Ga. Comp. R. & Regs. Dept. 111 | Ga. Comp. R. & Regs. Department 111 — Rules of Department of Community Health

Chapter 111-1 Administration

Subject 111-1-1 Regulations for Petition for Promulgation

Ga. Comp. R. & Regs. r. 111-1-1-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-1-1-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-1-1-.01}

In these rules, unless the content otherwise requires, the terms set forth, herein shall mean the following;

(1) "Department" means the Department of Community Health, any division, section, or unit of the Department, and any agency attached to the Department for administrative purposes.

(2) "Person" means any individual, partnership, corporation, association, governmental subdivision, or public or private organization of any character other than an agency.

(3) "Petition" means a petition for promulgation, amendment, or repeal of rules made by an interested person pursuant to O.C.G.A. § 50-13-9 .

(4) "Rule" means each Department regulation, standard, or statement of general applicability that implements, interprets, or prescribes law or policy or describes the organization, procedure, or practice requirements of the Department. The term includes the amendment or repeal of a prior rule but does not include the following:

(a) Statements concerning only the internal management of the Department and not affecting private rights or procedures available to the public;

(b) Declaratory rulings issued pursuant to O.C.G.A. § 50-13-11 ;

(d) Statements of policy or interpretations that are made in the decision of a contested case;

(e) Rules which relate to the acquiring, sale, development, and management of the property, both real and personal, of the state or of the Department;

(f) Rules which relate to contracts for the purchases and sales of goods and services by the state or of the Department;

(g) Rules which relate to the employment, compensation, tenure, terms, retirement, or regulation of the employees of the state or of the Department;

(h) Rules relating to loans, grants, and benefits by the state or of the Department; or

(i) The approval or prescription for the future of rates or prices.

History

Authority: O.C.G.A. §§ 50-13-4, 50-13-9, 31-2-1et seq
History. Original Rule entitled "Definitions" adopted. F. Mar. 15, 2023; eff. Apr. 4, 2023.

Ga. Comp. R. & Regs. r. 111-1-1-.02 Petition by Interested Person {#sec-ga.-comp.-r.-regs.-r.-111-1-1-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-1-1-.02}

(1) Form of Petition. Each petition for promulgation, amendment, or repeal of rules made pursuant to O.C.G.A. § 50-13-9 shall be submitted in writing to the Department's Commissioner and General Counsel. The petition shall include:

(a) The name, address, telephone number, and email address of the petitioner;

(b) The full text of the rule requested to be promulgated, or the full text of the rule desired to be amended or repealed, including strike through of any text of an existing rule the petitioner seeks to remove by amendment;

(c) A statement of the reason(s) such rule should be promulgated, amended, or repealed, including a statement of all pertinent facts which relate to petitioner's interest in the matter;

(d) Citations of legal authority which authorize, support, or require the action requested by petition;

(e) A notarized verification by the petitioner stating that petitioner has reviewed the petition and that the statement of pertinent facts is true to the best of petitioner's information and belief.

(2) Department's Action on the Petition. Upon receipt of the Petition, the Department shall determine what action, if any, is required by the petition.

(a) The Department is only required to take action regarding petitions which include all requirements of Ga. Comp. R. & Regs. r. 111-1-1-.02(1) .

(b) Within thirty (30) days after submission of a petition in conformance with the requirements of Ga. Comp. R. & Regs. r. 111-1-1-.02(1) , the Department shall either deny the petition in writing, stating its reasons for denial, or shall initiate rule-making proceedings in accordance with O.C.G.A. § 50-13-4 . Petitions submitted which fail to conform with the requirements of Ga. Comp. R. & Regs. r. 111-1-1-.02(1) shall be denied without further action required by the Department.

History

Authority: O.C.G.A. §§ 50-13-4, 50-13-9, 31-2-1et seq
History. Original Rule entitled "Petition by Interested Person" adopted. F. Mar. 15, 2023; eff. Apr. 4, 2023.

Subject 111-1-2 Vendor Relationships

Ga. Comp. R. & Regs. r. 111-1-2-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-1-2-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-1-2-.01}

(1) "Lobbyist" shall have the meaning given in O.C.G.A. § 21-5-70(6) as it presently exists or as it may hereafter be amended. In addition, for the purpose of these regulations, the term shall also be deemed to include:

(a) any person who, for compensation, either individually or as an employee of another person, corporation, or association, undertakes to influence a public employee or state agency in the selection of a vendor to supply any goods or services to any state agency where the total value of any single contract, including authorized or anticipated renewals, exceeds $50,000 in value or where the total value of all contracts the lobbyist promotes or opposes, including authorized or anticipated renewals, exceeds $100,000 in a calendar year, but does not include a person solely on the basis that such person participated in preparing a written bid, written proposal, bid protest, or other document relating to a potential involvement with or sale to the Department; or

(b) any natural person who makes expenditures totaling more than $250.00 in a calendar year, not including the person's own travel, food, and lodging expenses, or informational material, to promote or oppose the awarding of any contract to a particular vendor or vendors by the Department where the total value of any single contract, including authorized or anticipated renewals, exceeds $50,000 in value or where the total value of all contracts the lobbyist promotes or opposes, including authorized or anticipated renewals, exceeds $100,000 in a calendar year.

(2) "Department" means the Department of Community Health, any division, section, or unit of the Department, and any agency attached to the Department for administrative purposes.

(3) "Public employee" shall have the meaning given in O.C.G.A. § 45-1-6(a)(4) as it presently exists or as it may hereafter be amended. In addition, for the purpose of these regulations, the term shall also be deemed to include all persons holding a state elective office.

(4) "Vendor" shall have the meaning given in O.C.G.A. § 45-1-6(a)(5) as it presently exists or as it may hereafter be amended. For the purpose of these regulations, a person seeking or opposing a certificate of need shall also be deemed to be a vendor.

(5) "Contract" shall mean any agreement, written or verbal, by which the Department agrees to purchase goods and/or services from a vendor. For the purpose of these regulations, the term shall also be deemed to include a certificate of need.

(6) "Certificate of need" shall have the meaning given in Article 3 of Chapter 6 of Title 31 of the Official Code of Georgia Annotated as it presently exists or as it may hereafter be amended. The term shall further include the determination by the Department that a project is exempt from the requirements of Article 3 of Chapter 6 of Title 31 of the Official Code of Georgia Annotated.

(7) "Person" shall mean an individual, partnership, committee, association, corporation, labor organization, or any other organization or group of persons.

History

Authority: O.C.G.A. Secs. 21-5-70et seq., 45-1-6
History. Original Rule entitled "Definitions" adopted. F. Jan. 21, 2004; eff. Feb. 10, 2004.

Ga. Comp. R. & Regs. r. 111-1-2-.02 Registration Requirements {#sec-ga.-comp.-r.-regs.-r.-111-1-2-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-1-2-.02}

(1) All current or prospective vendors who employ, retain, or associate one or more lobbyists shall require such lobbyists to register with the State Ethics Commission in accordance with the provisions of Article 4 of Chapter 5 of Title 21 of the Official Code of Georgia Annotated.

(2) All current or prospective vendors who employ, retain, or associate one or more lobbyists shall require such lobbyists to file the disclosures required by Article 4 of Chapter 5 of Title 21 of the Official Code of Georgia Annotated.

(3) In addition to the disclosures required by Article 4 of Chapter 5 of Title 21 of the Official Code of Georgia Annotated, such lobbyists shall further disclose:

(a) the name of any vendor(s) by which the lobbyist is employed, retained, or associated;

(b) an identification of the contract(s) regarding which the lobbyist is lobbying, including the contract or procurement number, if one has been assigned by the Department; and

(c) a good faith estimate of the total amounts of all income to the lobbyist from the vendor (or from any other person on behalf of the vendor) other than income for matters unrelated to lobbying.

(4) The disclosures made to the State Ethics Commission pursuant to this Chapter shall be considered to be "information voluntarily supplied" pursuant to O.C.G.A. § 21-5-6(b)(3) .

(5) The registrations and disclosures to the State Ethics Commission pursuant to this Chapter shall be cumulative of, and shall not supplant or substitute for, any reports required to be made by O.C.G.A. § 45-1-6 .

History

Authority: O.C.G.A. Secs. 21-5-70et seq., 45-1-6
History. Original Rule entitled "Registration Requirements" adopted. F. Jan. 21, 2004; eff. Feb. 10, 2004.

Ga. Comp. R. & Regs. r. 111-1-2-.03 Certification Requirements {#sec-ga.-comp.-r.-regs.-r.-111-1-2-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-1-2-.03}

(1) All current or prospective vendors who submit a bid, response to request for proposals, or any response to any other procurement method, shall certify:

(a) that the vendor has not employed, retained, or associated one or more lobbyists required to register with the State Ethics Commission in accordance with these regulations; or

(b) that any lobbyist employed, retained, or associated by the vendor has registered with the State Ethics Commission and made the disclosures required by law and by these regulations.

(2) Any vendor who submits an application for a certificate of need, confirmation of status, letter of non-reviewability, or opposition to any such application or letter, shall certify:

(a) that the vendor has not employed, retained, or associated one or more lobbyists required to register with the State Ethics Commission in accordance with these regulations; or

(b) that any lobbyist employed, retained, or associated by the vendor has registered with the State Ethics Commission and made the disclosures required by law and by these regulations.

History

Authority: O.C.G.A. Sec. 21-5-70et seq
History. Original Rule entitled "Certification Requirements" adopted. F. Jan. 21, 2004; eff. Feb. 10, 2004.

Ga. Comp. R. & Regs. r. 111-1-2-.04 Forms {#sec-ga.-comp.-r.-regs.-r.-111-1-2-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-1-2-.04}

(1) The registration of lobbyists as required by these regulations shall be made on forms prescribed by and in the manner prescribed by the State Ethics Commission.

(2) The disclosures required of lobbyists by these regulations shall be made on forms prescribed by and in the manner prescribed by the State Ethics Commission.

(3) The certifications required of vendors by these regulations shall be made on forms prescribed by and in the manner prescribed by the Department.

(4) The Department will not execute any contract with any vendor that fails to make the certifications required by these regulations, and may rescind any previously executed contract upon a determination that any certification contained misrepresentations or falsehoods. Such misrepresentations or falsehoods may, in the sole discretion of the Department, be deemed to be a material breach of the contract by the vendor.

History

Authority: O.C.G.A. Secs. 21-5-70et seq., 45-1-6, 45-12-130et seq
History. Original Rule entitled "Forms" adopted. F. Jan. 21, 2004; eff. Feb. 10, 2004.

Chapter 111-2 Health Planning

Subject 111-2-1 Administration

Ga. Comp. R. & Regs. r. 111-2-1-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-2-1-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-1-.01}

(1) "Board" means the Board of Community Health, the body created under O.C.G.A. § 31-2-3 , appointed by the Governor, that establishes the general policy to be followed by the Department of Community Health.

(2) "Certificate of Need Appeal Panel" or "appeal panel" means the panel of independent hearing officers created pursuant to O.C.G.A. § 31-6-44 to conduct appeal hearings.

(3) "Commissioner" means the commissioner of community health established under O.C.G.A. § 31-2-6 .

(4) "Department" means the Department of Community Health established under O.C.G.A. § 31-2-4 .

(5) "Health Strategies Council" or "Council" means the body created by this chapter to advise the Department of Community Health.

History

Authority: O.C.G.A. §§31-2et seq., 31-6 et seq
History. Original Rule entitled "Definitions" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.

Ga. Comp. R. & Regs. r. 111-2-1-.02 Health Planning Functions of the Department {#sec-ga.-comp.-r.-regs.-r.-111-2-1-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-1-.02}

(1) The Department is authorized to administer the health planning and Certificate of Need programs established under O.C.G.A. § 31-6 et seq. and a state health plan approved by the Board. The Department shall review and update the state health plan at least every five years beginning no later than January 1, 2025, to ensure the plan meets the evolving needs of the state. The Department shall provide by rule for procedures to administer its functions. As appropriate, the Commissioner may delegate the authority to administer any function or duty prescribed by law or these Rules to one or more authorized designees in the Office of Health Planning and the Office of General Counsel.

(2) The functions of the Department shall be:

(a) to conduct the health planning activities of the State and, within appropriations made available by the General Assembly and consistent with the laws of the State of Georgia, to implement such parts of the State Health Plan as may relate to State government;

(b) to prepare and revise a draft State Health Plan with recommendations from technical advisory committees;

(d) to adopt, promulgate, and implement rules and procedures necessary to carry out the provisions of O.C.G.A. § 31-6 et seq. in accordance with O.C.G.A. § 50-13 et seq ., the Georgia Administrative Procedure Act.

(e) to define the form, content, schedules, fees, and procedures for submission of applications for Certificates of Need, other determinations and periodic reports;

(f) to establish time periods and procedures consistent with O.C.G.A. § 31-6 et seq . to hold hearings and to obtain the viewpoints of interested persons prior to issuance or denial of a Certificate of Need;

(g) to provide for such payment as may be necessary to share the costs of preparing the record for Certificate of Need appeals before the Certificate of Need Appeal Panel;

(h) to provide for a reasonable and equitable fee schedule for Certificate of Need applications; provided, however, that a Certificate of Need application filed by or on behalf of a hospital in a rural county shall be exempt from any such fee;

(i) to grant, deny, suspend, rescind, cancel, or revoke a Certificate of Need as applied for or as amended;

(j) to impose civil penalties as permitted or required by law for violation of these Rules and O.C.G.A. § 31-6 et seq .; and

(k) to study the amount of uncompensated indigent and charity care provided by each type of health care facility, recommend requirements for the levels of uncompensated indigent and charity care required to be performed by each health care facility type and develop standardized reporting requirements for the Department to accurately track the amount of uncompensated indigent and charity care provided by each health care facility.

(3) The Commissioner shall have the power to establish and abolish technical advisory committees as he or she deems necessary, in consultation with the board, to inform effective strategy development and execution.

History

Authority: O.C.G.A. § 31-6 et seq
History. Original Rule entitled "Health Planning Functions of the Department" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Amended: F. Dec. 10, 2024; eff. Dec. 30, 2024.

Subject 111-2-2 Certificate of Need

Ga. Comp. R. & Regs. r. 111-2-2-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.01}

As used in these Rules, the term:

(1) "Acquisition of an existing health care facility" means to come into possession or control of a health care facility by purchase, gift, merger of corporations, lease, purchase of stock, inheritance, or by any other legal means.

(2) "Acquisition of diagnostic, therapeutic, or other imaging equipment":

(a) as it relates to a diagnostic, treatment, or rehabilitation center, means to come into possession, or control of, or to otherwise use diagnostic, therapeutic, or other imaging equipment by purchase, gift, donation, lease, transfer, or by any other legal means by or on behalf of diagnostic, treatment, or rehabilitation center; and

(b) as it relates to a health care facility, means to come into possession or control of diagnostic, therapeutic, or other imaging equipment by purchase or lease by or on behalf of the health care facility.

(3) "Ambulatory surgery" means surgical procedures that include but are not limited to those recognized by the Centers for Medicare and Medicaid Services ("CMS"), by the Georgia Division of Medical Assistance ("DMA"), by the State Health Benefit Plans, or by any successor entities as reimbursable ambulatory surgery procedures. Ambulatory surgery is provided only to patients who are admitted to a facility which offers ambulatory surgery, and which does not admit patients for treatment that normally requires stays that are overnight or exceed 24 hours and which does not provide accommodations for treatment of patients for periods of twenty-four hours or longer.

(4) "Ambulatory surgical or obstetrical facility", as defined at O.C.G.A. § 31-6-2(1) , means a public or private facility, not a part of a hospital, which provides surgical or obstetrical treatment performed under general or regional anesthesia in an operating room environment to patients not requiring hospitalization.

(5) "Applicant" means the owner or lessee of an existing health care facility or the person who would be the owner or lessee of a proposed facility, as named in the application. An applicant may also be multiple owners or lessees of existing health care facilities who share common ownership or corporate affiliation and wish to submit an application to the Department for a single Certificate of Need for certain non-clinical health services, for example, but not limited to parking decks, infrastructure improvement or replacement, and capital renovation expenditures.

(6) "Application", as defined at O.C.G.A. § 31-6-2(2) , means a written request for a Certificate of Need made to the Department, containing such documentation and information as the Department may require.

(7) "Approved date" means the date that the Department issues a Certificate of Need to an applicant.

(8) "Associated with and simultaneously developed or proposed" means that if the Department determines that a single project or the substantial equivalent of a single project is divided into separate components which are associated and which are developed or planned simultaneously, so that the project or the substantial equivalent of a project or any component thereof does not require a total capital expenditure in excess of the capital expenditure or diagnostic, therapeutic, or other imaging equipment threshold as applicable, the Department shall combine the components for purposes of computing the amount of the total capital expenditure or expense and shall treat the combined components as a single project or substantial equivalent of a project. The Department shall include items and expenditures which are related and which occur simultaneously in computing an applicable threshold regardless of whether the items or expenditures individually may otherwise be below the threshold or may be otherwise unreviewable exclusive of the items exempted from review by Ga. Comp. R. & Regs., r. 111-2-2-.03(1)-(3) and Ga. Comp. R. & Regs., r. 111-2-2-.03(5)-(19) ;

(a) The Department may determine that activities, services, expenditures, and items are associated if they share a relationship or association based on law, regulation, definition, function, procedure, or process; and

(b) The Department shall determine that expenditures related to activities, services, and items are simultaneously developed or planned if such expenditures occur within a 6-month period. The 6-month period shall run from operation of the activity, service or item to initial capital expenditure on the second activity or item or from operation of the activity or item to operation of the second activity or item. For services, the date of operation shall be the date that the service is actually offered. If applicable, for facilities, the date of operation shall be the date a Certificate of Occupancy is issued.

(9) Reserved.

(10) "Basic perinatal services" means providing basic inpatient care for pregnant women and newborns without complications; managing perinatal emergencies; consulting with and referring to specialty and subspecialty hospitals; identifying high-risk pregnancies; providing follow-up care for new mothers and infants; and providing public/community education on perinatal health.

(11) "Bed capacity", as defined at O.C.G.A. § 31-6-2(4) , means space used exclusively for inpatient care, including space designed or remodeled for inpatient beds even though temporarily not used for such purposes. The number of beds to be counted in any patient room shall be the maximum number for which adequate square footage is provided as established by Rules of the Department, except that single beds in single rooms shall be counted even if the room contains inadequate square footage.

(12) "By or on behalf of" means any expenditures made by a health care facility, a political subdivision of the State, a diagnostic, treatment, or rehabilitation center, or a hospital authority, itself as well as capital expenditures made by other persons or related entities to assist the facility, subdivision, center, or authority, directly or indirectly, to offer services to its patients or residents. Related entities include entities that are associated or affiliated with, have control over or are controlled by, or have any direct financial interest in, the health care facility, political subdivision of the State, diagnostic, treatment, or rehabilitation center, or hospital authority, including, without limitation, an underwriter, guarantor, parent organization, sister organization, subsidiary or sub-entity, foreign corporation, joint venturer, partner, general partner, or building lessor, as applicable.

(13) "Capital expenditure" in relation to a proposed modification, renovation, or addition to a health care facility or to a diagnostic, treatment, or rehabilitation center, or acquisition of equipment, means an expenditure by or on behalf of a health care facility or diagnostic, treatment, or rehabilitation center that, under generally accepted accounting principles, is not properly chargeable as an expense of operation or maintenance. Any series of capital expenditures, which are associated and simultaneously developed or proposed, will be presumed to be a single project.

(14) "Certificate of Need" or "CON", as defined at O.C.G.A. § 31-6-2(6) , means an official finding by the Department, evidenced by certification issued pursuant to an application, that the action proposed in the application satisfies and complies with the criteria contained in the Statute and Rules promulgated pursuant thereto.

(15) Reserved.

(16) "Clinical health services", as defined at O.C.G.A. § 31-6-2(8) , means diagnostic, treatment, or rehabilitative services provided in a health care facility and includes, but is not limited to, the following: radiology and diagnostic imaging, such as magnetic resonance imaging and positron emission tomography (PET); radiation therapy; biliary lithotripsy; surgery; intensive care; coronary care; pediatrics; gynecology; obstetrics; general medical care; medical-surgical care; inpatient nursing care, whether intermediate, skilled or extended care; cardiac catheterization; open heart surgery; inpatient rehabilitation; and alcohol, drug abuse, and mental health services.

(17) "Consumer", as defined at O.C.G.A. § 31-6-2(10) , means a person who is not employed by any health care facility or provider and who has no financial or fiduciary interest in any health care facility or provider.

(18) "Cost estimate" means an estimate of the total cost of a project's development and construction prepared by a licensed architect or engineer within sixty days prior to the date of submittal of an application.

(19) "Defined location", as it relates to the approved location of a project or substantial equivalent of a project, means the address of the project, or in the case of a health care facility or diagnostic, treatment, or rehabilitation center with multiple addresses, the campus of such health care facility or diagnostic, treatment, or rehabilitation center. However, in no case shall a campus be considered a single defined location if varying locations and facilities of such campus are more than 3 miles apart or within more than one county.

(20) Reserved.

(21) "Develop", as defined at O.C.G.A. § 31-6-2(14) , with reference to a project, means constructing, remodeling, installing, or proceeding with a project, or any part of a project. Notwithstanding the provisions of this paragraph, the expenditure or commitment or incurring an obligation for the expenditure of funds to develop Certificate of Need applications, studies, reports, schematics, preliminary plans and specifications, or working drawings, or to acquire, develop, or prepare sites shall not be considered to be the developing of a project.

(22) "Diagnostic imaging" means magnetic resonance imaging, computed tomography (CT) scanning, positron emission tomography (PET) scanning, positron emission tomography/computed tomography, and other advanced imaging services as defined by the Department by rule, but such term shall not include X-rays, fluoroscopy, or ultrasound services.

(23) "Diagnostic, treatment, or rehabilitation center", as defined at O.C.G.A. § 31-6-2(16) , means any professional or business undertaking, whether for profit or not for profit, which offers or proposes to offer any clinical health service in a setting which is not part of a hospital; provided, however, that any such diagnostic, treatment, or rehabilitation center that offers or proposes to offer surgery in an operating room environment and to allow patients to remain more than twenty-three (23) hours shall be considered a hospital for purposes of O.C.G.A. §31-6 et seq.

(24) "Effective date" means:

(a) for approved projects that have not been appealed pursuant to the appeal provisions of the Rules of the Certificate of Need Appeal Panel, the approved date;

(b) for projects, which are appealed pursuant to the appeal provisions of the Rules of the Certificate of Need Appeal Panel, the date of the final resolution of any such administrative appeal if the resolution results in the approval of the project; or

(c) for projects which undergo judicial review, the effective date shall be the date referenced in (b) above, unless the Department, pursuant to Ga. Comp. R. & Regs., r. 111-2-2-.07(2)(h) , or the reviewing court stays the effective date of the project pending the outcome of the judicial review. If the Department or the reviewing court stays the effective date, the effective date shall be the date of the final resolution of any such judicial review if the resolution results in approval of the project.

(25) "Expiration date" is the date upon which a Certificate of Need expires and becomes null and void.

(26) "Functionally related diagnostic, therapeutic, or other imaging equipment" means that pieces of diagnostic, therapeutic, or other imaging equipment are interdependent to the extent that one piece of equipment is unable to function in the absence of or without the functioning piece or equipment, or that pieces of equipment are normally used together in the provision of a single health care facility or diagnostic, treatment, or rehabilitation center service.

(27) "General cancer hospital" means an institution which was an existing and approved destination cancer hospital as of January 1, 2019; has obtained final Certificate of Need approval for conversion from a destination cancer hospital to a general cancer hospital in accordance with O.C.G.A. § 31-6-40.3 ; and offers inpatient and outpatient diagnostic, therapeutic, treatments, and rehabilitative cancer care service or other services to diagnose or treat co-morbid medical conditions or diseases of cancer patients so long as such services do not result in the offering of any new or expanded clinical health service that would require a Certificate of Need under this chapter unless a Certificate of Need or letter of determination has been obtained for such new or expanded services.

(28) "Health care facility", as defined at O.C.G.A. § 31-6-2(17) , means hospitals; destination cancer hospitals; other special care units, including but not limited to podiatric facilities; skilled nursing facilities; intermediate care facilities; personal care homes; ambulatory surgical or obstetrical facilities; freestanding emergency departments or facilities not located on a hospital's primary campus; health maintenance organizations; home health agencies; diagnostic, treatment, or rehabilitation centers, but only to the extent that O.C.G.A. § 31-6-40(a)(3) or (7) or both are applicable thereto.

(29) "Health maintenance organization", as defined at O.C.G.A. § 31-6-2(18) , means a public or private organization organized under the laws of this state which:

(a) provides or otherwise makes available to enrolled participants health care services, including at least the following basic health care services: usual physicians' services, hospitalization, laboratory, X-ray, emergency and preventive services, and out-of-area coverage;

(b) is compensated, except for co-payments, for the provision of the basic health care services listed in subparagraph (a) of this paragraph to enrolled participants on a predetermined periodic rate basis; and

directly through physicians who are either employees or partners of such organization; or
through arrangements with individual physicians organized on a group practice or individual practice basis.

(30) "Home health agency", as defined at O.C.G.A. § 31-6-2(20) , means a public agency or private organization, or a subdivision of such an agency or organization, which is primarily engaged in providing to individuals who are under a written plan of care of a physician, on a visiting basis in the places of residence used as such individuals' homes, part-time or intermittent nursing care provided by or under the supervision of a registered professional nurse, and one or more of the following services:

(a) physical therapy;

(b) occupational therapy;

(d) medical social services under the direction of a physician; or

(e) part-time or intermittent services of a home health aide.

(31) "Hospital", as defined at O.C.G.A. § 31-6-2(21) , means an institution which is primarily engaged in providing to inpatients, by or under the supervision of physicians, diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons or rehabilitation services for the rehabilitation of injured, disabled, or sick persons. Such term includes public, private, psychiatric, rehabilitative, geriatric, osteopathic, micro-hospitals, general cancer hospitals, and other specialty hospitals.

(32) "Incur a financial obligation", in relation to the offering of a new institutional health service, means that, within time periods described in Ga. Comp. R. & Regs., r. 111-2-2-.02(5) and (6) of these Rules, the applicant has fulfilled the following performance requirements.

(a) With regard to new construction or renovation:

has acquired title, an option to purchase or a leasehold to an appropriate site;
has filed with the Department the complete set of plans, drawings, and specifications for the project in the electronic format designated by the Department;
has obtained a firm commitment for adequate capital financing; and
has entered into a construction contract that provides for a specific date for commencement, and completion of construction within a reasonable time span.

(b) With regard to equipment not associated with a construction project, a purchase or lease agreement has been entered into or, if acquired by a comparable arrangement, the applicant has possession of the equipment.

(33) Reserved.

(34) "Intermediate care facility", as defined at O.C.G.A. § 31-6-2(22) , means an institution which provides, on a regular basis, health related care and services to individuals who do not require the degree of care and treatment which a hospital or skilled nursing facility is designed to provide but who, because of their mental or physical condition, require health related care and services beyond the provision of room and board.

(35) "Joined applications" means two or more applications which involve similar projects in the same service area or overlapping service areas all of which have been declared complete by the twenty-fifth (25th) calendar day of the review cycle of the first application, and whose time limits are scheduled to run from the latest date that any one of the joined applications was received.

(36) "Joint venture ambulatory surgical center" means a freestanding ambulatory surgical center that is jointly owned by a hospital in the same county as the center or a hospital in a contiguous county if there is no hospital in the same county as the center and a single group of physicians practicing in the center and that provides surgery in a single specialty as defined by the Department. Such ambulatory surgical center shall only be utilized by physicians who are of the same single specialty, who may include physicians who are not owners or employees of the single group practice of physicians that own and operate the center; provided, however, that general surgery, a group practice which includes one or more physiatrists who perform services that are reasonably related to the surgical procedures performed in the center, and a group practice in orthopedics which includes hand surgeons with a certificate of added qualifications in Surgery of the Hand from the American Board of Plastic and Reconstructive Surgery shall be considered a single specialty. The ownership interest of the hospital shall be no less than thirty percent (30%) and the collective ownership of the physicians or group of physicians shall be no less than thirty percent (30%). Nothing in this paragraph shall prohibit the owners of the center from entering into an arrangement with an outside entity for practice management, administrative services, or both.

(37) "Life plan community" means an organization, whether operated for profit or not, whose owner or operator undertakes to provide shelter, food, and either nursing care or personal services, whether such nursing care or personal services are provided in the facility or in another setting, and other services, as designated by agreement, to an individual not related by consanguinity or affinity to such owner or operator providing such care pursuant to an agreement for a fixed or variable fee, or for any other remuneration of any type, whether fixed or variable, for the period of care, payable in a lump sum, lump sum and monthly maintenance charges or in installments. Agreements to provide continuing care include agreements to provide care for any duration, including agreements that are terminable by either party.

(38) "Medical use rights" means rights or interests in real property in which the owner of the property has agreed not to sell or lease such real property for identified medical uses or purposes.

(a) It shall be unlawful for any health care facility to purchase, renew, extend, lease, maintain, or hold medical use rights.

(39) "Micro-hospital" means a hospital in a rural county which has at least two and not more than seven inpatient beds and which provides emergency services seven days per week and 24 hours per day.

(40) "Mobile unit" means an object with the ability by structure, function or design to move or be moved from one site to another, such that upon arriving at a site the object is not permanently fixed but is temporarily secured for the purpose of providing a service to individuals.

(41) "New and emerging health care service" means a health care service or utilization of medical equipment which has been developed and has become acceptable or available for implementation or use but which has not yet been addressed under the Rules and regulations promulgated, adopted and included within and hereto.

(42) "New institutional health service", as defined at O.C.G.A. § 31-6-40(a) means:

(a) the construction, development, or other establishment of a new, expanded, or relocated health care facility, except as otherwise provided in O.C.G.A. § 31-6-47 ;

(b) Reserved.

(c) any increase in the bed capacity of a health care facility, regardless of whether a capital expenditure is made, which increases the total bed capacity. An exception to this Rule will be made in accordance with Ga. Comp. R. & Regs., r. 111-2-2-.03(14) ;

(d) clinical health services that are offered in or through a health care facility, which were not offered on a regular basis in or through such health care facility within the twelve (12) month period prior to the time such services would be offered;

(e) any conversion or upgrading of any general acute care hospital to a specialty hospital or of a facility such that it is converted from a type of facility not covered by these Rules to any of the types of health care facilities which are covered by these Rules;

(f) the purchase or lease by or on behalf of a health care facility of diagnostic or therapeutic equipment except as otherwise provided in O.C.G.A. § 31-6-47 and Ga. Comp. R. & Regs., r. 111-2-2-.03 and Ga. Comp. R. & Regs., r. 111-2-2-.10 ;

(g) clinical health services which are offered in or through a diagnostic, treatment, or rehabilitation center which were not offered on a regular basis in or through that center within the twelve (12) month period to the time such services would be offered, but only if the clinical health services are any of the following:

Radiation therapy;
Biliary lithotripsy;
Surgery in an operating room environment, including but not limited to ambulatory surgery; and
Cardiac catheterization.

(h) The conversion of a destination cancer hospital to a general cancer hospital.

(43) "Nonclinical health services", as defined at O.C.G.A. § 31-6-2(25) , means services or functions provided or performed by a health care facility, and the parts of the physical plant where they are located in a health care facility that are not diagnostic, therapeutic, or rehabilitative services to patients and are not clinical health services as defined in this chapter.

(44) "Offer", as defined at O.C.G.A. § 31-6-2(26) , means that the health care facility is open for the acceptance of patients or performance of services and has qualified personnel, equipment, and supplies necessary to provide specified clinical health services.

(45) "Operating room environment", as defined at O.C.G.A. § 31-6-2(27) , means an environment which meets the minimum physical plant and operational standards specified in the applicable administrative rules of the state which shall consider and use the design and construction specifications as set forth in the Guidelines for Design and Construction of Health Care Facilities published by the American Institute of Architects.

(46) "Pediatric cardiac catheterization" means the performance of angiographic, physiologic, and as appropriate, therapeutic cardiac catheterization on children fourteen (14) years of age or younger.

(47) "Person", as defined at O.C.G.A. § 31-6-2(29) , means any individual, trust, or estate, partnership, limited liability company or partnership, corporation (including associations, joint-stock companies and insurance companies), state, political subdivision, hospital authority, or instrumentality (including a municipal corporation) of a state as defined in the laws of this State. This term shall include all related parties, including individuals, business corporations, general partnerships, limited partnerships, limited liability companies, limited liability partnerships, joint ventures, nonprofit corporations, or any other for profit or not for profit entity that owns or controls, is owned or controlled by, or operates under common ownership or control with a person.

(48) "Personal Care Home", as defined at O.C.G.A. § 31-6-2(30) , means a residential facility that is certified as a provider of medical assistance for Medicaid purposes pursuant to Article 7 of Chapter 4 of Title 49 having at least twenty-five (25) beds and providing, for compensation, protective care and oversight of ambulatory, non-related persons who need a monitored environment but who do not have injuries or disabilities which require chronic or convalescent care, including medical, nursing, or intermediate care. Personal care homes including those facilities which monitor daily residents' functioning and location, have the capability for crisis intervention, and provide supervision in areas of nutrition, medication, and provision of transient medical care. Such term does not include:

(a) Old age residences which are devoted to independent living units with kitchen facilities in which residents have the option of preparing and serving some or all of their own meals; or

(b) Boarding facilities that do not provide personal care.

(49) "Primary campus" means the building at which the majority of a hospital's or a remote location of a hospital's licensed and operational inpatient hospital beds are located and includes the healthcare facilities of such hospital within 1,000 yards of such building. Any health care facility operated under a hospital's license prior to July 1, 2019, but not on the hospital's primary campus shall remain part of such hospital but shall not constitute such hospital's primary campus unless otherwise meeting the requirements of this paragraph.

(50) "Project", as defined at O.C.G.A. § 31-6-2(31) , means a proposal to take an action for which Certificate of Need review is required under these Rules. A project or proposed project may refer to the proposal from its earliest planning stages up through the point at which the new institutional health service is offered. In accordance with the definition of "associated with and simultaneously developed or proposed", the Department shall consider simultaneous activities, including, but not limited to, construction, remodeling, development, and acquisitions, unless expressly not included by other provisions of these Rules, which are determined by the Department to be associated with one another, to be a single project.

(51) "Remote location of a hospital" means a hospital facility or organization that is either created by, or acquired by, a hospital that is the main provider for the purpose of furnishing inpatient hospital services under the name, ownership, and financial and administrative control of the main provider.

(52) "Rural county" means a county having a population of less than 50,000 according to the United States decennial census of 2010 or any future such census.

(53) "Service-specific Rule" means those rules that are part of Ga. Comp. R. & Regs., r. 111-2-2 that regard specific clinical health care services as outlined at Ga. Comp. R. & Regs., r. 111-2-2-.20 et seq.

(54) "Single specialty ambulatory surgical center" means an ambulatory surgical center where surgery is performed in the offices of an individual private physician or single group practice of private physicians if such surgery is performed in a facility that is owned and operated by the individual private physician or single group practice of private physicians who are also of a single specialty; such ambulatory surgical center shall only be utilized by physicians who are of the same single specialty, who may include physicians who are not owners or employees of the individual private physician or single group practice of private physicians that own and operate the center; provided, however, that general surgery, a group practice which includes one or more physiatrists who perform services that are reasonably related to the surgical procedures performed in the center, and a group practice in orthopedics which includes plastic hand surgeons with a certificate of added qualifications in Surgery of the Hand from the American Board of Plastic and Reconstructive Surgery shall be considered a single specialty. Nothing in this paragraph shall prohibit an individual private physician or a single group practice of private physicians from entering into an arrangement with an outside entity for practice management, administrative services, or both.

(55) "Skilled nursing facility", as defined at O.C.G.A. § 31-6-2(34) , means a public or private institution or a distinct part of an institution which is primarily engaged in providing inpatient skilled nursing care and related services for patients who require medical or nursing care or rehabilitation services for the rehabilitation of injured, disabled, or sick persons.

(56) "Specialty hospital" means a hospital that is primarily or exclusively engaged in the care and treatment of one of the following: patients with a cardiac condition, patients with an orthopedic condition, patients receiving a surgical procedure, or patients receiving any other specialized category of services defined elsewhere in these Rules. A "specialty hospital" does not include a destination cancer hospital or a general cancer hospital.

(57) "State health plan", as defined at O.C.G.A. § 31-6-2(36) , means a comprehensive program based on recommendations by the Health Strategies Council and the board, approved by the Governor, and implemented by the State of Georgia for the purpose of providing adequate health care services and facilities throughout the State. The State Health Plan is divided into a series of component plans. The Department shall review and update the state health plan at least every five years beginning no later than January 1, 2025, to ensure the plan meets the evolving needs of the state.

(58) "Substantial equivalent of a project" means a proposal to take an action for which a letter of determination is sought under these Rules. A substantial equivalent of a project may refer to the proposal from its earliest planning stages up through the point at which the service is offered. In accordance with the definition of "associated with and simultaneously developed or proposed", the Department shall consider simultaneous activities, including, but not limited to, construction, remodeling, development, and acquisitions, unless expressly not included by other provisions of these Rules, which are determined by the Department to be associated with one another, to be a single substantial equivalent of a project.

(59) "Threshold" means the dollar amount of capital expenditures.

(a) In calculating the dollar amounts of a proposed project for purposes of 111-2-2-.01(54) and (36) of these Rules, the capital costs of all items subject to review by these Rules and items not subject to review by these Rules associated with and simultaneously developed or proposed with the project shall be counted;

(b) The following threshold amounts are effective as of July 1, 2024:

Reserved;
Reserved ;
The physician-owned, single-specialty, office-based ambulatory surgery center threshold of Ga. Comp. R. & Regs., r. 111-2-2-.01(54) is $2.5 million;
The joint venture ambulatory surgical center threshold of Ga. Comp. R. & Regs., r. 111-2-2-.01(36) is $5 million;

(i) With respect to (b)3. and 4. above, beginning on July 1, 2009, the Department shall update or adjust this CON threshold amount by the annual percentage of change in an appropriate composite price index that, in the judgment of the Department, represents national construction prices for the preceding calendar year such as those published by the Department of Commerce of the United States government or other government agency;

(ii) Diagnostic or other imaging services that are not offered in a hospital or in the offices of an individual private physician or single group practice of physicians exclusively for use on patients of that physician or group practice shall be deemed to be a new institutional health service regardless of the cost of the equipment except as provided in O.C.G.A. § 31-6-47 and Ga. Comp. R. & Regs. 111-2-2-.03 and exclusive of the expenditure or commitment of or incurring an obligation for the expenditure of funds to develop Certificate of Need applications, studies, reports, schematics, preliminary plans and specifications or working drawings, or to acquire sites.

(c) For purposes of computing the capital expenditure threshold of the physician-owned, single specialty ambulatory surgical center threshold of Ga. Comp. R. & Regs., r. 111-2-2-.03(21) and the joint venture ambulatory surgical center threshold of Ga. Comp. R. & Regs., r. 111-2-2-.03(22) , the Department shall include, but not be limited to, the following guidelines:

Pursuant to the definition of "associated with and simultaneously developed or proposed", the total cost of all associated capital expenditures for items to be obligated for or purchased within a six (6) month period for a single program, service, plan, or project, regardless of whether or not the cost of any individual item is in excess of the capital expenditure threshold and regardless of whether or not the expenditure or item is otherwise reviewable under these Rules or the CON Statute, is included in the computation;
The cost of depreciable equipment that is not used for diagnosis or treatment, such as office equipment, usual business equipment, and office and waiting room furniture, is included in the computation, if such items are associated with and simultaneously developed or proposed with the project. If such furnishing and equipment are used, the cost that shall be used in calculating the threshold shall be the depreciated value or current market value of the furnishings or equipment, whichever is greater;
The cost of normal inventories of supplies, such as glassware, chemicals, drugs, linens, and paper, is exempt from the computation as an operating expense;
The value of the facilities to be acquired by lease, gift, donation or other means is based on a current (within six (6) months) appraisal of the facility, except that the value of newly constructed facilities shall be based on the actual square footage cost to construct the facility;
For facilities that are acquired by lease, the computation of value shall be based on the rentable square footage of the facility and not the useable square footage. Notwithstanding this Rule, lease payments shall be considered to be operating expenses for leases other than capital leases;
For facilities that are only partly occupied by a person, the computation shall include a pro-rata share of the value of the common space, unless the rentable square footage is provided as required by 5. above and that rentable square footage already includes an allocation for common space, as documented by the lease agreement; and
In the case of a gift or donation, the value of equipment, furnishings or facilities is the fair market value of the equipment, furnishings, or facilities;

(d) For purposes of computing the equipment threshold Ga. Comp. R. & Regs., r. 111-2-2-.01(42)(f) , the Department shall include, but not be limited to, the following guidelines:

The cost of diagnostic, therapeutic, or other imaging equipment includes all capital costs, expenditures, charges, fees and assessments which are reasonably necessary to put the equipment into use for the purposes for which the equipment was intended, including but not limited to the following expenses:

(i) Any expense incurred for the purchase of a warranty on the diagnostic, therapeutic, or other imaging equipment from the manufacturer or vendor for the first five years of operation;

(ii) Any expense incurred for operator training;

(iii) Any expense incurred for installation and assembly of the equipment;

(iv) Any expense incurred for transportation and insurance costs pertaining to the purchase and/or delivery of the equipment;

(v) Any expense incurred for functionally related diagnostic, therapeutic or other imaging equipment, such as, but not limited to, water chillers, surge protectors, laser cameras, computer workstations, etc.

(vi) Any expense incurred for any options, extra packages, or accessories to be used in the operation of the equipment;

(vii) Any expense incurred for RF shielding, lead shielding, magnetic shielding necessary to protect patients or staff in the operation of the equipment;

(viii) Any dollar amount attributable to service contracts for the first five (5) years of operation;

(ix) Any dollar amount attributable to volume or bulk purchase discounts given to the party requesting a letter of determination by the manufacturer or vendor of the equipment;

(x) For mobile units of equipment, expenditures and values associated with the motor coach, trailer, van, rig, or other form of modular or transitional housing shall be included in the computation of the threshold;

The acquisition by whatever means of one or more items of functionally related diagnostic, therapeutic, other imaging equipment shall be considered as one project. The acquisition of functionally related accessories shall also be counted. Pursuant to the definition of "functionally related diagnostic, therapeutic, or other imaging equipment", any individual components or pieces of diagnostic, therapeutic, or other imaging equipment, which depend on one another in order to function and that are purchased within a six (6) month period, shall be considered in the aggregate in calculating the threshold;
Diagnostic, therapeutic, or other imaging equipment shall include single and multiple units of equipment, if such units are associated with and simultaneously developed or proposed with one another. Pursuant to the definition of "associated with and simultaneously developed or proposed", the Department may determine that individual pieces or units of diagnostic, therapeutic, or other imaging equipment are associated with one another if such pieces or units of equipment are used for the same or similar health services and if such pieces or units of equipment are developed, proposed, or acquired simultaneously. Such associated and simultaneous units purchased within a six (6) month period shall be aggregated to calculate the threshold;
Purchase or lease shall include purchases, contracts, encumbrances of funds, lease arrangements, conditional sales or comparable arrangements that purport to be a transfer of ownership in whole or in part;
In the case of a lease, loan, or gift, the value of the diagnostic, therapeutic, or other imaging equipment is the fair market value of the diagnostic, therapeutic, or other imaging equipment, as evidenced by documentation from a reputable vendor or manufacturer.

(60) "Uncompensated indigent or charity care" means the dollar amount of "net uncompensated indigent or charity care after direct and indirect (all) compensation" as defined by, and calculated in accordance with, the Department's Hospital Financial Survey and related instructions.

(61) "Urban county" means a county having a population equal to or greater than 50,000 according to the United States decennial census of 2010 or any future such census.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Definitions" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Oct. 19, 2018; eff. Nov. 8, 2018.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.01, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.02 Nature of Certificate of Need {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.02}

(1) Purpose . The purpose of the Certificate of Need evaluation process is to ensure that adequate health care services and facilities are developed in an orderly and economical manner and are made available to all Georgians and that only those health care services that are found to be in the public interest shall be provided in the State. The goals are to:

(a) Review proposed health care services;

(b) Contain health costs;

(d) Ensure compatibility of health care services with the needs of various areas and populations of Georgia; and

(e) Prevent unnecessary duplication or services.

(1.1) Any new institutional health service shall be required to obtain a Certificate of Need pursuant to O.C.G.A.§ 31-6 and Ga. Comp. R. & Regs., r. 111-2-2.

(2) Contents. The certificate, or attachments, shall specify, but not be limited to:

(a) the scope of the project;

(b) the defined location of the project;

(d) the maximum capital expenditure, if any, which may be obligated under the certificate;

(e) the service area of the project;

(f) the valid dates;

(g) the schedule of time periods to be followed in making the service or equipment available or in completing the project;

(h) the services or units of services, which have been approved; and

(i) when the progress reporting requirements under Ga. Comp. R. & Regs., r. 111-2-2-.04(2) and Ga. Comp. R. & Regs., r. 111-2-2-.02(5) are due.

(3) Validity. A Certificate of Need shall be valid only for the defined scope, physical location, cost, service area, and person named in the application as the applicant.

(4) Non-transferability. A Certificate of Need shall not be transferable or assignable, nor shall a project for which a Certificate of Need has been issued be transferred from or assigned by one person to another, except under the following circumstances:

(a) the death of the holder of the Certificate, provided the transfer is solely from the estate of the holder to his or her heirs; or

(b) an existing licensed health care facility to which a Certificate has been issued is acquired by another person, in which instance the Certificate shall be valid for the person who acquires the facility and for the scope, location, cost, and service area previously approved by the Department.

(5) Effective Period. Unless otherwise provided by a service-specific rule, or unless the Department in accordance with Ga. Comp. R. & Regs., r. 111-2-2-.02(7) has extended the effective period, the effective period of a Certificate of Need shall be as follows:

(a) Certificates involving neither construction nor equipment acquisition shall be effective for twelve (12) months;

(b) Certificates solely involving acquisition of equipment shall be effective for twelve (12) months, by which date the applicant must be in possession of the equipment; and

(c) Certificates for projects involving construction shall be effective based on a reasonable, phased timetable presented in the application, which may be amended during the review cycle, as planned, developed, proposed, and submitted by the applicant. In determining the reasonableness of the proposed phases and time periods, the Department will be guided by the applicable horizon year for the project. However, in appropriate circumstances, the Department may approve an effective period in excess of the applicable horizon year. The approved and valid phases and effective period shall be included in the Certificate of Need. When the Department extends the effective period pursuant to Ga. Comp. R. & Regs., r.111-2-2-.02(7) or when, due to an appeal of a project, a project's effective date is not the approved date, the Department will update the effective period, including the horizon year, of the project accordingly.

(6) Initial 12-month Implementation Period for Projects Involving Construction. Unless otherwise provided in a service-specific rule or unless the Department in accordance with Ga. Comp. R. & Regs., r. 111-2-2-.02(7) has extended the initial 12-month implementation period, all projects involving construction regardless of the dollar amount must, within twelve (12) months of the effective date of the certificate, demonstrate, as evidenced by a progress report (as described at Ga. Comp. R. & Regs., r. 111-2-2-.04(2) and supporting documentation, substantial performance in beginning the project. Substantial performance shall be demonstrated by the following:

(a) The construction plans have been approved by the Department's Architect;

(b) The construction contract has been signed and specifically indicates beginning and completion dates; and

(7) Extension of Time Periods. The Department may, upon written request of the certificate holder, grant an extension of the effective period of a Certificate of Need or of the initial 12-month implementation period if the applicant's request is received by the Department 30 days prior to expiration of the Certificate of Need or of the initial 12-month implementation period, as applicable.

(a) A request for an extension of the initial 12-month implementation period, or any extension thereof, shall demonstrate:

that failure to perform as required is caused by circumstances beyond the control of the certificate holder. Occurrences that may justify an extension of the initial 12-month implementation period may include, without limitation, fire, flood, explosion, catastrophic weather conditions, riots or other civil disturbances, work stoppages or strikes, zoning or permitting changes, and similar occurrences. Ordinarily, lack of adequate or accurate planning, uncertainty as to reimbursement and/or financial difficulties will not justify an extension of the implementation period;
that the certificate holder has made substantial and timely progress in implementing the project. In order to show substantial and timely progress in implementing the project, the certificate holder must show that the project was on schedule and could reasonably have been implemented during the initial 12-month implementation period or extension thereof, but for the occurrence or circumstance beyond the certificate holder's control;

(b) A request for an extension of the effective period of a Certificate of Need, or any phase or extension thereof, shall:

demonstrate that failure to perform as required is caused by circumstances beyond the control of the certificate holder. Occurrences that may justify an extension of the effective period, or any phase or extension thereof, may include, without limitation, fire, flood, explosion, catastrophic weather conditions, riots or other civil disturbances, work stoppages or strikes, zoning or permitting changes, and similar occurrences.
demonstrate that but for the circumstance beyond the control of the certificate holder, the project, or phase thereof, would have been completed within the effective period;
demonstrate that the certificate holder has made substantial and timely progress in completing the project, or phase thereof;
indicate the expected completion date of the project, or phase thereof, as applicable; and
affirm that the project, or phase thereof, will be completed within the requested extension period.

(c) The length of an extension of the effective period or of the initial 12-month implementation period of a Certificate of Need shall be determined by the Department and shall be reasonable and consistent with the circumstances. In no case, shall the Department extend the initial 12-month implementation period of a Certificate of Need beyond an additional 12 months.

(d) In circumstances where the certificate holder is precluded from normal progression due to litigation involving the Certificate or where the method of financing is precluded by litigation, the Department may, at its discretion, suspend any or all of the time periods specified herein until the litigation has been resolved.

(8) Expiration and Cancellation . If, within the effective period specified in Ga. Comp. R. & Regs., r. 111-2-2-.02(5) and initial 12-month implementation period specified in Ga. Comp. R. & Regs., r. 111-2-2-.02(6) , as applicable, the required performance standards are not met, the Certificate will be deemed to have expired unless an extension has been obtained from the Department pursuant to Ga. Comp. R. & Regs., r. 111-2-2-.02(7) . Unless the certificate holder demonstrated good cause not to deem the Certificate to have expired, which shall be determined by the Department, the Certificate will be canceled and notifications of same issued to the applicant, local governing authorities, Regional Development Center, and a newspaper of general circulation in the area where the application originated. An applicant whose Certificate has expired may not resubmit an application for the same or a substantially similar project until at least 120 days after expiration of the Certificate.

