty (20) calendar days before each meeting.

(6) The committee may give the applicant and affected persons an opportunity to make brief presentations at the meeting according to the Missouri Health Facilities Review Committee Meeting Format and Missouri Health Facilities Review Committee Meeting Protocol. The applicant and affected persons shall conform to the following procedures:

(A) The applicant’s presentation shall be a key points summary based on the written application and shall not exceed ten (10) minutes inclusive of all presenters with five (5) minutes additional time for summation;

(B) Others in support or opposition to the applicant’s project (such as political representatives, citizens of the community and other providers) shall be categorized as unrelated parties and shall appear after the applicant’s presentation;

(C) Regardless of the number of presenters involved in the presentation, individual presentations by unrelated parties in support of, neutral, or in opposition to the applicant’s project shall not exceed three (3) minutes each;

(D) No new material shall be introduced with the exception of materials or information provided in response to the CONP staff or at the request of a committee member;

(E) Rebuttals by applicants of presentations by affected persons are generally allowed;

(F) All presenters shall complete and sign a Representative Registration (Form MO 580-1869 included herein), and give it to the sign-in coordinator prior to speaking;

(G) The reserved area in the hearing room may be used by an applicant only during the applicant’s presentation and then vacated for the next group (individuals waiting to present shall remain clear of the podium and staff area until specifically called by the chairman); and (H) Prescribed time limits shall be monitored by the timekeeper, and presenters shall observe the timekeeper’s indications of lapsed time to ensure that each presenter has an opportunity to present within the allotted time.

(7) Additional meetings of the committee may be held periodically. These meetings may include educational workshops for members to gain knowledge, meetings with organizations for cooperative purposes, discussion of rules, seeking legal advice from counsel, and other issues.

Emergency rescission and rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Emergency amendment Filed Oct. 1, 2010, effective May 30, 2011. Amended: Filed Aug. 9, 2019, effective March 30, 2020. Amended: Filed June 29, 2022, effective Jan. 30, 2023. Amended: Filed Aug. 19, 2025, effective April 30, 2026.

19 CSR 60-50.900 Administration {#sec-19-csr-60-50.900 omnilex-key=us-mo-regs-official--title-19--19 CSR 60-50.900}

PURPOSE: This rule describes the duties and responsibilities of the Certificate of Need (CON) Program staff.

(1) The role of the Missouri Health Facilities Review Committee (committee) includes the following:

(A) Make specific decisions about applications, applicability and administrative matters;

(B) Make policy decisions to include the development of rules; and (C) Oversee operations of the Certificate of Need Program (CONP) staff.

(2) The role of the CONP staff includes the following:

(A) Act as an agent of the committee; and (B) Perform administrative tasks.

(3) The CONP staff shall be staffed as follows:

(A) The committee shall employ a CONP coordinator and additional staff to perform the duties assigned to it by law;

(B) The committee shall designate the CONP coordinator, or his/her designee, to perform any administrative functions that may be required of the committee by law; and (C) The CONP staff shall be housed at the principal office of the committee.

(4) The committee shall maintain its principal office in Jefferson City where the CONP staff will:

(A) Accept letters of intent, applications and any other written communication related to the conduct of the CONP;

(B) Accept service of legal process;

(5) The CONP staff shall provide technical assistance to potential applicants.

(6) The committee and CONP staff shall post information on the CONP website containing the status of reviews being conducted, the reviews completed since the last report, and the decisions made, plus an annual summary of activities for the past calendar year.

Emergency rescission and rule filed Dec. 14, 2001, effective Jan. 1, 2002, expired June 29, 2002. Rescinded and readopted: Filed Dec. 14, 2001, effective June 30, 2002. Emergency amendment Filed Aug. 9, 2019, effective March 30, 2020.

Division 70 Division of Chronic Disease Prevention and Health Promotion

Chapter 21 Cancer

19 CSR 70-21.010 Reporting of Cancer Cases {#sec-19-csr-70-21.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 70-21.010}

PURPOSE: This rule establishes a method of mandatory reporting of all cancer cases of inpatients and outpatients in order to conduct cancer incidence surveillance and epidemiologic studies and to facilitate development, implementation and evaluation of cancer prevention and control measures in Missouri as required by sections 192.650, 196.653, 192.655 and 192.657, RSMo Supp. 1999.

PUBLISHER’S NOTE: The publication of the full text of the material that the adopting agency has incorporated by reference in this

(1) The following are definitions of terminology used throughout this rule.

(A) Cancer—those malignant neoplasms included in the list of cancers with a fifth digit of two or three listed under the heading, “Morphology of Neoplasms,” contained in the current editions of “International Classification of Diseases” (ICD) or “International Classification of Diseases for Oncology” (ICD-O) published by the World Health Organization.

(B) Department—the Missouri Department of Health.

(C) Non-melanomatous skin cancers— cutaneous, malignant basal and squamous cell neoplasms as defined in the current edition of the Missouri Cancer Registry Abstract Code Manual, which is incorporated by reference in this rule.

(D) State registry—a centralized cancer reporting system maintained by the Missouri Department of Health for the collection, storage, analysis and interpretation of data on cancer patients.

(E) Reporting entity—hospital, pathology laboratory, ambulatory surgical center, freestanding cancer clinic and treatment center, physician office, skilled nursing facility, intermediate care facility or residential care facility I or II.

(F) Case—A primary incidence of cancer.

A patient may have more than one primary incidence of cancer.

(2) The administrator or designated representative of a reporting entity shall report every case of cancer—with the exception of nonmelanomatous skin cancers—to the director of the department or to the director’s designated representative. Hospitals that electronically report shall use the North American Association of Central Cancer Registries (NAACCR) layout and shall use information provided by the physician to complete the report. Hospitals with more than 75 cases of cancer annually who do not electronically report shall use the paper report format “Cancer Registry Initial Abstract” provided by the state registry and shall use information provided by the physician to complete the report. Hospitals with less than 75 cases of cancer annually who do not electronically report shall use the paper report format “Missouri Cancer Registry Initial Abstract” provided by the state registry completed using information provided by the physician or submit copies of medical record documentation sufficient for abstraction of required cancer incidence data. All non-hospital reporting entities shall report all required data items using the paper form supplied by the state registry or in an electronic format designated by the state registry.

(A) Reports shall be made by the administrator or designated representative of the reporting entity within six months after the diagnosis or within six months after the date of first contact for this primary incidence of cancer at the reporting entity. Coding will be completed as described in the current edition of the Missouri Cancer Registry Abstract Code Manual.

(3) All patients seen, diagnosed or treated for cancer for the first time by a physician or other health care provider on an inpatient or outpatient basis are to be reported. Subsequent reports on such patients are not required unless a new primary incidence of cancer is diagnosed.

(A) Physician offices are exempt from reporting cases that are directly referred to or previously have been admitted to any other facility that is required to report as described in subsection (1)(E) above (i.e., hospital, pathology laboratory, ambulatory surgical center, free-standing cancer clinic and treatment center, physician office, skilled nursing facility, intermediate care facility or residential care facility I or II). Physicians may be contacted by the state registry if additional information regarding a directly referred or previously admitted case is considered necessary for abstraction of required cancer incidence data.

(4) The minimum data reported on each case shall include those data elements required by the Centers for Disease Control and Prevention (CDC) National Program of Cancer Registries (NPCR) and years of tobacco use.

The department recommends reporting all data elements required and/or recommended by the American College of Surgeons (ACoS), not already included in the NPCR requirements and toxic exposure, the Missouri-specific optional data element.

(5) The department may provide training or written instructions for individuals designated by a reporting entity’s administrator or designated representative to facilitate submission of required information.

(6) A reporting entity is considered compliant if it meets the requirements of sections 192.650 and 192.653, RSMo. A non-compliant reporting entity will be notified in writing as to their non-compliant status within 30 days following the end of the six-month period and will be given an opportunity to take corrective action within 60 days from the date of the notification letter. If the reporting entity does not comply within 60 days, a second notification letter will be sent directing the reporting entity to comply within 30 days.

(7) A researcher requesting data must provide the department with a current curriculum vitae and publication list, indicate in precise detail the data which are desired, provide a copy of the research protocol describing the

purpose(s) for which the data are to be used and a copy of their Institutional Review Board (IRB) approval.

(A) In the event the data requested include the identity of any patient, physician, health care provider or reporting entity and provided that the department has determined that identifying data are necessary for the research, has approved it through the department’s IRB and has determined that the research is worthwhile, the researcher must agree in writing to protect the confidentiality of the data and to use such data only for purposes stated in the written agreement and not for any secondary purpose. Identifying data will be released only after consent for this

purpose has been obtained from the patient, physician, health care provider or reporting entity—whichever is appropriate—as authorized in section 192.655, RSMo and may not be made available to any other individual, agency, institution, or firm.

Rebecca McDowell Cook (11/30/00)

(B) No follow-back of any type shall be made to any individual, institution or agency without written authorization by the department. Any data released by a researcher shall be restricted to aggregate data and shall not identify any individual or institution. The department shall be given credit as the source of the data. A copy of the results of the research shall be furnished to the department.

(C) If electronic media are provided, such media, after serving the purpose set forth in this subsection, shall be erased unless specific authority is required and granted for their retention and future use.

(D) The researcher will be billed prior to delivery of the data for a reasonable fee to cover actual costs to the department for retrieving and preparing the requested data, together with costs of postage and handling fees.

(8) The data provided by each reporting entity and single copies of analyses based upon data from that entity will be provided to hospitals in the form of management reports and routine periodic quality control reports at no cost to the hospital for purposes of advancement of research, education and treatment.

Management reports and routine periodic quality control reports will be made available upon written request to other reporting entities at no cost.

(A) Single copies of reports summarizing the data from all reporting entities will be provided upon written request to each reporting entity at no cost. Multiple copies will be made available upon receipt of a fee sufficient to cover the cost of reproduction of the document together with postage and handling fees.

(B) Special reports requested by a reporting entity will be made available upon receipt of a fee sufficient to cover the cost of analysis, interpretation, compilation and reproduction of the document together with postage and handling fees.

rule was previously filed as 13 CSR 50- 115.010, 19 CSR 30-17.010 and 19 CSR 20- 21.010. Original rule filed May 11, 1984, effective Aug. 11, 1984. Amended: Filed June 19, 1987, effective Sept. 11, 1987. Rescinded and readopted: Filed June 14, 2000, effective Dec. 30, 2000. *Original authority: 192.006, RSMo 1993, amended 1995; 192.650-192.657 see Missouri Revised Statutes 2000.

4CODE OF STATE REGULATIONS

(11/30/00) Rebecca McDowell Cook

History

AUTHORITY: sections 192.006 and 192.650–192.657, RSMo Supp. 1999. This

Division 73 Missouri Board of Nursing Home Administrators

Chapter 1 Organization and Description of Board

19 CSR 73-1.010 General Organization {#sec-19-csr-73-1.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-1.010}

PURPOSE: The purpose of this regulation is to comply with section 536.023(3), RSMo, which requires each agency to adopt as a regulation, a description of its operations and methods and procedures where the public may obtain information or make submission or requests.

(1) The Missouri Board of Nursing Home Administrators is a licensing board within the Department of Health and Senior Services.

(2) It is the function of the board to— (A) Determine the qualifications of applicants for licensure to practice administration of a long-term care facility, as defined in section 344.010, RSMo, in this state;

(B) Issue licenses to those persons who meet the standards of professional competence set forth in the statutes and as determined at the discretion of the board; and (C) Approve continuing education activities and courses of instruction and training required of applicants or licensees.

(3) The board is further charged with maintaining high standards of professional competence and ethical conduct among licensed administrators, as defined in 19 CSR 73- 2.020, 19 CSR 73-2.022, and 19 CSR 73- 2.023.

(4) The board has authority to discipline licensees either through the Administrative Hearing Commission and/or enter into settlement agreements as specifically set out in

Chapter 344, RSMo.

(5) The board will meet as necessary to attend to the matters before the board. All meetings will be posted according to section 610.020, RSMo, and information may be obtained by contacting the board at http://www.health.mo.gov/information/board s/bnha or by telephone at (573) 751-3511.

(6) The public may obtain information or make submissions or requests by writing the board office.

Filed Oct. 1, 1987, effective Jan. 13, 1988.

Moved and amended: Filed Jan. 31, 2003, effective Aug. 30, 2003. Amended: Filed June 15, 2011, effective Jan. 30, 2012. Amended:

Filed Nov. 23, 2021, effective June 30, 2022. *Original authority: 344.070, RSMo 1969, amended 1979, 1993, 1995, 2007.

History

AUTHORITY: section 344.070, RSMo 2016. This rule was previously filed as 13 CSR 73- 1.010. Original rule filed Sept. 10, 1976, effective Dec. 11, 1976. Rescinded and readopted: Filed May 13, 1980, effective Aug. 11, 1980. Amended: Filed April 14, 1983, effective July 11, 1983. Amended: Filed Oct. 16, 1985, effective Feb. 28, 1986. Amended:

Chapter 2 General Rules

19 CSR 73-2.020 Procedures and Requirements for Licensure of Nursing Home {#sec-19-csr-73-2.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.020}

19 CSR 73-2.022 Procedures and Requirements for Licensure of Residential Care and {#sec-19-csr-73-2.022 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.022}

19 CSR 73-2.023 Procedures and Requirements for Limited Licensure of {#sec-19-csr-73-2.023 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.023}

19 CSR 73-2.130 Notice of Change of Contact Information and Missouri Administrator SERVICES {#sec-19-csr-73-2.130 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.130}

19 CSR 73-2.010 Definitions {#sec-19-csr-73-2.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.010}

PURPOSE: This rule clearly defines terms as used in Chapter 344, RSMo, and in these rules. by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here.

(1) Administrator shall mean a person that is currently licensed by the board to administer, manage, or supervise a long-term care facility, including individuals who have ownership of a facility and/or individuals who share administrative duties and functions with others.

(2) Clock hour shall mean sixty (60) minutes of formal instruction by a board-approved presenter.

(3) Continuing education means post-licensure education to maintain professional competency to practice administration of long-term care facilities, as defined in section 344.010, RSMo.

(4) Health care administration shall mean the completion of a course of instruction designed to teach the elements of health care facility administration and management.

(5) Examination shall mean a written examination, an oral examination, or a computer-based examination, in conformance with the Americans with Disabilities Act of 1990, 42 U.S.C. Chapter 126, which is incorporated by reference in this

rule as published by and available at the U.S. Government Printing Office, Superintendent of Documents, PO Box 371954, Pittsburgh, PA 15250-7954, or at www.gpoaccess.gov/uscode/.

This rule does not include any later amendments or additions.

(6) Experience in health-care administration shall mean having management responsibility, which shall include the on-site supervision of at least three (3) staff persons in a licensed longterm care or acute-care facility or a licensed mental health facility, or a department of one of these facilities.

(7) Health care facility shall mean a licensed long-term care facility, licensed acute-care facility, or licensed inpatient mental health facility.

(8) Health care or aging-related experience shall mean full-time equivalency experience in a licensed home health agency, licensed hospice agency, licensed acute-care or long-term care facility, licensed adult day care program, or licensed mental health facility.

(9) Nursing Home Administrator shall mean an administrator, as defined in section (1), that administers, manages, or supervises a long-term care facility, as defined in section 344.010, RSMo.

(10) Resident shall mean a person residing in a long-term care facility, as defined in section 344.010, RSMo.

(11) Residential Care and Assisted Living Administrator shall mean an administrator, as defined in section (1), that administers, manages, or supervises an assisted living facility or residential care facility, as defined in Chapter 198, RSMo. This includes residential care facilities that were licensed as a residential care facility II on or before August 27, 2006, and that continue to meet the licensure standards for a residential care facility II in effect on August 27, 2006.

(12) Training agency shall mean— (A) An accredited educational institution; or (B) A statewide or national membership agency, association, professional society, or organization in the fields of health care or health care management approved by the board to provide courses of instruction and training. previously filed as 13 CSR 73-2.010. Original rule filed March 5, 1974, effective March 15, 1974. Rescinded and readopted: Filed May 13, 1980, effective Aug. 11, 1980. Amended: Filed April 14, 1983, effective July 11, 1983. Amended: Filed Oct. 16, 1985, effective March 14, 1986. Amended: Filed Oct. 1, 1987, effective Jan. 14, 1988.

Amended: Filed April 30, 1998, effective Oct. 30, 1998. Moved to 19 CSR 73-2.010, effective March 3, 2003. Emergency amendment filed May 5, 2011, effective May 15, 2011, expired Feb. 23, 2012.

Amended: Filed June 15, 2011, effective Jan. 30, 2012. *Original authority: 344.070 RSMo 1969, amended 1979, 1993, 1995, 2007.

19 CSR 73-2.011 Fee Waiver for Military Families and Low- Income Individuals {#sec-19-csr-73-2.011 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.011}

PURPOSE: This rule complies with section 324.015.6, RSMo, which requires the Board of Nursing Home Administrators to promulgate rules to implement the provisions of section 324.015, RSMo, the waiver of occupational fees for military families and low-income individuals for a period of two (2) years.

(1) For purposes of this regulation, all terms shall have the same definition as contained in section 324.015.1, RSMo.

(2) Individuals seeking a waiver must apply with the Board of Nursing Home Administrators in writing and include documentation that establishes eligibility for the waiver pursuant to section 324.015, RSMo.

Original rule filed Feb. 21, 2019, effective Aug. 30, 2019. *Original authority: 324.015, RSMo 2018.

History

AUTHORITY: section 324.015, RSMo Supp. 2018. Emergency rule filed Feb. 21, 2019, effective March 3, 2019, expired Aug. 29, 2019.

19 CSR 73-2.015 Fees {#sec-19-csr-73-2.015 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.015}

PURPOSE: This rule establishes and fixes the various fees and charges authorized by Chapter 344, RSMo.

(1) The following fees are required by the Board of Nursing Home Administrators:

(A) Application Review Fee (including reciprocity) $150 (B) License Renewal Fee 1. One- (1-) year license $ 50 2. Two- (2-) year license $100 3. Inactive License $ 50 (C) License Renewal Late Penalty Fee (This fee is in addition to the renewal fee listed in subsection (1)(B)) $ 25 (D) Inactive License Fee $ 50 (E) Reactivate Inactive License Fee $100 (F) Retired License Fee $ 50 (G) Single Offering Fee (per requested clock hour) $ 15 (H) Single Offering Late Filing Fee $ 50 (I) Insufficient Funds Charge $ 25 (2) Fees must be made payable to the Department of Health and Senior Services in the form of a cashier’s check, personal check, company check, money order, or through the on-line application system by credit card.

(3) All fees are nonrefundable.

(4) The provisions of this rule are declared severable. If any fee fixed by this rule is held invalid by a court of competent jurisdiction or by the Administrative Hearing Commission, the remaining provisions of this rule shall remain in full force and effect, unless otherwise determined by a court of competent jurisdiction or by the Administrative Hearing Commission.

Amended: Filed Nov. 23, 2021, effective June 30, 2022.

History

AUTHORITY: section 344.070, RSMo 2016. This rule was previously filed as 13 CSR 73-2.015. Original rule filed Jan. 3, 1992, effective May 14, 1992. Amended: Filed March 4, 1993, effective Aug. 9, 1993. Emergency amendment filed Nov. 17, 1999, effective Dec. 11, 1999, expired June 7, 2000. Amended: Filed Nov. 1, 1999, effective April 30, 2000. Emergency amendment filed Nov. 30, 2001, effective Jan. 1, 2002, expired June 29, 2002. Amended: Filed Nov. 30, 2001, effective June 30, 2002. Moved and amended: Filed Jan. 31, 2003, effective Aug. 30, 2003. Amended: Filed Dec. 15, 2005, effective July 30, 2006. Amended: Filed Dec. 28, 2007, effective Aug. 30, 2008. Amended: Filed June 15, 2011, effective Jan. 30, 2012.

19 CSR 73-2.020 Procedures and Requirements for Licensure of Nursing Home Administrators {#sec-19-csr-73-2.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.020}

PURPOSE: This rule specifies the minimum requirements for licensure as a nursing home administrator in Missouri.

(1) An applicant interested in becoming a licensed nursing home administrator shall obtain an application form from the board. The application form, MO 580-2518 (03-11), Application for Licensure NHA, is incorporated by reference in this rule and is available on the web at www.health.mo.gov/information/ boards/bnha or by contacting the board at PO Box 570, Jefferson City, MO 65102, (573) 751-3511. This rule does not incorporate any subsequent amendments or additions. The application shall be completed and returned to the board with the fee referenced in 19 CSR 73-2.015. Information provided in the application shall be attested by signature to be true and correct to the best of the applicant’s knowledge and belief.

(2) The completed application form shall provide satisfactory proof that the applicant has met the following minimum requirements for Missouri nursing home administrator licensure:

(A) Twenty-one (21) years of age or over;

(B) A high school diploma or equivalent;

(D) Has not been convicted of any crime, an essential element of which is fraud, dishonesty or moral turpitude, or which involves the operation of a long-term care facility or other health-care facility, whether or not sentence is imposed.

A copy of the record of conviction or plea of guilty or nolo contendere shall be conclusive evidence of the conviction; and (E) Experience and/or education from an accredited educational institution in one (1) of the following areas:

Experience: A minimum of three (3) years of experience in health-care administration, full-time equivalency; or 2. Education:

A. Associate degree in health-care administration, including a minimum of twenty-one (21) semester hours of course work directly in health-care administration; or B. Baccalaureate degree (Bachelor of Science or Bachelor of Arts) in one (1) of the following areas:

(I) Health-care administration;

(II) Gerontology (including a long-term care practicum, internship, or both);

(III) Nursing (BSN or diploma nurse); or C. Master’s degree or beyond in one (1) of the following (I) Health-care administration;

(II) Gerontology (including a long-term care practicum, internship or both);

(III) Nursing; or 3. Experience and education in one (1) of the following A. Associate degree AND two (2) years experience in a health-care facility; or B. Baccalaureate degree (BS or BA) AND one (1) year experience in a health-care facility; or C. Master’s degree or beyond AND one (1) year experience in a health-care facility.

(3) The applicant shall be eligible to take the examinations (4) If the board determines the applicant has failed to meet one (1) of the criteria outlined in 19 CSR 73-2.020(2)(E)1.–3., the applicant— (A) Must complete the course of instruction and training approved by the board pursuant to 19 CSR 73-2.031. The planned curriculum, including a description of each planned course, must be submitted to the board in writing for PRIOR review and approval. Failure to do so within six (6) months following notification of the board’s decision will cause reapplication to become necessary for any future consideration.

(B) May submit additional information for reevaluation if done so no later than two (2) weeks prior to the next board meeting. The applicant will be given notice of the next board meeting date.

Filed Dec. 4, 1989, effective March 1, 1990. Emergency amendment filed Nov. 17, 1999, effective Dec. 11, 1999, expired June 7, 2000.

Amended: Filed Nov. 1, 1999, effective April 30, 2000. Amended:

Filed April 30, 2001, effective Jan. 1, 2002. Moved and amended:

Filed Jan. 31, 2003, effective Aug. 30, 2003. Amended: Filed Dec. 28, 2007, effective Aug. 30, 2008. Emergency amendment filed May 5, 2011, effective May 15, 2011, expired Feb. 23, 2012. Amended: Filed June 15, 2011, effective Jan. 30, 2012.

History

AUTHORITY: section 344.070, RSMo Supp. 2010. This rule was previously filed as 13 CSR 73-2.020. Original rule filed March 5, 1974, effective March 15, 1974. Rescinded and readopted: Filed May 13, 1980, effective Aug. 11, 1980. Amended: Filed April 14, 1983, effective July 11, 1983. Amended: Filed Oct. 16, 1985, effective March 14, 1986. Amended: Filed Oct. 1, 1987, effective Jan. 14, 1988. Amended:

19 CSR 73-2.022 Procedures and Requirements for Licensure of Residential Care and Assisted Living {#sec-19-csr-73-2.022 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.022}

PURPOSE: This rule specifies the minimum requirements for licensure as a residential care and assisted living administrator in Missouri to make the rule consistent with the changes that were made to sections 344.010 and 344.020, RSMo, as part of CCS No. 2 for HCS for SCS for SB 754, 95th General Assembly, Second Regular Session (2010).

(1) An applicant interested in becoming a licensed residential care and assisted living administrator shall obtain an application form prescribed by the board. The application form, MO 580-2987 (03-11), Application for Licensure RCAL, is incorporated by reference in this rule and is available on the web at www.health.mo.gov/information/boards/bnha or by contacting the board at PO Box 570, Jefferson City, MO 65102, (573) 751-3511. This rule does not incorporate any subsequent amendments or additions. The application shall be completed and returned to the board with the fee referenced in 19 CSR 73- 2.015. Information provided in the application shall be attested by signature to be true and correct to the best of the applicant’s knowledge and belief.

(2) The completed application form shall provide satisfactory proof that the applicant has met the following minimum requirements for Missouri residential care and assisted living administrator licensure:

(A) Twenty-one (21) years of age or over;

(B) A high school diploma or equivalent;

(D) Has not been convicted of any crime, an essential element of which is fraud, dishonesty, or moral turpitude, or which involves the operation of a long-term care facility or other health care facility, whether or not sentence is imposed. A copy of the record of conviction or plea of guilty or nolo contendere shall be conclusive evidence of the conviction; and (E) Experience and/or education from an accredited educational institution in one (1) of the following areas:

Experience: A minimum of two (2) years of health care or aging-related experience including management responsibility and supervision of two (2) staff persons; or 2. Experience and education in one (1) of the following A. Associate degree AND one (1) year of health care or aging-related experience including six (6) months of management responsibilities and supervision of at least two (2) staff persons; or B. Baccalaureate degree (BS or BA) or beyond AND six (6) months of health care or aging-related experience including management responsibilities and supervision of at least two (2) staff persons.

(3) The applicant shall be eligible to take the examinations (4) If the board determines the applicant has failed to meet one (1) of the criteria outlined in 19 CSR 73-2.022(2)(E)1.–2., the applicant— (A) May submit additional information for reevaluation if done so no later than two (2) weeks prior to the next board meeting. The applicant will be given notice of the next board meeting date; or (B) Must complete the course of instruction and training approved by the board pursuant to 19 CSR 73-2.031. The planned curriculum, including a description of each planned course, must be submitted to the board in writing for PRIOR review and approval. Failure to do so within six (6) months following notification of the board’s decision will cause reapplication to become necessary for any future consideration.

Original rule filed June 15, 2011, effective Jan. 30, 2012.

History

AUTHORITY: section 344.070, RSMo Supp. 2010. Emergency rule filed May 5, 2011, effective May 15, 2011, expired Feb. 23, 2012.

19 CSR 73-2.023 Procedures and Requirements for Limited Licensure of Administrators {#sec-19-csr-73-2.023 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.023}

PURPOSE: This rule specifies the minimum requirements for limited licensure as a nursing home administrator in Missouri as outlined in section 344.030.3, RSMo.

(1) An applicant interested in becoming a licensed nursing home administrator in an institution certified by the Commission for Accreditation of Christian Science Nursing Organizations/Facilities, Inc. as outlined in section 344.030.3, RSMo, shall either file an application on a form furnished by the board or through the board’s electronic online system. The application form, MO 580-2518 (03-11), Application for Licensure NHA, is incorporated by reference in this rule and is available on the web at www.health.mo.gov/information/boards/bnha or by contacting the board at PO Box 570, Jefferson City, MO 65102, (573) 751-3511. This rule does not incorporate any subsequent amendments or additions. The application shall be completed and returned to the board with the fee referenced in 19 CSR 73- 2.015. Information provided in the application shall be attested by signature to be true and correct to the best of the applicant’s knowledge and belief.

(2) The completed application for the limited licensure pursuant to section 344.030.3, RSMo, shall provide satisfactory proof that the applicant has met the following minimum requirements:

(A) Eighteen (18) years of age or over;

(B) A high school diploma or equivalent;

(C) Of good moral character; and (D) Has not been convicted of any crime, an essential element of which is fraud, dishonesty or moral turpitude, or which involves the operation of a long-term care facility or other health-care facility, whether or not sentence was imposed. A copy of the record of conviction or plea of guilty or nolo contendere shall be conclusive evidence of the conviction.

(3) The applicant shall be eligible to take the state examination (4) If the board determines the applicant has failed to meet one (1) of the criteria outlined in this rule, the applicant may submit additional information for reevaluation if done so no later than two (2) weeks prior to the next board meeting. The applicant shall be given notice of the next board meeting date.

(5) A limited license shall be issued to the applicant upon passing of the state examination.

(6) The licensee shall renew his/her license as outlined in 19 CSR 73-2.050. The licensee shall be exempt from the required ten (10) patient care related clock hours.

History

AUTHORITY: section 344.070, RSMo 2016. Original rule filed Aug. 31, 2018, effective April 30, 2019.

19 CSR 73-2.025 Licensure by Reciprocity {#sec-19-csr-73-2.025 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.025}

PURPOSE: This rule describes the procedures and requirements for reciprocity licensure.

PUBLISHER’S NOTE: The secretary of state has determined that publication of the entire text of the material that is incorporated (1) An applicant who holds a valid current license as an administrator in any state, branch of the military, territory, or the District of Columbia may apply for the appropriate licen sure level by reciprocity (nursing home administrator license or residential care and assisted living administrator license).

The application forms MO 580-2518 (03-11), Application for Licensure NHA, and MO 580-2987 (03-11), Application for Licensure RCAL, are incorporated by reference in this rule and are available on the web at www.health.mo.gov/informa tion/boards/bnha or by contacting the board at PO Box 570, Jefferson City, MO 65102, (573) 751-3511. Information provided in the application must be attested by signature to be true and correct. This rule does not incorporate any subsequent amendments or additions.

(2) The applicant must file the appropriate application for licensure, along with a nonrefundable application fee referenced in 19 CSR 73-2.015, and supply the board with satisfactory evidence that the following requirements have been met:

(A) Eighteen (18) years of age or older;

(B) The applicant meets one (1) of the following criteria:

Health Services Executive (HSE) qualified by the National Association of Long Term Care Administrator Boards (NAB); or 2. Obtained a passing score on the national examination and has held in good standing for at least one (1) year a current administrator license issued by another state, a branch of the military, a territory of the United States, or the District of Columbia, so long as such administrator license is equivalent to the license being applied for as determined by the board; and (C) If the applicant has a criminal conviction as defined in

section 324.012, RSMo, the board will follow the provisions of section 324.012, RSMo, in deciding whether to grant reciprocity.

(3) A reciprocity questionnaire must be forwarded by the applicant to the appropriate jurisdictional administrator licensure board(s) or NAB for those applicants HSE qualified where the applicant was/is licensed. Upon return of the completed questionnaire to the board office, the information supplied to the board shall be reviewed to determine if the licensee meets the criteria in section (2) of this rule and has/has not been disciplined in another jurisdiction.

(4) In the event of a record of discipline, the board must consider the provisions of sections 344.050 and 324.009, RSMo, in deciding whether to grant reciprocity.

(5) Upon meeting the requirements of this rule and upon board approval, the applicant must complete and pass the state examination.

(6) If the applicant is unable to meet the requirements of this

rule, the applicant will be required to follow and meet the criteria set forth in the appropriate rule, either 19 CSR 73-2.020 or 19 CSR 73-2.022.

(7) Applicants for licensure by reciprocity must not act or serve in the capacity of an administrator in this state with out first procuring a license from this board as provided in

Chapter 344 and section 324.009, RSMo. ously filed as 13 CSR 73-2.025. Original rule filed June 28, 1990, effective Dec. 31, 1990. Emergency amendment filed Feb. 4, 1992, effective Feb. 14, 1992, expired June 12, 1992. Amended: Filed Feb. 14, 1992, effective June 25, 1992. Amended: Filed March 4, 1993, effective Aug. 9, 1993. Moved and amended: Filed Jan. 31, 2003, effective Aug. 30, 2003. Amended: Filed Dec. 28, 2007, effective Aug. 30, 2008. Emergency amendment filed May 5, 2011, effective May 15, 2011, expired Feb. 23, 2012. Amended: Filed June 15, 2011, effective Jan. 30, 2012. Amended: Filed April 25, 2023, effective Nov. 30, 2023.

19 CSR 73-2.031 Prescribed Course of Instruction and Training {#sec-19-csr-73-2.031 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.031}

PURPOSE: This rule describes the course of instruction and training that may be prescribed by the board under the authority as set forth in section 344.030.1., RSMo.

(1) Applicants who do not otherwise qualify for examination shall complete one (1) of the following courses of instruction and training. The formal instruction shall be coursework qualifying for academic credit, completed with a grade of not less than “C.” A portion of the formal instruction may be from an intensive and comprehensive seminar of at least forty (40) clock hours specific to long-term care administration which has been approved by the board. An applicant who has completed— (A) A high school education or the equivalent, must complete three hundred fifteen (315) clock hours of formal instruction and a minimum of two thousand (2,000) clock hours of internship;

(B) A licensed practical nurse program, must complete two hundred twenty-five (225) clock hours of formal instruction and a minimum of eight hundred (800) clock hours of internship;

(D) A three (3) year diploma program or a baccalaureate of science (BS)/baccalaureate of arts (BA), must complete five hundred (500) clock hours of internship; or (E) A masters or beyond, must complete five hundred (500) clock hours of internship.

(2) The course of instruction and training shall follow the core of knowledge areas and other subject matter as deemed necessary by the board to properly prepare an applicant for health care administration. The core of knowledge shall include, but shall not be limited to, the following subject areas:

(A) Nursing and Physician Services:

Restorative nursing;
Rehabilitation;
Definition, concept, and procedures of nursing;
Skin and wound care;
Infection control procedures;
Drug administration and drug effects;
Disease recognition and process;
Quality assurance;
Physician’s role in the facility; and 10. Physician/resident relationships;

(B) Social Services:

Resident rights;
Living wills and advance directives;
Social, emotional, religious, and financial needs of the resident;
Family counsel and consultation;
Grieving process;
Death and dying;
Communication with the resident; and 8. Ombudsman program;

Proper nutrition;
Therapeutic diets; and 3. Resident satisfaction;

(D) Social and Therapeutic Recreational Activities:

Needs of the resident;
Community resources;
Rehabilitation services;
Volunteers and auxiliaries; and 5. Chemical dependency of the resident;

(E) Medical Record Keeping:

Medical records systems;
Appropriate charting and documentation; and 3. Evaluation and revision of care plans;

(F) Pharmaceutical Services:

Proper drug handling and control;
Proper drug dispensing; and 3. Drug interactions;

(G) Personnel Management:

Maintaining a positive atmosphere;
Grievance procedures;
Effective communication;
Evaluation procedures;
Recruitment of staff;
Interviewing candidates;
Selecting future employees;
Staff development and training;
Personnel policies and procedures;
Health and safety; 11 Departmental organization and management;
Professional ethics and conduct;
Total quality management; and 14. Health care reform;

(H) Financial Management:

Budgeting;
Marketing principles;
Asset management; and 4. Accounting;

(I) Marketing and Public Relations:

Public relation principles;
Marketing principles;
Newsletters;
Community and social organizations; and 5. Working with the media;

(J) Physical Resource Management:

Building and grounds management;
Environmental services and sanitation;
Safety procedures and programs; and 4. Fire and disaster plans; and (K) Laws, Regulatory Codes, and Governing Boards:
Medicare and Medicaid;
Omnibus Budget Reconciliation Act (OBRA);
Occupational Safety and Health Administration (OSHA);
Americans With Disabilities Act (ADA);
Life safety;
Legislative process;
Board responsibilities; and 8. By-laws.