(9) Modification by Operation of Law of Certificate for Failure to Complete . Upon expiration of the effective period, if a certificate holder has not completed all activities or has not implemented all services or units of services granted in the Certificate of Need issued on the approved date (or if appealed, the effective date), the Certificate shall be modified upon such expiration to include and be valid for only those activities, services, or units of services, which have been completed and implemented as of the date of expiration.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Nature of Certificate of Need" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.02, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.03 Exemptions from Review {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.03}

The following shall not be subject to Certificate of Need review and shall be exempted from the provisions of these Rules regarding Certificate of Need Review except as otherwise provided:

(1) infirmaries operated by educational institutions for the sole and exclusive benefit of students, faculty members, officers, or employees thereof;

(2) infirmaries or facilities operated by businesses for the sole and exclusive benefit of officers or employees thereof, provided that such infirmaries or facilities make no provision for overnight stay by persons receiving their services;

(3) institutions operated exclusively by the federal government or by any of its agencies;

(4) offices of private physicians or dentists, as determined in the sole discretion of the Department, whether for individual or group practice except as otherwise provided in Ga. Comp. R. & Regs., r. 111-2-2-.01(54) and Ga. Comp. R. & Regs., r. 111-2-2-.01(42)(f) . Simple ownership of a facility by a practitioner or a group of practitioners of the healing arts does not, in and of itself, exempt such facility from the scope of these Rules. Seeking licensure of a place, building, or facility as a health care institution is inconsistent with an assertion that such place, building, or facility is being occupied exclusively as the office of private physicians or dentists. Therefore, any person who seeks licensure as a health care facility must secure a Certificate of Need if a new institutional health service is being offered or developed;

(5) Religious, nonmedical health care institutions as defined in 42 U.S.C. Section 1395x(ss)(1) , listed and certified by a national accrediting organization;

(6) site acquisitions for health care facilities or preparation or development costs for such sites prior to filing a Certificate of Need application;

(7) expenditures related to adequate preparation and development of an application for a Certificate of Need;

(8) the commitment of funds conditioned upon the obtaining of a Certificate of Need;

(9) transfers from one health care facility to another such facility of major medical equipment previously approved under or exempted from Certificate of Need review, except where such transfer results in the institution of a new clinical health service for which a Certificate of Need is required in the facility acquiring said equipment, provided that such transfers are recorded at net book value of the medical equipment as recorded on the books of the transferring facility;

(10) expenditures for the restructuring or acquisition of existing health care facilities by stock or asset purchase, merger, consolidation, or other lawful means;

(11) the purchase of a closing hospital or of a hospital that has been closed for no more than twelve (12) months by a hospital in a contiguous county to repurpose the facility as a micro-hospital;

(12) capital expenditures otherwise covered by this Chapter required solely to eliminate or prevent safety hazards as defined by federal, state or local fire, building, environmental occupational health, or life safety codes of regulations, to comply with licensing requirements of the Healthcare Facility Regulation Division, or to comply with accreditation standards of the Joint Commission or another nationally recognized health care accreditation body;

(13) all cost overruns are excluded from prior Certificate of Need review and approval;

(14) increases in the bed capacity of a hospital up to ten beds or twenty percent (20%) of capacity, whichever is greater, in any consecutive three-year period, in a hospital that has maintained an overall occupancy rate greater than sixty percent (60%) (exclusive of any skilled nursing units or comprehensive inpatient rehabilitation units) for the previous twelve (12) month period;

(15) The acquisition, replacement, or repair of diagnostic therapeutic, or other imaging equipment by any health care facility in existence prior to July 1, 2024, that is not owned by a group practice of physicians or a hospital and that provides diagnostic imaging services so long as it does not result in the offering of any new clinical health services;

(16) An expenditure for the minor or major repair of a health care facility or a facility that is exempt from the requirements of these Rules, parts thereof or services provided therein;

(17) new institutional health services offered by or on behalf of a Health Maintenance Organization, or a health facility controlled, directly or indirectly, by a Health Maintenance Organization or a combination of Health Maintenance Organizations, provided specific and detailed documentation is provided to the Department that one of the following conditions are met:

(a) that seventy-five percent (75%) of the patients who can reasonably be expected to use the service will be individuals enrolled in a Health Maintenance Organization certified by the State of Georgia;

(b) that the service is needed by the Health Maintenance Organization in order to operate efficiently and economically and that it is not otherwise readily accessible to the Health Maintenance Organization because:

existing similar services are not available under a contract of reasonable duration;
full and equal staff privileges are not available in existing facilities; or
arrangements with existing facilities are not administratively feasible;

(18) capital expenditures for a project otherwise requiring a Certificate of Need if those expenditures are for a project to remodel, renovate, replace, or any combination thereof, a medical-surgical hospital and all the following conditions are met:

(a) the hospital has a bed capacity of not more than fifty (50) beds;

(b) the hospital is located in a county in which no other medical-surgical hospital is located;

(d) the hospital has at least forty-five percent (45%) of its patient revenues derived from Medicare, Medicaid, or any combination thereof, for the immediately preceding three years;

(e) the project has at least eighty percent (80%) of its capital expenditures financed by proceeds of a special purpose county sales and use tax imposed pursuant to Article 3 of Chapter 8 of Title 48;

(f) the proposed replacement hospital is located within a five (5)-mile radius of and within the same county as the hospital's existing facility; and

(g) the project does not result in any of the following:

the offering of any new clinical health services;
any increase in bed capacity;
any redistribution of existing beds among existing clinical health services; and
any increase in the capacity of existing clinical health services;

(19) Expenditures for nonclinical projects, including parking lots, parking decks, and other parking facilities; computer systems, software, and other information technology; medical office buildings; administrative office space; conference rooms; education facilities; lobbies; common spaces; clinical staff lounges and sleep areas; waiting rooms; bathrooms; cafeterias; hallways; engineering facilities; mechanical systems; roofs; grounds; signage; family meeting or lounge areas; other nonclinical physical plant renovations or upgrades that do not result in new or expanded clinical health services; and state mental health facilities;

(20) Life plan communities, provided that the skilled nursing component of the facility is for the exclusive use of residents of the life plan community and that a written exemption is obtained from the Department; provided, however, that new sheltered nursing home beds may be used on a limited basis by persons who are not residents of the life plan community for a period up to five years after the date of issuance of the initial nursing home license, but such beds shall not be eligible for Medicaid reimbursement. For the first year, the life plan community sheltered nursing facility may utilize not more than fifty percent (50%) of its licensed beds for patients who are not residents of the life plan community. In the second year of operation, the life plan community shall allow not more than forty percent (40%) of its licensed beds for new patients who are not residents of the life plan community. In the third year of operation, the life plan community shall allow not more than thirty percent (30%) of its licensed beds for new patients who are not residents of the life plan community. In the fourth year of operation, the life plan community shall allow not more than twenty percent (20%) of its licensed beds for new patients who are not residents of the life plan community. In the fifth year of operation, the life plan community shall allow not more than ten percent (10%) of its licensed beds for new patients who are not residents of the life plan community. At no time during the first five (5) years shall the life plan community sheltered nursing facility occupy more than fifty percent (50%) of its licensed beds with patients who are not residents under contract with the life plan community. At the end of the five (5) year period, the life plan community sheltered nursing facility shall be utilized exclusively by residents of the life plan community and at no time shall a resident of a life plan community be denied access to the sheltered nursing facility. At no time shall any existing patient be forced to leave the life plan community to comply with this paragraph. The Department is authorized to promulgate rules and regulations regarding the use and definition of the term "sheltered nursing facility" in a manner consistent with Code section. Agreements to provide continuing care include agreements to provide care for any duration, including agreements that are terminable by either party;

(21) Any single specialty ambulatory surgical center that:

(a)

Has capital expenditures associated with the construction, development, or other establishment of the clinical health services which do not exceed $2.5 million; or
Is the only single specialty ambulatory surgical center in the county owned by the group practice and has two (2) or fewer operating rooms; provided, however, that a center exempt pursuant to this paragraph shall be required to obtain a Certificate of Need in order to add any additional operating rooms;

(b) Has a hospital affiliation agreement with a hospital within a reasonable distance from the facility or the medical staff at the center has admitting privileges or other acceptable documented arrangements with such hospital to ensure the necessary backup for the center for medical complications. The center shall have the capability to transfer a patient immediately to a hospital within a reasonable distance from the facility with adequate emergency room services. Hospitals shall not unreasonably deny a transfer agreement or affiliation agreement to the center;

(c)

Provides care to Medicaid beneficiaries and, if the facility provides medical care and treatment to children, to PeachCare for Kids® beneficiaries and provides uncompensated indigent and charity care in an amount equal to or greater than two percent (2%) of its adjusted gross revenue, and on or after January 1, 2026, in an amount equal to or greater than the minimum amount established by the Department shall be reviewed by the Department every 12 months; or
If the center is not a participant in Medicaid or the PeachCare for Kids® Program, provides uncompensated care to Medicaid beneficiaries and, if the facility provides medical care and treatment to children, to PeachCare for Kids® beneficiaries, uncompensated indigent and charity care, or both in an amount equal to or greater than four percent (4%) of its adjusted gross revenue, and on or after January 1, 2026, in an amount equal to or greater than the minimum amount established by the Department which shall be reviewed by the Department every 12 months; provided, however, single specialty ambulatory surgical centers owned by physicians in the practice of ophthalmology shall not be required to comply with this subparagraph; and

(d) Provides annual reports in the same manner and in accordance with O.C.G.A. § 31-6-70 . Noncompliance with any condition of this paragraph shall result in a monetary penalty in the amount of the difference between the services which the center is required to provide and the amount actually provided and may be subject to revocation of its exemption status by the Department for repeated failure to pay any fines or moneys due to the Department or for repeated failure to produce data as required by O.C.G.A. § 31-6-70 after notice to the exemption holder and a fair hearing pursuant to Chapter 13 of Title 50, the Georgia Administrative Procedure Act. The dollar amount specified in this paragraph shall be adjusted annually by an amount calculated by multiplying such dollar amount (as adjusted for the preceding year) by the annual percentage of change in the composite index of construction material prices, or its successor or appropriate replacement index, if any, published by the United States Department of Commerce for the preceding calendar year, commencing on July 1, 2009, and on each anniversary thereafter of publication of the index. In calculating the dollar amounts of a proposed project for purposes of this paragraph, the costs of all items subject to review by this chapter and items not subject to review by this chapter associated with an simultaneously developed or proposed with the project shall be counted, except for the expenditure or commitment of or incurring an obligation for the expenditure of funds to develop Certificate of Need applications, studies, reports, schematics, preliminary plans and specifications or working drawings, or to acquire sites;

(22) Any joint venture ambulatory surgical center that:

(a) Has capital expenditures associated with the construction, development, or other establishment of the clinical health service which do not exceed $5 million;

(b)

Provides care to Medicaid beneficiaries and, if the facility provides medical care and treatment to children, to PeachCare for Kids® beneficiaries and provides uncompensated indigent and charity care in an amount equal to or greater than two percent (2%) of its adjusted gross revenue, and on or after January 1, 2026, in the amount equal to or greater than the minimum amount established by the Department, which shall be reviewed by the Department every 12 months; or
If the center is not a participant in Medicaid or the PeachCare for Kids® Program, provides uncompensated care to Medicaid beneficiaries and, if the facility provides medical care and treatment to children, to PeachCare for Kids® beneficiaries, uncompensated indigent and charity care, or both in an amount equal to or greater than four percent (4%) of its adjusted gross revenue, and on and after January 1, 2026, in an amount equal to or greater than the minimum amount established by the Department which shall be reviewed by the Department every 12 months; and

(c) Provides annual reports in the same manner and in accordance with O.C.G.A. § 31-6-70 . Noncompliance with any condition of this paragraph shall result in a monetary penalty in the amount of the difference between the services which the center is required to provide and the amount actually provided and may be subject to revocation of its exemption status by the Department for repeated failure to pay any fines or moneys due to the Department or for repeated failure to produce data as required by O.C.G.A. § 31-6-70 after notice to the exemption holder and a fair hearing pursuant to Chapter 13 of Title 50, the Georgia Administrative Procedure Act. The dollar amount specified in this paragraph shall be adjusted annually by an amount calculated by multiplying such dollar amount (as adjusted for the preceding year) by the annual percentage of change in the composite index of construction material prices, or its successor or appropriate replacement index, if any, published by the United States Department of Commerce for the preceding calendar year, commencing on July 1, 2009, and on each anniversary thereafter of publication of the index. In calculating the dollar amounts of a proposed project for purposes of this paragraph, the costs of all items subject to review by this chapter and items not subject to review by this chapter associated with and simultaneously developed or proposed with the project shall be counted, except for the expenditure or commitment of or incurring an obligation for the expenditure of funds to develop Certificate of Need applications, studies, reports, schematics, preliminary plans and specifications or working drawings, or to acquire sites;

(23) Expansion of services by an imaging center based on a population needs methodology taking into consideration whether the population residing in the area served by the imaging center has a need for expanded services, as determined by the Department in accordance with its rules and regulations, if such imaging center:

(a) Was in existence and operational in this state on January 1, 2008;

(b) Is owned by a hospital or by a physician or a group of physicians comprising at least eighty percent (80%) ownership who are currently board certified in radiology;

(d) Accepts all patients regardless of ability to pay; and

(e) Provides uncompensated indigent and charity care in an amount equal to or greater than the amount of such care provided by the geographically closest general acute care hospital; provided, however, this paragraph shall not apply to an imaging center in a rural county;

(24) Diagnostic cardiac catheterization in a hospital setting on patients fifteen (15) years of age and older;

(25) Therapeutic cardiac catheterization in hospitals meeting the following criteria:

(a) A hospital that wishes to receive authorization to perform therapeutic cardiac catheterization procedures must:

submit a request for a letter of determination on the required form with the proper filing fee between May 1 and May 15 of each year, beginning with calendar year 2009; the sufficiency of the information submitted in the request shall be determined within the administrative discretion of the Department;
provide documentation which demonstrates it can perform a minimum of two hundred (200) percutaneous cardiac interventions (PCI) per year by the beginning of the third year of operation of a program, including both elective and primary PCI, with a minimum of thirty-six (36) primary PCI per year beginning the third year of operation;
provide documentation to support the criteria referenced in subsection 2 above that includes substantive information on the number of diagnostic cardiac catheterization procedures performed at the hospital, or referred to existing PCI providers by the hospital, in or out of the state of Georgia, in the two (2) calendar years immediately preceding the request;
provide documentation that it will have, prior to beginning a PCI program, on active medical staff, at least one (1) interventional cardiologist who will meet the American College of Cardiology (ACC) and American Heart Association (AHA) competency standards, including the performance of at least seventy-five (75) PCI procedures per year;
provide documentation that the interventional cardiologist is board certified, or is in the process at the time of the request, of obtaining board certification in Interventional Cardiology from the American Board of Internal Medicine;
provide documentation of access to at least one (1) other interventional cardiologist who meets the criteria of subsections 4. and 5. above, to participate in its program on an as-needed basis as determined by the hospital;
agree to report annually the data on number of PCI procedures, type, and outcomes to the National Cardiovascular Data Registry Cath/PCI registry;
provide documentation to show that one (1) or more interventional cardiologist(s), as qualified in subsections 4., 5. and 6. above, are available to perform primary PCI procedures twenty-four (24) hours a day, seven (7) days a week, three hundred sixty-five (365) days a year;
provide documentation one (1) or more interventional cardiologist(s) are required to respond to a call, within the calendar availability specified in subsection 8. above, within sixty (60) minutes;
provide documentation that competent and trained nursing and technical cardiac catheterization staff are available at all times and are required to respond in a manner determined by the hospital in conjunction with the interventional cardiologists;
provide documentation of a transfer agreement with a tertiary medical facility that has an open heart surgery service to which a patient can be transferred when necessary within a period of sixty (60) minutes, by any means of transportation as chosen by the hospital, from the time the need for transfer is identified;

(i) if the provider of an open heart surgery service within the travel time parameters of this subsection refuses to enter into a transfer agreement with the requesting hospital, the hospital may submit documentation on the reasons given for the denial, and the Department may consider these reasons;

(ii) the Department may allow a requesting hospital to submit a transfer agreement with a provider of an open heart surgery service that is beyond the travel time parameters in this subsection if the reasons given for the denial of a transfer agreement by the tertiary provider are determined by the Department to be unreasonable;

(iii) if the Department determines the reasons for the denial of a transfer agreement by the tertiary provider within the time travel parameters in this subsection are reasonable, the Department may require the requesting hospital to address the reasons for the denial and enter into further negotiations for a transfer agreement prior to receiving a favorable determination from the Department;

provide documentation of an agreement with an ambulance service capable of advanced life support and intra-aortic balloon pump services and that guarantees a thirty (30) minute or less response time;
agree to provide accurate and timely data, including outcomes analysis and formal periodic external and internal case review as required by the Department;
provide documentation to show that guidelines for determining patients appropriate for PCI procedures in a setting without on-site open heart backup consistent with C-PORT and ACC standards will be developed and maintained;
provide documentation to show the cardiac catheterization laboratory(s) at the requesting hospital is equipped Iin a manner consistent with C-PORT and ACC guidelines;
agree to participate in an elective and primary PCI Development Program at its expense, the successful completion of which will be verified by the Department through the use of an identified third-party; and
affirmatively agree authorization to begin a therapeutic cardiac catheterization program is expressly contingent upon successful completion of the development program as referenced in subsection 16. above.
no hospital shall unreasonably deny a transfer agreement with another hospital.

(b) Any hospital approved to perform therapeutic cardiac catheterization procedures as a result of a request submitted between May 1 and May 15 of any calendar year after the adoption of this rule, must, between May 1 and May 15, of each subsequent year, submit a request which documents its compliance with the standards of this Rule, and the Department must re-affirm the hospital's current compliance in writing in order for the hospital to continue its therapeutic cardiac catheterization program.

(c) Any administrative proceeding held pursuant to Ga. Comp. R. & Regs., r. 111-2-2-.10(6) , in opposition to a Department approval of a request from a hospital to perform therapeutic cardiac catheterization procedures in accordance with the standards established in this section, or in opposition to a Department decision to deny a hospital request to perform therapeutic cardiac catheterization procedures, shall not conduct a de novo review of the Department decision, and such decision shall only be reversed by an administrative hearing officer upon a showing the Department's action was without reason, arbitrary, or capricious;

(26) Infirmaries for facilities operated by, on behalf of, or under contract with the Department of Corrections or the Department of Juvenile Justice for the sole and exclusive purpose of providing health care services in a secure environment to prisoners within a penal institution, penitentiary, prison, detention center, or other secure correctional institution, including correctional institutions operated by private entities in this state which house inmates under the Department of Corrections or the Department of Juvenile Justice;

(27) The relocation of any skilled nursing facility, intermediate care facility, or micro-hospital within the same county, any other health care facility in a rural county within the same county, and any other health care facility in an urban county within a five-mile radius of the existing facility so long as the facility does not propose to offer any new or expanded clinical health services at the new location;

(28) Facilities which are devoted to the provision of treatment and rehabilitative care for periods continuing for twenty-four (24) hours or longer for persons who have traumatic brain injury, as defined in O.C.G.A. § 37-3-1 ;

(29) The renovation, remodeling, refurbishment, or upgrading of a health care facility, so long as the project does not result in any of the following:

(a) The offering of any new or expanded clinical health services;

(b) Any increase in inpatient bed capacity;

(30) The acquisition of diagnostic, therapeutic, or other imaging equipment, by or on behalf of:

(a) A hospital; or

(b) An individual private physician or single group practice of physicians exclusively for use on patients of such private physician or single group practice of physicians and such private physician or member of such single group practice of physicians is physically present at the practice location where the diagnostic or other imaging equipment is located at least seventy-five percent (75%) of the time that the equipment is in use.

(31) Any capital expenditures by a hospital at such hospital's primary campus for:

(a) The expansion or addition of the following clinical health services: operating rooms, other than dedicated outpatient operating rooms; medical-surgical services; gynecology; procedure rooms; intensive care; pharmaceutical services; pediatrics; cardiac care or other general hospital services; provided, however, that such expenditure does not include the expansion or addition of inpatient beds or the conversion of one type of inpatient bed to another type of inpatient bed; or

(b) The movement of clinical health services from one location on the hospital's primary campus to another location on such hospital's primary campus.

Pursuant to O.C.G.A. § 31-6-40(c)(1) , any person who had a valid exemption granted or approved by the former Health Planning Agency or the Department of Community Health prior to July 1, 2008, shall not be required to obtain a Certificate of Need in order to continue to offer those previously offered services.

(32) New or expanded psychiatric or substance abuse inpatient programs or state funded beds that serve Medicaid and uninsured patients that:

(a) Are open 365 days per year, seven days per week, and 24 hours per day;

(b) Provide uncompensated indigent and charity care in an amount equal to or greater than 3 percent of its adjusted gross revenue, and on and after January 1, 2026, in an amount equal to or greater than the minimum amount established by the department by rule which shall be at least 3 percent, and which shall be reviewed by the department every 12 months;

(d) Have hospital affiliation agreements with acute care hospitals within a reasonable distance from the programs or state funded beds or the medical staffs at the programs or state funded beds have admitting privileges or other acceptable documented arrangements with such hospitals to ensure the necessary backup for the programs or state funded beds for medical complications. The programs or state funded beds shall have the capability to transfer a patient immediately to a hospital within a reasonable distance from the programs or state funded beds with adequate emergency room services. Acute care hospitals shall not unreasonably deny a transfer agreement or affiliation agreement with the programs or state funded beds;

(e) Provide annual reports in the same manner as in accordance with Code Section 31-6-70 ; Noncompliance with any condition of this subsection shall result in a monetary penalty in the amount of the difference between the services which the exemption holder is required to provide and the amount actually provided and shall be subject to revocation of its exemption status by the Department for repeated failure to meet any one or more requirements for exemption, for repeated failure to pay any fines or moneys due to the Department, or for repeated failure to produce data as required by Code Section 31-6-70 after notice to the exemption holder and a fair hearing pursuant to Chapter 13 of Title 50, the "Georgia Administrative Procedure Act." "Expanded" means exceeding a health car facility's total approved inpatient bed capacity through the addition of beds to an existing CON-authorized or exempt or grandfathered freestanding psychiatric and/or substance abuse hospital.

(33) The offering of new or expanded basic perinatal services, as defined in Ga. Comp. R. & Regs., r. 111-2-2-.24(2)(a) , by a hospital in a rural county, as defined at Ga. Comp. R. & Regs. r. 111-2-2-.24(2)(k) provided that:

(a) Such services are available 365 days per year, seven days per week, and 24 hours per day;

(b) The hospital participates as a provider of medical assistance for Medicaid purposes;

(c) The hospital has a hospital affiliation agreement with an acute care hospital with at least Level III perinatal services, as defined in Ga. Comp. R. & Regs., r. 111-2-2-.24(2)(c) , within a reasonable distance from the hospital providing the perinatal services or the medical staff at the hospital providing the perinatal services has admitting privileges or other acceptable documented arrangements with such acute care hospital to ensure the necessary backup for the hospital providing the perinatal services for medical complications. The hospital providing the perinatal services shall have the capability to transfer a patient immediately to the acute care hospital within a reasonable distance from the hospital providing the perinatal services with adequate emergency room services. Acute care hospitals shall not unreasonably deny a transfer agreement or affiliation agreement with the hospital providing the perinatal services. This subparagraph shall not apply if the hospital providing the basic perinatal services is itself an acute care hospital with at least Level III perinatal services; and

(d) Provides annual reports in the same manner and in accordance with Code Section 31-6-70 ; Noncompliance with any condition of this subsection shall result in a monetary penalty in the amount of the difference between the services which the exemption holder is required to provide and the amount actually provided and shall be subject to revocation of its exemption status by the Department for repeated failure to meet any one or more requirements for the exemption, for repeated failure to pay any fines or moneys due to the Department, or for repeated failure to produce data as required by ode Section 31-6-70 after notice to the exemption holder and a fair hearing pursuant to Chapter 13 of Title 50, the "Georgia Administrative Procedures Act."

(33.1) Any new or expanded building or facility where human births occur on a regular and ongoing basis and which is classified as a birthing center pursuant to Ga. Comp. R. & Regs., r. 111-8-7 et seq ., provided that:

(a) Services are available 365 days per year, seven days per week, and 24 hours per day;

(b) The birthing center participates as a provider of medical assistance for Medicaid purposes;

(c) The birthing center has a hospital affiliation agreement with an acute care hospital with at least Level III perinatal services within a reasonable distance from the birthing center or the medical staff at the birthing center has admitting privileges or other acceptable documented or medical arrangements with such acute care hospital to ensure the necessary backup for the birthing center for medical complications. The birthing center shall have the capability to transfer a patient immediately to the acute care hospital within a reasonable distance from the birthing center. Acute care hospitals shall not unreasonably deny a transfer agreement or affiliation agreement with the birthing center;

(d) The birthing center:

Provides basic perinatal services, as defined at Ga. Comp. R. & Regs., r. 111-2-2-.24(2)(a) , which shall include but not be limited to a combination of such services as determined by the department;
Meets the standards for certification established by the American Association of Birthing Centers, or equivalent or higher standards as determined by the department;
Schedules routine visits and visits with other appropriate providers, as necessary, and tracks patients to verify that services have been received;
Prior to 20 weeks gestation, certifies that a patient has been deemed to be a low risk patient, as defined by the department for purposes of this paragraph;
Admits and provided services only to patients certified as low risk; and
Refers patients to other appropriate providers if, at any point between the 20 weeks gestation certification and antepartum, the birthing center determines that a patient no longer qualifies as a low risk patient for any reason; and

(e) The birthing center provides annual reports in the same manner and in accordance with Code Section 3-6-70 ;

(f) For purposes of this exemption, "expanded" means any capital renovation or construction project which results in the addition of a birth room as defined at Ga. Comp. R. & Regs., r. 111-8-7-.01(c) . Noncompliance with any condition of this subsection shall result in a monetary penalty in the amount of the difference between the services which the exemption holder is required to provide and the amount actually provided and shall be subject to revocation of its exemption status by the Department for repeated failure to meet any one or more requirements for the exemption, for repeated failure to pay any fines or moneys due to the Department, or for repeated failure to produce data as required by Code Section 31-6-70 after notice to the exemption holder and a fair hearing pursuant to Chapter 13 of the Title 50, the "Georgia Administrative Procedure Act."

(34) A new general acute care hospital in a rural county, as defined at Ga. Comp. R. & Regs., r. 111-2-2-.20(2)(l) that:

(a)

Attains status as a teaching hospital, as defined in Ga. Comp. R. & Regs., r. 111-2-2-.20(2)(p) withing 36 months of opening, and maintains such status thereafter; or
Obtains verification as a Level I, II, III, or IV trauma center from the American College of Surgeons within 36 months of opening, and maintains such verification thereafter;

(b) Provides emergency, inpatient, and outpatient psychiatric and behavioral health services;

(d) Provides uncompensated indigent and charity care in an amount equal to or greater than 3 percent of its adjusted gross revenue, and on and after January 1, 2026, in an amount equal to or greater than the minimum amount established by the department by rule which shall be no less than 3 percent and which shall be reviewed by the department every 12 months;

(e) Participates as a provider of medical assistance for Medicaid purposes; and

(f) Provides annual reports in the same manner and in accordance with Code Section 31-6-70 ; Noncompliance with any condition if this subsection shall result in a monetary penalty in the amount of the difference between the services which the exemption holder is required to provide and the amount actually provided and ball be subject to revocation of its exemption status by the Department for repeated failure to meet any one or more requirements for the exemption, for repeated failure to pay any fines or moneys due to the Department, or for repeated failure to produce data as required by Code Section 3-6-70 after the exemption holder and a fair hearing pursuant to Chapter 13 of Title 50, the "Georgia Administrative Procedure Act."

(35) A new acute care hospital where a short-stay general hospital in a rural county, as defined at Ga. Comp. R. & Regs., r. 111-2-2-.20(2)(i) , has been closed for more than 12 months and a new replacement hospital has not opened that:

(a) Is located in the same rural county where the short-stay general hospital was closed;

(b) Has no more than the number of licensed beds that were previously licensed in the closed hospital;

(d) Providers all required clinical health services as generally offered by a short-stay general hospital to meet licensure requirements pursuant to Ga. Comp. R. & Regs., r. 111-8-40 et seq .; and

(e) Providers uncompensated indigent and charity care in an amount equal to or greater than 3 percent of its adjusted gross revenue, and on and after January 1, 2026, in an amount equal to or greater than the minimum amount established by the department by rule which shall be no less than 3 percent and which shall be reviewed by the department every 12 months. Such acute care hospital may provide basic perinatal services as defined at Ga. Comp. R. & Regs., r. 111-2-2-.24(2)(a);

(36) A new short-stay general hospital to address the underserved population previously served by a short-stay general hospital that was closed within the 48 months preceding the filing of a request for a letter of determination that:

Is located within a county with a population of more than 1 million according to the United States decennial census of 2020 or any future such census:
Is located within five miles of and in the same county as the main campus of a medical school that is accredited by the Liaison Committee on Medical Education to confer Doctor of Medicine (M.D.) degrees;
Has in place at the time of filing of a request for a letter of determination a written agreement to serve as a teaching hospital, as defined at Ga. Comp. R. & Regs., r. 111-2-2-.20(2)(p) , for students of the medical school described in division (ii) of this paragraph;
Has a maximum number of short-stay general hospital beds not greater that 50 percent of the maximum number of short-stay general hospital beds for which the closed short-stay general hospital had previously been licensed at any time during the 12 months prior to its closure;
Has an emergency Department that is open 365 days per year, seven days per week, and 24 hours per day; and
Provides uncompensated indigent and charity care in an amount equal to or greater than 3 percent of its adjusted gross revenue, and on and after January 1, 2026, in an amount equal to or greater than the minimum amount established by the department by rule which shall be no less than 3 percent and which shall be reviewed by the Department every 12 months;

(a) An exemption for a new short-stay general hospital under this subsection shall include an exemption for all clinical services and equipment generally utilized at an acute care short-stay general hospital and required for licensure, including, but not limited to, an emergency department; Level II perinatal/neonatal services, including labor, delivery, recovery, and Level II neonatal intermediate care services; diagnostic imaging services; and surgical services; and

(b) For a period of ten years following the issuance of its original license, a new short-stay general hospital approved for an exemption pursuant to this subsection shall be entitled to one or more determinations from the department to add additional short-stay general hospital beds, so long as the total licensed capacity of such hospital does not exceed the maximum number of short-stay general hospital beds for which the closed short-stay general had previously been licensed at any time during the 12 months prior to its closure; and

(37) Transfer of existing beds from one general acute care hospital's primary campus to another general acute care hospital's primary campus within the same hospital system within a 15-mile radius of the original campus, provided that all of the following are satisfied:

(a) Both hospitals involved in the transfer are general acute care hospitals and neither is a specialty hospital;

(b) Both hospitals involved in the transfer are under common ownership or control;

(c) The transferring hospital may not, for a period of 12 months after the transfer is effective, seek to expand the bed type which was transferred; and

(d) The transferring hospital is open and operational at the time of transfer and shall not close within 12 months after the transfer is effective.

(e) Written notice is provided to the Department within thirty (30) calendar days of the transfer confirming the number and types of beds transferred and that the transfer complies with all the requirements of this subsection.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Exemptions from Review" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. May 1, 2009; eff. May 21, 2009.
Amended: F. Oct. 19, 2018; eff. Nov. 8, 2018.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.03, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.04 Periodic Reports {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.04}

The availability of accurate, current data is critical for adequate health planning and for the review process. Therefore, all inpatient and outpatient health care facilities and services subject to Certificate of Need review will be required to provide complete and accurate data, in a timely manner, as required by the Department. Pursuant to O.C.G.A. § 31-6-70(a), this reporting requirement shall also apply, beginning July 1, 2008, to all ambulatory surgical centers and imaging centers, whether or not exempt from obtaining a Certificate of Need under O.C.G.A. § 31-6 et seq. and these Rules.

(1) Annual and Special Questionnaires.

(a) All CON-regulated facilities and services, as well as all ambulatory surgical centers and imaging centers, whether or not exempt from obtaining a Certificate of Need under these Rules, shall complete and submit certain surveys annually and periodically to the Department, as deemed necessary by the Department.

(b) Any facility offering ambulatory surgery pursuant to the exclusion designated on June 30, 2008, as division (14)(G)(iii) of O.C.G.A. § 31-6-2 ; any diagnostic, treatment, or rehabilitation center offering diagnostic imaging or other imaging services in operation and exempt prior to July 1, 2008; or any facility operating pursuant to a letter of non-reviewability and offering diagnostic imaging services prior to July 1, 2008, shall:

Provide notice to the Department of the name, ownership, location, single specialty, and services provided in the exempt facility; and
Beginning on January 1, 2009, provide annual reports in the same manner and in accordance with the provisions of this Rule.

(c) The Department shall publish a notice giving a date when the information responsive to subsection (b)1. of this Rule by December 30, 2008, or the Department does not receive the annual report referenced in subsection (a), and subsection (b)2., of this Rule from a health care facility requiring a Certificate of Need or an ambulatory surgical center or imaging center, whether or not exempt from obtaining a Certificate of Need under these Rules, on or before the date such report is due or receives a timely but incomplete report, the Department shall notify the health care facility or center regarding the deficiencies and shall be authorized to fine such health care facility or center an amount not to exceed $2,000.00 per day for every day up to thirty (30) days and $5,000.00 per day for every day over thirty (30) days for every day the Department has not received a report or an incomplete report has not been sufficiently corrected based on the Department's notice of deficiencies.

(d) Survey notices will be mailed or electronically transmitted by the Department to each such facility. The accurately and fully completed survey, covering the report period indicated, shall be filed with the Department within the time frame specific in the notice. The survey shall be filed with the Department in the electronic format designated by the Department in the Survey Notice or on the Department's website. The survey shall include an electronic signature as authorized by law, of the chief executive officer or principal administrator of the facility, who shall attest to the accuracy and completeness of the information provided.

(e) Reporting requirements shall also apply to new health facilities and services approved through Certificate of Need review. Generally, new facilities and services will be required to report if approved for operation or occupancy for sixty (60) days or more of the report period.

(f) Surveys submitted to the Department pursuant to these Rules and any service-specific Rules shall not be available for public review until after the deadline for submission for all surveys of that type;

(g) Required surveys submitted for a given period of time may not be revised by the facility or service after the survey filing deadline unless the request for revision is approved by the Department at its sole discretion.

(h) If the Department does not receive an annual report from a health care facility within one hundred eighty (180) days following the date such report was due or receives a timely but incomplete report which is not sufficiently completed within such one hundred eighty (180) days, the Department shall be authorized to revoke the Certificate of Need of the health care facility in accordance with O.C.G.A. § 31-6-45 and Ga. Comp. R. & Regs., r. 111-2-2-.05 .

(i) The Department shall make publicly available all annual reports submitted pursuant to O.C.G.A. § 31-6-70 on the Department website. The Department shall also provide a copy of such annual reports to the Governor, the President of the Senate, the Speaker of the House of Representatives, and the chairpersons of the House Committee on Health and Human Services and the Senate Health and Human Services Committee.

(j) All health care facilities, ambulatory surgical centers, and imaging centers required to submit an annual report pursuant to O.C.G.A. § 31-6-70(a) shall make such annual reports publicly available on their websites.

(2) Post-Approval Reporting.

(a) All entities receiving a Certificate of Need shall maintain a valid and accurate mailing and electronic mail address with the Department. Any notification, notice, or letter required by these Rules is deemed to be received by the certificate holder when the Department sends such notification, notice, or letter to the mailing or electronic mail address on file with the Department.

(b) Persons holding Certificates for construction projects shall, within twelve (12) months of the effective date of the Certificate, i.e., at the end of the implementation period, provide a progress report to the Department including documentation of the following:

that the construction plans have been approved by the Department;
that a construction contract has been signed, specifically indicating beginning and completion dates;
that construction materials and equipment are on the site and construction of the project has actually begun.

(c) The Department shall monitor the Certificate of Need holder's progress in completing the project and phases thereof, as applicable, within the effective period as specified at Ga. Comp. R. & Regs., r. 111-2-2-.02(5) . Each Certificate of Need issued requires a regular reporting of the different stages of development to completion. All projects approved as presented with phases shall submit a progress report within forty-five (45) days of the completion of each phase. All Certificate of Need projects must satisfy the pertinent reporting requirements or the Certificate shall be subject to revocation. These reports shall include information as to the total dollar amount of capital expenditures that have been obligated under the certificate, and any changes in amounts of proposed or previously obligated capital expenditures or changes to the timing of phases, if approved by the Department in advance. These reports will be made on a form provided by the Department on its website and will be due on the date or dates indicated by the Department on attachments to the Certificate of Need and in subsequent correspondence.

(d) The Department may also request additional reports as often as necessary in order to determine:

if the timetable specified in the certificate is being met;
if the scope of the project is being completed as described on the certificate and in the application for the Certificate of Need;
if the condition(s) of approval, if any, have been satisfactorily met.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Periodic Reports" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.04, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.05 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.05}

(1) Revocation

(a) In the event that the Department has cause to consider revocation of a Certificate, in whole or in part, the Department shall provide notice to the holder of the Certificate and shall hold a hearing to determine whether the holder has:

Intentionally provided false information to the Department;
Failed to incur a financial obligation in accordance with the Certificate as granted;
Failed to implement the project in accordance with the specific purpose(s) for which the certificate was granted or failed to meet the initial twelve (12) month performance standards or failed to request an extension of such standards. For certificates issued on or after July 1, 2008, failed to implement the services or units of services for which the Certificate of Need was issued, and that were outlined in or on the certificate granted, in a timely manner as also outlined in or on the certificate granted, as provided by O.C.G.A. § 31-6-45 (a.1);
Transferred controlling ownership in the facility before completion of the project without prior written approval of the Department, except as authorized by Ga. Comp. R. & Regs., r. 111-2-2-.02(4) ;
Changed the defined location of the project except as allowed by O.C.G.A. § 31-6-45(a) authorizing change in location under certain conditions;
Failed to comply with any and all requirements or conditions of the Certificate;
Failed to submit a timely or complete periodic report within 180 days following the date the report is due pursuant to O.C.G.A. § 31-6-70 and as otherwise required by Ga. Comp. R. & Regs., r. 111-2-2-.04 ;
Failed repeatedly to pay any fines or moneys due to the Department;
Failed to maintain minimum quality of care standards that are outlined within the Certificate as granted; or
Failed to participate as a provider of medical assistance for Medicaid purposes if made a condition of the Certificate as granted pursuant to O.C.G.A. § 31-6-45.2(a) .

(b) In the event that there is sufficient evidence to justify revocation of a Certificate, the Department shall provide written notification to the holder, which shall be effective as of the date it is sent electronically by the Department. Notice shall also be provided to the public, to the county or municipal authority and to the appropriate Regional Development Center. Any person whose Certificate is revoked under this Rule is entitled to judicial review, pursuant to O.C.G.A. § 50-13 et seq.

(c) A person whose Certificate of Need has been revoked or denied may not reapply for a Certificate of Need for the same or substantially similar project for at least one hundred twenty (120) days from the date that the revocation or denial becomes final, at which time the person may submit a new application. For purposes of this subparagraph, a decision revoking or denying a Certificate of Need shall become final when the time for appealing that decision expires without an appeal of such decision having been timely filed. If an appeal is timely filed, the decision is not final until the resolution of the administrative appeal, if any.

(d) A person holding a Certificate of Need may voluntarily request revocation of the Certificate without prejudice by submitting such request to the Department in writing.

(e) A health care facility which has a Certificate of Need or is otherwise authorized to operate pursuant to this chapter shall have such Certificates of Need or authority to operate automatically revoked by operation of law without any action by the Department when that facility's permit to operate pursuant to O.C.G.A. § 31-7-4 is finally revoked by order of the Healthcare Facility Regulation Division. For purposes of this subsection, the date of such final revocation shall be as follows:

When there is no appeal of the order pursuant to O.C.G.A. § 31-5, the one hundred and eightieth (180th) day after the date upon which expires the time for appealing the revocation order without such an appeal being filed; or
When there is an appeal of the order pursuant to O.C.G.A. § 31-5, the date upon which expires the time to appeal the last administrative or judicial order affirming or approving the revocation or revocation order without such appeal being filed.

(f) A certificate shall be subject to revocation for the following failures, without limitation:

Failure to incur a project-specific capital expenditure, within the initial twelve (12) month implementation period specified at Ga. Comp. R. & Regs., r. 111-2-2-.02(6) and in the Certificate itself or within an extension implementation period granted by the Department, through initiation of substantial project above-ground construction or lease or purchase of the proposed equipment;
Failure to file the required Progress Report(s);
Failure to meet the conditions on the face of the Certificate; or
Failure to pay any penalty assessed pursuant to O.C.G.A. § 31-6-40.1 .

(2) Sanctions.

(a) Any health care facility offering a new institutional health service without having obtained a Certificate of Need and which has not been previously licensed as a health care facility shall be denied a license to operate by the Healthcare Facility Regulation Division.

(b) In the event that a new institutional health service is knowingly offered or developed without having obtained a Certificate of Need as required by O.C.G.A. § 31-6 et seq., or by these Rules, or the Certificate of Need for such service is revoked according to the provisions of Ga. Comp. R. & Regs., r. 111-2-2-.05(1) , a facility or person may be fined an amount not to exceed $5,000.00 per day up to thirty (30) days, $10,000.00 per day from thirty-one (31) days through sixty (60) days, and $25,000.00 per day after sixty (60) days for each day that the violation of these Rules and O.C.G.A. § 31-6 et seq. has existed and knowingly and willingly continues; provided however, that the expenditure or commitment of or incurring an obligation for the expenditure of funds to take or perform actions not subject to this chapter or to acquire, develop or prepare a health care facility site for which a Certificate of Need application is denied, shall not be a violation of this Chapter and shall not be subject to such a fine. The Commissioner or his designee shall determine, after notice and a hearing if requested, whether the fines provided in the Code section shall be levied.

(c) Any person who acquires a health care facility by stock or asset purchase, merger, consolidation, or other lawful means shall notify the Department of such acquisition, the date thereof, and the names and address of the acquiring person. Such notification shall be made in writing to the Commissioner or his designee within forty-five (45) days following the acquisition and the acquiring person may be fined by the Department in the amount of $500.00 for each day that such notification is late.

(d) The Department may require that any applicant for a Certificate of Need commit to provide a specified amount of clinical health services to indigent or charity, Medicare, Medicaid, PeachCare, and similar patients as a condition for the grant of a Certificate of Need. A grantee or successor in interest of a Certificate of Need or authorization to operate under O.C.G.A. § 31-6 et seq. which violates such an agreement, whether made before or after July 1, 1991, shall be liable to the Department for a monetary penalty in the amount of the difference between the amount of services so agreed to be provided and the amount actually provided. Penalties authorized under this Code section shall be subject to the same notices and hearing for the levy of fines under Ga. Comp. R. & Regs., r. 111-2-2-.05(2)(b) .

(e) All hearings under this Section shall be in accordance with the Georgia Administrative Procedure Act. Any person so penalized under this Rule is entitled to judicial review, pursuant to O.C.G.A. § 50-13 et seq.

(f) If the person assessed fails to pay the amount of the assessment to the Department within thirty (30) days after notice of assessment is postmarked to him, or within such longer period, not to exceed ninety (90) days, as the Department may specify, the Department may institute a civil action to recover the amount of the assessment or may revoke the Certificate of Need. The Department may add reasonable interest to the assessment.

(g) For purposes of this Rule, the State of Georgia, acting by and through the Department or any other interested person, shall have standing in any court of competent jurisdiction to maintain an action for injunctive or other appropriate relief to enforce the provisions of this Rule.

(3) Department's Right to Inspect and Audit . The Department or an authorized representative or employee designated by the Department shall have the right to inspect and audit any facility, site, location, book, document, paper, files, or other record of the holder of the Certificate of Need or letter of non-reviewability or other determination that is related to any project authorized by the Certificate of Need or letter of non-reviewability or other determination, in order to monitor and evaluate the person's compliance with the terms of issuance of the Certificate of Need or the letter of non-reviewability or other determination. The Department shall have the authority to make public or private investigations or examinations inside or outside of the state of Georgia to determine whether all provisions of O.C.G.A. § 31-6-2 et seq. or any other law, rule, regulation, or formal order relating to the provisions of O.C.G.A. § 31-6-40 in particular, has been violated. Such investigations may be initiated at any time in the discretion of the Department and may continue during the pendency of any action initiated by the Department pursuant to section (1)(a) of this Rule. For the purpose of conducting any investigation or inspection pursuant to this subsection, the Department shall have the authority, upon providing reasonable notice, to require the production of any books, records, or other information related to any Certificate of Need issue.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Enforcement" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.05, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.06 Application for Certificate of Need {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.06}

(1) Letter of Intent. Beginning July 15, 2008, all persons who wish to submit an application for a Certificate of Need for a new institutional health service or health ca re facility, as provided in O.C.G.A. § 31-6-40(a) and (b) , must submit a letter of intent notifying the Department of their intent to do so at least twenty-five (25) days prior to submission of the Certificate of Need application. The notice must be in writing, must be submitted via the Department's web portal, and must contain the following information:

(a) Name and address of the legal applicant;

(b) Person to whom inquiries must be addressed;

(d) Proposed project site location with specificity;

(e) Brief summary description of proposal;

(f) Proposed service area; and

(g) Cost of the project. The Department will not accept any notices of intent submitted by either telephone, facsimile, or electronic mail, pursuant to Ga. Comp. R. & Regs., r. 111-2-2-.06(6). Beginning with the date referenced above, no Certificate of Need application will be accepted without a previously filed letter of intent. The Certificate of Need application must be submitted no later than twenty-five (25) calendar days after the letter of intent has been received by the Department. In the event that the twenty-fifth (25th) calendar day falls either on a weekend or a legal holiday, the twenty-fifth (25th) calendar day shall become automatically the next business day that is neither a weekend nor a legal holiday. If a Certificate of Need application is not submitted as provided herein, it will not be accepted and an applicant filing an application beyond the time period specified will be required to submit a new letter of intent in the manner specified above.

(2) Contents of Application . Applications shall contain all relevant data, information and assurances required by the Department. The Department will provide application forms on request, and all applications must be on the form supplied by the Department or a copy thereof and comply with the content requirements specified thereon. Applications shall provide information including, but not necessarily limited to, the following categories as they relate to the proposed projects:

(a) identification of the applicant;

(b) ownership;

(d) compliance with State and local codes and ordinances, including flood hazards;

(e) a detailed and complete description of proposed project;

(f) project justification, including specific documentation of the need (utilizing the Department's data and methodology) that the population to be served has for the project;

(g) staffing and operation;

(h) financial information, which shall include positive evidence of ability to obtain financing, the source of financing, and maximum interest rates, which will be paid to the lender. Applications submitted for or on behalf of a health care institution shall include one copy of the latest audit report (or internal financial statement for investor-owned facilities). Also submitted shall be all pro forma financial data requested in the application;

(i) cost containment and quality of care considerations;

(j) project design and construction schedule including as applicable:

Schematic Design Documents meeting the standards defined by the American Institute of Architects in section 2.4.2 of the Standard AIA Contract Language. These Schematic Design Documents shall establish the conceptual design of the Project illustrating the scale and relationship of the Project components. The Schematic Design Documents shall also include a conceptual site plan, if appropriate, and preliminary building plans, sections and elevations. Preliminary selections of major building systems and construction materials shall be noted on the drawings or described in writing;
A written summary of the Architect's evaluation and planning findings and recommendations meeting the standards defined by the American Institute of Architects in section 2.3 of the Standard AIA Contract Language. This summary shall include, as applicable, an evaluation of the Applicant's program and schedule requirements and budget for the Cost of the Work, each in terms of the other, a preliminary evaluation of the Applicant's site for the Project based on the information provided by the Applicant of site conditions, and the Applicant's program, schedule and budget for the Cost of the Work, and an evaluation of the applicant's proposed method of contracting for construction services; and
A detailed description of the proposed timeline and phases for project completion.

(k) a cost estimate prepared by a licensed architect or engineer within the sixty (60) days immediately preceding submission of the application;

(l) documentation from the Healthcare Facility Regulation Division of no uncorrected licensure operational standards in the applicant's facility, if applicable.

(3) Submittal of Applications.

(a) Using the Department's web portal, Applicants should submit one (1) copy of the application signed by the applicant or the legal representative of the applicant. Failure to do so will result in non-acceptance of the application.

(b) Applications received after 3:00 p.m. on any business day will be considered to have been received on the next business day. Receipt of the application will be acknowledged in writing by the Department.

(4) Filing Fee Required.

(a) Each application for a Certificate of Need review shall be accompanied by a fee, except for the provisions covered in Ga. Comp. R. & Regs., r. 111-2-2-.06(4)(d) and Ga. Comp. R. & Regs., r. 111-2-2-.06(4)(e) , the amount of which shall be determined by the following schedule:

for applications with a total project cost from zero to $1,000,000.00, the fee shall be $1,000.00; and
for applications with a total project cost greater than $1,000,000.00, the fee shall be one-tenth of one percent (.001) of the total cost but not to exceed $50,000.00; and
Reserved.

(b) For any project, which is to be accomplished by lease, gift or other means of acquisition, the dollar value for purposes of computing the fee will be based on the value of the major medical equipment or facilities to be acquired. The value of the major medical equipment is the expenditure, which would be required for purchase. The value of the facilities to be acquired is based on a current (within six (6) months of the submittal of the Certificate of Need application) appraisal of the property.

(c) Payment of the fee shall be by credit/debit card via the Department's website, certified check, or money order made payable to the State of Georgia and must be received by the Department before an application will be accepted for review. Failure to provide payment of the appropriate fee will result in non-acceptance of the application. Fee payments are collected as general State revenue.

(d) State-owned institutions shall be exempt from payment of a filing fee.

(e) The Department may waive payment of a filing fee, or any portion thereof, for certain hospital authority facilities and for certain public non-profit providers when the Department determines that financial circumstances exist, which would justify such action. A party requesting a waiver must make such request at the time the application is submitted to the Department.

(f) Subject to the Rules in (a) through (e) above, applicants shall submit an additional filing fee for additional information or amendments provided during the review period that increase the cost of the project. For such supplementary information which increases the cost of the project, the amount that shall be submitted is an amount equal to the difference between the calculation of the filing fee based on the total amended project costs as outlined in (a) and the filing fee paid at the time of application, except that in no case shall the amount submitted be less than $500.00. Should such supplementary information decrease the costs associated with a project, the filing fee shall not be reduced or refunded. The Department shall not issue decisions on applications for which such supplementary information has been provided where an applicant has not submitted the additional filing fee, as applicable.

(5) Review for Completeness.

(a) The Department will have 120 days to review an application, beginning on the day the application is received.

(b) The Department shall notify the applicant within seven (7) calendar days following receipt of the application that the application is complete as submitted or that additional information is required to complete the application. If additional information is required, the notice shall include a statement of the specific additional information required. Said notice shall be effective the date it is sent electronically by the Department.

(c) The Department shall notify the applicant no later than seven (7) calendar days following receipt of the additional information whether such additional information is sufficient to complete the application. If the additional information is not sufficient, the notice shall include a specific statement of the information which does not adequately respond to the original request.

(d) The Department will deem an application to be withdrawn if the applicant fails to provide the Department with information sufficient to complete the application, as requested on a notice of incompleteness, by the 15th calendar of the review cycle.

(e) An application will be determined to be incomplete if any of the following were not either provided with the application or as may be specified in this Section, submitted previously to the Department:

all the required data, information and assurances provided on the correct forms, including but not limited to the following:

(i) detailed description of the proposed project as required by Ga. Comp. R. & Regs., r. 111-2-2-.06(2)(e) ;

(ii) financial program to meet the requirements of Ga. Comp. R. & Regs., r. 111-2-2-.06(2)(h) ;

(iii) documentation of necessary financing for the project, such as a letter of credit, etc.;

(iv) financial pro forma to meet the requirements of Ga. Comp. R. & Regs., r. 111-2-2-.06(2)(h) ; and

(v) most recent audited financial statements, or personal financial statements if audited statements are not available (tax returns would meet this requirement for unaudited entities and individuals);

(vi) for projects invoking service-specific Rules, as outlined in Ga. Comp. R. & Regs., r. 111-2-2-.20 et seq., the appropriate service-specific review considerations;

(vii) for projects involving construction, renovation, and/or expansion, schematic plans and cost estimates certified by an architect, engineer, or general contractor, as appropriate and as required by Ga. Comp. R. & Regs., r. 111-2-2-.06(2)(j) and (k) ;

(viii) for projects involving the acquisition of equipment, purchase orders or invoices, as appropriate;

signature of the applicant;
payment of the filing fee, as described in Ga. Comp. R. & Regs., r. 111-2-2-.06(4) ;
the most recent three (3) years of all required surveys, as may be previously submitted to the Department, including the Annual Hospital Questionnaire, Annual Nursing Home Questionnaire, survey of home health agencies, or other data-gathering instruments required by the Department for any health care facilities and services owned or operated by the applicant, to include data requested pursuant to O.C.G.A. § 31-6-70 . In order for an application to be deemed complete, such surveys and data-gathering instruments shall be complete and accurate, as determined by the Department. Further, an application submitted by a component of an entity which owns or operates other health care facilities will be determined to be incomplete unless all health care facilities under the same ownership or operation have submitted completed questionnaires with to Department;
written verification certifying entitlement to any necessary real estate property or leasehold as described by the applicant in the application. Verification of entitlement shall include, but not be limited to, deeds, contracts, lease arrangements, conditional sales agreements or a comparable arrangement that purports to be a transfer of ownership in whole or in part. If an unsigned lease arrangement is submitted, the Applicant shall also submit an original letter documenting both the lessor's and lessee's commitment to participate in the lease once the CON is approved;
authorization to conduct business, including but not limited to, as appropriate:

(i) if the applicant is an entity requiring authorization by the Secretary of State to become a legal entity entitled to do business in the State of Georgia, such documentation;

(ii) by-laws, articles of incorporation, or articles of organization; and

(iii) if the applicant is an existing and licensed or permitted entity, a copy of such license or permit.

The applicant shall file one copy of the application with the office of the County Commissioner of the county in which the project exists or is proposed. The applicant shall submit with the application an exact copy of the letter addressed and submitted to the County Commission that accompanied the submittal of the application to the County Commission;
all post-approval reporting requirements as mandated at Ga. Comp. R. & Regs., r. 111-2-2-.04(2) for all previously approved projects, as may be previously submitted to the Department. Further, an application submitted by a component of an entity which owns or operates other health care facilities will be determined to be incomplete unless all health care facilities under the same ownership or operation have met the said post-approval reporting requirements for all previously approved projects with the Department;
the written vendor lobbyist certification required by Ga. Comp. R. & Regs., r. 111-1-2-.03(2) ;
In order to be determined complete, an applicant must be current with all indigent and charity care commitments, if any, made to the Department as a condition or requirement for past approval of a project. Further, an application submitted by a component of an entity which owns or operates other health care facilities will be determined to be incomplete unless all health care facilities under the same ownership or operation are current with any and all indigent and charity care commitments made to the Department; and
In order to be determined complete, an applicant must be current with any and all fines, if any, levied by the Department for violation of these Rules.
No applicant for a new Certificate of Need, a modification to an existing Certificate of Need, or a conversion of a Certificate of Need that has any outstanding amounts owed to the state including fines, penalties, fees, or other payments for noncompliance with any requirements contained in O.C.G.A. §§ 31-6-40.1 , 31-6-45.2 , 31-6-70 , 31-7-280 , or 31-8-179.2 shall be eligible to receive a new Certificate of Need or a modification to an existing Certificate of Need unless such applicant pays such outstanding amounts to the state. Any such fines, penalties, fees, or other payments for noncompliance shall be subject to the same notices and hearing for the levy of fines under O.C.G.A. § 31-6-45 .

(f) In addition to the provisions of a paragraph (b) above, additional requirements shall be in effect where the application involves the acquisition of a hospital owned or operated by or on behalf of a political subdivision, any combination of such subdivisions, or by or on behalf of a hospital authority. These requirements shall be as follows:

in the event that a health care facility, which has been assisted at any time during the past twenty years through a grant of State funds, is proposed to be acquired by a non-grant-eligible entity, the Department, in accordance with O.C.G.A. §§ 31-7-53(c) and 31-7-57(d) , is required to recover the funds granted by the State. A commitment regarding return to the State of such monies consistent with the Code should be forwarded to the Department no later than the end of the review period.
there shall be submitted a written agreement between the parties containing the following commitments:

(i) that the purchaser or lessee will annually allocate funds for the purpose of providing indigent/charity care. The funds allocated will be no less than three percent (3%) of the gross revenues of the hospital after provisions for bad debt and Medicaid and Medicare contractual adjustments have been deducted. The funds allocated will be based on the previous year's financial records, except the first year of operation following an acquisition the three percent (3%) will be based on the gross revenues of the hospital after provisions for bad debt and Medicaid and Medicare adjustments have been deducted. For purposes of this Rule; gross revenues will include all income derived from all sources;

(ii) that the purchaser will agree that no resident of the county in which the hospital resides will be denied emergency care (including emergency obstetrical care) due to inability to pay;

(iii) that the purchaser will participate in the Medicaid and Medicare programs and the State Health Benefit Plan, if authorized by the Department.

(6) Submission of Information and Documents. For the purposes of meeting any deadlines imposed by either these Rules or O.C.G.A. § 31-6-1et seq, all information and documents shall be submitted electronically through the Department's designated web portal. Except as otherwise provided, information and documents received after 5:00 p.m. on any business day will be considered to have been received on the next business day.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Application for Certificate of Need" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Aug. 28, 2006; eff. Sept. 17, 2006.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.06, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.07 Review Procedures {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.07}

(1) Beginning of Review Process.

(a) When an application is deemed by the Department to be complete, the Department shall provide written notice to the applicant of the completeness of the application and the schedule for review. The Department shall provide similar notice to a newspaper of general circulation in the county of the project, to the appropriate Regional Development Center, and to the chief elected official of the county and municipal government, if any, within whose boundaries the proposed project would be located.

(b) The Department will schedule reviews so that, unless joined with another application, no review shall, except as noted in (d) below, take longer than one hundred and twenty (120) days beginning on the day the Department receives the application until the date the decision to issue or not to issue a Certificate of Need is sent electronically to the applicant. Absent good cause, the Department generally will not issue a decision prior to the sixtieth (60th) day of the review cycle.

(c) In the event that, from the time an application is received until the twenty-fifth (25th) calendar day of the review cycle, one or more additional applications are declared complete which involve similar projects in the same or overlapping service areas, the Department may declare that such applications will be joined with the first application for review purposes. Following such joinder, none of the subsequent applications so joined may be considered as a first application for purposes of future joinder. The Department shall notify all applicants whose applications have been joined and shall set a new time parameter for Department actions. The one hundred and twenty (120) day final decision deadline shall run from the latest date that any one of the joined applications was received. Except as otherwise provided in Ga. Comp. R. & Regs., r. 111-2-2-.08(1) , such joinder shall be the sole method of comparative review for all applications filed after July 1, 2008.

(d) Where the Department determines that conditions exist which make it impractical to complete a review in one hundred and twenty (120) days, the Department may, on notification to the applicant, extend the time limit another thirty (30) days to one hundred and fifty (150) days. Conditions, including but not limited to the following, may constitute cause for extending the time:

The Department anticipates issuance of new demographic or utilization, data affecting the application;
The Department has received conflicting or contradictory information necessitating further investigation;
Results of impending legal action may have an effect on the application.

(e) For good cause shown, as shall be determined by the Department, a public hearing will be held at a time and location specified by the Department.

A request for a public hearing shall be signed by at least fifty (50) residents of the area where the project is located and must be received by the Department within twenty (20) days after the beginning date of the review cycle. The request shall include justification for the public hearing based on circumstances described in this paragraph.
To the extent possible, notification will be provided in a newspaper of general circulation in the area where the project is located approximately two weeks in advance of the hearing.
Any person desiring to offer testimony at the hearing will be given the opportunity to do so, but providing such testimony or evidence shall not confer upon the person or persons so testifying the status of "party" as that term is used in the Administrative Procedure Act.
Where distance and the nature of the project warrant, and within the budget constraints of the Department, the public hearing may be held by the Department in the area where the project is proposed to be located. Circumstances, which may indicate good cause for a hearing in the area, include but are not limited to:

(i) Projects, which could have significant effect on access to frequently used services by a sizable population group;

(ii) Projects generating strong conflicting viewpoints by the residents of an area;

(iii) Projects with potential for unusually significant impact on existing services.

A summary report of the hearing will be prepared, a copy of which will be sent to the party requesting the hearing and to the applicant. Such report will be made a part of the master record regarding the project. The Department may charge a fee for the summary report.

(f) If during the first thirty (30) days of the review of the application the Department finds there are factors that create a potential for denial of the application, the Department shall, on or before the thirtieth (30th) day of the review period, provide the applicant an opportunity to meet with the Department. The problems with the application will be described and an opportunity offered to amend or to withdraw the application or to submit additional information. The thirty (30) day meeting with the applicant(s) is restricted to the Department and the applicant(s). Parties opposing an application(s) may not attend or participate in an applicant thirty (30) day meeting. Such addition information must be submitted on or before the forty-fifth (45th) day of the review period.

"Additional information" is information and data submitted in response to a direct request from the Department at the meeting afforded an applicant on or before the thirtieth day of the review of the application or in response to issues and concerns raised by the Department in said meeting, or in the lack of such a meeting or request by the Department, information and data submitted consistent with the scope, physical location, cost, charges, service, and owners in the originally submitted application. Additional information must be submitted to the Department on or before the forty-fifth (45th) day of the review period;
"Amendment" is a revision to the additional information or application as originally submitted that is submitted to the Department no later than the ninetieth (90th) day of the review cycle and that constitutes a change in scope, physical location, cost, charge, service, or owner. The following changes in an application will qualify as an amendment:

(i) A reduction or increase in the proposed physical space capacity; or

(ii) A reduction or increase in the number of proposed beds or service units (e.g., operating rooms); or

(iii) A change in the owners of the legal applicant entity, as long as the legal applicant entity remains the same; or

(iv) A reduction or increase in a proposal's capital or operating costs; or

(v) A change in site within five miles of the site proposed in the original application or within the same service area as long as the population to be served and the service area to be served is not substantially different from that originally proposed as long as the proposed change does not require the application of a new need study or different rules; or

(vi) A reduction or subtraction in the scope of the original application; or

(vii) A change in the amount of commitment to indigent or charity care, projected utilization, financial information or patient charges that do not alter the basic financing or operations of the proposed project.

(g) The Department shall be notified with either a new application or written amendment to the current completed application when there are changes in the scope, physical location, cost, charges, service or owners of the applicant entity. Any revisions that constitute a total change in or addition to the scope of an application, in the location (except for the exemption in Ga. Comp. R. & Regs., r. 111-2-2-.07(1)(f)2(v) , or in the legal applicant that would require the submission of a new application. If the Department determines that the amendment constitutes a total change in either the scope, location, or legal applicant, the original application will be considered to be withdrawn and the applicant will be so notified. An application may be amended by the applicant at any time up to the ninetieth (90th) day of the review cycle.

(g.1) No party may oppose an application for a Certificate of Need for a proposed project unless:

Such party offers substantially similar services as proposed within a 35 mile radius, in Georgia, of the proposed project or has a service area in Georgia that overlaps the applicant's proposed service area; or
Such party has submitted a competing application in the same batching cycle and is proposing to establish in Georgia the same type of facility proposed or offers, in Georgia, substantially similar services as proposed and has a service area located in Georgia that overlaps the applicant's proposed service area.

(h) Any party, pursuant to O.C.G.A. § 31-6-43(d)(2) , who is permitted to oppose an application, or an application(s) joined for review, must submit a notice of opposition, on the form provided by the Department, no later than the thirtieth (30th) day of the review cycle. The notice must contain the information specified by the form. The notice of opposition form submission shall also include one signed original of the written vendor lobbyist certification required by Ga. Comp. R. & Regs., r. 111-1-2-.03(2) . The notice of opposition must not contain the substantive arguments against a particular application.

Those parties who are opposed to an application will be given an opportunity to meet with the Department at a time and place specified by the Department after a review of the opposition notices. The opposition meeting provided for by O.C.G.A. § 31-6-43(h) , shall be held no earlier than the sixtieth (60th) day of the review cycle. The applicant(s) shall be entitled to attend the opposition meeting. Only one designated person on behalf of each party opposed to a particular application will be allowed to speak on behalf of the opposition to said application at the opposition meeting. The time period provided for the opposition spokesperson shall be determined in the sole discretion of the Department. The applicant(s) will not be allowed to speak in rebuttal of the opposition remarks at the opposition meeting. The Department shall make no formal substantive comments regarding the review of the application(s) at the opposition meeting. The opposition parties shall submit via the Department's web portal, substantive written comments and arguments regarding the nature of their opposition to the particular project. The opposition parties must provide one copy of the substantive opposition comments to the applicant at the opposition meeting. In order for an opposing party to have standing to appeal an adverse decision pursuant to O.C.G.A. § 31-6-44, such party must attend and participate in an opposition meeting. Substantive opposition comments must pertain to only one application and one applicant. In no case shall the Department accept substantive opposition comments that concern multiple applicants or applications.
Applicants shall be given the opportunity to submit final amendments and/or letters of support for a particular application pursuant to and in compliance with Ga. Comp. R. & Regs., r. 111-2-2-.06(6) via the Department's web portal no later than the ninetieth (90th) day of the review cycle.
Applicants shall be given the opportunity to respond to the substantive opposition comments made orally and submitted in writing at the opposition meeting. The last day for the applicant(s) to respond to the opposition meeting comments shall be the seventy-fifth (75th) day of the review cycle. The Department reserves the right, but is not required to, ask the applicant(s) for information in response to the substantive opposition comments. If the Department asks the applicant for information as a result of the comments provided at the opposition meeting, the applicant must submit the information requested no later than seventy-fifth (75th) day of the review cycle.
The Department shall provide written notification of its decision to issue or deny a Certificate of Need no later than the one hundred and twentieth (120th) day of the review cycle, or, if the project was extended, no later than the one hundred and fiftieth (150th) day of the review cycle.

(i) The Department, in accordance with the provisions of subsections (k)-(m) below, will give special expedited consideration to the emergency offering of services required solely to cope with a situation posing an immediate threat to the health and safety of patients, visitors, or staff. The General Counsel, or his designee, upon a showing that a proposed replacement facility is critical to the welfare, health and stability of the immediate community as evidenced by written support from the local, county and state governing bodies may, authorize approval based on a request by telephone, with written documentation to be provided later. In the event that the approval requires an application to replace an existing health care facility, the application will not be subject to joinder. "Emergency expenditures" as set forth in this subparagraph (i) shall include but not be limited to expenditures necessitated by circumstances arising from an authorized hazardous condemnation as well as from acts of God including but not limited to earthquakes, hurricanes, tornados or floods.

(j) Reserved.

(k) Pursuant to the provisions of O.C.G.A. § 31-6-43(g) , the Department shall conduct an expedited review with a review period of no longer than (30) thirty days for those projects deemed an emergency. When the Governor has declared a state of emergency in a region of the state, existing health care facilities in the affected region may seek emergency approval from the Department to offer services that may otherwise require a Certificate of Need. The Department shall give special expedited consideration to such requests and may authorize such requests for good cause. Once the state of emergency has been lifted, any services offered by an affected health care facility under this subsection shall cease to be offered until such time as the health care facility that received the emergency authorization has requested and received a Certificate of Need. For purposes of this subsection, the term "good cause" means that authorization of the request shall directly resolve a situation posing an immediate threat to the health and safety of the public.

(l) The Department shall issue a decision on applications for a Certificate of Need for emergency projects as provided in subsection (k) above, no later than thirty (30) days after the application has been received; failure to issue the decision on or before the thirtieth (30th) day after it has been received shall result in an automatic approval of the application, subject to subsection (n) below; the decision issued by the Department shall be a summary statement of the findings during the review of the project;

(m) If, during the course of the review period, the Department finds that there are factors that create the potential for denial of the application, the Department shall immediately discontinue its emergency review, notify the applicant in writing of that decision, and review the application in accordance with the applicable non-emergency review procedures set forth in Ga. Comp. R. & Regs., r. 111-2-2-.07 .

(n) The review of such projects as outlined in subsections (k) - (m) above shall be governed by the emergency provisions of the referenced subsections and not the provisions of subsections (a) - (h) above.

(o) The filing fee for applications of the type specifically listed in subsections (k) - (n) above shall be $1,000.00, notwithstanding the filing fee provisions of Ga. Comp. R. & Regs., r. 111-2-2-.06(4)(a) .

(2) Department Review.

(a) In reviewing the application, the Department will take into consideration the review considerations and policies provided in Ga. Comp. R. & Regs., r. 111-2-2-.09 . The latest applicable data from official data sources will be used in the Department analysis, unless otherwise provided by a service-specific Rule. Such data sources will include, but not be limited to, the Governor's Office of Planning and Budget, Medicare/Medicaid Cost Reports, and questionnaires or surveys initiated by the Department.

(b) Upon completion of review, the Department shall provide written notification of its decision to issue or deny a Certificate of Need. In the event of a favorable decision, the letter shall serve as the Certificate.

Such decision will be issued no later than one hundred twenty (120) days beginning on the day the Department receives the application unless the total review period is extended in accordance with Ga. Comp. R. & Regs., r. 111-2-2-.07(1)(d) .
The date of the decision shall be the date on the notification letter of the Department.

A detailed statement of the findings related to each applicable consideration and standard relevant to the decision to issue or deny a Certificate of Need; and
Information pertaining to the availability of an appeal hearing.

(d) The decision shall be to approve or deny the application as submitted or as amended by the applicant during the course of review.

(e) A copy of the notification will be sent to the applicant or, in the case of joined applications, to all applicants, to the appropriate Regional Development Center and to the chief elected official of the applicable county and municipal government, if any. A copy may be made available to other interested persons on request.

(f) Should the Department fail to issue a decision letter on a Certificate of Need application within the time limits set forth in these Rules, the application shall be deemed approved as of the one hundred and twenty-first (121st) day, or the one hundred fifty-first (151st) day if the review period was extended pursuant to Ga. Comp. R. & Regs., r. 111-2-2-.07(1)(d) , beginning on the day the Department receives the application, or the last of any applications joined pursuant to Ga. Comp. R. & Regs., r. 111-2-2-.07(1)(c) was declared complete for review.

(g) Appeals of the decision of the Department shall be processed in accordance with rules promulgated by the Certificate of Need Appeal Panel found in Ga. Comp. R. & Regs. Chapter 274.

(h) When a project undergoes judicial review, the Department may stay the effective date of the CON pending the outcome of the judicial review upon appropriate terms for good cause shown.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Review Procedures" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Nov. 13, 2007; eff. Dec. 3, 2007.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Jan. 21, 2009; eff. Feb. 10, 2009.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Amended: F. Oct. 14, 2022; eff. Nov. 3, 2022.
Note: Rule 111-2-2-.07, the incorrect version of the Rule was filed on October 14, 2022 (i.e., paragraph (2), "Department Review," was inadvertently omitted). The Rule in its entirety was updated on the Rules and Regulations website June 30, 2023, the original filed and effective dates (i.e., Oct 14, 2022; eff. Nov. 3, 2022.) were retained, as requested by the Agency. Effective June 30, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.08 Alternative Application and Review Procedures {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.08}

(1) Batching Review Process

(a) Pursuant to O.C.G.A. § 31-6-43(e) , the Department may limit the time periods during which it will accept applications for the following health care facilities and/or services: skilled nursing facilities; intermediate care facilities; home health agencies, open heart surgical services, pediatric cardiac catheterization and open heart services, perinatal services, freestanding birthing centers, psychiatric and substance abuse services, comprehensive inpatient physical rehabilitation services, ambulatory surgical services, positron emission tomography services, and megavoltage radiation therapy services. Limitation of the time periods shall be to only such times after the Department has determined there is an unmet need for such facilities and/or services, or will accept applications pursuant to any service-specific need standard exceptions. The Department shall make a determination as to whether or not there is an unmet need for each type of facility at least every six (6) months and shall notify those requesting such notification of that determination. No application for the services listed above will be accepted for review by the Department except as provided for pursuant to Ga. Comp. R. & Regs., r. 111-2-2-.08(1) . For purposes of batching only, the applications entered into the one hundred twenty (120) day review period shall be evaluated according to the data used to publish the unmet need, or to accept applications pursuant to any service-specific need standard exceptions, for the particular service at issue, for those services listed above, and not the latest available data at the time of decision, as is the case with all non-batched applications.

(b) Upon the determination of an unmet need for a particular facility/service in a given service area, the Department shall provide notice indicating which applications will be considered in that particular batching cycle to all interested parties requesting notice of that determination. It shall be the sole and exclusive responsibility of the interested party to notify the Department in writing of that party's desire to be informed of the Department's unmet need determination(s) for batching purposes. The Department's notice shall contain the unmet need for the type of facility/service in the given service area(s) and shall also contain the pertinent time frames and deadlines for submission of notices of intent to apply, for submission of applications, and the review of such applications.

(c) All parties interested in applying for the particular unmet need in a given service area must notify the Department of that party's intent to apply.

The notice must be in writing, submitted via the Department's web portal, and must address specifically the type of unmet need and service area(s) for which the applicant intends to apply.
The notice of intent must be received by the Department no later than the close of business on the twenty-fifth (25th) calendar day following the date that the Department publishes the determination of unmet need. In the event that the twenty-fifth (25th) calendar day falls on either a weekend or a legal holiday, the twenty-fifth (25th) calendar day shall become automatically the next business day that is neither a weekend nor a legal holiday.
Notwithstanding any other relevant provisions within this Rule, the notice of intent to apply must be received by the Department before the submission of the actual application in accordance with the notice of intent deadline.
In the event that the Department fails to receive the notice of intent to apply by the stated deadline, the interested party shall be disqualified automatically from applying during that batching cycle.

(d) Subject to the proper submission of a notice of intent to apply, any interested party shall use the Department's web portal to submit an application no later than 12:00 P.M. on the twenty-fifth (25th) calendar day following the date that the Department receives the notice of intent. In the event that the twenty-fifth (25th) calendar day falls either on a weekend or a legal holiday, the twenty-fifth (25th) calendar day shall become automatically the next business day that is neither a weekend nor a legal holiday. For purposes of batching only, all properly submitted applications will be deemed received on the twenty-fifth (25th) day, regardless of the actual date of submission.

(e) For the purposes of batching only, an application which has been deemed received according to (d) above, will only be deemed properly submitted and complete if the following requirements, in addition to the requirements of Ga. Comp. R. & Regs., r. 111-2-2-.06(5)(b) , are met:

The appropriate Certification Statement of Completeness is submitted simultaneously with the original application; and
All of the items addressed in the Certification Statement of Completeness are provided, as certified, with the original application.

(f) In the event that an application is deemed in receipt by (d) above, but is not deemed to be properly submitted and complete by (e) above by 12:00 PM on the twenty-fifth (25th) calendar day following the date that the Department receives the notice of intent (in the event that the twenty-fifth (25th) calendar day falls either on a weekend or a legal holiday, the twenty-fifth (25th) calendar day shall become automatically the next business day that is neither a weekend nor a legal holiday), the application will be disqualified from the batching review.

(g) The batching review cycle will be conducted in the following manner:

The batching review cycle shall be one hundred and twenty (120) days in duration. As a result, no party participating in the batching review process, including the Department, shall either request or be granted an extension of time past the one hundred and twentieth (120th) day.
The first day of the batching review cycle shall be the day upon which all properly submitted applications are deemed to be received. [See Ga. Comp. R. & Regs., r. 111-2-2-.08(1)(d) above.]
On or before the thirtieth (30th) day of the batching review cycle, the Department shall provide the applicant(s) an opportunity to meet with the Department. The Department will describe any issues with the application and provide an opportunity to the applicant(s) to amend or withdraw the application or to submit additional information. Any and all additional information must be submitted on or before the forty-fifth (45th) day of the batching review cycle. The thirty (30) day meeting with the applicant(s) is restricted to the Department and the applicant(s). Parties opposing an application(s) may not attend or participate in an applicant thirty (30) day meeting.
Any party who is opposed to one or more applications submitted during a batching cycle must submit a notice of opposition via the Department's web portal, on the form provided by the Department, no later than thirty (30) days of receipt by the Department of such application. The notice must contain the information specified by the form. The notice of opposition form submission shall also include one signed original of the written vendor lobbyist certification required by Ga. Comp. R. & Regs., r. 111-1-2-.03(2) . The notice of opposition must not contain the substantive arguments against a particular application. Those parties who are opposed to an application will be given an opportunity to meet with the Department at a time and place specified by the Department after a review of the opposition notices. The opposition meeting, provided for by O.C.G.A. § 31-6-43(h), shall be held no earlier than the sixtieth (60th) day of the batching review cycle. The applicant(s) shall be entitled to attend the opposition meeting. Only one designated person on behalf of each party opposed to a particular application will be allowed to speak on behalf of the opposition to said application at the opposition meeting. The time period provided for that opposition spokesperson shall be determined in the sole discretion of the Department. The applicant(s) will not be allowed to speak in rebuttal of the opposition remarks at the opposition meeting. The Department shall make no formal substantive comments regarding the review of the application(s) at the opposition meeting. The opposition parties shall submit via the Department's web portal, substantive written comments and arguments regarding the nature of their opposition to the particular project. The opposition parties must provide one copy of the substantive opposition comments to the applicant at the opposition meeting. In order for an opposing party to have standing to appeal an adverse decision pursuant to O.C.G.A. § 31-6-44, such party must attend and participate in an opposition meeting. Substantive opposition comments must pertain to only one application and one applicant. In no case shall the Department accept substantive opposition comments that concern multiple applicants or applications. Applicants shall be given the opportunity to submit final amendments and/or letters of support for a particular application pursuant to and in compliance with Ga. Comp. R. & Regs., r. 111-2-2-.06(6) via the Department's web portal no later than the ninetieth (90th) day of the batching review cycle.
Applicants shall be given the opportunity to respond to the substantive opposition comments made orally and submitted in writing at the opposition meeting. The last day for the applicant(s) to respond to the opposition meeting comments, shall be the seventy-fifth (75th) day of the batching review cycle. The Department reserves the right, but is not required to, ask the applicant(s) for information in response to the substantive opposition comments. If the Department asks the applicant for information as a result of the comments provided at the opposition meeting, the applicant must submit the information requested no later than the seventy-fifth (75th) day of the batching review cycle.
No later than the one hundred and twentieth (120th) day of the batching review cycle, the Department shall provide written notification of its decision to issue or deny a Certificate of Need to the pertinent applicant(s).

(h) In evaluating batched applications, if any or all of the batched applications equally meet the statutory considerations, priority consideration will be given to a comparison of the applications with regard to:

The past and present records of the facility, and other existing facilities in Georgia, if any, owned by the same parent organization, regarding the provision of service to all segments of the population, particularly including Medicare, Medicaid, minority patients and those patients with limited or no ability to pay;
Specific services to be offered;
Appropriateness of the site, i.e., the accessibility to the population to be served, availability of utilities, transportation systems, adequacy of size, cost of acquisition, and cost to develop;
Demonstrated readiness to implement the project, including commitment of financing;
Patterns of past performance, if any, of the applicants in implementing previously approved projects in a timely fashion;
Past record, if any, of the applicant facility, and other existing facilities owned by the same parent organization, if any, in meeting licensure requirements and factors relevant to providing accessible, quality health care;
Evidence of attention to factors of cost containment, which do not diminish the quality of care or safety of the patient, but which demonstrate sincere efforts to avoid significant costs unrelated to patient care; and
Past compliance, if any, with survey and post-approval reporting requirements and indigent and charity care commitments.

(i) In the event of a favorable decision, the Department's notification letter shall serve as the Certificate of Need. The date of the decision shall be the date on the notification letter of the Department. The decision shall be to approve or deny the application(s) as submitted or as amended by the applicant(s) during the course of the batching review cycle, whichever is applicable. The effective date of the Certificate shall be the decision or approval date if not appealed. If administratively appealed in a timely fashion, the effective date of the Certificate shall be the date of final resolution of any administrative hearing. The Department may stay the effective date of a project appealed through judicial process at the request of any party to such appeal or upon the Department's own initiative. Any determination by the Department to stay the effective date will be based upon sound health planning principles. If the Department stays the effective date of a project appealed through judicial process, the effective date shall be the date of final resolution of any judicial appeal.

(j) The decision letter shall contain at least the following:

A detailed statement of the findings related to each applicable consideration and standard relevant to the decision to issue or deny a Certificate of Need; and
Information pertaining to the availability of an appeal hearing.

(k) A copy of the notification letter shall be sent to the applicant(s), to the appropriate Regional Development Center and to the chief elected official of the applicable county and municipal government, if any. The Department's decision shall be subject to the provisions of the Open Records Act.

(l) Appeals of the Decision of the Department shall be in accordance with the Rules promulgated by the Certificate of Need Appeal Panel found in Ga. Comp. R. & Regs. Chapter 274.

(2) Alternative Healthcare Models

(a) Applicability.

For Certificate of Need purposes, Alternative Healthcare Models are defined as new and/or innovative models of providing new or existing institutional health services delivered in a proposed or existing healthcare facility.
For Certificate of Need purposes, the applicant for an Alternative Healthcare Model CON will be as follows:

(i) If the service(s) will be provided within a single healthcare facility, the owner of that facility will be the applicant;

(ii) If the service(s) will be provided within two or more healthcare facilities that are part of a healthcare services network, the owner(s) of the facility(ies) in which the service(s) will be provided will be the co-applicant(s).

The Department shall evaluate the performance of the Alternative Healthcare Model according to the scope as defined by the Department decision and the standards set forth in these Rules. If after a review the Department determines that the Alternative Healthcare Model does not meet the defined scope or expected standards, the Department may either immediately revoke the Certificate of Need or grant a specified time period during which the Alternative Healthcare Model must meet the defined scope and the expected standards or lose its Certificate of Need.

(b) Definitions

"Alternative healthcare model" means a new and/or innovative model of providing new or existing institutional health service(s) delivered in or through a healthcare facility(ies) and/or healthcare services networks.
"Authorized service" means a Department sanctioned Alternative Healthcare Model, which is either existing or approved. An existing service is an authorized service, which has become operational, and an approved service is an authorized service, which has not yet become operational.
"Board" means the Board of Community Health.
"Health care facility", as defined at O.C.G.A. § 31-6-2(17) , means hospitals; destination cancer hospitals; other special care units, including but not limited to podiatric facilities; skilled nursing facilities; intermediate care facilities; personal care homes of at least twenty-five (25) beds; ambulatory surgical or obstetrical facilities; freestanding emergency departments or facilities not located on a hospital's primary campus; health maintenance organizations; home health agencies; diagnostic, treatment, or rehabilitative centers, but only to the extent that O.C.G.A. § 31-6-40(a)(3) or (7) or both are applicable thereto.
"Healthcare services network" means a collaborative arrangement that consists of at least one healthcare facility plus one or more physician groups and/or one or more third party payers, or a collaborative arrangement that includes at least two or more healthcare facilities.
"Most recent year" means the most recent calendar year prior to submission of an application.
"Official inventory" means the inventory of all authorized Alternative Healthcare Models maintained by the Department based on CON approval and official Department records.
"Official state component plan" means the most recent document(s) that is/are most closely related to those services being provided by the Alternative Healthcare Model. The most recent document(s) will have been developed by the Department and approved by the Board.
"State health policies" means the most recent policies developed by the Board, which provide a framework for the service-specific policies included within each component of the State Health Plan. These state health policies include health promotion, financial accessibility, least restrictive care, regionalization, cost containment, health planning and citizen participation, healthcare personnel, and healthcare data and information networks.

Within the period of April 1 through May 31 of each year, the Board may accept abstracts describing potential Alternative Healthcare Models, based on the recommendation of the Department. The Board will review these abstracts, if any are solicited for that year, by August 31 of that year and select a list of those categories for which Alternative Healthcare Model Certificate of Need applications may be submitted.
Within thirty (30) days of the determination by the Board of the particular categories under which Alternative HealthCare Model Certificate of Need applications may be submitted, the Department shall provide notice of these categories to all interested parties. The notice shall contain:

(i) the listing of category(ies) related goals and desired outcomes and the probable scope of services;

(ii) the pertinent time frames and deadlines for submission of notices of intent to apply for Alternative Healthcare Model Certificate of Need;

(iii) the pertinent time frames and deadlines for submission of CON applications; and

(iv) the pertinent time frames and deadlines for the review of such applications, and any related criteria for review.

(d) Intent to Apply

All parties wanting to apply for Alternative Healthcare Model Certificates of Need under the selected categories must notify the Department of that party's intent to apply.
This notice must be:

(i) in writing, submitted via the Department's web portal, and must address specifically the particular category under which the applicant intends to apply;

(ii) received by the Department no later than the close of business on the sixtieth (60th) calendar day following the date that the Department publishes the notice of the selected categories. In the event that the sixtieth (60th) calendar day falls on either a weekend or a legal holiday, the sixtieth (60th) calendar day shall become automatically the next business day that is neither a weekend nor a legal holiday; and

(iii) in the event that the Department fails to receive the notice of intent to apply by the stated deadline, the interested party automatically shall be disqualified from applying during that particular review cycle.

(e) Application Process

Certificate of Need applications pertaining to the selected categories will be submitted via the Department's web portal on or before 3:00 p.m. June 1 of the year following the year in which the categories were selected by the Board. (Although applications may be submitted prior to 3:00 p.m. June 1, all applications will be deemed received on June 1.) In the event that June 1 falls either on a weekend or a legal holiday, the day of submission shall become automatically the next business day that is neither a weekend nor a legal holiday;
Alternative Healthcare Model Certificate of Need applications must comply with the requirements in Ga. Comp. R. & Regs., r. 111-2-2-.06(2) and (3) .
For the purposes of Alternative Healthcare Model Certificate of Need applications, an application will be deemed properly submitted if the following requirements are met:

(i) a summary of the Certificate of Need application is included to be used as information for the Board and general public;

(ii) a Certification Statement of Completeness is included designating under which category the application is being submitted; and

(iii) all items addressed in the Certification Statement of Completeness are provided with the application.

(f) The Review Cycle

The review cycle shall be automatically one hundred and twenty (120) days in duration. As a result, no party participating in the review process, including the Department, shall either request or be granted an extension of time past the one hundred and twentieth (120th) day;
The first day of the review cycle shall be the day upon which all properly submitted applications are deemed to be received as specified in Ga. Comp. R. & Regs., r. 111-2-2-.08(2)(e) .

(a) In the event that an application is deemed in receipt by (e)1. above, but does not comply with the requirements of (e)2. and (e)3. above by 3:00 p.m. on June 1 of the year following the year in which the categories were selected by the Board, the application will be disqualified from the review.

Reserved .
Reserved .
If the review indicates potential for denial of the application(s), the Department, on or before the thirtieth (30th) day of the review cycle, shall provide the applicant(s) an opportunity to meet with the Department. The problems with the application(s) will be described and an opportunity offered to amend or withdraw the application or to submit additional information. Any and all additional information must be submitted on or before the forty-fifth (45th) day of the review cycle.
Any party who is opposed to one or more applications submitted during the review cycle must submit a notice of opposition via the Department's web portal, on the form provided by the Department, no later than thirty (30) days of receipt by the Department of such application. The notice must contain the information specified by the form. The notice of opposition form submission shall also include one signed original of the written vendor lobbyist certification required by Ga. Comp. R. & Regs., r. 111-1-2-.03(2) . The notice of opposition must not contain the substantive arguments against a particular application.

(a) The last day for interested parties (including, but not limited to, competing applicant(s) and/or existing competing health care facilities) to submit letters of opposition addressing the underlying merits, or lack thereof, of any pending application(s) shall be the sixtieth (60th) day of the review cycle and must be submitted via the Department's web portal.

(b) Any letters of opposition that are received after the sixtieth (60th) day of the review cycle shall not be considered by the Department in its review of the pertinent application(s) and the letter(s) shall not become part of the master file compiled for the pertinent application(s).

(c) Those parties who are opposed to an application will be given an opportunity to meet with the Department at a time and place specified by the Department after a review of the opposition notices. The opposition meeting, provided for by O.C.G.A. § 31-6-43(h) , shall be held no earlier than the sixtieth (60th) day of the review cycle. The applicant(s) shall be entitled to attend the opposition meeting. Only one designated person on behalf of each party opposed to a particular application will be allowed to speak on behalf of the opposition to said application at the opposition meeting. The time period provided for that opposition spokesperson shall be determined in the sole discretion of the Department. The applicant(s) will not be allowed to speak in rebuttal of the opposition remarks at the opposition meeting. The Department shall make no formal substantive comments regarding the review of the application(s) at the opposition meeting.

(d) Applicants shall be given the opportunity to respond to the letters of opposition by the seventy-fifth (75th) day of the review cycle.

The last day for applicant(s) to submit final amendments and letters of support shall be the ninetieth (90th) day of the review cycle.
No later than the one hundred and twentieth (120th) day of the review cycle, the Department shall provide a written letter notifying the applicant of the decision to issue or deny a Certificate of Need to the pertinent applicant(s).
In the event of a favorable decision, this letter shall serve as the Certificate of Need. The date of the decision shall be the date on the notification letter from the Department. The decision shall be to approve or deny the application(s) as submitted or as amended by the applicant(s) during the course of the review cycle, whichever is applicable.
The decision letter shall contain at least the following:

(i) a detailed statement of the findings related to each applicable consideration and standard relevant to the decision to issue or deny a Certificate of Need; and

(ii) information pertaining to the availability of an appeal hearing.

A copy of the notification letter shall be sent to the applicant(s), to the appropriate Regional Development Center and to the chief elected official of the applicable county and municipal government, if any. The Department's decision shall be subject to the provisions of the Open Records Act.
Appeals of the decision of the Department shall be in accordance with the Rules promulgated by the Certificate of Need Appeal Panel.

(g) Standards

An Alternative Healthcare Model must be consistent with the State Health Policies adopted by the Board.
An Alternative Healthcare Model must clearly define its target population/community.
An Alternative Healthcare Model must:

(i) include a hypothesis(es) to be tested within a time-limited period not to exceed five (5) years;

(ii) demonstrate, as applicable, how it will support research, new service development, health professional education and training, and/or affiliation with an academic center of higher learning; and

(iii) demonstrate that the community supports the Alternative Healthcare Model.

An applicant for an Alternative Healthcare Model CON shall demonstrate the feasibility of operating the Alternative Healthcare Model in Georgia, based on a review of the experience in other states including the impact on health professionals of other healthcare programs or facilities and how the project is impacted by payers and regulatory entities.
An applicant for an Alternative Healthcare Model CON shall demonstrate the potential of the Alternative Healthcare Model to reduce healthcare costs to consumers, third party payors and the system as a whole.
An applicant for an Alternative Healthcare Model CON shall demonstrate the potential of the Alternative Healthcare Model to maintain or improve the standards of healthcare quality in some measurable fashion.
An applicant for an Alternative Healthcare Model CON shall demonstrate the potential of the Alternative Healthcare Model to provide increased choices or access for consumers to a continuum of services within the target community.
An applicant for an Alternative Healthcare Model CON shall demonstrate the potential of the Alternative Healthcare Model to meet existing or emerging health status and/or health system needs.
For any applicant that meets the requirements of this Rule the Department may waive all or part of otherwise applicable service-specific Ga. Comp. R. & Regs., r. 111-2-2-.20 et seq.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Alternative Application and Review Procedures" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.08, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.09 General Review Considerations {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.09}

(1) General Considerations. The burden of proof for producing information and evidence that an application is consistent with the applicable considerations and review policies, which follow, shall be on the applicant. In conducting review and making findings for Certificates of Need, the Department will consider whether:

(a) the proposed new institutional health services is reasonably consistent with the relevant general goals and objectives of the State Health Plan. The goals and objectives related to issues and addressed in the State Health Plan, which are relevant to the Certificate of Need proposal, will be considered in the review. It should be recognized that the goals of the State Health Plan express the ideal and, in some respects, may be incompatible with the concept of cost containment. The statutes and Rules represent the final authority for review decisions and the content of the Plan, or any component thereof shall not supersede the Rules in such determination;

(b) the population residing in the area served, or to be served, by the new institutional health service has a need for such services;

Population projections used by the Department will be resident population figures prepared or approved by the Office of Planning and Budget or other official figures that may be applicable as determined by the Department.
Updated resident population projections will be utilized upon the official effective date as stated by the Department, pursuant to these Rules, replacing and superseding the older data.
The projection period or horizon year for need determinations will be five years for hospital services and three years for all other services, unless otherwise provided by the Rules for the specified service. The projection period or horizon year will be advanced to the next projection year or horizon year on or about April 1 of each year.
Inpatient facilities will be inventoried on the basis of bed capacity approved, grandfathered, or authorized through the Certificate of Need process regardless of the number of beds in operation at any given time or which may be licensed by the Healthcare Facility Regulation Division.
Data sources to be utilized by the Department to evaluate need, population characteristics, referral patterns, seasonal variations, utilization patterns, financial feasibility, and future trends will include, but not be limited to, the following:

(i) any surveys required by the Department, including but not limited to those for hospitals, nursing facilities, home health agencies, specialized services, and ambulatory surgery facilities;

(ii) Cost reports submitted to fiscal intermediaries and the Department;

(iii) periodic special studies or surveys, as produced or formally adopted or used by the Department;

(iv) the United States Census and other studies conducted by the Census and other Federal and State agencies and bureaus, including but not limited to, the Department of Labor; and

(v) such other data sources utilized by the Department for measurement of community health status. Such data may include information submitted by the applicant pursuant to Ga. Comp. R. & Regs. 111-2-2-.06(2)(f) , which may be necessary for the Department to ensure that the project is consistent with applicable general consideration provisions.

All data used by the Department in a Certificate of Need review will be available to the applicant on request, in accordance with Department policies on requested information. The most recent data reported and validated will be used in the analysis of a proposal.

(c) existing alternatives for providing services in the service area the same as the new institutional health service proposed are neither currently available, implemented, similarly utilized, nor capable of providing a less costly alternative, or no Certificate of Need to provide such alternative services has been issued by the Department and is currently valid

The Department supports the concept of regionalization of those services for which a service-specific Rule exists.
The Department shall consider economies of scale where need exists for additional services or facilities.
Utilization of existing facilities and services similar to a proposal to initiate services shall be evaluated to assure that unnecessary duplication of services is avoided. Where there exists significant unused capacity, initiating a similar service in another health care facility would require strong justification under other criteria.

(d) the project can be financed adequately and is in the immediate and long term, financially feasible;

(e) the effects of the new institutional health service on payors for health services, including governmental payors, are reasonable;

(f) the costs and methods of a proposed construction project, including the costs and methods of energy provision and conservation, are reasonable and adequate for quality health care. Construction plans will be reviewed in detail to assure that space is designed economically. Space shelled-in for some future use will not be accepted unless the applicant demonstrates that the shelled-in space will not be directly related to the provision of any clinical health service;

(g) the new institutional health service proposed is reasonably financially and physically accessible to the residents of the proposed service area and will not discriminate by virtue of race, age, sex, handicap, color, creed or ethnic affiliation;

In accordance with the provision found in O.C.G.A. § 31-6-42(7) , the Department will evaluate the extent to which each applicant applying for a Certificate of Need participates in a reasonable share of the total community burden of care for those unable to pay. This provision shall not apply to applicants for life plan communities, skilled nursing facilities or units, and to projects that are reviewed by the Department on an emergency basis in accordance with Ga. Comp. R. & Regs., r. 111-2-2-.07(1)(k) . In all other instances, the following indicators will be evaluated:

(i) administrative policies and directives related to acceptance of indigent, medically indigent, and Medicaid patients;

(ii) policies relating medical staff privileges, if applicable, to reasonable acceptance of emergency referrals of Medicaid and PeachCare patients and all other patients who are unable to pay all or a portion of the cost of care;

(iii) evidence of specific informational efforts targeted toward patients regarding arrangements for satisfying charges;

(iv) documented records of refunds, if any, received from the Federal, State, county, city, philanthropic agencies, donations, and any other source of funds other than from direct operations, such as indigent care trust fund distributions and disproportionate share payments, if applicable;

(v) the applicant's commitment to participate in the Medicare/Medicaid and PeachCare programs; to provide legitimate emergency care, if applicable, regardless of ability to pay; and to provide indigent and charity care; and

(vi) documented records of care provided to patients unable to pay, Medicare and Medicaid contractual adjustment, Hill-Burton payments (if applicable), other indigent care, and other itemized deductions from revenue including bad debt. Such records shall demonstrate that the levels of care provided correspond to a reasonable proportion of those persons who are medically or financially indigent and those who are eligible for Medicare or Medicaid within the service area.

The evaluation in 1. above is in addition to satisfaction of a minimum indigent and charity care commitment required by prior CON(s), if any.

(h) the proposed new institutional health service has a positive relationship to the existing health care delivery system in the service area;

(i) the proposed new institutional health service encourages more efficient utilization of the health care facility proposing such service;

(j) the proposed new institutional health service provides, or would provide a substantial portion of its services to individuals not residing in its defined service area or the adjacent service area;

(k) the proposed new institutional health service conducts biomedical or behavioral research projects or new service development that is designed to meet a national, regional, or statewide need;

(l) the proposed new institutional health service meets the clinical needs of health professional training programs;

(m) the proposed new institutional health service fosters improvements or innovations in the financing or delivery of health services; promotes health care quality assurance or cost effectiveness; or fosters competition that is shown to result in lower patient costs without a significant deterioration in the quality of care;

(n) the proposed new institutional health service fosters the special needs and circumstances of Health Maintenance Organizations;

(o) the proposed new institutional health service meets the Department's minimum quality standards, including, but not limited to, standards relating to accreditation, minimum volumes, quality improvements, assurance practices, and utilization review procedures;

(p) the proposed new institutional health service can obtain the necessary resources, including health care management personnel; and

(q) the proposed new institutional health service is an underrepresented health service, as determined annually by the Department. The Department shall, by rule, provide for an advantage to equally qualified applicants that agree to provide an underrepresented service in addition to the services for which the application was originally submitted.

(2) Reserved.

(3) General Cancer Hospital

(a) On and after July 1, 2019, a destination cancer hospital, approved prior to January 1, 2010, may apply for a letter of determination in accordance with O.C.G.A. § 31-6-40(a)(8) .

(b) Upon its receipt of a complete application for a destination cancer hospital to convert to a general cancer hospital, the Department shall issue such determination within 60 days.

The general cancer hospital may continue to provide all institutional health care services and other services it provided as of the date of such conversion, including but not limited to inpatient beds, outpatient services, surgery, radiation therapy, imaging, and positron emission tomography (PET) scanning, without any further approval from the Department;
The destination cancer hospital shall be classified as a general cancer hospital under this chapter and shall be subject to all requirements and conditions applicable to hospitals under this article, including but not limited to, indigent and charity care and inventories and methodologies to determine need for additional providers or services; and
The hospital's inpatient beds, operating rooms, radiation therapy equipment, and imaging equipment existing on the date of conversion shall not be counted in the inventory by the Department for purposes of determining need for additional providers or services, except that any inpatient beds, operating rooms, radiation therapy equipment, and imaging equipment added after the date of conversion shall be counted in accordance with the Department's rules and regulations.

(d) In the event that a destination cancer hospital does not convert to a general cancer hospital, it shall remain subject to all requirements and conditions applicable to destination cancer hospitals under this article.

(4) In the case of applications for basic perinatal services in counties where:

(a) Only one civilian health care facility or health system is currently providing basic perinatal services; and

(b) There are not at least three (3) different health care facilities in a contiguous county providing basic perinatal services, the Department shall not apply the consideration contained in paragraph (b) of section (1) of this Rule.

(5) Osteopathic Considerations. When an application is made for a Certificate of Need to develop or offer a new institutional health service or health care facility for osteopathic medicine, the need for such facility shall be determined on the basis of the need and availability in the community for osteopathic services and facilities. Nothing in this chapter shall, however, be construed as recognizing any distinction between allopathic and osteopathic medicine.

(6) Minority-Administered Hospital Considerations. If the denial of an application for a Certificate of Need for a new institutional health service proposed to be offered or developed by a minority-administered hospital serving a socially and economically disadvantaged minority population in an urban setting, or by a minority-administered hospital utilized for the training of minority medical practitioners, would adversely impact upon the facility and population served by said facility, the special needs of such hospital facility and the population to be served by said facility for the new institutional health service shall be given extraordinary consideration by the Department in making its determination of need. The term "minority-administered" means a hospital controlled or operated by a governing body or administrative staff composed predominantly of members of a minority race. The Department shall have the authority to vary or modify strict adherence to the provisions of Code Chapter 31-6-42(c) and this Chapter in considering the special needs of said facility and its population served and to avoid an adverse impact on the facility and the population served thereby.

(7) Considerations for Joined Applications.

(a) In evaluating joined applications, if the services proposed are found to be needed, and if any or all applications equally meet the statutory considerations, priority consideration will be given to a comparison of the applications with regard to:

the past and present records of the facility, and other existing facilities in Georgia, if any, owned by the same parent organization, regarding the provision of service to all segments of the population, particularly including Medicare, Medicaid, minority patients and those patients with limited or no ability to pay;
specific services to be offered;
appropriateness of the site, i.e., the accessibility to the population to be served, availability of utilities, transportation systems, adequacy of size, cost of acquisition, and cost to develop;
demonstrated readiness to implement the project, including commitment of financing;
patterns of past performance, if any, of the applicants in implementing previously approved projects in timely fashion;
past record, if any, of the applicant facility, and other existing facilities owned by the same parent organization, if any, in meeting licensure requirements and factors relevant to providing accessible, quality health care;
evidence of attention to factors of cost containment, which do not diminish the quality of care or safety of the patient, but which demonstrate sincere efforts to avoid significant costs unrelated to patient care;
past compliance, if any, with survey and post-approval reporting requirements and indigent and charity care commitments;
hospital and physician collaborations that promote greater cost efficiency to patients, ensure greater quality assurance outcomes and foster positive relationships within the existing healthcare delivery network which benefits both providers and members within the impacted service area population; and
proposed services that include or involve a clinical healthcare service that is or has been underrepresented in the proposed service area for more than twelve (12) months as evidenced by geographical barriers to the service, insufficient staffing to provide the service and/or recent termination of the service in the proposed planning area.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "General Review Considerations" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Nov. 13, 2007; eff. Dec. 3, 2007.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.09, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.10 Determinations {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.10}

(1) General Provisions Relating to Determinations

(a) Determinations are conclusions of the Department that are based on specific facts and are limited to the specific issues addressed in the request for determination, as applicable. Therefore, the conclusions of a specific determination shall have no binding precedent in relation to parties not subject to the request and to other facts or factual situations that are not presented in the request.

(b) This Rule shall not be construed as providing an administrative remedy for decisions made by the Department pursuant to O.C.G.A. § 31-6-43 , which involve the approval or denial of applications for certificates of need.

(c) A person requesting a determination shall make such a request in writing and shall specify in detail all relevant facts, which relate to the proposed action or course of conduct. The request shall be submitted via the Department's web portal. The Department shall respond to the request in writing. The request shall include, at a minimum, the following components:

a statement citing by appropriate reference the statutory provision or other authority under which the request is to be granted by the Department.
the exact legal name of each person whose rights are affected and who is requesting a determination and the address or principal place of business of each such person. A request may be submitted by an attorney or other party on behalf of such person, but the request must include the information required by this subsection relating to the person whose rights are affected;
The name, title, address, telephone number, facsimile telephone number and electronic mail address of the attorney or other person, if any, to whom correspondence or communications in regard to the request shall be addressed; and
An explanation of any unusual circumstances involved in the request which the Department will be expected to direct its particular attention, including the existence of emergency conditions.

(d) Requests for determination shall address only one matter per request.

(e) Requests for determination shall be submitted pursuant to and in compliance with Ga. Comp. R. & Regs., r. 111-2-2-.06(6) . Such requests shall also include one signed original of the written vendor lobbyist certification required by Ga. Comp. R. & Regs., r. 111-1-2-.03(2) .

(f) Requests for determination shall include payment of a request fee. Payment of the fee shall be by credit/debit card via the Department's website, certified check, or money order made payable to the State of Georgia Department of Community Health and must be received by the Department before a determination request will be reviewed. Failure to provide payment of the appropriate fee will result in non-acceptance of the request.

The request fee for determination shall be $500.00;
State-owned institutions shall be exempt from payment of these fees; and
The Department may waive payment of these fees for certain hospital authority facilities and for certain public non-profit providers when the Department determines that financial circumstances exist, which would justify such action. Such requests for waiver must be received at the time of the initial request.

(2) Letters of Determination. Pursuant to O.C.G.A. § 31-6-47 , if a person believes or has reason to believe that the application of a Department Rule or statutory provision may directly affect or impair the legal rights of that person as to some proposed action or course of conduct being considered by that person, including, but not limited to, determinations regarding reviewability, grandfathering decisions, and relocation or replacement determinations, such person may request a written determination from the Department regarding the application of such Department Rule or statutory provision upon that person's proposed action or course of conduct. A determination request is distinguished from a general question as a determination does not address general issues relating to policy and procedure. Any person proposing an activity that would make it a health care facility unless exempted from prior CON review and approval pursuant to O.C.G.A. § 31-6-47, or any other part of the CON statute at O.C.G.A. § 31-6 et seq. shall be required to, pursuant to O.C.G.A. § 31-6-47.1, submit a request for a letter of determination from the Department. The Department's written response which confirms that the proposed activity is exempt from review shall act as the official confirmation of exemption provided in this Code section. A party is not authorized to commence or undertake the activity in question which it believes to fall within any one or more of the statutory exemptions in O.C.G.A. § 31-6-47 until written approval is issued by the Department in response to a request for a letter of determination as provided in this Rule. The Department requires submission of a request for a letter of determination for any activity which is believed to be exempt pursuant to paragraphs (10), (10.1), (14), (15), (17), (18), (19), (20), (21), (22), (24), (26), (27), (28), (29), (30), (31), (31.1), (32), (33), and (34) of subsection (a) of Code Section 31-6-47 and Ga. Comp. R. & Regs., r. 111-2-2-.03 (14), (15), (16), (17), (18), (20), (21), (22), (23), (24), (25), (29), (30), (31), (32), (33), (33.1), (34), (35), and (36). The Department requires submission of a request for a letter of determination for any activity which is believed to be exempt pursuant to paragraph (25) of subsection (a) of Code Section 31-6-47 and Ga. Comp. R. & Regs., r. 111-2-2-.03 (28), which establish a new health care facility. In reviewing a determination request to relocate all or a portion of an existing skilled nursing facility, intermediate care facility, or intermingled nursing facility, pursuant to O.C.G.A. § 31-6-47(a)(24) and Ga. Comp. R. & Regs., r. 111-2-2-.03(27), the Department may allow such facility to divide into two or more such facilities if the Department determines that the proposed division is financially feasible and would be consistent with quality patient care. Under no circumstances will the Department allow, via a favorable determination, a facility as listed above to relocate as one facility, or divide into more than one facility, with more than the total number of beds authorized in the facility's location prior to any relocation and/or division.

(a) No person shall be entitled to request a determination that relates to an actual or proposed action or course of conduct which has been taken or which would be taken by a third party; and

(b) In addition to the requirements of Ga. Comp. R. & Regs., r. 111-2-2-.10(1) , a determination request shall include a concise and explicit iteration of the facts on which the Department is expected to rely in granting the determination.

(c) The Department shall establish timeframes, forms, and criteria to request a letter of determination that an activity is properly exempt or excluded under this chapter prior to its implementation.

If no objection to a request for determination is filed within 30 days of the Department's receipt of such request for Determination, the Department shall have 60 days from the date of the Department's receipt of such request to review the request and issue a letter of determination.
Where conditions exist which make it impractical to complete a review in 60 days, the Department may, on notification to the requester, extend the time limit another 30 days to 90 days.

(d) The Department shall publish notice of all requests for letters of determination regarding exempt activity and opposition to such request.

(e) Reserved.

(3) Requests for Letters of Determination for Diagnostic, Therapeutic, or Other Imaging Equipment. A party requesting a letter of determination for the acquisition of diagnostic, therapeutic, or other imaging equipment must submit with the request a sworn affidavit from a person capable of making a binding commitment on behalf of the party containing the following affirmations:

(a) that the affiant is:

a hospital; or
an individual private physician or single group practice of physicians and is

(i) acquiring the equipment exclusively for use on patients of such private physician or single group practice of physicians; and

(ii) such private physician or member of such single group practice of physicians is physically present at the practice location where the diagnostic or other imaging equipment is located at least seventy-five percent (75%) of the time that the equipment is in use.

that the affiant is capable of making a binding commitment on behalf of the party;
Reserved.
Reserved .
Reserved.
Reserved .
Reserved .
Reserved .

(b) Reserved .

Reserved .
Reserved .
Reserved .
Reserved .
Reserved .
Reserved .
Reserved .
Reserved .
Reserved .
Reserved .
Reserved .
Reserved .

(d) Reserved .

(e) Reserved .

(f) A letter of determination for the acquisition of diagnostic, therapeutic, or other imaging equipment shall be valid only for the defined equipment, physical location, cost, and entity or person named in the request as the acquirer and operator of the equipment and only to the pertinent facts that were disclosed in the request. Such letters are non-transferable and may not be acquired. If the facts pertinent to the letter of determination change in any way, the letter is no longer valid;

(g) Upon completion of the acquisition of the equipment, the party requesting a determination shall submit a final statement of project completion. If the acquisition of the equipment and associated activities are not completed within one hundred and eighty (180) days of the issuance of the determination, the party requesting a determination shall submit an interim statement within two weeks of the end of that one hundred and eighty (180) day period and within two weeks of the end of each succeeding ninety (90) day period until the final statement is submitted upon completion of the acquisition. Each of the interim statements shall disclose any good faith estimates of the percentage of completion. The accuracy and completeness of the interim and final statements shall be verified by sworn affidavits from an authorized owner or officer of the party requesting a determination. Failure to comply with the provisions of this subsection may result in the rescission of the determination issued.

(4) Requests for Letters of Determination for Exempt Single Specialty or Joint Venture Ambulatory Surgical Centers.

(a) When the Department receives a request for a letter of determination for the establishment of a physician-owned, single specialty, office-based ambulatory surgery facility, or a joint venture ambulatory surgical center, pursuant to O.C.G.A. § 31-6-2(33), (23) , and O.C.G.A. § 31-6-47(a)(18), (19) , the party requesting such a letter must comply with the following:

Identify the name and address of the proposed ambulatory surgery facility, including the principal business address of the sole physician or group practice that will own the facility.
Identify the individual private physician, or all owners (e.g. stockholders, partners, members) of the single group practice of private physicians who are also on the same single specialty, that will own, operate, and utilize the proposed facility. All members of the single group practice must be of the same specified surgical specialty. Physicians who perform procedures within the single specialty ambulatory surgical center must own at least eighty-five percent (85%) of the group practice and the surgery center. The Department will issue a determination, if all other criteria are met, to a single group practice which utilized the services of employee physicians of the same specialty in the surgery center if these employee physicians are not a member or employee of any other medical practice. All employee physicians must be identified, and an affirmative statement with regard to their practice affiliation must be included. Such ambulatory surgical center shall only be utilized by physicians who are of the same single specialty, who may include physicians who are not owners or employees of the individual private physician or single group practice of private physicians that own and operate the center. The Department will allow no more than fifteen percent (15%) non-physician ownership in the physician(s) practice requesting a determination, and/or the surgery center in a single specialty ambulatory surgical center. Evidence of non-physician ownership, including the percentage of such ownership, must be provided with the determination request. For a joint venture ambulatory surgical center, the ownership interest of the hospital shall be no less than thirty percent (30%) and the collective ownership of the physicians or group of physicians shall be no less than thirty percent (30%). Any evidence of non-hospital or non-physician or group of physician's ownership in a joint venture ambulatory surgical center must be provided with the determination request.
All physicians who utilize the surgery center must be licensed to practice in the state of Georgia, and must submit a copy of such license; should any physician members of a single group practice perform procedures in the ambulatory surgery facility created by the issuance of a determination lose their license to practice medicine in Georgia, the determination shall be revoked, unless within sixty (60) days of such physician losing their license, the group practice submits new evidence documenting that the physician ownership of the facility by the group practice does not include the physician who lost their license.
Submit evidence of the sole physician professional corporation or the entity comprising the single group practice of private physicians, to include authorizing and governing documents such as articles of incorporation, by-laws, operating agreements, partnership agreements, etc. Submit a sworn affidavit, signed by the owners, which lists all owners of the sole or group practice and the proposed surgery facility.
The physician(s) must show evidence of ownership by warranty deed or lease of the space housing the ambulatory surgery facility including the clinical office space.
Provide a detailed description of the proximity of the physician's or the group practice's clinical offices to the ambulatory surgery facility. The Department will only grant a determination to those proposed ambulatory surgical facilities, which are deemed to be in reasonable proximity to the clinical offices of the sole physician or single group practice that will own the proposed facility. Reasonable proximity will be determined on a case-by-case basis. Example of reasonable proximity include those ambulatory surgical facilities on the same floor and physically attached to the clinical offices; surgical suites on a different floor of the same building as the clinical offices with one public entrance to the proposed facility.
State the number of operating rooms in the proposed ambulatory surgery facility.
State the total square footage in the proposed ambulatory surgery facility. This total includes the square footage associated with all operating suites, reception and waiting areas, business offices, pre and post-operation areas, all building common areas including a pro rata share of the common areas of buildings utilized by multiple tenants, which are new and/or renovated and involve expenditures to be incurred in the development, construction and establishment of the proposed surgery facility.
List costs attributable to new construction or renovation of the total area comprising the ambulatory surgery facility. Documentation of the total costs of constructing, developing, and establishing the proposed ambulatory surgical facility, and the costs of all items associated with or simultaneously developed with the project, including, but not limited to, fixed equipment not included in the construction contract, moveable equipment, architectural and engineering fees, legal and administrative fees, interim financing (interest during construction), and underwriting costs. The documentation of construction and renovation costs must be in the form of a letter from a licensed Georgia architect verifying the estimated construction costs of the proposed ambulatory surgery facility. With regard to the construction of a new building (or a new wing including space devoted to services other than the surgery center) to house an ambulatory surgery facility, a pro-rata portion of the building shell costs, including all building common areas, must be allocated to the costs of the proposed ambulatory surgery facility. Other costs to be included are:

(i) The cost of new space (even if the space will be leased) based on the construction cost of the new space. Appropriate documentation from an architect licensed in Georgia must be submitted. A copy of all leases must be submitted;

(ii) The cost of all equipment (medical and non-medical) purchases for the ambulatory surgery facility.

(iii) The present value of any equipment to be leased for the surgery facility.

(iv) The Department must have a line item breakdown of all amounts attributable to new construction, renovation, furnishings, leases, and items of equipment in accordance with the provisions outlined above, including new expenditures for furnishings for non-patient care areas such as waiting areas, reception areas, and business offices. The Department will require a sworn affidavit that no party associated with the practice, no party who will utilize the surgery center, and none of the physicians requesting a determination, by virtue of ownership or employment, has incurred any expenditure for equipment of any kind to be utilized in the surgery center that has been subsequently donated to the practice for use in the surgery center and the cost of that equipment, whether purchased or leased, was not included in the dollar threshold applicable to the surgery center.

A schematic floor plan must be provided to the Department. This documentation must be clear and readable. The floor plan must clearly show all areas of the proposed ambulatory surgery facility.
Pursuant to O.C.G.A. § 31-6-2(14) , list the cost of all other items, regardless of whether they are independently subject to Certificate of Need review, that are associated and to be simultaneously developed with the proposed ambulatory surgery facility, except for the expenditure or commitment of funds to develop studies, reports, schematics, preliminary plans and specifications or working drawings, or to acquire sites.
The Department will not issue a determination to any sole physician or single specialty group practice of physicians proposing to bill a professional fee through a larger multi-specialty group practice in which the single specialty group practice requesting the determination remains a part of. For purposes of these Rules, this provision does not preclude the issuance of a determination to a physician(s), which utilizes a larger group practice for the sole purpose of billing services under the provider number of the sole physician or single group practice. Nothing in this section shall prohibit an individual private physician or a single group practice of private physicians from entering into an arrangement with an outside entity for practice management, administrative services, or both.
The Department will not issue a determination to any physician(s) who is a member of more than one single group practice, pursuant to O.C.G.A. § 43-1B-3(5) of the Georgia Patient Self-Referral Law.
The Department will not issue a determination to any group practice of physicians if any members of that group practice are also members of a multi-specialty clinical practice. For purposes of these Rules a multi-specialty clinical group practice does not mean any volume purchasing association or managed care network whose function is managed care contracting in which the physician or group practice participates.
The Department will not issue a determination to any party proposing to share operating rooms or common space in a proposed ambulatory surgical facility between more than one group practice of the same specialty or between more than one surgical group practice of different specialties, or between more than one sole physician of the same or different specialties.
Provide a sworn affidavit, signed by the physician(s) owners, that the party requesting a determination will not incur any additional capital expenditures involving new construction or renovation of physical space or the addition or replacement of equipment within three (3) years after the issuance of the determination, which, when coupled with prior expenditures, would exceed the threshold amount applicable to the statutory exemption for this type of facility unless it first secures a Certificate of Need. A party holding a determination issued by the Department may request, in writing, a waiver from this provision for expenditures for equipment involving newly recognized and innovative medical technologies (FDA approved) present in the marketplace. Any such expenditure will be applied to the original threshold amount unless the written consent of the Department is obtained prior to the expenditure.
Upon completion of construction of the ambulatory surgery facility, the party requesting a determination shall submit a final statement of the total costs of the facility, including a separate line item completed project cost sheet with the same detail and documentation as required in subsection (4)(a)11. above. In addition, if the proposed ambulatory surgery facility is not completed within one hundred and eighty (180) days of the issuance of a determination, the party requesting a determination shall submit an interim statement within two weeks of the end of that one hundred and eighty (180) day period and within two weeks of the end of each succeeding ninety (90) day period until the final statement is submitted upon completion of the facility. Each of the interim statements shall disclose the cost of the facility incurred to date, and any good faith estimates of the percentage of completion of the facility and the amount of costs expected to be incurred to complete the facility. The accuracy and completeness of the interim and final statements shall be verified by sworn affidavits from an authorized owner or officer of the party requesting a determination and from the general contractor. Failure to comply with the provisions of this subsection may result in the rescission of the determination issued.
The determination is not transferable to a purchaser of the sole physician or single group practice, which originally received a determination. This provision is not intended to limit the transferability of a sole physician practice or a group practice but is intended to put the new physician owners on notice that they must request a new determination as new owners of that practice. Such a new request will be evaluated based on the determination criteria applicable at the time of the new request, and the acquisition costs of the practice will not be a part of the applicable capital expenditure threshold.