(3) The course of instruction and training shall include instruction in the services which must be provided in long-term care facilities, the protection of the rights and interests of the residents, and the elements of good long-term care administration, as well as other subject matter as deemed necessary by the board to properly prepare that applicant for long-term care administration.

(4) Instruction and training prescribed by the board shall be recognized as meeting the requirements of this rule only if it is offered by an accredited educational institution or affiliate which has been duly registered with the Missouri Board of Nursing Home Administrators.

(5) Internships as required by section (1) shall be under the direct supervision of a licensed administrator approved and designated as a preceptor by the Missouri Board of Nursing Home Administrators. An administrator may be approved and designated as a preceptor for a period of two (2) years, if s/he— (A) Has been licensed for at least three (3) years;

(B) Has been employed as a Missouri administrator for at least one (1) year within the three (3) years before applying to be a designated preceptor;

(C) Is currently serving as the administrator of a duly licensed intermediate care facility (ICF), skilled nursing facility (SNF), assisted living facility (ALF), or any Residential Care Facility (RCF) that was licensed as a residential care II on or before August 27, 2006, that continues to meet the licensure standards for a residential care facility II in effect on August 27, 2006, with thirty (30) or more beds;

(D) Is an administrator of an ICF, SNF, ALF, or RCF (as described above) with thirty (30) or more beds, which is in substantial compliance with the rules governing long-term care facilities; and (E) Has not been the subject of any action by any board of nursing home administrators or licensing authority which resulted in discipline, including but not limited to, formal reprimand, probation, suspension, or revocation of license or privileges as an administrator; and (F) Has successfully completed a board-approved preceptor training program.

(6) Designated preceptors shall request in writing board approval to conduct an internship for an applicant who has been found not qualified for licensure by the board, based upon

(B) Agrees to give the intern an opportunity to observe and take part in the managerial tasks of the preceptor;

(C) Will acquaint the intern with the organization and operation of all the various departments of the facility by permitting his/her observation and/or participation in department activities;

(D) Will hold an exit interview with the intern upon completion of an internship to point out noted strengths and weaknesses; and (E) Upon satisfactory completion of the internship will prepare and return to the board office the mandatory form certifying the completion of the required hours of internship.

(7) The board, for good cause, may refuse to approve or renew a preceptor designation or may refuse to approve an assignment of an intern to a preceptor.

(8) A preceptor may supervise no more than one (1) intern concurrently.

(9) Internships shall be completed within eighteen (18) months of completion of classroom or other formal instruction unless approved by the board.

(10) A portion of an internship for a nursing home administrator applicant may be completed in a duly licensed ALF or RCF (as described above) with thirty (30) or more beds if the intern desires such experience. The residential care and assisted living administrator applicant may complete its entire portion of an internship in a duly licensed ALF or RCF (as described above) with thirty (30) or more beds. The maximum hours of nursing home administrator internship that may be served in such an ALF or RCF (as described above) are designated as follows.

Nursing home administrator applicants may complete up to— (A) 667 clock hours if 2,000 clock hours are required by the board;

(B) 267 clock hours if 800 clock hours are required by the board;

(C) 214 clock hours if 640 clock hours are required by the board; or (D) 167 clock hours if 500 clock hours are required by the board.

(11) Each day of an internship experience shall include at least one (1) four (4)-hour block of time within the primary working hours of the administrator. previously filed as 13 CSR 73-2.031. Original rule filed May 13, 1980, effective Aug. 11, 1980. Amended: Filed April 14, 1983, effective July 11, 1983. Amended: Filed Oct. 16, 1985, effective March 14, 1986.

Amended: Filed Oct. 1, 1987, effective Jan. 14, 1988. Amended: Filed Jan. 3, 1992, effective May 14, 1992. Amended: Filed July 14, 1993, effective Jan. 13, 1994. Amended: Filed June 30, 1994, effective Feb. 1, 1995. Amended: Filed May 15, 1995, effective Nov. 30, 1995.

Amended: Filed April 30, 1998, effective Oct. 30, 1998. Moved and amended: Filed Jan. 31, 2003, effective Aug. 30, 2003. Amended:

Filed Dec. 28, 2007, effective Aug. 30, 2008. Amended: Filed June 15, 2011, effective Jan. 30, 2012.

19 CSR 73-2.050 Renewal of Licenses renewal of a nursing home administrator license according to the provisions of section 344.040, RSMo. {#sec-19-csr-73-2.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.050}

(1) By April 1 of each year, the board shall notify by mail or electronic communication every person whose license is due to be renewed by June 30 during the current year.

(2) Licenses will be renewed if the licensee— (A) Files an application for renewal on the appropriate licensure-level (nursing home administrator or residential care and assisted living administrator) form furnished by the board or renews through the board’s electronic online system on or before May 30 to ensure receipt of a new license prior to June 30. The application forms, MO 580-2991 (03-11), Application for License Renewal NHA, and MO 580-2988 (03-11), Application for License Renewal RCAL, are incorporated by reference in this

rule and are available on the web at www.health.mo.gov/information/boards/bnha or by contacting the board at PO Box 570, Jefferson City, MO 65102, (573) 751-3511. This rule does not incorporate any subsequent amendments or additions. Information provided in the application shall include an attestation verifying that the licensee has completed at least forty (40) clock hours of board-approved continuing education, as outlined in 19 CSR 73-2.050(3). Any number of continuing education hours earned in the month of June in excess of the required hours may be carried over to the next renewal period.

Licensees shall maintain proof of having completed the number of continuing education hours claimed at the time of renewal.
Upon request of the board, make that proof available for audit to verify completion of the number and validity of hours claimed;

(B) Submit the renewal fee referenced in 19 CSR 73-2.015; and (C) A two (2)-year license shall be issued.

(3) Licensees shall maintain proof of having completed the number of continuing education hours claimed at the time of renewal and shall, upon request of the board, make that proof available for audit to verify completion of the number and validity of hours claimed. Documentation to prove completion of continuing education hours shall be maintained by each licensee for four (4) years from the last day of the licensure year in which the hours were earned.

(A) A minimum of ten (10) clock hours shall be in patient care related offerings, as defined in 19 CSR 73-2.031(2)(A)–(F).

A maximum of twenty (20) clock hours of the forty (40) clock hours may be from on-line continuing education programs if a Missouri board-approved training agency offers the program or approved by the National Continuing Education Review Service (NCERS) under the National Association of Long Term Care Administrator Boards (NAB). The continuing education programs and the academic courses shall meet the following criteria:

Be approved by the board. In the case of academic courses, the licensee shall submit a course description from the college for board review. A maximum of five (5) clock hours per semester hour may be approved by the board. Upon successful completion of the course (grade of “C” or above), an official transcript or grade report shall be submitted to the board office, upon request, as verification of course completion;
Be offered by a registered training agency approved by the board or a single offering provider (as outlined in 19 CSR 73-2.060);
Be approved by another state licensure board for long-term care administrators or by the National Continuing Education Review Service (NCERS) under the National Association of Long Term Care Administrator Boards (NAB).

(B) A maximum of ten (10) clock hours toward the forty (40) required may be obtained as follows:

For the purposes of this subsection, the following definitions shall apply:

A. Referred publication—a publication that undergoes an anonymous review process that determines whether or not the article will be published; and B. National health-care publication—a publication that is— (I) Published by a health-care association whose mission statement/bylaws indicate its scope is national;

(II) Mailed nationwide; and (III) Addressing content contained within the longterm care core of knowledge outlined in 19 CSR 73-2.031(2)(A)– (K);

Publishing health-care related articles of at least fifteen hundred (1,500) words shall be granted one (1) clock hour if

article is published in a magazine or journal publication; and 3. An administrator lecturing at a board-approved seminar may receive credit equal to each hour or quarter hour of presentation time with a maximum of six (6) hours credit earned per licensure period. This credit may be in addition to actual hours of attendance at the seminar, but credit shall be granted for only one (1) presentation of the same seminar.

(C) Serving as a registered preceptor for an applicant who has been required by the board to complete an internship as described in 19 CSR 73-2.031. One (1) clock hour per full month as a preceptor shall be granted with a maximum of ten (10) clock hours per internship. During the two (2)-year licensure period, a maximum of twenty (20) clock hours shall be granted.

(D) Each licensee whose initial licensure period is less than twenty-four (24) months shall be required to obtain at least one and one-half (1 1/2) hours of continuing education for each month in the initial licensure period which shall include programs covering patient-care related topics as defined in 19 CSR 73-2.031(2)(A)–(F). The licensee may complete up to fifty percent (50%) of the prorated hours through on-line continuing education programs. The minimum number of clock hours required in patient-care (PC) related programs is as follows.

Initial licensure period of— 1. 23 months to 18 months—8 PC clock hours 2. 17 months to 12 months—6 PC clock hours 3. 11 months to 6 months—4 PC clock hours 4. 5 months or less—2 PC clock hours.

(4) The board shall annually select, on a random basis, at least five percent (5%) of the licensees applying for renewal to have their claims of continuing education hours audited for compliance with board requirements. A licensee will be notified by mail when a renewal application has been selected for audit and will have up to thirty (30) days to provide copies of all certificates of attendance and other documentation supporting the continuing education clock hours claimed on the renewal application. Nothing in this section shall prevent the board from requiring any individual licensee to provide evidence satisfactory to the board of having completed the continuing education hours required for license renewal. Failure to provide proof of continuing education hours as reported on the renewal application or submission of falsified records can be cause for discipline pursuant to section 344.050.2, RSMo.

(5) When the required information, documentation, and fee are received and approved by the board within the specified time period, the board shall issue the license.

Emergency amendment filed March 19, 1991, effective April 1, 1991, expired July 20, 1991. Amended: Filed April 1, 1991, effective Aug. 30, 1991. Amended: Filed Jan. 3, 1992, effective July 1, 1992.

Amended: Filed June 30, 1994, effective Feb. 1, 1995. Amended:

Filed Jan. 31, 1996, effective July 30, 1996. Moved and amended:

Filed Jan. 31, 2003, effective Aug. 30, 2003. Amended: Filed Dec. 15, 2005, effective July 30, 2006. Amended: Filed Dec. 28, 2007, effective Aug. 30, 2008. Amended: Filed June 15, 2011, effective Jan. 30, 2012. Amended: Filed Aug. 31, 2018, effective April 30, 2019. ** *Original authority: 344.040, RSMo 1969, amended 1979, 1987, 1989, 2000, 2005, 2007 and 344.070, RSMo 1969, amended 1979, 1993, 1995, 2007. **Pursuant to Executive Order 21-07, 19 CSR 73-2.050, paragraph (2)(A)2. and section (4) was suspended from April 2, 2020 through May 1, 2021 and section (3) was suspended from April 2, 2020 through August 31, 2021.

History

AUTHORITY: sections 344.040 and 344.070, RSMo 2016. This rule was previously filed as 13 CSR 73-2.050. Original rule filed May 13, 1980, effective Aug. 11, 1980. Amended: Filed Oct. 16, 1985, effective March 14, 1986. Amended: Filed Oct. 1, 1987, effective Jan. 14, 1988. Amended: Filed June 28, 1990, effective Dec. 31, 1990.

19 CSR 73-2.051 Retired Licensure Status {#sec-19-csr-73-2.051 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.051}

PURPOSE: This rule establishes the procedures by which a currently licensed administrator may retire his/her license and the procedures for reactivating the license, pursuant to section 344.105, RSMo.

(1) Any currently licensed administrator may request to retire the license if s/he has maintained an active Missouri license at least ten (10) years and has retired from the practice of longterm care administration.

(2) Licensees interested in making application shall submit the following information to the board prior to June 30 of the year of renewal of the administrator’s active license:

(A) The fee referenced in 19 CSR 73-2.015; and (B) Original wall license and all other evidence of licensure or evidence satisfactory to the board that the license has been lost, stolen, or destroyed.

(3) The board shall issue a new license to the licensee indicating that the licensee is retired once the board has received the required information and has approved the request for retired licensure status.

(4) A retired license may be reactivated within five (5) years of the granting of the retired license by filing the following information with the board:

(A) A request to reactivate the retired license;

(B) The fee referenced in 19 CSR 73-2.015; and (C) Satisfactory evidence of the completion of twenty (20) clock hours of board approved continuing education, as described in 19 CSR 73-2.050, for each calendar year the license was retired. All clock hours shall be completed after the granting of the retired license or completed within the same licensure year the licensee was granted the retired license. The board may prorate the required clock hours for any portion of a calendar year as follows:

Ten (10) months or more, but less than twelve (12) months—twenty (20) clock hours (including a minimum of five (5) patient care hours);
Seven (7) months or more, but less than ten (10) months— fifteen (15) clock hours (including a minimum of five (5) patient care hours);
Four (4) months or more, but less than seven (7) months— ten (10) clock hours (including a minimum of two and one-half (2.5) patient care hours); or 4. Less than four (4) months—five (5) clock hours (including a minimum of two and one-half (2.5) patient care hours).

(5) If more than five (5) years have passed since the issuance of a retired license to a licensee, the licensee shall follow the procedures for initial licensure stated in section 344.030, RSMo.

(6) No person shall act or serve in the capacity of an administrator in this state or hold himself or herself out as an administrator if his or her license is retired.

(7) Retired licensees shall remain subject to disciplinary action for violations of Chapter 344, RSMo, and the rules promulgated thereunder. ously filed as 13 CSR 73-2.051. Original rule filed Oct. 24, 2000, effective May 30, 2001. Moved and amended: Filed Jan. 31, 2003, effective Aug. 30, 2003. Amended: Filed Dec. 28, 2007, effective Aug. 30, 2008. Amended: Filed June 15, 2011, effective Jan. 30, 2012.

Amended: Filed Aug. 31, 2018, effective April 30, 2019. ** **Pursuant to Executive Order 21-07, 19 CSR 73-2.051, subsection (4)(C) was suspended from April 2, 2020 through August 31, 2021.

19 CSR 73-2.053 Inactive Licensure Status {#sec-19-csr-73-2.053 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.053}

PURPOSE: This rule establishes the procedures by which a currently licensed administrator may place his/her license on an inactive status and the procedures for reactivating the license, pursuant to section 344.108, RSMo.

(1) Any administrator possessing a current license to practice as an administrator in Missouri may request an inactive license.

(2) Licensees interested in requesting an inactive license shall submit the following information to the board prior to June 30 of the year of renewal of the administrator’s active license:

(A) The fee referenced in 19 CSR 73-2.015;

(B) Original wall license and all other evidence of licensure, or evidence satisfactory to the board that the license has been lost, stolen, or destroyed; and (C) Evidence satisfactory to the board of completion of ten (10) clock hours of continuing education in the area of patient care. The licensee may complete up to five (5) hours out of the ten (10) hours of continuing education from on-line continuing education programs if a Missouri board-approved training agency offers the program or approved by the National Continuing Education Service (NCERS) under the National Association of Long Term Care Administrator Boards (NAB).

(3) The board shall provide written notification to the licensee indicating that the license is inactive once the board has received the required information and has approved the request for inactive licensure status.

(4) An inactive license shall expire on June 30 of the second year following the year of issuance and every other year thereafter.

(5) Licensees seeking to renew shall, on or before June 30 of the year of renewal, either file an application or renew through the board’s electronic online system, as provided in 19 CSR 73-2.050, that includes evidence satisfactory to the board of completion of a minimum of ten (10) clock hours of continuing education in the area of patient care and shall be accompanied by the renewal fee referenced in 19 CSR 73-2.015.

(6) A license may be carried in inactive status for up to six (6) years from the date of issuance. If the licensee does not reactivate the license during the six (6)-year period, the license shall expire on the last day of the six (6)-year period.

(7) An inactive license may be reactivated by submitting a request to the board, accompanied by evidence satisfactory to the board of the completion of forty (40) clock hours of continuing education and the fee referenced in 19 CSR 73-2.015.

The forty (40) clock hours of continuing education shall be earned no earlier than six (6) months prior to the request for reactivation and no later than six (6) months after the inactive license has been reactivated. If the holder of an inactive license requests reactivation prior to completing the forty (40) clock hours of continuing education, the board shall issue a six (6)-month interim license to the licensee. The interim license shall expire six (6) months from the date of issuance or at such earlier time as the licensee earns the forty (40) clock hours of continuing education deemed satisfactory to the board of completion of the required hours.

(8) No person shall practice as an administrator or hold himself or herself out as an administrator in this state while his or her license is inactive.

(9) An inactive license shall remain subject to discipline for violations of Chapter 344, RSMo, and the rules promulgated thereunder.

History

AUTHORITY: section 344.070, RSMo 2016. Original rule filed Dec. 28, 2007, effective Aug. 30, 2008. Amended: Filed June 15, 2011, effective Jan. 30, 2012. Amended: Filed Aug. 31, 2018, effective April 30, 2019. Pursuant to Executive Order 21-07, 19 CSR 73-2.053, subsection (2)(C) was suspended from April 2, 2020 through August 31, 2021.

19 CSR 73-2.055 Renewal of Expired License renewing a license that has expired. {#sec-19-csr-73-2.055 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.055}

(1) Any licensee who fails to submit the required application, documentation, and/or fee for license renewal prior to expiration of that license on June 30 may be relicensed by meeting the requirements of this regulation provided that the license has not been expired for a period of more than twelve (12) months.

(2) The licensee must complete and file a license renewal application referenced in 19 CSR 73-2.050, along with a renewal fee referenced in 19 CSR 73-2.015 for a two- (2-) year license, plus the penalty fee. Satisfactory evidence of board-approved continuing education (as outlined in 19 CSR 73-2.050) must also be submitted with the license renewal application. Information provided in the application must be attested to by signature to be true and correct to the best of the applicant’s knowledge and belief and include an attestation verifying that the licensee has completed the required number of board-approved continuing education clock hours obtained during the current licensure period.

(3) The licensee must also supply the board with a statement indicating employment status from the point the license expired through the filing of the application for late renewal.

The licensee must include in the statement written reasons why the license was not renewed prior to the expiration date of June 30.

(4) The board-approved continuing education must be obtained as described in 19 CSR 73- 2.050.

(5) Upon receipt of the required application, documentation, and fee, the board may issue the license effective the date the late renewal is approved by the board.

(6) A person whose license has expired for a period of more than twelve (12) months must meet the requirements set out in 19 CSR 73- 2.020, 19 CSR 73-2.022, 19 CSR 73-2.023, or 19 CSR 73-2.025 for licensure.

(7) Upon expiration of the license, a licensee cannot act in the capacity of an administrator. To do so is a violation of section 344.020, RSMo, and may be grounds for denial of the late renewal application or be cause for discipline of the license.

Amended: Filed Dec. 28, 2007, effective Aug. 30, 2008. Amended:

Filed June 15, 2011, effective Jan. 30, 2012. ** Amended: Filed Nov. 23, 2021, effective June 30, 2022. *Original authority: 344.040, RSMo 1969, amended 1979, 1987, 1989, 2000, 2005, 2007, 2013, and 344.070, RSMo 1969, amended 1979, 1993, 1995, 2007. **Pursuant to Executive Order 21-07, 19 CSR 73-2.055, section (2) was suspended from April 2, 2020 through August 31, 2021.

History

AUTHORITY: sections 344.040 and 344.070, RSMo 2016. This rule was previously filed as 13 CSR 73-2.055. Original rule filed June 28, 1990, effective Dec. 31, 1990. Amended: Filed June 30, 1994, effective Feb. 1, 1995. Amended: Filed Jan. 31, 1996, effective July 30, 1996. Moved and amended: Filed Jan. 31, 2003, effective Aug. 30, 2003. Amended: Filed Dec. 15, 2005, effective July 30, 2006.

19 CSR 73-2.060 Registration of Training Agencies and Single Offering Providers {#sec-19-csr-73-2.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.060}

PURPOSE: This rule sets forth the requirements for registration with the board for training agencies and single offering providers offering courses of study and training intended to qualify applicants for initial licensing or renewal of license as a nursing home administrator.

(1) All organizations described in 19 CSR 73-2.010(12) as a training agency which offer any course of study or program of instruction and training to prepare applicants for licensure as administrators or for the renewal of license as administrators shall register with the board.

(A) These entities shall complete the application for registration as a training agency and submit it to the board along with the supporting documentation required by the form.

(B) This registration, if granted by the board, shall be established for up to two (2) years and notice of this registration and time periods shall be made available to licensees by the board office. The registration of any agency may be terminated at any time at the discretion of the board and with thirty (30) days written notice to the training agency. The agency’s board approval number shall be printed in all program promotional materials that are approved for licensed administrators.

(C) The program shall follow the long-term care core of knowledge areas as described in 19 CSR 73-2.031. All approved training agencies shall submit to the board office in advance, the following information regarding each program they wish to approve for administrator clock hours:

Date, time, and location of presentation broken down into specific time periods, topic titles, and speakers;
A program outline including the purpose and content objectives;
Statements regarding presenter qualifications in his/her particular subject matter area;
Number of clock hours requested, deleting time allotted for breaks and lunch; and 5. For on-line (web-based, teleconference, self-study, and webinar) continuing education courses, the program materials shall also include:

A. Description of the total learning package including the method/rationale used for determining the number of study hours required to complete the program. One (1) clock hour shall be awarded for each hour needed to complete the course.

B. Instruction for program completion; and C. Post-test as part of the total learning package, except for webinars and teleconferences. The information shall demonstrate test security, include a minimum of five (5) multiple choice or true/false questions per clock hour, and require a grade of seventy-five percent (75%) or higher in order to pass.

(D) Thirty (30) days prior to the date the training agency status will expire, the agency shall make reapplication if the agency wishes to continue as an approved provider beyond the designated period. The training agency’s ability to comply with the board’s rules and policies for offering continuing education programs to licensed administrators shall be carefully reviewed during the reapplication process.

(2) Organizations or persons who do not qualify under 19 CSR 73-2.010(12) as a training agency, but wish to sponsor in-person education seminars shall submit the application for approval of a single offering a minimum of thirty (30) days in advance of the presentation. If the application for a single offering is submitted less than thirty (30) days in advance of the presentation, there shall be a separate, nonrefundable late fee of fifty dollars ($50).

(A) The sponsoring agency and its role shall be clearly identified in the application. For first time single offering providers, the organization’s mission statement/goals shall be included.

(B) There shall be a separate, nonrefundable fee as referenced in 19 CSR 73-2.015 for each single offering application filed with the board. The education and training unit of any state agency, or a section of a department, shall be exempt from these application fees.

(D) Single offering applications approved by the board shall reflect the board approval number in the program’s promotional materials.

(3) In order to provide topical education that may be of an immediate nature, the education and training unit of the Missouri Department of Health and Senior Services shall be exempt from the thirty- (30-) day advance notice stipulation.

(4) The training agency and single offering provider shall— (A) Record attendance accurately at each presentation, reflecting the number and type of clock hours of actual attendance of each administrator;

(B) Submit, within thirty (30) days of the conclusion of the approved program, to the board office a summative evaluation and a roster including license number, number and type of clock hours issued to each licensee; and (C) Provide each administrator written evidence of his/her attendance which shall include: title of offering, date of offering, number and type of clock hours actually attended and the board approval number. ously filed as 13 CSR 73-2.060. Original rule filed May 13, 1980, effective Aug. 11, 1980. Amended: Filed Aug. 12, 1981, effective Nov. 12, 1981. Amended: Filed April 14, 1983, effective July 11, 1983.

Amended: Filed Oct. 16, 1985, effective March 14, 1986. Amended:

Filed Oct. 1, 1987, effective Jan. 14, 1988. Amended: Filed Dec. 4, 1989, effective March 1, 1990. Rescinded and readopted: Filed Jan. 3, 1992, effective May 14, 1992. Moved and amended: Filed Jan. 31, 2003, effective Aug. 30, 2003. Amended: Filed Dec. 28, 2007, effective Aug. 30, 2008. Amended: Filed Aug. 31, 2018, effective April 30, 2019.

19 CSR 73-2.070 Examination examination. {#sec-19-csr-73-2.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.070}

(1) The board shall approve the content and form of all examinations administered to applicants for licensure.

(2) The examination(s) must be taken within twelve (12) months of the written notice of board evaluation and qualification.

Failure to do so will cause full reapplication to be necessary.

(3) Qualified applicants will be eligible to take the appropriate licensure-level (nursing home administrator license or residential care and assisted living administrator license) national examination through the National Association of Boards of Examiners of Long Term Care Administrators (NAB).

(4) Qualified applicants will be eligible to take the appropriate licensure-level (nursing home administrator license or residential care and assisted living administrator license) state examination prescribed by the board.

(5) Individuals making initial application for licensure, within twenty-one (21) days of a board meeting date, may be required to wait until a subsequent date to be evaluated.

(6) Applicants shall obtain a passing score on the examination(s) prescribed by the board. The passing score shall be based upon the scale score passing point of one hundred thirteen (113) on the national examination and seventy-five percent (75%) on the state examination.

(7) If an applicant fails to make a passing grade on one or both of the required examinations, the applicant may make application for reexamination and pay the required fees. If an applicant fails only one of the required examinations and then fails to retake and pass the examination within a twelve (12)month period, the applicant shall be required to take and pass both examinations before the board will issue the applicant a license.

(8) If an applicant fails either of the examination(s) a third time, the applicant must complete a course of instruction prescribed and approved by the board. After completion of the board-prescribed course of instruction, the applicant may reapply for board-approved examination(s). No applicant shall be licensed by the board after a third licensure examination failure unless the applicant successfully completes the board-prescribed course of instruction and passes the board-approved examination(s). With regard to any nationally certified examination required for licensure, no examination scores from other states shall be recognized by the board after the applicant has failed for a third time to pass the examination. previously filed as 13 CSR 73-2.070. Original rule filed May 13, 1980, effective Aug. 11, 1980. Amended: Filed Oct. 16, 1985, effective March 14, 1986. Amended: Filed Oct. 1, 1987, effective Jan. 14, 1988. Amended: Filed Dec. 4, 1989, effective March 1, 1990.

Emergency amendment filed Dec. 13, 1991, effective Dec. 23, 1991, expired April 20, 1992. Amended: Filed Jan. 3, 1992, effective May 14, 1992. Amended: Filed April 30, 1998, effective Oct. 30, 1998.

Amended: Filed March 1, 1999, effective Aug. 30, 1999. Emergency amendment filed Nov. 17, 1999, effective Dec. 11, 1999, expired June 7, 2000. Amended: Filed Nov. 1, 1999, effective April 30, 2000.

Emergency amendment filed Nov. 30, 2001, effective Jan. 1, 2002, expired June 29, 2002. Amended: Filed Nov. 30, 2001, effective June 30, 2002. Moved to 19 CSR 73-2.070, effective March 3, 2003.

Amended: Filed Dec. 28, 2007, effective Aug. 30, 2008. Emergency amendment filed May 5, 2011, effective May 15, 2011, expired Feb. 23, 2012. Amended: Filed June 15, 2011, effective Jan. 30, 2012. ** **Pursuant to Executive Orders 20-04, 20-10, and 20-12, 19 CSR 73-2.070, section (2) was suspended from April 2, 2020 through July 13, 2020.

19 CSR 73-2.080 Temporary Emergency Licenses {#sec-19-csr-73-2.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.080}

PURPOSE: This rule sets forth the procedure for requesting an emergency license and extension and the conditions which must be met.

PUBLISHER’S NOTE: The secretary of state has determined that publication of the entire text of the material that is incorporated (1) The application for a temporary emergency license must be filed with the board. The application form MO 580-2664 (2-2023), Temporary Emergency License Application, is in corporated by reference in this rule and is available on the web at www.health.mo.gov/information/boards/bnha or by contacting the board at PO Box 570, Jefferson City, MO 65102, (573) 751-3511. This rule does not incorporate any subsequent amendments or additions. The application must demonstrate that the applicant meets the requirements for a temporary emergency license as set forth in section 344.030.4, RSMo, and must include the following:

(A) The signature of the appropriate authority at the facility where the emergency exists and of the person for whom the license is requested;

(B) The name of the licensed administrator who has died, been removed, or vacated the position and the effective date of the death, removal, or vacancy;

(C) A complete initial application for licensure and a fee for the person for whom the emergency license is requested; and (D) The complete initial application, fee, and application for a temporary emergency license must be filed with the board immediately upon notification of, or realization by, the person making the application, but in no event more than ten (10) working days from the effective date referred to in subsection (1)(B).

(2) After receipt and review of the required information, the board may issue a temporary emergency license for a period not to exceed one hundred twenty (120) days. The person to whom it is issued is fully responsible for the facility as if initially licensed as an administrator and must confirm his/her understanding of this fact in a statement upon receipt of the temporary emergency license.

(3) A temporary emergency license may be issued only to a person— (A) Eighteen (18) years of age or over and who is a high school graduate or equivalent;

(B) Who had been preceded in the position by a fully licensed administrator; and (C) In the event of a record of discipline of an administrator’s license, the board must consider the provisions of sections 344.030.4 and 344.050, RSMo, in determining whether to grant a temporary emergency license.

Amended: Filed Dec. 10, 1984, effective April 11, 1985. Amended:

Filed Oct. 1, 1987, effective Jan. 14, 1988. Moved and amended:

Filed Jan. 31, 2003, effective Aug. 30, 2003. Amended: Filed Dec. 28, 2007, effective Aug. 30, 2008. Amended: Filed June 15, 2011, effective Jan. 30, 2012. ** Amended: Filed April 25, 2023, effective Nov. 30, 2023. *Original authority: 344.030, RSMo 1969, amended 1979, 1987, 1988, 1989, 1996, 2007, 2018, 2020, and 344.070, RSMo 1969, amended 1979, 1993, 1995, 2007. **Pursuant to Executive Orders 20-04, 20-10, and 20-12, 19 CSR 73-2.080, sections (2) and (5) was suspended from April 2, 2020 through July 13, 2020.

History

AUTHORITY: section 344.070, RSMo 2016, and section 344.030, RSMo Supp. 2023. This rule was previously filed as 13 CSR 73- 2.080. Original rule filed May 13, 1980, effective Aug. 11, 1980.

19 CSR 73-2.085 Public Complaints {#sec-19-csr-73-2.085 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.085}

PURPOSE: This rule establishes a procedure for receipt, handling, and disposition of public complaints by the board of nursing home administrators.

(1) The Board of Nursing Home Administrators receives and processes each complaint made against any licensed administrator, or other person or entity, which complaint alleges certain acts or practices which may constitute one (1) or more violations of the provisions of Chapter 344, RSMo. Any member of the public or the profession, or any federal, state, or local official, may make and file a complaint with the board.

Complaints received from sources outside Missouri will be processed in the same manner as those originating within Missouri. No voting members of the Board of Nursing Home Administrators will file a complaint with this board while s/he holds that office, unless that member excuses him/herself from further board deliberations or activity concerning the matters alleged within that complaint. Any staff member or employee of the board may file a complaint pursuant to this rule in the same manner as any member of the public.

(2) Written complaints should be sent to the following: Board of Nursing Home Administrators, PO Box 570, Jefferson City, MO 65102 or email at bnha@health.mo.gov. However, actual receipt of the complaint by the board at its administrative offices in any manner shall be sufficient. Complaints may be based upon personal knowledge, or upon information and belief, reciting information received from other sources.

(3) All complaints shall be made in writing and shall fully identify their maker by name and address. Complaints may be made on forms provided by the board, which shall be available upon request. Oral or telephone communications will not be considered or processed as complaints. Any person attempting to make an oral or telephone complaint against an individual will be provided with a complaint form and requested to complete it and return it to the board. Any staff member or employee of the board may make and file a complaint based upon information and belief, in reliance upon oral, telephone, or written but unsigned communications received by the board, unless those communications are believed by that staff member or employee to be false.

(4) A record of each complaint received under this rule shall be retained by the board. Complaints shall be logged in the order as received and shall contain a record of each complainant’s name and address; the name and address of the subject(s) of the complaint; the date each complaint is received by the board; a brief statement of the acts complained of, including the name of any person injured or victimized by the alleged acts or practices; a notation whether the complaint resulted in its dismissal by the board or in formal charges being filed with the Administrative Hearing Commission; and the ultimate disposition of the complaint. The complaint information shall be a closed record of the board.

(5) Each complaint shall be acknowledged in writing. The acknowledgment shall state that the complaint is being investigated and shall be referred to the board or an appropriate board subcommittee for consideration following the investigation. The complainant may be notified of the ultimate disposition of the complaint, excluding judicial appeals, and may be provided with a copy of the decisions (if any) of the Administrative Hearing Commission and the board. The provisions of this section shall not apply to complaints filed by staff members or employees of the board, based upon information and belief, acting in reliance on third-party information received by the board.

(6) Both the complaint and any information obtained as a result of the complaint investigation shall be considered a closed record of the board and shall not be available for inspection by the public.

(7) This rule shall not be deemed to limit the board’s authority to file a complaint with the Administrative Hearing Commission or with a court, charging a licensee, permittee, or other person or entity with any actionable conduct or violation, whether or not this complaint exceeds the scope of the acts charged in a preliminary public complaint filed with the board and whether or not any public complaint has been filed with the board.

(8) The board interprets this rule, which is required by law, to exist for the benefit of those members of the public who submit complaints to the board. This rule is not deemed to protect or to inure to the benefit of those licensees, permit holders, registrants or other persons or entities against whom the board has instituted or may institute administrative or judicial proceedings concerning possible violations of the provisions of Chapter 344, RSMo.

Amended: Filed Nov. 23, 2021, effective June 30, 2022.

History

AUTHORITY: section 344.070, RSMo Supp. 2016. This rule was previously filed as 13 CSR 73-2.085. Original rule filed Oct. 4, 1988, effective March 15, 1989. Amended: Filed Jan. 3, 1992, effective May 14, 1992. Moved and amended: Filed Jan. 31, 2003, effective Aug. 30, 2003. Amended: Filed Dec. 28, 2007, effective Aug. 30, 2008. Amended: Filed June 15, 2011, effective Jan. 30, 2012.

19 CSR 73-2.090 Disciplinary Action {#sec-19-csr-73-2.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.090}

PURPOSE: This rule describes the condition and procedure for disciplinary action, as defined in section 344.050, RSMo, against licenses.