(b) A single specialty ambulatory surgical center that requests a letter of determination shall provide documentation, in addition to the requirements outlined in section (a) of this Rule above, to show that it:

Has capital expenditures associated with the construction, development, or other establishment of the clinical health service which do not exceed $2,500,000.00; or
Is the only single specialty ambulatory surgical center in the county owned by the group practice and has two or fewer operating rooms; provided, however, that a center exempt pursuant to this provision shall be required to obtain a Certificate of Need in order to add any additional operating rooms;
Has a hospital affiliation agreement with a hospital within a reasonable distance from the facility or the medical staff at the center has admitting privileges or other acceptable documented arrangements with such hospital to ensure the necessary backup for the center for medical complications. The center shall have the capability to transfer a patient immediately to a hospital within a reasonable distance from the facility with adequate emergency room services. A party requesting a letter of determination must provide documentation to support an assertion that a hospital, pursuant to this requirement, has unreasonably denied a transfer agreement or affiliation agreement to the center;
Provides care to Medicaid beneficiaries and, if the facility provides medical care and treatment to children, to PeachCare for Kids® beneficiaries and provides uncompensated indigent and charity care in an amount equal to or greater than two percent (2%) of its adjusted gross revenue and or after January 1, 2026, in an amount equal to or greater than the minimum amount established by the Department which shall be reviewed by the Department every 12 months; or
If the center is not a participant in Medicaid or the PeachCare for Kids Program, provides uncompensated care to Medicaid beneficiaries and, if the facility provides medical care and treatment to children, to PeachCare for Kids® beneficiaries, uncompensated indigent and charity care, or both in an amount equal to or greater than four percent (4%) of its adjusted gross revenue and on after January 1, 2026, in an amount equal to or greater than the minimum amount established by the Department which shall be reviewed by the Department every 12 months; provided, however, single specialty ambulatory surgical centers owned by physicians in the practice of ophthalmology shall not be required to comply with this subparagraph; and
Provides annual reports in the same manner and in accordance with O.C.G.A. § 31-6-70 and Ga. Comp. R. & Regs., r. 111-2-2-.04 . Noncompliance with any condition of subsections 4. and 5. of Section (4)(b) of this Rule shall result in a monetary penalty in the amount of the difference between the services which the center is required to provide and the amount actually provided and may be subject to revocation of its exemption status by the Department for repeated failure to pay any fines or moneys due to the Department or for repeated failure to produce data as required by O.C.G.A. § 31-6-70, and subsection 6. of section (4)(b) of this Rule, after notice to the exemption holder and a fair hearing pursuant to Chapter 13 of Title 50, the Georgia Administrative Procedure Act. The dollar amount specified in this paragraph shall be adjusted annually by an amount calculated by multiplying such dollar amount (as adjusted for the preceding year) by the annual percentage of change in the composite index of construction material prices, or its successor or appropriate replacement index, if any, published by the United States Department of Commerce for the preceding calendar year, commencing on July 1, 2009, and on each anniversary thereafter of publication of the index.

(c) Any joint venture ambulatory surgical center that requests a letter of determination shall provide documentation, in addition to the requirements outlined in section (a) of this Rule above, to show that it:

Has capital expenditures associated with the construction, development, or other establishment of the clinical health service which do not exceed $5 million,
Provides care to Medicaid beneficiaries and, if the facility provides medical care and treatment to children, to PeachCare for Kids® beneficiaries and provides uncompensated indigent and charity care in an amount equal to or greater than two percent (2%) of its adjusted gross revenue and on and after January 1, 2026, in an amount equal to or greater than the minimum amount established by the Department which shall be reviewed by the Department every 12 months; or
If the center is not a participant in Medicaid or the PeachCare for Kids® Program, provides uncompensated care to Medicaid beneficiaries and, if the facility provides medical care and treatment to children, to PeachCare for Kids® beneficiaries, uncompensated indigent and charity care, or both in an amount equal to or greater than four percent (4%) of its adjusted gross revenue and on and after January 1, 2026, in an amount equal to or greater than the minimum amount established by the Department which shall be reviewed by the Department every 12 months; and
Provides annual reports in the same manner and in accordance with O.C.G.A. § 31-6-70 and Ga. Comp. R. & Regs., r. 111-2-2-.04 . Noncompliance with any condition of subsections 2. and 3. of section (4)(c) of this Rule shall result in a monetary penalty in the amount of the difference between the services which the center is required to provide and the amount actually provided and may be subject to revocation of its exemption status by the Department for repeated failure to pay any fines or moneys due to the Department or for repeated failure to produce data as required by O.C.G.A. § 31-6-70, and subsection 4. of section (4)(c) of this Rule, after notice to the exemption holder and a fair hearing pursuant to Chapter 13 of Title 50, the Georgia Administrative Procedure Act. The dollar amount specified in this paragraph shall be adjusted annually by an amount calculated by multiplying such dollar amount (as adjusted for the preceding year) by the annual percentage of change in the composite index of construction material prices, or its successor or appropriate replacement index, if any, published by the United States Department of Commerce for the preceding calendar year, commencing on July 1, 2009, and on each anniversary thereafter of publication of the index.

(5) Requirements Applicable to Valid Holders of Ambulatory Surgery or Diagnostic or Therapeutic Equipment Exemptions Prior to July 1, 2008.

(a) Any facility offering ambulatory surgery pursuant to the exclusion designated on June 30, 2008, as division (14)(G)(iii) of O.C.G.A. § 31-6-2 ; any diagnostic, treatment, or rehabilitation center offering diagnostic imaging or other imaging services in operation and exempt prior to July 1, 2008; or any facility operating pursuant to a letter of non-reviewability and offering diagnostic imaging services prior to July 1, 2008, shall:

Provide annual reports in the same manner and in accordance with O.C.G.A. § 31-6-70 and in accordance with the provisions of Ga. Comp. R. & Regs., r. 111-2-2-.04(1)(b)2.

(b) If, on or after July 1, 2008, any facility referenced in subsection (5)(a) above that, makes a capital expenditure associated with the construction, development, expansion, or other establishment of a clinical health service or the acquisition or replacement of diagnostic or therapeutic equipment with a value in excess of $800,000.00 over a two-year period; builds a new operating room; or chooses to relocate in accordance with Ga. Comp. R. & Regs., r. 111-2-2-.03 , it shall:

Provide care to Medicaid beneficiaries and, if the facility provides medical care and treatment to children, to PeachCare for Kids® beneficiaries and provide uncompensated indigent and charity care in an amount equal to or greater than two percent (2%) of its adjusted gross revenue, and on and after January 1, 2026, in an amount equal to or greater than the minimum amount established by the Department which shall be reviewed by the Department every 12 months; or
If the facility is not a participant in Medicaid or the PeachCare for Kids® Program, provide uncompensated care for Medicaid beneficiaries and, if the facility provides medical care and treatment to children, for PeachCare for Kids® beneficiaries, uncompensated indigent and charity care, or both in an amount equal to or greater than four percent (4%) of its adjusted gross revenue and on and after January 1, 2026, in an amount equal to or greater than the minimum amount established by the Department which shall be reviewed by the Department every 12 months. Noncompliance with any condition of subsection (b)1. and 2. above shall result in a monetary penalty in the amount of the difference between the services which the center is required to provide and the amount actually provided and may be subject to revocation of its exemption status by the Department for repeated failure to pay any fees or monies due to the Department or for repeated failure to produce data as required by O.C.G.A. § 31-6-70 after notice to the exemption holder and a fair hearing pursuant to Chapter 13 of Title 50, the Georgia Administrative Procedure Act. The dollar amount specified in this paragraph shall be adjusted annually by an amount calculated by multiplying such dollar amount (as adjusted for the preceding year) by the annual percentage of change in the consumer price index, or its successor or appropriate replacement index, if any, published by the United States Department of Labor for the preceding calendar year, commencing on July 1, 2009. In calculating the dollar amounts of a proposed project for the purposes of this paragraph, the costs of all items subject to review by this chapter and items not subject to review by this chapter associated with and simultaneously developed or proposed with the project shall be counted, except for the expenditure or commitment of or incurring an obligation for the expenditure of funds to develop Certificate of Need applications, studies, reports, schematics, preliminary plans and specifications or working drawings, or to acquire sites. Subsections (b)1. and 2. of section (5) of this Rule, shall not apply to facilities offering ophthalmic ambulatory surgery pursuant to the exclusion designated on June 30, 2008, as division (14)(G)(iii) of O.C.G.A. § 31-6-2 that are owned by physicians in the practice of ophthalmology.

(6) Administrative Remedies for Adverse Determinations. When the Department makes a determination or decision pursuant to Ga. Comp. R. & Regs., r. 111-2-2-.10(1) through (5) of this Rule or any other determination or decision over which the Certificate of Need Appeal Panel lacks subject matter jurisdiction, the person who requests and receives the determination or decision may appeal to the Commissioner or his designee for an administrative hearing pursuant to the Administrative Procedures Act if such person is aggrieved by the Department's determination or decision. Such request for a hearing must be made in writing and must be received by the Department within thirty (30) days of the date of the Department's determination or decision. If such written request is not received by the Department within thirty (30) days, the Department's determination or decision shall become final upon the thirty-first (31st) day. The Department shall publish notice of all requests for letters of determination regarding exempt activity and opposition to such request, whether pursuant to O.C.G.A. § 31-6-47 or any other provision of Code Section 31-6 and these Rules. Persons opposing a request for approval of an exempt activity, whether pursuant to an express statutory exemption or any other provision of the health planning statute or these Rules, shall be entitled to file a written objection with the Department and the Department shall consider any filed objection when determining whether an activity is exempt. A person who wishes to file a written objection to an exemption determination request, including requests for letters of determination for a single specialty ambulatory surgical center or a joint venture ambulatory surgical center, must do so no later than thirty (30) days after the date of Department receipt of the initial request for the exemption determination. Such written opposition should be submitted via the Department's web portal. The opposition shall be submitted in accordance with Ga. Comp. R. & Regs., r. 111-2-2-.06(6). If no objection to a request for determination is filed within 30 days of the Department's receipt of such request for Determination, the Department shall have 60 days from the date of the Department's receipt of such request to review the request and issue a letter of determination. The Department may adopt rules for deciding when it is not practicable to provide a determination in 60 days and may extend the review period upon written notice to the requestor but only for an extended period of no longer than an additional 30 days. After the issuance of an approval to a response to the request for an exemption determination, including requests for letters of determination for a single specialty ambulatory surgical center or a joint venture ambulatory surgical center, a person in opposition that has complied with the provisions outlined above, shall have the right to a fair hearing pursuant to Chapter 13 of Title 50, the Georgia Administrative Procedure Act, and judicial review of a final decision in the same manner and under the same provisions as in O.C.G.A. § 31-6-44.1. A person who requested and received the exemption determination shall have automatic standing to participate in any such administrative proceeding to defend the approved exemption determination. The Department may also participate to defend its decision. A person who opposes an exemption determination request that is denied, and who has complied with the written opposition submission requirements provided above, shall have standing to participate in any administrative proceeding requested by the person denied an approved exemption determination. If the written opposition is not submitted in accordance with the provisions outlined above, the Department shall not consider the opposition, and the rights to an administrative hearing, and/or any participation in any proceeding as outlined above, will not adhere to the opposing person.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Determinations and Letters of Non-Reviewability" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Aug. 28, 2006; eff. Sept. 17, 2006.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Nov. 14, 2008; eff. Dec. 4, 2008.
Amended: New title, "Determinations." F. Mar. 11, 2022; eff. March 10, 2023.
Note: Rule 111-2-2-.10, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.11 Service-Specific Review Considerations Generally {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.11}

(1) The Department has adopted the following service-specific requirements and review considerations:

(a) Acute Care and Acute Care-Related Rules :

Short-Stay General Hospital Services, Ga. Comp. R. & Regs., r. 111-2-2-.20 ;
Adult Cardiac Catheterization Services, Ga. Comp. R. & Regs., r. 111-2-2-.21 ;
Open Heart Surgical Services, Ga. Comp. R. & Regs., r. 111-2-2-.22 ;
Pediatric Cardiac Catheterization and Open Heart Services, Ga. Comp. R. & Regs., r. 111-2-2-.23 ; and
Perinatal Services, Ga. Comp. R. & Regs., r. 111-2-2-.24 ;
Reserved .
Reserved .

(b) Long-Term Care Rules :

Skilled Nursing and Intermediate Care Facility Services, Ga. Comp. R. & Regs., r. 111-2-2-.30 ;
Personal Care Home Services, Ga. Comp. R. & Regs., r. 111-2-2-.31 ;
Home Health Services, Ga. Comp. R. & Regs., r. 111-2-2-.32 ;
Life Plan Community ("LPC") Sheltered Nursing Facilities, Ga. Comp. R. & Regs., r. 111-2-2-.33 ;
Traumatic Brain Injury Services, Ga. Comp. R. & Regs., r. 111-2-2-.34 ; and
Comprehensive Inpatient Physical Rehabilitation Services, Ga. Comp. R. & Regs., r. 111-2-2-.35 ;
Long Term Care Hospitals, Ga. Comp. R. & Reg. r., 111-2-2-.36 .

Ambulatory Surgical Services, Ga. Comp. R. & Regs., r. 111-2-2-.40 ;
Positron Emission Tomography Units, Ga. Comp. R. & Regs., r. 111-2-2-.41 ; and
Radiation Therapy Services, Ga. Comp. R. & Regs., r. 111-2-2-.42 .

(2) The review considerations and standards that are promulgated in service-specific rules are considerations and standards that apply to specific services in addition to the general considerations in Ga. Comp. R. & Regs., r. 111-2-2-.09 . Any conflict between the meaning or application of a service-specific requirement and the general considerations shall be interpreted in favor of the service-specific consideration, unless a general consideration specifically indicates that it supersedes any and all service-specific considerations.

(3) The meaning of words as they are defined in a particular service-specific rule only applies to that service-specific rule unless a specific citation is made to another service-specific rule.

(4) Numerical Need Calculations.

(a) The numerical need calculations, which shall apply to an application for a clinical health service for which service-specific rules exist, shall be the calculated need in effect on the date the application is deemed complete for review less any subsequently approved units and services during the review period. This provision does not apply to batching reviews as the need applicable to batching decisions is the need stated in the batching notice.

(b) In the instance of joined projects where one project is reviewed as an exception based on utilization and the other is reviewed as need-based, the approval of the utilization exception shall not preclude an approval based on a numerical need projection should, prior to the approval of any of the joined projects, the numerical need projection indicates a need for the clinical health service.

(c) Approved projects that affect service-specific numerical need calculations shall be added to the Department's service-specific inventories and the numerical need projections shall be adjusted as of the approved date of the project.

(d) Approved projects that are reversed through administrative and/or judicial appeal final resolution shall be subtracted from the Department's service-specific inventories and the numerical need projections shall be adjusted as of the date of such final resolution.

(5) Service-specific component plans provide general background on specific considerations that were undertaken in developing service-specific rules. The service-specific rules shall supersede a component plan.

(6) If any provision of these service-specific rules, or the application thereof to any person or circumstance is held invalid, the invalidity does not affect other provisions or applications of the particular service-specific rule in question or of the service-specific rules in general which can be given effect without the invalid provision or application, and to this end the provisions of these service-specific rules are severable.

(7) The commissioner shall be authorized, with the approval of the board, to place a temporary moratorium of up to six (6) months on the issuance of certificates of need for new and emerging health care services. Any such moratorium placed shall be for the purpose of promulgating service-specific rules and regulations regarding such new and emerging health care services. A moratorium may be extended one time for an additional three (3) months if circumstances warrant, as approved by the board. In the event that final service-specific rules and regulations are not promulgated within the time period allowed by the moratorium, any applications received by the Department for a new and emerging health care service shall be reviewed under existing general statutes and regulations relating to certificates of need. Upon the identification by the Department of a new and emerging health care service as defined by Ga. Comp. R. & Regs., r. 111-2-2-.01(41) , and the request for and receipt of approval by the board of a moratorium as provided in this subsection, the Department shall publish notice of the moratorium and the identified service in a manner used in the normal course for other Certificate of Need information and announcements.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Service-Specific Review Considerations Generally" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Dec. 14, 2007; eff. Jan. 3, 2008.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.11, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.12 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.12}

Ga. Comp. R. & Regs. r. 111-2-2-.13 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.13}

Ga. Comp. R. & Regs. r. 111-2-2-.14 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.14}

Ga. Comp. R. & Regs. r. 111-2-2-.15 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.15}

Ga. Comp. R. & Regs. r. 111-2-2-.16 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.16}

Ga. Comp. R. & Regs. r. 111-2-2-.17 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.17}

Ga. Comp. R. & Regs. r. 111-2-2-.18 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.18}

Ga. Comp. R. & Regs. r. 111-2-2-.19 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.19}

Ga. Comp. R. & Regs. r. 111-2-2-.20 Specific Review Considerations for Short-Stay General Hospital Beds {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.20}

(1) Applicability.

(a) A Certificate of Need will be required prior to the establishment of a new hospital, replacement of an existing hospital, or expansion of an existing hospital.

(b) The provisions in these Rules do not apply to the following situations:

bed replacements in existing hospital facilities; or
changing the physical location of existing beds within an existing facility; or
projects that are otherwise exempt from review pursuant to O.C.G.A. § 31-6-47(a) and Ga. Comp. R. & Regs., r. 111-2-2-.03 .

(c) An existing hospital seeking an expansion to be used for new institutional health services, including perinatal services, or rehabilitation services, must meet the applicable service-specific Rules found in this chapter and, as a threshold matter, meet the need standards set forth in Ga. Comp. R. & Regs., r. 111-2-2-.20(3)(b)(3) but shall not be required to meet the other requirements in Ga. Comp. R. & Regs., r. 111-2-2-.20 .

(d) A hospital that has been approved through the Certificate of Need process to use a certain number of short-stay hospital beds for long-term acute care ("LTAC") beds shall have such LTAC beds removed from the official inventory of available short-stay beds once the LTAC is certified by Medicare; provided, however, that such beds will revert to the hospital's official inventory of available short-stay beds at any point that the LTAC ceases operation or is no longer certified by Medicare. An application to use existing short-stay hospital beds for LTAC beds shall not be subject to the guidelines in Ga. Comp. R. & Regs., r. 111-2-2-.20 .

(2) Definitions .

(a) "Age cohorts" for purposes of these Rules refers to the following age groups: persons zero (0) to seventeen (17); persons eighteen (18) to sixty-four (64); and persons sixty-five (65) and older.

(b) "Available beds" or "CON approved beds" means the total number of beds authorized for use by a hospital or group of hospitals based on capacity approved or authorized through the Certificate of Need process.

(c) "Children's hospital" means a hospital in which ninety percent (90%) or more of the patients served by the hospital are seventeen (17) or less years of age.

(d) "Critical Access Hospital" means a hospital designated as a critical access hospital pursuant to the state's rural health plan and the guidelines of the Medicare Rural Hospital Flexibility Program authorized by section 4201 of the Balanced Budget Act of 1997.

(e) Reserved .

(f) "Expansion" means the addition of available beds or CON approved beds for an existing hospital.

(g) "Health planning area" or "planning area" means the twelve (12) state service delivery regions as defined in O.C.G.A. § 50-4-7 .

(h) "Horizon year" means the last year of a five (5) year projection period for need determinations.

(i) "Optimal Occupancy Rate" means a target or expected level of use of available beds as calculated based on the annual patient days divided by the available beds multiplied by three hundred sixty-five (365). The optimal occupancy rate is variable based on the following:

for hospitals located in a rural county, sixty-five percent (65%);
for hospitals located in a non-rural county, seventy-five percent (75%); and
for teaching or children's hospitals, seventy percent (70%).

(j) "Patient days" means the number of days of inpatient services based on the most recent full year of hospital discharge data or the annual hospital questionnaire.

(k) "Replacement" means new construction to substitute another facility for an existing facility. New construction may be considered a replacement only if the replacement site is located three (3) miles or less from the facility being replaced or, in the case of the facility proposing a replacement site beyond the three (3) mile limit, if the replacement site is located within the same county and would serve substantially the same patient population, based on patient origin by zip code and payer mix, as the existing facility.

(l) "Rural county" means a county having a population of less than 50,000 according to the United States decennial census of 2010 or any future such censes, as defined in O.C.G.A. § 31-7-94.1(c)(2) .

(m) "Safety net hospital" is defined as a hospital that meets at least two (2) of following criteria:

the hospital is a children's hospital or a teaching hospital;
the hospital is designated by the Healthcare Facility Regulation Division as a trauma center;
Medicaid and Peach Care inpatient admissions constitute twenty percent (20%) or more of the total hospital inpatient admissions;
Uncompensated charges for indigent patients constitute six percent (6%) or more of hospital adjusted gross revenue; or
Uncompensated charges for indigent and charity patients constitute ten percent (10%) or more of hospital adjusted gross revenue.

(n) "Short stay hospital" or "hospital" is defined as a facility with an average length of stay of less than thirty (30) days.

(o) "Target service area population" means the total populations of all counties, which are in part or in whole, within a ten (10) mile radius of the planned location of a new, expanded, or replacement hospital.

(p) "Teaching hospital" means a hospital designated as a teaching hospital by the Georgia Board for Physician Workforce, which serves as a sponsoring or major participating hospital for a program of graduate medical education accredited by the Accreditation Council for Graduate Medical Education (ACGME) or the American Osteopathic Association (AOA) and maintains a written affiliation agreement with an accredited medical school located in Georgia or is owned and operated by an accredited medical school in Georgia.

(3) Standards.

(a) A new hospital must be at least fifty (50) beds in size if located in a rural county and at least one hundred (100) beds in size if located in a county other than a rural county.

(b) The need for a new, replacement or expanded hospital shall be determined through application of an appropriate numerical need methodology designed to assess need for the specific purpose sought in the application.

The numerical need for a new hospital shall be determined through application of a demand-based forecasting model. The model is outlined in the steps below:

(i) Calculate the use rate for current hospital services in the target service area population by dividing the patient days for each age cohort by the population for each age cohort for same year as patient days were calculated.

(ii) Project the horizon year use rate for hospital services in the target service area population by multiplying the use rate for current hospital services by age cohort by the horizon year population by age cohort.

(iii) Divide the results of the calculations in Step (ii) by 365 and sum these numbers to determine a baseline bed need.

(iv) Adjust the baseline bed need by adding a factor to account for use of the hospital services located within the target service area population by persons from out of state. The factor shall be determined by calculating the patient days for the hospitals in the target service area that may be attributed to persons from out of state as a percentage of total patient days, and then dividing that percentage into the baseline bed need. In addition, if the target service area population includes any county or counties outside the state of Georgia, the projected bed need of the out-of-state counties should be calculated by applying the projected rate of beds needed per 1,000 for in-state counties in the target service area population to the prorated portion of population in out-of-state counties.

(v) Divide the baseline bed need by the optimal occupancy rate, as determined by the size of the proposed new facility, to project the total number of beds needed for the target service area population.

(vi) Calculate the number of available beds for the target service area population by adding all of the short stay beds located in the counties, including those outside of Georgia if applicable, which are in part or in whole within a ten (10) mile radius of the planned location of the new hospital.

(vii) Subtract the number of available beds from the total number of beds needed for the target service area population to determine the net number of beds needed.

A new hospital shall be approved only if the total target service area population is at least 50,000 persons.
The numerical need for a replacement or expanded hospital shall be determined through application of a demand-based forecasting model. The model is outlined in the steps below:

(i) Calculate the county use rate for the current hospital's services by dividing the patients days for Georgia residents by county within each age cohort by the population by county for each age cohort for the same year as patient days were calculated.

(ii) Project the horizon year use rate for the hospital's services by multiplying each county use rate by age cohort by the horizon year population of each county by age cohort.

(iii) Sum the number of patients resulting from Step (ii) and divide by three hundred and sixty-five (365) to determine a baseline bed need rate.

(iv) Adjust the baseline bed need rate by adding a factor to account for use of the hospital's services by persons from out of state. The factor shall be determined by calculating the patient days for the hospital that may be attributed to persons from out of state as a percentage of total patient days, and then dividing that number into the baseline bed need.

(v) Divide by optimal occupancy rate, as determined by the size of the proposed facility, to project the total number of beds needed for the replacement or expanded hospital.

(vi) Compare the results of Step (v) with the number of beds requested for the replacement or expanded hospital and, if appropriate, the number of available beds to determine whether the proposed replacement or expanded hospital meets the need standards.

(c) The Department may allow an exception to need and adverse impact standards outlined in Ga. Comp. R. & Regs., r. 111-2-2-.20(3)(b) and (d) for a facility meeting any one of the following criteria:

The facility is an existing facility designated by the Department of Public Health as a trauma center;
The facility is an existing teaching hospital;
The facility is a sole community provider and more than twenty percent (20%) of the capital cost of any new, replacement or expanded facility is financed by the county governing authority, as defined in O.C.G.A. § 1-3-3(7) , of the home county or the county governing authorities of a group of counties; or
The facility is a designated critical access hospital and is seeking replacement of its existing facility at a size not to exceed twenty-five (25) CON approved beds; or
The facility is an existing short-stay general hospital meeting one of the following conditions:

(i) A facility in an urban county or rural county seeking to add short-stay general hospital beds in response to the closure of a short-stay general hospital located within a five (5) mile radius;

(ii) A facility in a rural county seeking to add short-stay general hospital beds in response to the closure of a short-stay general hospital located in the same rural county or a contiguous county; or

(iii) A facility in an urban county seeking to add short-stay general hospital beds in response to the closure of a short-stay general hospital located in a contiguous rural county. To qualify for an exception under Ga. Comp. R. & Regs., r. 111-2-2-.20(3)(c)5, the existing hospital must demonstrate that it will serve substantially the same patient population based on patient origin and payor mix data as the closed hospital, to be determined in the sole discretion of the Department. The expansion under Ga. Comp. R. & Regs., r. 111-2-2-.20(3)(c)5 may be for up to twenty percent (20%) of capacity of the applicant hospital and the application for a certificate of need under this exception shall be filed no more than eighteen (18) months after the closure of the short-stay general hospital. Notwithstanding the foregoing, the exception set forth in Ga. Comp. R. & Regs., r. 111-2-2-.20(3)(c)5 may be requested by an applicant only one (1) time in response to the closure of a particular short-stay general hospital unless such applicant provides written justification in support of a second request that is granted by the department in its sole discretion, if such justification was submitted within no more than eighteen (18) months after closure of that hospital.

(d)

An applicant for a new, replacement or expanded hospital shall demonstrate the expected effects of the proposed services on other hospitals within the target service area population, including how any enhanced competition will have a positive impact upon the cost, quality, and access to the services proposed; and in the case of applications for a new, replacement or expanded hospital where competition between providers will not have a favorable impact on cost, quality and access, the applicant shall be required to document that its application will not have an adverse impact.
An applicant for a new, replacement or expanded hospital shall document in its application that the new, replacement or expanded facility is not predicted to be detrimental to safety net hospitals within the planning area. Such demonstration shall be made by providing an analysis in the application that compares current and projected changes in market share and payer mix for the applicant and any safety net hospitals. Impact on an existing safety net hospital shall be determined to be adverse if, based on the utilization projected by the applicant, any existing safety net hospital would have a total decrease of ten percent (10%) or more in its average annual utilization, as measured by patient days for the two most recent and available preceding calendar years of data.
An applicant for a new, replacement or expanded hospital shall document in its application that the new, replacement or expanded facility is not predicted to be detrimental to any teaching hospitals in the state. Such demonstration shall be made by providing an analysis in the application that compares current and projected changes in market share and payer mix for the applicant and any teaching hospitals. Impact on an existing teaching hospital shall be determined to be adverse if, based on the utilization projected by the applicant, any existing teaching hospital would have a total decrease of five percent (5%) or more in its average annual utilization, as measured by patient days for the two most recent and available preceding calendar years of data.

(e) In considering applications joined for review, the Department may give favorable consideration to whichever of the applicants historically has provided the higher annual percentage of unreimbursed care to indigent and charity patients and the higher annual percentage of services to Medicare, Medicaid and Peach Care patients.

(f) An applicant for a new, replacement or expanded hospital shall foster an environment that assures access to individuals unable to pay, regardless of payment source or circumstances, by the following:

providing evidence of written administrative policies that prohibit the exclusion of services to any patient on the basis of age, race, sex, creed, religion, disability or the patient's ability to pay;
providing a written commitment that services for indigent and charity patients will be offered at a standard that meets or exceeds three percent (3%) of annual, adjusted gross revenues for the hospital;
providing a written commitment to participate in the Medicare, Medicaid and Peach Care programs;
providing a written commitment to participate in any other state health benefits insurance programs for which the hospital is eligible; and
providing documentation of the past record of performance of the applicant, and any facility in Georgia owned or operated by the applicant's parent organization, of providing services to Medicare, Medicaid, and indigent and charity patients.

(g)

An applicant for a replacement or expanded hospital shall document that the hospital is fully accredited by the Joint Commission or another nationally recognized accrediting body, and also shall provide sufficient documentation that the hospital has no history of significant licensure deficiencies and no history of conditional level Medicare and/or Medicaid certification deficiencies in the past three (3) years and has no outstanding licensure and Medicare and/or Medicaid certification deficiencies. In the event that the hospital is not accredited by the Joint Commission or another nationally recognized health care accreditation body and relies solely on state licensure, the applicant should provide sufficient documentation that the hospital has no history of significant licensure deficiencies and no history of conditional level Medicare and/or Medicaid certification deficiencies in the past five (5) years and has no outstanding licensure and Medicare and/or Medicaid certification deficiencies.
An applicant for a new, replacement or expanded hospital shall:

(i) provide a written commitment that the applicant presently participates, or in the case of a new hospital, will participate, in a statewide or national external reporting and peer review process related to patient safety and control of medical errors;

(ii) provide evidence of the availability of resources, including health care providers, management personnel and funds for capital and operating needs, for the provision of the hospital services; and

(iii) document a plan for obtaining and maintaining staff and service quality standards necessary to promote effective patient care and clinical outcomes.

(h)

An applicant for a new, replacement or expanded hospital shall document a plan to operate an emergency room licensed by the Healthcare Facility Regulation Division.
An applicant for a new, replacement or expanded hospital shall provide a description of the proposed service area for the hospital and document a community planning process that addresses primary care relationships and the range of transfer and referral activities across the range of care levels. The descriptions and community planning process should address:

(i) Estimated geographic boundaries of primary and secondary service areas and the primary and outpatient providers in these areas;

(ii) Demographic and income characteristics of the service area by age, gender and racial compositions;

(iii) Anticipated payer sources by population totals and percentages to include public payers and indigent and charity care services;

(iv) Patient access to the full continuum of care, including discharge planning and long-term care options;

(v) The projected financial and economic impact that the project will have on the community;

(vi) Strategies related to physician recruitment and medical staffing to include the hospital's plan to ensure that the care provided by physicians and other clinicians is made available to patients without regard for ability to pay;

(vii) The manner in which the facility coordinates or will coordinate with the existing health care system;

(viii) The manner(s) in which the hospital will make available the necessary ancillary and support services; and

(ix) The manner in which the hospital will support the operation of any affiliated critical access hospitals, if applicable.

An applicant for a new, replacement or expanded hospital shall demonstrate the availability of funds for capital and operating needs as well as the immediate and long-term financial feasibility of the proposal, based upon reasonable projections of the costs of and charges for providing health services by the hospital.
An applicant for a new, replacement or expanded hospital shall demonstrate that proposed charges for services shall compare favorably with charges for other similar hospital services in the planning area when adjusted for annual inflation. When determining the accuracy of an applicant's projected charges for hospital services, the Department may compare the applicant's history of charges if applicable, with other hospitals in the planning area(s) previously served by the applicant or its parent company.

(i)

To respond to changes in the health care delivery system and to promote improved efficiency, access and cost-containment, the Department may authorize the consolidation of two or more hospitals located in one rural county or in contiguous rural counties. A proposal to consolidate hospitals into a single, new consolidated hospital requires a Certificate of Need and must comply with the following criteria.
Two or more existing facilities, each of which are operational at the time of approval and each of which are located in the same rural county or in contiguous rural counties, may seek a consolidation to create a single consolidated facility at an existing site or a new site within the same rural county or one of the same rural counties. The applicant or applicants for such a consolidated facility must be able to meet the following conditions:

(i) The available beds for the proposed consolidated facility must not exceed the total number of available beds of the existing facilities proposed for consolidation;

(ii) The applicant(s) for the proposed consolidated facility must show, using patient origin data, that the proposed new facility and/or location is reasonably projected to continue to meet the utilization needs of those populations that historically utilized the existing facilities;

(iii) The applicant(s) must explain the impact of consolidation on the service area's health care delivery system and show that any negative impacts on existing and approved providers will be outweighed by the benefits of the proposal;

(iv) The applicant must submit documentation demonstrating that the consolidation will promote the most efficient handling of patient needs; improve the ability to update medical technology infrastructure; maximize efficiency for capital and physical plant needs; and improve consumer access to enhanced quality and depth of services; and

(v) The applicant(s) must comply with all other provisions of this Rule with exception of the need and adverse impact standards set forth in Ga. Comp. R. & Regs., r. 111-2-2-.20(3)(b) and (d) .

(j)

To respond to changes in the health care delivery system and to promote improved efficiency, access and cost-containment, the Department may authorize the consolidation of two or more hospitals located in one non-rural county. A proposal to consolidate hospitals into a single, new consolidated hospital requires a Certificate of Need and must comply with the following criteria.
Two or more existing facilities, each of which are operational at the time of approval and each of which are located in the same non-rural county, may seek a consolidation to create a single consolidated facility at an existing site or a new site within the same non-rural county. The consolidating facilities must apply as co-applicants. The applicant or applicants for such a consolidated facility must be able to meet the following conditions:

(i) The available beds sought for the proposed consolidated facility must not exceed the sum of the total number of beds for which each of the consolidating facilities would be authorized, at the time the application is filed, pursuant to the demand-based forecasting model for determining need set forth in Ga. Comp. R. & Regs., r. 111-2-2-.20(3)(b)3.

(ii) The applicant(s) for the proposed consolidated facility must show, using patient origin data by zip code, that the proposed new facility and/or location is reasonably projected to continue to meet the utilization needs of those populations that historically utilized the existing facilities;

(iii) The applicant(s) must explain the impact of consolidation on the facilities to be consolidated existing service area(s) health care delivery system and show that any negative impacts on existing and approved providers will be outweighed by the benefits of the proposal;

(v) The consolidating facilities must not seek to offer in a consolidation application any new clinical health service at the proposed new site not offered in each or all of the facilities to be consolidated.

History

Authority: O.C.G.A. §§ 31-2-8, 31-7-2.2, 31-7-4, 31-7-3.5
History. Original Rule entitled "Specific Review Considerations for Short-Stay General Hospital Beds" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Nov. 14, 2008; eff. Dec. 4, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.20, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Feb. 14, 2024; eff. Mar. 5, 2024.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.21 Specific Review Considerations for Adult Cardiac Catheterization Services {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.21}

(1) Applicability.

(a) For Certificate of Need purposes, Adult Cardiac Catheterization Services is classified as a specialized service and is defined as a new institutional health service which must be delivered in a permanently fixed location in either an acute care hospital or in a diagnostic, treatment, or rehabilitation center ("DTRC"). A Certificate of Need will be required prior to the establishment of a new or expanded adult cardiac catheterization service, if not exempt as provided by O.C.G.A. § 31-6-47(a)(21) and Ga. Comp. R. & Regs., r. 111-2-2-.03(24) .

(b) If the service will be provided within a licensed acute care hospital, the hospital shall be the applicant.

(c) If cardiac catheterization services will be provided in a DTRC, the organizational entity that develops the service shall be the applicant.

(d) Seeking and receiving approval from the Department under the provisions of Ga. Comp. R. & Regs., r. 111-2-2-.21(3)(f)3. shall neither be considered a new adult cardiac catheterization service nor an expanded service. Additionally, the issuance of such an approval shall not be construed to be anything other than a time-limited approval to participate in the particular medical research trial specified in Ga. Comp. R. & Regs., r. 111-2-2-.21(3)(f)(3) .

(2) Definitions.

(a) "Adjacent acute care hospital" means an acute care hospital which is physically connected to another acute care hospital in a manner that emergency transport of a patient by a stretcher or gurney can be achieved rapidly, conveniently, and effectively without the use of motorized vehicles.

(b) "Adult" means a person fifteen (15) years of age and over.

(c) "Authorized service" means an adult cardiac catheterization service that is either existing or approved. An existing service is an authorized service that has become operational, and an approved service is an authorized service that has not yet become operational.

(d) "Capacity" means 1300 adult cardiac catheterization procedure equivalents per dedicated and multipurpose room per year. In the computation of the use rate (percent of capacity) of authorized adult cardiac catheterization rooms, each adult diagnostic cardiac catheterization and other cardiac catheterizations of similar complexity shall equal a 1.0 procedure equivalent, each coronary angioplasty procedure shall equal 1.5 procedure equivalents, and each electrophysiological (EP) study shall equal 2.0 procedure equivalents. If pediatric catheterizations are performed in a room in which adult cardiac catheterizations are performed, each pediatric procedure shall equal 2.0 procedure equivalents.

(e) "Cardiac catheterization" means a medical diagnostic or therapeutic procedure during which a catheter is inserted into a vein or artery in the patient; subsequently, the free end of the catheter is manipulated by the physician to travel along the course of the blood vessel into the chambers or vessels of the heart. X-rays and an electronic image intensifier are used as aids in placing the catheter tip in the desired position. When the catheter is in place, the physician is able to perform various diagnostic studies and/or therapeutic procedures on the heart or its vessels.

(f) "Cardiac catheterization service" means an organized program which serves inpatients and/or outpatients of an acute care hospital or diagnostic, treatment and rehabilitation center (DTRC) with a room or a suite of rooms, with equipment to perform angiographic, physiologic, and as appropriate, therapeutic cardiac catheterization procedures. An authorized adult cardiac catheterization service is prohibited from performing coronary angioplasty procedures unless the acute care hospital where the service is located meets the requirements identified in Ga. Comp. R. & Regs., r. 111-2-2-.21(3)(f) .

(g) "Coronary angioplasty" means a cardiac catheterization procedure to treat coronary artery disease by utilizing a catheter with a balloon, laser, laser-assisted device, rotational device, stent placement or other mechanical means to unblock an occluded coronary artery.

(h) "Diagnostic cardiac catheterization" means the performance of cardiac catheterization for the purpose of detecting and identifying defects in the great arteries or veins of the heart, or abnormalities in the heart structure, whether congenital or acquired. Post-operative evaluation of the effectiveness of prostheses (e.g. heart valves or vein grafts) also can be accomplished through use of diagnostic cardiac catheterization.

(i) "Diagnostic, treatment, or rehabilitation center (DTRC)" means any professional or business undertaking, whether for profit or not for profit, which offers or proposes to offer any clinical health service in a setting that is not part of a hospital.

(j) "Expanded Service" or "Expansion" means an adult cardiac catheterization service that acquires a piece of diagnostic or therapeutic equipment which is to be utilized in the provision of cardiac catheterization services (unless it is a replacement of such equipment or otherwise exempt); or that seeks the addition of a new catheterization laboratory or room regardless of cost. Replacement or repair of existing diagnostic or therapeutic equipment utilized in the provision of such services is not an expansion for purposes of these Rules.

(k) "Horizon year" means the last year of a five-year projection period for need determinations for any adult cardiac catheterization services.

(l) "Official inventory" means the Department's inventory of all authorized hospital-based and diagnostic, treatment, or rehabilitation center (DTRC) adult cardiac catheterization laboratories or any other authorized laboratory approved for operation at the time of adoption of these Rules.

(m) "Official state component plan" means the document related to specialized cardiovascular services developed by the Department adopted by the Health Strategies Council and approved by the Board of Community Health.

(n) "Procedure" means a cardiac catheterization study or treatment or combination of studies and/or treatments performed in a single session on a single patient who appears for cardiac catheterization.

(o) "Planning area" means each of the planning areas designated in the official State Component Plan.

(p) "Therapeutic cardiac catheterization" means the performance of cardiac catheterization for the purpose of ameliorating certain conditions that have been determined to exist in the heart or great arteries or veins of the heart.

(3) Standards.

(a) The need for new or expanded adult cardiac catheterization services shall be determined through application of a numerical need method and an analysis of service demand based on an assessment of the aggregate utilization rate of existing services;

the numerical need for new or expanded adult cardiac catheterization services shall be determined by a population-based formula which includes current usage patterns and projected population as follows:

(i) calculate the current state adult cardiac catheterization rate for the most recent year of reported survey or hospital and outpatient discharge data by dividing the total number of adult cardiac catheterizations performed on Georgia residents by the total state adult Resident population;

(ii) determine the projected adult cardiac catheterization procedures for the horizon year by multiplying the state rate by the adult Resident population for the planning area for the horizon year;

(iii) adjust the projected adult cardiac catheterization procedures for the planning area by adding the out-of-state hospital-based catheterizations for the most recent year based on the percentage of total procedures performed on out-of-state patients by hospitals in each planning area;

(iv) convert projected adult cardiac catheterization procedures to procedure equivalents by multiplying the projected procedures by the statewide rate of equivalents per catheterization; and

(v) determine the projected net surplus or deficit for adult cardiac catheterization capacity, expressed in terms of rooms/laboratories, in the planning area by subtracting the rooms/laboratories needed for the total projected procedure equivalents calculated in steps (i) through (iv) from the total capacity (1300 procedure equivalents per room/laboratory) based on the official inventory.

before a new or expanded adult cardiac catheterization service will be approved in any planning area, the aggregate utilization rate of all adult cardiac catheterization services in that planning area shall be eighty-five percent (85%) or more during the most recent year;

(b)

The Department may allow an exception to Ga. Comp. R. & Regs., r. 111-2-2-.21(3)(a) in the following circumstances:

(i) actual utilization in the applicant's existing service has exceeded ninety percent (90%) of capacity over the past two (2) years;

(ii) to remedy an atypical barrier to adult cardiac catheterization services based on cost, quality, financial access, or geographic accessibility. The types of atypical barriers outlined below are intended to be illustrative and not exclusive.

(I) An atypical barrier to services based on cost may include the failure of existing providers of adult cardiac catheterization services to provide services at reasonable cost, as evidenced by the providers' charges and/or reimbursement being significantly higher (one or more standard deviations from the mean) than the charges and/or reimbursement for other providers in the state and/or planning area.

(II) An atypical barrier to services based on quality may include the failure of existing providers of adult cardiac catheterization services to provide services with outcomes generally in keeping with accepted clinical guidelines of the American College of Cardiology, peer review programs and comparable state rates for similar populations.

(III) An atypical barrier to services based on financial access may include the repeated failure, as exhibited by a documented pattern over two or more years prior to the submission of the application, of existing providers of services within the community to provide services to indigent, charity, and Medicaid patients.

(IV) An atypical barrier to services based on geographic accessibility may include a planning area which has an adult cardiac catheterization rate significantly less than the state rate (two or more standard deviations from the mean), a cardiovascular disease rate as projected through death and hospital discharge data which is significantly higher than the state rate (two or more standard deviations from the mean), and other demographic risk factors which can be documented through research and clinical studies.

(V) An applicant seeking approval for a new or expanded adult cardiac catheterization service solely for the purpose of providing cardiac electrophysiological studies may apply for consideration under the terms of an atypical barrier; provided, however, that any such applicant if approved shall be restricted to the provision of electrophysiological studies.

The Department may allow an exception to Ga. Comp. R. & Regs., r. 111-2-2-.21(3)(a) and (3)(c) for any cardiac catheterization service seeking an expansion, other than the addition of another laboratory or room; provided the applicant complies with the general considerations and policies of Ga. Comp. R. & Regs., r. 111-2-2-.09 and submits an application that demonstrates the applicant's compliance with or documents a plan and agreement to comply with Ga. Comp. R. & Regs., r. 111-2-2-.21(3)(d),(e),(f),(g),(h),(j),(k) and (l) .

(c) An applicant for a new or expanded adult cardiac catheterization service shall document that authorized cardiac catheterization services which could be adversely impacted by the establishment of the new or expanded service are not predicted to perform less than eighty percent (80%) of capacity as a result of the establishment of the new or expanded service. In the case of an approved service, service volume should be projected in accordance with the volume projections in the approved application.

(d) An applicant for a new or expanded adult catheterization service shall demonstrate a plan whereby the service and its medical staff agree to provide a full array of cardiovascular services to the community, including, but not limited to, education and outreach, prevention and screening, diagnosis and treatment, and rehabilitation.

(e) An applicant for a new or expanded adult cardiac catheterization services shall:

demonstrate the ability to meet the optimal clinical and physical environment standards established in the most recent American College of Cardiology/American Heart Association's Guidelines for Cardiac Catheterization and Cardiac Catheterization Laboratories. These standards include, but are not limited to, physical facility requirements, staffing, training, quality assurance, patient safety, screening patients for appropriate settings, and linkages with supporting emergency services;
document the availability of, or shall present a plan for recruiting, at least two board-certified cardiologists with training and qualification in cardiac catheterization, and, if applicable with training and qualification in coronary intervention, who will reside within one hour drive of the service site; and
document a plan for obtaining a sufficient number of clinical, professional and technical staff to safely and effectively operate the service.

(f) An authorized adult cardiac catheterization service shall not perform catheterization procedures requiring open heart surgery backup as part of its service unless the acute care hospital where the service is located:

operates an existing adult open heart surgery service;
has a Department approved written agreement for open heart surgery backup with an adjacent acute care hospital as defined by these Rules; or
has been accepted as a participant in a randomized medical research trial comparing patient outcomes after non-primary Percutaneous Coronary Intervention (PCI) in hospitals with and without cardiac surgery on-site, which also requires the performance of Primary PCI and has a parallel Primary PCI Registry, and which is coordinated by the Atlantic Cardiovascular-Patient Outcomes Research Team (Atlantic C-PORT). The authorized adult cardiac catheterization service must receive such Atlantic C-PORT acceptance and also must obtain written approval from the Department to perform such procedures, except that the Department may approve no more than ten (10) existing and authorized hospital services for participation, regardless of the number of such services that are accepted by Atlantic C-PORT.

(i) Any request for such Departmental approval must be submitted to the Department no later than June 30, 2005 in writing on a form developed by the Department for such purposes. Prior to final approval to participate by the Department, the requesting authorized service must provide written proof it has been accepted by Atlantic C-PORT as a participant in said trial under all applicable protocols;

(ii) In reviewing and approving such requests, the Department shall take into consideration such factors including, but not limited to, rural, suburban or urban location of the service, mix of patients to be treated, whether the service has the capability of performing a minimum of 100 PCIs (elective and primary combined) during the first year of such approval, 200 PCIs (elective and primary combined) during the second year of such approval unless a lower number, but not below 150 PCIs, is approved for specific reasons by both the Department and the trial chairperson, and 200 PCIs (elective and primary combined) during the third year of such approval, and whether the service has on its staff physicians and support staff with training and experience in both therapeutic and diagnostic cardiac catheterizations;

(iii) The selection of an authorized service for participation pursuant to this Rule will be made at the sole discretion of the Department; however, the Department shall consult with medical experts in the fields of cardiology and percutaneous coronary intervention when making the decision to approve or not approve a particular service for participation in such trial;

(iv) Any approval obtained from the Department in this regard shall only be valid for as long as the health care facility receiving such approval is an active participant in the trial; however, in no case shall such approval continue to be valid upon Atlantic C-PORT declaring the trial concluded, or under no circumstance for a period in excess of three (3) years from the time the authorized service's first procedure is conducted under the authority of the Department's approval and Atlantic C-PORT's acceptance to begin active participation in the trial; whichever event occurs first; and

(v) As any such Departmental approval is conditioned on being an active participant in the trial, should an authorized service which has received approval under the provisions of this Rule be expelled or otherwise lose the approval of Atlantic C-PORT to continue participation, the Department's approval will be simultaneously withdrawn without said service's or facility's right to an appeal of the Department's withdrawal of its approval to participate in such trial.

(g) Catheterization procedures requiring open heart surgery backup include coronary angioplasty and the following:

catheter atherectomy;
catheter endomyocardial biopsy;
left ventricular puncture;
percutaneous transluminal coronary angioplasty;
percutaneous catheter balloon valvuloplasty; and
transeptal catheterization.

(h) An applicant for a new or expanded adult cardiac catheterization service shall:

submit a written plan to the Department which, when implemented, will ensure access to cardiac catheterization services for all segments of the population in the documented and proposed service area of the applicant. Such plan shall provide a detailed strategy to reach patients not currently served within the service area, ensure continuity of care for patients transferred between facilities and shall promote planning for a continuum of cardiac services within the service area; and
propose a heart disease prevention and clinical intervention program to be provided by the applicant or through formal referral agreements which, when implemented, shall include:

(i) A clinical intervention program for all catheterization patients that shall provide for the following in a comprehensive, systematic way:

(I) Assessment of risk factors including lipid disorders, hypertension, diabetes, obesity, cigarette smoking, and sedentary lifestyle;

(II) Assessment of risk factors and referral for appropriate care in first-degree relatives; and

(III) Assure risk management including modification of lipid disorders by diet/exercise/drugs, modification of blood pressure level by diet/exercise/drugs, control of blood glucose level by diet/exercise/drugs, dietary counseling aimed at reduced caloric and fat intake and appropriate weight management, smoking cessation, and exercise prescription. Patients should be referred to their primary care provider with documentation of treatments provided and actions recommended including preventive therapies.

(ii) The program, if not operated by a facility with an existing Open Heart Surgical Service, shall submit a written affiliation agreement with at least one Open Heart Surgical Service that provides, at a minimum, for:

(I) a plan to transplant and handle acute cardiac emergencies;

(II) a plan to facilitate referral of patients for whom surgery or angioplasty may be indicated without unnecessarily repeating diagnostic studies; and

(III) a plan for ongoing communications between representatives of the Open-Heart Surgical Service and the proposed applicant, to allow for review of pre-operative and post-operative processes and specific cases.

(iii) The program shall provide for annual support and participation in at least three (3) professional education programs targeted to community-based health professionals, related to heart disease risk assessment, diagnostic procedures, disease management in clinical settings, and case finding and referral strategies.

(iv) Community based heart health promotion:

(I) The program shall provide for organization of or participation in a consortium of community-based organizations to complete an assessment of heart disease risk factors in the community as well as resources available to provide programs and services. The objective of this consortium is to mobilize and coordinate resources to target at-risk populations in the community; and

(II) Organization of or participation in at least one major community-based campaign each year related to major heart disease risk factors.

propose a system of outcome monitoring and quality improvement and identify at least five clinical outcomes that the applicant proposes to monitor for performance on a regular basis.

(i) An applicant for a new or expanded adult cardiac catheterization service must project and, if approved, shall document that the proposed service will be performing a minimum of 1040 adult cardiac catheterization procedure equivalents within three (3) years of initiation of the service and annually thereafter within the authorized guidelines for such services. Such projections, at a minimum, shall include consideration of patient origin data for catheterization services, the use rate of existing services, referral data and market patterns for existing hospital and DTRC services in the community, and cardiovascular disease incidence rates and related health indicators. An applicant seeking approval solely for the purpose of providing electrophysiological (EP) studies shall not be required to document a projected performance minimum but shall be required to document compliance with guidelines for EP studies issued by the American College of Cardiology.

(j) An applicant for a new or expanded adult cardiac catheterization service shall provide documentation that the service is fully accredited by the Joint Commission or another nationally recognized health care accreditation body, in the case of an applicant proposing a new facility location, shall provide a written commitment to secure full accreditation by the Joint Commission or another nationally recognized health care accreditation body within eighteen (18) months of initiating operation.

(k) An applicant for a new or expanded adult cardiac catheterization service shall foster an environment that assures access to individuals unable to pay, regardless of payment source or circumstances, by the following:

providing a written policy regarding the provision of any services provided by or on behalf of the applicant to include disease prevention and intervention services outlined in Ga. Comp. R. & Regs., r. 111-2-2-.21(3)(h) , that such services shall be provided regardless of race, age, sex, creed, religion, disability or patient's ability to pay, and documentation or evidence that the applicant has a service history reflecting the principles of such a policy;
providing a written commitment that services for indigent and charity patients will be offered at a standard which meets or exceeds three percent (3%) of annual, adjusted gross revenues for the adult cardiac catheterization service, or the applicant may request that the Department consider allowing the commitment for services to indigent and charity to patients to be applied to the entire facility;
providing a written commitment to accept any patient within the facility's service area, without regard to the patient's ability to pay, unless such patient is clinically inappropriate;
providing a written commitment to participate in the Medicaid, PeachCare and Medicare programs and to accept any Medicaid-, PeachCare and/or Medicare-eligible patient for services unless such patient is clinically inappropriate;
providing a written commitment that the applicant, subject to good faith negotiations, will participate in any state health benefits insurance programs for which the service is deemed eligible; and
providing documentation of the past record of performance of the applicant, and any facility in Georgia owned or operated by the applicant's parent organization, of providing services to Medicare, Medicaid and indigent and charity patients. The applicant's or its parent organization's failure to provide services at an acceptable level to Medicare, Medicaid and indigent and charity patients, and/or the failure to fulfill any previously made commitment to indigent and charity care may constitute sufficient justification to deny the application.

(l) An applicant for a new or expanded adult cardiac catheterization service must agree in writing to the following conditions:

establishment and maintenance of a system of continuity of care and coordination of service, as evidenced by regular and ongoing planning and quality improvement sessions with community health providers and advocacy programs;
participation in a data reporting, quality improvement, outcome monitoring, and peer review system within the applicant hospital or DTRC as well as a national, state or multi-program system which benchmarks outcomes based on national norms and which shall be named in the application and which provides for peer review between and among professionals practicing in facilities and programs other than the applicant hospital or DTRC;
development of procedures to ensure that cardiologists and any other physicians providing care in the cardiac catheterization service or related services shall be required to accept Medicaid, PeachCare and Medicare payment for services without discrimination;
commitment that charges for services shall be reasonable and comparable to other providers in the state and the service area;
provision of all required data and survey information to the Department as requested; and
commitment to act in good faith to fulfill all provisions and commitments documented in the application for a new or expanded service.

(m) The Department may revoke a Certificate of Need after notice to the holder of the certificate and a fair hearing pursuant to the Georgia Administrative Procedure Act for failure to comply with the defined scope, location, cost, service area, and person named in an application as approved by the Department and for the intentional provision of false information to the Department by an applicant in that applicant's application.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Adult Cardiac Catheterization Services" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Apr. 18, 2005; eff. May 8, 2005.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.21, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.22 Specific Review Considerations for Adult Open Heart Surgery Services {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.22}

(1) Applicability. A Certificate of Need will be required prior to the establishment of a new or, subject to certain stipulations, expanded adult open heart surgical service.

(2) Definitions.

(a) "Adult" means persons 15 years of age and over.

(b) "Authorized service" means an adult open heart surgery service that is either existing or approved. An existing service is an authorized service that has become operational, and an approved service is an authorized service that has not become operational.

(c) "Coronary Angioplasty" means a cardiac catheterization procedure to treat coronary heart disease by utilizing a catheter with a balloon, laser, laser-assisted device, rotational device, stent placement or other mechanical means to unblock an occluded coronary artery.

(d) "Expanded Service" or "Expansion" means an adult open heart surgery service that, for any service a full four (4) years or more following implementation of an approved Certificate of Need, increases adult open heart surgery volume to a level resulting in a twenty-five percent (25%) or more increase in procedures being performed by the service over the higher annual number of procedures having been performed during the most recent prior two calendar years. Replacement or repair of existing diagnostic or therapeutic equipment utilized in the provision of such service is not an expansion for purposes of these Rules.

(e) "Official State Component Plan" means the document related to specialized cardiovascular services developed by the Department established by the Health Strategies Council, and adopted by the Board of Community Health.

(f) "Open heart surgery" means surgery performed directly on the heart or its associated veins or arteries during which a heart and lung by-pass machine (extracorporeal pump) may be used to perform the work of the heart and lungs.

(g) "Open heart surgery service" means an organized surgical program that serves inpatients of a hospital that has a suitable operating room or suite of operating rooms, equipment, staff, intensive care unit, and all support services required to perform adult open-heart surgery. The adult open heart surgery service shall be located in an acute care hospital that has an authorized adult cardiac catheterization service.

(h) "Procedure" means an adult open heart surgery operation or combination of operations performed in a single session on a single patient who appears for open heart.

(3) Standards.

(a)

An application for new adult open heart surgery services shall be considered by the Department only if each and all of the following conditions are met:

(i) an applicant must have operated an existing adult cardiac catheterization service which is located in an acute care hospital setting for at least three (3) years prior to the date of application; and

(ii) an applicant shall document, based on actual service data of the applicant, survey data provided to the Department and other supporting research and documentation, that the hospital's existing adult cardiac catheterization service generated a minimum of 250 or more adult open heart surgery procedures in each of the two (2) calendar years immediately prior to submittal of the application; and

(iii) an applicant shall project and, if approved, shall document that the proposed adult open heart surgery service will be performing a minimum of 300 adult open heart surgery procedures per year within three years of initiation of the service. Such projections, at a minimum, shall include consideration of patient origin data for open heart and catheterization services, the use rate of existing services, and referral data and market patterns for existing hospital services, and cardiovascular disease incidence rates and related health indicators; and

(iv) an applicant shall document that existing and approved adult open heart surgery services in the state are not predicted to be adversely impacted as a result of the establishment of the new service. Impact on an existing or approved service shall be determined to be adverse if, based on the number of cases projected to be performed by the applicant, any of the existing or approved services would have either a decrease in volume equal to or greater than ten percent (10%) of the average annual service volume in the preceding two calendar years or a decrease of less than ten percent (10%) of the annual service volume in the preceding two calendar years but which would result in such service falling below a minimum of 200 open heart surgical procedures annually. In the case of an approved service, service volume should be projected in accordance with the volume projections in the approved application. An existing service that has been operational for four or more years and has not performed a minimum of 200 open heart surgical procedures in at least one of the past four years shall be excluded from a determination of adverse impact; and

(v) if multiple applications are joined or comparatively reviewed, the Department shall determine whether the individual impact of the establishment of each proposed service or the cumulative impact of the establishment of two or more proposed services would adversely impact an existing or approved service or any of the proposed services if established.

The Department may allow an exception to the need standard and adverse impact requirements in Ga. Comp. R. & Regs., r. 111-2-2-.22(3)(a)1. of this paragraph to remedy an atypical barrier to open heart surgery services based on cost, quality, financial access, or geographic accessibility. The types of atypical barriers outlined below are intended to be illustrative and not exclusive.

(i) An atypical barrier to services based on cost may include the failure of existing providers of open-heart surgical services to provide services at reasonable cost, as evidenced by the providers' charges and/or reimbursement being significantly higher (one or more standard deviations from the mean) than the charges and/or reimbursement for other providers in the state.

(ii) An atypical barrier to services based on quality may include the failure of existing providers of open-heart surgical services to provide services with outcomes generally in keeping with accepted clinical guidelines, peer review programs and comparable state rates for similar populations.

(iii) An atypical barrier to services based on financial access may include the repeated failure as exhibited by a documented pattern over two or more years prior to the submission of the application, of an existing provider or group of providers of open-heart surgical services within the community to provide services to indigent, charity and Medicaid patients.

(b)

An existing adult open heart surgery service seeking an expansion or expanded service due to a capital or equipment expenditure shall be approved if the applicant complies with the general considerations and policies of Ga. Comp. R. & Regs., r. 111-2-2-.09 and submits an application that demonstrates the applicant's compliance with or documents a plan and agreement to comply with the provisions of Ga. Comp. R. & Regs., r. 111-2-2-.22(3)(c),(d),(e),(g),(h) and (j) .
Any existing service seeking an expansion or expanded service based on an increase in procedures pursuant to the definition in Ga. Comp. R. & Regs., r. 111-2-2-.22(2)(d) may request a determination from the Department that the service is fully in compliance with the provisions of Ga. Comp. R. & Regs., r. 111-2-2-.22(3)(c),(d),(e),(g),(h) and (j) . The Department may issue a determination that the service is in compliance. If the Department issues such a determination, the service will not be required to apply for a Certificate of Need. If the Department determines that the service is not in compliance with the above referenced conditions, the service will be required to submit a Certificate of Need application.

(c) An applicant requesting a new or expanded adult open heart surgery service shall comply with the following three requirements:

Document that the open-heart surgery service shall have the capability to implement circulatory assist devices such as intra-aortic balloon assist and prolonged cardiopulmonary procedures, including at a minimum:

(i) repair and replacement of heart valves;

(ii) cardiac revascularization;

(iii) treatment of cardiac trauma;

(iv) repair of congenital defects in adults; and

(v) repair of acute aortic dissection.

Document that the applicant has available to the open-heart surgery service a full range of hospital-based diagnostic, ancillary, and support services, including the following organizational departments or services:

(i) medicine: cardiology, hematology, nephrology;

(ii) radiology: diagnostic, nuclear medicine;

(iii) surgery: cardiovascular, thoracic;

(iv) pathology: anatomic, clinical, blood bank, coagulation laboratory;

(v) anesthesiology: inhalation therapy; echocardiology in the operating room;

(vi) neurology;

(vii) special laboratories: cardiac catheter/angiographic;

(viii) clinical dietary;

(ix) cardiac surgical intensive care unit;

(x) pacemaker therapy;

(xi) cardiac rehabilitation services;

(xii) renal dialysis; and

(xiii) social services.

Document that the service shall be available for elective procedures as needed, at least eight hours per day, five days a week, and shall document the capability to rapidly mobilize surgical and medical support teams for emergency cases 24 hours per day, seven days per week, including a plan for utilizing this capability when needed to perform emergency procedures.

(d) An applicant for a new or expanded adult open heart surgery service shall:

submit a written plan to the Department which, when implemented, will ensure access to cardiac surgical services for all segments of the population in the documented and proposed service area of the facility and service. Such plan shall provide a detailed strategy to reach patients not currently served within the service area, ensure continuity of care for patients transferred between facilities and shall promote planning for a continuum of cardiac services within the service area;
propose a heart disease prevention program to be provided by the applicant or through formal referral agreements which, when implemented, shall include:

(i) Clinical intervention for cardiac patients (any inpatient or outpatient with a principal diagnosis of ischemic heart disease). These patients are at high risk for development of adverse cardiovascular events and the program shall provide for the following in a comprehensive, systematic way:

(I) Assessment of risk factors including lipid disorders, hypertension, diabetes, obesity, cigarette smoking, and sedentary lifestyle;

(II) Assessment of risk factors and referral for appropriate care in first-degree relatives;

(IV) Establishment and maintenance of systems to assist in tracking and follow-up to determine attendance at referred services and status of risk management.

(ii) Clinical intervention for non-cardiac patients (any inpatient or outpatient whose principal diagnosis is not ischemic heart disease). For these patients, the program shall encourage the following:

(I) Assessment of risk factors including, hypertension, hypercholesterolemia, smoking, obesity, sedentary lifestyle, and history of diabetes;

(II) Provision of appropriate counseling and referral for diagnostic evaluation, treatment and risk factor modification; and

(III) Establishment and maintenance of record systems to assist in documenting risk factors identified, referrals made, and other follow-up action taken.

(iii) The program shall assure access to cardiac rehabilitation services, provided either by the hospital itself or through formal referral agreements.

(iv) The program shall provide for annual support and participation in at least three professional education programs targeted to community-based health professionals, related to heart disease risk assessment, disease management in clinical settings, and case finding and referral strategies.

(v) Community based heart health promotion:

(II) Organization of or participation in at least one major community-based campaign each year related to major heart disease risk factors; and

propose a system of outcome monitoring and quality improvement and identify at least five clinical outcomes that the applicant proposes to monitor for performance on a regular basis.

(e) An applicant for a new or expanded adult open heart surgery service shall foster an environment which assures access to individuals unable to pay, regardless of payment source or circumstances, by the following:

providing a written policy regarding the provision of any services provided by or on behalf of the applicant to include disease prevention and intervention services outlined in Ga. Comp. R. & Regs., r. 111-2-2-.22(3)(d) , that such services shall be provided regardless of race, age, sex, creed, religion, disability, or patient's ability to pay, and documentation or evidence that the applicant has a service history reflecting the principles of such a policy;
providing a written commitment that services for indigent and charity patients will be offered at a standard which meets or exceeds three percent (3%) of annual, adjusted gross revenues for the adult open heart surgery service, or the applicant may request that the Department allow the commitment for services to indigent and charity to patients to be applied to the entire facility;
providing a written commitment to accept any patient without regard to the patient's ability to pay, unless such patient is clinically inappropriate;
providing a written commitment to participate in the Medicaid, PeachCare and Medicare programs and to accept any Medicaid-, PeachCare and/or Medicare-eligible patient for services unless such patient is clinically inappropriate;
providing a written commitment that the applicant, subject to good faith negotiations, will participate in any state health benefits insurance programs for which the service is deemed eligible; and
providing documentation of the past record of performance of the applicant, and any facility in Georgia owned or operated by the applicant's parent organization, of providing services to Medicare, Medicaid, and indigent and charity patients. The applicant's or its parent organization's failure to provide services at an acceptable level to Medicare, Medicaid and indigent and charity patients, and/or the failure to fulfill any previously made commitment to indigent and charity care may constitute sufficient justification to deny the application.

(f) In considering applications joined for review for new adult open heart surgery services, the Department may give favorable consideration to an applicant which historically has provided a higher annual percentage of unreimbursed services to indigent and charity patients and a higher annual percentage of services to Medicare and Medicaid patients.

(g) An applicant for a new or expanded adult open heart surgery service shall comply with the following three requirements:

Demonstrate the intent to achieve the optimal standards established by the American College of Surgeons and the Advisory Council for Cardiothoracic Surgery of the American College for evaluating the clinical and physical environments of cardiac surgical services and covering professional qualifications and responsibilities, staffing requirements, support services, physical plant, and equipment.
Document the availability of; or shall present a plan for recruiting, a qualified surgeon certified by the American Board of Thoracic Surgery with special qualifications in cardiac surgery.
Document a plan for obtaining a sufficient number of professional and technical staff; including cardiac intensive care nurses, for the size of the adult open heart surgery program proposed and document that the operating room team necessary for an adult open heart surgical procedure shall be available, including a cardiovascular surgeon who is board certified by the American Board of Thoracic Surgery; a second physician who is a cardiovascular or thoracic surgeon or surgical resident; a board-certified anesthesiologist trained in open heart surgery; a circulating nurse or scrub nurse (RN); an operating room technician or registered nurse trained in cardiac procedures; and one or two pump technicians, with one being certified and one qualified.

(h) An applicant for a new or expanded adult open heart surgery service shall provide documentation that the hospital is fully accredited by the Joint Commission or another nationally recognized health care accreditation body, and also shall provide sufficient documentation that the hospital has no history of significant licensure deficiencies and no history of conditional level Medicare and/or Medicaid certification deficiencies in the past three years and has no outstanding licensure and Medicare and/or Medicaid certification deficiencies.

(i) An applicant for a new adult open heart surgery service shall demonstrate that charges and/or reimbursement rates for the service shall compare favorably with charges and/or reimbursement rates in existing adult open heart surgery services in the state when adjusted for annual inflation. When determining the accuracy of an applicant's projected charges for adult open heart surgery procedures, the Department may compare the applicant's history of charges and/or reimbursement rates for cardiac catheterization procedures and other treatments and/or interventions for disorders of the circulatory system and for open heart procedures, if applicable, with such charges and/or reimbursement rates in other similar hospitals.

(j) An applicant for a new or expanded adult open heart surgery service must agree in writing to the following conditions:

establishment and maintenance of a system of continuity of care and coordination of service, as evidenced by regular and ongoing planning and quality improvement sessions with community health providers and advocacy programs; and
participation in a data reporting, quality improvement, outcome monitoring, and peer review system within the applicant hospital as well as a national, state or multi-hospital system which benchmarks outcomes based on national norms and which shall be named in the application and which provides for peer review between and among professionals practicing in facilities and programs other than the applicant hospital;
development of procedures to ensure that any surgeon authorized to perform open heart surgery for the hospital shall be required to perform at least 100 procedures on annual basis across his or her various practice settings, and shall be required to accept Medicaid or Medicare payment for services without discrimination;
commitment that charges for services shall be reasonable and comparable to other providers in the state and the service area;
provision of all required data and survey information to the Department as requested; and
commitment to act in good faith to fulfill all provisions and commitments documented in the application for a new or expanded service.

(k) The Department may revoke a Certificate of Need after notice to the holder of the certificate and a fair hearing pursuant to the Georgia Administrative Procedure Act for failure to comply with the defined scope, location, cost, service area, and person named in an application as approved by the Department and for the intentional provision of false information to the Department by an applicant in that applicant's application.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Adult Open Heart Surgery Services" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.22, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.23 Specific Review Considerations for Pediatric Cardiac Catheterization and Open-Heart Surgery {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.23}

(1) Definitions.

(a) "Authorized service" means a pediatric cardiac catheterization service or pediatric cardiac surgery service that is either existing or approved. An existing service is an authorized service that has become operational, and an approved service is an authorized service that has not become operational.

(b) "Capacity" means:

for a pediatric catheterization service:

(i) in considering applications for a new pediatric cardiac catheterization service, 750 procedures per year per authorized service regardless of the number of rooms used; or

(ii) in considering applications for expansion of an existing service, 750 pediatric cardiac catheterization procedures per dedicated room per year in the existing service (3 per day per room, 5 days per week, 50 weeks per year) and for each multipurpose room in the existing service, 750 procedures (special procedures and pediatric cardiac catheterization procedures) per year. If adult and pediatric cardiac catheterization are performed in the same room in a service seeking to expand, the capacity of the room shall be equivalent to 750 pediatric procedures with adult procedures performed in the room weighted in proportion to pediatric procedures as being 0.50 for each adult cardiac catheterization or special procedure, except for each adult coronary angioplasty, which shall be 0.75, in order to determine the service's use rate; or

for a pediatric cardiac surgery service, the number of pediatric cardiac surgery procedures which could be performed annually as reported by each hospital with an authorized service and based on survey and other reported data. In determining capacity, a hospital must consider factors such as available operating rooms which can be used for pediatric cardiac surgery, cardiac surgical intensive care beds and other pediatric intensive care beds available for pediatric patients, general bed capacity, and any other factors which impact the determination.

(c) "Cardiac catheterization" means a medical diagnostic or therapeutic procedure during which a catheter is inserted into a vein or artery in the patient; subsequently, the free end of the catheter is manipulated by the physician to travel along the course of the blood vessel into the chambers or vessels of the heart. X-rays and an electronic image intensifier are used as aids in placing the catheter tip in the desired position. When the catheter is in place, the physician is able to perform various diagnostic studies and/or therapeutic procedures on the heart or its vessels.

(d) "Closed heart surgery" means an operation performed directly on the heart or its associated veins or arteries that does not require use of a heart and lung bypass machine (extracorporeal pump) to perform the work of the heart and lungs. Such operations often require the bypass machine to be available on standby for use if the surgery needs to be changed to open heart with the machine then performing the work of the heart and lungs.

(e) "Official State Component Plan" means the document related to specialized cardiovascular services developed by the Department, established by the Health Strategies Council, and adopted by the Board of Community Health.

(f) "Open heart surgery" means surgery performed directly on the heart or its associated veins or arteries during which a heart and lung bypass machine (extracorporeal pump) is used to perform the work of the heart and lungs.

(g) "Pediatric" refers to children 14 years of age and under.

(h) "Pediatric cardiac catheterization service" means an organized program which serves pediatric patients of a hospital which has a room or suite of rooms with the equipment, staff, and all support services required to perform angiographic, physiologic, and, as appropriate, therapeutic cardiac catheterization procedures. The pediatric cardiac catheterization service shall be located in a pediatric tertiary hospital. Procedures may be performed in a room dedicated to cardiac catheterization and/or in a special procedures or multipurpose room not exclusively used for cardiac catheterization.

(i) "Pediatric cardiac surgery" means an operation performed directly on a pediatric patient's heart or its associated veins or arteries, including open heart and closed heart surgery procedures but excluding surgical procedures for the closure of neonatal patent ductus arteriosus.

(j) "Pediatric cardiac surgery service" means an organized surgical program which serves pediatric inpatients of a hospital which has a suitable operating room or suite of operating rooms, equipment, staff, and all support services required to perform closed heart and open-heart operations for pediatric patients. The pediatric cardiac surgery service shall be located in a pediatric tertiary hospital.

(k) "Pediatric tertiary hospital" means a teaching center, specialty medical or large community hospital characterized by serving pediatric patients from a large region or the entire state with sophisticated technology and support services to provide highly specialized medical and surgical care for unusual and complex medical problems of pediatric patients.

(l) "Procedure" means a cardiac catheterization study or treatment or combination of studies and/or treatments performed in a single session on a single patient who appears for cardiac catheterization or a pediatric open or closed heart operation or combination of operations performed in a single session on a single patient who appears for pediatric cardiac surgery.

(m) "Service area", for pediatric cardiac catheterization and pediatric cardiac surgery means the State of Georgia.

(2) Standards.

(a) An applicant for new pediatric cardiac catheterization and pediatric cardiac surgery services must be a pediatric tertiary hospital. Due to the highly specialized nature of pediatric cardiac catheterization and pediatric cardiac surgery services, applicants for these services must propose to provide both pediatric cardiac catheterization and pediatric cardiac surgery. Only those projects that meet all applicable standards for both services will be approved.

(b) New pediatric cardiac catheterization services shall be approved in the state only if each and all of the following conditions are met:

the combined use rate for all existing and approved pediatric cardiac catheterization services in the state has been at or above eighty percent (80%) of capacity for the past two (2) years as documented through surveys submitted to the Department;
an applicant must project that the proposed service will be operating at a minimum of one-hundred fifty (150) procedures per year within three (3) years of initiation of the service in order to maintain and strengthen skills. Such projection at a minimum shall include consideration of patient origin data and the use rate of existing services; and
an applicant must show that authorized pediatric cardiac catheterization services that would be impacted by the establishment of the new service are not predicted to perform less than the minimum quality level of one-hundred fifty (150) procedures annually as a result of the establishment of the new service.

(c) An application for expansion of an existing pediatric cardiac catheterization service shall be approved in the state only if the applicant's existing service has operated at a use rate of at least eighty percent (80%) of capacity for each of the past two (2) years and the applicant can project a minimum of one-hundred fifty (150) additional pediatric procedures per year within three (3) years of initiation of the service expansion and the applicant demonstrates compliance with or documents a plan and agreement to comply with the applicable provisions of Ga. Comp. R. & Regs., r. 111-2-2-.23(2)(f) through (o) .

(d) New pediatric cardiac surgery services shall be approved in the state only if each and all of the following conditions are met:

the combined use rate of all authorized pediatric cardiac surgery services in the state has been at or above eighty percent of (80%) capacity for the past two (2) years as documented through surveys submitted to the Department;
an applicant must project that the proposed service will be operating at a minimum of one hundred (100) pediatric cardiac surgery procedures per year, of which at least fifty (50) are open heart operations, within three years of initiation of the service in order to maintain and strengthen skills. Such projections at a minimum shall include consideration of patient origin data and the use rate of existing services; and
an applicant must show that authorized pediatric cardiac surgery services which would be impacted by the establishment of the new services are not predicted to perform less than the minimum quality level of one hundred (100) procedures annually, of which at least fifty (50) are open heart operations, as a result of the establishment of the new service.

(e) An application for expansion of an existing pediatric cardiac surgery service shall be approved in the state only if the applicant's existing service has operated at a use rate of at least eighty percent (80%) of capacity for each of the past two years and the applicant can project a minimum of one hundred 100 additional pediatric cardiac surgery procedures, of which at least fifty (50) are open heart operations, within three (3) years of initiation of the service expansion and the applicant demonstrates compliance with or documents a plan and agreement to comply with the applicable provisions of Ga. Comp. R. & Regs., r. 111-2-2-.23(2)(f) through (o) .

(f) An applicant for a new or expanded pediatric cardiac catheterization service shall:

document that the applicant is a pediatric tertiary hospital, which serves pediatric patients from a large region or the entire state, with sophisticated technology and support services to provide highly specialized medical and surgical care for unusual and complex medical problems of pediatric patients; and
document that, in addition to the basic requirements described for adult cardiac catheterization services, the hospital shall have support services and equipment necessary for the diagnosis and treatment of infants and children as specified by the American College of Cardiology and the American Academy of Pediatrics.

(g) An applicant for a new or expanded pediatric cardiac surgery service shall:

document that the applicant is a pediatric tertiary hospital, which serves pediatric patients from a large region or the entire state, with sophisticated technology and support services to provide highly specialized medical and surgical care for unusual and complex medical problems of pediatric patients; and
document that, in addition to the basic requirements described for adult open-heart surgery, the hospital shall have support services and equipment necessary for surgery on infants and children as specified by the American College of Cardiology and the American Academy of Pediatrics, Guidelines for Pediatric Cardiology Diagnostic and Treatment Centers. This includes a complete pediatric cardiology unit, a neonatal intensive care unit, a pediatric intensive care unit, and a general pediatric unit with pediatric sub-specialists in hematology, endocrinology, pulmonary neurology, and radiology.

(h) An applicant for a new or expanded pediatric cardiac catheterization service or for a new or expanded pediatric cardiac surgery service shall document that the service shall be available for the performance of procedures as needed at least eight hours per day, five days per week, and shall document the capability to rapidly mobilize the surgical and medical support teams for emergency procedures 24 hours per day, seven days per week, including a plan for utilizing this capability when needed to perform emergency procedures.

(i) An applicant for a new or expanded pediatric cardiac catheterization service and/or pediatric cardiac surgery service shall:

submit a written plan to the Department which, when implemented, will ensure access to services for all segments of the population in the documented and proposed service area of the applicant. Such plan shall provide a detailed strategy to reach patients not currently served within the service area, ensure continuity of care for patients transferred between facilities and shall promote planning for a continuum of cardiac services within the service area;
propose a heart disease prevention and clinical intervention program to be provided by the applicant or through formal referral agreements which, when implemented, shall include:

(i) A clinical intervention program for all patients that shall provide for the following in a comprehensive, systematic way:

(I) Assessment of risk factors including lipid disorders, hypertension, diabetes, obesity, cigarette smoking, and sedentary lifestyle;

(II) Assessment of risk factors and referral for appropriate care in first-degree relatives; and

(ii) The program shall provide for annual support and participation in at least three professional education programs targeted to community-based health professionals, related to heart disease risk assessment, diagnostic procedures, disease management in clinical settings, and case finding and referral strategies.

(iii) Community based heart health promotion:

(II) Organization of or participation in at least one major community-based campaign each year related to major heart disease risk factors; and

propose a system of outcome monitoring and quality improvement and identify at least five (5) clinical outcomes that the applicant proposes to monitor for performance on a regular basis.

(j) An applicant for new or expanded pediatric cardiac catheterization and pediatric cardiac surgery services shall foster an environment which assures access to individuals unable to pay, regardless of payment source or circumstances, by the following:

providing a written policy regarding the provision of any services provided by or on behalf of the applicant regardless of race, age, sex, creed, religion, disability or patient's ability to pay, and documentation or evidence that the applicant has a service history reflecting the principles of such a policy;
providing a written commitment that services for indigent and charity patients will be offered at a standard which meets or exceeds three percent (3%) of annual, adjusted gross revenues for the pediatric cardiac catheterization and surgical services, or the applicant may request that the Department consider allowing the commitment for services to indigent and charity to patients to be applied to the entire facility;
providing a written commitment to accept any patient within the facility's service area, without regard to the patient's ability to pay, unless such patient is clinically inappropriate;
providing a written commitment to participate in the Medicaid and PeachCare programs and to accept any Medicaid- and/or PeachCare eligible patient for services unless such patient is clinically inappropriate;
providing a written commitment that the applicant, subject to good faith negotiations, will participate in any state health benefits insurance programs for which the service is deemed eligible; and
providing documentation of the past record of performance of the applicant, and any facility in Georgia owned or operated by the applicant's parent organization, of providing services to Medicare, Medicaid, and indigent and charity patients. The applicant's or its parent organization's failure to provide services at an acceptable level to Medicare, Medicaid and indigent and charity patients, and/or the failure to fulfill any previously made commitment to indigent and charity care may constitute sufficient justification to deny the application.

(k) An applicant for a new or expanded pediatric cardiac catheterization service shall:

demonstrate the intent to achieve the optimal standards established by the American Academy of Pediatrics, Guidelines for Pediatric Cardiology Diagnostic and Treatment Centers for evaluating the clinical and physical environments of cardiac catheterization services and covering professional qualifications and responsibilities, staffing requirements, supporting services, physical plant, and equipment;
document the availability of, or shall present a plan for recruiting, a qualified service director who is a physician, board-certified in pediatrics, with subspecialty training and board eligibility in pediatric cardiology and who is competent to perform physiologic and angiographic procedures or both; and
document a plan for obtaining a sufficient number of professional and technical staff for the size of the pediatric cardiac catheterization service proposed, including a pediatric nurse, radiologic technologist, cardiopulmonary technician, and darkroom technician and document that the staff required for most procedures shall be available, including two physicians, one nurse, and two technicians, with the nurse and technicians cross trained to cover technical responsibility of the monitoring and recording technicians.

(l) An applicant for a new or expanded pediatric cardiac surgery service shall comply with the following three requirements:

Demonstrate the intent to achieve the optimal standards established by the Advisory Council for Cardiothoracic Surgery of the American College of Surgeons, and the American Academy of Pediatrics, Guidelines for Pediatric Cardiology Diagnostic and Treatment Centers for evaluating the clinical and physical environments of cardiac surgical services and covering professional qualifications and responsibilities, staffing requirements, supporting services, physical plant, and equipment.
Document the availability of, or shall present a plan for recruiting, a qualified pediatric cardiac surgery director who is a pediatric cardiovascular surgeon, board-certified in thoracic surgery, with special emphasis and experience in surgery for congenital heart disease.
Document a plan for obtaining a sufficient number of professional and technical staff, including pediatric cardiac intensive care nurses, for the size of the pediatric cardiac surgery service proposed, including at least two board-qualified cardiac surgeons on the staff of the hospital and a cardiovascular surgical team which includes a neonatologist, a pediatric anesthesiologist, a pediatric radiologist, a pediatric cardiologist, a nurse clinician, and backup of medical social services.

(m) An applicant for new or expanded pediatric cardiac catheterization and pediatric cardiac surgery services shall provide documentation that the hospital is fully accredited by the Joint Commission or another nationally recognized health care accreditation body and also shall provide sufficient documentation that the hospital has no history of significant licensure deficiencies and no history of conditional level Medicare and Medicaid certification deficiencies in the past three (3) years and has no outstanding licensure and Medicare and Medicaid certification deficiencies.

(n) An applicant for new or expanded pediatric cardiac catheterization and pediatric cardiac surgery services shall demonstrate that the applicant's charges and/or reimbursement for pediatric cardiac catheterization and pediatric cardiac surgery services shall compare favorably with charges and/or reimbursement in existing pediatric cardiac catheterization and pediatric cardiac surgery services in the state, when adjusted for annual inflation.

(o) An applicant for new or expanded pediatric cardiac catheterization and/or pediatric cardiac surgery services must agree in writing to the following conditions:

establishment and maintenance of a system of continuity of care and coordination of service, as evidenced by regular and ongoing planning and quality improvement sessions with community health providers and advocacy programs;
participation in a data reporting, quality improvement, outcome monitoring, and peer review system within the applicant hospital as well as a national, state or multi-hospital system which benchmarks outcomes based on national norms and which shall be named in the application and which provides for peer review between and among professionals practicing in facilities and programs other than the applicant hospital;
development of procedures to ensure that any surgeon or cardiologists authorized to perform pediatric cardiac services for the hospital shall be required to accept Medicaid and PeachCare payment for services without discrimination;
commitment that charges for services shall be reasonable and comparable to other providers in the state and the service area;
provision of all required data and survey information to the Department as requested; and
commitment to act in good faith to fulfill all provisions and commitments documented in the application for a new or expanded service.

(p) The Department may revoke a Certificate of Need after notice to the holder of the certificate and a fair hearing pursuant to the Georgia Administrative Procedure Act for failure to comply with the defined scope, location, cost, service area, and person named in an application as approved by the Department and for the intentional provision of false information to the Department by an applicant in that applicant's application.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Pediatric Cardiac Catheterization and Open Heart Surgery" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: New title, "Specific Review Considerations for Pediatric Cardiac Catheterization and Open-Heart Surgery." F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.23, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.24 Specific Review Considerations for Perinatal Services {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.24 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.24}

(1) Applicability. For Certificate of Need purposes, Basic Perinatal Services, Neonatal Intermediate Care Services (Specialty/Level II), and Neonatal Intensive Care Services (Subspecialty/Level III) shall be defined as new institutional health services.

(2) Definitions.

(a) "Basic Perinatal Services (Level I)" means providing basic inpatient care for pregnant women and newborns without complications; managing perinatal emergencies; consulting with and referring to specialty and subspecialty hospitals; identifying high-risk pregnancies; providing follow-up care for new mothers and infants; and providing public/community education on perinatal health.

(b) "Most recent year" means the most current twelve-month period within a month of the date of completion of an application or within a month of the date of completion of the first application when applications are joined. If the Department has conducted a survey within six (6) months of the date of completion of the first application when applications are joined, the Department may consider the most recent year to be the report period covered by the prior survey.

(c) "Neonatal Intensive Care Service (Subspecialty/Level III)" means a hospital service that meets the requirements for a Neonatal Newborn Care Service and meets the definition of a Subspecialty Perinatal Hospital Service as contained in the most recent edition of the Recommended Guidelines for Perinatal Care in Georgia, as published by the Council on Maternal & Infant Health.

(d) "Neonatal Intermediate Care Service (Specialty/Level II)" means a hospital service that meets the requirements for a Neonatal Newborn Care Service and meets the definition of a Specialty Perinatal Hospital Service as contained in the most recent edition of the Recommended Guidelines for Perinatal Care in Georgia, as published by the Council on Maternal & Infant Health.

(e) "Neonatal Newborn Care Service (Basic/Level I)" means a hospital service which meets the minimum standards contained in Chapter 111-8-40 of the Rules of the Healthcare Facility Regulation Division, such chapter being entitled "Newborn Service. Amended."

(f) "Obstetric Service" means a hospital service that meets the minimum standards contained in Chapter 111-8-40 of the Rules of the Healthcare Facility Regulation Division, such chapter being entitled "Maternity and Obstetric Service Amended."

(g) "Official Inventory" means the inventory for each hospital of Basic Perinatal Service and Neonatal Intermediate and Intensive Care Service beds maintained by the Department based upon responses to the Annual Hospital Questionnaire (AHQ) and/or its Perinatal Addendum and any Certificate of Need approved beds after the period covered by the AHQ and with the following provisions:

the official inventory for each facility will remain unchanged for the year following the last day of the report period on each hospital's completed AHQ and/or its Perinatal Addendum unless the Department approves a change of bed capacity through the Certificate of Need process; and
the capacity of existing freestanding birthing centers will not be counted as part of the official inventory of available services when computing unmet numerical need for Basic Perinatal Services in a planning area.

(h) "Perinatal physician training program" refers to obstetrics and gynecology, family practice and pediatrics disciplines.

(i) "Planning Areas" means fixed sub-state regions for reviewable services as defined in the State Health Component Plan for Perinatal Services.

(j) "Regional Perinatal Center" (RPC) means those hospitals designated by the Department of Public Health to serve a defined geographic area to provide the highest level of comprehensive perinatal health care services for pregnant women, their fetuses and neonates of all risk categories. The RPC accepts patients in need of these services from its region regardless of race, creed, religion, ability to pay, or funding source. The RPC provides consultation and transport for patients requiring special services; coordination and assurance of follow-up medical care for maternal and neonatal patients requiring special care; educational support to ensure quality care in institutions involved in perinatal health care; compilation, analysis, and evaluation of perinatal data from the center and referring hospitals and coordination of perinatal health care within the region.

(k) "Urban County" means a county with a projected population for the horizon year of 100,000 or more and a population density for that year of 200 or more people per square mile. All other counties are "rural."

(3) Standards.

(a) The need for a new or expanded Obstetric Service, Neonatal Intermediate Care Service and Neonatal Intensive Care Service shall be determined through application of a Numerical Need method and an assessment of the aggregate occupancy rate of existing services.

The numerical need for a new or expanded Obstetric Service in a planning area shall be determined through the application of a demand-based forecasting model. The model is outlined in the steps listed below, and all data elements relate to each planning area:

(i) Calculate the average obstetric utilization rate (UR) by dividing the obstetric days (OBDays) reported by hospitals for the two most recent 12-month reporting periods of the Annual Hospital Questionnaire and/or its Perinatal Addendum by the female population ages 15 to 44 (FP) for the corresponding years:

(ii) Multiply the obstetric utilization rate by the projected female population ages 15 to 44 (PFP) for the horizon year to determine the number of projected obstetric days (POBDays):

(iii) Calculate the number of projected obstetric beds (POBBeds) by dividing the number of projected obstetric days by 273.75 (the result of 365 days multiplied by the occupancy standard of seventy-five percent (75%)) with any fraction rounded up to a whole bed:

(iv) Determine the net numerical unmet need (UN) for new or additional obstetric beds by subtracting the number of beds in the Official Inventory (OI) from the number of projected obstetric beds:

The numerical need for a new or expanded Level II Neonatal Intermediate Care Service in a planning area shall be determined through the application of a demand-based forecasting model. The model is outlined in the steps below, and all data elements relate to each planning area:

(i) Calculate the average resident live-birth rate (ABR) using the sum of the resident live births (RB) for the three most recent calendar years available from the Department of Public Health or other official source divided by the corresponding years' female population ages 15 to 44 (FP):

(ii) Determine the number of projected resident live births (PRB) for the horizon year by multiplying the average resident live-birth rate by the estimated female population ages 15 to 44 (PFP) for the horizon year:

(iii) Calculate the projected number of neonatal intermediate care patient days (PN2Days) in the horizon year by multiplying the average number of patient days (N2Days) in neonatal intermediate care beds reported by hospitals for the two most recent 12-month reporting periods of the Annual Hospital Questionnaire and/or its Perinatal Addendum by the number of projected resident live births divided by the actual number of resident live births (RB) available from the Department of Public Health or other official source for the most recent calendar year:

(iv) Project neonatal intermediate care bed need (N2Beds) into the horizon year by dividing the projected patient days for neonatal intermediate care services by 292 (the result of 365 days multiplied by the occupancy rate of eighty percent (80%)) with any fraction rounded up to a whole bed:

(v) To determine unmet numerical bed need (UN), subtract the official inventory (OI) from the projected neonatal intermediate care bed need:

The numerical need for a new or expanded Level III Neonatal Intensive Care Service in a planning area shall be determined through the application of a demand-based forecasting model. The model is outlined in the steps below, and all data elements relate to each planning area:

(iii) Calculate the projected number of neonatal intensive care patient days (PN2Days) in the horizon year by multiplying the average number of patient days (N2Days) in neonatal intensive care beds reported by hospitals for the two most recent 12-month reporting periods of the Annual Hospital Questionnaire and/or its Perinatal Addendum by the number of projected resident live births divided by the actual number of resident live births (RB) available from the Department of Public Health or other official source for the most recent calendar year:

(iv) Project neonatal intensive care bed need (N2Beds) into the horizon year by dividing the projected patient days for neonatal intensive care services by 292 (the result of 365 days multiplied by the occupancy rate of eighty percent (80)) with any fraction rounded up to a whole bed:

(v) To determine unmet numerical bed need (UN), subtract the official inventory (OI) from the projected neonatal intensive care bed need:

Prior to approval of a new or expanded Obstetric Service, Neonatal Intermediate Care Service or Neonatal Intensive Care Service in a planning area, the aggregate occupancy rate for all similar services in that planning area shall equal or exceed seventy-five percent (75%) for an Obstetric Service and eighty percent (80%) for a Neonatal Intermediate Care Service or Neonatal Intensive Care Service for each of the two (2) most recent years.

(b) Exceptions to need may be considered by the Department as follows:

To provide that an applicant for new basic perinatal services shall not be subject to the need standard of section (3)(a)1. or the aggregate occupancy standard of section (3)(a)4. of this Rule if:

(i) The proposed new service would be located in a county where only one civilian health care facility or health system is currently providing basic perinatal services; and

(ii) There are not at least three (3) different health care facilities in a contiguous county providing basic perinatal services.

To allow expansion of an existing Level I or Level II or Level III service, if the actual utilization of that service has exceeded 80 percent occupancy over the most recent two years; or
To remedy an atypical barrier to perinatal services based on cost, quality, financial access, or geographic accessibility. An applicant seeking such an exception shall have the burden of proving to the Department that the cost, quality, financial access, or geographic accessibility of current services, or some combination thereof, result in a barrier to services that should typically be available to citizens in the planning area and/or the communities under review. In approving an applicant through the exception process, the Department shall document the bases for granting the exception and the barrier or barriers that the successful applicant would be expected to remedy.

(c) An applicant for a new or expanded Basic Perinatal Service or Neonatal Intermediate Care or Neonatal Intensive Care Service shall document the impact on existing and approved services in the planning area with the goal of minimizing adverse impact on the delivery system and as follows:

An existing perinatal physician training program shall not be adversely impacted by the establishment of a new or expanded perinatal service to the extent that the existing service could not sustain a sufficient number and variety of patients to maintain an appropriate number of providers and provider competencies and the training program's accreditation and funding status;
An existing nurse midwifery training program shall not be adversely impacted by the establishment of a new or expanded perinatal service to the extent that the existing service could not sustain an appropriate number of providers and provider competencies to sustain a sufficient number and variety of patients to maintain the training program's accreditation; and
An existing regional perinatal center shall not be adversely impacted by the establishment of a new or expanded perinatal service to the extent that the existing service could not sustain a sufficient volume and case mix of patients including both low risk and high risk deliveries to maintain its regional center status.

(d) An applicant for a new or expanded Basic Perinatal Service or Neonatal Intermediate Care Service or Neonatal Intensive Care Service shall foster an environment that assures access to services to individuals unable to pay and regardless of payment source or circumstances by the following:

providing evidence of written administrative policies and directives related to the provision of services on a nondiscriminatory basis;
providing a written commitment that unreimbursed services for indigent and charity patients will be offered at a standard which meets or exceeds three percent (3%) of annual gross revenues for the entire facility after Medicare and Medicaid contractual adjustments and bad debt have been deducted;
providing a written commitment to participate in the Medicaid program;
providing a written commitment to participate in any other public reimbursement programs available for perinatal services for which the hospital is eligible; and
providing documentation of the demonstrated performance of the applicant, and any facility in Georgia owned or operated by the applicant's parent organization, of providing services to individuals unable to pay based on the past record of service to Medicare, Medicaid, and indigent and charity patients, including the level of unreimbursed indigent and charity care.

(e) The desired minimum bed size for a Basic Perinatal Service, Neonatal Intermediate Care Service or Neonatal Intensive Care Service is as follows:

At least four beds for a new Basic Perinatal, Neonatal Intermediate Care, or Neonatal Intensive Care Service.
The Department may grant an exception to these standards when the Department determines that unusual circumstances exist that justify such action.

(f) An applicant for a new or expanded Basic Perinatal Service or Neonatal Intermediate Care Service or Neonatal Intensive Care Service shall provide evidence of ability to meet the following continuity of care standards:

Document a plan whereby the hospital and its medical staff agree to provide a full array of perinatal services to the community, including but not limited to community education and outreach, prenatal, intrapartum, postpartum, newborn, and postnatal services; and
As appropriate, provide a formal transfer agreement with at least one hospital within reasonable proximity that provides services to high-risk mothers and babies.

(g) An applicant for a new or expanded Basic Perinatal Service or Neonatal Intermediate Care Service or Neonatal Intensive Care Service shall provide evidence of the ability to meet the following quality of care standards:

evidence that qualified personnel will be available to ensure a quality service to meet licensure, certification and/or accreditation requirements;
written policies and procedures for utilization review consistent with state, federal and other accreditation standards. This review shall include assessment of medical necessity for the service, quality of patient care, and rates of utilization;
written statement of its intent to comply with all appropriate licensure requirements and operational procedures required by the Healthcare Facility Regulation Division; and
evidence that there are no uncorrected operational standards in any existing Georgia hospitals owned and/or operated by the applicant or the applicant's parent organization. Plans of correction in the applying facility must be included in the application.

(h) An applicant for a new or expanded Basic Perinatal Service or Neonatal Intermediate Care Service or Neonatal Intensive Care Service shall document an agreement to provide Department requested information and statistical data related to the operation and provision of services and to report that data to the Department in the time frame and format requested by the Department.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Perinatal Services" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.24, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.25 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.25 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.25}

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Freestanding Birthing Centers" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.25, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Repealed: F. Dec. 24, 2024; eff. Jan. 13, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.26 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.26 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.26}

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Psychiatric and Substance Abuse Inpatient Programs" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Nov. 22, 2006; eff. Dec. 12, 2006.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.26, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Repealed: F. Dec. 24, 2024; eff. Jan. 13, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.27 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.27 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.27}

Ga. Comp. R. & Regs. r. 111-2-2-.28 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.28 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.28}

Ga. Comp. R. & Regs. r. 111-2-2-.29 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.29 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.29}

Ga. Comp. R. & Regs. r. 111-2-2-.30 Specific Review Considerations for Skilled Nursing and Intermediate Care Facilities {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.30 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.30}

(1) Applicability . A Certificate of Need will be required prior to the establishment of a new or expanded skilled nursing facility, intermediate care facility, or an intermingled facility.

(2) Definitions.

(a) "Horizon year" means the last year of the three-year projection period for need determinations for a nursing facility.

(b) "Hospital-based nursing facility" means a nursing facility which meets the current definition of "Hospital-Based Nursing Facilities" as defined in the current Policies and Procedures for Nursing Facility Services by the Georgia Department of Community Health, Division of Medical Assistance. A new hospital-based nursing facility can only result from conversion of existing inpatient space on the hospital's campus.

(c) "Intermediate care facility" ("ICF") means an institution which provides, on a regular basis, health related care and services to individuals who do not require the degree of care and treatment which a hospital or skilled nursing facility is designed to provide but who, because of their mental or physical condition, require health related care and services beyond the provision of room and board.

(d) "Intermingled facility" means a nursing facility that provides both skilled intermediate levels of care.

(e) "Medicare distinct part skilled nursing unit" means a unit which meets the current definition of "Distinct Part of an Institution as SNF" as defined in the current Medicare Part A Intermediary Manual by the Centers for Medicare and Medicaid Services ("CMS") of the U.S Department of Health and Human Services.

(f) "Nursing facility" means a facility classified as either a skilled nursing facility, an intermediate care facility or an intermingled facility which admits patients by medical referral and provides for continuous medical supervision via 24-hour-a-day nursing care and related services in addition to food, shelter, and personal care.

(g) "Official State Health Component Plan" means the document related to the above-named services developed by the Department, established by the Georgia State Health Strategies Council, and adopted by the Board of Community Health.

(h) "Planning area" for all nursing facilities, with the exception of state nursing facilities, means the geographic regions in Georgia defined in the "Official State Health Component Plan". "Planning area for a state nursing facility" means the State of Georgia.

(i) "Retirement community-based nursing facility" means a nursing facility which operates as a lesser part of a retirement community which is a planned, age-restricted, congregate living development which offers housing, recreation, security, dietary services, and shared living areas accessible to all residents.

(j) "Skilled nursing facility" ("SNF") means a public or private institution or a distinct part of an institution which is primarily engaged in providing inpatient skilled nursing care and related services for patients who require medical or nursing care or rehabilitation services for the rehabilitation of the injured, disabled or sick persons.

(k) "State nursing facility" is a facility that meets the definition of a Nursing Facility as defined above and is owned and operated by a branch or branches of government of the State of Georgia.

(l) "Urban county" means a county with a projected population for the horizon year of 100,000 or more and population density for that year of 200 or more people per square mile. All other counties are "rural".

(3) Standards .

(a) The need for a new or expanded nursing facility in a planning area in the horizon year shall be determined through application of a numerical, supply-oriented need method and an assessment of current planning area utilization designed to measure demand for services.

The numerical need for a new or expanded nursing facility in any planning area in the horizon year shall be determined by a population-based formula which is a sum of the following:

(i) a ratio of 0.43 beds per 1,000 projected horizon year Resident population age 64 and younger;

(ii) a ratio of 9.77 beds per 1,000 projected horizon year Resident population age 65 through 74;

(iii) a ratio of 32.5 beds per 1,000 projected horizon year Resident population age 75 through 84; and

(iv) a ratio of 120.00 beds per 1,000 projected horizon year Resident population age 85 and older.

The demand for services in each planning area will be measured by the cumulative facility bed utilization rate during the most recent survey year period. The utilization rate shall be determined by dividing the actual bed days of resident care by the bed days available for resident care.
In order to establish need for a new or expanded nursing facility in any planning area, the utilization rate in that planning area shall have equaled or exceeded ninety-five percent (95%) during the most recent survey year.

(b) The required bed size for a new nursing facility in a rural or urban county is as follows: (Rural/urban designation shall be based on the county within which the proposed facility is to be located.)

A freestanding nursing facility in a rural county: a minimum of 60 beds;
A freestanding nursing facility in an urban county: a minimum of 100 beds;
A hospital-based nursing facility in a rural county: a minimum of 10 beds and a maximum of 20 beds;
A hospital-based nursing facility in an urban county: a minimum of 20 beds and a maximum of 40 beds;
A retirement community-based nursing facility: 1 nursing home bed for each 4 residential units, with a minimum of 20 beds and a maximum of 30 beds.

(c) In competing applications, favorable consideration may be given for the inclusion of services for special needs populations, such as but not limited to, persons with Alzheimer's Disease and related disorders, medically fragile children, or persons with HIV/AIDS. An applicant must document a need for the service and that it is cost effective.

(d) The Department may allow an exception to Ga. Comp. R. & Regs. r. 111-2-2-.30(3)(a) under the following circumstances:

the establishment of a new Medicare distinct part skilled nursing unit if the proposed unit is to be in a county that does not have an existing Medicare unit; and if the applicant can document that there is limited access in the proposed planning area for skilled nursing services for Medicare patients. Limited access means that existing nursing facilities have not provided the proposed services in response to a demonstrated demand for the services over the three (3) most recent years. The implementation of an approved Certificate of Need will be valid only if the proposed beds will be limited to Medicare recipients. This exception is available to existing nursing facilities and hospitals; or
the applicant for a new or expanded nursing facility can show that there is limited access in the proposed geographic service area for special groups such as, but not limited to medically fragile children and HIV/AIDS patients. Limited access means that existing nursing facilities have not provided the proposed services in response to a demonstrated demand for the services over the three (3) most recent years.

(e) An applicant for a new or expanded facility must document provision of continuity of care by meeting each of the following:

An applicant shall provide a community linkage plan which demonstrates factors such as, but not limited to, referral arrangements with appropriate services of the healthcare system and working agreements with other related community services assuring continuity of care; and
An applicant shall document the existence of proposed and/or existing referral agreements with a nearby hospital to provide emergency services and acute-care services to residents of the proposed or existing facility; and
An applicant shall provide existing or proposed rehabilitation plans for services to facility residents; and
An applicant shall provide existing or proposed discharge planning policies.

(f) An applicant for a new or expanded nursing facility must provide evidence of the intent to meet all appropriate requirements regarding quality of care as follows:

An applicant shall provide a written statement of its intent to comply with all appropriate licensure requirements and operational procedures required by the Healthcare Facility Regulation Division;
An applicant shall provide evidence that there are no uncorrected operational standards in any existing Georgia nursing homes owned and/or operated by the applicant or by the applicant's parent organization. Plans to correct physical plant deficiencies in the applying facility must be included in the application;
An applicant and any facility owned and/or operated by the applicant or its parent organization shall have no previous conviction or Medicaid or Medicare fraud;
An applicant shall demonstrate the intent and ability to recruit, hire and retain qualified personnel to meet the current Medicaid certification requirements of the Department's Division of Medical Assistance for the services proposed to be provided and that such personnel are available in the proposed geographic service area;
An applicant shall provide a plan for a comprehensive quality improvement program that includes, but is not limited to, procedures and plans for staff training and a program to monitor specific quality indicators and measure the facility's performance; accordingly, and
In competing applications, favorable consideration will be given to an applicant that provides evidence of the ability to meet accreditation requirements of appropriate accreditation agencies within two years after the facility becomes operational.

(g) An applicant or a new or expanded facility must provide evidence of meeting the following standards pertaining to financial accessibility:

An applicant shall provide a written commitment of intent to participate in the Medicaid and Medicare programs if appropriate;
An applicant shall demonstrate a case-mix of Medicaid, Medicare and private pay patients; and
Document policies and practices of nondiscrimination by past performance of the applicant or its parent organization.

(h) A new or expanded state nursing facility may be exempted from the provisions of Ga. Comp. R. & Regs. r. 111-2-2-.30(3)(a), (b), (c), (d), and (g) when the facility meets all of the following criteria:

documentation that the proposed facility will meet the definition of a state nursing facility as defined in Ga. Comp. R. & Regs. r. 111-2-2-.30(1) ((k);
documentation that the applicant will admit patients from any of Georgia's counties with a primary focus on a pre-designated, multi-county service area or region;
the facility intends to become accessible to patients whose care, because of income and other limitations, would normally come under the jurisdiction of the state; and
such other considerations as may be considered necessary by the Department at the time of the application.

(i) An applicant for a new or expanded nursing facility shall document an agreement to provide Department requested information and statistical data related to the operation and provision of nursing facility services and to report that data to the Department in the time frame and format requested by the Department.

History

Authority: O.C.G.A. §§31-2et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Skilled Nursing and Intermediate Care Facilities" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.30, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.

Ga. Comp. R. & Regs. r. 111-2-2-.31 Specific Review Considerations for Personal Care Homes {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.31 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.31}

(1) Applicability. A Certificate of Need for a personal care home will be required prior to the establishment of a new personal care home, of twenty-five beds or more, and the expansion of any personal care home which is or will be twenty-five beds or more.

(2) Definitions.

(a) "Health planning area" for all personal care homes, means the geographic regions in Georgia defined in the State Health Plan or Component Plan.

(b) "Horizon Year" means the last year of a three-year projection period for need determinations for a personal care home.

(c) "Official State Health Component Plan" means the document related to personal care homes developed by the Department adopted by the State Health Strategies Council and approved by the Board of Community Health.

(d) "Personal care home" means a residential facility that is certified as a provider of medical assistance for Medicaid purposes pursuant to Article 7 of Chapter 4 of Title 49 having at least twenty-five (25) beds and providing, for compensation, protective care and oversight of ambulatory, non-related persons who need a monitored environment but who do not have injuries or disabilities which require chronic or convalescent care, including medical, nursing, or intermediate care. Personal care homes include those facilities which monitor daily residents' functioning and location, have the capability for crisis intervention, and provide supervision in areas of nutrition, medication, and provision of transient medical care. Such term does not include:

old age residences which are devoted to independent living units with kitchen facilities in which residents have the option of preparing and serving some or all of their own meals; or
boarding facilities that do not provide personal care.

(3) Standards.

(a)

The numerical need for a new or expanded personal care home in a health planning area shall be determined by a population-based formula which is used to project the number of personal care home beds needed in the horizon year and which is a sum of the following:

(i) a ratio of 18.00 beds per 1,000 projected horizon year Resident population age 65 through 74;

(ii) a ratio of 40.00 beds per 1,000 projected horizon year Resident population age 75 through 84; and

(iii) a ratio of 60.00 beds per 1,000 projected horizon year Resident population age 85 and older.

The net numerical unmet need for personal care home beds in each health planning area shall be determined by subtracting the number of existing and approved personal care home beds in the health planning area from the projected number of personal care home beds needed in the horizon year; provided, however, that if the net numerical unmet need exceeds fifty percent (50%) of the current existing and approved beds in the planning area, the net numerical unmet need shall be limited to fifty percent (50%) of the existing and approved beds at the time the calculation is made.

(b) The Department may allow an exception to Ga. Comp. R. & Regs. r. 111-2-2-.31(3)(a) as follows:

to allow expansion of an existing personal care home if actual utilization has exceeded ninety percent (90%) average annual occupancy based on number of licensed beds for the two-year period immediately preceding application;
to allow expansion of an existing personal care home if the applicant has substantial occupancy by out-of-state residents. "Substantial occupancy by out-of-state residents" shall be defined as having at least thirty-three percent (33%) of the available licensed beds in the personal care home utilized by individuals who resided outside of the State of Georgia immediately prior to moving into the personal care home; or
to remedy an atypical barrier to personal care home services based on cost, quality, financial access, or geographic accessibility.

(c) In competing applications, favorable consideration may be given to any applicant for a new or expanded personal care home which historically has provided and/or provides sufficient documentation of plans to provide a higher percentage of un-reimbursed services to indigent and charity residents than requirement by the indigent and charity standard of Ga. Comp. R. & Regs. r. 111-2-2-.31(3)(j) . Favorable consideration also may be given to any applicant for a new or expanded personal care home which historically has provided and/or provides sufficient documentation of plans to provide personal care home residential services at monthly and/or annual rates that are affordable to the greatest number of individuals based on analysis of the national rate for services and the income ranges of individuals at or above age 65 and in the applicant's market area(s).

(d) A new or expanded personal care home shall be approved in a health planning area only if the applicant complies with the following physical standards:

the physical plant design and the program design shall support the concept of a non-institutional, home-like setting;
the proposed physical plant design is in compliance with the Rules and licensure standards of the Healthcare Facility Regulation Division and the applicant stipulates that the services required by such Rules and licensure standards will be provided and any services prohibited by such Rules and licensure standards will not be provided and will not be implied to be provided either through advertising or other means;
there shall be a designated area for staff on duty in each personal care home and on each floor in the case of a multistory facility;
the facility has the option of building kitchens or kitchenettes in the living units as long as the facility intends to provide three meals per day to residents. The kitchens or kitchenettes must comply with the Fire Marshal's and the Healthcare Facility Regulation Division's minimum licensure standards; and
the facility provides assurance that it will not lease or contract space within the personal care home to an outside entity to provide services that the personal care home would otherwise not be allowed to provide.

(e) An applicant for a new or expanded personal care home must document provision of continuity of care by providing a community linkage plan which demonstrates factors such as, but not limited to, referral arrangements with appropriate services of the healthcare system and working agreements with other related community services assuring continuity of care.

(f) An applicant for a new or expanded personal care home shall provide evidence of intent to comply with all appropriate licensure requirements, resident life safety standards and operational procedures required by the Healthcare Facility Regulation Division.

(g) An applicant for a new or expanded personal care home shall provide evidence of the intent and ability to recruit, hire, and retain qualified personnel and that such personnel are available in the proposed geographic service area.

(h) An applicant for a new or expanded personal care home shall provide evidence that no existing Georgia personal care home of any size owned and/or operated by the applicant, a related entity or by the applicant's parent organization has had a permit or license revoked, denied or otherwise sanctioned through formal licensure enforcement action by the Healthcare Facility Regulation Division within the two years immediately preceding application.

(i) An applicant for a new or expanded personal care home shall provide a plan for assuring quality of care which includes, but is not limited to, procedures and plans for staff training and a program to monitor specific quality indicators.

(j) An applicant for a new or expanded personal care home shall foster an environment which assures access to services to individuals by providing a written commitment that un-reimbursed services to residents who are indigent or meet the guidelines of a charity policy of the personal care home will be offered at a standard which meets or exceeds one percent (1%) of annual gross revenues for the personal care home after bad debt has been deducted.

(k) An applicant for a new or expanded personal care home shall agree to provide the Department with requested information and statistical data related to the operation and provision of personal care homes and to report that data to the Department in the time frame and format requested.

History

Authority: O.C.G.A. §§31-2et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Personal Care Homes" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.31, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.

Ga. Comp. R. & Regs. r. 111-2-2-.32 Specific Review Considerations for Home Health Services {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.32 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.32}

(1) Applicability. A Certificate of Need for a home health agency will be required prior to the establishment of a new home health agency or the expansion of the geographic service area of an existing home health agency unless such expansion is a result of a non-reviewable acquisition of another existing home health agency.

(2) Definitions.

(a) "Home health agency" means a public agency or private organization, or a subdivision of such an agency or organization, which is primarily engaged in providing to individuals who are under a written plan of care of a physician, on a visiting basis in the place of residence used as such individual's home, part-time or intermittent nursing care provided by or under the supervision of a registered professional nurse, and one or more of the following services: physical therapy, occupational therapy, speech therapy, medical-social services under the direction of a physician, or part-time or intermittent services of a home health aide.

(b) "Horizon year" means the last year of the three-year projection period for need determinations for a new or expanded home health agency.

(c) "Geographic service area" means a grouping of specific counties within a planning area for which the home health agency is authorized to provide services to individuals residing in the specific counties pursuant to an existing or future Certificate of Need. For purposes of establishing a service area for a new home health agency, the geographic service area shall consist of any individual county or combination of contiguous counties which have an unmet need as determined through the numerical need formula or the exception. For purposes of an expansion of an existing agency, the geographic service area shall consist of an individual county or any combination of counties which have an unmet need, and which are within any planning area in which the home health agency already provides service; however, in no case may an existing home health agency apply to provide services outside the health planning areas in which its current geographic service area is located.

(d) "Nursing care" means such services provided by or under the supervision of a licensed registered professional nurse in accordance with a written plan of medical care by a physician. Such services shall be provided in accordance with the scope of nursing practice laws and associated rules.

(e) "Planning area" for all home agencies means the geographic regions in Georgia defined in the State Health Plan or Component Plan.

(3) Standards.

(a) The need for a new or expanded home health agency shall be determined through application of a numerical need method and an assessment of the projected number of patients to be served by existing agencies.

The numerical need for a new or expanded home health agency in any planning area in the horizon year shall be based on the estimated number of annual home health patients within each health planning area as determined by a population-based formula which is a sum of the following for each county within the health planning area:

(i) a ratio of 4 patients per 1,000 projected horizon year Resident population age 17 and younger;

(ii) a ratio of 5 patients per 1,000 projected horizon year Resident population age 18 through 64;

(iii) a ratio of 45 patients per 1,000 projected horizon year Resident population age 65 through 79; and

(iv) a ratio of 185 patients per 1,000 projected horizon year Resident population age 80 and older.