(1) The board may refuse to issue or renew any certificate of registration or authority, permit or license required pursuant to this chapter for one (1) or any combination of causes stated in section (2) of this rule. The board shall notify the applicant in writing of the reasons for the refusal and shall advise the applicant of his/her right to file a complaint with the Administrative Hearing Commission as provided by Chapter 621, RSMo. As an alternative to refusal to issue or renew any certificate, registration or authority, permit or license, the board may, at its discretion, issue a license which is subject to probation for any one (1) or any combination of causes stated in section (2) of this

rule. The board’s order of probation shall contain a statement of the discipline imposed, the basis therefore, the date such action shall become effective, and a statement that the applicant has thirty (30) days to request in writing a hearing before the Administrative Hearing Commission. If the board issues a probationary license to an applicant for licensure, the applicant may file a written petition with the Administrative Hearing Commission within thirty (30) days of the effective date of the probationary license seeking review of whether cause exists to discipline the licensee under section (2) of this rule. If no written request for a hearing is received by the Administrative Hearing Commission within the thirty (30)-day period, the right to seek review of the board’s decision shall be waived.

(2) The board may cause a complaint to be filed with the Administrative Hearing Commission as provided by Chapter 621, RSMo, against any holder of any certificate of registration or authority, permit or license required by this chapter or any person who has failed to renew or has surrendered his/her certificate or registration or authority, permit or license for any one (1) or any combination of the following causes:

(A) Use or unlawful possession of any controlled substance, as defined in Chapter 195, RSMo, or alcoholic beverage to an extent that this use impairs a person’s ability to perform the work of any profession licensed or regulated by this chapter;

(B) Has been finally adjudicated and found guilty, or entered a plea of guilty or nolo contendere, pursuant to criminal prosecution under the laws of any state or of the United States, for any offense reasonably related to the qualifications, functions or duties of any professional licensed or regulated under this

chapter, for any offense an essential element of which is fraud, dishonesty or an act of violence, or for any offense involving moral turpitude, whether or not sentence is imposed;

(C) Use of fraud, deception, misrepresentation or bribery in securing any certificate of registration or authority, permit or license issued pursuant to this chapter or in obtaining permission to take any examination given or required pursuant to this chapter;

(D) Obtaining or attempting to obtain any fee, charge, tuition or other compensation by fraud, deception or misrepresentation;

(E) Performing incompetent, misconduct, gross negligence, fraud, misrepresentation or dishonesty in the performance of the functions or duties of any profession licensed or regulated by this chapter (refer to 19 CSR 73-2.095 for a partial listing of those functions and duties);

(F) Violating, assisting or enabling any person to violate, any provision of this chapter, or of any lawful rule adopted pursuant to this chapter;

(G) Violation of, or assisting or enabling any person to violate, any provision of Chapter 198, RSMo, or any lawful rule or

regulation promulgated thereunder;

(H) Impersonation of any person holding a certificate of registration or authority, permit or license, or allowing any person to use such person’s certificate of registration or authority, permit, license or diploma from any school;

(I) Disciplinary action against the holder of a license or other right to practice any profession regulated by this chapter granted by another state, territory, federal agency or country upon grounds for which revocation or suspension is authorized in this state;

(J) A person is finally adjudged incapacitated or disabled by a court of competent jurisdiction;

(K) Assisting or enabling any person to practice or offer to practice any profession licensed or regulated by this chapter who is not registered and currently eligible to practice under this chapter;

(L) Issuance of a certificate of registration or authority, permit or license based upon a material mistake of fact;

(M) Violation of the drug laws or rules and regulations of this state, any other state or the federal government;

(N) Knowingly failing to report abuse or neglect of a resident in a long-term care facility, as required by section 198.070, RSMo, of which he or she has actual knowledge that it is abuse or neglect;

(O) Violation of any professional trust or confidence; or (P) Having served as the administrator, operator, or any principal involved in the operation of a facility licensed under

Chapter 198, RSMo, and during such time the facility has had its license revoked under section 198.036, RSMo, has entered into a consent agreement to obtain a probationary license under subsection 5 of section 198.026, RSMo, has had a license denied under subsection 2 of section 198.022, RSMo, or has surrendered its license while under investigation.

(3) The Administrative Hearing Commission shall have no authority to require issuance of a license, pending a final determination by the commission, in any case in which an applicant is seeking initial licensure.

(4) No license may be suspended or revoked and no application for renewal of a license may be denied under this section until the licensee has been afforded an opportunity for hearing after due notice as provided in sections 621.015–621.205, RSMo.

(5) Upon a finding by the Administrative Hearing Commission that the grounds, provided in section (2) of this rule, for disciplinary action are met, singly or in combination, the board may censure or place the person named in the complaint on probation on such terms as the board deems appropriate, or may suspend or revoke the certificate, permit or license.

(6) The board may exclude any application for up to five (5) years for any person who has had his or her license revoked by the board or has surrendered his or her license to the board.

Moved and amended: Filed Jan. 31, 2003, effective Aug. 30, 2003.

Amended: Filed Dec. 28, 2007, effective Aug. 30, 2008.

History

AUTHORITY: section 344.070, RSMo Supp. 2007. This rule was previously filed as 13 CSR 73-2.090. Original rule filed May 13, 1980, effective Aug. 11, 1980. Amended: Filed Oct. 16, 1985, effective March 14, 1986. Amended: Filed Oct. 1, 1987, effective Jan. 14, 1988. Amended: Filed Dec. 4, 1989, effective March 1, 1990.

19 CSR 73-2.095 Standards of Professional Conduct {#sec-19-csr-73-2.095 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.095}

PURPOSE: The Board of Nursing Home Administrators is committed to high standards of care for the aging population in Missouri nursing homes. To assure that those standards are met by licensed administrators in Missouri, the board provides standards of conduct consistent with accepted standards of the nursing home administration profession. Behavior (acts, knowledge and practice) which fails to conform to the accepted standards shall constitute unprofessional conduct. This rule sets out those standards which must be maintained by the nursing home administrator.

(1) The administrator shall— (A) Be held responsible for informing him/herself of the needs of the residents and the needs of the facility and apprise the operator of these needs on a routine basis;

(B) Be held responsible for the actions of all employees with regard to Chapter 198, RSMo, unless— 1. Upon learning of the violation, the administrator attempted to immediately correct the violation;

The administrator did not sanction the violation; and 3. The administrator did not attempt to avoid learning of the violation;

(D) Establish and enforce policies and procedures for the protection of residents rights, funds and property;

(E) Establish and enforce policies and procedures for all nursing home rules as stated in 19 CSR 30-82 through 19 CSR 30-89;

(F) Not permit or allow another person to use his/her nursing home administrator license for any purpose;

(G) Report through the proper channels the incompetent, unethical or illegal practice of any health care professional; and (H) Devote reasonable time and attention to the management of the health, safety and welfare of the residents of the facility.

(2) Failure of the licensee to comply with any of the provisions of section (1) of this rule in performing any of the acts covered by the licensure law may be considered by the board to be conduct which is detrimental to the interest of the public and may be deemed in violation of the licensure law and shall be sufficient cause for the board to pursue a complaint against the offending licensee to the Administrative Hearing Commission.

History

AUTHORITY: section 344.070, RSMo 2000. This rule was previously filed as 13 CSR 73-2.095. Original rule filed Jan. 19, 1988, effective April 11, 1988. Amended: Filed June 28, 1990, effective Dec. 31, 1990. Moved and amended: Filed Jan. 31, 2003, effective Aug. 30, 2003. Original authority: 344.070, RSMo 1969, amended 1979, 1993, 1995.

19 CSR 73-2.100 Restoration and Rehabilitation of Suspended/Revoked Licenses the restoration and rehabilitation of suspended/revoked licenses. {#sec-19-csr-73-2.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.100}

(1) Each applicant seeking to restore to good standing a license, issued under Chapter 344, RSMo, which has been revoked, suspended or if there has been a finding of cause for discipline, must present with his/her application whatever evidence the board may have required at the time of the revocation or suspension. The board may require whatever steps as are rationally related to the cause of disciplinary action.

History

AUTHORITY: section 344.070, RSMo Supp. 1993. This rule was previously filed as 13 CSR 73-2.100. Original rule filed May 13, 1980, effective Aug. 11, 1980. Amended: Filed Oct. 4, 1988, effective March 15, 1989. Moved to 19 CSR 73-2.100, effective March 3, 2003. Original authority: 344.070, RSMo 1969, amended 1979, 1993.

19 CSR 73-2.105 Disciplinary Proceedings {#sec-19-csr-73-2.105 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.105}

PURPOSE: This rule describes the board’s procedure for the investigation of a complaint or referral and stipulates the conduct of disciplinary hearings upon receipt of a ruling from the Administrative Hearing Commission that a licensee has violated

Chapter 344, RSMo.

(1) Upon receipt of a complaint or referral, the board shall investigate the actions of the licensee against whom the complaint is made. In conducting an investigation, the board, in its discretion, may request the licensee under investigation to answer the charges made against him/her in writing, and to produce relevant documentary evidence and may request him/ her to appear before the board. A copy of any written answer of the licensee may be furnished to the complainant.

(2) Upon final ruling by the Administrative Hearing Commission that the acts of a licensee constitute a violation of the licensure law or these rules, the board shall proceed to revoke or suspend the license of the offending licensee or take other authorized action as it shall deem appropriate.

(3) After the hearing, the board, singly or in combination, may censure or place the licensee on probation on terms and conditions as the board deems appropriate. These conditions may include, but shall not be limited to, satisfactory completion of certain educational requirements, passage of a written examination of the type given to applicants for licensure, making personal appearances before and periodic reports to the board, and restitution of money or property.

History

AUTHORITY: section 344.070, RSMo Supp. 1993. This rule was previously filed as 13 CSR 73-2.105. Original rule filed Oct. 4, 1988, effective March 15, 1989. Moved to 19 CSR 73-2.105, effective March 3, 2003. Original authority: 344.070, RSMo 1969, amended 1979, 1993.

19 CSR 73-2.110 Display of License {#sec-19-csr-73-2.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.110}

PURPOSE: This rule describes the requirement for display of license.

(1) Every person licensed as a nursing home administrator or residential care and assisted living administrator must display the license in a conspicuous place in the office or place of business of employment of that license. Affixed to the license will be verification from the board of current renewal.

Filed Nov. 23, 2021, effective June 30, 2022.

History

AUTHORITY: section 344.070, RSMo 2016. This rule was previously filed as 13 CSR 73-2.110. Original rule filed May 13, 1980, effective Aug. 11, 1980. Amended: Filed Oct. 16, 1985, effective March 14, 1986. Moved to 19 CSR 73-2.110, effective March 3, 2003.Original
authority: 344.070, RSMo 1969, amended 1979, 1993. Amended:

19 CSR 73-2.120 Duplicate License {#sec-19-csr-73-2.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.120}

PURPOSE: This rule describes the conditions and procedure for obtaining a duplicate license.

(1) If an administrator requires a duplicate license, the administrator must submit a written request for a duplicate license to the board office, along with a written explanation as to why the original license is no longer available. ously filed as 13 CSR 73-2.120. Original rule filed May 13, 1980, effective Aug. 11, 1980. Amended: Filed Oct. 16, 1985, effective March 14, 1986. Moved to 19 CSR 73-2.120, effective March 3, 2003.

Amended: Filed Dec. 28, 2007, effective Aug. 30, 2008. Amended:

Filed June 15, 2011, effective Jan. 30, 2012. Amended: Filed Nov. 23, 2021, effective June 30, 2022.

19 CSR 73-2.130 Notice of Change of Contact Information and Missouri Administrator Employment reporting change of address. {#sec-19-csr-73-2.130 omnilex-key=us-mo-regs-official--title-19--19 CSR 73-2.130}

(1) Each administrator shall notify the board office of his/her current contact information within ten (10) calendar days of change for any of the following:

(A) Personal contact information, which shall include administrator license number, personal mailing address, email, and telephone number(s); and (B) Missouri administrator employment, which shall include, administrator license number, facility name, mailing address, telephone number(s), and employment dates. ously filed as 13 CSR 73-2.130. Original rule filed May 13, 1980, effective Aug. 11, 1980. Amended: Filed Oct. 17, 1985, effective March 14, 1986. Moved to 19 CSR 73-2.130, effective March 3, 2003.

Amended: Filed June 15, 2011, effective Jan. 30, 2012. Amended:

Filed Nov. 28, 2022, effective June 30, 2023.

Division 80 State Cancer Center

Chapter 1SN * - moved to 6 CSR 250-7

19 CSR 80-1SN * - moved to 6 CSR 250-7 {#sec-19-csr-80-1sn omnilex-key=us-mo-regs-official--title-19--19 CSR 80-1SN}

MATTBLUNT(1/29/03)

Rules of Department of Health and Senior Services Division 80óState Cancer Center SPECIAL NOTICE

Chapter 1óFinancial Administration of the State Cancer Center On November 1, 1990, Division 80óState Cancer Center transferred to Division 250óUniversity of Missouri. The rules of the State Cancer Center may be found at 6 CSR 250-7.

Division 90 Missouri Senior Rx Program

Chapter 1 Eligible Seniors

19 CSR 90-1.010 Definitions Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-1.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-1.010}

19 CSR 90-1.020 Eligibility and Application Process Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-1.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-1.020}

19 CSR 90-1.030 General Payment Provisions Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-1.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-1.030}

19 CSR 90-1.040 Claimant’s Responsibilities Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-1.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-1.040}

19 CSR 90-1.050 Process for Reenrollment into the Program Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-1.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-1.050}

19 CSR 90-1.060 Authorized Agent Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-1.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-1.060}

19 CSR 90-1.070 Program Identification Card Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-1.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-1.070}

19 CSR 90-1.080 Termination from the Program Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-1.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-1.080}

19 CSR 90-1.090 Appeal Process Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-1.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-1.090}

JOHNR. ASHCROFT(7/31/18)

Chapter 2 Participating Pharmacies

19 CSR 90-2.010 Definitions Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-2.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-2.010}

19 CSR 90-2.020 Eligibility and Application Process Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-2.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-2.020}

19 CSR 90-2.030 Responsibilities of Enrolled Participating Pharmacies Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-2.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-2.030}

19 CSR 90-2.040 Termination or Suspension from the Program Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-2.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-2.040}

19 CSR 90-2.050 Appeal Process Supp. 2001. Emergency rule filed Jan. 16, Jan. 5, 2018, effective Aug. 30, 2018. {#sec-19-csr-90-2.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-2.050}

JOHNR. ASHCROFT(7/31/18)

Chapter 3 Manufacturers Rebate Program

19 CSR 90-3.010 Manufacturers Rebate {#sec-19-csr-90-3.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 90-3.010}

MATTBLUNT(9/30/02)

Chapter 3óManufacturers Rebate Program19 CSR 90-3

History

AUTHORITY: section 208.553.3(5), RSMo Supp. 2001. Emergency rule filed Feb. 15, 2002, effective March 1, 2002, expired Aug. 27, 2002.

Division 100 Division of Cannabis Regulation

Chapter 1 Marijuana

19 CSR 100-1.010 Definitions {#sec-19-csr-100-1.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.010}

PURPOSE: This rule defines terms used in Chapter 1.

(1) “Administer” means the direct application of marijuana by way of any of the following methods:

(A) Ingestion of capsules, teas, oils, and other marijuanainfused products;

(B) Vaporization or smoking of dried flowers, buds, plant material, extracts, oils, and other marijuana-infused products;

(D) Transdermal patches and suppositories;

(E) Consuming marijuana-infused food products; or (F) Any other method recommended by a qualifying patient’s physician or nurse practitioner.

(2) “Administrative hold” means a status given to marijuana product by the department that prohibits any activity with the marijuana product including waste, sale, or transfer of the marijuana product until the hold is lifted.

(3) “Advertisement” means any dissemination of information by print, audio, or video means, whether through the media or otherwise, including but not limited to billboards, radio, television, motion pictures, newspapers, internet, email, texting, website, mobile applications, magazines or similar publications or other printed or graphic matter, or any electronic means, except that the term shall not include— (A) Any packaging or label affixed to packaging of marijuana product; and (B) Any editorial in any periodical or publication or newspaper for the preparation or publication of which no money or other valuable consideration is paid or promised, directly or indirectly, by or on behalf of any entity subject to these regulations.

(4) “Applicant” means the entity applying for a license, certification, or identification card.

(5) “Applicant identifier” means a number assigned to an application for the purposes of conducting a lottery to award licenses or certifications.

(6) “Batch” means a specific, identified quantity of marijuana, from immature plant stage to harvest that is uniform in strain, and cultivated utilizing the same growing practices.

(7) “Church” means a permanent building primarily and regularly used as a place of religious worship.

(8) “Clone” means a marijuana vegetative cutting.

(9) “Comprehensive facility” means a comprehensive marijuana cultivation facility, comprehensive marijuana dispensary facility, or a comprehensive marijuana-infused products manufacturing facility.

(10) “Comprehensive marijuana cultivation facility” means a facility licensed by the department where marijuana cultivation operations for medical or adult use occur.

(11) “Comprehensive cultivation licensee” means an entity cultivating marijuana for medical or adult use at a comprehensive marijuana cultivation facility.

(12) “Comprehensive marijuana dispensary facility” means a facility licensed by the department where marijuana product is dispensed for medical or adult use.

(13) “Comprehensive dispensary licensee” means an entity dispensing marijuana product for medical or adult use at a comprehensive marijuana dispensary facility.

(14)

“Comprehensive marijuana-infused products manufacturing facility” means a facility licensed by the department where marijuana-infused products and prerolls are manufactured for medical or adult use.

(15) “Comprehensive manufacturing licensee” means an entity manufacturing marijuana-infused products and prerolls for medical or adult use at a comprehensive marijuana-infused products manufacturing facility.

(16) “Congressional district” means a United States congressional district in the state of Missouri pursuant to the map of each of the eight (8) congressional districts as drawn and effective on December 6, 2018.

(17) “Consumer” means a person who is at least twenty-one (21) years of age.

(18) “Contractor” means a person performing work or service of any kind for a marijuana facility in accordance with a contract with that facility.

(19) “Cultivation facility” means a medical marijuana cultivation facility, a comprehensive marijuana cultivation facility, or a microbusiness wholesale facility licensed to cultivate marijuana.

(20) “Dangerous material” means any substance or material that is capable of posing an unreasonable risk to health, safety, and property.

(21) “Daycare” means a child-care facility, as defined by section 210.201, RSMo, or its successor provisions, that is licensed by the state of Missouri.

(22) “Delivery” means the movement of marijuana from a dispensary facility to a consumer, qualifying patient, or primary caregiver.

(23) “Department” means the Department of Health and Senior Services, or its successor agency.

(24) “Dispensary facility” means a medical marijuana dispensary facility, a comprehensive marijuana dispensary facility, or a microbusiness dispensary facility.

(25) “Disqualifying felony offense” means a violation of, and conviction or guilty plea to, state or federal law that is, or would have been, a felony under Missouri law, regardless of the sentence imposed. Exceptions for both medical and marijuana facility owners can be found in Article XIV of the Missouri Constitution.

(26) “Dried, unprocessed marijuana or its equivalent” means the marijuana flower after it has been cured and trimmed, or its equivalent amount of marijuana concentrate or tetrahydrocannabinol (THC) content. For purposes of purchase and possession limitations, one (1) ounce of dried, unprocessed marijuana is equivalent to eight (8) grams of marijuana concentrate or eight hundred (800) milligrams of THC in infused products.

(27) “Elementary or secondary school” means any public school as defined in section 160.011, RSMo, or any private school giving instruction in a grade or grades not higher than the twelfth grade, including any property owned by the public or private school that is regularly used for extracurricular activities, but does not include any private school in which education is primarily conducted in private homes.

(28) “Enclosed, locked facility” means a stationary, fully enclosed, locked space— (A) Equipped with functioning security devices that permit access to only the consumer(s), qualifying patient(s), or primary caregiver(s) who have informed the department that this is the space where they will cultivate marijuana; and (B) Where plants are not be visible to the unaided eye from a public space.

(29) “Entity” means a natural person, corporation, professional corporation, nonprofit corporation, cooperative corporation, unincorporated association, business trust, limited liability company, general or limited partnership, limited liability partnership, joint venture, or any other legal entity.

(30) “Facility” means the physical structure(s), including strip malls, and the premises on which the physical structures are located which are used by a licensed or certified entity to perform its licensed or certified functions, whether the entity is licensed or certified as a medical facility or a marijuana facility.

(31) “Facility agent” means an individual who holds an agent identification card issued by the department.

(32) “Financial interest” all the economic rights and benefits owed to the holder of an equity ownership position in an entity.

(33) “Final marijuana product” means marijuana product that is intended for human use and includes all ingredients whether or not the ingredients contain cannabinoids. Where marijuana will be sold in a method of administration, the marijuana product must be processed into its method of administration before it is a final marijuana product.

(34) “Flowering plant” means a marijuana plant from the time it exhibits the first signs of sexual maturity through harvest.

(35) “Flowering plant canopy space” means a space dedicated to growing flowering marijuana plants. Flowering plant canopy space is calculated in square feet and is measured from the outermost point of a flowering plant in a designated growing area and continuing around the outside of all flowering plants in that designated growing area, but not including space allocated for walkways or ancillary equipment. This space may be spread over a single tier or multiple tiers. If growing spaces are stacked vertically, each level of space shall be measured and included as part of the total flowering plant canopy space measurement. When measuring flowering plant canopy space before flowering plants are in the space, the square footage is calculated by measuring the facility-designated growing area, but not including space allocated for walkways or ancillary equipment.

(36) “Harvest lot” means a specifically identified quantity of marijuana that is uniform in strain, cultivated utilizing the same growing practices, harvested within a seventy-two- (72-) hour period at the same location, and cured under uniform conditions.

(37) “Historic rate of incarceration” means the average annual number of incarcerated offenders for marijuana-related offenses, per one hundred thousand (100,000) individuals of the general population within the same jurisdiction, for twenty (20) years prior to the passage of Article XIV, Section 2 of the Missouri Constitution.

(38) “Homogeneity” means the amount of cannabinoids within a marijuana product being consistent and reasonably equally dispersed throughout the marijuana product, including each portion of the marijuana product.

(39) “Identification card” means a document, whether in paper or electronic format, issued by the department that authorizes a consumer cultivator, qualifying patient, primary caregiver, or facility agent to access marijuana as provided by law.

(40) “Immature plant” means a non-flowering marijuana plant that is neither taller than eight (8) inches nor wider than eight (8) inches.

(41) “Infused preroll” means a consumable or smokable marijuana product, generally consisting of— (A) Wrap or paper;

(B) Dried flower, buds, and/or plant material; and (C) A concentrate, oil, or other type of marijuana extract, either within or on the surface of the product.

Infused prerolls may or may not include a filter or crutch at the base of the product.

(42) “Licensee” means an entity licensed or issued a certificate by the department to operate a medical or marijuana facility under Article XIV of the Missouri Constitution.

(43) “Limited access area” means all areas within a facility other than any public access points where individuals are screened for approval to enter.

(44) “Local government” means, in the case of an incorporated area, a village, town, or city; and, in the case of an unincorporated area, a county.

(45) “Majority owned” means more than fifty percent (50%) of the financial interests (other than a security interest, lien, or encumbrance) or more than fifty percent (50%) of the voting interests of an entity, including any parent and subsidiary entities.

(46) “Mandatory test” means a test required before a marijuana product can be sold to consumers, qualifying patients, or primary caregivers.

(47) “Manufacturing facility” means a medical marijuanainfused products manufacturing facility, a comprehensive marijuana-infused products manufacturing facility, or a microbusiness wholesale facility licensed to manufacture marijuana.

(48) “Marijuana” or “marihuana” means Cannabis indica, Cannabis sativa, and Cannabis ruderalis, hybrids of such species, and any other strains commonly understood within the scientific community to constitute marijuana, as well as seeds, clones, and resin extracted from the marijuana plant.

“Marijuana” or “marihuana” does not include industrial hemp as defined by Missouri statute, or commodities or products manufactured from industrial hemp.

(49) “Marijuana facility” means a comprehensive marijuana cultivation facility, comprehensive marijuana dispensary facility, comprehensive marijuana-infused products manufacturing facility, marijuana testing facility, transportation facility, microbusiness wholesale facility, microbusiness dispensary facility, or any other type of marijuana-related facility or business licensed or certified by the department pursuant to

Article XIV, Section 2 of the Missouri Constitution, but shall not include a medical facility or marijuana research facility.

(50) “Marijuana-infused products” means products that are infused, dipped, coated, sprayed, or mixed with marijuana or an extract thereof, including but not limited to products that are able to be vaporized or smoked, edible products, ingestible products, topical products, suppositories, and infused prerolls.

(51) “Marijuana microbusiness facility” means a facility licensed by the department as a microbusiness dispensary facility or microbusiness wholesale facility.

(52) “Marijuana product” means marijuana, marijuana-infused products, or other products made using marijuana, including prerolls, as those terms are defined herein, unless otherwise provided for in these rules.

(53) “Marijuana research facility” means a facility licensed by the department where activities intended to facilitate scientific research or education related to marijuana product occur.

(54) “Marijuana research licensee” means an entity licensed by the department to engage in activities intended to facilitate scientific research or education related to marijuana product at a marijuana research facility.

(55) “Marijuana testing facility” means a facility certified by the department where testing of marijuana product is authorized to occur.

(56) “Marijuana testing licensee” means an entity certified by the department to engage in the testing of marijuana product at a marijuana testing facility.

(57) “Medical facility” means any medical marijuana cultivation facility, medical marijuana dispensary facility, or medical marijuana-infused products manufacturing facility.

(58) “Medical marijuana cultivation facility” means a facility licensed by the department where marijuana cultivation operations occur that is limited to medical use.

(59) “Medical cultivation licensee” means an entity licensed by the department to engage in the process of cultivating marijuana that is limited to medical use at a medical marijuana cultivation facility.

(60) “Medical marijuana dispensary facility” means a facility licensed by the department where marijuana is dispensed only for medical use.

(61) “Medical dispensary licensee” means an entity licensed by the department to engage in the process of dispensing marijuana only for medical use at a medical marijuana dispensary facility.

(62) “Medical marijuana-infused products manufacturing facility” means a facility licensed by the department where marijuana-infused products and prerolls are manufactured only for medical use.

(63) “Medical-infused products manufacturing licensee” means an entity licensed by the department to engage in the process of manufacturing marijuana-infused products and prerolls only for medical use at a medical marijuana-infused products manufacturing facility.

(64) “Medical use” means the production, possession, delivery, distribution, transportation, or administration of marijuana or a marijuana-infused product, or drug paraphernalia used to administer marijuana or a marijuana-infused product, for the benefit of a qualifying patient to mitigate the symptoms or effects of the patient’s qualifying medical condition.

(65) “Method of administration” means the tool(s) used to administer marijuana product.

(66) “Microbusiness dispensary facility” means a microbusiness facility licensed by the department where marijuana is dispensed for medical or adult use.

(67) “Microbusiness dispensary licensee” means an entity licensed by the department to engage in the process of dispensing marijuana for medical or adult use at a microbusiness dispensary facility.

(68) “Microbusiness facility” means a microbusiness dispensary facility or a microbusiness wholesale facility.

(69) “Microbusiness wholesale facility” means a microbusiness facility licensed by the department where marijuana cultivation operations for medical or adult use occur and/or where marijuana-infused products and prerolls are manufactured for medical or adult use.

(70) “Microbusiness wholesale licensee” means an entity licensed by the department to engage in the process of cultivating marijuana for medical or adult use and/or manufacturing marijuana-infused products and prerolls for medical or adult use at a microbusiness wholesale facility.

(71) “Non-emancipated qualifying patient” means a qualifying patient under the age of eighteen (18) who has not been emancipated under Missouri law.

(72) “Non-violent marijuana offense” means a marijuana offense that does not include, within the same criminal episode, any other offense that is violent in nature.

(73) “Nurse practitioner” means an individual who is licensed and in good standing as an advanced practice registered nurse, or successor designation, under Chapter 335 of the Revised Statutes of Missouri.

(74) “Owner” means an individual or other entity having a financial or voting interest in ten percent (10%) or greater of a medical or marijuana facility license.

(75) “Ownership interest” means any amount of financial or voting interest in a medical or marijuana facility license.

(76) “Physician” means an individual who is licensed as a physician pursuant to section 334.031, RSMo, and in good standing to practice medicine or osteopathy under Missouri la w.

(77) “Physician or nurse practitioner certification” means a document, whether handwritten, electronic, or in another commonly used format, signed by a physician or nurse practitioner and stating that, in the physician’s or nurse practitioner’s professional opinion, the patient suffers from a qualifying medical condition.

(78) “Preroll” means a consumable or smokable marijuana product, generally consisting of— (A) A wrap or paper; and (B) Dried flower, buds, and/or plant material.

Prerolls may or may not include a filter or crutch at the base of the product.

(79) “Primary caregiver” means an individual twenty-one (21) years of age or older who has significant responsibility for managing the well-being of a qualifying patient and who is designated as such on the primary caregiver’s application for an identification card under this section or in other written notification to the department.

(80) “Principal officers or managers” means persons who, regardless of title, have responsibility for supervising the management, administration, or operation of an entity, including, but not limited to: presidents, vice presidents, or general counsels; chief executive, financial, or operating officers; general partners, managing partners, or controlling partners; managing members; or trustees.

(81) “Process lot” means, once production is complete, any amount of marijuana concentrate or marijuana extract of the same type and processed using the same extraction methods, standard operating procedures, and harvest lots; or any amount of marijuana-infused product or prerolls of the same type and processed using the same ingredients, standard operating procedures, and harvest lots.

(82) “Product category” means a defined group of marijuana products that are in the same form, such as flower, concentrates, and infused products. Broad product categories may be further broken down into additional product categories such as vape cartridges and shake/trim.

(83) “Qualifying medical condition” means the condition of, symptoms related to, or side-effects from the treatment of— (A) Cancer;

(B) Epilepsy;

(D) Intractable migraines unresponsive to other treatment;

(E) A chronic medical condition that causes severe, persistent pain or persistent muscle spasms, including but not limited to those associated with multiple sclerosis, seizures, Parkinson’s disease, and Tourette’s syndrome;

(F) Debilitating psychiatric disorders, including but not limited to post-traumatic stress disorder, if diagnosed by a state licensed psychiatrist;

(G) Human immunodeficiency virus or acquired immune deficiency syndrome;

(H) A chronic medical condition that is normally treated with a prescription medication that could lead to physical or psychological dependence, when a physician or nurse practitioner determines that medical use of marijuana could be effective in treating that condition and would serve as a safer alternative to the prescription medication;

(I) Any terminal illness; or (J) In the professional judgment of a physician or nurse practitioner, any other chronic, debilitating or other medical condition, including, but not limited to, hepatitis C, amyotrophic lateral sclerosis, inflammatory bowel disease, Crohn’s disease, Huntington’s disease, autism, neuropathies, sickle cell anemia, agitation of Alzheimer’s disease, cachexia, and wasting syndrome.

(84) “Qualifying patient” means an individual diagnosed with at least one (1) qualifying medical condition.

(85) “Quarantine” means to isolate a marijuana product or facility asset when it is deemed potentially unfit for use.

(86) “Seed-to-sale tracking system” means a software system designed to assist with functions necessary to fulfill a licensed or certified facility’s responsibilities in tracking marijuana from either the seed or immature plant stage until the marijuana is sold to a consumer, qualifying patient, or primary caregiver.

(87) “Shared space” means space shared by one (1) or more licensees, which may include services utilized as part of sharing space.

(88) “Signature” means a handwritten, typed, or electronic signature.

(89) “SOP” means standard operating procedure.

(90) “State-wide track and trace system” means the system the department uses to track marijuana from either the seed or immature plant stage until the marijuana is sold to a consumer, qualifying patient, or primary caregiver.

(91)

“Substantially common control, ownership, or management” means the power to direct or cause the direction of the management or policies of a facility, in light of the totality of the circumstances, including through financial or voting interests, by contract, or otherwise.

(92) “Transfer” means the movement of marijuana between (93) “Transportation” means the transfer or delivery of marijuana.

(94) “Transportation facility” means a facility certified by the department to house operations involving the transport of marijuana product to or from a marijuana facility or medical facility; or to a qualifying patient, primary caregiver, or consumer.

(95) “Transportation licensee” means an entity certified by the department to engage in the transportation of marijuana product to or from a medical or marijuana facility; or to a qualifying patient, primary caregiver, or consumer.

(96) “Unit for sale” means an individual package of marijuana product intended to be sold to a consumer, qualifying patient, or primary caregiver.

(97) “Variance” means an alternate requirement from a rule or specific provision of a rule which, if approved by the department, allows a licensee to be considered compliant with the rule or specific requirement of rule by complying with the approved alternate requirement (98) “Waiver” a department exemption from compliance with a rule or specific provision of a rule which, if approved by the department, allows a licensee to be considered compliant with the exempted rule or specific provision of rule.

(99) “Warehouse” means a facility granted a certificate by the department for off-site storage of marijuana product.

Article XIV, Mo. Const. Emergency rule filed Jan 20, 2023, effective Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.020 Generally Applicable Provisions {#sec-19-csr-100-1.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.020}

PURPOSE: The Department of Health and Senior Services has the authority to promulgate rules for the enforcement of Article XIV, Sections 1 and 2 of the Missouri Constitution. This rule applies to all individuals and entities regulated under Article XIV and explains what general provisions are necessary for the enforcement of the Article.

(1) Variances and waivers.

(A) The department may waive or vary from, at its discretion and for good cause, provisions of this chapter, on its own initiative or by request.

(B) Requests for a waiver or variance from the requirements of any provision of this chapter shall be made in writing.

Requests shall include— 1. An administrative and processing fee of one hundred dollars ($100);

A list of each requirement and specific rule for which a variance or waiver is requested;
A detailed explanation for why the applicant, ID card holder, or licensee believes there is good cause to vary from or waive the requirement; and 4. For a variance, a description of an adequate alternative the entity will implement in lieu of the rule requirement.

(2) Number of facility licenses.

(A) The department will restrict the aggregate number of medical and comprehensive licenses combined, as authorized by Article XIV, section 1.3(15-17). The number of combined medical and comprehensive licenses are limited as follows:

Dispensary licenses: 27 in each congressional district;
Manufacturing licenses: 88; and 3. Cultivation licenses: 65.

(B) The department will restrict the aggregate number of microbusiness licenses granted in each congressional district to eighteen (18), by granting six (6) in each of the three (3) rounds, as authorized by Article XIV, section 2.4(13).

(C) The department shall issue additional medical or marijuana licenses if the department determines additional licenses are needed to— 1. Meet the demand for marijuana product;

Ensure a competitive market while also preventing an over-concentration of marijuana facilities within the boundaries of any particular local government; or 3. Maintain the minimum number of combined medical and comprehensive licenses required by Article XIV, section 1.3(15-17).