The net numerical unmet need for home health services shall be determined by subtracting the projected number of patients for the current calendar year from the projected need for services as calculated in (3)(a)1. The projected number of patients for the current calendar year is determined by multiplying the number of patients having received services in each county, as reported in the most recent survey year, by the county population change factor. The county population change factor is the percent change in total population between the most recent survey year and the current calendar year.

(b)

The Department shall accept applications for review as enumerated below:

(i) If the net numerical unmet need in a given planning area is 250 patients or more, the Department shall authorize the submission of applications for an expanded home health agency; or

(ii) If the net numerical unmet need in a given planning area is 500 patients or more, the Department shall authorize the submission of applications for a new home health agency as well as an expanded home health agency.

An applicant must propose to provide service only within a county or group of counties, each of which reflects a numerical unmet need, and contained within the given planning area for which the Department has authorized the submission of applications.
The Department shall only approve applications in which the applicant has applied to serve all of the unmet numerical need in any one county in which need is projected. The need within counties shall not be divided or shared between any two or more applicants.

the applicant for a new or expanded home health agency can show that there is limited access in the proposed geographic service area for special groups such as, but not limited to, medically fragile children, newborns and their mothers, and HIV/AIDS patients. For purposes of this exception, an applicant shall be required to document, using population, service, special needs and/or disease incidence rates, a projected need for services in the planning area of at least 200 patients within a defined geographic service area. A successful applicant applying under this section will be restricted to serving the special group or groups identified in the application within the county or counties stipulated in the application; or
a particular county is served by no more than two (2) home health agencies and either of the following conditions exists:

(1) less than one percent (1%) of the county's population has received home health services, or

(2) one of the two home health agencies has demonstrated a failure to adequately serve Medicaid patients as evidenced by a level of service to such individuals that is less than the statewide average within each of the past two years as reported on the Annual Home Health Services survey. For purposes of this exception, an applicant must already be approved to provide service in a contiguous county or be approved to provide service in a county that is no further than 15 miles from the county authorized through the exception. In all other aspects of the application process, the applicant shall be required to comply with provisions applicable to expanded home health agencies. For purposes of this exception, "served by" shall mean the agency(ies) are licensed to serve the county by the Healthcare Facility Regulation Division of the Georgia Department of Community Health.

(d) An applicant for a new or expanded home health agency shall provide a community linkage plan which demonstrates factors such as, but not limited to, referral arrangements with appropriate services of the healthcare system and working agreements with other related community services assuring continuity of care focusing on coordinated, integrated systems which promote continuity rather than acute, episodic care. Working agreements with other related community services may include the ability to streamline referrals to other appropriate services and to participate in the development of cross-continuum care plans with other providers.

(e) An applicant for a new or expanded home health agency shall provide a written statement of its intent to comply with all appropriate licensure requirements and operational procedures required by the Healthcare Facility Regulation Division of the Georgia Department of Community Health.

(f) An applicant for a new or expanded home health agency or agency(ies) owned and/or operated by the applicant or its parent organization shall have no history of uncorrected or repeated conditional level violations or uncorrected standard deficiencies as identified by licensure inspections or equivalent deficiencies as noted from Medicare or Medicaid audits.

(g) An applicant for a new or expanded home health agency or agency(ies) owned and/or operated by the applicant or its parent organization shall have no previous conviction of Medicaid or Medicare fraud.

(h) An applicant for a new or expanded home health agency shall provide a written plan which demonstrates the intent and ability to recruit, hire and retain the appropriate numbers of qualified personnel to meet the requirements of the services proposed to be provided and that such personnel are available in the proposed geographic service area.

(i) An applicant for a new home health agency shall provide evidence of the intent to meet the appropriate accreditation requirements of The Joint Commission (TJC), the Community Health Accreditation Program, Inc. (CHAP), and/or other appropriate accrediting agencies.

(j) An applicant for an expanded home health agency shall provide documentation that they are fully accredited by The Joint Commission (TJC), the Community Health Accreditation Program, Inc. (CHAP), and/or other appropriate accrediting agency.

(k) An applicant for a new or expanded home health agency shall provide its existing or proposed plan for a comprehensive quality improvement program.

(l) An applicant for a new or expanded home health agency shall assure access to services to individuals unable to pay and to all individuals regardless of payment source or circumstances by:

providing evidence of written administrative policies that prohibit the exclusion of services to any patient on the basis of age, disability, gender, race, or ability to pay;
providing a written commitment that services for indigent and charity patients will be offered at a standard which meets or exceeds one percent (1%) of annual, adjusted gross revenues for the home health agency or, in the case of an applicant providing other health services, the applicant may request that the Department allow the commitment for services to indigent and charity patients to be applied to the entire facility;
providing documentation of the demonstrated performance of the applicant, and any facility in Georgia owned or operated by the applicant's parent organization, of providing services to Medicare, Medicaid, and indigent and charity patients;
providing a written commitment to participate in the Medicare, Medicaid and PeachCare for Kids® programs; and
providing a written commitment to participate in any other state health benefits insurance programs for which the home health service is eligible.

(m) An applicant for a new or expanded home health agency shall demonstrate that their proposed charges compare favorably with the charges of existing home health agencies in the same geographic service area.

(n) An applicant for a new or expanded home health agency shall document an agreement to provide Department requested information and statistical data related to the operation and provision of home health services and to report that data to the Department in the time frame and format requested by the Department.

(o) The Department may authorize an existing home health agency to transfer one county or several counties to another existing home health agency without either agency being required to apply for a new or expanded Certificate of Need, provided the following conditions are met:

the two agencies agree to the transfer and submit such agreement and a joint request to transfer in writing to the Department at least thirty (30) days prior to the proposed effective date of the transfer;
the two agencies document within the written request that the transfer would result in increased and improved services for the residents of the county or counties including Medicare and Medicaid patients;
the agency to which the county or counties are being transferred currently offers services in at least one contiguous county or within the health planning area(s) in which county or counties are located; and
the two agencies are in compliance with all other requirements of these Rules; such compliance to be evaluated with the written transfer request. No such transfer shall become effective without written approval from the Department.

History

Authority: O.C.G.A. §§31-2et seq., 31-6et seq
History. Original Rule entitled "Specific Review Considerations for Home Health Services" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: New Rule entitled "Specific Rule Considerations for Home Health Services" adopted. F. Feb. 16, 2010; eff. Mar. 8, 2010.
Amended: New title, "Specific Review Considerations for Home Health Services." F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.32, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.

Ga. Comp. R. & Regs. r. 111-2-2-.33 Specific Review Considerations for Life Plan Community (LPC) Sheltered Nursing Facilities {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.33 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.33}

(1) Applicability. A Certificate of Need will be required prior to the establishment of a new or expanded LPC Sheltered Nursing Facility, if not exempt as provided by O.C.G.A. § 31-6-47(a)(17) and Ga. Comp. R. & Regs. r. 111-2-2-.03(20) . These Rules apply to sheltered nursing facilities located in LPC facilities defined herein as Type A and Type B Life Plan Communities. A LPC that has obtained nursing facility beds approved under the standards contained in Ga. Comp. R. & Regs. r. 111-2-2-.30 does not qualify for sheltered nursing facility beds, and to convert existing nursing facility beds to sheltered nursing facility beds, such a LPC must apply for a new Certificate of Need. Conversely, a LPC that obtains sheltered nursing facility beds under these Rules may not qualify for beds under Ga. Comp. R. & Regs. r. 111-2-2-.30 , and is therefore only required to complete these specific review considerations for the sheltered nursing facility beds.

(2) Duration. Notwithstanding Ga. Comp. R. & Regs. r. 111-2-2-.02(6) , the initial implementation period of a Certificate of Need granted for a new or expanded LPC Sheltered Nursing Facility pursuant to these Rules shall be twenty-four (24) months from the effective date.

(3) Definitions.

(a) "A Life Plan Community" (LPC) is an organization which offers a contract to provide an individual of retirement status, other than an individual related by consanguinity or affinity to the provider furnishing the care, with board and lodging, licensed nursing facility care and medical or other health related services, or both. These services are provided for a minimum period of more than one (1) year and may be for as long as the lifetime of the resident.

(b) "Type A Life Plan Community" (Type A LPC) provides LPC services at the same location for the life of an individual, including mutually terminable contracts, and in consideration of the payment of an entrance fee with or without other periodic charges. A Type A LPC offers nursing facility care for a little or no substantial increase in monthly payments, except normal operating costs and inflation adjustments.

(c) "Type B Life Plan Community" (Type B LPC) provides LPC services at the same location for a period in excess of one year, including mutually terminable contracts, and in consideration of the payment of an entrance fee with other periodic charges. A Type B LPC offers a specified amount of nursing facility care for little or no substantial increase in monthly payments except normal operating costs and inflation adjustments. After the specified amount of nursing care is received, residents pay either a discounted rate or the full per diem rate for nursing care required.

(d) "A Continuing Care Contract" means furnishing pursuant to an agreement shelter, food, and either nursing care or personal services, whether such nursing care or personal services are provided in the facility or in another setting designated by the agreement for continuing care, to an individual not related by consanguinity or affinity to the provider furnishing such care upon payment of an entrance fee. Other personal services provided shall be designated in the continuing care agreement. Agreements to provide continuing care include agreements to provide care for any duration, including agreements that are terminable by either party.

(e) "LPC Sheltered Nursing Facility", for purposes of these Rules, is a nursing facility that meets the definition of a nursing facility as defined by Ga. Comp. R. & Regs. r. 111-2-2-.30 of the Rules of the Department. A LPC Sheltered Nursing Facility shall be for the exclusive use of residents of a Type A or Type B LPC.

(f) "Official State Health Component Plan" means the document related to the above-named services developed by the Department, established by the Georgia Health Strategies Council, and signed by the Governor of Georgia.

(g) "Resident" is an individual entitled to receive continuing care in a Type A or Type B Life Plan Community.

(4) Standards.

(a) The numerical need for a new LPC sheltered nursing facility shall be based on a ratio of one nursing facility bed for each five independent living units. The applicant for a LPC Sheltered Nursing Facility shall demonstrate to the Department that the potential market for LPC Independent Living Units in the proposed service area is based on a valid feasibility study which takes into account factors such as, but not limited to, the age and annual household income of the target population and the geographic area to be served.

(b) The numerical need for an expanded LPC sheltered nursing facility shall be based on a ratio of one nursing facility bed for each four independent living units provided that the LPC's existing nursing facility has experienced an occupancy rate of at least eighty percent (80%) during the most recent year.

(c) Sheltered nursing facility beds approved under these Rules shall be used exclusively for persons who are residents of the LPC, and who are a party to a continuing care contract with the facility or the parent organization and who have lived in a non-nursing unit of the LPC for a period of at least ninety (90) days. Exceptions shall be allowed when one spouse or sibling is admitted to the nursing unit at the time the other spouse or sibling moves into a non-nursing unit, or when the medical condition requiring nursing care was not known to exist or be imminent when the individual became a party to the continuing care contract.

(d) The applicant shall provide evidence of intent that at no time will the nursing facility be certified for participation in the Medicaid Program.

(e) A LPC which is the applicant for a new or expanded LPC sheltered nursing facility shall provide evidence of the intent and ability to meet all appropriate authorization and disclosure requirements of the Georgia State Department of Insurance and of any appropriate accrediting agency(ies). The LPC shall furnish reports in such form and at such times as may be specified, which accurately and fully disclose it has met specified requirements.

(f) A new or expanded LPC sheltered nursing facility shall provide evidence of the intent and ability to meet all appropriate requirements regarding licensure and accreditation of the nursing facility as follows:

Compliance with all appropriate licensure requirements and operational procedures required by the Healthcare Facility Regulation Division;
No uncorrected operational standards in any existing Georgia general or LPC sheltered nursing facilities owned and/or operated by the entity, its affiliates, or its principals. Plans to correct physical plant deficiencies must be provided;
No previous conviction of Medicaid and/or Medicare fraud by the entity, its affiliates, or its principals;
Provision of a plan for a comprehensive quality improvement program which includes, but is not limited to, procedures and plans for staff training and a program to monitor specific quality indicators and measure the facility's performance and patient outcomes accordingly; and
Intent to meet accreditation requirements of the appropriate accrediting agency(ies).

(g) A LPC which is the applicant for a new or expanded LPC sheltered nursing facility shall demonstrate the existence of a Health Care Fund whose liability is documented by a relevant Actuarial Study and certified by a qualified actuary; or the existence of a Long Term Care Insurance Policy issued to individual residents; or a Group Long Term Care Insurance Policy issued to the LPC for the coverage of all residents. An Individual or Group Insurance Policy must conform to all the requirements of Chapter 120-20-16 of the Rules and Regulations of the State of Georgia Insurance Department entitled "Long Term Care Insurance Regulation". The period and scope of coverage must be identical to the period and scope of coverage in the continuing care contract.

(h) A LPC in which a new or expanded sheltered nursing facility is to be located shall provide the Department with requested information and statistical data related to the operation and programmatic elements of the LPC and the Sheltered Nursing Facility. Analyses are predicated upon accurate, consistent, and systematically obtained information.

History

Authority: O.C.G.A. §§31-2et seq., 31-6et seq
History. Original Rule entitled "Specific Review Considerations for Continuing Care Retirement Community ("CCRC") Sheltered Nursing Facilities" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Nov. 13, 2007; eff. Dec. 3, 2007.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: New title, "Specific Review Considerations for Life Plan Community (LPC) Sheltered Nursing Facilities." F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.33, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.

Ga. Comp. R. & Regs. r. 111-2-2-.34 Specific Review Considerations for Traumatic Brain Injury Facilities {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.34 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.34}

(1) Applicability. The following Rules apply to Traumatic Brain Injury Facilities defined herein as providing transitional living programs and/or lifelong living programs.

(a) A Certificate of Need shall be required prior to the establishment of a new or the expansion of an existing Transitional Living Program, if not exempt as provided by O.C.G.A. § 31-6-47(a)(25) and Ga. Comp. R. & Regs., r. 111-2-2-.03(28) . An application for Certificate of Need for a new or expanded Transitional Living Program shall be reviewed under the General Review Considerations of Ga. Comp. R. & Regs., r. 111-2-2-.09 and the service-specific review considerations of this Rule.

(b) A Certificate of Need shall be required prior to the establishment of a new or the expansion of an existing Life Long Living Program, if not exempt as provided by O.C.G.A. § 31-6-47(a)(25) and Ga. Comp. R. & Regs., r. 111-2-2-.03(28) . An application for Certificate of Need for a new or expanded Life Long Living Program shall be reviewed under the General Review Considerations of Ga. Comp. R. & Regs., r. 111-2-2-.09 and the service-specific review considerations of this Rule.

(2) Definitions.

(a) "Expansion" or "Expanded Service" means increasing the number of beds in an existing Traumatic Brain Injury Facility or program; or an existing Traumatic Brain Injury Facility or program; or an existing Traumatic Brain Injury Facility or program which seeks to add a program which it currently does not offer.

(b) "Life Long Living Program" means such treatment and rehabilitative care as shall be delivered to traumatic brain injury clients who have been discharged from a more intense level of rehabilitation, but who cannot live at home independently, and who require on-going lifetime support. Such clients are medically stable, may have special needs, but need less than 24 hour per day medical support.

(c) "New" means a facility that has not operated as a Traumatic Brain Injury Facility in the previous twelve (12)months. For purposes of these Rules, an existing Traumatic Brain Injury Facility or program which proposes to be relocated to a location more than three miles from its present location shall be considered "new".

(d) "Official State Health Component Plan" means the document related to Traumatic Brain Injury Facilities developed by the Department, established by the Georgia State Health Strategies Council and signed by the Governor of Georgia.

(e) "Planning Region" means one of the twelve state service delivery regions established by O.C.G.A. § 50-4-7 .

(f) "Transitional Living Program" means such treatment and rehabilitative care as shall be delivered to traumatic brain injury clients who require education and training for independent living with a focus on compensation for skills which cannot be restored. Such care prepares clients for maximum independence, teaches necessary skills for community interaction, works with clients on pre-vocational and vocational training and stresses cognitive, speech, and behavioral therapies structured to the individual needs of clients. Such clients are medically stable, may have special needs, but need less than twenty-four (24) hour per day medical support.

(g) "Traumatic Brain Injury" means a traumatic insult to the brain and its related parts resulting in organic damage thereto that may cause physical, intellectual, emotional, social, or vocational changes in a person. It shall also be recognized that a person having a traumatic brain injury may have organic damage or physical or social disorders but shall not be considered mentally ill.

(h) "Traumatic Brain Injury Facility" means a building or place which is devoted to the provision of residential treatment and rehabilitative care in a transitional living program or a lifelong living program for periods continuing for twenty-four (24) hours or longer for persons who have traumatic brain injury. Such a facility is not classified by the Healthcare Facility Regulation Division as a hospital, nursing home, intermediate care facility or personal care home.

(3) Standards.

(a) An application for a new or expanded Traumatic Brain Injury Facility or program shall provide sufficient documentation of the need for such a program in the Planning Region. In the case of an application for an expanded program, the applicant shall justify the need for the expansion by, at a minimum, documenting that the expansion program has achieved an occupancy rate of eighty percent (80%) or more for the most recent twelve (12) months prior to submitting application.

(b) An applicant for a new or expanded Traumatic Brain Injury Facility or program shall document that the establishment or expansion of its Facility or program will not have an adverse impact on existing and approved programs of the same type in its Planning Region. An applicant for a new or expanded Traumatic Brain Injury Facility or program shall have an adverse impact on existing and approved facilities or programs of the same type if it will:

decrease annual utilization of an existing facility or program, whose current utilization is at or above eighty-five percent (85%), to a projected annual utilization of less than seventy-five percent (75%) within the first twelve (12) months following the acceptance of the applicant's first patient; or
decrease annual utilization of an existing facility or program, whose current utilization is below eighty-five percent (85%), by ten percent (10%) over the twelve (12) months following the acceptance of the applicant's first patient. The applicant shall provide evidence of projected impact by taking into account existing planning region market share of facilities or programs of the same type and future population growth or by providing sufficient evidence that the current population is underserved by the existing Traumatic Brain Injury facility or program of the same type within the planning region.

(c) The Department may grant an exception to the need methodologies of Ga. Comp. R. & Regs., r. 111-2-2-.34(3)(a) and (3)(b) to remedy an atypical barrier to the services of a Traumatic Brain Injury Facility or program based on cost, quality, financial access, or geographic accessibility.

(d) Minimum bed size for a Traumatic Brain Injury Facility or program is six beds; A Life Long Living Program may not exceed thirty beds, except that an applicant for a new or expanded Life Long Living Program may be approved for total beds to exceed thirty (30) beds only if the applicant provides documentation satisfactory to the Department that the program design, including staffing patterns and the physical plant, are such as to promote services which are of high quality, are cost-effective and are consistent with client needs.

(e) An applicant for a new or expanded Traumatic Brain Injury Facility shall demonstrate the intent to meet the standards of the Commission on Accreditation of Rehabilitation Facilities (CARF) which apply to post acute brain injury programs and residential services within twenty-four (24) months of accepting its first patient. An applicant for an expanded Traumatic Brain Injury Facility or program shall be CARF-certified as of the date of its application and shall furnish proof of the certification as a part of the Certificate of Need application process.

(f) An applicant for a new or expanded Traumatic Brain Injury Facility shall demonstrate the intent to meet the licensure Rules of the Healthcare Facility Regulation Division for such facilities. An applicant for an expanded Traumatic Brain Injury Facility or program shall demonstrate a lack of uncorrected deficiencies as documented by letter from the Healthcare Facility Regulation Division.

(g) An applicant for a new or expanded Traumatic Brain Injury Facility shall have written policies and procedures for utilization review. Such review shall consider the rehabilitation necessity for the service, quality of client care, rates of utilization and other considerations generally accepted as appropriate for review.

(h) An applicant for a new or expanded Traumatic Brain Injury Facility shall document the existence of referral arrangements, including transfer agreements, with an acute care hospital within the planning region to provide emergency medical treatment to any patient who requires such care. If the nearest acute-care hospital is in an adjacent planning region, the applicant may document the existence of transfer agreements with that hospital in lieu of such agreements with a hospital located within the planning region.

(i) An applicant for a new or expanded Traumatic Brain Injury Facility shall document that the Facility will be financially accessible by:

providing sufficient documentation that un-reimbursed services for indigent and charity patients in a new or expanded Facility shall be offered at a standard which meets or exceeds three percent (3%) of annual gross revenues for the Facility after provisions have been made for bad debt and Medicaid/Medicare contractual adjustments have been deducted. If an applicant, or any facility owned or operated by the applicant's parent organization, received a Certificate of Need for a Traumatic Brain Injury Facility and the Certificate of Need included an expectation that a certain level of un-reimbursed indigent and/or charity care would be provided in the Facility(ies), the applicant shall provide sufficient documentation of the Facility's provision of such care. An applicant's history, or the history of any facility owned or operated by the applicant's parent organization, of not following through with a Certificate of Need expectation of providing indigent and/or charity care at or above the level agreed to will constitute sufficient justification to deny an application; and
agreeing to participate in the Medicare and Medicaid programs, whenever these programs are available to the Facility.

(j) Reserved .

(k) An applicant for a new or expanded Traumatic Brain Injury Facility shall document an agreement to provide the Department requested information and statistical data related to the operation of such a Facility and to report that information and statistical data to the Department on a yearly basis, and as needed, in a format requested by the Department and in a timely manner.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Traumatic Brain Injury Facilities" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Nov. 22, 2006; eff. Dec. 12, 2006.
Amended: F. Nov. 13, 2007; eff. Dec. 3, 2007.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.34, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.35 Specific Review Considerations for Comprehensive Inpatient Physical Rehabilitation Services {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.35 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.35}

(1) Applicability.

(a) A Certificate of Need shall be required prior to the establishment of a new or the expansion of an existing Comprehensive Inpatient Physical Rehabilitation Adult Program. An application for Certificate of Need for a new or expanded Comprehensive Inpatient Physical Rehabilitation Adult Program shall be reviewed under the General Review Considerations of Ga. Comp. R. & Regs., r. 111-2-2-.09 and the service-specific review considerations of this Rule.

(b) A Certificate of Need shall be required prior to the establishment of a new or the expansion of an existing Comprehensive Inpatient Physical Rehabilitation Pediatric Program. An application for Certificate of Need for a new or expanded Comprehensive Inpatient Physical Rehabilitation Pediatric Program shall be reviewed under the General Review Considerations of Ga. Comp. R. & Regs., r. 111-2-2-.09 and the service-specific review considerations of this Rule.

(2) Definitions.

(a) "Adults" means persons eighteen (18) years of age and over. However, a Certificate of Need authorized or grandfathered Comprehensive Inpatient Physical Rehabilitation Adult Program will not be in violation of the Certificate of Need laws and regulations if it provides service to a patient older than fifteen years if the provider has determined that such service is medically necessary, provided that the treatment days and patient census associated with patients sixteen and seventeen years of age do not exceed ten percent (10%) of annual treatment days and annual census, respectively. Rehabilitation programs specifically focused towards treatment of spinal cord injuries and disorders and which existed prior to the effective date of this version of Ga. Comp. R. & Regs., r. 111-2-2-.35 shall not be subject to the adult age limitations; such programs may treat any patient aged twelve (12) and over.

(b) "Comprehensive Inpatient Physical Rehabilitation Programs" means rehabilitation services, which have been classified by Medicare as an inpatient rehabilitation facility pursuant to 42 C.F.R. § 412.23(b)(2) , provided to a patient who requires hospitalization, which provides coordinated and integrated services that include evaluation and treatment, and emphasizes education and training of those served. The program is applicable to those individuals who require an intensity of services which includes, as a minimum, physician coverage twenty-four (24) hours per day, seven (7) days per week, with daily (at least five (5) days per week) medical supervision, complete medical support services including consultation, 24-hour-per-day nursing, and daily (at least five (5) days per week) multidisciplinary rehabilitation programming for a minimum of three hours per day. For regulatory purposes, the definition includes a program which asserts its intent to be Medicare-classified as an inpatient rehabilitation facility no later than twenty-four (24) months after accepting its first patient. If a program, which has been awarded a CON pursuant to this Rule, has not been so classified by Medicare within the timeframe outlined above, the CON issued to that entity shall be revoked.

(c) "Expansion" and "Expanded" mean the addition of beds to an existing CON-authorized or grandfathered Comprehensive Inpatient Physical Rehabilitation Program. However, a CON-authorized or grandfathered provider of Comprehensive Inpatient Physical Rehabilitation in a freestanding rehabilitation hospital may increase the bed capacity of an existing program by the greater of twenty percent (20%) of existing capacity or ten (10) beds if it has maintained an overall occupancy rate greater than sixty percent (60%) for the previous twelve (12) calendar months provided that there has been no such increase in the prior three years.

(d) "Freestanding Rehabilitation Hospital" means a specialized hospital organized and operated as a self-contained health care facility that provides one or more rehabilitation programs and which has been classified as an inpatient rehabilitation facility by the Medicare program pursuant to 42 C.F.R. § 412.23(b)(2) . For regulatory purposes, the definition includes a hospital which asserts its intent to be Medicare-classified as an inpatient rehabilitation facility no later than twenty-four (24) months after accepting its first patient. If an entity, which has been awarded a CON pursuant to this Rule, has not been so classified by Medicare within the timeframe outlined above, the CON issued to that entity shall be revoked. An entity, which has had its CON revoked pursuant to this Rule, shall not have the authority to operate as a general acute care hospital.

(e) "New" means a Program that has not been classified by the Medicare program as a rehabilitation hospital or program in the previous twelve (12) months. Adult programs described in Ga. Comp. R. & Regs., r. 111-2-2-.35(1)(a) and pediatric programs described in Ga. Comp. R. & Regs., r. 111-2-2-.35(1)(b) shall be considered independent programs such that a provider seeking to add a program not offered by that provider in the previous twelve (12) months shall be considered to be offering a new program for which a Certificate of Need must be obtained. For purposes of these Rules, an existing program which proposes to be relocated to a location more than three (3) miles from its present location shall be considered "new".

(f) "Official State Health Component Plan" means the document related to Physical Rehabilitation Programs and Services developed by the Department, established by the Georgia Health Strategies Council and signed by the Governor of Georgia.

(g) "Pediatric" means persons seventeen (17) years of age and under. However, a CON-authorized or grandfathered Comprehensive Inpatient Rehabilitation Pediatric Program will not be in violation of the CON laws and regulations if it provides service to a patient younger than twenty-two (22) years if the provider has determined that such service is medically necessary, provided that the treatment days and patient census associated with patients eighteen, nineteen, twenty, and twenty-one years of age do not exceed ten percent (10%) of annual treatment days and annual census, respectively. Rehabilitation programs specifically focused towards treatment of spinal cord injuries and disorders and which existed prior to the effective date of this version of Ga. Comp. R. & Regs., r. 111-2-2-.35 shall not be subject to the pediatric age limitations; such programs may treat any patient aged twelve (12) and over.

(h) "Planning Region" means one of the four sub-state regions for Physical Rehabilitation Programs and Services as follows:

Rehabilitation Region 1, including the following counties: Dade, Walker, Catoosa, Whitfield, Murray, Gilmer, Fannin, Union, Towns, Rabun, Stephens, Habersham, White, Lumpkin, Dawson, Pickens, Gordon, Chattooga, Floyd, Bartow, Cherokee, Forsyth, Hall, Banks, Franklin, Hart, Elbert, Madison, Jackson, Barrow, Gwinnett, Fulton, Cobb, Paulding, Polk, Haralson, Carroll, Douglas, DeKalb, Rockdale, Walton, Oconee, Clarke, Oglethorpe, Greene, Morgan, Newton, Butts, Henry, Clayton, Fayette, Coweta, Heard, Troup, Meriwether, Pike, Spalding, Lamar, and Upson.
Rehabilitation Region 2, including the following counties: Wilkes, Lincoln, Columbia, McDuffie, Warren, Taliaferro, Hancock, Glascock, Putnam, Jasper, Monroe, Jones, Baldwin, Washington, Jefferson, Richmond, Burke, Screven, Jenkins, Emmanuel, Johnson, Treutlen, Montgomery, Wheeler, Telfair, Wilcox, Dodge, Laurens, Pulaski, Bleckley, Houston, Peach, Twiggs, Wilkinson, Bibb, and Crawford.
Rehabilitation Region 3, including the following counties: Harris, Talbot, Taylor, Muscogee, Chattahoochee, Marion, Schley, Macon, Dooly, Sumter, Webster, Stewart, Quitman, Randolph, Terrell, Lee, Crisp, Ben Hill, Irwin, Turner, Worth, Dougherty, Calhoun, Clay, Early, Baker, Mitchell, Colquitt, Miller, Cook, Tift, Berrien, Lanier, Echols, Lowndes, Brooks, Thomas, Grady, Decatur, and Seminole.
Rehabilitation Region 4, including the following counties: Effingham, Bulloch, Candler, Toombs, Tattnall, Evans, Bryan, Chatham, Liberty, Long, Wayne, Appling, Jeff Davis, Coffee, Bacon, Pierce, Brantley, McIntosh, Glynn, Camden, Charlton, Ware, Atkinson, and Clinch.

(3) Service-Specific Review Standards.

(a) The need for a new or expanded Comprehensive Inpatient Physical Rehabilitation Program ("CIPR") shall be determined and applied as follows:

The need for new or expanded Comprehensive Inpatient Physical Rehabilitation Adult Program in a planning region shall be determined using the following demand-based need projection:

(i) Determine the comprehensive inpatient physical rehabilitation utilization rate per 1,000 for the current year for each planning region by dividing the total number of inpatient physical rehabilitation discharges from licensed providers of inpatient rehabilitation in the planning region for patients aged eighteen (18) and over by current year projected resident population (aged 18 and over) for the planning region and multiplying by 1,000. The source of current year discharge data for purposes of this Rule include data collected pursuant to O.C.G.A. § 31-7-280(c)(14) , or in the Department's discretion, discharge data collected on the most recent Annual Hospital Questionnaire. The source for current and horizon year resident population shall be resident population projections from the Governor's Office of Planning and Budget. For the first Horizon Year projection using this Rule, and for the first horizon year projection only, the utilization rate per 1,000 for each planning region shall be reduced by sixteen percent (16%) to account for anticipated utilization reduction after full implementation of the Center for Medicare and Medicaid Services' ("CMS") seventy-five percent (75%) rule.

(ii) Calculate the projected horizon year discharges for each planning region by multiplying the planning region utilization rate obtained in Step (i) by the horizon year resident population projection (aged 18 and over) for that planning region.

(iii) Determine the comprehensive inpatient physical rehabilitation average length of stay for the current year for each planning region by dividing the total number of inpatient physical rehabilitation discharge days of care from licensed providers of inpatient rehabilitation in the planning region for patients aged eighteen (18) and over by the current year inpatient rehabilitation discharges determined in Step (i).

(iv) Multiply the projected discharges obtained in Step (ii) by the current year's average length of stay (aged 18 and over) determined in Step (iii) to determine the horizon year projected patient days for each planning region.

(v) Divide the product obtained in Step (iv) by the number of calendar days in the horizon year to obtain the average projected daily census in each planning region.

(vi) Divide the result obtained in Step (v) by .85 to determine the number of projected beds utilizing an eighty-five percent (85%) capacity standard for each planning region.

(vii) Determine the current inventory of comprehensive inpatient physical rehabilitation beds for adults in the planning region from Departmental data. For all CIPR providers, which have been licensed as a Rehabilitation Hospital by the Healthcare Facility Regulation Division, the current inventory of CIPR beds shall reflect the number of beds reported as CON-authorized in the Facility Inventory prior to the date of adoption of these Rules augmented from that time forward only by increases in bed capacity approved through the CON process (or by exemptions thereto) and by decreases due to a provider ceasing to provide such services for a period in excess of twelve (12) months. For purposes of this Rule, the initial inventory shall not include the beds of licensed Long Term Care Hospitals; the beds of such facilities shall be included in the applicable Long Term Care Hospital inventory.

(viii) If the projected bed need in Step (vi) is greater than the current inventory of adult CIPR beds in the planning region, the application for the Certificate of Need should reflect a number of beds equal to or lesser than the resulting unmet bed need.

The need for new or expanded Comprehensive Inpatient Physical Rehabilitation Pediatric Program in a planning region shall be determined using the following demand-based need projection:

(iii) Determine the comprehensive inpatient physical rehabilitation average length of stay for the current year for each planning region by dividing the total number of inpatient physical rehabilitation discharge days of care from licensed providers of inpatient rehabilitation in the planning region for patients aged seventeen (17) and under by the current year inpatient rehabilitation discharges determined in Step (i).

(iv) Multiply the projected discharges obtained in Step (ii) by the current year's average length of stay (aged 17 and under) determined in Step (iii) to determine the horizon year projected patient days for each planning region.

(v) Divide the product obtained in Step (iv) by the number of calendar days in the horizon year to obtain the average projected daily census in each planning region.

(vi) Divide the result obtained in Step (v) by .85 to determine the number of projected beds utilizing an eighty-five percent (85%) capacity standard for each planning region.

(vii) Determine the current inventory of comprehensive inpatient physical rehabilitation beds for pediatric patients in the planning region from Departmental data. For all CIPR providers, which have been licensed as a Rehabilitation Hospital by the Healthcare Facility Regulation Division, the current inventory of CIPR beds shall reflect the number of beds reported as CON-authorized in the Facility Inventory prior to the date of adoption of these Rules augmented from that time forward only by increases in bed capacity approved through the CON process (or by exemptions thereto) and by decreases due to a provider ceasing to provide such services for a period in excess of twelve (12) months. For purposes of this Rule, the initial inventory shall not include the beds of licensed Long-Term Care Hospitals; the beds of such facilities shall be included in the applicable Long Term Care Hospital inventory.

(viii) If the projected bed need in Step (vi) is greater than the current inventory of pediatric CIPR beds in the planning region, the application for the Certificate of Need should reflect a number of beds equal to or lesser than the resulting unmet bed need.

(b) An applicant for a new or expanded Comprehensive Inpatient Physical Rehabilitation Program shall document that the establishment or expansion of its program will not have an adverse impact on existing and approved programs of the same type in its planning region. An applicant for a new or expanded Comprehensive Inpatient Physical Rehabilitation Program shall have an adverse impact on existing and approved programs of the same type if it will:

decrease annual utilization of an existing program, whose current utilization is at or above eighty-five percent (85%), to a projected annual utilization of less than seventy-five percent (75%) within the first twelve (12) months following the acceptance of the applicant's first patient; or
decrease annual utilization of an existing program, whose current utilization is below eighty-five percent (85%), by ten percent over the twelve (12) months following the acceptance of the applicant's first patient.

The Department may grant an exception to the need methodology of Ga. Comp. R. & Regs., r. 111-2-2-.35(3)(a) 1. and to the adverse impact standard of Ga. Comp. R. & Regs., r. 111-2-2-.35(3)(b) for an applicant proposing a program to be located in a county with a population of less than 75,000 and to be located a minimum of fifty (50) miles away from any existing program in the state.
The Department may grant an exception to the need methodologies of either Ga. Comp. R. & Regs., r. 111-2-2-.35(3)(a) 1. or 111-2-2-.35(3)(a) 2. and to the adverse impact standard of Ga. Comp. R. & Regs., r. 111-2-2-.35(3)(b) to remedy an atypical barrier to Comprehensive Inpatient Physical Rehabilitation Programs based on cost, quality, financial access or geographic accessibility or if the applicant's annual census demonstrates thirty percent (30%) out of state utilization for the previous two years.
The Department may grant an exception to the need methodologies of Ga. Comp. R. & Regs., r. 111-2-2-.35(3)(a) 1. or Ga. Comp. R. & Regs., r. 111-2-2-.35(3)(a) 2. in a planning area which has no existing provider provided that the applicant demonstrates a need for the service based on patient origin data.

(d) A new Comprehensive Inpatient Physical Rehabilitation Program shall have the following minimum bed sizes based on type of program offered:

A new Comprehensive Inpatient Physical Rehabilitation Adult Program shall have a minimum bed size of twenty (20) beds in a freestanding rehabilitation hospital already offering another Comprehensive Inpatient Physical Rehabilitation Program, twenty (20) beds or in an acute-care hospital, and forty (40) beds for a new freestanding rehabilitation hospital not already offering another Comprehensive Inpatient Physical Rehabilitation Program.
A new Comprehensive Inpatient Physical Rehabilitation Pediatric Program shall have a minimum of 10 beds in a freestanding rehabilitation hospital already offering another Comprehensive Inpatient Physical Rehabilitation Program, 10 beds in an acute-care hospital, and forty (40) beds for a new freestanding rehabilitation hospital not already offering another Comprehensive Inpatient Physical Rehabilitation Program.

(e) An applicant for a new Comprehensive Inpatient Physical Rehabilitation Program shall demonstrate the intent to meet the standards of the Commission on Accreditation of Rehabilitation Facilities ("CARF") applicable to the type of Program to be offered within eighteen (18) months of offering the new service.

(f) An applicant for an expanded Comprehensive Inpatient Physical Rehabilitation Program shall be accredited by the CARF for the type of Program which the applicant seeks to expand prior to application. The applicant must provide proof of such accreditation.

(g) An applicant for a new freestanding rehabilitation hospital shall demonstrate the intent to meet the licensure Rules of the Healthcare Facility Regulation Division for such hospitals.

(h) An applicant for an expanded freestanding rehabilitation hospital shall demonstrate a lack of uncorrected deficiencies as documented by letter from the Healthcare Facility Regulation Division.

(i) An applicant for a new or expanded Comprehensive Inpatient Physical Rehabilitation Program shall have written policies and procedures for utilization review. Such review shall consider, but is not limited to, factors such as medical necessity, appropriateness and efficiency of services, quality of patient care, and rates of utilization.

(j) An applicant for a new or expanded freestanding rehabilitation hospital shall document the existence of referral arrangements, including transfer agreements with an acute-care hospital(s) within the planning region to provide emergency medical treatment to any patient who requires such care. If the nearest acute-care hospital is in an adjacent planning region, the applicant may document the existence of transfer agreements with that hospital in lieu of such agreements with a hospital located within the planning region.

(k) An applicant for a new or expanded Comprehensive Inpatient Physical Rehabilitation Program shall foster an environment that assures access to services to individuals unable to pay and regardless of payment source or circumstances by the following:

providing evidence of written administrative policies and directives related to the provision of services on a nondiscriminatory basis;
providing a written commitment that un-reimbursed services for indigent and charity patients in the service will be offered at a standard which meets or exceeds three percent (3%) of annual gross revenues for the service after Medicare and Medicaid contractual adjustments and bad debt have been deducted; and
providing documentation of the demonstrated performance of the applicant, and any facility in Georgia owned or operated by the applicant's parent organization, of providing services to individuals unable to pay based on the past record of service to Medicare, Medicaid, and indigent and charity patients, including the level of un-reimbursed indigent and charity care.

(l) Reserved .

(m) An applicant for a new or expanded Comprehensive Inpatient Physical Rehabilitation Program shall agree to provide the State Health Department with requested information and statistical data related to the operation of such a Program on a yearly basis, or as needed, and in a format requested by the Department.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Comprehensive Inpatient Physical Rehabilitation Services" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Nov. 22, 2006; eff. Dec. 12, 2006.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.35, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.36 Specific Review Considerations for Long Term Care Hospitals {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.36 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.36}

(1) Applicability. A Certificate of Need ("CON") shall be required prior to the establishment of a new or the expansion of an existing Long Term Care Hospital. An application for Certificate of Need for a new or expanded Long Term Care Hospital shall be reviewed under the General Review Considerations of Ga. Comp. R. & Regs., r. 111-2-2-.09 and the service-specific review considerations of this Rule.

(2) Definitions.

(a) "Expansion" or "Expanded" means the addition of beds to an existing CON-authorized or grandfathered Long Term Care Hospital. A CON-authorized or grandfathered Long Term Care Hospital may increase the bed capacity of an existing hospital by the greater of twenty percent (20%) of existing capacity or ten (10) beds if it has maintained an overall occupancy rate greater than sixty percent (60%) for the previous twelve (12) calendar months provided that there has been no such increase in the prior three years.

(b) "Free-standing LTCH" or "Free-standing LTACH" means a Long-Term Care Hospital organized and operated as a self-contained health care facility.

(c) "Hospital-within-a-Hospital LTCH" or "Hospital-within-a-Hospital LTACH" means a Long-Term Care Hospital co-located within the same building or the same campus as another CON-Authorized hospital.

(d) "Long Term Care Hospital" or "LTCH" or "Long Term Acute Care Hospital" or "LTACH" means a hospital that is classified as a long-term hospital by the Medicare program pursuant to 42 CFR 412.23(e) . These hospitals typically provide extended medical and rehabilitative care for patients who are clinically complex and may suffer from multiple acute or chronic conditions. Services typically include comprehensive rehabilitation, respiratory therapy, head trauma treatment, and pain management. For regulatory purposes, the definition includes a hospital which asserts its intent to be Medicare-classified as a long-term hospital within twenty-four (24) months of accepting its first patient. If an entity, which has been awarded a CON pursuant to this Rule, has not been so classified by Medicare within this timeframe, the CON issued to that entity shall be revoked. An entity, which has had its CON revoked pursuant to this Rule, shall not have the authority to operate as a general acute care hospital. However, an acute care hospital, which has been awarded a CON to convert acute care beds for use as a long-term care hospital, may again use such beds for acute care if such beds have not been Medicare-classified as a long-term care hospital within twenty-four (24) months of accepting its first patient. Furthermore, a hospital that has been approved through the Certificate Of Need process to use all of its short-stay beds for a Freestanding LTCH shall have such beds removed from the official inventory of available short-stay beds when the LTCH is certified by Medicare; provided, however, that the hospital's beds will revert to the official inventory of available short-stay beds at any point that the facility ceases to be certified by Medicare as an LTCH.

(e) "New" means a hospital that has not been classified by the Medicare program as a long-term hospital in the previous twelve (12) months. For purposes of these Rules, an existing hospital which proposes to be relocated to a location more than three miles from its present location shall be considered "new".

(f) "Occupancy Rate" means the ratio of beds occupied by inpatients as reported on the most recent Annual Hospital Questionnaire divided by the total licensed beds.

(g) "Official State Health Component Plan" means the document related to Long Term Care Hospitals developed by the Department, established by the Georgia Health Strategies Council and signed by the Governor of Georgia.

(h) "Planning Region" means one of the four sub-state regions for Long Term Care Hospitals, as follows:

LTCH Region 1, including the following counties: Dade, Walker, Catoosa, Whitfield, Murray, Gilmer, Fannin, Union, Towns, Rabun, Stephens, Habersham, White, Lumpkin, Dawson, Pickens, Gordon, Chattooga, Floyd, Bartow, Cherokee, Forsyth, Hall, Banks, Franklin, Hart, Elbert, Madison, Jackson, Barrow, Gwinnett, Fulton, Cobb, Paulding, Polk, Haralson, Carroll, Douglas, DeKalb, Rockdale, Walton, Oconee, Clarke, Oglethorpe, Greene, Morgan, Newton, Butts, Henry, Clayton, Fayette, Coweta, Heard, Troup, Meriwether, Pike, Spalding, Lamar, and Upson.
LTCH Region 2, including the following counties: Wilkes, Lincoln, Columbia, McDuffie, Warren, Taliaferro, Hancock, Glascock, Putnam, Jasper, Monroe, Jones, Baldwin, Washington, Jefferson, Richmond, Burke, Screven, Jenkins, Emmanuel, Johnson, Treutlen, Montgomery, Wheeler, Telfair, Wilcox, Dodge, Laurens, Pulaski, Bleckley, Houston, Peach, Twiggs, Wilkinson, Bibb, and Crawford.
LTCH Region 3, including the following counties: Harris, Talbot, Taylor, Muscogee, Chattahoochee, Marion, Schley, Macon, Dooly, Sumter, Webster, Stewart, Quitman, Randolph, Terrell, Lee, Crisp, Ben Hill, Irwin, Turner, Worth, Dougherty, Calhoun, Clay, Early, Baker, Mitchell, Colquitt, Miller, Cook, Tift, Berrien, Lanier, Echols, Lowndes, Brooks, Thomas, Grady, Decatur, and Seminole.
LTCH Region 4, including the following counties: Effingham, Bulloch, Candler, Toombs, Tattnall, Evans, Bryan, Chatham, Liberty, Long, Wayne, Appling, Jeff Davis, Coffee, Bacon, Pierce, Brantley, McIntosh, Glynn, Camden, Charlton, Ware, Atkinson, and Clinch.

(3) Service-Specific Review Standards.

(a) The need for new or expanded Long Term Care Hospital in a LTCH planning region shall be determined using the following need projection:

Determine the total discharges from general acute care hospitals less LTCH discharges, and less perinatal and neonatal discharges, and less psychiatric and substance abuse discharges, and less comprehensive inpatient physical rehabilitation discharges for the planning region in which the Long-Term Care Hospital is or will be located. The source of discharge data for purposes of this Rule include data collected pursuant to O.C.G.A. § 31-7-280(c)(14) , or in the Department's discretion, discharge data collected on the most recent Annual Hospital Questionnaire.
Calculate the discharge rate for each planning region by dividing the number of current acute care discharges obtained in Step 1 in each planning region by the corresponding year's resident population projection from the Governor's Office of Planning and Budget in each planning region.
Calculate the projected discharges for each planning region by multiplying the discharge rate obtained in Step 2 by the horizon year resident population projection for that planning region and then reduce that figure by six percent (6%) to account for overlap with rehabilitation facilities.
Calculate gross beds needed in the horizon year as follows:

(i) Multiply the projected discharges obtained in Step 3 by a utilization factor of 1.3% to determine the projected number of acute care discharge who may benefit from services at a LTCH.

(ii) Multiply the product obtained in Step 4(i) by the average LTCH length of stay for the most recent previous three-year period. Beginning with the first need calculation and continuing until the third complete year of survey data collected pursuant to this Rule, the Department shall use 28.1 as a proxy for the average LTCH length of stay for the previous three years.

(iii) Divide the product obtained in Step 4(ii) by 365 to determine the projected daily LTCH census.

(iv) Divide the result obtained in Step 4(iii) by .85 to determine the number of projected LTCH beds utilizing an eighty-five percent (85%) capacity standard.

Determine the current inventory of LTCH beds in the planning region from Departmental data. For all long-term care hospital providers, which have been licensed as a Long-Term Care Hospital by the Healthcare Facility Regulation Division, the current inventory of LTCH beds shall reflect the number of beds reported as CON-authorized in the Facility Inventory prior to the date of adoption of these Rules augmented from that time forward only by increases in bed capacity approved through the CON process (or by exemptions thereto) and by decreases due to a provider ceasing to provide such services for a period in excess of twelve (12) months. For purposes of this Rule, the initial inventory shall not include the beds of licensed rehabilitation hospitals even if such hospitals have a reported average length of stay of greater than twenty-five (25) days for Medicare patients; the beds of such facilities shall continue to be included in the applicable Comprehensive Inpatient Physical Rehabilitation inventory.
If the projected LTCH bed need in Step 4(iv) is greater than the current inventory of LTCH beds in the planning region, the application for the Certificate of Need should reflect a number of beds equal to or lesser than the resulting unmet bed need.

(b) An applicant for a new or expanded Long Term Care Hospital shall document that the establishment or expansion of its hospital will not have an adverse impact on an existing and approved long-term care hospital in its planning region. An applicant for a new or expanded Long Term Care Hospital shall have an adverse impact on existing and approved hospitals of the same type if it will:

decrease annual utilization of an existing hospital, whose current utilization is at or above eighty-five percent (85%), to a projected annual utilization of less than seventy-five percent (75%) within the first twelve (12) months following the acceptance of the applicant's first patient; or
decrease annual utilization of an existing hospital, whose current utilization is below eighty-five percent (85%), by ten percent (10%) over the twelve (12) months following the acceptance of the applicant's first patient. The applicant shall provide evidence of projected impact by taking into account existing planning region market share of hospitals of the same type and future population growth or by providing sufficient evidence that the current population is underserved by the existing Long Term Care Hospitals within the planning region.

(c) The Department may grant an exception to the need methodology of Ga. Comp. R. & Regs., r. 111-2-2-.36(3)(a) and to the adverse impact standard of Ga. Comp. R. & Regs., r. 111-2-2-.36(3)(b) for an applicant proposing a program to be located in a county with a population of less than 75,000 and to be located a minimum of fifty (50) miles away from any existing program in the state; or to remedy an atypical barrier to the services of a Long Term Care Hospital based on cost, quality, financial access or geographic accessibility. The Department may grant an exception to the need methodologies of either Ga. Comp. R. & Regs., r. 111-2-2-.36(3)(a) and to the adverse impact standard of Ga. Comp. R. & Regs., r. 111-2-2-.36(3)(b) if the applicant's annual census demonstrates thirty percent (30%) out of state utilization for the previous two years.

(d) A new or expanded Long Term Care Hospital shall have the following minimum bed sizes:

A new freestanding LTCH shall have a minimum bed size of forty (40) beds.
A new Hospital-within-a-Hospital LTCH shall have a minimum bed size of twenty (20) beds.
The minimum number of beds for the expansion of an existing Long Term Care Hospital, including satellite locations, shall be ten (10) beds or ten percent (10%) of the total current authorized bed capacity of the Long-Term Care Hospital, whichever is less.

(e) An applicant for a new Long Term Care Hospital shall demonstrate the intent to meet the standards of the Joint Commission or another nationally recognized health care accreditation body within twenty-four (24) months of accepting its first patient. An applicant for an expanded Long Term Care Hospital shall be Joint Commission-certified or certified by another nationally recognized health care accreditation body as of the date of its application and shall furnish proof of the certification as a part of the Certificate of Need application process.

(f) An applicant for a new Long-Term Care Hospital shall demonstrate the intent to meet the Licensure Rules of the Healthcare Facility Regulation Division for such hospitals. An applicant for an expanded Long Term Care Hospital shall demonstrate a lack of uncorrected deficiencies as documented by letter from the Healthcare Facility Regulation Division.

(g) An applicant for a new or expanded Long Term Care Hospital shall have written policies and procedures for utilization review. Such review shall consider, but is not limited to, factors such as medical necessity, appropriateness and efficiency of services, quality of patient care, and rates of utilization.

(h) An applicant for a new or expanded Long Term Care Hospital shall document the existence of referral arrangements, including transfer agreements, with an acute-care hospital(s) within the planning region to provide emergency medical treatment to any patient who requires such care. If the nearest acute-care hospital is in an adjacent planning region, the applicant may document the existence of transfer agreements with that hospital in lieu of such agreements with a hospital located within the planning region.

(i) An applicant for a new or expanded Long Term Care Hospital shall foster an environment that assures access to services to individuals unable to pay and regardless of payment source or circumstances by the following:

providing evidence of written administrative policies and directives related to the provision of services on a nondiscriminatory basis;
providing a written commitment that un-reimbursed services for indigent and charity patients in the service will be offered at a standard which meets or exceeds three percent (3%) of annual gross revenues for the service after Medicare and Medicaid contractual adjustments and bad debt have been deducted;
providing documentation of the demonstrated performance of the applicant, and any facility in Georgia owned or operated by the applicant's parent organization, of providing services to individuals unable to pay based on the past record of service to Medicare, Medicaid, and indigent and charity patients, including the level of un-reimbursed indigent and charity care;
providing documentation of current or proposed charges and policies, if any, regarding the amount or percentage of charges that charity patients, self pay patients, and the uninsured will be expected to pay; and
agreeing to participate in the Medicare and Medicaid programs if such programs reimburse for such services.

(j) Reserved .

(k) An applicant for a new or expanded Long Term Care Hospital shall agree to provide the Department with requested information and statistical data related to the operation of such a Program on a yearly basis, or as needed, and in a format requested by the Department.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Long Term Care Hospitals" adopted. F. Nov. 17, 2005; eff. Dec. 7, 2005.
Amended: F. Nov. 22, 2006; eff. Dec. 12, 2006.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.36, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.37 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.37 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.37}

Ga. Comp. R. & Regs. r. 111-2-2-.38 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.38 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.38}

Ga. Comp. R. & Regs. r. 111-2-2-.39 Reserved {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.39 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.39}

Ga. Comp. R. & Regs. r. 111-2-2-.40 Specific Review Considerations for Ambulatory Surgery Services {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.40 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.40}

(1) Applicability. For Certificate of Need purposes, an Ambulatory Surgery Service is considered a new institutional health service if it is to be offered in an ambulatory surgery facility ("ASF") or in a diagnostic, treatment, or rehabilitation center ("DTRC").

(a) If the ambulatory surgery service is or will be provided as "part of a hospital", the hospital's provision of such service is not subject to Certificate of Need review under this Rule. For purposes of this Rule, the following are always considered to be "part of a hospital":

a) if the service is located within a hospital; or

b) if the service is located in a building on the hospital's primary campus and that building, or relevant portion thereof, is included within the hospital's permit issued by the State's licensing agency, subject to determination by the Department. The Department also will make a determination of reviewability on a case-by-case basis in other situations involving hospitals.

(b) The entity that develops any ambulatory surgery service shall be the applicant.

(c) A single specialty ambulatory surgery service will be issued a single specialty CON. A new CON will be required to become a multi-specialty service.

(d) These Rules do not apply to adult open-heart surgery, adult cardiac catheterization, pediatric cardiac catheterization, pediatric open-heart surgery, and obstetric services because these services are covered under other CON Rules. If an ambulatory surgery service, which is part of a hospital, expands the number of ambulatory surgery operating rooms, the project will be reviewed under Ga. Comp. R. & Regs., r. 111-2-2-.40 .

(2) Definitions.

(a) "Ambulatory surgery" means surgical procedures that include but are not limited to those recognized by the Centers for Medicare and Medicaid Services ("CMS"), the Department's Division of Medical Assistance ("DMA"), the State Health Benefit Plans, or by any successor entities, as reimbursable ambulatory surgery procedures. Ambulatory surgery is provided only to patients who are admitted to a facility which offers ambulatory surgery, and which does not admit patients for treatment that normally requires stays that are overnight or exceed twenty-four (24) hours and which does not provide accommodations for treatment of patients for periods of twenty-four hours or longer.

(b) "Ambulatory surgery facility" means a public or private facility, not part of a hospital, which provides surgical treatment performed under general or regional anesthesia in an operating room environment to patients not requiring hospitalization. In addition to operating rooms, an ambulatory surgery facility includes all components of pre- and post-operative ambulatory surgery care.

(c) "Ambulatory surgery operating room" means an operating room located either in a hospital, in an ambulatory surgery facility, or in a DTRC facility that is equipped to perform surgery and is constructed to meet the specifications and standards of the Healthcare Facility Regulation Division.

(d) "Ambulatory surgery service" means the provision of ambulatory surgery including pre- and post-operative care to patients not requiring hospitalization. An ambulatory surgery service may be provided within any of the following types of healthcare facilities: hospitals, ambulatory surgery facilities, or DTRCs.

(e) "Ambulatory surgery services patient" means a person who makes a single visit to an operating room during which one or more surgical procedures are performed.

(f) "Authorized ambulatory surgery service" means a Department sanctioned ambulatory surgery service, which is either existing or approved prior to the date on which the Department renders a decision on a proposed project. An existing ambulatory surgery service is an authorized service, which has become operational, and an approved ambulatory surgery service is an authorized service, which has not yet become operational, including any approvals under appeal.

(g) "Diagnostic, treatment, or rehabilitation center ("DTRC") facility" means, for purposes of this Rule, any professional or business undertaking, whether for profit or not-for-profit, which offers or proposes to offer an ambulatory surgery service in a setting that is not part of a hospital.

(h) "Most recent year" means the most current twelve-month period within a month of the date of completion of an application or within a month of the date of completion of the first application when applications are joined. If the Department has received an annual or ad hoc survey within six (6) months of the date of completion of the application (or first application when applications are joined), the Department may consider the report period covered in such a survey as the most recent year.

(i) "Multi-specialty ambulatory surgery service" means an ambulatory surgery service offering surgery in more than one of, but not limited to, the following specialties; dentistry/oral surgery, gastroenterology, general surgery, obstetrics/gynecology, ophthalmology, orthopedics, otolaryngology, pain management/anesthesiology, plastic surgery, podiatry, pulmonary medicine, or urology.

(j) "Not requiring hospitalization" means patients who do not require an inpatient admission to an acute care general hospital prior to receiving ambulatory surgery services, who normally would not require a stay that is overnight or exceeds twenty-four (24) hours, and who are not expected to require an inpatient admission after receiving such services.

(k) "Official inventory" means the inventory of all facilities authorized to perform ambulatory surgery services maintained by the Department based on responses to the most recent Annual Hospital Questionnaire ("AHQ") Surgical Services Addendum and Freestanding Ambulatory Surgery Center Survey and/or the most recent appropriate surveys and questionnaires.