(3) In addition to other penalties specifically delineated in this chapter, the department may impose penalties on facility licenses and certifications as follows:

(A) Licenses and certifications found in violation of any rule in this chapter or provision in Article XIV may be subject to penalties, including but not limited to any of the following:

Limitation or restriction on a license or certification;
Fines up to an amount equal to the average daily gross receipts of the previous calendar month of the facility;
Revocation, suspension, or nonrenewal of a license or certification; and/or 4. Orders to immediately cease or suspend operations;

(B) Fines may be assessed for each day a licensee is in violation. Assessment of a fine does not bar additional penalties or further investigation;

(C) A license shall be revoked if, after issuance, the department determines the applicant provided false or misleading information in the application;

(D) A licensee may be subject to the penalties in (3)(A) if the licensee provides false or misleading information to the department at any time after a license is issued;

(E) A licensee that organizes an event may be subject to the penalties in (3)(A) for any violations of 19 CSR 100-1 that occur at that event;

(F) The department may impose any other remedies not inconsistent with these rules or Article XIV; and (G) Prior to revoking or suspending a facility license, the department shall issue a notice to the designated contact for the licensee by sending such notice to the email address provided by the designated contact for the licensee. The notice shall list the basis for a pending revocation or suspension.

Except where there is a credible and imminent threat to public safety, the revocation or suspension will not take effect until thirty (30) days from the date the notice is sent. During the thirty (30) day period, the licensee will have the opportunity to cure the deficiencies listed in the notice and/or respond to the allegations and submit records or information demonstrating why the license should not be revoked or suspended.

If there is a credible and imminent threat to public safety, the department may order the licensed facility to immediately suspend all or part of the operations, including placing an administrative hold on marijuana product, until the threat has been eliminated. An imminent threat to public safety includes, but is not limited to:

A. A dangerous condition at the facility that is likely to harm employees or the public;

B. A credible report, such as from law enforcement, that diversion or inversion of marijuana product is occurring at the licensed facility;

C. A credible report that a facility’s practices are permitting marijuana product to enter the regulated market without being compliantly tested.

(4) Appeals.

(A) An applicant, licensee, or identification card holder may seek review of the following department decisions at the administrative hearing commission:

Denial of a facility license or certification;
Any penalties imposed by the department; and 3. Denial or revocation of patient, primary caregiver, patient cultivation, caregiver cultivation, consumer cultivation, or facility agent identification cards.

(B) Any person or entity entitled to a review under this rule must file a petition with the administrative hearing commission within thirty (30) days after the date the department decision is sent to the person or entity. An untimely appeal will not be considered.

(C) Notwithstanding the limits on licenses and certifications set forth in this rule, the department may grant additional facility licenses or certifications as a remedy to timely appeals when— 1. Ordered to do so by the administrative hearing commission or a court of competent jurisdiction; or 2. The department determines doing so in settlement of such an appeal best serves implementation of Article XIV.

(5) Marijuana records.

(A) Qualifying patient, primary caregiver information, and proprietary business information maintained by the department shall not be released outside the department except for purposes authorized by federal law or Article XIV, including— 1. In response to a request by law enforcement officials seeking verification that a person who presented an identification card is lawfully in possession of such card and is lawfully in possession of a particular amount of marijuana product;

In response to a request by law enforcement officials seeking information during the process of requesting a search or arrest warrant relating to cultivation of marijuana plants;
For the purposes of a dispensary verifying whether a particular person may purchase an amount of marijuana product; and 4. In response to a valid grand jury, judicial, or law enforcement subpoena.

(6) Licensees, cardholders, and applicants have a continuing duty to provide the department with up-to-date contact information, including the individual who shall be the designated contact for all department communications.

Licensees, cardholders, and applicants are deemed to have received all communications and notifications from the department on the date the department sends an email to the to the email address of the designated contact for the licensee, cardholder, or applicant.

(7) Unless otherwise stated, any reference to days in this

chapter will mean calendar days. In computing any period of time prescribed or allowed by the department in this chapter, the designated period of time begins to run the day after the relevant act or event.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.030 Complaints, Inspections, and Investigations {#sec-19-csr-100-1.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.030}

PURPOSE: Article XIV, Sections 1 and 2 of the Missouri Constitution authorizes the Department of Health and Senior Services to promulgate rules for the implementation and enforcement of the Article and to ensure the right to, availability, and safe use of marijuana product. This section applies to complaints, inspections, and investigations of licensed or certified facilities, licensees, and identification card holders.

(1) Complaints. The department may receive complaints related to any medical or marijuana facility or licensee, or any individual holding a department issued identification card. Complaints may be submitted through the department (A) Upon receipt of a complaint, the department will determine whether the allegations in the complaint warrant further investigation. The department can either close the complaint or conduct an investigation.

(B) If the department determines a complaint against a licensed facility warrants further investigation, the department will advise the licensee of the nature of the allegations in the complaint and provide the licensee with opportunity to respond.

rule violations to the department may not be subjected to retaliation of any kind by the licensee because of their report.

(2) Inspections and investigations.

(A) The department may conduct an investigation related to an individual card-holder if the department has reason to believe the individual has or is violating any rule in this chapter or provision of Article XIV that could affect the individual’s right to continue holding the authority granted by the department.

(B) The department may conduct an inspection or investigation of a licensee or facility at any time, including an inspection of any part of the premises or records of a licensed or certified entity.

No medical or marijuana facility licensee may refuse representatives of the department the right to inspect the facility or to audit records of the licensee, including records created or maintained by a third party under an agreement with a licensee.
A department employee conducting an inspection or investigation may access all areas of the licensed or certified facility, including vehicles utilized by or on behalf of a licensee, without a warrant and without prior notice to the licensee or its third party contractors.
Licensees must provide documents or records requested as part of an inspection or investigation within seven (7) days of the department issuing the request unless additional time is requested and granted.

A. Failure to timely provide requested documents or records may result in a fine of up to five thousand dollars ($5,000) for every day the requested documents or records have not been provided after the deadline.

B. A department request for documents or records made as part of reviewing an application submitted by a licensee, such as a change request, shall be considered an inspection of records.

The department may request to interview any employees, contractors, owners, or volunteers of a licensed or certified facility, and the licensee shall arrange for the interview to occur as soon as possible but not later than seven (7) days after the department makes the request to the designated contact on file with the department.
Upon receiving a notice of investigation, licensees must preserve all records of any type related to the subject of the investigation at the expense of the licensee, including video camera recordings and facility access control records, until the licensee receives notice that the investigation is concluded.
As part of an investigation, the department may take any reasonable action to enforce this chapter, including coordinating with law enforcement.
As part of an inspection or investigation, the department may direct the licensee to have marijuana product tested by a certified marijuana testing facility, at the cost of the licensee, when the department finds good cause to do so, which may include credible allegations of rule violations or other indications that the marijuana product does or would create a threat to the health or safety of the public.
In the course of any investigation of a licensee, the department may issue an investigative subpoena or subpoena duces tecum to any entity with documents or information relevant to the investigation. The department may enforce its subpoena by applying to the circuit court of Cole County or the county where the premises, records, or entities are located.

(C ) Applicants and licensees must cooperate in any investigation conducted by the department. Failure to cooperate with a department investigation may be grounds for denial of an application, penalties, or other remedies not inconsistent with this chapter or Article XIV.

(3) Commencement inspections.

(A) Licensees must request and pass a commencement inspection before they may do any of the following: begin operations under a new license or certification; occupy or utilize new space for which the licensee has not previously received approval to operate, including vehicles; share space with another licensee; change the use of spaces; or, in the case of microbusiness wholesale facilities, begin cultivating or manufacturing where that activity was not already approved after inspection.

Requests to begin operations under a new license or certification or new location after change request is approved must be submitted when the licensee believes it will, within thirty (30) days, be ready to begin operations at the facility, and the request must include at least the following:

A. Blueprints of the facility labeling the intended use of all spaces and how those spaces comply with the physical security requirements applicable to them;

B. All SOPs necessary for the licensee to conduct operations in compliance with regulations applicable to it;

C. Records documenting the completion of all required training regarding compliant operation of the state-wide track and trace system; and D. Documentation showing compliance with all applicable federal, state, and local requirements for the 2. Requests to occupy new space at an operational facility must be submitted prior to beginning construction or renovation, and the request must include at least the A. The proposed blueprints for the facility labeling the intended use of all spaces and how those spaces comply with the physical security requirements applicable to them;

B. Documentation to demonstrate compliance with C. A written explanation of any changes that will occur within the existing space due to the addition of new space and how those changes will comply with applicable regulations;

D. An attestation that the proposed new space complies with the facility location requirements of this chapter and any location and zoning requirements of the local government.

Requests to share space or modify the sharing of space with another licensee must be submitted prior to making any changes to the existing space or most recently approved plan for a space, and the request must include at least the A. Descriptions, schematics, or blueprints for the facility clearly indicating what spaces will be shared or no longer shared;

B. A written explanation of the operations that will occur in each shared space for each licensee sharing the space and how those operations and any related changes to existing space will comply with applicable regulations;

C. Documentation to demonstrate compliance with D. Copies of agreements between the licensees concerning their respective roles and their relationship for management, operation, and maintenance of the shared spaces, including an acknowledgment that all licensees sharing space will be jointly responsible for compliance with the applicable department regulations for the shared spaces, or documentation showing previously provided agreements are no longer effective, if applicable; and E. An attestation that the proposed sharing of space complies with any zoning requirements of the local government.

Requests to change the use of spaces must be submitted prior to making any changes to the existing space or most recently approved plan for a space, and the request must include at least the following:

A. Descriptions, schematics, or blueprints for the facility clearly indicating the spaces that will be used differently than the most recently approved use of the space;

B. A written explanation of the proposed changes and how all affected spaces will comply with applicable regulations; and C. Documentation to demonstrate compliance with certifications, training plans, contracts, etc.

Requests by microbusiness wholesale licensees to begin cultivation or manufacturing processes not already approved during a prior commencement inspection must be submitted prior to beginning construction or renovation or making any changes to the existing space or most recently approved plan for a space, and the request must include at least the A. Descriptions, schematics, or blueprints for the facility labeling the intended use of all spaces and how those spaces comply with the physical security requirements applicable to them;

B. A written explanation of any changes that will occur within the existing space due to the addition of new processes and how those changes will comply with applicable regulations;

C. Documentation to demonstrate compliance with applicable rules as related to the Commencement Inspection D. Records documenting the completion of all required training in compliant operation of the state-wide track and trace system; and E. Documentation showing compliance with all applicable federal, state, and local requirements for the (B) In any commencement inspection process, if the department determines the licensee who requested the commencement inspection was not prepared to complete the commencement inspection process when it made the request, the department may set aside the request and require the licensee to make a new request once it is ready to proceed.

(C) Licensees who are constructing or renovating in an operational facility are responsible for ensuring the approved spaces are secured while the unapproved spaces are being constructed, which must include at a minimum, ensuring that all access requirements for limited access areas are maintained during construction and that operational spaces are protected from all potential contaminates related to construction.

(D) Licensees may not commence any operations that are subject to a commencement inspection until the department issues written approval to do so.

(E) After submitting a commencement inspection request, licensees are required to actively work to complete the changes outlined in the request and complete the changes within the time frame outlined by the licensee at the time of the commencement inspection request.

(4) Notices of violation.

(A) If the department determines that a licensee is not in compliance with the department’s regulations, the department may issue a warning or an Initial Notice of Violation to the licensee that explains how the licensee has violated the department’s regulations and what remedial actions the department expects the licensee to take.

Once a licensee has been issued an Initial Notice of Violation, the licensee shall, within fifteen (15) days, complete the specified remedial actions and notify the department in writing of that completion, or request additional time for remediation if necessary.
In its written notification to the department, if the licensee can demonstrate, to the satisfaction of the department, that the Initial Notice of Violation should not have been issued, the department will withdraw the Initial Notice of Violation.

(B) Licensees that have received an Initial Notice of Violation for more than three (3) rules in a twelve (12) month period or that have ever received more than one (1) Initial Notice of Violation for violating the same regulation in a twelve (12) month period, may be required by the department to:

Acquire certification or accreditation to a quality management system standard chosen by the department at the expense of the licensee; or 2. Be subject to an audit of the licensee’s processes or practices relevant to the violations by a third party auditor chosen by the department at the expense of the licensee.

(C) The department may conduct a follow-up inspection or review of the licensee or its response to the Initial Notice of Violation. If during such inspection or review the department determines violations have not been cured or remedial actions have not been taken, the department may issue a Final Notice of Violation to the licensee explaining how the licensee continues to violate the department’s regulations, what remedial actions the department expects the licensee to take, and that the license may be suspended or fined if the specified remedial actions are not taken or the violations are not cured within thirty (30) days.

(D) If the violations have not been cured or specified remedial actions have not been taken within thirty (30) days after a Final Notice of Violation is sent, the department may either suspend the license or fine the licensee up to an amount equal to the average daily gross receipts of the previous calendar month of the facility per day, until the corrective or remedial actions have been taken by the licensee.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.040 Consumers, Qualifying Patients, and Primary Caregivers {#sec-19-csr-100-1.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.040}

PURPOSE: Under Article XIV, Section 1 of the Missouri Constitution, patients with qualifying medical conditions have the right to discuss freely with their physicians the possible benefits of medical marijuana use and the right to use medical marijuana for treatment under the ethical supervision of a physician or nurse practitioner. Additionally, under Article XIV,

Section 2 of the Missouri Constitution, adults at least twenty-one (21) years of age have the right to access marijuana. Pursuant to the same article, the Department of Health and Senior Services is tasked with ensuring patient access to medical marijuana and adult access to marijuana, subject to reasonable restrictions. This

rule explains how the department will implement provisions of

Article XIV related to consumers, qualifying patients, and primary (1) Consumers. Individuals twenty-one (21) years of age and older may purchase and possess marijuana product in accordance with the rules set forth herein. Consumers may obtain

(2) Qualifying patients. Individuals eighteen (18) years of age or older and emancipated individuals under the age of eighteen (18) may obtain a medical marijuana patient identification card to purchase and possess medical marijuana product in accordance with the rules set forth herein. Non-emancipated individuals under the age of eighteen (18) may obtain a medical marijuana patient identification card with the written consent of a custodial parent or legal guardian. Qualifying patients, with the exception of non-emancipated minors, may also obtain authority to cultivate as set forth below.

(A) Medical marijuana patient identification cards are valid for three (3) years.

(B) Physician or nurse practitioner certification.

All qualifying patients must have a physician or nurse practitioner certification confirming the qualifying patient has at least one qualifying medical condition.
A physician or nurse practitioner certification is required for all new and renewal patient applications.
The physician or nurse practitioner certification must be submitted within a new or renewal patient application, and the signature date on the certification must be less than thirty (30) days old on the application’s submission date.

No qualifying patient shall smoke marijuana product for medical use in a public place, unless provided by law.
No qualifying patient who is under the care of a primary caregiver may serve as the primary caregiver for another qualifying patient.
If a qualifying patient is no longer entitled to medical marijuana product or no longer wishes to hold a medical marijuana identification card, they must notify the department within ten (10) days of that change. The department will confirm in writing that the qualifying patient has voluntarily surrendered the identification card and that the identification card is no longer valid.

(D) Non-emancipated qualifying patients. Individuals under the age of eighteen (18) may obtain a medical marijuana patient identification card with the written consent of a custodial parent or legal guardian.

A physician or nurse practitioner shall not issue a certification for the medical use of marijuana product for a non-emancipated qualifying patient without the written consent of a parent or legal guardian of the qualifying patient.
The department shall not issue a qualifying patient identification card on behalf of a non-emancipated qualifying patient without the written consent of a parent or legal guardian of the qualifying patient. Such card shall be issued to the parent or guardian and not directly to the patient.
Only a parent or legal guardian may serve as a primary caregiver for a non-emancipated qualifying patient.
Only the qualifying patient’s parent or legal guardian who holds a primary caregiver identification card shall purchase or possess medical marijuana product for a nonemancipated qualifying patient.
A parent or legal guardian who holds a primary caregiver identification card shall supervise the administration of medical marijuana product to a non-emancipated qualifying patient.

(3) Primary caregivers. Individuals twenty-one (21) years of age or older may obtain a primary caregiver identification card which allows them to purchase and possess medical marijuana product on behalf of up to six (6) qualifying patients. Primary caregivers may also obtain authority to cultivate as set forth below.

(A) Primary caregiver identification cards are valid for three (3) years.

(B) Individuals seeking primary caregiver status for nonemancipated qualifying patients must be the parent or legal guardian of the qualifying patient.

No individual shall serve as the primary caregiver for more than six (6) qualifying patients.
No individual shall serve as a primary caregiver for a qualifying patient who is already served by two (2) primary 3. If a primary caregiver is no longer entitled to serve as a primary caregiver or no longer wishes to hold a primary caregiver identification card, they must notify the department within ten (10) days of that change. The department will confirm in writing that the primary caregiver has voluntarily surrendered the identification card and that the identification card is no longer valid.
Primary caregivers shall provide ethical, safe, and secure access to medical marijuana product for the associated patient by way of purchase, possession, administration, and cultivation, if applicable.

(4) Purchase and possession limitations.

(A) Consumers.

Consumers may only purchase up to three (3) ounces of dried, unprocessed marijuana product, or its equivalent, in a single transaction.
Consumers may only possess— A. In the case of consumers who do not cultivate, up to three (3) ounces of dried, unprocessed marijuana product, or its equivalent; or B. In the case of consumers who are cultivating marijuana, any supply of marijuana cultivated by the consumer in excess of the consumer’s three (3) ounce limit must remain in an enclosed, locked facility at a private residence.

(B) Qualifying patients and primary caregivers.

Absent a certification from a physician or nurse practitioner authorizing more, qualifying patients may only purchase, or have purchased on their behalf by their primary caregivers, up to six (6) ounces of dried, unprocessed marijuana, or its equivalent, per qualifying patient, in a thirty- (30-) day period.
The six (6) ounce purchase limit established in this

section shall not apply to a qualifying patient with a certification from a physician or nurse practitioner that there are compelling reasons why the qualifying patient needs a greater amount than the limit established in this section.

A. In such a case, the physician or nurse practitioner must state in their certification what amount the qualifying patient requires, which shall then be that patient’s limit.

B. If the patient’s amount is increased after they receive a qualifying patient identification card, the patient must submit a request to the department to increase their purchase limit within thirty (30) days of the physician’s or nurse practitioner’s signature date. The department shall, within thirty (30) days, either approve or deny the request. The increase will not be effective until the department approves the request.

Qualifying patients may only possess, or instruct a primary caregiver to possess on their behalf— A. In the case of qualifying patients who do not cultivate or have medical marijuana cultivated on their behalf, up to a sixty- (60-) day supply of dried, unprocessed marijuana per qualifying patient, or its equivalent; or B. In the case of qualifying patients who are cultivating marijuana for medical use or whose primary caregivers are cultivating marijuana on their behalf, up to a ninety- (90-) day supply of dried, unprocessed marijuana or its equivalent, so long as the supply of medical marijuana product in excess of a sixty- (60-) day supply remains in an enclosed, locked facility.
Primary caregivers may possess a separate legal limit for each qualifying patient under their care and a separate legal limit for themselves if they are a qualifying patient, each of which shall be stored separately for each qualifying patient and labeled with the qualifying patient’s name.
Possession of between the legal limit and up to twice the legal limit shall subject the possessor to department sanctions, including an administrative penalty of up to two hundred dollars ($200) and loss of the possessor’s identification card(s) for up to a year.
A patient is not permitted to exceed the possession or purchase limitations in this section by combining purchases as a patient and as a consumer.

(5) Consumer personal cultivation, qualifying patient cultivation, and primary caregiver cultivation, generally.

(A) Except for good cause, any consumer, licensed qualifying patient with the exception of non-emancipated qualifying patients, or licensed primary caregiver on behalf of a qualifying patient may obtain authorization to cultivate up to six (6) flowering marijuana plants, six (6) non-flowering marijuana plants fourteen (14) inches tall or more, and six (6) non-flowering plants under fourteen (14) inches tall at any given time in a single enclosed, locked facility, subject to the limitations below.

(B) Non-emancipated qualifying patients are not eligible for patient cultivation authorization, but a parent or legal guardian who is the primary caregiver may obtain authorization to cultivate on behalf of the non-emancipated qualifying patient.

(C) A qualifying patient may not be authorized for both qualifying patient cultivation and consumer personal cultivation at the same time.

(D) All consumer personal cultivation, qualifying patient cultivation, and primary caregiver cultivation shall take place in an enclosed, locked facility, as defined in this chapter.

(E) Nothing in this section shall convey or establish a right to cultivate marijuana in a location where state law or a private contract would otherwise prohibit doing so.

(F) Consumer personal cultivation, qualifying patient cultivation, and primary caregiver cultivation shall not take place at a place of business.

(G) The department shall provide each consumer, qualifying patient, or primary caregiver who receives a cultivation authorization with a cultivation authorization identification card, which shall be clearly displayed within the enclosed cultivation area and in close proximity to the marijuana plants. The authorization shall list the name of the consumer, qualifying patient, or primary caregiver who has been authorized to cultivate, and the address at which that individual is authorized to cultivate marijuana.

(H) Consumer personal cultivation.

All consumer personal cultivation must take place at a private residence.
Up to two (2) consumers, who both hold valid consumer personal cultivation identification cards, may grow marijuana at the same private residence.
No more than twelve (12) flowering marijuana plants, twelve (12) non-flowering plants fourteen (14) inches tall or more, and twelve (12) non-flowering plants under fourteen (14) inches tall may be cultivated by consumers at a single private residence, regardless of the number of consumers who live at that private residence.
Plants and marijuana produced by the plants in excess of three (3) ounces must be kept at a private residence in an enclosed, locked facility.
All cultivated flowering marijuana plants in the possession of a consumer shall be clearly labeled with the consumer’s name.
A consumer personal cultivation identification card shall be valid for twelve (12) months from its date of issuance and shall be renewable with the submittal of a renewal application.

(I) Qualifying patient cultivation.

Up to two (2) qualifying patients, who both hold valid qualifying patient cultivation identification cards, may share one (1) enclosed, locked facility.
No more than twelve (12) flowering marijuana plants, twelve (12) non-flowering plants fourteen (14) inches tall or more, and twelve (12) non-flowering plants under fourteen (14) inches tall may be cultivated in a single enclosed, locked 3. Under no circumstance will a qualifying patient be entitled to cultivate, or have cultivated on his or her behalf, more than six (6) flowering marijuana plants.
Only one (1) individual in a patient-caregiver relationship may be authorized for cultivation on behalf of the qualifying patient.
All cultivated flowering marijuana plants in the possession of a qualifying patient shall be clearly labeled with the qualifying patient’s name. 6.

A patient cultivation identification card shall be valid as long as the qualifying patient’s identification card is still A. The cultivation application fee will be the same for all cultivation applications no matter how much time remains on the validity of the patient’s identification card.

B. The cultivation identification card shall be renewable by submitting a renewal patient cultivation application, as long as the individual has an approved renewal patient application.

(J) Primary caregiver cultivation.

A primary caregiver may cultivate on behalf of more than one (1) qualifying patient and may utilize one (1) or more enclosed, locked facilities.
No primary caregiver cultivating marijuana for more than one (1) qualifying patient may exceed a total of twenty-four (24) flowering plants, twenty-four (24) non-flowering plants fourteen (14) inches tall or more, and twenty-four (24) non-flowering plants under fourteen (14) inches tall.
Only one (1) individual in a patient-caregiver relationship may be authorized for cultivation on behalf of the qualifying patient.
All cultivated flowering marijuana plants in the possession of a primary caregiver shall be clearly labeled with the qualifying patient’s name.
A primary caregiver cultivator who is also authorized as a qualifying patient cultivator may grow the plants that belong to them as a qualifying patient cultivator, and the plants grown on behalf of their qualifying patient(s) using the same enclosed, locked facility.
A primary caregiver cultivator who is also authorized as a consumer personal cultivator may not grow the plants that belong to them as an authorized consumer personal cultivator and the plants grown on behalf of their qualifying patient(s) using the same enclosed, locked facility.
A caregiver cultivation identification card shall be valid as long as the primary caregiver’s identification card is still A. The cultivation application fee will be the same for all cultivation applications no matter how much time remains on the validity of the primary caregiver’s identification card.

B. The cultivation identification card shall be renewable by submitting a renewal caregiver cultivation application, as long as the individual has an approved renewal caregiver application.

(6) Identification cards.

(A) Application requirements.

The department will receive applications for qualifying patient, primary caregiver, and cultivation authorization identification cards electronically through a department-provided, web-based application system. In the event of application system unavailability, the department will arrange to accept applications in an alternative, department-provided format and will notify the public of those arrangements through its A. Qualifying patients and primary caregivers shall obtain identification cards from the department, which will include unique, identifying numbers for each patient and each caregiver.

B. A qualifying patient or their primary caregiver(s) who wish to cultivate shall also obtain an identification card to cultivate for the exclusive use of that qualifying patient, which will include unique, identifying numbers for each authorized cultivator.

C. Consumers who wish to cultivate marijuana shall obtain identification cards from the department, which will include unique, identifying numbers for each authorized cultivator.

Qualifying patient identification cards. All applications for qualifying patient identification cards and renewal of such identification cards shall include at least the following information:

A. The qualifying patient’s name, date of birth, and Social Security number;

B. The qualifying patient’s residence address and mailing address or, if the qualifying patient has no residence or mailing address, an address where the qualifying patient can receive mail;

C. The qualifying patient’s email address;

D. A statement confirming that— (I) One (1) physician or nurse practitioner certification, which is less than thirty (30) days old, has been submitted on behalf of the qualifying patient and is available for review within the submitted application; and (II) If applicable, there are compelling reason(s) why the qualifying patient needs a greater amount than six (6) ounces in a thirty- (30-) day period;

E. A legible copy of the qualifying patient’s photo identification card issued by a state or federal government entity;

F. A clear, color photo of the applicant’s face taken G. If the qualifying patient is an emancipated qualifying patient under the age of eighteen (18), a certified emancipation order from the issuing court;

H. If the qualifying patient is a non-emancipated qualifying patient— (I) Written consent of a parent or legal guardian who will serve as primary caregiver for the qualifying patient, dated within the previous ninety (90) days; and (II) An attestation that the individual signing the application is the qualifying patient’s parent or legal guardian and— (a) A copy of a birth certificate or adoption record showing proof of relationship as qualifying patient’s parent; or (b) A copy of documentation establishing legal guardianship;

I. An attestation that the information provided in the J. The signature of the qualifying patient and date the qualifying patient signed, or, in the case of a non-emancipated qualifying patient, the signature of the parent or legal guardian who completed the qualifying patient application and will serve as primary caregiver for the qualifying patient; and K. All applicable fees.

Primary caregiver identification cards. All applications for primary caregiver identification cards and renewal of such identification cards shall include at least the following information:

A. The primary caregiver’s name, date of birth, and Social Security number;

B. The primary caregiver’s residence address and mailing address;

C. The primary caregiver’s email address;

D. The name and patient license number of the qualifying patient for whom the applicant seeks to serve as primary caregiver;

E. A legible copy of the primary caregiver’s photo identification card issued by a state or federal government entity;

F. A clear, color photo of the applicant’s face taken G. Except in the case of a non-emancipated qualifying patient, patient authorization signed by the qualifying patient who the primary caregiver will serve and dated within the previous ninety (90) days;

H. If the qualifying patient is a non-emancipated qualifying patient, written consent of the parent or legal guardian who will serve as the qualifying patient’s primary caregiver, dated within the previous ninety (90) days, and— (I) A copy of a birth certificate or adoption record showing the primary caregiver as the qualifying patient’s parent; or (II) A copy of documentation establishing legal guardianship of the primary caregiver over the qualifying patient;

I. An attestation that the information provided in the J. The signature of the primary caregiver and date the primary caregiver signed; and K. All applicable fees.

Cultivation cards. All applications for consumer personal cultivation identification cards, qualifying patient cultivation identification cards, and primary caregiver cultivation identification cards and renewal of such cards shall include at least the following information:

A. The applicant’s name, date of birth, and Social Security number;

B. The applicant’s residence address and mailing address;

C. A statement that the applicant’s cultivation will take place in Missouri;

D. The applicant’s email address;

E. A legible copy of the applicant’s photo identification card issued by a state or federal government entity;

F. A clear, color photo of the applicant’s face taken G. The address of the location in which the applicant will cultivate marijuana;

H. For consumer personal cultivation authorization, attestation that the cultivation will be located at a private residence in a single enclosed, locked facility that permits access to only the applicant;

I. For qualifying patient or primary caregiver cultivation authorization, attestation that the cultivation will be located in a single enclosed, locked facility that permits access to only the qualifying patient and his or her licensed caregiver(s), as applicable;

J. If the cultivation will be by or on behalf of a qualifying patient— (I) The qualifying patient’s name and patient license number; and (II) The primary caregiver’s name and license number, if applicable;

K. If a qualifying patient seeks to share an enclosed, locked facility, the name and patient license number of up to one (1) other qualifying patient with whom the cultivation space will be shared;

L. If a primary caregiver, requesting authorization to cultivate on behalf of a qualifying patient, seeks to grow plants for multiple patients in a single enclosed, locked facility, the names and patient license numbers of up to five (5) other qualifying patients, plus their own name and qualifying patient license number if the space is going to be used for their own qualifying patient cultivation and cultivation on behalf of their qualifying patient(s);

M. If a consumer seeks to grow marijuana at the same private residence as one (1) other licensed consumer personal cultivator, the name and license number of one (1) other licensed consumer personal cultivator who will be cultivating at that private residence;

N. A statement affirming the applicant’s agreement to immediately make available access to the cultivation space upon request from the department. Such access will be only for purposes of confirming compliance with this rule and will be limited to the enclosed, locked facility and any areas necessary to reach and enter the facility on a path of the applicant’s choosing;

O. An attestation that the information provided in the P. The signature of the applicant and date the applicant signed; and Q. All applicable fees.

(B) Application processes.

The department shall charge a non-refundable fee for marijuana identification card applications.

A. There will be a separate fee for each application to be a qualifying patient, each application to be a primary caregiver on behalf of a specific qualifying patient, and each application to cultivate marijuana.

B. Requests for authority to cultivate medical marijuana on behalf of a qualifying patient may be made following approval of a qualifying patient or primary caregiver identification card.

(I) A cultivation authorization will only remain valid as long as the qualifying patient or primary caregiver’s identification card is still valid.

(II) The fee for an application to cultivate on behalf of a qualifying patient will be the same for all applications no matter how much time remains on the validity of the patient or caregiver’s identification card at the time of the request for cultivation authorization is submitted.

(III) The cultivation authorization must be renewed at the time the patient or caregiver identification card is renewed.

C. Current fees, including any adjustments, will be posted on the department’s website.

An application for an identification card will be considered received when the department receives a complete application. A complete application is an application that includes all information required by this rule. The department will notify an applicant once if an application is incomplete and will specify in that notification what information is missing.
Upon receiving a complete application for a qualifying patient identification card, primary caregiver identification card, or qualifying patient cultivation identification card, the department shall, within thirty (30) days, either approve the application or provide a written explanation for its denial.

A. In the case of qualifying patient and patient cultivation identification cards, if the department fails to deny or fails to approve a complete application within thirty (30) days, a card will be issued that will be valid for three (3) years and will serve all the same functions as would a card issued after application approval.

If the name or address of a consumer personal cultivator, qualifying patient, or primary caregiver changes after an identification card is issued, the consumer, qualifying patient, or primary caregiver shall notify the department within fourteen (14) calendar days of the change.
Denial. Qualifying patient, primary caregiver, and cultivation identification cards may be denied.

A. If an applicant provides false or misleading information in an application, the card for which the applicant is applying will be denied.

B. If an applicant fails to provide a complete application within fourteen (14) calendar days of being notified that an application is incomplete, the card for which the applicant is applying will be denied.

(I) An applicant will be considered notified on the date the department sends a written explanation of how the application is incomplete to an email address provided by the applicant.

C. If the department determines there is good cause to do so, an application for an identification card may be denied.

D. If the applicant fails to pay the requisite application fee(s) associated with an application, the qualifying patient, primary caregiver, or cultivation identification card will be denied.

E. Any denial shall be issued by the department in writing to the consumer, qualifying patient, or primary caregiver, and shall include the specific reasons for the denial and the process for requesting review of the department’s decision.

Renewal.

A. Qualifying patient identification cards are valid for three (3) years from their date of issuance and shall be renewdays but no sooner than sixty (60) days, a new or renewal application, which shall include all required information, including a new physician certification.

B. Primary caregiver identification cards are valid for three (3) years from their date of issuance and shall be renewdays but no sooner than sixty (60) days, a new or renewal application, which shall include all required information.

(I) A qualifying patient with a primary caregiver(s) must renew their qualifying patient identification card before the associated primary caregiver renewal application(s) will be processed.

(II) The approved primary caregiver renewal application will only serve to renew the primary caregiver identification card if the associated qualifying patient has an approved renewal patient application.

C. Qualifying patient cultivation and primary caregiver cultivation identification cards are valid as long as the qualifying patient’s or primary caregiver’s identification card is still (I) The cultivation identification card shall be renewdays but no sooner than sixty (60) days, a new or renewal patient or caregiver cultivation application.

(II) The renewal cultivation application shall include all required information.

(III) The application will only serve to renew the cultivation identification card if the individual has an approved renewal patient or caregiver application.

D. Consumer cultivation identification cards are valid for one (1) year from their date of issuance and shall be renewable by submitting, prior to expiration by at least thirty (30) days but no sooner than sixty (60) days, a new or renewal application, which shall include all required information.

Qualifying patient, primary caregiver, and cultivation identification cards may be sanctioned.

A. If a card holder violates any provision of this chapter or Article XIV, any identification cards currently held by that individual may be revoked.

B. If, after an identification card has been issued, the department determines that an applicant has failed to provide a complete application including requisite application fees, or has provided false or misleading information in the application, the department may revoke the identification card.

C. If a card holder is found to be in possession of an amount of marijuana product between the legal limit applicable to that individual and up to twice the legal limit applicable to that individual, they shall be subject to department sanctions, including an administrative penalty of up to two hundred dollars ($200) and loss of their identification card for up to a year.

D. If a qualifying patient, primary caregiver, or cultivation card holder commits a criminal offense related to distribution of marijuana product, whether or not a criminal charge has been filed, any marijuana identification cards currently held by that individual shall be revoked.

E. If a cultivation identification card holder fails to immediately make available access to his or her cultivation facility upon request from the department, the cultivation identification card shall be revoked.

F. If a consumer cultivator, qualifying patient, or primary caregiver uses combustible gases or other dangerous materials to extract resins from marijuana, the individual’s identification card may be subject to department sanctions, including an administrative penalty of one thousand dollars ($1000) and loss of their identification card for up to one (1) year.

G. If a qualifying patient, primary caregiver, or cultivation card holder advertises to sell or sells marijuana product, the individual’s identification card may be revoked.

In any case of identification card revocation, the department may notify the card holder that it will not accept a new application for the same card type for a designated period of time.
Any revocation shall be issued by the department in writing to the consumer or qualifying patient or, in the case of a primary caregiver, to the qualifying patient and the primary caregiver, and shall include the specific reasons for the revocation and the process for requesting review of the department’s decision.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

History

authority to cultivate as set forth below.

19 CSR 100-1.050 Physicians and Nurse Practitioners {#sec-19-csr-100-1.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.050}

PURPOSE: Under Article XIV, Section 1 of the Missouri Constitution, patients with qualifying medical conditions have the right to discuss freely with their physicians and nurse practitioners the possible benefits of medical marijuana use, and physicians and nurse practitioners have the right to provide professional advice concerning the same. This rule explains how the department will implement provisions of Article XIV, Section 1, related to physicians and nurse practitioners.

(1) Certifying physician or nurse practitioner qualifications. All physicians or nurse practitioners who intend to certify patients for their patient medical marijuana licenses must be licensed to practice in their respective fields and must be in good standing.

(A) A certifying physician must have a current license to practice medicine or osteopathy. Practice of medicine or osteopathy means practice by persons who hold a physician and surgeon license pursuant to Chapter 334, RSMo.

(B) A nurse practitioner must have a current Missouri or compact RN license and be recognized by the Missouri State Board of Nursing as an advanced practice registered nurse.

(C) A physician is in good standing if— 1. The physician’s license is registered with the State Board of Registration for the Healing Arts as current, active, and not restricted in any way, such as by designation as temporary or limited; and 2. The physician is not currently on the list of individuals from whom the department will not accept certifications.

(D) A nurse practitioner is in good standing if — 1. That individual’s license is registered with the Missouri State Board of Nursing as current and active;

That individual’s license is not restricted in any way, such as by designation as cease and desist, denial of license, expired, restriction, revoked, suspension, voluntary agreement to refrain from practice, or voluntary surrender; and 3. That person is not currently on the list of individuals from whom the department will not accept certifications.

(2) Physician or nurse practitioner certification. Physicians or nurse practitioners will submit certifications electronically through a department-provided, web-based system. In the event of system unavailability, the department will arrange to accept physician or nurse practitioner certifications in an alternative, department-provided format and will notify the public of those arrangements through its website.

(A) Physician or nurse practitioner certifications must be issued no earlier than thirty (30) days before the date the patient will apply for a patient identification card or renewal of a patient identification card.

(B) Physician or nurse practitioner certifications must include at least the following information:

The physician’s or nurse practitioner’s name, as it appears in the records of the Missouri Division of Professional Registration;
The physician’s or nurse practitioner’s licensee number;
Whether the physician or nurse practitioner is licensed to practice medicine or osteopathy, or is licensed as an advanced practiced registered nurse;
The physician’s or nurse practitioner’s business address, telephone number, and email address;
The qualifying patient’s name, date of birth, and Social Security number;
The qualifying patient’s qualifying condition;
The physician’s or nurse practitioner’s recommendation for the amount of medical marijuana product the qualifying patient should be allowed to purchase in a thirty- (30-) day period if the recommended amount is more than six (6) ounces of dried, unprocessed marijuana or its equivalent.

A. If the recommended amount is more than six (6) ounces in a thirty- (30-) day period, the physician or nurse practitioner shall provide compelling reason(s) why the qualifying patient needs a greater amount;

Statements confirming the following:

A. In the case of a non-emancipated qualifying patient under the age of eighteen (18), before certifying the qualifying patient for use of medical marijuana product, the physician or nurse practitioner received the written consent of a parent or legal guardian who asserts he or she will serve as a primary caregiver for the qualifying patient;

B. The physician or nurse practitioner met with and examined the qualifying patient, reviewed the qualifying patient’s medical records or medical history, reviewed the qualifying patient’s current medications and allergies to medications, discussed the qualifying patient’s current symptoms, and created a medical record for the qualifying patient regarding the meeting;

C. In the opinion of the physician or nurse practitioner, the qualifying patient suffers from the qualifying condition;

D. The physician or nurse practitioner discussed with the qualifying patient risks associated with medical marijuana, including known contraindications applicable to the patient, risks of medical marijuana use to fetuses, and risks of medical marijuana use to breastfeeding infants; and 9. The signature of the physician or nurse practitioner and date signed.

(3) The department may request to interview any physician or nurse practitioner who chooses to certify individuals as qualifying patients. If such a request is made, the physician or nurse practitioner shall arrange for the interview to occur as soon as possible but no later than thirty (30) days after the department makes the request. If the physician or nurse practitioner refuses an interview with the department, the department may refuse to accept certifications from the physician or nurse practitioner until the interview occurs.

(4) Physician or nurse practitioner investigations. All complaints against physicians or nurse practitioners may be submitted either via forms available on the department’s website or by otherwise notifying the department. Complaints shall include the name and address of the physician or nurse practitioner against whom the complaint is made and a clear description of what violation(s) the complainant believes the physician or nurse practitioner has committed.

(A) After receiving a complaint against a physician or nurse practitioner, the department will determine whether an investigation is warranted. Investigations may also be initiated by the department.

(B) If the department conducts an investigation pursuant to a complaint, the physician or nurse practitioner will receive a copy of the complaint. In the event the investigation is initiated by the department, the physician or nurse practitioner will receive a written description of the violation the department believes the physician or nurse practitioner has committed.

Dismissing the complaint;
Referring the complaint to the Missouri State Board of Registration for the Healing Arts or Missouri State Board of Nursing, as applicable;
Referring the complaint to law enforcement; and 4. Refusing to accept any new certifications from the physician or nurse practitioner for a reasonable period of time as determined by the department and adding the physician’s or nurse practitioner’s name to a publicly available list of physicians or nurse practitioners from whom the department is not accepting certifications. Such action shall only be taken upon concluding the physician or nurse practitioner has violated a provision of this chapter, Article XIV of the Missouri Constitution, or any other rule or law applicable to implementation of Article XIV. The length of time the department shall refuse to accept the physician’s or nurse practitioner’s certifications shall be based upon the following criteria:

A. Whether the physician or nurse practitioner acted recklessly or knowingly in violating an applicable rule or law;

B. The degree of imminent danger to the health of a qualifying patient the physician’s or nurse practitioner’s actions caused;

C. The degree or recurrence of falsification of a physician or nurse practitioner certification;

D. Whether the department has previously received substantiated complaints against the physician or nurse practitioner; and E. Any aggravating circumstances.

(D) Upon completion of an investigation, the department shall notify the physician or nurse practitioner of any department action, the reasons for that action, and the procedure for filing an application for a hearing.

(E) Any physician or nurse practitioner aggrieved by the department’s actions taken pursuant to this section may file an application for a hearing with the department. The department shall grant the application within fourteen (14) days after receipt by the department and set the matter for hearing.

(F) The provisions of Chapter 536, RSMo, for a contested case, except those provisions or amendments that are in conflict with this section, shall apply to and govern the proceedings contained in this section and the rights and duties of the parties involved. The person requesting a hearing shall be entitled to present evidence, pursuant to the provisions of Chapter 536, RSMo, relevant to the allegations.

(G) Upon the record made at the hearing, the director of the department or the director’s designee shall determine all questions presented and shall determine whether the initial decision shall stand. The director of the department or the director’s designee shall clearly state the reasons for his or her decision.

(H) A person aggrieved by the decision following the hearing shall be informed of his or her right to seek judicial review as provided under Chapter 536, RSMo. If the person fails to appeal the director of the department’s findings within thirty (30) days of their issuance, those findings shall constitute a final determination.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.060 Facility Applications and Selection {#sec-19-csr-100-1.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.060}

PURPOSE: This rule explains how medical and marijuana facility licensing and certification applications, with the exception of seed-to-sale tracking system entity applications, are submitted and how the Department of Health and Senior Services selects licenses and certificates.

(1) Conversion from a medical facility license to a comprehensive facility license.

(A) A medical facility licensee may request its medical facility license convert to a comprehensive facility license.

Conversion requests must be submitted in a departmentprovided, web-based application system.
Conversion requests shall include a plan that explains how the applicant will serve both the medical and adult-use markets, while maintaining adequate supply at a reasonable cost to qualifying patients.
Conversion requests shall include a plan to promote and encourage participation in the regulated marijuana industry by people from communities that have been disproportionately impacted by marijuana prohibition.
Conversion requests shall be accompanied by a nonrefundable fee of two thousand dollars ($2000).
A conversion request is deemed received when all required documents and fees are received by the department.
The department shall approve or deny conversion requests by email to the licensee’s designated contact within sixty (60) days after the conversion request is received. Conversion requests not processed within sixty (60) days of department receipt shall be deemed approved.
If the comprehensive facility previously received approval to operate as a medical facility, the comprehensive licensee may begin operating without additional approvals or inspections from the department. If the comprehensive facility did not previously receive approval to operate as a medical facility, the comprehensive licensee may not operate until it requests a commencement inspection and receives approval to operate as a comprehensive facility.
A conversion request will be granted unless the medical facility licensee is not in good standing with the department.

Good standing means the license is not suspended or revoked at the time the request is made.

(B) Converted comprehensive licenses will retain the same expiration date assigned to the medical license.

(2) Facility application process.

(A) The department will publish on its website time periods during which it will accept applications and, when applicable, publish the number of licenses to be selected by lottery. The department may extend an existing application time period by posting a new application deadline on its website.

(B) Applications will be considered complete if the application includes all documents required for applications by this

rule.

(C) The department will receive applications for all medical and marijuana facility licenses or certifications electronically through a department-provided, web-based application system. In the event of application system unavailability, the department will arrange to accept applications in an alternative, department-provided format and will notify the public of those arrangements through its website.

The department shall charge each applicant seeking an available medical or marijuana facility license an application fee to be submitted with the application. The department shall publish the current fees, including any adjustments, on its 2. Application fees are nonrefundable, except that a microbusiness facility applicant not chosen by lottery may request a refund of its application fee using the email address provided for the designated contact in the application.

A. Requests for a refund will be accepted via the form available on the department’s website, beginning thirty-one (31) days after the date of the denial but no later than six (6) months after the date of the denial. Refund requests received later than six (6) months from the date of the denial may be submitted along with a variance request pursuant to 19 CSR 100-1.020.

B. The application fee will be refunded if the department determines the microbusiness facility applicant met the criteria to apply for a microbusiness facility license and the applicant has no pending or future legal actions related to the denial of the application. Issuance of a refund is not a determination from the department that the applicant is qualified for licensure or is entitled to a license in future applications.

(D) The issuance of a facility license or certification does not authorize the facility licensee to begin activities related to marijuana authorized by the license. A facility licensee will be granted final approval to operate upon passing a commencement inspection.

(E) A facility license or certification shall be valid for three (3) years from its date of issuance.

(3) Application requirements. Entities must obtain a license or certification to operate a medical or marijuana facility in Missouri. Applications for facility licenses or certifications, except for off-site storage of marijuana product, shall include at least the following information:

(A) Name, address, phone number, and email of the designated contact for the applicant entity. For microbusinesses, the designated contact must be an eligible individual contributing to the majority ownership of the microbusiness;

(B) Legal name of the applicant entity, including fictitious business names;

(C) A visual representation of the applicant entity’s ownership structure showing the percentage of each individual’s ownership in the microbusiness. Examples of such visual representations may be found on the department’s website at http:// cannabis.mo.gov;

(D) For all entities licensed or certified or applying for licensure or certification in Missouri to cultivate, manufacture, or dispense marijuana product, an attestation that the entity is not and will not be under substantially common control, ownership, or management as a testing facility;

(E) For a testing facility application, an attestation that the entity is not and will not be under substantially common control, ownership, or management as a cultivation facility licensee, manufacturing facility licensee, or dispensary facility (F) For a microbusiness facility license application, an attestation that— 1. The applicant does not have an owner who is also an owner of an existing medical, comprehensive, or another microbusiness marijuana facility license;

The applicant has not entered, and will not enter into until after successful completion of eligibility verification and mandatory post-award training, any agreement that removes from the eligible majority owners listed in the application the power to— A. Order or direct the management, managers, and policies of the license;

B. Enter into and exit agreements on behalf of the license; and C. Otherwise make decisions for the license or that diminishes the controlling interests of those eligible individuals;

The designated contact is an eligible individual with ownership in the microbusiness license;
The microbusiness is and will continue to be majority owned and operated by eligible individuals;
If selected by lottery, a microbusiness applicant will respond to all requests for documentation relevant to determining that the license is owned and operated by eligible individuals within ten (10) days from the date the request is sent, unless an extension has been requested and approved; and 6. Mandatory pre-application training was completed by an eligible individual contributing to majority ownership;

(G) For medical and comprehensive facility applicants, a list of all owners who are also owners of a microbusiness facility license and the relevant microbusiness license number(s);

(H) Proposed address of the facility and— 1. An attestation that the proposed facility location complies with the facility location requirements of this chapter;

An attestation that the proposed facility location complies with any facility location requirements of the local government; and 3. A copy of, and, where available, a hyperlink to, all local government requirements for facility location, such as zoning requirements, if applicable. Applicable sections shall be highlighted in the copy of the regulations;

(I) Proposed blueprints that outline the entire facility and feature all rooms and areas clearly labeled, including purpose and square footage, camera locations, limited access areas, and access permissions;

(J) For applicants that will be cultivating marijuana, the cultivation practices(s) (indoor, outdoor, or greenhouse) used by the facility, and, if using a combination of practices, the ratio of cultivation space limits for each cultivation practice, as provided in the cultivation section of this chapter;

(K) An attestation that all individuals subject to analysis for disqualifying felony offenses will submit fingerprints within two (2) weeks after the application submission for a state and federal fingerprint-based criminal background check to be conducted by the Missouri State Highway Patrol;

(L) An attestation that no individual subject to analysis for a disqualifying felony offense has a disqualifying felony offense;

(M) All applicable fees; and (N) For each comprehensive facility applicant, the application shall include a plan that explains how the applicant would serve both the medical and adult-use markets, while maintaining adequate supply at a reasonable cost to qualifying patients, and a plan to promote and encourage participation in the regulated marijuana industry by people from communities that have been disproportionately impacted by marijuana prohibition.

(4) In addition to the application requirements in section (3) above, microbusiness facility applicants must also provide the (A) A visual representation of the applicant entity’s ownership structure showing the percentage of each individual’s ownership in the microbusiness. Examples of such visual representations may be found on the department’s website at: http:// cannabis.mo.gov;

(B) Documents demonstrating eligibility for microbusiness facility ownership as follows:

A valid (not expired) government-issued photo ID; and 2. For applicants claiming a net worth of less than two hundred fifty thousand dollars ($250,000) and low income— A. Sworn, notarized financial statements demonstrating a net worth at the time of the application of less than two hundred fifty thousand dollars ($250,000). This includes all marital property, unless applicant provides evidence sufficient to demonstrate that property is not jointly owned; and B. Documentation establishing that the applicant’s household adjusted gross income was below two hundred fifty percent (250%) of the federal poverty guidelines issued by the U.S. Department of Health and Human Services for at least three (3) of the last ten (10) years from the date of the application. Income for each year claimed may be established by tax returns, paycheck stubs summarizing the full income from the source for the year, W-2s, evidence of job loss, or other documentation sufficient to demonstrate gross income below two hundred fifty percent (250%) of the federal poverty level during the applicable year. Household income is determined using an individual’s income combined with their spouse’s income. A household is made up of an individual, their spouse, and any dependents. If household size cannot be determined from the documentation above, applicant must submit a list of dependents’ first and last names, SSNs, and relationships to the applicant;
For applicants claiming a service-connected disability— A. A copy of the front of the applicant’s current veteran health identification card demonstrating a service-connected disability; or B. A copy of the applicant’s VA benefit summary letter, dated within six (6) months before the date of the application, demonstrating a service-connected disability; or C. A copy of the applicant’s VA award letter, dated within six (6) months before the date of the application, demonstrating a service-connected disability; or D. If none of these proofs are available, some other current evidence of service-connected disability which the department determines is sufficient proof of service-connected disability;
For applicants claiming an arrest, prosecution, or conviction for a non-violent marijuana offense— A. A copy of the relevant arrest record; or B. A copy of the relevant FBI background check; or C. A copy of the relevant arrest record and a letter from the prosecutor’s office indicating the charge filed; or D. A copy of the relevant arrest record and a certified copy of the judgment of conviction; or E. A copy of the relevant arrest record and a certificate of expungement from a court; or F. If none of these proofs are available, some other evidence of the arrest, prosecution, or conviction which the department determines is sufficient proof of arrest, prosecution, or conviction of a non-violent marijuana offense; and G. If the arrest, prosecution, or conviction was for the applicant’s parent, guardian, or spouse— (I) A valid (not expired), government-issued photo ID of the parent, guardian, or spouse; and (II) Proof of relationship— (a) A certified copy of the applicant’s birth certificate; or (b) A certified copy of the judgment of adoption or guardianship; or (c) A certified copy of the marriage certificate; or (d) If none of these proofs are available, some other evidence of relationship which the department determines is sufficient proof of relationship;
For applicants claiming residency in a ZIP code or census tract area where either thirty percent (30%) or more of the population lives below the federal poverty level or the rate of unemployment is fifty percent (50%) higher than the state average, the application must include— A. Two (2) separate types of utility bills (i.e., one (1) water bill, one (1) electric bill) dated within the last four (4) months, (I) The name of the applicant;

(II) The dates of service;

(III) The service address; and (IV) The billing address; or B. A copy of a current residential lease, which must include the name of the applicant, the full address, the date the lease went in to effect and expires, and an affidavit from the applicant stating the applicant resides at that address; or C. A copy of a residential mortgage that includes the name of the applicant and the full address, and an affidavit from the applicant stating the applicant resides at that address;

D. A copy of the applicant’s real or personal property taxes, dated within the past twelve (12) months, which must include the applicant’s name, address, and the date assessed;

E. Other documentation sufficient to demonstrate residency; and F. Documentation or screenshot from the most recent five- (5-) year estimates published by the American Community Survey of the U.S. Census Bureau, for the department to verify the claimed resident ZIP code tabulation area or census tract contains the qualifying poverty or unemployment rate;

For applicants claiming residency in a ZIP code or census tract area where the historic rate of incarceration for marijuana-related offenses is fifty percent (50%) higher than the rate for the entire state— A. Two (2) separate types of utility bills (i.e., one (1) water bill, one (1) electric bill) dated within the last four (4) months, (I) The name of the applicant;

(II) The dates of service;

(III) The service address; and (IV) The billing address; or B. A copy of a current residential lease, which must include the name of the applicant, the full address, the date the lease went in to effect and expires, and an affidavit from the applicant stating the applicant resides at that address; or C. A copy of a residential mortgage which includes the name of the applicant and the full address, and an affidavit from the applicant stating the applicant resides at that address;

D. A copy of the applicant’s real or personal property taxes, dated within the past twelve (12) months, which must include the applicant’s name, address, and the date assessed;

E. Other documentation sufficient to demonstrate residency;

A list of qualifying ZIP codes in Missouri, using data obtained from the Missouri State Highway Patrol, is included herein.

For individuals residing in a different state, the application must include data from a comparable state authority sufficient to demonstrate the claimed resident ZIP code or census tract contains the qualifying incarceration rate for marijuana offenses.

Zip Codes in Missouri with Qualifying Historic Rate of Incarceration 63050 63555 64469 65103 65483 63065 63556 64473 65104 65532 63066 63565 64477 65105 65536 63084 63633 64482 65106 65560 63101 63640 64601 65107 65565 63105 63645 64633 65108 65582 63150 63651 64640 65111 65607 63169 63664 64653 65201 65613 63188 63670 64683 65205 65622 63195 63736 64701 65212 65625 63199 63755 64759 65216 65653 63301 63779 64766 65233 65656 63302 63834 64772 65248 65661 63334 63857 64776 65259 65667 63361 63869 64856 65261 65668 63379 64028 65018 65265 65712 63380 64067 65020 65275 65721 63383 64068 65036 65299 65785 63435 64079 65041 65301 65801 63457 64085 65051 65302 65802 63459 64106 65055 65340 65805 63466 64184 65082 65401 63469 64187 65084 65402 63548 64198 65101 65409 63552 64424 65102 65466 7. For applicants claiming graduation from a school district that was unaccredited, or had a similar successor designation, at the time of graduation— A. Documentation from the school district or a state accrediting authority sufficient for the department to verify that the school district was unaccredited at the time of graduation;

B. An official copy of the applicant’s high school diploma;

C. A letter from the applicant’s high school demonstrating that the applicant graduated from the school and the year the applicant graduated;

For applicants claiming residency in a ZIP code containing an unaccredited school district, or similar successor designation for three (3) of the past five (5) years— A. Documentation from the school district or a state accrediting authority sufficient for the department to verify that the school district was unaccredited during at least one (1) of the three (3) years the applicant resided in the school district; and B. A copy of two (2) separate types of utility bills (i.e., one (1) water bill, one (1) electric bill,) for each quarter of the three (3) years that the applicant claims to have lived in said location (I) The name of the applicant;

(II) The dates of service;

(III) The service address; and (IV) The billing address; or C. Copies of residential leases for three (3) of the past five (5) years, which must include the name of the applicant, the full address, and the effective date and the expiration date of the lease; or D. A copy of a residential mortgage that includes the name of the applicant and the address, along with an affidavit that the applicant resided at that address during the applicable years; or E. A copy of three (3) of the last five (5) years’ real or personal property taxes for the applicant, which must include the applicant’s name, address, and the date; or F. Other documentation sufficient to establish residency;

G. An applicant may provide any of the acceptable types of documentation for each year they are claiming residency in the ZIP code (i.e., utility bills from one year, lease from a separate year, and property taxes for a third year);

(C) Names, phone numbers, addresses, and email addresses for all eligible individuals contributing toward majority ownership;

(D) Certificates of completion or other records documenting completion of mandatory pre-application training for at least one (1) eligible individual contributing to majority ownership;

(E) All business agreements that affect ownership or control related to the application or future license, existing at the time of application, including all management agreements, consulting agreements, partnership agreements, or loans.

(5) Application requirements for warehouses. Licensees must obtain a separate certification for each warehouse facility used for storing marijuana product at a location other than the approved location of the licensee. Such requests must be submitted after the licensee’s facility has passed a commencement inspection and shall include at least the following information:

(A) Proposed blueprints for the facility that outline the entire facility and feature all rooms and areas clearly labeled, including purpose and square footage, camera locations, limited access areas, and access permissions;

(B) An attestation that the proposed location for the warehouse complies with the facility location requirements of this

chapter and any facility location requirements of the local government;

(C) Documentation from the local government with jurisdiction over the facility’s location confirming that the proposed warehouse location complies with local distance requirements, (D) A copy of, and, where available, a hyperlink to, all local government requirements for warehouse location, such as zoning requirements, if applicable. Applicable sections shall be highlighted in the copy of the regulations;

(E) An attestation that the warehouse will comply with all other rules applicable to the licensee for which the warehouse is being established;

(F) An administrative and processing fee of two thousand five hundred dollars ($2500). This fee shall be increased or decreased each year by the percentage of increase or decrease from the end of the previous calendar year of the Consumer Price Index, or successor index as published by the U.S.

Department of Labor, or its successor agency; and (G) Approved warehouse certificates shall have the same expiration and renewal date as the license or certification for which the warehouse is being established.

(6) Application approval and denial process.

(A) In cases where there are more applicants than available licenses or certificates, the department will select applicants for available licenses or certifications by lottery.

All timely applications submitted with an application fee during an application time period will be entered into the lottery. Untimely applications or applications without an application fee will be denied.
Applications entered into the lottery will be assigned an application identifier by the department. The assigned identifiers will be transmitted to the entity conducting the lottery. The individual(s) conducting the lottery will do so without reference to the identities of the applicants.
Identifiers will be randomly drawn and listed in the order drawn. If licenses are issued by congressional district, separate drawings will occur for each congressional district.
After identifiers are drawn, the department will review the application corresponding to the selected identifier, beginning with the first identifier drawn, to determine if the applicant is eligible for licensure prior to issuing the license.

A. Applicants are responsible for submitting a complete and accurate application as set out in this chapter. However, the department may request an applicant to provide additional information or documents needed to determine eligibility for a license by sending the request to the email address of the designated contact associated with the application. If requested, the applicant will have three (3) business days from the date the email is sent to provide the requested information or documents.

B. The department will determine that microbusiness licenses will be awarded to and be operated by eligible applicants in good standing by requesting, if necessary— (I) Additional documentation demonstrating that eligible individuals collectively hold more than fifty percent (50%) of voting power in the licensed entity; and (II) Additional documentation showing that eligible individuals have more than fifty percent (50%) of the power to direct the management, managers, and policies of the license, enter into and exit agreements on behalf of the license and otherwise make decisions for the license.

If during the application review period the department determines an application meets all of the license eligibility requirements in this chapter and Article XIV, the license will be issued.
An application will be denied if— A. The application is not complete;

B. The applicant, application, or any proposal in the application is in violation of any rule in this chapter or Article XIV;

C. Awarding a license would result in an entity being an owner in more licenses than permitted by Article XIV Section 2.3(9-11);

D. The applicant provides false or misleading information in an application;

E. The applicant fails to timely provide information or records requested by the department;

F. An entity, which includes an individual, holds an ownership interest in more than one (1) microbusiness applicant in the same microbusiness application period, all microbusiness applications where the entity holds an ownership interest will be denied; or G. The department determines an application fails to meet the license eligibility requirements in this chapter and 7. If an application is denied, the department will review the next application in the order drawn until the available licenses or certifications are issued.

Once all available licenses or certifications are issued, the remaining applications entered into the lottery for that application time period will be denied for failure to be selected in the lottery.

(B) In cases where fewer applications are received in an application time period than there are available licenses or certifications, or for applications for licenses and certifications without a limit on the number to be issued, all complete applications meeting the license eligibility requirements in this chapter and Article XIV will be granted. Applications will be denied if subject to denial in paragraph (6)(A)6.

(C) Any denial shall be issued by the department in writing to the applicant and shall include the specific reasons for the denial and the process for requesting review of the department’s decision.

(D) All applicants that are issued a license or certification will be given forty-eight (48) hours to confirm they accept the license or certification. Failure to accept the license or certification in this time frame may result in deactivation of the license or certification, and the department may then offer a license or certification to the next eligible applicant in the order drawn.

(E) The department will have sixty (60) days after license issuance to verify that microbusiness licenses have been awarded to and are being operated by eligible applicants in good standing.

(7) Renewals. Renewal requests must be submitted in a department-provided, web-based application system at least thirty (30) days, but no sooner than ninety (90) days, prior to expiration.

(A) Renewal requests shall be accompanied by a nonrefundable renewal fee to be submitted with the request. The department shall publish the current fees, including any adjustments, on its website at http://cannabis.mo.gov.

(B) A renewal request is deemed received when both the request and renewal fee is received by the department.

(C) Except for good cause, a renewal request will be granted unless the facility licensee is not in good standing with the department. Good standing means the license is not suspended or revoked at the time the request is made.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023, effective July 30, 2023. Amended: Filed Nov. 6, 2025, effective May 30, 2026.

19 CSR 100-1.070 Facility Ownership and Employment {#sec-19-csr-100-1.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.070}

PURPOSE: The Department of Health and Senior Services has the authority to promulgate rules for the enforcement of Article XIV, Sections 1 and 2 of the Missouri Constitution. This rule explains what general provisions are necessary for ownership and employment related to regulated medical and marijuana facilities, with the exception of seed-to-sale tracking system entities.

(1) Facility ownership.

(A) No medical facility shall be owned, in whole or in part, by an individual with a disqualifying felony offense.

(B) A marijuana facility shall not have as an owner any individual with a disqualifying felony offense.

(C) Facility owners must notify the department of any charges for felony offenses, including the assigned case number, within thirty (30) days of being charged.

(D) No medical or marijuana licensee may be owned by or affiliated with an entity that holds a contract with the state of Missouri for any product or service related to the department’s marijuana program.

(E) An entity, which includes an individual, may not be an owner in more than ten percent (10%) of the total number of comprehensive and medical licenses, within a facility type, as described in Article XIV Section 2.3(9-11).

(F) No marijuana testing facility shall be owned by an entity or entities under substantially common control, ownership, or management as a cultivation facility, marijuana-infused products manufacturing facility, or dispensary facility.

(G) An owner of a marijuana microbusiness facility may not also be an owner of another licensed marijuana facility or medical facility.

(H) If the ownership of a medical or marijuana facility license is disputed to an extent that the dispute impairs the operations of the facility or the department’s review of an application, the department may restrict or suspend the operations of the facility license until the dispute is resolved, or it may deny a pending application. If a facility license is restricted or suspended for this reason for longer than one (1) year, the department may revoke the facility license or pursue other remedies consistent with this chapter or Article XIV.

(2) Facility employment.

(A) All employees, contractors, owners having access to a medical or marijuana facility, and volunteers of a medical or marijuana facility must obtain an agent identification card from the department before beginning employment, work, or volunteer services at a licensed or certified facility.

An individual performing maintenance work (such as plumbing) or other similar work not related to testing, transporting, growing, manufacturing, or dispensing marijuana product at any licensed or certified facility for no more than fourteen (14) days in a calendar year, is not required to have an agent identification card to perform such work. The licensee is responsible for supervising such individuals while they are in the facility.

(B) All facility agents must be twenty-one (21) years of age or older. Individuals under twenty-one (21) who possess a facility agent identification card prior to the effective date of this rule may remain facility agents.

(C) Agent identification card holders must have their cards visible and on their person at all times while performing work in a facility or on behalf of a licensed or certified entity. Agents must have a government-issued photo ID on their person at all times while the agent identification card is visible.

(D) A licensee may require a criminal background check as a condition of employment.

(E) If authorized or directed by statute, the department may require fingerprint submission to screen agent identification card applicants for disqualifying felony offenses.

(F) Agent identification cards are valid for three (3) years from their date of issuance and shall be renewable by submitting, prior to expiration by at least thirty (30) days but no sooner than sixty (60) days, a new or renewal application.

(G) All facility agents must keep the department apprised of their current contact information and agree to receive department communications by email, including denials and revocations. If the name, address, or email address of an agent changes after an identification card is issued, the agent shall notify the department within fourteen (14) days of the change.

(H) All applications and renewals for agent identification cards shall include at least the following information in a department-approved format:

Name, address, and Social Security number of the applicant;
A government-issued photo identification that confirms the age of the applicant is over twenty-one (21) years of age;
A copy of a written offer or confirmation of employment from a licensed or certified facility; and 4. All applicable fees.

(I) Upon receiving a complete application or renewal application for an agent identification card, the department shall either approve the application or provide a written explanation for its denial.

An application for an agent identification card will be considered received when an application is submitted to the department that includes all information required by this

rule.

The department shall charge an administration and processing fee of seventy-five dollars ($75) for identification cards, which shall be due at the time of application or renewal.

(J) Denial and revocation. Agent identification cards may be denied or revoked for the following reasons:

Submission of an incomplete application;
Submission of information in the application or renewal application that is deceptive, misleading, incorrect, false, or fraudulent, whether directly, or by omission or ambiguity, including lack of disclosure or insufficient disclosure;
Fraudulent use of the agent identification card, including, tampering, falsifying, altering, modifying, duplicating, or allowing another person to use, tamper, falsify, alter, modify, or duplicate an agent identification card;
Selling, distributing, transferring in any manner, or giving marijuana product to any unauthorized individual or entity, or an amount of marijuana product not authorized by law;
Tampering with or falsifying video recordings or equipment, point of sale systems or records, the state-wide track and trace system or records, or any other facility records, whether at the direction of a licensee or otherwise;
Failing to comply with the state-wide track and trace system requirements;
Violation of any requirement in this chapter;
If the individual is prohibited by law from holding an agent identification card;
If the agent has committed theft or other criminal offense, whether or not a criminal charge has been filed, in the performance of the functions or duties of the facility agent;
Refusal to cooperate with a department investigation;
If an agent card was revoked and the applicant applies for a new identification card, the application shall be denied unless the department finds good cause to issue an agent card.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.080 Facility Employee Training facilities. {#sec-19-csr-100-1.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.080}

This rule explains what training all medical and marijuana facility licensees are required to provide to employees.

(1) Licensees must ensure all facility employees, contractors, and volunteers, are trained in at least the following and must maintain records of employee training for at least five (5) years:

(A) The use of security measures and controls that have been adopted by the licensee for the prevention of diversion, inversion, theft, or loss of marijuana product, as applicable to the employee’s duties;

(B) Proper use of the state-wide track and trace system, as applicable to the employee’s duties;

(C) Procedures for responding to an emergency, including severe weather, fire, natural disasters, and unauthorized intrusions;

(D) The safety and sanitation procedures of the facility, as applicable to the employee’s duties;

(E) Department rules and guidance as applicable to the employee’s duties;

(F) All processes and procedures used by the facility that are applicable to that employee’s duties;

(G) Transportation and dispensary licensees must ensure employees responsible for assisting customers or handling customer purchase records are trained in standards for maintaining the confidentiality of information related to the use of marijuana product and in procedures for verifying the identity and age of consumers, qualifying patients, and primary caregivers; and (H) Dispensary licensees must ensure that employees responsible for assisting customers are trained in the following:

Procedures for verifying purchase limitations of consumers, qualifying patients, and primary caregivers;
The differences in the purported effects and effectiveness of the strains of marijuana available for purchase at their dispensary and the methods of their use;
The expected timeframes for individuals to feel the effects of marijuana product based on their chosen method of use; and 4. Procedures for verifying a purchaser of marijuana product is of lawful age pursuant to this chapter.

(2) All required employee training shall be completed no later than one (1) week after an individual begins work at a licensed facility or performs activities covered by a new or modified S OP.

(3) Licensees must make all training records available for review during inspections.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.090 Facility Security {#sec-19-csr-100-1.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.090}

PURPOSE: The Department of Health and Senior Services has the authority to establish security requirements for any premises licensed or certified under Article XIV, Sections 1 and 2 of the Missouri Constitution. This section provides the security requirements of all licensed or certified medical and marijuana (1) All medical and marijuana facility licensees shall ensure the security of marijuana product and the facility, including any offsite warehouses, by taking security measures and maintaining security equipment as follows:

(A) Devices or a series of devices to detect unauthorized intrusion, which may include a signal system interconnected with a radio frequency method, such as cellular or private radio signals, or other mechanical or electronic devices;

(B) Except in the case of outdoor cultivation, exterior lighting to facilitate surveillance, which shall cover the exterior of all buildings and the perimeter of the facility; and (C) Electronic video monitoring, which shall include video cameras with a recording resolution of at least 1920 x 1080p, or the equivalent, capable of recording videos at a rate of at least fifteen (15) frames per second, that operate in such a way as to provide continuous monitoring and allow identification of people and activities in all lighting levels, and that are capable of being accessed remotely at all times by the department or a law enforcement agency in real time.