(l) "Official state component plan" means the document related to ambulatory surgery services adopted by the State Health Strategies Council, approved by the Board of Community Health, and implemented by the State of Georgia for the purpose of providing adequate health care services and facilities throughout the state.

(m) "Operating room environment" means an environment, which meets the minimum physical plant and operation standards specified by Chapter 111-8-4 of the Rules of the Healthcare Facility Regulation Division or such substantially equivalent standards as determined by the Department. Such acceptable standards shall be maintained on the Department's website.

(n) "Planning Area" means fixed sub-state regions for reviewable services as defined in the State Health Component Plan for Ambulatory Surgery Services.

(o) "Single specialty ambulatory surgery service" means an ambulatory surgery service providing surgery in only one of the specialty areas as defined in Ga. Comp. R. & Regs., r. 111-2-2-.40(2)(i) .

(3) Standards.

(a) The need for an ambulatory surgery service shall be determined through application of a numerical need method and an assessment of the aggregate utilization rate of existing services.

The numerical need for an ambulatory surgery service shall be determined by a demographic formula which includes the number of ambulatory surgery services cases in a planning area. The following need calculation applies to each planning area:

(i) determine the projected ambulatory surgery services patients for the horizon year by multiplying the planning area ambulatory surgery patients' rate by the total Resident population for the planning area for the horizon year;

(ii) determine the number of operating rooms needed by dividing the number of projected ambulatory surgery services patients (step i) by the capacity per operating room. Capacity per operating room per year is 1000 patients. (This is based on 250 operating room days per year (50 weeks x 5 days/weeks) x 5 patients per room per day x 80% utilization.);

(iii) determine the existing and approved inventory of ambulatory surgery operating rooms by adding:

(I) The pro-rata portion of hospital shared inpatient/ambulatory surgery operating rooms devoted to ambulatory surgery services. This portion is determined as follows: (# ambulatory surgery patients x 90 min.) {(ambulatory surgery patients x 90 min) + (inpatient patients x 145 min.)} x # shared rooms;

(II) # of hospital dedicated ambulatory surgery operating rooms; and

(III) # of freestanding ambulatory surgery operating rooms.

(iv) determine the projected net surplus or deficit for ambulatory surgery services by subtracting the total ambulatory surgery operating rooms needed (step iii) from the inventory of existing and approved ambulatory surgery services operating rooms in the planning area.

Prior to approval of a new or expanded ambulatory surgery service in any planning area, the aggregate utilization rate of all existing and approved ambulatory surgery service in that planning area shall equal or exceed eighty percent (80%) during the most recent year; and
A proposed multi-specialty ambulatory surgery service shall have a minimum of three operating rooms and a single specialty ambulatory surgery service shall have a minimum of two operating rooms.

(b) The Department may allow an exception to the need standard referenced in (3)(a), in order to remedy an atypical barrier to ambulatory surgery services based on cost, quality, financial access, or geographic accessibility. An applicant seeking such an exception shall have the burden of proving to the Department that the cost, quality, financial access, or geographic accessibility of current services, or some combination thereof, result in a barrier to services that should typically be available to citizens in the planning area and/or the communities under review. In approving an applicant through the exception process, the Department shall document the bases for granting the exception and the barrier or barriers that the successful applicant would be expected to remedy.

(c) Each applicant shall have a hospital affiliation agreement and/or the medical director must have admitting privileges and other acceptable documented arrangements to insure the necessary backup for medical complications. The applicant must document the capability to transfer a patient immediately to a hospital with adequate emergency room services.

(d) An applicant shall submit written policies and procedures regarding discharge planning. These policies should include, where appropriate, designation of responsible personnel, participation by the patient, family, guardian or significant other, documentation of any follow-up services provided and evaluation of their effectiveness.

(e) An applicant shall provide evidence of a credentialing process that provides that surgical procedures will be performed only by licensed physicians who have been granted privileges to perform these procedures by the organization's governing body.

(f) An applicant shall assure that an anesthesiologist, a physician qualified to administer anesthesia, an oral surgeon, or a nurse anesthetist trained and currently certified in emergency resuscitation procedures is present on the premises at all times a surgical patient is present.

(g) An applicant shall submit evidence that qualified personnel will be available to ensure a quality service to meet licensure, certification and/or accreditation requirements.

(h) An applicant shall submit a policy and plan for reviewing patient care, including a stated set of criteria for identifying those patients to be reviewed and a mechanism for evaluating the patient review process.

(i) An applicant shall submit written policies and procedures for utilization review consistent with state federal and accreditation standards. This review shall include review of the medical necessity for the service, quality of patient care, and rates of utilization.

(j) An applicant shall provide a written statement of its intent to comply with all appropriate licensure requirements and operational procedures required by the Healthcare Facility Regulation Division.

(k) An applicant for a new ambulatory surgery service shall provide a statement for the intent to meet, within twelve (12) months of obtaining state licensure, the appropriate accreditation requirements of the Joint Commission or another nationally recognized health care accreditation body, the Accreditation Association for Ambulatory Health Care (AAAHC), the American Association for Accreditation of Ambulatory surgery Facilities, Inc. (ASF) and/or other appropriate accrediting agency.

(l) An applicant for an expanded ambulatory surgery service shall provide documentation that they fully meet the appropriate accreditation requirements of the Joint Commission or another nationally recognized health care accreditation body, the Accreditation Association for Ambulatory Health Care ("AAAHC"), the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. ("ASF") and/or other appropriate accrediting agency.

(m) An applicant shall provide documentation that charges are reasonable compared to other similar surgery services serving the same planning area.

(n) An applicant shall foster an environment that assures access to services to individuals unable to pay and regardless of payment source or circumstances by the following:

providing evidence of written administrative policies and directives related to the provision of services on a nondiscriminatory basis;
providing a written commitment that unreimbursed services for indigent and charity patients in the service will be offered at a standard which meets or exceeds three percent (3%) of annual gross revenues for the service after Medicare and Medicaid contractual adjustments and bad debt have been deducted; and
providing documentation of the demonstrated performance of the applicant, and any facility in Georgia owned or operated by the applicant or the applicant's parent organization, of providing services to individuals unable to pay based on the past record of service to Medicare, Medicaid, and indigent and charity patients, including the level of unreimbursed indigent and charity care.

(o) An applicant for an ambulatory surgery service shall document an agreement to provide Department requested information and statistical data related to the operation and provision of ambulatory surgery and to report that data to the Department in the time frame and format requested by the Department. This information shall include, but not be limited to, any changes in the number of ambulatory surgery operating rooms that may occur as a result of service expansion.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Ambulatory Surgery Services" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Amended: F. Dec. 14, 2007; eff. Jan. 3, 2008.
Amended: F. Sept. 11, 2008; eff. Oct. 1, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.40, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.41 Specific Review Considerations for Positron Emission Tomography Units {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.41 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.41}

(1) Applicability.

(a) A Certificate of Need shall be required for a new or expanded positron emission tomography ("PET") unit except as otherwise provided in O.C.G.A. § 31-6-47 and Ga. Comp. R. & Regs., r. 111-2-2-03.

(b) On or after January 1, 2008, the Department shall only consider and approve applications for dual modality PET units; stand-alone PET units shall not be approved.

(c) On or after July 1, 2024, an applicant for a mobile unit site shall be the DTRC which has entered into an agreement to receive mobile services. The actual mobile service provider shall not be the applicant. The hospital or DTRC that is serviced by the mobile provider shall be responsible for the provision of annual surveys and the provision of information to the Department.

(d) Reserved .

(e) A Certificate of Need obtained by a hospital or DTRC to offer mobile PET services shall be valid for the provision of mobile PET services only. ADTRC approved to offer mobile PET services must obtain a separate CON prior to offering fixed PET services.

(2) Definitions.

(a) "Health Planning Area" or "planning area" means the thirteen (13) geographic regions in Georgia as defined in the official State Health Component Plan for use in planning for PET Scan services.

(b) "Horizon Year" means the last year of a five-year projection period for need determinations.

(c) "Expansion" or "expanded service" means the addition of a fixed or mobile unit at a DTRC. The addition of a component or components, such as computer tomography (CT) imaging, to an existing fixed or mobile unit or the upgrade of an existing fixed or mobile unit shall not be considered an expansion and shall not be subject to the need standards.

(d) "Fixed Unit" means a unit that is stationary within one approved facility.

(e) "Mobile Unit" means a unit that is operated by one or shared by two or more health care facilities and which has a data acquisition system and a computer. In order to meet the definition of mobile unit, the applicant must provide proof of the following:

The unit must not be on site at any Facility more than three (3) consecutive operating days per week or sixteen (16) total days per month.
The facilities involved with the mobile unit are fully informed and participating in the service as evidenced by written agreements or correspondence provided in the application.
For applications approved prior to January 1, 2008, a mobile provider is limited to providing service only to those facilities approved in the mobile provider's application for CON. On or after January 1, 2008, a mobile provider may serve any DTRC that receives a Certificate of Need for mobile PET services, provided that no DTRC may be serviced by more than one mobile provider at a time.
The applicant shall project scans per facility on a pro-rated basis for the first year of operation, and such projections shall be used in any need determinations during that first year of operation. Thereafter, in annual surveys, the applicant, if successful, must document scans by each service facility for use in need determinations.

(f) "Optimal Utilization" refers to scans per year and shall be defined as 2,750 PET scans per year. A PET Scan or Study means the gathering of data during a single patient visit from which one or more images may be constructed.

(g) "PET Scan Service" or "Service" means a facility that owns one or more units and provides diagnostic imaging through positron emission tomography exclusively or as a dedicated PET/CT or dual modality unit.

(h) "Positron Emission Tomography" or "PET" means a noninvasive diagnostic technology, which enables the body's physiological and biological processes to be observed through the use of positron emitting radiopharmaceuticals.

(i) "Unit" means a single piece of equipment that performs PET scans.

(3) Standards.

(a) The need for a new or expanded service shall be determined through the application of a Numerical Need method and an assessment of the aggregate utilization rate of existing and approved units.

The numerical need for a new unit in a planning area shall be determined through the application of a demand-based forecasting model. The model is outlined in the steps listed below, and all data elements relate to each planning area:

(i) Calculate the projected incidence of cancer for each county by multiplying the most recent Cancer Incidence Rate, as published by the State Cancer Registry, for each county by the horizon year population for the county;

(ii) Multiply the projected incidence of cancer by fifty percent (50%) to determine the projected number of patients diagnosed with cancer who might benefit from a scan.

(iii) Add the number of cancer cases that might benefit from a scan for each county within a Health Planning Area to determine the estimated need for services within a Health Planning Area for persons diagnosed with cancer.

(iv) Multiply the number of cancer cases for each Health Planning Area from subsection (iii) by 1.4 to accommodate for non-oncology patients and for follow-up scans for oncology patients in the projected need for services. On or after January 1, 2010, in lieu of multiplying by 1.4 each year, the Department shall use actual data from the previous 2 survey years to determine the multiplication factor by adding 1 to the ratio of cardiology, neurology and follow up oncology scans to the number of initial oncology scans.

(v) Calculate the number of needed units by dividing the number of individuals who might receive scanning services as determined from subsection (iv) by 2,750, which represents the optimal utilization of a unit.

(vi) Determine the net numerical unmet need for PET scan unit(s) by subtracting the total number of PET/CT or dual modality units currently existing or approved for use from the number of needed units. Mobile units shall be subtracted based on the number of days providing service to sites within a planning area in the most recent survey year divided by 365. Stand-alone PET units shall not be included in the inventory and shall not be subtracted to determine the net numerical unmet need.

(vii) If the net numerical unmet need in any Health Planning Area is at or above seventy-five percent (75%) of a unit (approximately 2,062 individuals needing scans), the needed units shall be rounded up by one unit. If the balance net numerical need in any Health Planning Area is at or above 3.2875% of a unit (approximately (90) individuals needing scans), a mobile unit may be approved to serve the planning area. The maximum number of days a mobile unit may be approved to provide services in the planning area shall be determined using the following formula: APPROVED DAYS PER YEAR < NET NUMERICAL UNMET NEED 365

Prior to the approval of a new or expanded unit in a planning area, the aggregate utilization rate for all units in that planning area that existed during the most recent survey year and that provided data to the Department for the most recent survey year shall equal or exceed eighty percent (80%) of optimal utilization for the most recent survey year.

(b) Exceptions to the need standards and requirements in (3)(a) may be granted by the Department:

to an applicant seeking to remedy an atypical barrier to services based on cost, quality, financial access, or geographic accessibility when the applicant has documented such a barrier;
to an applicant seeking the addition of a fixed unit who has been served solely by a mobile PET when the applicant demonstrates that 850 studies have been performed on the mobile unit at the applicant's facility in the most recent survey year; and
Reserved .

(c) In considering applications joined for review, the Department may give favorable consideration to an applicant that has historically provided a higher annual percentage of un-reimbursed services to indigent and charity patients.

(d) An applicant for a new or expanded service shall foster an environment that assures access to individuals unable to pay, regardless of payment source or circumstances, by the following:

providing a written policy regarding the provision of any services provided by or on behalf of the applicant that stipulates that any such services shall be provided regardless of race, age, sex, creed, religion, disability, or patient's ability to pay, and documentation or evidence that the applicant has a service history reflecting the principles of such a policy; and
providing a written commitment that services for indigent and charity patients will be offered at a standard which meets or exceeds five percent (5%) of annual, adjusted gross revenues of the PET scan service; or
providing a written commitment to participate in Medicaid, Peach Care and Medicare programs, to the extent such programs reimburse for PET scan services, and to accept any Medicaid-, Peach Care- and/or Medicare-eligible patient for services;
providing a written commitment that the applicant, subject to good faith negotiations, will participate in any state health benefits insurance programs for which the service is deemed eligible; and
providing documentation of the past record of performance of the applicant, and any facility in Georgia owned or operated by the applicant's parent organization, of providing services to Medicare, Medicaid, and indigent and charity patients. The applicant's or its parent organization's failure to provide services at an acceptable level to Medicare, Medicaid and indigent and charity patients, and/or the failure to fulfill any previously made commitment to indigent and charity care may constitute sufficient justification to deny the application.

(e) An applicant for a new or expanded service shall provide evidence of the ability to meet the following quality of care standards:

Document certification or a plan for securing certification for operation of a unit from the Georgia Department of Natural Resources.
Document that the unit proposed for purchase is approved for use by the U.S. Food and Drug Administration and for reimbursement by the Center for Medicare and Medicaid Services.
Document that the service will function as a component of a comprehensive diagnostic service and that appropriate referral to treatment and follow-up will be provided. The applicant must have accessible the following modalities and capabilities on site or through agreements, as evidenced by documentation provided at the time of application: computed tomography, magnetic resonance imaging, nuclear medicine, and conventional radiography.
Document that the PET service shall be under the direction of a physician who is board certified in nuclear medicine or diagnostic radiology; and is licensed as an authorized user of radioactive materials in accordance with the Rules of the Georgia Department of Natural Resources.
Document that the PET services has arrangements with board-certified interpreting physician(s) that are licensed in the State of Georgia.
Document the training and experience in PET scan services of the physician, nuclear medicine technologist, and radiology technologist. Such personnel shall be certified by appropriate national accreditation bodies.
Document fully the safe and timely access to radiopharmaceuticals.

(f) An applicant for a new or expanded service shall provide evidence of the ability to meet the following continuity of care standards:

Document that the applicant provides or has signed emergency transfer agreements and arrangements with one or more acute care hospital(s) located within the applicant's health planning area or in the case where the nearest acute care hospital is located in an adjacent health planning area, the nearest acute care hospital.
Document a referral system that includes a feedback mechanism for communicating scan results and any other pertinent patient information to the referring physician.
Document that the applicant will maintain current listings of appropriate clinical indications for PET procedures and will provide such listings to referring physicians and patients.
Document how medical emergencies will be managed in conformity with accepted medical practice.

(g) An applicant for a new or expanded service shall agree to provide the Department with all requested information and statistical data related to the operation and provision of services and to report that data to the Department in the time and format requested by the Department.

History

Authority: O.C.G.A. §§ 31-2 et seq., 31-6 et seq
History. Original Rule entitled "Specific Review Considerations for Positron Emission Tomography Units" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: New Rule of same title adopted. F. May 13, 2008; eff. June 2, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.41, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.
Amended: F. Dec. 24, 2024; eff. Jan. 13, 2025.
Amended: F. June 12, 2025; eff. July 2, 2025.

Ga. Comp. R. & Regs. r. 111-2-2-.42 Specific Review Considerations for MegaVoltage Radiation Therapy Services/Units {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.42 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.42}

(1) Applicability.

(a) A Certificate of Need will be required for the establishment of any new or expanded MegaVoltage Radiation Therapy Service.

(b) MegaVoltage Radiation Therapy, including Stereotactic Radiosurgery (SRS) and Stereotactic Body Radiation Therapy (SBRT) may be conducted on non-special units or on special purpose units.

(c) A Certificate of Need will be required for the addition of a non-special MRT unit. An application for the addition of a non-special MRT unit shall address the standards contained in Ga. Comp. R. & Regs. r. 111-2-2-.42(3) in addition to the general review considerations of Ga. Comp. R. & Regs. r. 111-2-2-.09(1) . A certificate holder who has been authorized to provide MRT service solely on a non-special unit may not provide service on a special purpose unit without obtaining a special purpose MRT Certificate of Need.

(d) A Certificate of Need will be required for the addition of a special purpose MRT unit. An application for the addition of a special purpose MRT unit shall address the standards contained in Ga. Comp. R. & Regs. r. 111-2-2-.42(4) in addition to the general review considerations of Ga. Comp. R. & Regs. r. 111-2-2-.09(1) . A certificate holder who has been authorized to provide MRT service solely on a special purpose unit may not provide service on a non-special unit without obtaining a non-special MRT Certificate of Need.

(e) An application for the establishment of a new or expanded MegaVoltage Radiation Therapy Service with the addition of both non-special and special purpose MRT units shall address the standards of Ga. Comp. R. & Regs. r. 111-2-2-.42(3) , 111-2-2-.42(4) and the general review considerations of Ga. Comp. R. & Regs. r. 111-2-2-.09(1) .

(2) Definitions.

(a) "Brachytherapy" means the administration of radiation therapy by applying a radioactive material inside or in close proximity to the patient. The material may be contained in various types of apparatus; may be on the surface of plaques; or may be enclosed in tubes, needles, wire, seeds, or other small containers. Common materials that are or have been used for the administration of brachytherapy include but are not limited to radium, Cobalt-60, Cesium-137, Iodine-125, Palladium-103 and Iridium-192.

(b) "Complex treatment visit" means a treatment visit involving three or more treatment sites, tangential fields with wedges, rotational or arc techniques or other special arrangements, or custom blocking.

(c) "Course of treatment" means the planned series of visits that compose a plan for treatment of one or more cancer sites for a single patient.

(d) "Gamma knife" means a special stereotactic radiosurgery unit consisting of multiple cobalt sources all simultaneously focused to irradiate cancer or other neoplasms in the brain or cerebrovascular system abnormalities.

(e) "Health Planning Area" or "Planning Area" means the geographic regions in Georgia for use in planning for MRT services.

The Health Planning Areas or Planning Areas for non-special MRT services are the twelve state service delivery regions established by O.C.G.A. § 50-4-7 .
The Health Planning Areas or Planning Areas for special purpose MRT services are five sub-state regions comprised as follows:

(i) Special Purpose MRT Region 1, including the following counties: Dade, Walker, Catoosa, Whitfield, Murray, Gilmer, Fannin, Union, Towns, Rabun, Stephens, Habersham, White, Lumpkin, Dawson, Pickens, Gordon, Chattooga, Floyd, Bartow, Cherokee, Forsyth, Hall, Banks, Franklin, Hart, Gwinnett, Fulton, Cobb, Paulding, Polk, Haralson, Douglas, DeKalb, Rockdale, Newton, Henry, Clayton, and Fayette;

(ii) Special Purpose MRT Region 2, including the following counties: Elbert, Madison, Jackson, Barrow, Oconee, Clarke, Oglethorpe, Greene, Morgan, Walton, Wilkes, Lincoln, Columbia, McDuffie, Warren, Taliaferro, Glascock, Jefferson, Richmond, Burke, Screven, Jenkins, and Emmanuel;

(iii) Special Purpose MRT Region 3, including the following counties: Carroll, Coweta, Heard, Troup, Meriwether, Pike, Spalding, Lamar, Upson, Harris, Talbot, Taylor, Muscogee, Chattahoochee, Marion, Schley, Macon, Sumter, Webster, Stewart, Quitman, Randolph, Terrell, Lee, Worth, Dougherty, Calhoun, Clay, Early, Baker, Mitchell, Colquitt, Miller, Brooks, Thomas, Grady, Decatur, and Seminole;

(iv) Special Purpose MRT Region 4, including the following counties: Hancock, Putnam, Jasper, Butts, Monroe, Jones, Baldwin, Washington, Johnson, Treutlen, Montgomery, Wheeler, Telfair, Wilcox, Dodge, Laurens, Pulaski, Bleckley, Houston, Peach, Twiggs, Wilkinson, Bibb, Crawford, Dooly, Crisp, Ben Hill, Irwin, Turner, Cook, Tift, Berrien, Lanier, Echols, and Lowndes; and

(v) Special Purpose MRT Region 5, including the following counties: Effingham, Bulloch, Candler, Toombs, Tattnall, Evans, Bryan, Chatham, Liberty, Long, McIntosh, Wayne, Appling, Jeff Davis, Coffee, Bacon, Pierce, Brantley, Glynn, Camden, Charlton, Ware, Atkinson, and Clinch.

(f) "Heavy particle accelerator" means a machine such as a cyclotron, which produces beams of high-energy particles such as protons, neutrons, pions, or heavy ions with rest masses greater than that of an electron (mc2 = 0.511 MeV).

(g) "Horizon Year" means the last year of a five-year projection period for need determinations for MRT services.

(h) "Intensity modulated radiation therapy" or "IMRT" means a treatment delivery utilizing a radiotherapy treatment plan optimized using an inverse or forward planning technique to modulate the particle or energy fluence to create a highly conformal dose distribution. This beam modulated treatment delivery can be accomplished either by the use of the computer controlled multi-leaf collimator or high resolution milled or cast compensators.

(i) "Intermediate treatment visit" means a treatment visit involving two separate treatment sites, three or more fields to a single treatment site, or the use of special blocking.

(j) "Megavoltage radiation therapy" or "MRT" means a clinical modality in which patients with cancer, other neoplasms, or cerebrovascular system abnormalities are treated with radiation which is delivered by an MRT unit.

(k) "MRT service" means the CON approved MRT utilization of a MRT unit(s) at one geographic location.

(l) "MRT unit" or "unit" means a CON approved linear accelerator; cobalt unit; or other piece of medical equipment operating at an energy level equal to or greater than 1.0 million electron volts (megavolts or MeV) for the purpose of delivering doses of radiation to patients with cancer, other neoplasms, or cerebrovascular system abnormalities.

(m) "Non-special MRT unit" or "non-special unit" means an MRT unit other than an MRT unit meeting the definition of a special purpose MRT unit.

(n) "Operating room based intraoperative MRT unit" or "OR-based IORT unit" means an MRT unit that is designed to emit only electrons, is located in an operating room in the surgical department of a licensed hospital and is available for the treatment of a patient undergoing a surgical procedure with megavoltage radiation.

(o) "Simple treatment visit" means a treatment visit involving a single treatment site, single treatment field, or parallel opposed fields with the use of no more than simple blocks.

(p) "Simulation" is the process of defining relevant normal and abnormal anatomy, acquiring the images and data necessary to develop the patient's approved radiation treatment plan. Simulation always occurs prior to treatment and may be repeated multiple times during the course of treatment depending on the type of cancer, the radiation therapy technique utilized and the patient's clinical response to treatment. Simulation is used to direct the treatment beams to the specific volume.

(q) "Special purpose MRT unit" or "special purpose unit" or "special unit" means any of the following types of MRT units:

(i) heavy particle accelerator;

(ii) gamma knife;

(iii) dedicated linear accelerator stereotactic radiosurgery unit (SRS LINAC), including CyberKnife; or

(iv) an OR-based IORT unit.

(r) "Stereotactic body radiation therapy (SBRT)" is a term used to describe extracranial stereotactic radiosurgery (SRS) or radiotherapy (SRT). SBRT is a radiotherapy treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body.

(s) "Stereotactic treatment visit" or "SRS treatment visit" means a visit involving SRS or SBRT treatment techniques.

(t) "Stereotactic Radiosurgery (SRS)" is performed in a limited number of treatment visits (up to a maximum of five), using a rigidly attached stereotactic guiding device, other immobilization technology and/or a stereotactic image-guidance system to treat lesions in the body (extracranial) or brain (intracranial). Technologies that are used to perform SRS include linear accelerators, particle beam accelerators and multi source Cobalt-60 units.

(u) "SRS LINAC" is a dedicated linear accelerator stereotactic radiosurgery unit that consists of three key components:

(i) an advanced linear accelerator (linac) (this device is used to produce a high energy megavoltage of radiation),

(ii) a device which can point the linear accelerator from a wide variety of angles, and

(iii) image-guidance patient positioning system using kilovoltage x-rays for either in-room diagnostic x-rays or tomographic images. The devices obtain pictures of the patient (planar x-ray or computed tomography) before or during treatment and use this information to target the radiation beam emitted by the linear accelerator, SRS LINAC includes units such as CyberKnives.

(v) "Treatment site" means the anatomical location of the MRT treatment.

(w) "Treatment visit" means one patient encounter during which MRT is administered. One treatment visit may involve one or more treatment ports or fields. Each separate encounter by the same patient at different times of the same day shall be counted as a separate treatment visit.

(x) "Unit" means a single machine used for MRT services.

(y) "Urban County" means a county with a projected population for the horizon year of 100,000 or more and a population density for that year of 200 or more people per square mile. All other counties are "rural."

(3) Standards for Non-Special MRT.

(a) The need for the addition of a non-special MRT unit shall be determined through the application of a Numerical Need method and an assessment of the aggregate utilization rate of existing services not including units added through the exception in section (3)(b)(2) of this Rule.

The numerical need for the addition of a non-special MRT unit in a planning area shall be determined through the application of a demand-based forecasting model. The model is outlined in the steps listed below, and all data elements relate to each planning area:

(i) Calculate the projected incidence of cancer excluding basal, epithelial, papillary, and squamous cell carcinomas of the skin from other than a genital area for each county by multiplying the most recent Cancer Incidence Rate, as published by the State Cancer Registry, for each county by the horizon year population for the county;

(ii) Multiply the projected incidence of cancer by fifty percent (50%) to determine the number of projected cancer cases in each county that could be treated with a non-special MRT unit;

(iii) Add the number of treatable cases for each county within a Health Planning Area to determine the projected number of patients needing treatment with a non-special MRT unit within the Health Planning Area in the horizon year;

(iv) Multiply the number obtained in step (iii) above by the most recent two year average of treatment visits per patient for the respective planning area of each county to project the number of projected patient visits in the horizon year;

(v) Determine the percentage of total visits in each planning area attributable to (1) Simple treatment visits, (2) Intermediate treatment visits, (3) Complex treatment visits, (4) IMRT, and (5) SRS treatment visits performed on non-special equipment as based on a running average of the most recent two annual surveys for facilities located in each respective planning area. Prior to the 2008 survey year, the percentage of total visits in each planning area shall be based on the most recent annual survey for facilities located in each respective planning area;

(vi) Determine the number of projected equivalent visits in the horizon year for each planning area as follows:

A. Project the number of equivalent simple visits by multiplying the percentage obtained in step (v) for simple visits by the projected patient visits in the horizon year obtained in step (iv);

B. Project the number of equivalent intermediate visits by multiplying the percentage obtained in step (v) for intermediate visits by the projected patient visits in the horizon year obtained in step (iv) and multiply the product by the weighted equivalent for intermediate visits, 1.1;

C. Project the number of equivalent complex visits by multiplying the percentage obtained in step (v) for complex visits by the projected patient visits in the horizon year obtained in step (iv) and multiply the product by the weighted equivalent for complex visits, 1.3;

D. Project the number of equivalent IMRT visits by multiplying the percentage obtained in step (v) for IMRT visits by the projected patient visits in the horizon year obtained in step (iv) and multiply the product by the weighted equivalent for IMRT visits, 1.8;

E. Project the number of equivalent SRS visits by multiplying the percentage obtained in step (v) for SRS visits by the projected patient visits in the horizon year obtained in step (iv) and multiply the product by the weighted equivalent for SRS visits, 7.0; and

F. Sum the products obtained in step (vi)A. through step (vi)E.;

(vii) Calculate the number of needed non-special MRT units by dividing the number of projected equivalent visits obtained in step (iv)F. by 9,000, which represents the weighted equivalent capacity of a non-special MRT unit within a given year; and

(viii) Determine the net numerical unmet need for non-special MRT units by subtracting the total number of non-special MRT units currently existing or approved for use, not including units approved pursuant to the exception in section (3)(b)2. of this Rule, from the number of needed non-special MRT units obtained in step (vii).

Prior to approval of an additional non-special MRT unit in a planning area, the aggregate utilization rate for all existing non-special MRT units, not including units approved pursuant to the exception in section (3)(b)2. of this Rule, in that planning area shall equal or exceed eighty percent (80%) of capacity based on 9,000 weighted equivalent visits. For those existing non-special MRT units that have not reported data in the most recent survey year, the Department shall include the non-reporting unit at the statewide average utilization rate.

(b) Exceptions to the need standard referenced in (3)(a) may be granted for applicants proposing any of the following:

To assure geographic access to non-special MRT services in rural areas when the proposed service is:

(i) to be located in a rural county;

(ii) to be located a minimum of 45 miles away from any existing or approved non-special MRT service; and

(iii) projected to serve a minimum of 150 patients per year. For purposes of this requirement, service projections must be submitted by the applicant using, at a minimum, state cancer registry data and documented cancer treatments within the service area.

To allow expansion of an existing service if the actual utilization of each radiation therapy unit within that service has exceeded ninety percent (90%) of optimal utilization over the most recent two years. Any such units approved pursuant to this exception shall not be included in the calculation of need and aggregate utilization for the applicable service delivery region but will be included in the Department non-special MRT unit inventory.
To allow the addition of a non-special MRT unit at the same defined location if the applicant has a substantial out-of-state patient base. 'Substantial out of state patient base' shall be defined as using at least thirty-three percent (33%) of capacity or 2,970 weighted equivalent visits at the applicant's own percentage of treatment visits weighted by treatment type using the statewide weighted equivalent factor for each non-special MRT unit over the most recent two years to treat patients who reside outside of the State of Georgia.
To remedy an atypical barrier to non-special MRT services based on cost, quality, financial access and geographic accessibility.

(c) An applicant for a new or expanded non-special MRT service shall document the impact on existing and approved services which already provide non-special MRT to the residents of the planning area with the goal of minimizing adverse impact on existing and approved services of the same type in its planning area. An applicant for a new or expanded non-special MRT service shall have an adverse impact on existing and approved programs if it will:

decrease annual utilization of an existing service, whose current utilization is at or above eighty percent (80%), to a projected utilization of less than seventy percent (70%) within the first twenty-four (24) months of the initial operation of the service or additional non-special MRT unit; or
decrease annual utilization of an existing service, whose current utilization is below eighty percent (80%), by ten percent (10%) or more within the first twenty-four (24) months of the initial operation of the service or additional non-special MRT unit. An applicant shall provide evidence of projected impact by taking into account existing planning area market share of existing non-special MRT services and future population growth or by providing sufficient evidence that the current population is underserved by the existing non-special MRT services, if any, within the planning area. An applicant proposing an additional non-special MRT unit pursuant to the exceptions to need standards referenced in (3)(b)2. shall not be required to document impact on existing and approved services as required by this paragraph.

(d) An applicant for a new or expanded non-special MRT service shall foster an environment that assures access to individuals unable to pay, regardless of payment source or circumstances, by the following:

providing evidence of written administrative policies that prohibit the exclusion of services to any patient on the basis of age, race, or ability to pay;
providing a written commitment that services for indigent and charity patients will be offered at a standard which meets or exceeds three percent (3%) of annual, adjusted gross revenues for the non-special MRT service;
providing a written commitment to participate in the Medicaid and Peach Care programs;
providing a written commitment to participate in any other state health benefits insurance programs for which the radiation therapy service is eligible; and
providing documentation of the past record of performance of the applicant, and any facility in Georgia owned or operated by the applicant's parent organization, of providing services to Medicare, Medicaid, and indigent and charity patients.

(e) An applicant for a new or expanded non-special MRT service shall provide evidence of a cancer treatment program, which shall include the provision of the following, either on-site or through written agreements with other providers:

Access to simulation capabilities, which may include a dedicated simulator, a radiation therapy treatment unit, a virtual-reality based three-dimensional simulation system, or other diagnostic X-ray, magnetic resonance, ultrasound, or nuclear medicine equipment that has been modified to localize volumes to define the area requiring treatment; and which must be at the defined location of the non-special MRT service;
Access to a computer-based treatment planning system, which shall be a computer system capable of interfacing with diagnostic patient data acquisition systems such as CT, MRI, PET-CT to obtain the patient specific anatomical data. The planning system must be able to display radiation doses and 3-D dose distributions within a patient's anatomical contour and utilize measured or modeled radiation output data from the specific unit used to treat the patient. The minimum software requirements for the treatment planning system are an external beam program, an irregular field routine, and a Brachytherapy package;
Non-Special MRT capability including electron beam capability;
Capability to fabricate treatment aids; and
Access to brachytherapy;

(f) The applicant must provide a written commitment that physicians providing professional radiation oncology services at the MRT facility shall at all times have privileges or be eligible for and have an active pending application for privileges and be members in good standing of the medical staff, or are eligible for and have an active pending application for privileges, of a hospital with a comprehensive cancer treatment program located within the applicant's service area which will provide those physicians with access to participate in all of the following:

Consultative services from all major disciplines needed to develop a comprehensive treatment plan.
A multi-disciplinary cancer committee, which shall be a standing committee that:

(i) includes representatives from the medical specialties or sub-specialties which refer patients to the MRT service; representatives from the specialties of diagnostic radiology, radiation oncology, and pathology; representatives from those who oversee the tumor registry; and representatives from administration, nursing, social services, pharmacy, and rehabilitation;

(ii) meets at least on a quarterly basis; and

(iii) is responsible for the following:

A. establishing educational and problem oriented multi-disciplinary, facility-wide cancer conferences that include the major anatomic locations of cancer seen at the facility;

B. monitoring, evaluating, and reporting to the medical staff and governing body on the quality of care provided to patients with cancer; and

C. oversight of the applicant's tumor registry for quality control, staging, and abstracting;

Patient care evaluation studies, which shall be a system of patient care evaluation, conducted annually, that documents the methods used to identify problems and the opportunities to improve patient care. Examples of patient care evaluation studies include nationwide patient evaluation studies; facility quality assurance activities; and ongoing monitoring, evaluating, and action planning; and
Cancer prevention and education programs.

(g) The applicant must participate and report to the Georgia Comprehensive Cancer Registry of the Georgia Department of Public Health.

(h) An applicant shall demonstrate that the following staff, at a minimum, will be identified and available:

One (1) FTE board-certified or board-qualified physician trained in radiation oncology, which shall be available by continuous means of direct communication with the non-special MRT unit in person or by radio, telephone, or telecommunication;
One (1) medical radiation physicist, who shall be an individual who is board-certified or board-qualified by the American Board of Radiology in therapeutic radiological physics; or board-certified by the American Board of Medical Physics in medical physics with a special competence in radiation oncology physics; and who shall be available by means of direct communication with the non-special MRT unit in person or by radio, telephone, or telecommunication;
One (1) medical dosimetrist, who shall be a member of the radiation oncology team who has the knowledge of the overall characteristics and clinical relevance of radiation oncology treatment machines and equipment, is cognizant of procedures commonly used in brachytherapy and has the education and expertise necessary to generate radiation dose distributions and dose calculations in collaboration with the medical physicist and radiation oncologists; and who shall be available by means of direct communication with the non-special MRT unit in person or by radio, telephone, or telecommunication;
Two (2) radiation therapy technologists, who shall be registered or eligible by the American Registry of Radiological Technologists (ARRT) or the American Registry of Clinical Radiography Technologists (ARCRT); and who shall be on-site at all times of operation of the facility; and
One (1) program director, who shall be a board-certified physician trained in radiation oncology who may also be the physician required under (h)1.; and who shall be available by means of direct communication with the non-special MRT unit in person or by radio, telephone, or telecommunication;

(i) An applicant for a new or expanded non-special MRT service shall agree to provide the Department with all requested information and statistical data related to the operation and provision of services and to report that data to the Department in the time frame and format requested by the Department.

(4) Standards for Special Purpose MRT.

(a) The need for the addition of a special purpose MRT unit shall be determined through analysis of the capacity and utilization of the existing units of the same type in the planning area and an applicant's reasonable and documented projection of a minimum volume as follows: Special MRT Equipment Capacity Minimum Aggregate Utilization Minimum Projected Volume Gamma Knife 500 80% 300 by 3rd Year of Operation Heavy Particle Accelerator 4,000 per Gantry 80% 2,400 per Gantry by 3ed Year of Operation Dedicated SRS LINAC (including CyberKnife) 850 80% 510 by 3rd Year of Operation OR-based IORT 350 80% 150 by 3rd Year of Operation Where capacity is measured in annual procedures; where minimum aggregate utilization is the aggregate utilization rate for all existing special purpose MRT units of the same type (Gamma Knife utilization for Gamma Knife, etc.) in the planning area, except that for those existing special purpose MRT units that have not reported data in the most recent survey year, the Department shall include the non-reporting unit at the statewide average utilization rate for special purpose equipment of the same type; and where the minimum projected volume is measured in procedures per year.

(b) Exceptions to the need standards referenced in (3)(a) may be granted for applicants proposing to remedy an atypical barrier to special purpose MRT services based on cost, quality, financial access and geographic accessibility.

(c) An applicant for a new or expanded special purpose MRT service shall document the impact on existing and approved services of the same type (Gamma Knife for Gamma Knife application, etc.) which already provide special purpose MRT to the residents of the planning area with the goal of minimizing adverse impact on existing and approved services of the same type in its planning area. An applicant for a new or expanded special purpose MRT service shall have an adverse impact on existing and approved programs if it will:

decrease annual utilization of an existing service of the same type, whose current utilization is at or above seventy percent (70%), to a projected utilization of less than sixty percent (60%) within the first twenty-four (24) months of the initial operation of the service or additional special purpose MRT unit; or
decrease annual utilization of an existing service of the same type, whose current utilization is below seventy percent (70%), by ten percent 10% or more within the first twenty-four (24) months of the initial operation of the service or additional special purpose MRT unit. An applicant shall provide evidence of projected impact by taking into account existing planning area market share of existing special purpose MRT services and future population growth or by providing sufficient evidence that the current population is underserved by the existing special purpose MRT services, if any, within the planning area.

(d) An applicant for a new or expanded special purpose MRT service shall foster an environment that assures access to individuals unable to pay, regardless of payment source or circumstances, by the following:

providing evidence of written administrative policies that prohibit the exclusion of services to any patient on the basis of age, race, or ability to pay;
providing a written commitment that services for indigent and charity patients will be offered at a standard which meets or exceeds three percent (3%) of annual, adjusted gross revenues for the special purpose MRT service;
providing a written commitment to participate in the Medicaid and PeachCare for Kids® programs;
providing a written commitment to participate in any other state health benefits insurance programs for which the radiation therapy service is eligible; and
providing documentation of the past record of performance of the applicant, and any facility in Georgia owned or operated by the applicant's parent organization, of providing services to Medicare, Medicaid, and indigent and charity patients.

(e) An applicant for a new or expanded special purpose MRT service shall provide evidence of a cancer treatment program, which shall include the provision of the following, either on-site or through written agreements with other providers:

Access to simulation capabilities, which may include a dedicated simulator, a radiation therapy treatment unit, a virtual-reality based three-dimensional simulation system, or other diagnostic X-ray, magnetic resonance, ultrasound, or nuclear medicine equipment that has been modified to localize volumes to define the area requiring treatment; and which must be at the defined location of the special purpose MRT service;
Access to a computer-based treatment planning system, which shall be a computer system capable of interfacing with diagnostic patient data acquisition systems such as CT, MRI, PET-CT to obtain the patient specific anatomical data. The planning system must be able to display radiation doses and 3-D dose distributions within a patient's anatomical contour and utilize measured or modeled radiation output data from the specific unit used to treat the patient; and
Capability to fabricate treatment aids as applicable.

(f) The applicant must provide written commitment that physicians providing professional radiation oncology services at the special purpose MRT facility shall at all times have privileges or be eligible for and have an active pending application for privileges and be members in good standing of the medical staff of a hospital with a comprehensive cancer treatment program located within the applicant's service area which will provide those physicians with access to participate in all of the following:

Consultative services from all major disciplines needed to develop a comprehensive treatment plan.
A multi-disciplinary cancer committee, which shall be a standing committee that:

(ii) meets at least on a quarterly basis; and

(iii) is responsible for the following:

A. establishing educational and problem oriented multi-disciplinary, facility-wide cancer conferences that include the major anatomic locations of cancer seen at the facility;

B. monitoring, evaluating, and reporting to the medical staff and governing body on the quality of care provided to patients with cancer; and

C. oversight of the applicant's tumor registry for quality control, staging, and abstracting;

Patient care evaluation studies, which shall be a system of patient care evaluation, conducted annually, that documents the methods used to identify problems and the opportunities to improve patient care. Examples of patient care evaluation studies include nationwide patient care evaluation studies; facility quality assurance activities; and ongoing monitoring, evaluating, and action planning; and
Cancer prevention and education programs.

(g) The applicant must participate and report to the Georgia Comprehensive Cancer Registry of the Georgia Department of Public Health.

(h) An applicant shall demonstrate that the following staff, at a minimum, will be identified and available;

For applicants seeking the addition of a Gamma Knife:

(i) One (1) FTE board-certified or board-qualified physician trained in radiation oncology, who shall have received special training in operating a Gamma Knife and who shall be available on-site; and

(ii) One (1) medical radiation physicist, who shall be an individual who is board-certified or board-qualified by the American Board of Radiology in therapeutic radiological physics; or board-certified by the American Board of Medical Physics in medical physics with special competence in radiation oncology physics; who shall have received special training in operating a Gamma Knife; and who shall be available on-site;

For applicants seeking the addition of a Heavy Particle Accelerator, Two (2) radiation therapy technologists, who shall be registered or eligible by the American Registry of Radiological Technologists ("ARRT") or the American Registry of Clinical Radiography Technologists ("ARCRT"); who shall have received special training in operating a Heavy Particle Accelerator and who shall be on-site at all times of operation of the facility;
For applicants seeking the addition of a dedicated SRS LINAC:

(i) One (1) FTE board-certified or board-qualified physician trained in radiation oncology, who shall have received special training in operating an SRS LINAC and who shall be available on-site; and

(iii) One (1) radiation therapy technologist, who shall be registered or eligible by the American Registry of Radiological Technologists or the American Registry of Clinical Radiography Technologists; who shall have received special training in operating an SRS LINAC; and who shall be on-site at all times of operation of the facility; and

For applicants seeking the addition of an OR-Based IORT unit:

(i) One (1) FTE board-certified or board-qualified physician trained in radiation oncology; who shall have received special training in operating an OR-Based IORT unit; and who shall be available on-site; and

(i) An applicant for a new or expanded special purpose MRT service shall agree to provide the Department with all requested information and statistical data related to the operation and provision of services and to report that data to the Department in the time frame and format requested by the Department.

History

Authority: O.C.G.A. §§31-2et seq., 31-6et seq
History. Original Rule entitled "Specific Review Considerations for Radiation Therapy Services" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: New Rule entitled "Specific Review Considerations for MegaVoltage Radiation Therapy Services/Units" adopted. F. May 13, 2008; eff. June 2, 2008.
Amended: F. Mar. 11, 2022; eff. Mar. 31, 2022.
Note: Rule 111-2-2-.42, the incorrect version of the Rule was inadvertently filed (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) and appeared on the Rules and Regulations website April 28, 2022 through March 12, 2023. The correct version, as promulgated and adopted on March 10, 2022, was updated on the Rules and Regulations website March 13, 2023, the original filed and effective dates (i.e., F. Mar. 11, 2022; eff. Mar. 31, 2022.) were retained, as requested by the Agency. Effective March 10, 2023.

Ga. Comp. R. & Regs. r. 111-2-2-.43 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-2-.43 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-2-.43}

History

Authority: O.C.G.A. Secs. 31-5Aet seq., 31-6et seq
History. Original Rule entitled "Specific Review Considerations for Stereotactic Radiosurgical Services" adopted. F. Nov. 17, 2005; eff. Dec. 7, 2005.
Repealed: F. May 13, 2008; eff. June 2, 2008.

Subject 111-2-3 Repealed

Ga. Comp. R. & Regs. r. 111-2-3-.01 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.01}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "Applicability" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.02 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.02}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "Definitions" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.03 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.03}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "Standards" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.04 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.04}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "Request for Independent Review" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.05 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.05}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "Procedure for Request for Independent Review" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.06 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.06}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "The Conduct of the Review by the Independent Review Organization" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.07 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.07}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "Independent Review Organization Decision" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.08 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.08}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "Independent Review Organization Telephone Access" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.09 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.09}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "Independent Review Organization Confidentiality Provisions" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.10 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.10}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "Complaints and Inquiries Regarding Conduct of Independent Review Organizations" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.11 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.11}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "On-Site Inspections by the Department" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.12 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.12}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "Violations by Independent Review Organizations" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.13 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.13}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "Fees for Independent Review" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-2-3-.14 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-2-3-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-3-.14}

History

Authority: O.C.G.A. §31-6et seq
History. Original Rule entitled "Assignment of Requests for Independent Review" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.
Repealed: F. Mar. 10, 2023; eff. Mar. 30, 2023.

Subject 111-2-4 Rural Hospital Assistance Act

Ga. Comp. R. & Regs. r. 111-2-4-.01 Implementation {#sec-ga.-comp.-r.-regs.-r.-111-2-4-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-2-4-.01}

The Department of Community Health, Office of Rural Health Services, is authorized to issue one or more request(s) for proposals, at the discretion of the Department, to implement the Rural Hospital Assistance Act in accordance with O.C.G.A. § 31-7-94et seq.

History

Authority: O.C.G.A. Secs. 31-5et seq., 31-7-94
History. Original Rule entitled "Implementation" adopted. F. Dec. 16, 2004; eff. Jan. 5, 2005.

Chapter 111-3 Medical Assistance

Subject 111-3-6 Indigent Care Trust Fund

Ga. Comp. R. & Regs. r. 111-3-6-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-3-6-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-6-.01}

(1) "Disproportionate share hospital" means a hospital licensed in Georgia which meets the criteria established by the Department for designation as a hospital which serves a disproportionate number of low-income patients with special needs.

(2) "Medically indigent" means a person with an income no greater than 200 percent of the federal poverty level guidelines as published by the United States Department of Health and Human Services.

(3) "Trust Fund" means the Indigent Care Trust Fund created by O.C.G.A. Title 31, Chapter 8, Article 6.

(4) "Private Hospital" means any hospital licensed in Georgia which is not a public hospital.

(5) "Public Hospital" means any hospital licensed in Georgia that is owned by the State of Georgia, a city, county, or an authority organized pursuant to the "Hospital Authorities Law," O.C.G.A. § 31-7-70 et seq.

History

Authority: O.C.G.A. Secs. 31-8-155, 49-4-142
History. Original Rule entitled "Definitions" adopted. F. May 31, 2006; eff. June 20, 2006.
Amended: F. Mar. 3, 2008; eff. Mar. 23, 2008.

Ga. Comp. R. & Regs. r. 111-3-6-.02 Contributions and Deposited and Transferred Revenues {#sec-ga.-comp.-r.-regs.-r.-111-3-6-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-6-.02}

(1) Contributions to the Trust Fund may be made by any person authorized to contribute to the Trust Fund pursuant to O.C.G.A. § 31-8-153 . Contributions to the Trust Fund shall be irrevocable and shall not include any limitation upon use of such contributions except as permitted in this article or by the Department. Contributions shall only be used for the purposes contained in O.C.G.A. § 31-8-154 .

(2) Contributions to the Trust Fund may be made within the time periods established by the Department during each calendar year. Such contributions may be deposited to the Trust Fund by means of electronic funds transfer, when pre-authorized by the Department.

(3) Hospital authorities, counties, municipalities, or other state or local public or governmental entities are authorized to deposit or transfer moneys to the Trust Fund. Transfer of these funds shall be a valid public purpose for which those funds may be expended. Such transfers shall be irrevocable and shall not include any limitation upon use of such transfer except as permitted in this article or by the Department. Transfers shall only be used for the purposes authorized by O.C.G.A. § 31-8-154 .

(4) Entities authorized to deposit or transfer moneys to the Trust Fund shall execute a contract, agreement or other instrument for the purpose of facilitating such deposit or transfer. Such contracts, agreements or other instruments shall be effective for a period of no more than twelve (12) months. Violation of the terms of a contract, agreement or other instrument executed pursuant to this Rule, or the failure of an entity to execute a contract, agreement, or other instrument, may result in the withholding or recoupment of Trust Fund payment adjustments to the subject disproportionate share hospital unless remedial action satisfactory to the Department is taken by such hospital within thirty (30) days of notice of deficiency by the Department.

(5) Contributions and revenues deposited and transferred to the Trust Fund may be made for expansions of Medicaid eligibility and services, for programs to support rural and other health care providers, primarily hospitals, who serve the medically indigent, for primary health care programs for medically indigent citizens and children of this state, or for any combination of purposes specified in this paragraph.

(6) Contributions and revenues deposited and transferred by or on behalf of a disproportionate share hospital later determined to be inappropriately so designated or which fails to meet the conditions of these Rules and the contracts, agreements, or other instruments executed pursuant to Rules 111-3-6-.02(4) and 111-3-6-.03(4)(e)14. , shall be returned to the contributor, depositor, or transferor with interest earned after collection of payments made to such hospital pursuant to the provisions of these rules.

(7) Contributions, revenues, or moneys deposited and transferred by or on behalf of a disproportionate share hospital which closes during the fiscal year in which the funds are received shall be returned with interest earned pro rata to such hospital, provided that the hospital has not received a disproportionate share hospital payment for that fiscal year. Such hospital shall not be eligible for further payments during that fiscal year.

(8) All contributions, revenues, or moneys transferred or deposited to the Trust Fund and any interest earned thereon which have not been appropriated by the end of the fiscal year or which have been appropriated but have been determined to be:

(a) Void because of having been appropriated in violation of O.C.G.A. § 31-8-156 ;

(b) Ineligible for anticipated federal matching funds;

(d) Subject to return pursuant to any rule of the Department; or

(e) Void because of violation by the Department of the terms of a contract, agreement, or other instrument executed pursuant to subsection (c) of O.C.G.A. § 31-8-155 ; shall be returned to the Trust Fund and refunded pro rata to the entities responsible for the deposit, transfer or contribution. The refund shall be made by the director of the Fiscal Division of the Department of Administrative Services no less than thirty (30) days following the end of the fiscal year or such a determination by the Department, as applicable.

History

Authority: O.C.G.A. Secs. 31-8-155, 49-4-142
History. Original Rule entitled "Contributions and Deposited and Transferred Revenues" adopted. F. May 31, 2006; eff. June 20, 2006.

Ga. Comp. R. & Regs. r. 111-3-6-.03 Use of Funds {#sec-ga.-comp.-r.-regs.-r.-111-3-6-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-6-.03}

(1) Funds appropriated by the General Assembly to the Department pursuant to O.C.G.A. § 31-8-156 shall be used for the purposes stated in Rule 111-3-6-.02(5) and shall be used to match federal funds which are available for such purposes.

(2) The Department shall provide for public notice of the manner of disbursement of the Trust Fund appropriation as provided in Rule 350-1-.02(3) and 350-2-.08 . Such funds may be transferred to disproportionate share hospitals by electronic funds transfer.

(3) The Department shall issue a manual of policies and procedures and other instructions for disproportionate share hospital programs (the "Manual"), and shall adopt the Manual as an appendix to Part II of the Department's Policies and Procedures for Hospital Services. The Manual shall contain policies, procedures, instructions, public notification plan requirements, forms and other items for hospitals' use in operating their programs consistent with these Rules. The Manual shall contain a procedure for accepting and resolving complaints concerning a hospital's compliance with these Rules. The Department may approve a plan for the operation of a disproportionate share hospital to coordinate its program with an existing program of care for the medically indigent sponsored by a local government, provided that the program is operated in a manner consistent with these Rules and further provided that the program is operated in a manner consistent with these Rules and further provided that no patients are rendered ineligible for services without charge or at a reduced charge who would have been eligible if the variance had not been granted.

(4) As a condition of receipt of such funds, providers of medical assistance must:

(a) continue participation in the Medicare program;

(b) comply with the Rules and the Department's Policies and Procedures, including specifically Part II of the Department's Policies and Procedures for Hospital Services and the Manual;

(d) use the funds to provide health care services to Medicaid recipients and medically indigent citizens of the state;

(e) use the funds during the fiscal year in which the payment is disbursed; and

(f) if the provider is a disproportionate share hospital, meet the following additional conditions:

continue participation in the Medicare program;
make available its services to Medicaid and Medicare recipients without discrimination;
continue to provide obstetrical care services if such services are presently provided;
comply with the patient transfer requirements provided in the Emergency Medical Treatment and Active Labor Act of 1986, as amended;
ensure that patients are not transferred or denied services based solely or in significant part on economic reasons;
make arrangements with sufficient numbers of physicians on each service to assure that Medicaid patients have full access to the facility's services without being required to pay physicians for Medicaid covered services;
make arrangements with physicians to ensure Medicaid and medically indigent patients are not required to have a physician with staff privileges as a condition of admission or treatment when such admission or treatment is determined to be medically necessary and within the scope of service capability of the hospital;
document which physicians with staff privileges accept and will treat Medicaid patients in their offices, and assist Medicaid patients with referrals to such physicians. The hospital shall encourage full provider participation in the Medicaid program;
ensure that preadmission deposits are not required on demand as a condition of treatment of Medicaid eligible persons or medically indigent persons;
for treatment of medically indigent patients, ensure that ability to pay does not act to deny or substantially delay receipt of medically necessary services. The hospital shall provide assistance to medically indigent patients by operating a program under which such patients may receive care without charge or at a reduced charge, except that no hospital shall be required to provide services without charge or at a reduced charge once the hospital's medical indigency services expenditures equals the amount described in Rule 111-3-6-.03(4)(e)12. (iii) . Consistent with the Rules and the Manual, the hospital shall:

(i) provide services for no charge to persons with incomes below 125 percent of the federal poverty level; and

(ii) provide services for no charge or adopt a sliding fee scale for persons with incomes between 125 percent and, at a minimum, 200 percent of the federal poverty level;

as more specifically set forth in the Manual, effectively advise the public of the hospital's participation in the program, the availability of services provided, the terms of eligibility for free and reduced charge services, the application process for free and reduced charge services, and the person or office to whom complaints or questions about the hospital's participation in or operation of the program may be directed; The hospital shall comply with such other provisions as may be reasonably established by the Department in the Manual. Upon request by the Department, the hospital shall demonstrate its compliance with the public notification requirements of this section and with the Manual.
submit to the Department a report on the use of Trust Fund payment adjustments each calendar year. Such reports shall:

(i) be in a format established by the Department;

(ii) be available to the public for examination; and

(iii) include a report of the number of medically indigent persons served without charge in both inpatient and primary care settings and the dollars expended for such services. Hospitals shall report dollars expended using a cost-to-charges ratio of 65 percent. Over a twelve month period, each hospital will be expected to report a medical indigency services expenditure of an amount equal to no less than 100 percent of the hospital's total Trust Fund payment adjustments minus the amount transferred or deposited to the Trust Fund by or on behalf of the hospital. Failure to provide such reports in the format prescribed and within the time periods established by the Department, or to demonstrate timely accessibility to Trust Fund supported services, may result in a withholding or recoupment of Trust Fund payment adjustments.

sign a letter of Agreement which incorporates the provisions of these Rules, the Department's Policies and Procedures and the Manual.
comply with the requirements of the Certificate of Need program under the Division of Health Planning of the Department, as set forth more specifically in O.C.G.A. §§ 31-6-40 et seq. , and the rules promulgated thereunder, and the annual reporting requirements under O.C.G.A. § 31-6-70 .

(5) The Department shall annually report to the General Assembly on the use of monies appropriated to the Department from the Trust Fund. Such report shall be submitted to the Lieutenant Governor, Speaker, legislative counsel and legislative budget officer no later than January 31 of each calendar year. Such reports shall be made available to the public pursuant to Rule 111-3-6-.04 .