The use of motion detection as a method of continuous monitoring is not permitted where marijuana product is or will be present.
Remote access shall be accomplished through https access or another department-approved format.
Video cameras must provide coverage of— A. All facility building entry and exit points, including windows;

B. All areas of the facility and facility premises where marijuana is or will be present;

C. Each point-of-sale location;

D. All vaults or safes where marijuana product is stored;

E. Any area on facility premises, including offsite warehouses and transport vehicles, where a seed-to-sale system or the state-wide track and trace system are accessed;

F. The entire perimeter of the facility, including at least twenty feet (20') of space around the perimeter of an outdoor grow area; and G. All marijuana product, from at least two (2) angles, where it is grown, cultivated, manufactured, sampled for testing, tested, stored, weighed, packaged, processed for sale, sold/distributed, rendered unusable, disposed, or loaded for transport.

All activities subject to video camera monitoring shall occur only in areas of the facility that are covered by the required video monitoring.
Licensees shall ensure that each video camera used pursuant to this section— A. Includes a date and time generator which accurately displays the date and time of recorded events on the recording in a manner that does not significantly obstruct the recorded view;

B. Is installed in a manner that prevents the video camera from being readily obstructed, tampered with, or disabled; and C. Is cabled and does not solely operate via wifi.

Video recording equipment must also include at least one (1) call-up monitor that is at least nineteen inches (19").
Facilities must have a printer capable of immediately producing a clear, color, still photo from any video camera image.
Licensees shall store recordings from the video cameras for at least sixty (60) days in a secure location or through a service or network that allows for providing copies of the recordings, in a department approved format, upon request and at the expense of the licensee.

A. The licensee shall provide the department with proof of a working storage mechanism upon request of the department and at the expense of the licensee.

B. If the licensee changes its recording storage mechanism, the licensee must provide the department with notification of such change and proof that the new storage mechanism is capable of storing all recordings for at least sixty (60) days within ten (10) days of said change.

C. Video storage must be encrypted.

Facilities shall have a failure notification system that provides an audible and visual notification of any failure in the electronic video monitoring system; and 10. Facilities shall have sufficient battery backup for video cameras and recording equipment to support at least sixty (60) minutes of recording in the event of a power outage.

(D) Controlled entry to limited access areas, which shall be controlled by electronic card access systems, biometric identification systems, or other equivalent means, except that, in addition to these means, all external access doors shall be equipped with a locking mechanism that may be used in case of power failure. Access information shall be recorded, and all records of entry shall be maintained for at least one (1) year;

(E) A method of immediate, automatic notification to alert local law enforcement agencies of an unauthorized breach of security at the facility;

(F) Manual, silent alarms affixed at each point-of-sale, reception area, vault, warehouse, and electronic monitoring station with capability of alerting local law enforcement agencies immediately of an unauthorized breach of security at the facility;

(G) Security film or shatter-proof glass on glass doors and storefronts;

(H) If windows are in a limited access area, the windows cannot be opened and must be designed to prevent intrusion or the window is otherwise inaccessible from the outside; and (I) Vaults must be secured in a manner that prevents access to unauthorized individuals through both physical and electronic security measures.

(2) Licensees shall establish and follow policies and procedures— (A) For restricting access to the areas of the facility that contain marijuana product to only facility agents who are employees, contractors, owners having access to a medical or marijuana facility, and volunteers of the facility. Individuals without an agent identification card may be present when necessary for legitimate business purposes, if they sign in and sign out of a visitor log and are escorted at all times by facility agents in a ratio of no less than one (1) facility agent per five (5) visitors;

(B) For identifying persons authorized to be in the areas of the facility that contain marijuana product;

(D) For monitoring the security for the facility;

(E) For the use of the automatic or electronic notification and manual, silent alarms to alert local law enforcement agencies of an unauthorized breach of security at the facility, including designation of on-call facility personnel to respond to, and to be available to law enforcement personnel responding to any alarms; and (F) For keeping local law enforcement and the department updated on whether the facility employs armed security personnel and how those personnel can be identified on sight.

(3) Medical and marijuana facility licensees with outdoor or greenhouse cultivation spaces, or cultivation or manufacturing facilities with multiple buildings in which cultivation or manufacturing are conducted, shall construct an exterior barrier around the perimeter of the facility that consists of a fence— (A) Constructed of nine (9) gauge metal or stronger chain link;

(B) That is at least eight (8) feet in height from the ground to the top of the fence;

(D) Screened such that an outdoor cultivation area is not easily viewed from outside the fence; and (E) That includes a secured gate that complies with the same security standards as the fence, as well as a method for controlling access through the gate.

(4) For any planned security outage, the licensee shall notify the department at least twenty-four (24) hours prior to the planned outage and provide a plan for facility and product security during the outage. For a planned security outage occurring in fewer than twenty-four (24) hours, the licensee shall notify the department as soon as a security issue requiring an outage is discovered.

(5) Licensees shall notify the department within twenty-four (24) hours after a security system malfunction is discovered and shall make a reasonable effort to repair a malfunction of any security equipment within seventy-two (72) hours after the malfunction is discovered.

(A) A malfunction occurs when any piece of security equipment fails to work as designed or intended, for more than sixty (60) seconds, either through defect, power outage, security breach, internet outage, compromise, or other reason.

(B) If the electronic video monitoring used pursuant to this

section malfunctions, the licensee shall immediately provide alternative video camera coverage or use other security measures until video camera coverage can be restored, such as assigning additional supervisory or security personnel, to provide for the security of the facility. If the licensee uses other security measures, the licensee must immediately notify the department.

(C) Each licensee shall maintain a log that documents each malfunction and repair of the security equipment of the facility. The log must state the date, time, and nature of each malfunction; the efforts taken to repair the malfunction and the date of each effort; the reason for any delay in repairing the malfunction; the date the malfunction is repaired and; if applicable, any alternative security measures that were taken.

The log must list, by date and time, all communications with the department concerning each malfunction and corrective action. The facility shall maintain the log for at least one (1) year after the date of last entry in the log.

(6) Each licensee shall employ a security manager who shall be responsible for— (A) Conducting a semi-annual audit of all security measures.

The semi-annual audit shall be an evaluation of the security of the facility, including warehouses, equipment, procedures, and training, as well as the facility’s compliance with this rule.
Audits shall take place at least five (5) months apart.
Security audit records shall be kept for at least five (5) years;

(B) Training employees on security measures, emergency response, and theft prevention and response within one (1) week of hiring and on an annual basis;

(C) Evaluating the credentials of any contractors or other individuals who intend to provide services to the facility before the contractor or individual is hired by or enters into a contract with the licensee; and (D) Evaluating the credentials of any third party who intends to provide security to the facility before the third party is hired by or enters into a contract with the facility.

(7) Each licensee shall ensure that the security manager of the facility, any facility agents who provide security for the facility, and the employees of any third party who provides security to the facility have completed the following training:

(A) Training in theft prevention or a related subject;

(B) Training in emergency response or a related subject;

(C) Training in the appropriate use of force or a related subject that covers when the use of force is and is not necessary;

(D) Training in the protection of a crime scene or a related subject;

(E) Training in the control of access to protected areas of a facility or a related subject;

(F) Not fewer than eight (8) hours of training at the facility in providing security services; and (G) Not fewer than eight (8) hours of classroom training in providing security services.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.100 Facilities Generally Constitution, the Department of Health and Senior Services is authorized to regulate and control the operations of medical and marijuana facilities. {#sec-19-csr-100-1.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.100}

This rule explains general operating requirements applicable to all licensed and certificated facilities.

(1) Licensing and location.

(A) An entity must obtain a separate license or certificate for each facility. Subject to department pre-approval, multiple licenses or certificates may be utilized at a single location.

Testing licensees may not share space with any other facility.

(B) Each license or certification shall be charged an annual fee once the license or certification is granted. The first annual fee will be due thirty (30) days after a license or certification is issued and shall be due annually on that same date as long as the license or certification remains valid, except for in the case of microbusinesses whose first annual fee will be due on the anniversary of their licensure. The department shall publish the current fees, including any adjustments, on its website. The fees due will be the amount that is effective as of that license or certification’s annual fee due date.

(C) Unless expressly allowed by the local government, no medical or marijuana facility, including any offsite warehouses, shall be sited, at the time of application for license, certification, or local zoning approval, whichever is earlier, or at time of application for relocation, within one thousand feet (1,000') of any then-existing elementary or secondary school, daycare, or church. The method of measuring distances is governed by (D) A dispensary or microbusiness will only be approved to relocate within the congressional district in which they were originally licensed.

(2) Marijuana facility business change applications. Marijuana facility licensees must apply for and obtain the department’s approval before they may— (A) Transfer their license to a different entity with the same ownership. Once the department has confirmed receipt of a complete application, it will approve or deny the application within sixty (60) days. Such a request must include at least the 1. Current legal name of the licensee, including fictitious business names, and proposed new legal name of the licensee, including fictitious business names;

All owners of the licensed entity and their individual ownership percentage, which must show the proposed new entity is owned by the same owners as is the licensee;
A visual representation of the licensee’s ownership structure, including all owner entities;
Other documentation as requested to verify ownership;
An administrative and processing fee of two thousand dollars ($2,000);

(B) Make any changes that would result in an individual becoming an owner of the licensed entity who was not previously an owner. Once the department has confirmed receipt of a complete application, it will approve or deny the application within ninety (90) days. Such requests must include at least the following:

All current and proposed owners of the licensed entity and their proposed individual ownership percentage;
A visual representation of the licensee’s proposed ownership structure, including all owner entities;
A chart comparing the previously approved ownership 4. Verification that the change will not result in any between a testing licensee and any other medical or marijuana 5. An attestation that all individuals subject to analysis for disqualifying felony offenses will submit fingerprints within two (2) weeks after the application submission, or have previously submitted such fingerprints, for a state and federal fingerprint-based criminal background check to be conducted by the Missouri State Highway Patrol;
For microbusinesses, if the proposed change affects eligibility, documentation sufficient to demonstrate eligibility for microbusiness facility ownership, as provided in the application and selection section of this chapter;
Other documentation as requested to verify ownership;
An administrative and processing fee of five thousand dollars ($5000), which shall only be assessed once on multiple (C) Make any changes that would result in an overall change in ownership interests of fifty percent (50%) or more from the last approved ownership of the licensee. Once the department has confirmed receipt of a complete application, it will approve or deny the application within one hundred fifty (150)

days. Such requests may only be submitted after the licensee’s facility has received approval to operate and must include at least the following:

All current and proposed owners of the licensed entity and their proposed individual ownership percentage;
A chart comparing the previously approved ownership 3. A visual representation of the licensee’s proposed ownership structure including all owner entities;
Verification that the change will not result in any between a testing licensee and any other marijuana licensee;
An attestation that all proposed owners will submit fingerprints within two (2) weeks after the application submission, or have previously submitted such fingerprints, for a state and federal fingerprint-based criminal background check to be conducted by the Missouri State Highway Patrol;
In the case of full asset transfer to a different entity, applications must also include:

A. Asset purchase agreement;

B. Merger, sale, transfer, Memorandum of Understanding (MOU), or other like agreement between the licensee and transferee;

C. Brand, management, consultant agreements or contracts, or any other agreement or contracts; and D. Location lease agreement or proof of ownership;

For microbusinesses, documentation sufficient to demonstrate eligibility for microbusiness facility ownership, as provided in the application and selection section of this

chapter;

Other documentation as requested to verify ownership;
An administrative and processing fee of eight thousand dollars ($8,000), which shall only be assessed once on multiple (D) Change the licensee’s facility or warehouse location.

Once the department has confirmed receipt of a complete application, it will approve or deny the application within ninety (90) days. Such requests shall include at least the 1. Proposed blueprints that outline the entire facility and feature all rooms and areas clearly labeled, including purpose and square footage, camera locations, limited access areas, and access permissions;

Documentation from the local government with jurisdiction over the facility’s location confirming that the proposed location complies with local distance requirements, 3. If the local government in which the facility will be located has enacted applicable zoning restrictions, documentation from the local government with jurisdiction over the facility’s location confirming that the proposed location complies with applicable zoning restrictions;
Location lease agreement and/or proof of ownership;
An administrative and processing fee of five thousand dollars ($5000);

(E) Any administrative and processing fee for a microbusiness change application shall be half the amount listed in (A)-(D) of this section; and (F) Change applications will be approved if the request contains all of the documents, fees, and information required by this section, and the resulting change in ownership or ownership interests does not violate any provision of this

chapter or Article XIV. Change requests will be denied if the request does not contain all the documents, fees, and information required by this section, or if the resulting change violates any provision of this chapter or Article XIV.

(3) Medical facility business change applications. Medical facility licensees must apply for and obtain the department’s approval before they may— (A) Transfer their license to a different entity with the same ownership. Such a request must include at least the following:

Current legal name of the licensee, including fictitious business names, and proposed new legal name of the licensee, including fictitious business names;
Any entity that owns any part of the licensed entity and their individual ownership percentage, which must show the proposed new entity is owned by the same entities as is the 3. A visual representation of the licensee’s ownership structure, including all entities that own any part of the licensed entity;
Other documentation as requested to verify ownership;
An administrative and processing fee of two thousand dollars ($2000);

(B) Make any changes that would result in an overall change in financial or voting interests of fifty percent (50%) or more from the last approved ownership of the licensee. Such requests may only be submitted after the licensee’s facility has received approval to operate and must include at least the following:

All current and proposed entities with any financial or voting interest in the licensed entity and their proposed individual ownership percentage;
A chart comparing the previously approved ownership 3. A visual representation of the licensee’s proposed ownership structure including all entities;
Verification that the change will not result in any between a testing licensee and any other medical licensee;
An attestation that all individuals subject to analysis for disqualifying felony offenses will submit fingerprints within two (2) weeks after the application submission, or have previously submitted such fingerprints, for a state and federal fingerprint-based criminal background check to be conducted by the Missouri State Highway Patrol;
In the case of full asset transfer to a different entity, applications must also include:

A. Asset purchase agreement;

B. Merger, sale, transfer, MOU, or other like agreement between the licensee and transferee;

C. Brand, management, consultant agreements or contracts, or any other agreement or contracts; and D. Location lease agreement or proof of ownership.

Other documentation as requested to verify ownership;
An administrative and processing fee of eight thousand dollars ($8,000), which shall only be assessed once on multiple (C) Change the licensee’s facility location. Such requests shall include at least the following:
Proposed blueprints for the facility that outline the entire facility and feature all rooms and areas clearly labeled, including purpose and square footage, camera locations, limited access areas, and access permissions;
Documentation from the local government with jurisdiction over the facility’s location confirming that the proposed location complies with local distance requirements, 3. If the local government in which the facility will be located has enacted applicable zoning restrictions, documentation from the local government with jurisdiction over the facility’s location confirming that the proposed location complies with applicable zoning restrictions;
Location lease agreement and/or proof of ownership;
An administrative and processing fee of five thousand dollars ($5,000); and (D) Change applications will be approved if the request contains all of the documents and information required by this

section and the resulting change in ownership or ownership interests does not violate any provision of this chapter or (4) General operations.

(A) Licenses shall be displayed within twenty feet (20') of the main entrance to a facility at all times.

(B) A medical or marijuana facility may not allow cultivation, manufacturing, sale, or display of marijuana product or marijuana accessories to be visible from a public place outside of the marijuana facility without the use of binoculars, aircraft, or other optical aids.

(D) Licensees shall implement a quality management system using a published standard, such as those offered by International Organization for Standardization, ASTM International, Cannabis Safety and Quality, or Foundation of Cannabis Unified Standards, within one (1) year of the date the facility receives department approval to operate. The chosen standard shall be applicable to the licensee’s facility type and be implemented with emphasis on regulatory compliance.

(E) All licensees must receive approval to operate within one (1) year of being issued a license or certification; except microbusiness licensees, which must receive approval to operate within two (2) years of issuance. Absent a granted waiver or variance, licenses may be revoked or sanctioned if not operational and active within the required time frame.

(F) In the event a licensee loses control of their approved location, facility, or license, the license shall be suspended or restricted until a new location is approved or access to the facility or license is restored.

(G) Only licensees may hold rights to marijuana product within licensed facilities.

(H) All marijuana-infused products shall be manufactured in a licensed manufacturing facility.

Any facility that extracts resins from marijuana using combustible gases or other dangerous materials, without a manufacturing license, shall incur a penalty of ten thousand dollars ($10,000).

(I) All marijuana product sold in Missouri shall have originated from marijuana grown and cultivated in a licensed cultivation facility located in Mis souri.

(J) All licensees shall establish and follow SOPs in the event the facility is suspended or ordered to cease operations.

(K) All licensees shall establish and follow detailed SOPs for marijuana product remediation.

(L) All licensees shall establish and follow SOPs to ensure marijuana remains free from contaminants. The systems, equipment, and documentation necessary to follow procedures must address, at a minimum:

The flow through a facility of any equipment or supplies that will come in contact with marijuana including receipt and storage;
Employee health and sanitation; and 3. Environmental factors, such as— A. In all areas of the facility where marijuana is or will be present, floors, walls, and ceilings made of smooth, hard surfaces that are easily cleaned;

B. Temperature and humidity controls;

C. A system for monitoring environmental conditions;

D. A system for cleaning and sanitizing rooms and equipment;

E. A system for maintaining any equipment used to control sanitary conditions; and F. For cultivation and manufacturing facilities, an air supply filtered through high-efficiency particulate air filters under positive pressure.

(M) Consumption of marijuana product on the licensed premises, including in any approved transport vehicles, is prohibited. All licensees shall post a sign at the employee and public access points to the facility that consumption of marijuana product is not allowed on the licensed premises.

(N) If a licensee enters into a contract with a management company or other entity to run all or part of the regulated marijuana operations under this chapter, the contract must permit the licensee to access the licensee-related records of the management company or other entity at the request of the department during an investigation or inspection.

(O) All licensees shall maintain any records required by this

chapter for at least five (5) years.

(P) The department may issue notice of marijuana product recall to licensees or the public if, in its judgment, any particular marijuana product presents a threat or potential threat to the health and safety of qualifying patients or consumers. All facilities are responsible for complying with recall notices.

Recalled items must be immediately pulled from production or inventory and quarantined until such time as the department determines the item is safe, may be remediated, or must be destroyed.

(5) Signage and advertising must comply with the following:

(A) A marijuana product may only be advertised or marketed in compliance with all applicable municipal ordinances, state law, and rules that regulate signs and advertising;

(B) No advertisement of marijuana may contain:

Any representation that is false or misleading in any way;
Any statement representing that the use of marijuana has curative or therapeutic effects or tending to create an impression that it has curative or therapeutic effects unless such statement has been evaluated and approved by the Food and Drug Administration;
Any content that is attractive to children, including but not limited to the shape or any part of the shape of an animal or fruit, including realistic, artistic, caricature, or cartoon renderings, and artistic, caricature, or cartoon renderings of the shape or any part of the shape of a human; or 4. Any statement concerning a brand of marijuana that is inconsistent with any statement on the labeling;

(C) Outdoor signage and, if visible from a public right of way, interior signage, must comply with any local ordinances for signs or advertising; and (D) No licensee shall use exterior signage or advertising that does not accurately reflect a licensee’s legal name, business name or d/b/a, or trade name on record with the department.

(6) Licensee notification and reporting. Licensees have a duty to keep the department apprised of certain information as described below. Failure of a licensee to report required information to the department may result in administrative penalties, to include a fine of up to ten thousand dollars ($10,000), suspension, or revocation of the license.

(A) Licensees have a continuing duty to provide the department with up-to-date contact information, including the individual who shall be the designated contact for all department communications.

Licensees shall notify the department in writing of any changes to the mailing addresses, phone numbers, email addresses, and other contact information they provide the department.

(B) Licensees must report, at least annually— 1. For marijuana facility licensees, all owners, with ownership percentage; and 2. For medical facility licensees, all entities that own any

part of the licensed entity, with ownership percentage.

(C) Licensees shall notify the department within five (5) days of the initiation and conclusion of any legal proceedings, government investigations, or any other activity that would impair the licensee’s ability to operate in accordance with department regulations or the department’s review of an application, including a petition for receivership, loss of lease or location, or disputes relating to the ownership or control of the facility or license.

(D) Licensees shall notify the department when a facility agent has been terminated for misconduct related to handling of marijuana product, including but not limited to, inventory, product integrity, marijuana product sales, theft, health and safety, or facility security.

(E) Licensees shall notify the department within twenty-four (24) hours following the occurrence of an event that affects the health and safety of the facility or its employees, including injury to employees or other persons at the facility resulting in medical care being administered by a medical professional.

(F) Licensees shall notify the department within twentyfour (24) hours of discovery of any theft or attempted theft of marijuana product.

(G) Licensees shall notify the department within twentyfour (24) hours of discovery of any criminal misconduct of an employee, contractor, owner, or volunteer.

(H) Cultivation licensees shall notify the department before changing its cultivation practice (indoor, outdoor, or greenhouse) or modifying the ratios of cultivation practices it uses, as provided in the cultivation section of this chapter.

(I) After the department approves a change in location, the licensee shall request a commencement inspection as required pursuant to this chapter.

(J) Licensees shall notify the department of any entity name changes or fictitious name changes.

(K) Licensees shall notify the department in writing prior to initiating a facility update that would be subject to 19 CSR 100- 1.090, such as adding point of sale equipment in a dispensary or replacing windows or doors. Within the notification, licensees shall provide their plan to remain in compliance with applicable rules of this chapter and ensure security of the facility and marijuana product during the update.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.110 Testing the authority to regulate and control marijuana facilities and to ensure the safe use of marijuana product. {#sec-19-csr-100-1.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.110}

This rule explains what regulations apply to the testing of marijuana product.

(1) Marijuana testing, generally.

(A) Testing licensees shall test all lots of marijuana product produced by medical and marijuana facilities, including prerolls created at dispensary facilities but excluding seeds and plants, before it may be sold for use by a patient or consumer.

(2) Marijuana testing facility certifications.

(A) Any licensee originally certified as a medical marijuana testing facility shall be deemed certified to conduct those activities with respect to all marijuana product.

(B) A testing licensee’s authority to engage in the process of testing marijuana product includes the acquisition, testing, certification, and transportation of marijuana product.

(3) Testing facility requirements. In addition to this chapter’s other requirements for licensed facilities and licensees, testing licensees shall also comply with the following:

(A) Standards for personnel.

A marijuana testing licensee must employ a laboratory director with a degree in a natural science, such as biology, chemistry, physics, engineering, or environmental sciences, and at least five (5) years of experience in a regulated laboratory environment or a degree in another applicable field with at least ten (10) years of experience in a regulated laboratory environment.
Individuals performing sampling and testing of marijuana product, or overseeing the sampling and testing of marijuana product, must have at least a bachelor’s degree in a natural science, such as biology, chemistry, physics, engineering, or environmental sciences, or at least two (2) years of applicable experience;

(B) Testing licensees shall be accredited by an International Laboratory Accreditation Cooperation recognized accreditation body under International Organization for Standardization (ISO)/International Electrotechnical Commission (IEC) standard 17025.

Testing licensees shall achieve such accreditation within one (1) year of the date the licensee receives department approval to operate and shall maintain its accreditation as long as the facility holds a certification.
The scope of the accreditation shall include all marijuana product testing required by this rule.
Loss of accreditation shall be reported to the department by the testing licensee within twenty-four (24) hours of the testing licensee receiving notice of the loss.
Inspection and audit reports from the accrediting body shall be submitted to the department by the testing licensee within twenty-four (24) hours of receipt.

A. During any periods of time when a licensee no longer conforms with ISO/IEC 17025, the licensee shall not conduct testing of marijuana product, until approved by the department in writing, and may be subject to a fine of up to one thousand dollars ($1,000) for every day the facility is not in compliance. Upon return to compliance, the licensee shall not resume testing without department approval.

B. If a licensee loses ISO/IEC 17025 accreditation, the licensee shall not conduct testing of marijuana product and may be subject to a fine of up to one thousand dollars ($1,000) for every day the licensee is not in compliance.

If a licensee does not receive ISO/IEC 17025 accreditation within one (1) year of the date the licensee receives department approval to operate, the licensee shall not conduct testing of marijuana product and may be subject to a fine of up to one thousand dollars ($1,000) for every day the licensee is not in compliance;

(C) After the testing licensee has received approval to operate, the licensee shall participate in an annual proficiency testing program provided by an organization that is accredited to ISO/IEC 17043.

The scope of proficiency testing shall include all marijuana testing methods performed at the facility for testing required by this rule.
The licensee shall notify the department of the proficiency testing provider the facility chooses prior to engaging with the provider in proficiency testing.
The licensee shall analyze proficiency test samples using the same procedures, number of replicates, standards, and equipment as used for testing marijuana product for each individual conducting those tests at the time.
The licensee shall submit copies of proficiency test results to the department within two (2) business days of receipt.
The licensee shall take, and report to the department, corrective action on all failed proficiency tests, and failed tests must be repeated until the licensee obtains an acceptable result for all analytes. If the licensee fails a proficiency test more than once, the department may require the licensee to suspend mandatory testing of the failed analyte(s) until an acceptable result is received;

(D) Testing licensees shall retain all remaining sample material that was not used in the testing process for a minimum of thirty (30) days after testing is complete.

Excess sample material shall be securely stored in a manner that mitigates sample degradation, contamination, and tampering, and the sample material must be made available to the department upon request.
When no longer subject to retention, sample material shall be disposed pursuant to the waste disposal requirements of this chapter;

(E) Testing licensees shall participate in inter-lab comparison efforts as follows:

Licensees must provide marijuana product from remaining sample material up to twice a year, at the direction of the department, to other licensed facilities for testing;
Facilities must receive remaining sample material up to ten (10) times a year, at the direction of the department, from other licensed facilities for testing;
The licensee receiving the marijuana product for testing will perform the sampling and be responsible for the transportation of the marijuana product, at the direction of the department; and 4. The department may use the inter-lab comparisons to initiate an investigation or other corrective action for a testing licensee producing inconsistent or anomalous testing results;

(F) Testing licensees shall maintain all sampling and testing records for at least five (5) years; and (G) Testing licensees must perform all testing using sampling, methods, and equipment that are appropriate for the tests performed, capable of producing data in a format that meets scientific and regulatory standards, and also permitted within the scope of the licensee’s accreditation under ISO/IEC 17025.

(4) Testing methods.

(A) Testing licensees shall use analytical and microbial testing methodologies that— 1. Are based upon published peer-reviewed methods;

Have been validated for cannabis testing by an independent third party; and 3. Have been internally verified by the testing licensee according to Appendix J or K of Official Methods of Analysis authored by the Association of Official Analytical Collaboration (AOAC) International, with guidance from published cannabis standard method performance requirements where available.

(B) In the absence of published, peer reviewed, validated cannabis methods, method validation requirements of

Appendix J or K of Official Methods of Analysis authored by the Association of Official Analytical Collaboration (AOAC)

International must be met in full with guidance from published cannabis standard method performance requirements, where available, and if published cannabis standard method performance requirements are not available, compendia or other reputable sources.

(C) Testing licensees shall report to the department what testing method will be used prior to using that method and submit lab method validations to the department prior to offering the applicable testing to other licensed facilities.

Validations must be submitted with an acceptable and graded external proficiency test by a third party, where all analytes are shown to have passed.
Validation protocols shall include all marijuana matrices tested, such as flower, infused products, and/or concentrates.

If the initial verification was not performed on a marijuana matrix, a verification shall be performed for each matrix to be tested.

Validation protocols for microbiological methods shall include inoculation of marijuana matrices with live organisms where feasible to ensure that both extraction and detection for the assay are assessed. To further assess the accuracy of the assay, probability of detection analyses, inclusivity, exclusivity, lot-to-lot stability, and robustness studies must be included.
Validation of analytical chemistry methods must, where feasible, verify accuracy, precision, analytical selectivity, limit of detection, limit of quantitation, and reportable range.
Validation involving microbiological methods must, where feasible, address accuracy, limit of detection, and reportable range.

(D) Testing licensees may acquire from cultivation, manufacturing, and dispensary facilities raw material, such as plant material, concentrates, extracts, and infused products, for testing method development.

(5) Sampling requirements for mandatory testing.

(A) Sampling of marijuana product for mandatory testing shall be done by the testing licensee at the harvest lot or process lot level. All samples must be collected, stored, and transported in a way that mitigates contamination and degradation.

(B) Sampling of each harvest lot or process lot shall be conducted with representative samples such that there is assurance that all harvest or process lots are adequately assessed for contaminants and that the cannabinoid profile is consistent throughout.

In the case of dry, unprocessed marijuana, the maximum amount of marijuana from which a sample may be selected is fifteen pounds (15 lbs.), and a minimum of five tenths of a percent (0.5%) of a harvest lot will be sampled for testing.
In the case of extracts, concentrates, distillates, or isolates the amount of material required for sampling is— 3. In the case of vape cartridges, prerolls, infused prerolls and all other infused products or items sold in a method of administration, the amount of material required for sampling is— 4. Where marijuana will be sold in a method of administration, the marijuana product must be sampled after it has been processed into its method of administration. All other marijuana products may be sampled in bulk after all processing of the harvest lot or process lot is complete.

Desiccate samples;
Pre-test samples;
Select the best or most desirable material from a lot or sample for testing; or 4. Manipulate samples in any way that would alter the sample integrity or homogeneity of the sample. All sample increments must have the same chances of being selected; sampling must be random.

(6) Mandatory sample ordering and chain of custody.

(A) Testing licensees shall collect samples of a marijuana product from other licensees for mandatory testing, and no licensee may interfere with, assist with, or otherwise participate in the physical collection of a representative sample by a testing licensee.

(B) At the time of sampling for mandatory testing, the cultivation, manufacturing, or dispensary licensee must make the entire harvest or process lot available to the testing licensee for sample collection.

(C) An employee of the cultivation, manufacturing, or dispensary licensee shall be physically present to observe the sampling process and to ensure representative samples are taken from throughout the lot.

(D) Sampling of the lot shall take place in a designated sample area within the cultivation, manufacturing, or dispensary licensee’s facility.

(E) Cultivation, manufacturing, and dispensary licensees will collaborate with testing licensees to create a chain of custody record that includes at least the following information:

The sending facility’s license number;
The legal name, address, and contact information of the licensee sending the marijuana product for testing;

Units for Sale Representative Sample Units Required 2-15 2 16-50 3 51-150 5 151-500 8 501-3,200 13 3,201 – 35,000+ 20 Process Lot Weight Sample Required (1±0.2 g)

Pounds Kilograms 0-0.50 0-0.23 4 0.51-1.5 0.24-0.68 8 1.51-3.00 0.69-1.36 12 3.01-6.00 1.37-2.72 16 6.01-10.00 2.73-4.58 20 10+ 4.58+ 32 Units for Sale Representative Sample Units Required 2-15 2 16-50 3 51-150 5 151-500 8 501-3,200 13 3,201 – 35,000+ 20 Process Lot Weight Sample Required (1±0.2 g) Pounds Kilograms 0-0.50 0-0.23 4 0.51-1.5 0.24-0.68 8 1.51-3.00 0.69-1.36 12 3.01-6.00 1.37-2.72 16 6.01-10.00 2.73-4.58 20 10+ 4.58+ 32 3. The testing facility’s license number;

The legal name, address, and contact information of the testing licensee;
For each lot to be sampled— A. The marijuana product category;

B. The marijuana product tag number;

C. Total mass of the harvest or process lot;

D. For infused products, the number of units for sale in the marijuana process lot;

E. The marijuana product sample tag number;

F. Total mass of the marijuana harvest or process lot sample;

G. For infused products, the number of units sampled of the marijuana process lot;

H. Identification of the test or tests requested;

I. Whether the test or tests requested are for mandatory testing or for voluntary testing;

J. Whether a lot is being re-sampled because of a failed mandatory test;

K. Whether the marijuana product was remediated; and L. The date, name, and signature of both the requesting facility’s representative who was present for sampling and the testing facility’s representative who conducted the sampling.

(F) Chain of custody records must be retained by both the requesting licensee and the testing licensee for at least five (5) years.

(G) For mandatory testing, it is the responsibility of the cultivation, manufacturing, or dispensary licensee to— 1. Order the tests necessary to comply with all applicable rules;

Ensure processing of the lot is complete prior to sampling;
Ensure the lot size from which a sample is taken meets the requirements of this chapter;
Only order a test for marijuana product produced by the 5. Not order more than one (1) test for the same marijuana product lot without written approval from the department;
Ensure the marijuana product is not on administrative hold and not awaiting approval for retesting; and 7. Ensure remediation of the marijuana product was approved by the department.

(H) Violation of sampling requirements or manipulation of samples may result in fines up to one hundred thousand dollars ($100,000) and suspension or revocation of license.

(I) If a licensee is permitted under this rule to transfer a lot that has failed testing, the licensee must notify the licensee to whom the lot is sold or transferred of the failed test.

(J) Once a marijuana product has passed mandatory testing, the marijuana product shall not be repackaged into a new lot in the state-wide track and trace system.

(K) Once marijuana product has passed mandatory testing, a copy of the certificate of analysis for mandatory testing shall be provided to all licensees receiving the lot. Copies of the certificate of analysis may be provided electronically.

(7) Mandatory testing requirements.

(A) Testing of each harvest lot or process lot shall be conducted such that there is assurance that all harvest or process lots are adequately assessed for contaminants and that the cannabinoid profile is consistent throughout.

(B) Reporting results.

Within ten (10) days of collecting a sample and within twenty-four (24) hours of completing analysis of a sample, the testing licensee shall file a report in the state-wide track and trace system detailing, at a minimum:

A. All test results showing whether the lot passed or failed each required test;

B. The certificate of analysis provided to the licensee or third party; and C. A photo of the sample received at the facility.

Testing licensees must notify the department if the timeframe for reporting results will not be met due to an equipment failure. The notification must include an explanation of the equipment failure and the estimated timeframe for the report to be filed in the state-wide track and trace system. The notification must be made prior to deadline for reporting results.

(C) Reporting of test results in the state-wide track and trace system must coincide with or precede any notice of test results to the originating facility.

(D) Harvest and process lots that have passed mandatory testing may not be retested for purposes of replacing mandatory testing results without written approval from the department.

(E) Testing of the cannabinoid profile of the final marijuana product shall include those analytes listed below and shall be reported on a dry weight basis for dried, unprocessed marijuana and prerolls and on an “as is” basis for all other marijuana product. The acceptable limits for each analyte will be a percentage deviation from the mean, using at least three (3) samples, in concentration throughout the lot of fifteen percent (15%) or less:

Delta-9-tetrahydrocannabinol (Δ9-THC), CAS number 1972-08-3;
Delta-9-tetrahydrocannabinolic acid (Δ9-THCA), CAS number 23978-85-0;
Cannabidiol (CBD), CAS number 13956-29-1;
Cannabidiolic acid (CBDA), CAS number 1244-58-2;
Cannabinol (CBN), CAS number 521-35-7;
Tetrahydrocannabivarin (THCV), CAS number 31262-37-0;
Cannabidivarin (CBDV), CAS number 24274-48-4; and 8. Delta-8-tetrahydrocannabinol (Δ8-THC), CAS number 5957-75-5.

(F) The testing licensee shall ensure that any samples for mandatory testing of marijuana are prepared in accordance with the following requirements:

The testing licensee shall first remove any sample increments required to conduct testing for microbials and water activity;
If the final marijuana product includes such things as stems, seeds, wrap, or leaves, those items must also be included in the sample, but if the final marijuana product will not include such things as stems, seeds, wrap, or leaves, those items must be removed from the product lot prior to sampling;
A wrap, crutch, or filter, if present, shall be removed for cannabinoid profile screening; and 4. In the preparation of samples intended for potency analysis, the laboratory may not adulterate or attempt to manipulate the potency of the sample.

(G) Testing for contaminants in the final marijuana product shall include, but shall not be limited to— 1. Microbial screening. A test will fail if it shows— A. A total mycotoxin concentration, including aflatoxins and ochratoxin A, of greater than twenty (20) micrograms per kilogram;

B. Pathogenic E. coli or salmonella concentrations detectable in one (1) gram; and C. Pathogenic Aspergillus species A. fumigatus, A. flavus, A. niger, or A. terreus detectable in one (1) gram;

Chemical residue screening. A test will fail if it shows— 3. Heavy metal screening. A test will fail if it shows— 4. Residual solvents. A test will fail if it shows— Banned Analytes Chemical Abstract Services (CAS)

Registry number Action Limit Abamectin 71751-41-2 > 0.5 Acephate 30560-19-1 > 0.4 Acequinocyl 57960-19-7 > 2 Acetamiprid 135410-20-7 > 0.2 Aldicarb 116-06-3 > 0.4 Azoxystrobin 131860-33-8 > 0.2 Bifenazate 149877-41-8 > 0.2 Bifenthrin 82657-04-3 > 0.2 Boscalid 188425-85-6 > 0.4 Carbaryl 63-25-2 > 0.2 Carbofuran 1563-66-2 > 0.2 Chlorantraniliprole 500008-45-7 > 0.2 Chlorfenapyr 122453-73-0 > 1 Chlormequat Chloride 7003-89-6 > 0.2 Chlorpyrifos 2921-88-2 > 0.2 Clofentezine 74115-24-5 > 0.2 Cyfluthrin 68359-37-5 > 1 Cypermethrin 52315-07-8 > 1 Daminozide 1596-84-5 > 1 DDVP (Dichlorvos) 62-73-7 > 1 Diazinon 333-41-5 > 0.2 Dimethoate 60-51-5 > 0.2 Ethoprophos 13194-48-4 > 0.2 Etofenprox 80844-07-1 > 0.4 Etoxazole 153233-91-1 > 0.2 Fenoxycarb 72490-01-8 > 0.2 Fenpyroximate 134098-61-6 > 0.4 Fipronil 120068-37-3 > 0.4 Flonicamid 158062-67-0 > 1 Fludioxonil 131341-86-1 > 0.4 Hexythiazox 78587-05-0 > 1 Imazalil 35554-44-0 > 0.2 Imidacloprid 138261-41-3 > 0.4 Kresoxim-methyl 143390-89-0 > 0.4 Malathion 121-75-5 > 0. 2 Metalaxyl 57837-19-1 > 0.2 Methiocarb 2032-65-7 > 0. 2 Methyl parathion 298-00-0 > 0.2 Myclobutanil 88671-89-0 > 0.2 Oxamyl 23135-22-0 > 1 Piperon yl_butoxide 51-03-6 > 2 Propoxu r 114-26-1 > 0.2 yridaben 96489-71-3 > 0.2 yrethrins+ 8003-34-7 > 1 Spinosa d 168316-95-8 > 0.2 Thiaclopri d 111988-49-9 > 0.2 Thiamethoxa m 153719-23-4 > 0.2 Triflox ystrobin 141517-21-7 > 0.2 **Only for inhalables and concentrates .

Cadmiu m > 0.2 > 0.5 Lea d > 0.5 > 0.5 Mercur y > 0.1 > 3.0 Meth yl parathion 298-00-0 > 0.2 M yclobutanil 88671-89-0 > 0.2 Oxam yl 23135-22-0 > 1 Piperonyl_butoxide 51-03-6 > 2 Propoxur 114-26-1 > 0.2 Pyridaben 96489-71-3 > 0.2 Pyrethrins+ 8003-34-7 > 1 Spinosad 168316-95-8 > 0.2 Thiacloprid 111988-49-9 > 0.2 Thiamethoxam 153719-23-4 > 0.2 Trifloxystrobin 141517-21-7 > 0.2 **Only for inhalables and concentrates.

Cadmiu m > 0.2 > 0.5 Lea d > 0.5 > 0.5 Mercur y > 0.1 > 3.0 Banned Analytes Chemical Abstract Services (CAS)

Registry number Action Limit Abamectin 71751-41-2 > 0.5 Acephate 30560-19-1 > 0.4 Acequinoc yl 57960-19-7 > 2 Acetamipri d 135410-20-7 > 0.2 Aldicarb 116-06-3 > 0.4 Azox ystrobin 131860-33-8 > 0.2 Bifenazate 149877-41-8 > 0.2 Bifenthrin 82657-04-3 > 0.2 Boscali d 188425-85-6 > 0.4 Carbar yl 63-25-2 > 0.2 Carbofuran 1563-66-2 > 0.2 Chlorantraniliprole 500008-45-7 > 0.2 Chlorfenap yr 122453-73-0 > 1 Chlormequat Chloride 7003-89-6 > 0.2 Chlorp yrifos 2921-88-2 > 0.2 Clofentezine 74115-24-5 > 0.2 C yfluthrin 68359-37-5 > 1 C ypermethrin 52315-07-8 > 1 Daminozide 1596-84-5 > 1 DDVP (Dichlorvos) 62-73-7 > 1 Diazinon 333-41-5 > 0.2 Dimethoate 60-51-5 > 0.2 Ethoprophos 13194-48-4 > 0.2 Etofenprox 80844-07-1 > 0.4 Etoxazole 153233-91-1 > 0.2 Fenox ycarb 72490-01-8 > 0.2 Fenp yroximate 134098-61-6 > 0.4 Fipronil 120068-37-3 > 0.4 Flonicamid 158062-67-0 > 1 Fludioxonil 131341-86-1 > 0.4 Hex ythiazox 78587-05-0 > 1 Imazalil 35554-44-0 > 0.2 Imidaclopri d 138261-41-3 > 0.4 Kresoxi m-methyl 143390-89-0 > 0.4 Malathion 121-75-5 > 0.2 Metalax yl 57837-19-1 > 0.2 Methiocarb 2032-65-7 > 0.2 Meth yl parathion 298-00-0 > 0.2 M yclobutanil 88671-89-0 > 0.2 Oxam yl 23135-22-0 > 1 Piperon yl_butoxide 51-03-6 > 2 Propoxu r 114-26-1 > 0.2 yridaben 96489-71-3 > 0.2 yrethrins+ 8003-34-7 > 1 Spinosa d 168316-95-8 > 0.2 Thiaclopri d 111988-49-9 > 0.2 Thiamethoxa m 153719-23-4 > 0.2 Triflox ystrobin 141517-21-7 > 0.2 **Only for inhalables and concentrates .

Cadmium > 0.2 > 0.5 Lead > 0.5 > 0.5 Mercury > 0.1 > 3.0 5. Water activity and moisture content screening. A test will fail if it shows— A. For dry, unprocessed marijuana, prerolls, and infused prerolls, water activity that exceeds 0.65 a w and moisture content below 5.0% or above 15.0%;

B. For manually extracted concentrates that are not oil, such as hash and kief, water activity that exceeds 0.65 a w; and C. For all solid infused products, water activity that exceeds 0.85 a w.

Foreign matter screening. Testing shall be performed on the total representative sample after preparation for microbial and water activity testing and prior to preparation for all other testing.

A. Quantitation of foreign matter shall be measured using a total surface area calculation.

B. All evaluation must be done on high power magnification.

C. Examine both the exterior and interior of the sample.

D. Must use a grading scale determine by the testing licensees which clearly dictates a failed sample.

E. A test will fail if it shows— (I) More than 5.0% of stems 3 mm or more in diameter;

(II) More than 2.0% of other foreign matter (powdery mildew, mold, mites, hair, dirt, etc.).

(8) Testing licensees may perform terpene analysis on a sample submitted for mandatory testing for purposes of reporting results on marijuana product packaging. Testing licensees who offer terpene analysis for mandatory samples must include terpene analysis in the scope of accreditation and scope of proficiency testing.

(9) Voluntary testing.

(A) Upon request from a cultivation, manufacturing, or dispensary licensee, testing licensees may also test material that was not collected by the testing licensee according to the rules for mandatory test sampling. Results from such voluntary tests will not satisfy mandatory testing requirements.

(B) Voluntary testing may be completed on a schedule agreeable to the submitting facility, but all test results from voluntary testing must be reported in the state-wide track and trace system.

(C) Reporting of test results in the state-wide track and trace system must coincide with or precede any notice of test results to the originating facility.

(10) Testing failures.

Solvent Chemical Abstract Services (CAS) Registry number Failure Level for Marijuana (Inhalation)

Failure Level for Marijuana- Infused 1,2-Dichloroethane 107-06-2 > 2 > 5 Acetone 67-64-1 > 750 > 5000 Acetonitrile 75-05-8 > 60 > 410 Benzene 71-43-2 > 1 > 2 Butanes (all isomers) 106-97-8 > 800 > 5000 Chloroform 67-66-3 > 2 > 60 Ethanol 64-17-5 > 1000 > 5000 Ethyl acetate 141-78-6 > 40 0 > 5000 Ethyl ether 60-29-7 > 500 > 5000 Ethylene Oxide 75-21-8 > 5 > 50 Heptane 142-82-5 > 500 > 5000 Hexanes (all isomers) 11054-3 > 50 > 290 Isopropyl alcohol 67-63-0 > 500 > 5000 Methanol 67-56-1 > 250 > 3000 Methylene chloride 75-09-2 > 125 > 600 Pentanes (all isomers) 109-66-0 > 750 > 5000 Propane 74-98-6 > 2100 > 5000 Toluene 108-88-3 > 150 > 890 Trichloroethylene 79-01-6 > 25 > 80 Total Xylenes (ortho-, meta-, para-) 1330-20-7 > 15 0 > 2170 (A) The department will place an administrative hold on marijuana product that fails mandatory testing through the state-wide track and trace system.

(B) All product that fails mandatory testing must be reanalyzed, remediated, or destroyed within three (3) months of initial test failure. Product that fails mandatory testing may be reanalyzed, remediated, or destroyed as follows:

Before taking action with any product that fails mandatory testing, licensees must, within fifteen (15) days of test failure, notify the department of their intent to proceed in one of the following ways:

A. Reanalysis of previously tested sample;

B. Remediation of the harvest or process lot through remediation actions specifically allowed by rule;

C. Destruction of the harvest or process lot; or D. Submission of a request to perform remediation not specifically allowed by rule;

After notifying the department, licensees may— A. Reanalyze the original sample collected for testing.

(I) Reanalysis may be performed by the testing facility that performed the initial analysis or a testing facility that did not perform the initial analysis.

(II) If the sample passes reanalysis, a testing facility that did not perform the initial analysis or reanalysis may sample the lot and perform testing on that new sample in compliance with all rules for mandatory testing;

B. Complete marijuana product remediation through a remediation process specifically allowed by this rule. After a product has been remediated, the testing facility that performed the initial analysis or a testing facility that did not perform the initial analysis shall resample the lot and perform testing on that new sample in compliance with all rules for mandatory testing;

C. Destroy the product; or D. Submit a request to remediate the product through a method not specifically approved by this rule. Such requests must be approved by the department, in writing, prior to the licensee taking any remediation actions.

(C) Heavy Metal Failures. Marijuana product that fails mandatory testing for heavy metals shall be placed on administrative hold through the state-wide track and trace system pending disposal or, if approved by the department, reanalysis. Product that fails testing for heavy metals may not be remediated.

(11) Approved remediation processes. Marijuana product that fails testing, except for heavy metal failure, may be remediated.

After notifying the department of intent to remediate, licensees may conduct the following remediation processes without additional approval:

(A) Failed microbial screening may be remediated through solvent-based extraction or processing, such as hydrocarbon, ethanol, or carbon dioxide;

(B) Failed residual solvent testing may be remediated by returning the product to a purging process within the facility;

(C) Failed water activity testing may be remediated by— 1. Solvent-based extraction or processing; or 2. Additional drying or curing;

(D) Failed chemical residue screening may be remediated through solvent-based extraction or processing, such as hydrocarbon, ethanol, or CO ;

(E) A lot that fails reanalysis may not be reanalyzed again but may be remediated one (1) time; and (F) A lot that fails remediation may not be remediated again but may be reanalyzed one (1) time.

(12) A medical or marijuana licensee may be required by the department to submit samples of marijuana product for testing at any time and without notice.

(A) The department may have the marijuana product tested at a marijuana testing facility, the Missouri State Public Health Laboratory, or any other lab authorized to conduct the required tests. If the department requests that a marijuana testing facility test the marijuana product, the facility may not charge the department any more than it would ordinarily charge any other entity for whom it performs the same or similar tests.

(B) Samples collected will be tested by the department to determine whether the marijuana product is safe for human consumption and is accurately labeled or to verify the result of marijuana testing conducted by a marijuana testing laboratory.

(C) Samples may be collected either through random process to determine accuracy of testing results or when the department has reasonable grounds to believe— 1. Marijuana product is contaminated or mislabeled;

A licensee is in violation of any rule, statute, or Article XIV; or 3. The results of a test would further an investigation by the department.

(13) Testing licensees may test marijuana product and hemp product received from entities that are not licensed marijuana (A) Samples for these tests must be delivered by the entity requesting the test to the testing facility.

(B) Prior to engaging in these services, testing licensees must submit standard operating procedures related to these services to the department for review, which must include:

Tagging and tracking;
Chain of custody; and 3. Testing methods if different from the testing methods established for testing of marijuana product for medical and marijuana facilities.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

This rule explains what packaging, labeling, and product design regulations apply to all medical and marijuana facility licensees.

(1) All marijuana product shall be produced, packaged, and labeled in a manner that protects public health and is not attractive to children.

(A) No marijuana product may be manufactured, packaged, or labeled in a false or misleading manner, such as by inaccurately representing product ingredients.

(B) Product and packaging design.

No marijuana product or packaging may be designed using the shape or any part of the shape of a human, animal, or fruit, including realistic, artistic, caricature, or cartoon renderings.
No marijuana product or packaging may be designed in such a way as to cause confusion between a marijuana product and any product not containing marijuana, such as where products or packaging are visually similar to any commercially similar product that does not contain marijuana.
All marijuana product packaging, with the exception of marijuana seeds and plants, shall be resealable, opaque, and certified as child resistant. Where marijuana product is packaged in a series of containers, the container closest to the product, excluding methods of administration or wrappers, must be compliant with this requirement.
All marijuana product packaging, with the exception of marijuana seeds and plants, shall be constructed from FDA-approved food contact substances. Where marijuana product is packaged in a series of containers, the container closest to the product, including methods of administration or wrappers, must be compliant with this requirement, unless the department approves application of this rule to a different container in the series.
All marijuana product packaging design, including that for exit packaging, may only utilize— A. Limited colors, including a primary color as well as up to two (2) logos or symbols of a different color or colors, whether images or text, including brand, licensee, or company logos, provided that the widest part of a logo or symbol is no wider than the length or height, whichever is greater, of the word “Marijuana” on the packaging;

B. A product name;

C. Text indicating side effects and behavioral effects of usage;

D. A label required by this rule; and E. A QR code linking to a website where a purchaser can learn more about the product.

Marijuana product packaging must be in compliance with applicable local, state, and federal requirements.

(C) Labeling. Except as specifically identified herein, labeling requirements apply to containers, wrappers, packages, and methods of administration that contain marijuana product, except seeds or plants. The labels required herein are not required on the paper for prerolls.

Unless alternative placement of “Marijuana” or the universal symbol has been approved by the department, all marijuana product shall be clearly and conspicuously labeled with “Marijuana” printed at least as large as any other words used, as well as a prominently displayed universal symbol in red and white print that consists of the following:

A. A diamond containing the letters “THC”;

B. The letter “M” located under the “THC” within the diamond; and C. For infused products, the number of milligrams of THC in the package, placed directly under the diamond.

Unless alternative placement of a label has been approved by the department, the marijuana product container closest to the product shall bear a label displaying only the following information, in the following order, from top to bottom and left to right:

A. All active and other ingredients, which shall not include groupings of ingredients that obscure the actual ingredients, such as “natural flavors” or “botanically derived terpenes” and shall include solvents used in the manufacturing process;

B. Servings and doses per package for marijuana licensees or doses per package for medical licensees;

C. A “best if used by” date;

D. The license number of the licensed entity from which the final marijuana product originated;

E. The testing licensee where the final marijuana product passed mandatory testing;

F. The state-wide track and trace system tag number associated with the mandatory testing results for the final G. The exact total weight of the marijuana included in the package— (I) For dried, unprocessed marijuana, concentrates, prerolls, and infused prerolls, weight shall be listed in grams;

(II) For infused products other than infused prerolls, weight shall be listed by milligrams of delta 9 tetrahydrocannabinol;

H. The exact delta-9-tetrahydrocannabinol (Δ9-THC), delta-9-tetrahydrocannabinolic acid (Δ9-THCA), cannabidiol (CBD), cannabidiolic acid (CBDA), cannabinol (CBN), tetrahydrocannabivarin (THCV), cannabidivarin (CBDV), and delta 8 tetrahydrocannabinol (Δ8-THC) per serving/dose, listed in milligrams;

I. Results of terpene analysis, if tested during mandatory testing;

J. Instructions for use;

K. Estimated length of time the serving or dosage will have an effect;

L. The department-issued product packaging approval number;

M. The following warning: “Cognitive and physical impairment may result from the use of marijuana. Keep out of reach of children.”

Marijuana seeds and plants shall be clearly and conspicuously labeled with “Marijuana” printed at least as large as any other words used on the packaging and a universal symbol designed as described in this rule.

A. Marijuana seed packaging must bear a label with the strain information.

B. Marijuana plant packaging must bear a label with the strain information and propagation date.

Marijuana product packaging may not contain any information other than that specifically required by this subsection, except information to be in compliance with applicable local, state, and federal requirements.

(2) Prior to use, all marijuana product designs, packaging designs, and label designs must be submitted to the department for review of compliance with section (1) of this rule.

(A) Submission must be made through a department provided, web-based system by the licensee that is responsible for ensuring compliant packaging and labeling, pursuant to

section (3) of this rule.

(B) Within thirty (30) days of submission, the department will communicate in writing to the licensee whether the submission is complete.

If deemed incomplete, the department will identify reasons why it determined the submission is incomplete and will deny the application.
If deemed complete, the submission will be approved or denied within sixty (60) days of the original submission.

(C) Once a design has been approved, the licensee will receive an approval number for the marijuana product, packaging, and label design, as a whole.

(3) All marijuana product shall be compliantly packaged and labeled by the cultivation, manufacturing, or microbusiness wholesale facility providing the final marijuana product for sale except where cultivation or microbusiness wholesale facilities are providing dried, unprocessed marijuana to dispensary licensees for use in creating prerolls or for dispensing directly to consumers or qualifying patients in custom amounts. In such a case, the dispensary facility is responsible for ensuring the product is compliantly packaged and labeled prior to sale.

(4) Final marijuana product shall not be packaged in a manner that exceeds three (3) ounces of dried, unprocessed marijuana, or its equivalent.

(5) Product packaging may not be designed in a manner such that the required elements for packaging and labeling are easily removed or separated from the package, such as placing required information on part of the package that must be removed in order to access the product.

(6) Any violation of this rule shall be punishable by an appropriate and proportional department sanction, up to and including an administrative penalty of five thousand dollars ($5,000) for each product/packaging category, identified by approval number, in which a requirement is violated.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.130 Inventory Control and Seed-to-Sale Tracking licensees. {#sec-19-csr-100-1.130 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.130}

This rule explains what regulations apply to medical and marijuana facility inventory control systems and procedures as well as to certification and operations of seed-to-sale tracking systems.

(1) Inventory control systems and procedures. All licensees shall implement inventory control systems and procedures as follows:

(A) Each licensee shall designate, in writing, a facility agent who is generally responsible for the inventory control systems and procedures for that facility;

(B) Licensees shall maintain all records required by this

section for at least five (5) years;

(C) All weighing and measuring of marijuana product and marijuana waste required by this rule must be conducted with a National Type Evaluation Program (NTEP) approved scale, which shall be recalibrated by a certified entity at least yearly.

Scales shall be tested and approved in accordance with the requirements in Chapter 413, RSMo, prior to being placed into service.
Facility agents shall inspect and log the inspection of each scale to verify it is clean and reading accurately at least once a month and each time the scale is moved.
Scale inspection logs shall indicate the date, method of accuracy verification, and by whom the accuracy is verified.
The licensee’s scale shall be designed for the type of weighing or measuring needed for the licensee’s facility type;

(D) Each licensee shall use the state-wide track and trace system as its system of record to track marijuana product from seed or immature plant stage until the marijuana product is either purchased by a consumer, qualifying patient, or primary caregiver; expended during testing; or destroyed;

(E) All marijuana product in a medical or marijuana facility must be traceable in the state-wide track and trace system at all times.

All immature plants at least eight (8) inches tall or eight (8) inches wide shall be tagged with traceability information.
All packaged marijuana product shall bear a tag with traceability information.
Licensees shall place a new package tag on marijuana product any time— A. A marijuana product changes product category; or B. The marijuana product is incorporated into a different (F) Licensees must enter into the state-wide track and trace system each day’s beginning inventory, harvests, acquisitions, sales, disbursements, remediations, disposals, transfers, deliveries, ending inventory, and any other data necessary to complete the inventory control records in the state-wide track and trace system. Records will not be considered complete unless all available fields for a particular action are completed, including the identity of the facility agent making the record;

(G) Discrepancies in marijuana product inventory records shall not be corrected by entering an inventory adjustment without first being documented, investigated by management personnel, and reported to the department within twenty-four (24) hours of discovering the discrepancy. A discrepancy is a situation where the marijuana product may not be accounted for physically or in the state-wide track and trace system;

(H) If a licensee identifies a reduction in the amount of marijuana product in the inventory of the facility due to suspected criminal activity by a facility agent, the licensee shall report the facility agent to the department and to the appropriate law enforcement agencies within twenty-four (24) hours of discovering the suspected criminal activity;

(I) Licensees must provide to the department a monthly physical inventory report that includes all adjustments and adjustment reasons and that demonstrates the physical inventory reconciles with the inventory recorded in the statewide track and trace system;

(J) Cultivation licensees must— 1. Report in the state-wide track and trace system all seeds and all plants of any size; and 2. Report in the state-wide track and trace system, by plant or location— A. All pesticides, herbicides, fertilizers, and other agricultural chemicals applied to marijuana plants and growing medium during production and processing at its B. All ingredients contained in each pesticide, herbicide, fertilizer, and other agricultural chemical applied to the marijuana plants and growing medium during production and processing at its facility.

(K) Manufacturing licensees shall— 1. Establish and maintain a perpetual inventory system that documents the flow of all non-marijuana materials through the manufacturing process;

Establish procedures to reconcile the raw marijuana material with the finished product on the basis of each process lot;
Record in the state-wide track and trace system all active and inactive ingredients in each final manufactured product;
Record in the state-wide track and trace system the serving or, in the case of medical marijuana product, dosage amounts for each final manufactured product.

(L) Dispensary licensees shall be responsible for ensuring that every amount of marijuana product sold or disbursed to a consumer, qualifying patient, or primary caregiver is immediately recorded in the state-wide track and trace system.

Amounts of marijuana product shall be recorded— 1. For dried, unprocessed marijuana and prerolls, in grams;

For concentrates and infused prerolls, in grams; or 3. For infused products, by milligrams of THC;

(M) All licensees must ensure the accuracy of information entered into the state-wide track and trace system on a daily

basis.

An error occurs when information is recorded incorrectly into the state-wide track and trace system, but the marijuana product can be accounted for.
Errors identified within the system must be immediately corrected. All corrections should be accompanied with a detailed note in the system clearly outlining the error that occurred and the corrective action taken.
Errors involving consumer and patient allotments must be reported to the department and corrected in the state-wide track and trace system within twenty-four (24) hours of being identified;

(N) In order to facilitate the use of the state-wide track and trace system, facilities may also employ a department-certified seed-to-sale tracking system that integrates with the state-wide track and trace system; and (O) In case of seed-to-sale system failure or loss of connection between the seed-to-sale system and the state-wide track and trace system, a licensee must cease performing all actions that are required to be tracked.

Upon system restoration, the licensee must confirm all inventory and tracking information is accurately reflected in the state-wide track and trace system.
Any such system failure or loss of connection must be reported to the department within three (3) hours of identifying the seed-to-sale system failure or loss of connection between the seed-to-sale system and the state-wide track and trace system.

(2) Seed-to-sale tracking.

(A) Access to seed-to-sale tracking system certifications.

Any entity certified to conduct seed-to-sale tracking for medical marijuana product as of the effective date of this

section shall be deemed certified to conduct those activities with respect to all marijuana product.

The department will accept applications for seed-tosale tracking system certifications via the online application system.
Incomplete applications for certification of seed-to-sale tracking systems may be denied.
The department shall charge an application fee for a seed-to-sale certification and also an annual fee once a certification is offered.

A. The first annual fee will be due thirty (30) days after a certification is offered and shall be due annually on that same date as long as the certification remains valid.

B. The department shall publish the current fees, including any adjustments, on its website. The fees due will be the fee that is effective as of the due date for the fee.

(B) Application requirements. All applications for seed-tosale tracking system certifications shall include at least the following information:

Name and address of the applicant;
Legal name of the entity, including any fictitious business names;
An attestation by an owner or principle of the entity that the seed-to-sale tracking system can and will comply with this

rule; and 4. All applicable fees or proof that all applicable fees have already been paid.

(C) Seed-to-sale tracking system requirements. All seed-tosale tracking systems used by licensees shall be capable of— 1. Interfacing with the state-wide track and trace system such that a licensee’s employees may enter and access information in the state-wide track and trace system as required for inventory control and tracking and for purchase limitations set forth in this chapter;

Providing the department with access to all information stored in the system’s database;
Maintaining the confidentiality of all patient and consumer data and records accessed or stored by the system such that all persons or entities other than the department may only access the information in the system that they are authorized by law to access; and 4. Producing analytical reports to the department regarding— A. Total quantity of daily, monthly, and yearly sales at the facility per product type;

B. Average prices of daily, monthly, and yearly sales at the facility per product type;

C. Total inventory or sales record adjustments at the D. API error report showing how many times the seedto-sale tracking system failed to upload information to the state-wide track and trace system, or failed in some other way.

(D) Seed-to-sale tracking system prohibitions.

No certified seed-to-sale tracking system entities may begin operations before receiving the department’s written approval to do so and signing the department’s Marijuana Application Programming Interface User Agreement.
No seed-to-sale tracking system entity may be owned by or affiliated with an entity that holds a contract with the state of Missouri for any product or service related to the department’s marijuana program.

(E) Tracking-related discipline.

The department may impose a fine of up to five thousand dollars ($5,000), and may restrict, suspend, or revoke a seedto-sale tracking system entity certification for the following reasons:

A. Failure of a seed-to-sale tracking system entity to comply with this rule;

B. Failure to abide by the department’s Marijuana Application Programming Interface User Agreement;

C. Failure of a seed-to-sale tracking system entity to timely interface with the state-wide track and trace system;

D. Persistent failure to interface with the state-wide track and trace system; or E. Providing false or misleading information to the statewide track and trace system.

If a licensee or its employees or contractors fail to comply with the state-wide track and trace system requirements or intentionally misuses or falsifies state-wide track and trace system tracking data, the department may impose a fine of up to fifty thousand dollars ($50,000), and may restrict, suspend, or revoke the facility’s license.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.140 Transportation and Storage the authority to regulate and control the storage of, warehouses for, and transportation of marijuana product. {#sec-19-csr-100-1.140 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.140}

This rule explains what regulations apply to all medical and marijuana facility licensees that transport and store marijuana product.

(1)

Any licensee transporting or storing marijuana product shall comply with the provisions of this section.

(2) Transfer of marijuana product, generally.

(A) A medical or marijuana licensee shall be allowed to transfer marijuana product between facilities, in compliance with the requirements and prohibitions provided in this

chapter.

(B) Marijuana product may only be transferred as follows:

From a medical facility to another medical facility or testing facility;
From a comprehensive facility to another comprehensive facility, medical facility, or testing facility;
From a microbusiness facility to another microbusiness facility or testing facility; and 4. Marijuana facility licensees not specifically identified above may transfer marijuana product with department approval, in compliance with the requirements and prohibitions of this chapter.

(D) The agent transferring marijuana product must— 1. Ensure accuracy of the transportation manifest;

Ensure marijuana product is stored and transported in a way that prevents contamination and degradation; and 3. Ensure a secure handoff.

(3) Delivery of marijuana product, generally.

(A) A dispensary licensee or a transportation licensee shall be allowed to deliver marijuana product to consumers, qualifying patients, and primary caregivers in compliance with the requirements and prohibitions provided in this chapter.

(B) Marijuana product may only be delivered as follows:

From a medical dispensary facility to a qualifying patient or primary caregiver; or From a comprehensive dispensary facility or microbusiness dispensary facility to a consumer, qualifying patient, or primary caregiver.

(C) Delivery to a consumer, qualifying patient, or primary caregiver may be completed at any address as directed by the consumer, qualifying patient, or primary caregiver, as long as the address is a location allowing for the legal possession of marijuana product.

(D) At the time of delivery, licensees must— 1. Require production of a qualifying patient or primary caregiver identification card if applicable;

Require production of a valid (not expired) governmentissued photo ID confirming the identity of the qualifying patient, primary caregiver, or consumer and that a consumer is at least twenty-one (21) years of age;
In the case of marijuana plant purchases, require production of a cultivation identification card; and 4. Record the delivery of product in the state-wide track and trace system.

(4) Security requirements related to transportation, except transfers between licensees operating on the same premises.

(A) Licensees authorized by the department to transport marijuana product shall transport all marijuana product from an originating facility to an authorized destination within thirty-six (36) hours of taking possession of the marijuana product.

If the transfer or delivery is unable to be completed for any reason, transportation licensees shall return the marijuana product to the originating licensee.
When extenuating circumstances necessitate holding marijuana product longer than thirty-six (36) hours, the licensee transporting the marijuana product shall notify the department of the circumstances and the location of the marijuana product prior to the end of the thirty-six (36) hour transportation deadline.

(B) All transportation must be completed using motor vehicles that are not marked in any way that indicates marijuana product is being transported by that vehicle and that are equipped with at least— 1. A secure lockbox or locking cargo area made of smooth, hard surfaces that are easily cleaned for storing marijuana product during transit;

A secure lockbox or lockboxes for storing payments and video monitoring recording equipment during transit;
Video monitoring of the driver and passenger compartment and of any space where marijuana product is stored or can be accessed during transit; and 4. GPS tracking.

(C) Facility agents transporting marijuana product shall— 1. Prior to transporting marijuana product, complete and print an inventory manifest for the trip generated from the state-wide track and trace system, which shall be provided by the facility from which the marijuana product is transported;

During transport— A. Have facility agent identification card(s) accessible at all times;

B. Have a valid (not expired) driver’s license accessible at all times;

C. Keep a copy of the applicable inventory manifest and trip plan in the transportation vehicle, which shall be within reach of the driver for the duration of the trip; and D. Have accessible at all times a cell phone or other means to readily communicate with individuals or entities outside the transport vehicle, including law enforcement and the department;

The facility agent transporting the marijuana product shall report any vehicle accidents in which the transport vehicle is involved within one (1) hour to law enforcement and the licensed or certificated entity for whom the agent is transporting; and 4. After transport, revise the trip plan to reflect the actual route taken and the end date and time of transportation, and deliver the revised trip plan to a person designated by the transporting entity for this purpose.

(D) Any vehicle accident, vehicle malfunction that occurs during the transport of marijuana product, theft, attempted theft, or loss of marijuana product shall be reported to the department within two (2) hours of the licensee becoming aware of the incident.

(E) All trip plans and revised trip plans shall be maintained by the facility transporting the marijuana product for at least five (5) years.

(F) Video and GPS monitoring in transportation vehicles.

Electronic video monitoring for transportation of marijuana product must include video cameras with a recording resolution of at least 1920 x 1080, or the equivalent, at a rate of at least fifteen (15) frames per second, that operate in such a way as to allow identification of people and activities in the monitored space, in all lighting levels, and that are installed in manner that will prevent the video camera from being readily obstructed, tampered with, or disabled.
Video cameras must provide coverage of the driver and passenger compartment of the vehicle, and any space where marijuana product is stored or can be accessed during transit, including any doors that lead to where the marijuana product is stored.
Licensees must store all recordings from the video cameras and GPS data for at least sixty (60) days in a secure on-site or off-site location or through a service or network that provides on-demand access to the recordings that allows for providing copies of the recordings to the department upon request, in the requested format, at the expense of the licensee.
Video monitoring must be active at all times when marijuana product is inside, entering, or exiting the vehicle.

(5) Security requirements related to transfers between licensees operating on the same premises.

(A) Facility agents transferring marijuana product between licensees operating on the same premises shall— 1. Prior to transferring marijuana product, complete and print an inventory manifest generated from the state-wide track and trace system, which shall be provided by the facility from which the marijuana product is transferred.

Transfer of marijuana product may be done by motor vehicle or other secure means. During transfer, facility agents must— A. Have facility agent identification card(s) accessible at all times; and B. Have a copy of the applicable inventory manifest and trip plan accessible for the duration of the transfer.

(B) Any incident of theft, attempted theft, or loss of marijuana product during transfer shall be reported to the department within two (2) hours of becoming aware of the incident.

(6) Warehouse storage, generally.

(A) Licensees shall be allowed to store marijuana product in compliance with the requirements and prohibitions provided in this chapter.

(B) Transportation facility certificate holders may only store marijuana product for purposes related to the transportation of marijuana product.

(C) Licensees shall store all marijuana product— 1. At designated location(s) within the facility where the licensee is approved to operate; or 2. In warehouses that have been approved by the department in writing, pursuant to this chapter.

(D) Licensees that utilize one (1) or more warehouses to store marijuana product must apply for and be granted a separate certificate to operate each warehousing premises.

Application requirements are included in the facility applications section of this chapter.
Approved warehouse certificates shall be associated with an existing facility license.
Transportation licensees will not be granted a warehouse certificate.
Transfers between a licensed facility and its warehouse must comply with the transportation security requirements provided in this rule.
Transfers may not be made between a licensed facility and a different licensee’s warehouse.
Warehouses for dispensary licensees must be located within the congressional district in which the underlying facility license was awarded.
Warehouses facilities may not share space with any other facility or licensee.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.150 Marijuana Waste Disposal Constitution, the Department of Health and Senior Services is authorized to regulate and control the operations of medical and marijuana facilities. {#sec-19-csr-100-1.150 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.150}

This rule explains how licensed and certified facilities, with the exception of transportation facilities, should dispose of any excess or unusable marijuana waste, unwanted marijuana product, or any waste from the facility.

(1) Unused marijuana product and any solid and liquid wastes generated during marijuana product production and processing must be stored, managed, and disposed of in accordance with applicable state, tribal, local, and municipal laws and regulations. Licensees must keep records of the final disposition of all such wastes for at least five (5) years or longer if required by federal, state, local law.

(2) Each licensee shall maintain a marijuana waste disposal log indicating the date and time, location, video camera names that captured the two (2) angles of destruction, method of destruction, mixing medium, and agent ID(s) of the employee(s) who destroyed the marijuana product.

(3) Wastewater generated during marijuana product production and processing must be disposed of in compliance with applicable state, tribal, local, and municipal laws and regulations.

(4) Marijuana waste must be stored securely before final disposition, which can be done within the facility in areas designated for disposal activities or, if necessary, outside the facility in a locked, tamper-resistant receptacle.

(5) Wastes from the production and processing of marijuana plants must be evaluated against state hazardous waste regulations to determine if those wastes qualify as hazardous waste. It is the responsibility of each licensee to properly evaluate their waste to determine if it is a hazardous waste per 40 CFR 262.11.

(A) All solid waste, as defined by 40 CFR 261.2, must be evaluated under the hazardous waste regulations, including:

Waste from marijuana flowers, trim, and solid plant material used to create an extract;
Waste solvents, pesticides, and other similar materials used in the cultivation, infused product manufacturing, or testing process;
Discarded plant waste, spent solvents, and laboratory wastes from any marijuana processing or quality assurance testing; and 4. Marijuana extract that fails to meet quality testing.

(B) Marijuana flowers, trim, and solid plant material are not in themselves considered hazardous waste unless they have been treated or contaminated with a hazardous waste constituent.

(C) If a licensee’s waste qualifies as a hazardous waste, then that waste is subject to the applicable hazardous waste management standards.

(D) Marijuana product waste that does not qualify as hazardous waste per 40 CFR 262.11 including plant waste, such as, stalks, leaves, and stems, must be rendered unusable prior to leaving a facility.

Marijuana product waste that does not qualify as hazardous waste may be rendered unusable by grinding and incorporating the marijuana product waste with other nonhazardous ground materials so the resulting mixture is at least fifty percent (50%) nonmarijuana waste by volume.

Material used to grind with the marijuana product waste may be either compostable waste or non-compostable waste. Other methods to render marijuana product waste unusable must be approved by the department in writing before implementation.

Marijuana product waste that has been rendered unusable may be disposed of at a permitted solid waste facility for final disposition. Other final disposition locations must be approved in writing by the department before implementation.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.160 Cultivation Facilities to facilities licensed to cultivate marijuana. {#sec-19-csr-100-1.160 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.160}

(1) Cultivation facilities, generally.

(A) A cultivation licensee’s authority to engage in the process of cultivating marijuana includes the ability to— 1. Acquire and transfer marijuana, marijuana seeds, and clones from another cultivation facility;

Acquire and transfer marijuana seeds from entities not licensed under this chapter if doing so does not violate state or federal law;
Acquire and transfer marijuana product from a manufacturing facility or dispensary facility;
Cultivate marijuana;
Process, package, and store (on- or off-site) marijuana product;
Transfer marijuana product to or from its own warehouse storage facility, another cultivation facility, manufacturing facility, or dispensary facility;
Transfer marijuana product to a testing facility; and 8. Sell marijuana product to another cultivation facility, manufacturing facility, dispensary facility, or testing facility.

(B) A cultivation licensee’s authority to process marijuana shall include the production and sale of prerolls, but shall not include the manufacture of marijuana-infused products.

(2) Cultivation facility and licensee requirements. In addition to this chapter’s requirements for licensed facilities and licensees, cultivation facilities and licensees shall also comply with the (A) Cultivation licensees may cultivate marijuana in indoor, outdoor, or greenhouse facilities or in any combination of these cultivation practices.

Each microbusiness wholesale facility utilizing any combination of indoor, outdoor, or greenhouse facilities will be limited to no more than two hundred fifty (250) flowering marijuana plants.
Each indoor medical or comprehensive facility utilizing artificial lighting will be limited to no more than thirty thousand (30,000) square feet of flowering plant canopy space.
Each outdoor medical or comprehensive facility utilizing natural lighting will be limited to no more than two thousand, eight hundred (2,800) flowering plants.
Each medical or comprehensive greenhouse facility using a combination of natural and artificial lighting will be limited to, at the election of the licensee, either no more than two thousand, eight hundred (2,800) flowering plants or no more than thirty thousand (30,000) square feet of flowering plant canopy space.
A medical or comprehensive facility that combines indoor, outdoor, and/or greenhouse cultivation space will be limited to a ratio of the limits described above for each applicable cultivation practice, not to exceed one hundred percent (100%) of total allowable flowering plant or flowering plant canopy space.
If multiple cultivation licenses are operating in the same facility, the capacity limitations of the cultivation facility will be multiplied by the number of licenses;

(B) Cultivation licensees must mitigate odors from all odor sources by— 1. Developing, implementing, and maintaining an odor control plan, which shall address odor mitigation practices such as system design and operational processes;

Engaging a professional engineer or certified industrial hygienist to review the odor control plan and certify that the plan is sufficient to effectively mitigate odors from all odor sources prior to commencing operations; and 3. Maintaining compliance with local ordinances related to odor; and (C) Marijuana product shall not be transferred to a dispensary facility, unless it is a seed or clone, until the marijuana product has been tested by a testing licensee, according to the provisions of this chapter, and the cultivation licensee has received verification from the testing licensee that the marijuana product passed mandatory testing.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.170 Manufacturing Facilities facilities. {#sec-19-csr-100-1.170 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.170}

This rule explains what regulations apply to facilities that manufacture marijuana product.

(1) Manufacturing facilities, generally.

(A) A manufacturing licensee’s authority to engage in the process of manufacturing marijuana-infused products includes the ability to— 1. Acquire and transfer marijuana from a cultivation facility;

Acquire and transfer marijuana product from another manufacturing facility to further process;
Acquire and transfer marijuana product from a dispensary facility;
Process and store (on- or off-site) marijuana product;
Manufacture and package marijuana-infused products and prerolls;
Transfer marijuana product to or from its own warehouse storage facility, another manufacturing facility, cultivation facility, or dispensary facility;
Transfer marijuana product to a testing facility; and 8. Sell marijuana product to another manufacturing facility, cultivation facility, dispensary facility, or testing facility.

(B) A manufacturing licensee’s authority to manufacture marijuana-infused products shall include the creation of prerolls and infused prerolls.

(2) Manufacturing licensee requirements. In addition to this

chapter’s requirements for licensed facilities and licensees, manufacturing licensees shall also comply with the following:

(A) Manufacturing licensees must mitigate odors from all odor sources by— 1. Developing, implementing, and maintaining an odor control plan, which shall address odor mitigation practices such as system design and operational processes;

Engaging a professional engineer or certified industrial hygienist to review the odor control plan and certify that the plan is sufficient to effectively mitigate odors from all odor sources prior to commencing operations; and 3. Maintaining compliance with local ordinances related to odor;

(B) Marijuana product shall not be transferred to a dispensary facility until the marijuana product has been tested by a testing licensee, according to the provisions of this chapter, and the manufacturing licensee has received verification from the testing licensee that the marijuana product passed mandatory testing;

(C) Manufacturing licensees that produce ingestible marijuana-infused products shall comply with the applicable food safety standards set forth in 19 CSR 20 and any relevant statutes controlling food safety standards. Such licensees are prohibited from producing frozen desserts or acidified foods, as defined by 19 CSR 20;

(D) Manufacturing licensees that use volatile solvents shall install air-handling systems and other controls designed to minimize the risks of explosions and fires. These controls should include systems to prevent ignition; Volatile Solvent Standard Operating Procedures; plans for safe storage, use, and disposal of solvents; and policies for continuous staff monitoring of all processes involving volatile solvents;

(E) Any tetrahydrocannabinol, such as THC-A, Delta- 8, or Delta-10, in a marijuana product manufactured by a manufacturing licensee shall only be derived from marijuana cultivated in Missouri by a licensed cultivator; and (F) Manufactured product may not contain chemical modification, conversion, or synthetic derivation of cannabinoids to produce intoxicating cannabinoid isomers, including those created by heat or other process during use by a patient or consumer, and all cannabinoids acquired from entities other than marijuana facilities for purpose of inclusion in marijuana product must be accompanied by a Certificate of Analysis at time of acquisition that identifies the testing lab that tested the product and lists the product’s ingredients.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.180 Dispensary Facilities to dispensary facilities and licensees. {#sec-19-csr-100-1.180 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.180}

(1) Dispensary facilities, generally.

(A) A dispensary licensee’s authority to engage in the process of dispensing marijuana product includes the ability to— 1. Acquire and transfer marijuana, marijuana seeds, clones, and prerolls from a cultivation facility;

Acquire and transfer marijuana-infused products and prerolls from a manufacturing facility;
Acquire and transfer marijuana product from another dispensary facility;
Create and sell prerolls, which does not include the grinding of marijuana for use in prerolls or manufacture of marijuana-infused products;
Package and store (on- or off-site) marijuana product and drug paraphernalia used to administer marijuana product;
Transport and sell or distribute marijuana product and drug paraphernalia to another dispensary facility, manufacturing facility, cultivation facility, testing facility, or individuals authorized to purchase marijuana product for personal or medical use, as follows:

A. A medical dispensary licensee may only sell or distribute to individuals who are qualifying patients or primary caregivers; and B. A comprehensive or microbusiness dispensary licensee may sell or distribute to individuals who are consumers, qualifying patients, or primary caregivers; and 7. Transfer marijuana product to or from its own warehouse.

(2) Dispensary facility and licensee requirements. In addition to this chapter’s requirements for licensed facilities and licensees, dispensary facilities and licensees shall also comply with the (A) Dispensary licensees must design their facility and staffing in such a way as to accomplish the following:

The general public may only enter the facility through one (1) public access point into an area where facility agents shall screen individuals for qualifying patient, primary caregiver, or consumer status. No marijuana product may be accessible in this area. Drive-through or pickup windows shall not constitute an additional access point to the facility;
No one under the age of twenty-one (21) may enter any areas beyond the facility’s public access point area, unless the individual is a qualifying patient or accompanying a parent or guardian who is a qualifying patient, primary caregiver, or consumer;
In any limited access area where marijuana product is accessible within the facility, the licensee must have at least one (1) facility agent present for every three (3) consumers, qualifying patients, or primary caregivers, combined. A facility agent serving a consumer, qualifying patient, or primary caregiver at a drive-through window or pick-up window is not available to accompany a consumer, qualifying patient, or primary caregiver in the limited access area as long as the staff person is serving the drive-through or pickup window consumer, qualifying patient, or primary caregiver;
Drive-through lanes and pickup windows must— A. Utilize drawers or pneumatic tubes for dispensing B. Provide for clear visibility of the consumer, qualifying patient, or primary caregiver for verification of identity. Drivethrough and pick-up windows must either be constructed so that they do not open or remain closed and locked at all times;

C. Be covered at all times by video camera monitoring and recording that meets the standards described in this

chapter; and 5. Dispensary facilities must have posted at each point of egress, and on, beside, or immediately above all drivethrough drawers, a department-approved sign that conveys the following warning:

“It is against the law to operate a dangerous device, motor vehicle, aircraft, or motorboat while under the influence of marijuana”;

(B) Prior to sale, delivery, or distribution, dispensary licensees shall verify all of the following through the state-wide track and trace system:

Any marijuana product the facility sells, delivers, or distributes has been tested by a testing facility, according to the provisions of this chapter, and passed mandatory testing for the product type, including prerolls created at a dispensary 2. The marijuana product has not been placed on administrative hold, recalled, or ordered or otherwise required to be destroyed;

(C) Dispensary licensees shall not sell, deliver, or distribute to a consumer, qualifying patient, or primary caregiver more marijuana product than the lawful amounts.

Licensees may not sell, deliver, or distribute to a consumer more than three (3) ounces of dried, unprocessed marijuana, or its equivalent, in a single transaction and shall report to the department any instances of consumers attempting to make multiple purchases in one (1) day that the licensee knows, or reasonably should know would likely result in the consumer exceeding the three (3) ounce possession limit.
Licensees may not sell, deliver, or distribute to a qualifying patient or primary caregiver on behalf of a qualifying patient, any amount of dried, unprocessed marijuana, or its equivalent, that would result in the purchase of more than that qualifying patient’s physician- or nurse practitioner-authorized amount;

(D) Transactions.

For every transaction, dispensary licensees must receive the transaction order directly from a consumer, qualifying patient, or primary caregiver in person, by phone, or via the internet.

A. If a dispensary licensee receives transactions via the internet, it must ensure that the third party entity providing services for online ordering— (I) Utilizes security measures sufficient to protect the confidentiality and security of consumer, qualifying patient, and primary caregiver information;

(II) Does not collect or distribute consumer, qualifying patient, or primary caregiver data for use in any way other than for the online ordering process; and (III) Seeks and obtains appropriate authority from the department for integration with the state-wide track and trace system, if integration is necessary, prior to providing services.

At the time of sale or distribution, licensees must— A. Verify through the state-wide track and trace system that— (I) Qualifying patients or primary caregivers making marijuana product purchases for medical use are currently authorized to purchase the amount of marijuana product requested;

(II) Consumers purchasing marijuana product do not exceed the purchase limits set forth above; and (III) A consumer, qualifying patient, or primary caregiver purchasing plants is currently authorized to cultivate marijuana;

B. Verify that the marijuana product is not past its “best if used by” date;

C. Require production of a qualifying patient or primary caregiver identification card if applicable or production of a substantially equivalent identification card issued in another jurisdiction, a valid (not expired) government-issued photo ID, and in the case of marijuana plant purchases, a cultivation identification card. In the case of delivery orders, such documentation must be produced at the time of delivery.

Licensees must verify that— (I) Patients acquiring marijuana product for medical use are at least eighteen (18) years of age or are emancipated individuals under the age of eighteen (18); or (II) Patients under the age of eighteen (18) have a primary caregiver who is making the acquisition on their behalf; or (III) All consumers are at least twenty-one (21) years of age;

D. For any transaction involving a qualifying patient, primary caregiver, or personal cultivation purchase, scan the department-issued identification card barcode in order to adequately track purchases in the state-wide track and trace system;

E. Receive payment before the marijuana product leaves the dispensary facility, or, in the case of a delivery order, receive payment at any point in time up until and including the time of delivery.

(I) In the case of a delivery order, payment is subject to refund if the delivery cannot be completed.

(II) If not receiving pre-payment for a delivery order, a dispensary licensee may deliver to no more than two (2) individuals at the same address on the same day; and F. Record the disbursement of marijuana product, including plants and seeds, in the state-wide track and trace system, even in instances where prices are discounted or waived;

(E) Dispensary licensees that sell marijuana-infused products for oral consumption, including marijuana products such as a tincture, shall ensure the storage and handling of the manufactured product complies with the applicable food safety standards set forth in chapter 19 CSR 20 and any relevant statutes controlling food safety standards;

(F) Dispensary licensees shall only sell marijuana plants acquired from licensed cultivation facilities.

Dispensary licensees shall not sell marijuana plants to a consumer, qualifying patient, or primary caregiver who is not currently authorized to cultivate marijuana.
Only plants less than eight (8) inches tall and less than eight (8) inches wide may be sold by dispensary licensees, and dispensary licensees may not alter the plant or care for it in any way other than watering and providing light.
If a dispensary licensee chooses to sell plants, the transaction shall proceed as follows:

A. Dispensary licensees shall receive an order and payment from a consumer, qualifying patient, or primary caregiver prior to arranging for transfer of the plant from a cultivation facility to the dispensary facility. The dispensary licensee may not hold any particular plant for more than five (5) days;

B. The licensee will schedule a time for the licensed consumer, qualifying patient, or primary caregiver to pick up the order within the five- (5-) day time frame;

C. When the licensee accepts transfer of a plant from a cultivation facility, it must store the plant, with the consumer’s, qualifying patient’s, or primary caregiver’s name and license number, in its vault;

D. If a consumer, qualifying patient, or primary caregiver does not pick up the order, the licensee must dispose of the plant upon expiration of the five (5) days and record the disposal and method of disposal in the state-wide track and trace system; and E. In a single day, no more than six (6) plants less than eight (8) inches tall and less than eight (8) inches wide may be sold to a consumer or to or on behalf of a particular patient;

(G) Refunds or credits may be issued as needed, but returns of marijuana product may only be accepted for purposes of disposal;

(H) Dispensary licensees must make available to all consumers, qualifying patients, and primary caregivers educational materials, whether digital or print, that include at least the following:

Local resources for concerns about addiction, including the phone number for the Substance Abuse and Mental Health Services Administration’s National Helpline;
Information about potential risks and possible side effects of marijuana use, including:

A. Marijuana use affects brain functioning and is likely to cause physical and mental impairment;

B. Those who consume marijuana should not operate a motor vehicle or other similar equipment;

C. Women who are or may become pregnant or are breastfeeding should avoid using marijuana as it may cause pregnancy complications, harm a baby’s development, and result in a lower birth weight;

D. Secondhand smoke from marijuana can have psychoactive effects and should be avoided for all children;

E. The risk of poisoning and the phone number for the Missouri Poison Center;

Information about the different ways to administer marijuana product and the differences in the anticipated time frames for the marijuana product to take affect; and 4. The department’s contact information and website address;

(I) Dispensary facilities may securely display samples of each marijuana product offered for sale.

Marijuana product used as a display sample may not be dispensed to consumers, qualifying patients, or primary 2. A facility agent may remove the sample from the secure display to allow a consumer, qualifying patient, or primary caregiver to inspect the display sample but shall immediately return the sample to the secure display once such inspection is complete.
Display samples shall be destroyed in accordance with this chapter within five (5) business days of the inventory associated with the mandatory test sample tag number being finished;

(J) Dispensary licensees shall store all marijuana product in a locked vault, a similarly secure locked enclosure, or in a warehouse when the facility is closed for business;

(K) Dispensaries shall limit the amount of money available in any retail area of the facility and shall notify the public that there is a minimal amount of money available, including by posting of a sign;

(L) Dispensary licensees may offer marijuana product disposal services for consumers, qualifying patients, and primary caregivers.

Dispensary licensees may charge a reasonable disposal fee.
Any marijuana product received for disposal must be logged in the state-wide track and trace system and disposed within forty-eight (48) hours of receipt at the dispensary (M) Any product of any kind available in a dispensary that is not marijuana product must be displayed separately from marijuana product and in a manner that clearly communicates the non-marijuana product is not regulated pursuant to this

chapter.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023,

19 CSR 100-1.190 Microbusinesses {#sec-19-csr-100-1.190 omnilex-key=us-mo-regs-official--title-19--19 CSR 100-1.190}

PURPOSE: Under Article XIV, Section 2, of the Missouri the authority to regulate and control marijuana microbusiness only to microbusiness facilities and licensees.

(1) Criteria to apply for, own, and operate a microbusiness license.

(A) Entities must obtain a license to cultivate, manufacture, and dispense marijuana product in Missouri as a marijuana microbusiness. Application requirements are outlined in the application section of this chapter.

An entity may apply for and obtain only one (1) license to operate a microbusiness facility, which may be either a microbusiness dispensary facility or a microbusiness wholesale facility. If an entity, which includes an individual, holds an ownership interest in more than one (1) microbusiness license applicant in the same microbusiness application period, all microbusiness applications where the entity holds an ownership interest will be denied.
An entity may be an owner of only one (1) license to operate a microbusiness facility, which may be either a microbusiness dispensary facility or a microbusiness wholesale (B) Applicants for a microbusiness license shall be majority owned and operated by individuals who each meet at least one (1) of the following qualifications:
Have a net worth of less than two hundred fifty thousand dollars ($250,000) and have had an income below two hundred fifty percent (250%) of the federal poverty level, or a successor level, as set forth in the applicable calendar year’s federal poverty income guidelines published by the U.S. Department of Health and Human Services or its successor agency, for at least three (3) of the ten (10) calendar years prior to applying for a microbusiness license;
Have a valid service-connected disability card issued by the United States Department of Veterans Affairs, or successor agency;
Be a person who has been, or a person whose parent, guardian, or spouse has been arrested for, prosecuted for, or convicted of a non-violent marijuana offense at least one (1) year prior to the effective date of this section, unless the conviction— A. Involved provision of marijuana to a minor; or B. Was for driving under the influence of marijuana;
Reside in a ZIP code or census tract area where— A. Thirty percent (30%) or more of the population lives below the federal poverty level; or B. The rate of unemployment is fifty percent (50%) higher than the state average rate of unemployment; or C. The historic rate of incarceration for marijuanarelated offenses is fifty percent (50%) higher than the rate for the entire state; or 5. Graduated from a school district that was unaccredited, or had a similar successor designation, at the time of graduation, or has lived in a ZIP code containing an unaccredited school district, or similar successor designation, for three (3) of the past five (5) years.

(C) Once an individual is deemed eligible for qualifying majority ownership of a licensed microbusiness facility under this rule, such eligibility shall be perpetual and unaffected by subsequent change in circumstances. The eligibility status will extend to the eligible individual’s descendants, spouse, siblings, or other relations approved by the department in the event that ownership in microbusiness facility is transferred by the eligible individual through will, trust, non-probate transfer, gift, or other estate planning instrument. An individual may subsequently be deemed ineligible if the individual provided false or misleading information or is in violation of other provisions in this chapter affecting owner status.

(D) An owner of a microbusiness facility may not also be an owner of another licensed marijuana or medical facility, except— 1. A microbusiness licensee may apply for other medical or marijuana facility licenses during an application time period.

A. Prior to submitting an application, the microbusiness licensee must notify the department of its status as a microbusiness licensee and notify the department if the licensee is claiming to be in operation for at least a year for purposes of selecting comprehensive licenses in Article XIV

Section 2.4(3).

B. If the microbusiness licensee is granted one (1) or more of these licenses, the microbusiness licensee shall transition the existing microbusiness facility to a medical or comprehensive facility on a reasonably practical timetable established by the department, and surrender its microbusiness license; and 2. An owner of a microbusiness license who wishes to become an owner in a marijuana or medical license, must relinquish their owner status by relinquishing at least the amount of ownership interest in the microbusiness license that places their ownership interest at or above ten percent (10%), prior to or at the time of department approval of the ownership change.

(E) Microbusiness facilities and licensees must comply with all applicable sections within this chapter.

(F) “Majority owned and operated” means the eligible individuals having majority ownership must also collectively hold more than fifty percent (50%) of voting power in the licensed entity and have more than fifty percent (50%) of the power to order or direct the management, managers, and policies of the license, enter into and exit agreements on behalf of the license, and otherwise make decisions for the license. Majority ownership cannot be subject to conditions that unduly diminish the controlling interests of the eligible individuals that constitute majority ownership, such as arrangements that subject those majority owners to control of a board or any agreements with disproportionate or exploitative termination fees.

(G) Pre-application technical assistance program.

At least one (1) eligible individual who is contributing to majority ownership shall complete pre-application training, as specified by the department, which shall include, at a minimum— A. Unconscionable business practices;

B. Expectations for owning and operating a microbusiness;

C. Funding and investment options; and D. Rule compliance expectations.

(H) Post-award technical assistance program.

All eligible individuals contributing to majority ownership shall complete post-award training within three (3) months of licensure or of becoming an individual contributing to majority ownership, as specified by the department, which may include— A. Unconscionable business practices;

B. Expectations for owning and operating a microbusiness;

C. Funding and investment options; and D. Rule compliance expectations.

Certificates of completion of mandatory training must be provided to the department when that training is completed.
Eligible applicants, eligible individuals, and licensees shall not enter into new final executed agreements that remove operational control from eligible individuals listed in the application or that would effectuate future automatic transfer of ownership until after successful completion of eligibility verification and mandatory post-award training, and if otherwise permitted.

(2) Microbusiness dispensary licensees, generally.

(A) A microbusiness dispensary facility is licensed to engage in the process of dispensing marijuana product for medical or adult use, in compliance with the dispensary facility rule in this chapter. A microbusiness dispensary licensee may choose to do all or only a subset of the activities authorized under its license.

(B) Microbusiness dispensary licensees shall only acquire marijuana product from a microbusiness wholesale facility or another microbusiness dispensary facility.

(3) Microbusiness wholesale licensees, generally.

(A) A microbusiness wholesale facility is licensed to engage in the process of cultivating and manufacturing marijuana product for medical or adult use, in compliance with the cultivation facility and manufacturing facility rules in this

chapter. A microbusiness wholesale licensee may choose to do all or only a subset of the activities authorized under its license.

(B) A microbusiness wholesale licensee may only transfer its products to a testing facility, transportation facility, microbusiness dispensary facility, or to another microbusiness wholesale facility.

Feb. 3, 2023, expired Aug. 1, 2023. Original rule filed Jan. 20, 2023, effective July 30, 2023. Amended: Filed Nov. 6, 2025, effective May 30, 2026.

19 CSR — Department of Health and Senior Services

Division 10 Office of the Director

Chapter 1 Organization

19 CSR 10-1.010 General Organization of the Department of Health {#sec-19-csr-10-1.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-1.010}

Chapter 2 Civil Rights Compliance

19 CSR 10-2.010 Civil Rights Compliance Requirements {#sec-19-csr-10-2.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-2.010}

Chapter 3 General and Family Physician Loan and Training Programs

19 CSR 10-3.020 Funding of the Programs to Increase General and Family Physician SERVICES Training Programs {#sec-19-csr-10-3.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-3.020}

19 CSR 10-3.010 Loan Program for Medical Students medical student loan program authorized by section 191.505, RSMo 1986. {#sec-19-csr-10-3.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-3.010}

19 CSR 10-3.020 Funding of the Programs to Increase General and Family Physician Training Opportunities {#sec-19-csr-10-3.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-3.020}

19 CSR 10-3.040 Rural Primary Care Physician Grant Program Rural Primary Care Physician Grant Program. {#sec-19-csr-10-3.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-3.040}

19 CSR 10-3.050 Graduate Medical Education Grant Program Graduate Medical Education Grant Program. {#sec-19-csr-10-3.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-3.050}

Chapter 4 Coordinated Health Care Services

19 CSR 10-4.010 Primary Care Resource Initiative for Missouri (PRIMO) Program {#sec-19-csr-10-4.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-4.010}

19 CSR 10-4.020 J-1 Visa Waiver Program {#sec-19-csr-10-4.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-4.020}

19 CSR 10-4.030 National Interest Waiver Program {#sec-19-csr-10-4.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-4.030}

19 CSR 10-4.040 Definition of a Public Health Setting {#sec-19-csr-10-4.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-4.040}

19 CSR 10-4.050 Healthy Communities Incentive Program {#sec-19-csr-10-4.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-4.050}

19 CSR 10-4.060 Substance Use Disorder Grant Program {#sec-19-csr-10-4.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-4.060}

Chapter 5 Procedures for the Collection and Submission of Data to Monitor Health Maintenance Organizations

19 CSR 10-5.010 Monitoring Health Maintenance Organizations Definitions {#sec-19-csr-10-5.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-5.010}

Chapter 6 Professional and Practical Nursing Student Loans

19 CSR 10-6.010 Nurse Loan and Nurse Loan Repayment Programs {#sec-19-csr-10-6.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-6.010}

Chapter 10 Vital Records

19 CSR 10-10.010 Birth {#sec-19-csr-10-10.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.010}

19 CSR 10-10.020 Vital Records Issuance {#sec-19-csr-10-10.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.020}

19 CSR 10-10.030 Filing a Delayed Birth Certificate {#sec-19-csr-10-10.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.030}

19 CSR 10-10.040 Filing a Certificate of Live Birth {#sec-19-csr-10-10.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.040}

19 CSR 10-10.050 Death Certificate Form {#sec-19-csr-10-10.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.050}

19 CSR 10-10.060 Report of Fetal Death {#sec-19-csr-10-10.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.060}

19 CSR 10-10.070 Certificate of Dissolution of Marriage {#sec-19-csr-10-10.070 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.070}

19 CSR 10-10.080 Report of Marriage {#sec-19-csr-10-10.080 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.080}

19 CSR 10-10.090 Access to Vital Records {#sec-19-csr-10-10.090 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.090}

19 CSR 10-10.100 Authorization for Cremation {#sec-19-csr-10-10.100 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.100}

19 CSR 10-10.110 Amending or Correcting Vital Records {#sec-19-csr-10-10.110 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.110}

19 CSR 10-10.120 New Certificate Through Legitimation {#sec-19-csr-10-10.120 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.120}

19 CSR 10-10.130 Missouri Adoptee Rights {#sec-19-csr-10-10.130 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-10.130}

Chapter 15 Abortions

19 CSR 10-15.040 Induced Termination of Pregnancy Consent Form {#sec-19-csr-10-15.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.040}

19 CSR 10-15.010 Abortion Report {#sec-19-csr-10-15.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.010}

19 CSR 10-15.020 Complication Report for Post-Abortion Care {#sec-19-csr-10-15.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.020}

19 CSR 10-15 DEPARTMENT OF HEALTH DIVISION 10—OFFICE OF THE {#sec-19-csr-10-15 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15}

13 CSR 50-151.020 and 19 CSR 30-15.020. Original rule filed Sept. 30, 1980, effective Jan. 12, 1981. Changed to 19 CSR 10-15.020 July 30, 1998. Amended: Filed Oct. 24, 2017, effective April 30, 2018. {#sec-13-csr-50-151.020 omnilex-key=us-mo-regs-official--title-19--13 CSR 50-151.020}

19 CSR 10-15.030 Content and Filing of Tissue Report {#sec-19-csr-10-15.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.030}

19 CSR 10-15.040 Induced Termination of Pregnancy Consent Form {#sec-19-csr-10-15.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.040}

19 CSR 10-15.050 Complication Plans for Certain Drug- and Chemically-Induced Abortions by Physicians via Hospitals {#sec-19-csr-10-15.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.050}

19 CSR 10-15.060 Prohibition on Expenditure of Funds {#sec-19-csr-10-15.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15.060}

19 CSR 10-15 DEPARTMENT OF HEALTH DIVISION 10—OFFICE OF THE {#sec-19-csr-10-15 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-15}

Chapter 33 Hospital and Ambulatory Surgical Center Data Disclosure

19 CSR 10-33.010 Reporting Patient Abstract Data by Hospitals, Ambulatory Surgical {#sec-19-csr-10-33.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.010}

19 CSR 10-33.020 Reporting Charges for Leading Diagnoses and Procedures by Hospitals and {#sec-19-csr-10-33.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.020}

19 CSR 10-33.040 Electronic Reporting of Patient Abstract Data by Hospitals for Public Health {#sec-19-csr-10-33.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.040}

19 CSR 10-33.050 Reporting of Healthcare-Associated Infection Rates by Hospitals, HEALTH AND SENIOR SERVICES Surgical Center Data Disclosure {#sec-19-csr-10-33.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.050}

19 CSR 10-33.010 Reporting Patient Abstract Data by Hospitals, Ambulatory Surgical Centers, and Abortion Facilities {#sec-19-csr-10-33.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.010}

19 CSR 10-33.030 Reporting Financial Data by Hospitals for reporting financial data by hospitals to the Department of Health. {#sec-19-csr-10-33.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.030}

19 CSR 10-33.050 Reporting of Healthcare- Associated Infection Rates by Hospitals, Ambulatory Surgical Centers, and Abortion Facilities {#sec-19-csr-10-33.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-33.050}

Chapter 60 Professional and Practical Loan and Training Programs

19 CSR 10-60.060 Health Professional Loan Repayment Program AND SENIOR SERVICES DIVISION 10—OFFICE OF THE DIRECTOR SERVICES and Training Programs {#sec-19-csr-10-60.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-60.060}

19 CSR 10-60.060 Health Professional Loan Repayment Program (Terminated October 6, 2023) {#sec-19-csr-10-60.060 omnilex-key=us-mo-regs-official--title-19--19 CSR 10-60.060}

Chapter 130SN * - moved to 19 CSR 30-1

19 CSR 10-130SN * - moved to 19 CSR 30-1 {#sec-19-csr-10-130sn omnilex-key=us-mo-regs-official--title-19--19 CSR 10-130SN}

Division 15 Division of Senior and Disability Services

Chapter 1 Organization

19 CSR 15-1.010 Organization and Operation {#sec-19-csr-15-1.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-1.010}

Chapter 2 Education and Program Enhancement

19 CSR 15-2.010 Alzheimer’s Pilot Project Grants {#sec-19-csr-15-2.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-2.010}

Chapter 3 Service Credit Program (Older Volunteer Service Bank)

19 CSR 15-3.010 Definitions as 13 CSR 15-3.010. Original rule filed Sept. 19 CSR 15-3.010, effective Aug. 28, 2001. {#sec-19-csr-15-3.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-3.010}

19 CSR 15-3.020 Sponsoring Agencies as 13 CSR 15-3.020. Original rule filed Sept. 19 CSR 15-3.020, effective Aug. 28, 2001. {#sec-19-csr-15-3.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-3.020}

19 CSR 15-3.030 Volunteers as 13 CSR 15-3.030. Original rule filed Sept. 19 CSR 15-3.030, effective Aug. 28, 2001. {#sec-19-csr-15-3.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-3.030}

19 CSR 15-3.040 Service Credits as 13 CSR 15-3.040. Original rule filed Sept. 19 CSR 15-3.040, effective Aug. 28, 2001. {#sec-19-csr-15-3.040 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-3.040}

19 CSR 15-3.050 Redemption of Credits as 13 CSR 15-3.050. Original rule filed Sept. 19 CSR 15-3.050, effective Aug. 28, 2001. {#sec-19-csr-15-3.050 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-3.050}

Chapter 4 Older Americans Act

19 CSR 15-4.160 Review, Submission, and Approval of Area Agency on Aging Area Plans {#sec-19-csr-15-4.160 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.160}

19 CSR 15-4.175 Funding for Establishment, Maintenance, Modernization, Acquisition, {#sec-19-csr-15-4.175 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.175}

19 CSR 15-4.190 Areas Agency on Aging Development of a Comprehensive and {#sec-19-csr-15-4.190 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.190}

19 CSR 15-4.220 Area Agency on Aging Technical Assistance, Monitoring, and Evaluation HEALTH AND SENIOR SERVICES Disability Services {#sec-19-csr-15-4.220 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.220}

19 CSR 15-4.010 Definition of Terms {#sec-19-csr-15-4.010 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.010}

19 CSR 15-4.020 Administration of the Older Americans Act {#sec-19-csr-15-4.020 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.020}

19 CSR 15-4.030 Governor’s Advisory Council on Aging {#sec-19-csr-15-4.030 omnilex-key=us-mo-regs-official--title-19--19 CSR 15-4.030}