(6) In the event that a disproportionate share hospital fails to comply with the Rules, the Department's Policies and Procedures or the Manual, the Department may, in addition to any other legal remedies available, assess liquidated damages against the disproportionate share hospital under its Letter of Agreement in an amount(s) established by the Department for each calendar day in which the hospital is non-compliant. These liquidated damages are not, and shall not be construed to be penalties, and shall be in addition to every other remedy now or hereinafter enforceable at law, in equity, by statute, or under contract.

(7) In the event that a disproportionate share hospital knowingly and willfully makes or causes to be made any false statement or misrepresentation of material fact with respect to the hospital's use of funds from the Trust Fund or in response to any request for information from the Department related to the Trust Fund, including without limitation the submission of any report required pursuant to these Rules, the Department may, in addition to any other legal remedies available, assess liquidated damages against the disproportionate share hospital under its Letter of Agreement in an amount not to exceed the disproportionate share payment for the year in which the false statement or misrepresentation occurred. These liquidated damages are not, and shall not be construed to be penalties, and shall be in addition to every other remedy now or hereinafter enforceable at law, in equity, by statute, or under contract.

(8) Disproportionate share hospital payment adjustments to private hospitals shall be funded by state general funds appropriated for this purpose, which shall be used to match federal funds available for this purpose.

(9) Disproportionate share hospital payment adjustments to public hospitals shall be funded by intergovernmental transfers or by certified public expenditures, or a combination thereof, which shall be used to match federal funds available for this purpose.

History

Authority: O.C.G.A. Secs. 31-8-155, 49-4-142
History. Original Rule entitled "Use of Funds" adopted. F. May 31, 2006; eff. June 20, 2006.
Amended: F. Mar. 3, 2008; eff. Mar. 23, 2008.

Ga. Comp. R. & Regs. r. 111-3-6-.04 Open Records {#sec-ga.-comp.-r.-regs.-r.-111-3-6-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-6-.04}

All Department records related to the Indigent Care Trust Fund shall be open for public inspection in accordance with the Open Records Act, O.C.G.A. § 50-18-70et seq.

History

Authority: O.C.G.A. Sec. 31-6
History. Original Rule entitled "Open Records" adopted. F. May 31, 2006; eff. June 20, 2006.

Ga. Comp. R. & Regs. r. 111-3-6-.05 Applicability of Medical Assistance Generally {#sec-ga.-comp.-r.-regs.-r.-111-3-6-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-6-.05}

Except where inconsistent with O.C.G.A., Title 31, Chapter 4 8, Articles 6, 6A, and 6B (Indigent Care Trust Fund), the provisions of O.C.G.A., Title 49, Chapter 4, Article 7 (Georgia Medical Assistance Act of 1977) shall apply to the Department in carrying out the purposes of the Trust Fund.

History

Authority: O.C.G.A. Sec. 31-6
History. Original Rule entitled "Applicability of Medical Assistance Generally" adopted. F. May 31, 2006; eff. June 20, 2006.

Subject 111-3-8 Estate Recovery

Ga. Comp. R. & Regs. r. 111-3-8-.01 Legal Authority {#sec-ga.-comp.-r.-regs.-r.-111-3-8-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-8-.01}

In accordance with Title XIX of the Social Security Act, 42 U.S.C. § 1396p, the State of Georgia has defined a process to recover the cost of medical assistance payments from the estates of deceased Members. The Official Code of Georgia gives the state the authority to recover these monies. O.C.G.A. § 49-4-147.1. In addition, the recovery methodology must adhere to statutory provisions of the Georgia Revised Probate Code of 1998, O.C.G.A. Title 53.

History

Authority: O.C.G.A. § 49-4-147.1
History. Original Rule entitled "Legal Authority" adopted. F. July 16, 2004; eff. August 5, 2004.
Amended: F. Aug. 17, 2004; eff. Sept. 6, 2004.
Amended: F. Oct. 19, 2006; eff. Nov. 8, 2006.
Amended: F. Mar. 27, 2020; eff. Apr. 16, 2020.

Ga. Comp. R. & Regs. r. 111-3-8-.02 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-3-8-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-8-.02}

(1) "Authorized representative" means a guardian or a person designated by the Member to act on his or her behalf during the Member's life.

(2) "Creditor" means an entity (person or institution) to whom an obligation is owed because a Member received something of value in exchange.

(3) "Debt" means a sum of money owed from one person to another, including the right of the creditor to receive and enforce payment.

(4) "Department" means the Georgia Department of Community Health, Division of Medical Assistance.

(5) "Discharge from the medical institution and return home" means a qualifying discharge, which involves the Member's dismissal from the nursing institution and/or facility for at least thirty (30) days wherein the Member's personal effects and bed are released at the same time of his or her discharge.

(6) "Equity interest in the home" means value of the property in which the Member holds legal interest beyond the amount owed on it in mortgages and liens.

(7) "Estate" means all real and personal property under the probate code, including real and personal property passing by reason of joint tenancy, right of survivorship, life estate, survivorship, trust, annuity, Individual Retirement Accounts, homestead or any other arrangement. Estate also includes excess funds from a burial trust or contract, promissory notes, cash, and personal property. Estates with a gross value of $25,000 or less are exempt from estate recovery.

(8) "Hearing" means a formal proceeding before an Administrative Law Judge or Probate Judge in which an aggrieved party affected by an action or an intended action of the Department shall be allowed to present testimony, documentary evidence, and argument as to why such action should or should not be taken.

(9) "Heirs" means heirs-at-law who are entitled under the statutes of intestate succession to property of a decedent and beneficiaries who are entitled to inherit the estate if there is a lawful will.

(10) "Lawfully residing" means permissive use by the owner/power of attorney at the law.

(11) "Lien" means a claim, encumbrance or charge against the Medicaid Member's real or personal property on account of medical assistance paid to the Member correctly under the State Plan. A Lien may be placed on the real property of a Member who is an inpatient of a nursing facility, intermediate care facility for individuals with intellectual disabilities, or other institution or a Lien may be placed on both real and personal property of a Member after the Member's death.

(12) "Long-term care" means a service provided in a long-term care facility or in the home, pursuant to federally approved home and community based services, as an alternative to institutionalization.

(13) "Medical assistance" means payment by the State's program under Title XIX of the Social Security Act or Medicaid program administered by the Department.

(14) "Member" means a person who has been certified as Medicaid eligible, pursuant to the terms of the State Plan, to have medical assistance paid on his or her behalf.

(15) "Member's home" means a true, fixed and permanent domicile and principal establishment to which the Member has the intention of returning to whenever absent.

(16) "Permanently institutionalized" means residing in a nursing facility or intermediate care facility for individuals with intellectual disabilities and developmentally disabled for six (6) consecutive months or more.

(17) "Personal representative" means an executor, administrator, guardian, conservator, committee, trustee, fiduciary, or other person having a status which by operation of law or written instrument confers upon such person a duty of distributing property to Heirs.

(18) "On a continuous basis" means that the qualifying relative lived with the Member in the Member's home at his or her principal place of residence during an uninterrupted timeframe. An absence of residence greater than six months is presumed to disrupt the continuity of residence.

(19) "Residing in the home for at least one or two years" means one is domiciled in the principal place of residence.

(20) "State Plan" means all documentation submitted by the Commissioner, on behalf of the Department, to and for approval by the Secretary of Health and Human Services pursuant to Title XIX of the federal Social Security Act of 1935, as amended.

History

Authority: O.C.G.A. § 49-4-147.1
History. Original Rule entitled "Definitions" adopted. F. July 16, 2004; eff. August 5, 2004.
Amended: F. Aug. 17, 2004; eff. Sept. 6, 2004.
Amended: F. Oct. 19, 2006; eff. Nov. 8, 2006.
Amended: F. Mar. 27, 2020; eff. Apr. 16, 2020.

Ga. Comp. R. & Regs. r. 111-3-8-.03 Notification to Member or Their Heirs {#sec-ga.-comp.-r.-regs.-r.-111-3-8-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-8-.03}

(1) If a debt is due pursuant to this section from the estate of a Member, the administrator of the nursing facility, intermediate care facility for individuals with intellectual disabilities, or medical institution in which the Member resided at the time of their death, the Medicaid case manager for community based services and/or the personal representative, if applicable, shall report the death to the Department within thirty (30) days of the death of the Member.

(2) If the personal representative of an estate makes a distribution either in whole or in part of the property of an estate to the Heirs, next of kin, distributes, legatees, or devisees without having executed the obligations pursuant to this section, the personal representative may be held personally liable for the amount of medical assistance paid on behalf of the Member, for the full value of the property belonging to the estate which may have been in the custody or control of the personal representative.

(3) When the Department receives notification of an affected Medicaid Member's death, a written notice will be provided to any known personal representative and any known Heirs which:

(a) Explains the terms and conditions of estate recovery and refers to the applicable statute and regulations;

(b) Advises of the Department's intent to recover the value of Medicaid benefits correctly paid on the Member's behalf from the Member's estate and states the amount;

(d) Explains that the Heirs may file an undue hardship waiver and the procedures and time frames for filing the waiver;

(e) Advises the Heirs of their right to a hearing and the method by which they may obtain a hearing; and

(f) Includes a statement advising the amount of the claim may increase if there are additional Medicaid claims that have not yet been processed.

History

Authority: O.C.G.A § 49-4-147.1
History. Original Rule entitled "Notification to Member or Their Heirs" adopted. F. July 16, 2004; eff. August 5, 2004.
Amended: F. Aug. 17, 2004; eff. Sept. 6, 2004.
Amended: F. Oct. 19, 2006; eff. Nov. 8, 2006.
Amended: F. Mar. 27, 2020; eff. Apr. 16, 2020.

Ga. Comp. R. & Regs. r. 111-3-8-.04 Recovery for Payments Made on Behalf of Medicaid-Eligible Persons {#sec-ga.-comp.-r.-regs.-r.-111-3-8-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-8-.04}

(1) These regulations shall be construed and applied to further the intent of the Legislature to supplement Medicaid funds that are used to provide medical services to eligible persons. Estate recovery shall be accomplished by the Department or its agent filing a statement of claim against the estate or with the closest identifiable surviving family members of a deceased Medicaid Member or any person who has an interest in property of the deceased member. Recovery shall be made pursuant to federal authority in § 13612 of the Omnibus Budget Reconciliation Act of 1993 which amends § 1917(b)(1) of the Social Security Act, 42 U.S.C. 1396p(b)(1) .

(2) Adjustment or recovery for all medical assistance and/or services pursuant to the State Plan will be from Medicaid Members:

(a) Who, at the time of death, were any age and an inpatient in a nursing facility, intermediate care facility for individuals with intellectual disability, or other medical institution if the Member is required, as a condition of receiving services in the facility under the State Plan, to spend for costs of medical care all but a minimal amount of the person's income required for personal needs; or

(b) Who, at the time of death, were fifty-five (55) years of age or older when the Member received medical assistance, but only for medical services consisting of nursing facility services, personal care services, home and community based services, and hospital and prescription drug services provided to Members in nursing facilities or receiving home and community based services.

(3) The Department shall provide written notice of the Estate Recovery program to Members at the time of application for medical assistance and the Members must sign a written acknowledgement of receipt of such notice. Notice will be given to Members thereafter at the annual redetermination. Members currently receiving medical assistance prior to the Estate Recovery program's effective date set forth in Paragraph (17) of this Rule will be notified at his or her annual redetermination. A notification by the Medicaid Eligibility Systems that the notice was sent and acknowledged by the Member and the Member's personal representative by U.S. mail or electronic means of communication for those who have elected to receive electronic communications to the last known address of the Member or the Member's personal representative shall be deemed to satisfy this notice requirement.

(4) The acceptance of public medical assistance, as defined by Title XIX of the Social Security Act, including mandatory and optional supplemental payments under the Social Security Act, shall create a debt to the agency in the amount recoverable under the State Plan. The Department shall be given priority status, upon filing a statement of claim in the estate proceeding if an estate proceeding has been filed. In addition, priority status attaches to the Department's interest regardless whether an estate proceeding has been initiated.

(5) The Department may amend the claim as a matter of right until the Member's estate has been closed.

(6) The Department's provider processing reports shall be admissible as prima facie evidence in substantiating the agency's claim.

(7) Any trust provision that denies recovery for medical assistance is void on and after the time of its making.

(8) Adjustment or recovery of debt will be made only after the death of the Member's surviving spouse, if any, and only at a time when the Member has no surviving child who is under the age of twenty-one (21), or a child who is blind or permanently and totally disabled pursuant to the eligibility requirements of Title XIX of the Social Security Act.

(9) With respect to a lien placed on the home of a permanently institutionalized Member, the Department will not seek adjustment or recovery of Medical assistance correctly paid on behalf of the Member until the following persons are not residing in the Member's home:

(a) A sibling of the Member with an equity interest in the home who was residing in the Member's home for at least one (1) year on a continuous basis immediately before the date that the Member was institutionalized; and

(b) A child of the Member who was residing in the Member's home for at least two (2) years on a continuous basis before the date that the Member was institutionalized and who has established to the satisfaction of the Department that he or she provided care that permitted the Member to reside at home rather than to become institutionalized.

(10) The sibling or child of the Member must demonstrate that he or she has been lawfully residing in the Member's home on a continuous basis for the periods described in Paragraphs (9)(a) and (b) respectively, since the date of the Member's admission to the medical institution, and must provide the Department with clear and convincing evidence to prove residency which may include, but not be limited to, receipts, mortgage statements, bills, mail forwarded to Member's address, or voter's registration. The sibling or child of the Member must demonstrate that he or she did not reside in any other residence except the Member's home during the periods of time set forth in Paragraphs (9)(a) and (b) respectively. The sibling or child shall maintain the burden of proof in all proceedings.

(11) No debt under this section shall be enforced against any property that is determined to be exempt from the claims of creditors under the constitution or laws of this state.

(12) The Department may delay or waive recovery from an estate if doing so would cause undue hardship for the qualified Heirs, as defined in Rule 111-3-8-.08 . The personal representative of an estate and any Heir may request that the agency waive recovery.

(13) The state's right to full reimbursement of the costs of medical assistance shall not be diminished by the recovery of any judgment, settlement, or award of an amount less than the value of the original or settled claim. To enforce its rights, the state may intervene or join in any action or proceeding brought by a claimant against a third party. To aid in the recovery of the cost of medical assistance, the state shall have a first lien in the full amount of the costs of medical assistance against the proceeds from all damages awarded in a suit or settlement.

(14) Transfers of real or personal property, on or after the look-back dates defined in 42 U.S.C. § 1396p , by a Member of such aid, or by their spouse, without adequate consideration are voidable and may be set aside by an action in court.

(15) Counsel fees, costs, or other expenses shall not reduce any third party recovery obtained by the state incurred by the Member or the Member's attorney.

(16) If, after the reported death of the Member, the Department is prohibited from Estate Recovery because of exemption conditions, the Department may postpone recovery until all exemption conditions are no longer present. An estate does not have to be open in order for the Department to execute its claim after all exemption conditions are no longer present. Termination of recovery will occur when all real and personal property included as part of the Member's estate is no longer accessible due to all estate property having been depleted through payment of costs of medical care for the Member and the Member's spouse.

(17) The effective date of the Medicaid Estate Recovery Program is May 3, 2006. Adjustment or recovery shall apply to those costs associated with medical assistance and/or services a Member received on or after the effective date.

(18) To prevent substantial and unreasonable hardship, the Commissioner shall waive any claim against the first $25,000.00 of any estate subject to an Estate Recovery claim for the deceased Medicaid Member with a date of death on or after July 1, 2018.

History

Authority: O.C.G.A. § 49-4-147.1, 42 U.S.C. 1396p
History. Original Rule entitled "Recovery for Payments Made on Behalf of Medicaid-Eligible Persons" adopted. F. July 16, 2004; eff. August 5, 2004.
Amended: F. Aug. 17, 2004; eff. Sept. 6, 2004.
Amended: F. Oct. 19, 2006; eff. Nov. 8, 2006.
Amended: F. Mar. 27, 2020; eff. Apr. 16, 2020.

Ga. Comp. R. & Regs. r. 111-3-8-.05 Recovery of Assistance; Probate {#sec-ga.-comp.-r.-regs.-r.-111-3-8-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-8-.05}

(1) After receipt of notice of the death of an affected Member, the Department will file a claim against the estate for the full value of the Medicaid benefits paid on behalf of the Member.

(2) No action to recover a debt due by the deceased Member shall be commenced against the personal representative until the expiration of six (6) months from the date of qualification of the first personal representative to serve.

(3) Notwithstanding any other law, a claim filed for recovery of Medicaid assistance has priority in order of payment from the estate over all other claims, except the following:

(a) Years support for the family;

(b) Funeral expenses in an amount not to exceed ten thousand dollars ($10,000). However, this amount is zero (0) if the deceased Member has prepaid funeral expenses that were excluded as a resource for Medicaid eligibility;

(d) Reasonable expensed of the deceased Member's last illness; and

(e) Unpaid taxes or other debts due the state or the United States. The category of Medicaid Estate Recovery is a debt due the state.

(4) The affidavit of a person designated by the Commissioner to administer this action is prima facie evidence of the amount of the claim.

(5) Notwithstanding any statute of limitations or other claim presentation deadline provided by law, a state claim against an estate is not barred for lack of timely presentation if it is presented in the probate proceeding within the time specified in the published notice to creditors.

(6) The personal representative must notify the Department in writing of the Member's death at least thirty (30) days before disbursing assets of the Member and shall not disburse assets prior to obtaining a release from the Department. Such notice must be sent to the Department via email at gaestaterecovery@dch.ga.gov or via mail at Georgia Department of Community Health, Office of Inspector General, Medicaid Estate Recovery Program, 19 th Floor, 2 M.L.K. Jr. Drive, SW, Atlanta, GA 30334, or such other mailing address listed for the Department's headquarters as set forth on its website located at www.dch.ga.gov. The personal representative is personally liable for any incorrectly paid assets if the Department is not informed of the Member's death and assets are distributed to Heirs and/or creditors without having first obtained a release from the Department. The Department shall issue a release within ten (10) business days from the satisfaction of the claim with the Department.

History

Authority: O.C.G.A. §§ 49-4-147.1, 53-7-42
History. Original Rule entitled "Recovery of Assistance; Probate" adopted. F. July 16, 2004; eff. August 5, 2004.
Amended: F. Oct. 19, 2006; eff. Nov. 8, 2006.
Amended: F. Mar. 27, 2020; eff. Apr. 16, 2020.
Amended: F. June 9, 2023; eff. June 29, 2023.

Ga. Comp. R. & Regs. r. 111-3-8-.06 Recovery of Assistance; No Estate {#sec-ga.-comp.-r.-regs.-r.-111-3-8-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-8-.06}

(1) The administrator of the program may present an affidavit to a financial institution requesting that the financial institution release account proceeds to recover the cost of services correctly provided to a Member. The affidavit shall include the following information:

(a) The name of the deceased Member;

(b) The name of any person who gave notice that the Member was a Medicaid Member and that person's relationship to the deceased Member;

(d) The account number;

(e) A description of the claim for estate recovery; and

(f) The amount of funds to be recovered.

(2) A financial institution shall release account proceeds to the administrator of the program if all of the following conditions apply;

(a) The deceased Member held an account at the financial institution that was in his or her name only;

(b) No estate has been, and it is reasonable to assume that no estate will be, opened for the deceased Member;

(d) The financial institution has received no objections or has determined that no valid objections to release proceeds have been received.

(3) If proceeds have been released pursuant to this section and the Department receives notice of a valid claim to the proceeds that has a higher priority under O.C.G.A. 53-7-40 than the claim of this section, the Department may refund the proceeds to the financial institution or pay them to the person or government entity with the claim.

History

Authority: O.C.G.A. §§ 49-4-147.1, 53-7-40
History. Original Rule entitled "Recovery of Assistance; No Estate" adopted. F. July 16, 2004; eff. August 5, 2004.
Amended: F. Oct. 19, 2006; eff. Nov. 8, 2006.
Amended: F. Mar. 27, 2020; eff. Apr. 16, 2020.

Ga. Comp. R. & Regs. r. 111-3-8-.07 Imposition of Liens {#sec-ga.-comp.-r.-regs.-r.-111-3-8-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-8-.07}

(1) The basis for authority to impose liens is based on the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA). The TEFRA lien law provides that the agency can place a Lien on the available real estate of a Member who enters a nursing home and is "permanently institutionalized."

(2) The state may place a Lien on the Member's home when there is not a reasonable expectation that the Member will return home and when none of the following persons are living in the home:

(a) The Member's spouse;

(b) A child under twenty-one (21) years of age;

(d) A sibling with an equity interest in the home who has lived in the home for at least one (1) year before the Member entered the nursing home, and is lawfully residing in such home. The sibling must provide the State with clear and convincing evidence which demonstrates residency on a continuous basis and the sibling's equity interest. Additionally, the sibling must demonstrate that he or she did not reside in any other residence except the Member's home during the period of time specified in this subparagraph (2)(d). The sibling has the burden of proof in all proceedings.

(3) Liens may be imposed to protect recovery of benefits correctly paid to Medicaid Members when permitted by federal and state law. However, the use of lien authority requires prior notification to the Member or any known Heirs.

(4) The Department shall notify the Member and the authorized representative, if applicable, of its determination that the Member is permanently institutionalized and not reasonably expected to return home and its intent to file a Lien on Member's real property. Notice must include an explanation of liens and their effect on a Member's ownership of real property. A Lien may not be filed less than thirty-one (31) days from the date of the notice to the Member and after any hearing process has been completed, if a hearing is requested.

(5) A Member or his or her authorized representative may, within thirty (30) days after receipt of notice request an administrative hearing under this Rule 111-3-8-.07 . A Member is deemed to have received notice within five (5) days from the date of the notice. Administrative hearings and appeals for Medicaid Members are governed by the procedures and time limits set forth in 42 C.F.R. § 431.200 et seq . Only one (1) appeal shall be afforded on behalf of a Member, for each notice received. The administrative law judge shall make the determination if a Member can or cannot reasonably be expected to be discharged from the medical institution and returned home or if a specific exception set forth in 111-3-8-.07(2) applies.

(6) The Department or its agent shall file a notice of Lien with the recorder of the county in which the real property subject to the Lien is located. The notice shall be filed prior to the Member's death and shall include the following:

(a) Name and place of residence, including the street and county in which the property is located, of the real property subject to the Lien; or

(b) Legal description of the real property subject to the Lien.

(7) The Department shall file one (1) copy of the notice of Lien with the local DFCS office in the county in which the real property is located. The county in which the real property is located shall retain a copy of the notice with the county office's records. The Department or its agent shall provide one (1) copy of the notice of Lien to the Member and the Member's authorized representative, if applicable, whose real property is affected.

(8) The Lien continues from the date of filing until the Lien is satisfied, released or expires. From the date on which the notice of Lien is recorded in the office of the county recorder, the notice of lien:

(a) Constitutes due notice against the Member or Member's estate for any amount then recoverable under this article; and

(b) Gives a specific Lien in favor of the Department on the Medicaid Member's interest in the real property.

(9) The Department has the authority to release any lien placed upon the property of a Member deemed permanently institutionalized should that Member be subject to a discharge from a medical institution and return home. The Department shall release a lien obtained under this rule within thirty (30) days after the Department receives notice that the Member is no longer institutionalized and is living in his or her home. If the real property subject to the lien is sold, the office shall release its lien at the closing and the lien shall attach to the net proceeds of the sale.

History

Authority: O.C.G.A. § 49-4-147.1, Ga. Comp. Rules & Regs., R. 290-1-1-.01
History. Original Rule entitled "Imposition of Liens" adopted. F. July 16, 2004; eff. August 5, 2004.
Amended: F. Sept. 15, 2005; eff. Oct. 5, 2005.
Amended: F. Oct. 19, 2006; eff. Nov. 8, 2006.
Amended: F. Mar. 27, 2020; eff. Apr. 16, 2020.

Ga. Comp. R. & Regs. r. 111-3-8-.08 Hardship Waiver {#sec-ga.-comp.-r.-regs.-r.-111-3-8-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-8-.08}

(1) Hardship waivers will be submitted to the program administrator for review. The denial of a hardship waiver may be appealed as provided under the Administrative Procedures Act, O.C.G.A. § 50-13-1 et. seq. The waiver is limited to the period in which the undue hardship exists.

(2) There is no hardship waiver provided at the time of lien placement against the real property of a deceased Medicaid Member. The equity interest of the heir will be considered to determine the percentage of the deceased member's interest in the property.

(3) Lien placement is utilized to delay recovery until such time as an exemption to recovery does not exist, or in the case of an undue hardship, until such time as the undue hardship no longer exists. The state's lien would be for the Medicaid benefits paid on behalf of the Member or the percentage of interest of the deceased Member at the time of sale, whichever is less.

(4) Recovery will be waived in whole or in part pursuant to Rule 111-3-8-.08(1) of any estate or lien recovery when the requesting party is able to show, through clear and convincing evidence, that the state's pursuit of recovery subjects them to undue hardship. In determining whether an undue hardship exists, the following criteria will be used:

(a) The asset to be recovered is an income producing farm and sole income source of one or more of the Heirs and the annual gross income is limited to $25,000 or less and is not merely rental income; or

(b) The recovery of assets would cause the applicant to become eligible for needs based governmental public assistance based on need and/or medical assistance programs.

(5) Notwithstanding the provisions of Paragraph (4) of this Rule, an undue hardship exists when an estate has a gross value of $25,000 or less. Therefore, estates with a gross value of $25,000 or less are exempt from estate recovery. In this instance, undue hardship does not need to be asserted.

(6) Undue hardship does not exist when:

(a) The adjustment or recovery of the Member's cost of assistance would merely cause the Member's family members inconvenience or restrict the family's lifestyle; or

(b) The Member and/or the Heirs divest assets to qualify under the undue hardship provision.

(7) To the extent that there is any conflict between the preceding criteria and the standards that may be specified by the secretary of the U.S. Department of Health and Human Services, the federal standards shall prevail.

(8) The personal representative and/or Heirs shall apply for an undue hardship exemption by:

(a) Making a written request to the Department within thirty (30) days of receipt of the notice; and

(b) Verifying to the Department's satisfaction the criteria specified in this section for an undue hardship waiver.

(9) The Department shall issue a decision on an undue hardship exemption request within thirty (30) days of receipt of the request and supporting documentation.

(10) If the state denies the personal representative's request for an undue hardship waiver, the personal representative may request an appeal. The denial of a waiver must state the requirements of an application for an adjudicative proceeding to contest the Department's decision to deny the waiver and where assistance may be obtained to make such application.

(11) If an appeal is requested, a hearing shall be conducted by the probate judge if the estate is in probate court. An administrative law judge shall conduct the administrative hearing if the case is not in probate court.

(12) If the Department deems an undue hardship does exist, the state may waive recovery or defer recovery until the death of eligible exempt dependents, on the sole discretion of the Department.

(13) The provisions of this section are severable. If any provision of this section is held invalid, the remaining provisions remain in effect.

History

Authority: O.C.G.A. § 49-4-147.1
History. Original Rule entitled "Hardship Waiver" adopted. F. July 16, 2004; eff. August 5, 2004.
Amended: F. Aug. 17, 2004; eff. Sept. 6, 2004.
Amended: F. Oct. 19, 2006; eff. Nov. 8, 2006.
Amended: F. Mar. 27, 2020; eff. Apr. 16, 2020.

Subject 111-3-9 Hospital Provider Payment Program

Ga. Comp. R. & Regs. r. 111-3-9-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-3-9-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-9-.01}

As used in Chapter 111-3-9:

(2) "Department" means the Department of Community Health established under O.C.G.A. § 31-2-1 .

(3) "Hospital" means an institution licensed pursuant to Chapter 7 of Title 31, which is primarily engaged in providing to inpatients, by or under the supervision of physicians, diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons or rehabilitation services for the rehabilitation of injured, disabled, or sick persons. Such term includes public, private, rehabilitative, geriatric, osteopathic, and other specialty hospitals but shall not include psychiatric hospitals, which shall of O.C.G.A. § 37-3-1 , critical access hospitals as defined in paragraph (3) of O.C.G.A. § 33-21A-2 , or any state owned or state operated hospitals.

(4) "Net Patient Revenue" means the total gross patient revenue of a Hospital less contractual adjustments; charity care; bad debt; Hill-Burton commitments; indigent care as defined by and calculated in the Department's annual Hospital Financial Survey; and gross patient revenues and contractual adjustments realized pursuant to section 1902(a)(10)(A)(i)(VIII) of the Social Security Act.

(5) "Provider Payment" means a payment assessed by the Department pursuant to this Chapter for the privilege of operating a Hospital.

(6) "Segregated Account" means an account for the dedication and deposit of Provider Payments which is established within the Trust Fund.

(7) "State Plan Amendment" means all documentation submitted by the Commissioner, on behalf of the Department, to and for approval by the Secretary of Health and Human Services pursuant to Title XIX of the federal Social Security Act of 1935, as amended.

(8) "Trauma Center" means a Hospital designated by the Department of Public Health as a Level I, II, III or IV Trauma Center.

(9) "Trust Fund" means the Indigent Care Trust Fund created by Article 6 of Chapter 8 of Title 31.

(10) "Waiver" means a waiver of the requirements for permissible health care related taxes, as provided for in 42 C.F.R. § 433.68 .

History

Authority: Act I of the 2013 Session of the Georgia General Assembly
History. Original Rule entitled "Definitions" adopted. F. May 13, 2013; eff. June 2, 2013.

Ga. Comp. R. & Regs. r. 111-3-9-.02 Payments to the Segregated Account {#sec-ga.-comp.-r.-regs.-r.-111-3-9-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-9-.02}

(1) There is established within the Trust Fund a Segregated Account for revenues raised through the imposition of the Provider Payment. Any Provider Payment assessed pursuant to this Chapter shall be deposited into the Segregated Account. No other funds shall be deposited into the Segregated Account. All funds shall be invested in the same manner as authorized for investing other moneys in the state treasury.

(2) Each Hospital shall be assessed a Provider Payment in the amount of 1.45 percent of the Net Patient Revenue of the Hospital; provided, however, that Trauma Centers shall be assessed a Provider Payment in the amount of 1.40 percent of the Net Patient Revenue of the Trauma Center.

(3) The Provider Payment shall be paid quarterly by each Hospital to the Department. The assessment shall be based on the Department's annual Hospital Financial Survey. Payment of the Provider Payment shall be due on the last day of the last month of each calendar quarter; the first payment shall be due on September 30, 2013 or 30 calendar days after the receipt of State Plan Amendment approval, whichever is later.

(4) The Department shall prepare and distribute a form on which each Hospital shall submit information to comply with this Chapter.

(5) Each Hospital shall keep and preserve for a period of seven (7) years such books and records as may be necessary to determine the amount for which it is liable under this Chapter. The Department shall have the authority to inspect and copy the records of a Hospital for purposes of auditing the calculation of the Provider Payment. All information obtained by the Department pursuant to this Chapter shall be confidential and shall not constitute a public record.

(6) The Department shall impose a penalty of up to six percent (6%) for any Hospital that fails to pay a Provider Payment within the time required by the Department for each month or fraction thereof that the Provider Payment is overdue. If a required Provider Payment has not been received by the Department by the last day of the last month of the calendar quarter, the Department shall withhold an amount equal to the Provider Payment and penalty owed from any medical assistance payment due such Hospital under the Medicaid program. Any Provider Payment assessed pursuant to this Chapter shall constitute a debt due the state and may be collected by civil action and the filing of tax liens in addition to such methods provided for in this Chapter. Any penalty that accrues pursuant to this Rule shall be credited to the Segregated Account.

(7) In the event the Department determines that a Hospital has underpaid the Provider Payment, the Department shall notify the Hospital of the balance of the Provider Payment that is due. Such payment shall be due within thirty (30) days of the Department's notice.

(8) The Provider Payment imposed under this Chapter shall be recognized by the Department as a form of expenditure for indigent or charity care under any agreement by a Hospital to provide a specified amount of clinical health services to indigent patients pursuant to subsection (c) of O.C.G.A. § 31-6-40.1 and may be considered a community benefit for purposes of any required or voluntary community benefit report filed or prepared by a Hospital; provided, however, that the Provider Payment shall not be considered charity or indigent care for purposes of calculating Net Patient Revenue pursuant to this Chapter.

History

Authority: Act I of the 2013 Session of the Georgia General Assembly
History. Original Rule entitled "Payments to the Segregated Account" adopted. F. May 13, 2013; eff. June 2, 2013.

Ga. Comp. R. & Regs. r. 111-3-9-.03 Use of Provider Payments {#sec-ga.-comp.-r.-regs.-r.-111-3-9-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-9-.03}

(2) Revenues appropriated to the Department by the General Assembly pursuant to Article 6C of Chapter 8 of Title 31 shall be used to match federal funds that are available for the purpose for which such funds have been appropriated.

(3) In recognition of the Provider Payments made by Hospitals pursuant to this Chapter, the Department shall add 11.88 percent to hospital inpatient base rates, capital add-on rates, graduate medical education add-on rates, outlier per case payments and outpatient payment rates.

(4) The Department may conduct an annual review of the percentage defined in paragraph 3 and may make prospective adjustments to such percentage to ensure the amount of the add-on payments to Hospitals are substantially equivalent in the aggregate to the total amount of Provider Payments made by Hospitals pursuant to this Chapter.

History

Authority: Act I of the 2013 Session of the Georgia General Assembly
History. Original Rule entitled "Use of Provider Payments" adopted. F. May 13, 2013; eff. June 2, 2013.

Ga. Comp. R. & Regs. r. 111-3-9-.04 Effective Date {#sec-ga.-comp.-r.-regs.-r.-111-3-9-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-9-.04}

Upon the adoption by the Board, Chapter 111-3-9 shall become effective on July 1, 2013.

History

Authority: Act I of the 2013 Session of the Georgia General Assembly
History. Original Rule entitled "Effective Date" adopted. F. May 13, 2013; eff. June 2, 2013.

Subject 111-3-10 Hospital Medicaid Financing Program

Ga. Comp. R. & Regs. r. 111-3-10-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-3-10-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-10-.01}

As used in this Chapter 111-3-10:

(1) "Advisory Committee" means the Georgia Hospital Medicaid Financial Program Advisory Committee created by Executive Order executed by the Governor on March 5, 2013.

(2) "Board" means the Board of Community Health, the body created under O.C.G.A. § 31-2-3 , appointed by the Governor, that establishes the general policy to be followed by the Department of Community Health.

(3) "Department" means the Department of Community Health established under O.C.G.A. § 31-2-1 .

(4) "Hospital" means an institution license pursuant to Chapter 7 of Title 31, which is Primarily engaged in providing to inpatients, by or under the supervision of physicians, diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons or rehabilitation services for the rehabilitation of injured, disabled, or sick persons. Such term includes public, private, rehabilitative, geriatric, osteopathic, and other specialty hospitals but shall not include psychiatric hospitals, which shall have the same meaning as facilities as defined in paragraph (7) of O.C.G.A. § 37-3-1 , critical assess hospitals as defined in paragraph (3) of O.C.G.A. § 33-21A-2 , or any state owned or state operated hospitals.

(5) "Long Term Acute Care Hospital" means a hospital defined in section 1886(d)(1)(B)(iv) of the Social Security Act that is enrolled in the Medicaid program as of the effective date of Article 6C of Chapter 8 of Title 31.

(6) "Non-Governmental Hospital" means a subclass of Hospitals, authorized to be defined by the Board pursuant to paragraph (a) of O.C.G.A. § 31-8-179.2 , that shall not include public, Long Term Acute Care, children's, rehabilitative, geriatric, osteopathic, and other specialty hospitals, psychiatric hospitals which shall have the same meaning as facilities as defined in paragraph (7) of O.C.G.A. § 37-3-1 , critical assess hospitals as defined in paragraph (3) of O.C.G.A. § 33-21A-2 , or any state owned or state operated hospitals.

(7) "Provider Payment" means a payment assessed by the Department pursuant to this chapter for the privilege of operating a Non-Governmental Hospital.

(8) "Segregated Account" means an account for the dedication and deposit of Provider Payments which is established within the Trust Fund.

(9) "State Plan Amendment" means all documentation submitted by the Commissioner, on behalf of the Department, to and for approval by the Secretary of Health and Human Services pursuant to Title XIX of the federal Social Security Act of 1935, as amended.

(10) "Trust Fund" means the Indigent Care Trust Fund created by Article 6 of Chapter 8 of Title 31.

(11) "Waiver" means a waiver of the requirements for permissible health care related taxes, as provided for in 42 C.F.R § 433.68 .

History

Authority: Act I of the 2013 Session of the Georgia General Assembly
History. Original Rule entitled "Definitions" adopted. F. May 13, 2013; eff. June 2, 2013.

Ga. Comp. R. & Regs. r. 111-3-10-.02 Payments to the Segregated Account {#sec-ga.-comp.-r.-regs.-r.-111-3-10-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-10-.02}

(2) Each Non-Governmental Hospital shall be assessed a Provider Payment not to exceed the amount necessary to obtain federal financial participation for medical assistance payments allowable under 42 C.F.R. § 447.272 and 42 C.F.R. § 447.321 . The amount of each Non-Governmental Hospital's Provider Payment shall be determined by the Department using available hospital financial data and other information as applicable, including, but not limited to, hospital cost reports and the annual Hospital Financial Survey. The Department shall seek any Waivers and State Plan Amendments necessary to fully implement this Chapter.

(3) The Provider Payment shall be paid quarterly by each Non-Governmental Hospital to the Department. Payment of the Provider Payment shall be due on the last day of the last month of each calendar quarter; the first payment shall be due on September 30, 2013 or 30 calendar days after the receipt of State Plan Amendment approval, whichever is later.

(4) The Department shall prepare and distribute a form on which each Non-Governmental Hospital shall submit information to comply with this Chapter.

(5) Each Non-Governmental Hospital shall keep and preserve for a period of seven (7) years such books and records as may be necessary to determine the amount for which it is liable under this Chapter. The Department shall have the authority to inspect and copy the records of a Non-Governmental Hospital for purposes of auditing the calculation of the Provider Payment. All information obtained by the Department pursuant to this Chapter shall be confidential and shall not constitute a public record.

(6) The Department shall impose a penalty of up to six percent (6%) for any Non- Governmental Hospital that fails to pay a Provider Payment within the time required by the Department for each month or fraction thereof that the Provider Payment is overdue. If a required Provider Payment has not been received by the Department by the last day of the last month of the calendar quarter, the Department shall withhold an amount equal to the Provider Payment and penalty owed from any medical assistance payment due such Non-Governmental Hospital under the Medicaid program. Any Provider Payment assessed pursuant to this Chapter shall constitute a debt due the state and may be collected by civil action and the filing of tax liens in addition to such methods provided for in this Chapter. Any penalty that accrues pursuant to this Rule shall be credited to the Segregated Account.

(7) In the event the Department determines that a Non-Governmental Hospital has underpaid the Provider Payment, the Department shall notify the Non-Governmental Hospital of the balance of the Provider Payment that is due. Such payment shall be due within thirty (30) days of the Department's notice.

History

Authority: Act I of the 2013 Session of the Georgia General Assembly
History. Original Rule entitled "Payments to the Segregated Account" adopted. F. May 13, 2013; eff. June 2, 2013.

Ga. Comp. R. & Regs. r. 111-3-10-.03 Use of Provider Payments {#sec-ga.-comp.-r.-regs.-r.-111-3-10-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-10-.03}

(1) The Department shall collect the Provider Payments imposed pursuant to this Chapter. All revenues raised pursuant to this Chapter shall be deposited into the Segregated Account. Such funds shall be dedicated and used for the sole purpose of obtaining federal financial participation for medical assistance payments to Non-Governmental Hospitals and Long Term Acute Care Hospitals on behalf of Medicaid recipients pursuant to Article 7 of Chapter 4 of Title 49. Such payments to Non-Governmental Hospitals and Long Term Acute Care Hospitals may include, among other things:

(a) general Medicaid rate increases;

(b) targeted payments for higher acuity Medicaid beneficiaries; and/or

(c) targeted payments for specific services such as organ transplant, certified breast or cancer centers, psychiatric, telemedicine or other services.

(2) Revenues appropriated to the Department by the General Assembly pursuant to Article 6C of Chapter 8 of Title 31, shall be used to match federal funds that are available for the purpose for which such funds have been appropriated.

(3) The Department shall remit any payments required under this Rule within ten (10) days of the Department's quarterly receipt of the Provider Payments pursuant to this Chapter.

History

Authority: Act I of the 2013 Session of the Georgia General Assembly
History. Original Rule entitled "Use of Provider Payments" adopted. F. May 13, 2013; eff. June 2, 2013.

Ga. Comp. R. & Regs. r. 111-3-10-.04 Advisory Committee {#sec-ga.-comp.-r.-regs.-r.-111-3-10-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-10-.04}

(1) The Advisory Committee shall develop and recommend to the Department new and amended rules, state plan amendments and waivers for the implementation of any provider payments established pursuant to Act 1 of the 2013 Georgia General Assembly.

(2) The Committee shall develop and recommend to the Department the methodology to calculate the annual UPL applicable to hospital payments under federal Medicaid law.

History

Authority: Act I of the 2013 Session of the Georgia General Assembly
History. Original Rule entitled "Advisory Committee" adopted. F. May 13, 2013; eff. June 2, 2013.

Ga. Comp. R. & Regs. r. 111-3-10-.05 Effective Date {#sec-ga.-comp.-r.-regs.-r.-111-3-10-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-10-.05}

Upon the adoption by the Board, Chapter 111-3-10 shall become effective on July 1, 2013;

provided however, the Advisory Committee which was created by Executive Order of the Governor became effective on March 5, 2013.

History

Authority: Act I of the 2013 Session of the Georgia General Assembly
History. Original Rule entitled "Effective Date" adopted. F. May 13, 2013; eff. June 2, 2013.

Subject 111-3-11 Hospital Directed Payment Program

Ga. Comp. R. & Regs. r. 111-3-11-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-3-11-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-11-.01}

As used in this Chapter 111-3-11:

(2) "Care Management Organization" means a managed care organization defined in 42 CFR § 438.2 and O.C.G.A. § 33-21A-2(1) .

(3) "Department" means the Department of Community Health established under O.C.G.A. § 31-2-3 .

(4) "Directed Payment" means any payment made to hospitals by Care Management Organizations pursuant to their Medicaid managed care contracts with the Department as authorized under 42 CFR § 438.6(c) .

(5) "Hospital" means an institution license pursuant to Chapter 7 of Title 31, which is primarily engaged in providing to inpatients, by or under the supervision of physicians, diagnostic services and therapeutic services for medical diagnosis, treatment, and care of injured, disabled, or sick persons or rehabilitation services for the rehabilitation of injured, disabled, or sick persons. Such term includes public, private, rehabilitative, geriatric, osteopathic, and other specialty hospitals but shall not include psychiatric hospitals, which shall have the same meaning as facilities as defined in paragraph (7) of O.C.G.A. § 37-3-1 , critical access hospitals as defined in paragraph (3) of O.C.G.A. § 33-21A-2 , or any state owned or state operated hospitals.

(6) "Non-Governmental Hospital" means a subclass of Hospitals, authorized to be defined by the Board pursuant to paragraph (a) of O.C.G.A. § 31-8-179.2 , that shall not include public, long term acute care, rehabilitative, geriatric, osteopathic, and psychiatric hospitals which shall have the same meaning as facilities as defined in paragraph (7) of O.C.G.A. § 31-8-179.2 , critical access hospitals as defined in paragraph (3) of O.C.G.A. § 33-21A-2 , or any state-owned or state-operated hospitals.

(7) "Provider Payment" means a payment assessed by the Department pursuant to this chapter for the privilege of operating a Non-Governmental Hospital.

(8) "Segregated Account" means an account for the dedication and deposit of Provider Payments which is established within the Trust Fund.

(9) "Trust Fund" means the Indigent Care Trust Fund created by Article 6 of Chapter 8 of Title 31.

(10) "Waiver" means a waiver of the requirements for permissible health care related taxes, as provided for in 42 C.F.R. § 433.68 .

History

Authority: O.C.G.A. § 31-8-179.1, et seq
History. Original Rule entitled "Definitions" adopted. F. July 20, 2022; eff. Aug. 9, 2022.
Amended: F. May 14, 2026; eff. June 3, 2026.

Ga. Comp. R. & Regs. r. 111-3-11-.02 Payments to the Segregated Account {#sec-ga.-comp.-r.-regs.-r.-111-3-11-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-11-.02}

(2) Each Non-Governmental Hospital shall be assessed a Provider Payment not to exceed the amount necessary to obtain federal financial participation for Directed Payments allowable under 42 CFR § 438.6(c) . The amount of each Non-Governmental Hospital's Provider Payment shall be determined by the Department using available hospital financial data and other information as applicable, including, but not limited to, hospital cost reports and the annual Hospital Financial Survey. The Department shall seek any Waivers and federal approvals necessary to fully implement this Chapter.

(3) The Provider Payment shall be paid at least annually by each Non-Governmental Hospital to the Department within 14 calendar days of the Department's notice to the Non-Governmental Hospital that payment is due. The Department shall send such Provider Payment notices to each Non-Governmental Hospital within 30 calendar days or as soon as reasonably practical after the receipt of federal approval of Directed Payment(s) for the applicable rating period.

(4) The Department or its designee shall prepare and distribute a form on which each Non-Governmental Hospital shall submit information to comply with this Chapter.

(6) The Department may impose a penalty of up to six percent (6%) for any Non- Governmental Hospital that fails to pay a Provider Payment within the time required by the Department for each month or fraction thereof that the Provider Payment is overdue. If a required Provider Payment has not been received by the Department 14 days after the payment due date as specified in 111-3-11-.02(3) , the Department may withhold an amount equal to the Provider Payment and penalty owed from any medical assistance payment due such Non-Governmental Hospital under the Medicaid program. Any Provider Payment assessed pursuant to this Chapter shall constitute a debt due the state and may be collected by civil action and the filing of tax liens in addition to such methods provided for in this Chapter. Any penalty that accrues pursuant to this Rule shall be credited to the Segregated Account.

(7) If the Department determines that a Non-Governmental Hospital has underpaid the Provider Payment, the Department shall notify the Non-Governmental Hospital of the balance of the Provider Payment that is due. Such payment shall be due within thirty (30) days of the Department's notice.

History

Authority: O.C.G.A. § 31-8-179.3
History. Original Rule entitled "Payments to the Segregated Account" adopted. F. July 20, 2022; eff. Aug. 9, 2022.

Ga. Comp. R. & Regs. r. 111-3-11-.03 Use of Provider Payments {#sec-ga.-comp.-r.-regs.-r.-111-3-11-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-11-.03}

(1) The Department shall collect the Provider Payments imposed pursuant to this Chapter. All revenues raised pursuant to this Chapter shall be deposited into the Segregated Account. Such funds shall be dedicated and used for the sole purpose of obtaining federal financial participation for Directed Payments to Non-Governmental Hospitals from Care Management Organizations on behalf of Medicaid recipients pursuant to Article 7 of Chapter 4 of Title 49. Directed Payments shall be exclusively used to provide Medicaid payments to Non-Governmental Hospitals based on each Non-Governmental Hospital's individual claims to Care Management Organizations.

(3) The Department shall require the Care Management Organizations to remit any payments required under this Rule within ten (10) days of the Department's receipt of the Provider Payments pursuant to this Chapter.

History

Authority: O.C.G.A. § 31-8-179.3
History. Original Rule entitled "Use of Provider Payments" adopted. F. July 20, 2022; eff. Aug. 9, 2022.

Ga. Comp. R. & Regs. r. 111-3-11-.04 Use of Directed Payments {#sec-ga.-comp.-r.-regs.-r.-111-3-11-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-11-.04}

(1) The Department may, in its sole discretion, create one or more directed payment programs in accordance with this Chapter.

(2) Non-Governmental Hospitals shall comply with Department requests to submit reports to the Department when necessary to comply with the requirements of 42 CFR 438.6(c)(2)(ii) .

History

Authority: O.C.G.A. § 31-8-179.3
History. Original Rule entitled "Use of Directed Payments" adopted. F. July 20, 2022; eff. Aug. 9, 2022.

Subject 111-3-12 Rules and Regulations for Hospital Care for the Indigent

Ga. Comp. R. & Regs. r. 111-3-12-.01 Authority {#sec-ga.-comp.-r.-regs.-r.-111-3-12-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-12-.01}

(1) Act No. 397, Georgia Laws 1957, contains legislative authority for the creation of a "Hospital Care for the Indigent" program. The purpose of the program is "to assist counties in the purchase of hospital care for persons who are ill or injured, and who can be helped by treatment in a hospital, and who are financially unable to meet the full cost of hospital care from their own resources or from the resources of those upon whom they are legally dependent."

(2) This program is a State-County jointly financed and administered approach to providing hospital care for the medically indigent. However, participation in the program is voluntary with each county. The program will support the preservation of the professional freedom of physicians and the local control of hospitals. Furthermore, local program administration will be encouraged.

(3) Generally speaking, payment for hospital care is the responsibility of the individual and the local community. It is the intent of this program to supplement local action. Accordingly, the program should not be construed as replacing Federal, State, or local programs for the indigent. It is a basic program objective to provide financial means for the payment of hospital care for indigent patients who are hospitalized outside of their respective county or residency.

(4) The "Hospital Care for the Indigent" Program has been developed in close liaison with the Medical Association of Georgia, the Georgia Association of County Commissioners, the Georgia Association of Hospital Governing Boards, and the Georgia Hospital Association. Each of these organizations have representation on the Hospital Care Advisory Council.

(5) The Legislature delegated the administration of the program to the Department of Community Health. The purpose of this program is to assist counties in the purchase of hospital care for persons who are ill or injured and who can be helped by treatment in a hospital but are financially unable to meet the full cost of hospital care from their own resources or from the resources of those upon whom they are legally dependent.

History

Authority: Ga. L. 1933, p. 7., O.C.G.A. § 31-8-1 (2009)
History. Original Rule entitled "Authority" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-3-12-.02 Method for County Participation in the Program {#sec-ga.-comp.-r.-regs.-r.-111-3-12-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-12-.02}

(1) Procedure for County Participation:

(a) For a county to initiate participation in the Program, the governing authority of such county, by formal resolution or by contract agreement, must satisfy the provisions of 111-3-12-.02(2) .

(b) For continued participation in the Program, the county must comply with the Rules and Regulations governing the administration of the Program, and the governing authority of the county annually must adopt a renewal resolution or renew its contract agreement. The annual resolution or contract must satisfy the provisions of 111-3-12-.02(2) and the required document must be filed with the Georgia Department of Community Health on or before the first day of April to assure participation for the entire ensuing fiscal year.

(c) The Georgia Department of Community Health shall make the determination, on a uniform state-wide basis, or whether a formal resolution, a contract agreement, or both shall be submitted by the county for participation in the Program.

(2) Requirements Regarding the Resolution or the Contract:

(a) The resolution or contract must declare the desire of the County to participate in the Program.

(b) The resolution or contract must certify that the County has approved a local budget providing funds necessary for participation in the Program. The amount of this local budget shall be specified in the resolution or contract. (See 111-3-12-.02(3) for comments on "Determining the Local Budget.")

(c) The resolution or the contract must indicate that the County has designated the County Board of Health as the local administrative agency or that the County has so designated an agency acceptable to both the governing authority of the county and the Georgia Department of Community Health.

(d) The resolution or contract must state that the County agrees to pay, within the limitations of the Program budget, for authorized or emergency out-of-county hospital care rendered to county residents who are properly certified as indigent or medically indigent.

(e) The resolution or contract should indicate that both the local medical society and the local hospital authority, if such exist, favor participation by the county in the Program.

(f) The resolution or contract must declare that the County will comply with the Rules and Regulations of the Program as promulgated by the Department of Community Health.

(3) Determining the Local Budget:

(a) The amount of local funds budgeted for the Program shall be determined by the governing authority of the county; however, such local budget should match available State funds except where a lesser amount is reasonably related to Program needs.

(b) The availability of State funds does not reduce local responsibility regarding hospital care, and it should not be used to justify termination of existing agreements with hospitals regarding the financing of operating deficits.

(c) The amount of State funds budgeted under the Program to each county shall be determined by the Georgia Department of Community Health on the basis of available State funds, the matching formula, and the available county funds.

(4) Effective Date of Participation. A County may request participation the Program at any time; however, after the first year of the Program, the actual commencement of Program participation, as evidenced by an allotment of State funds, shall be only on July 1 or January 1.

(5) A County may request the Georgia Department of Community Health to approve a revised resolution or contract prior to the expiration of a previously filed document for a given year. Decisions regarding such requests will be based on the circumstances and facts as submitted in each instance.

History

Authority: Ga. L. 1933, p. 7; O.C.G.A. § 31-8-1et seq
History. Original Rule entitled "Method for County Participation in the Program" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-3-12-.03 Method of Allotment and Matching of State Funds {#sec-ga.-comp.-r.-regs.-r.-111-3-12-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-12-.03}

(1) Calculating the Allotment of State Funds:

(a) Within the one dollar ($1.00) per capita legal limitation, State funds shall be allotted to each participating county according to two factors: population and median income.

The population shall be the latest official decennial population count of the U.S. Census Bureau, adjusted to exclude military personnel and wards of State institutions.
The median income, which is an index of relative economic ability, shall be obtained from the most recent "Characteristics of Population" for Georgia as prepared by the U. S. Census Bureau in connection with its official decennial population count.

(b) In calculating the county allotment, the following statistical procedure shall be used:

One thousand (1,000) divided by each county's median income to obtain the reciprocal weighting value.
Each county's population multiplied by the county's reciprocal weighting value to obtain county's weighted population.
The appropriation (or State funds available) divided by the sum of weighted population of all counties to obtain per capita allotment.
Per capita allotment multiplied by each county's weighted population to obtain each county's allotment.

(c) The above procedure shall be used in the initial allocation of State funds during a year, in the reallocation of any unexpended or unallotted funds, and in the allocation of any additional funds which may become available during a year.

(2) Matching Formula:

(a) All State funds allocated to a County, through an agreed joint participating budget, must be matched by local funds according to the matching formula.

(b) The matching formula for each county shall be determined by the following table: 1950 Population of County State Share Local Share 5,000 and under 75% 25% 5,001 - 10,000 65% 35% 10,001 - 20,000 55% 45% 20,001 - 50,000 50% 50% 50,001 - 100,000 40% 60% Over 100,000 30% 70%

(3) Method of Payment:

(a) Each Participating County must establish a "Hospital Care for the Indigent" Fund which shall consist of the local share of the approved joint budget.

(b) The Georgia Department of Community Health shall establish a State "Hospital Care for the Indigent" Fund which shall consist of all State funds available to the Program.

(c) The method of payment shall be to hospitals on an individual patient basis according to a dual payment procedure. Under this method, the County shall pay the hospital for the local share of authorized hospitalization and the Georgia Department of Community Health shall pay the hospital for the State share of authorized hospitalization.

(d) Disbursement to a hospital from the Georgia Department of Community Health will be made only on proper local certification and after the County has paid the local share of the request for payment as submitted by the Participating Hospital.

(e) The official per diem rate shall be used by each Participating County when authorizing hospital care under the Program and the local share of such rate shall be the basis for county payment under the Program.

(f) The County is primarily responsible for obligations authorized by its certifications and the Georgia Department Community Health will assist only to the extent of State funds allocated to that county.

History

Authority: Ga. L. 1933, p. 7; O.C.G.A. § 31-8-1et seq
History. Original Rule entitled "Method of Allotment and Matching of State Funds" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-3-12-.04 Method of Local Administration {#sec-ga.-comp.-r.-regs.-r.-111-3-12-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-12-.04}

(1) Supervision of Local Program:

(a) The governing authority of the county shall have the following Program role:

to determine whether the Program should be activated in the county and to establish the local budget needed;
to review and to adopt the County Program Plan;
to make an annual review of Program performance and to determine whether the Program is to be continued in its county.

(b) The County Board of Health shall have the following Program role:

to bear responsibility for the proper administration of the Program in its county;
to develop or supervise the development of a County Program Plan;
to adopt local policies necessary to Program administration;
to delegate administrative Program functions as it deems desirable.

(c) The County Board of Health, except as indicated in paragraph (a) above shall represent the county in official negotiations with the Division of Hospital Services, Georgia Department of Community Health.

(2) County Program Plan:

(a) Annually, the County Board of Health shall prepare a County Program Plan which contains the following elements:

a selection of hospitals to be used by the County in accordance with 111-3-12-.04(3) ;
resolutions from the medical staff and the governing board of each selected hospital stating acceptance of participation in the local Program;
a policy or standard for determining indigency and medical indigency in accordance with 111-3-12-.05 ;
a policy or method for determining the need for hospitalization in accordance with 111-3-12-.06 ;
a policy or method relating to out-of-county hospital care in accordance with 111-3-12-.06(3) ;
a method or procedure for the payment of funds in accordance with 111-3-12-.03(3) ;
a statement defining the area of responsibility for any agency to which the county has delegated administrative Program responsibility in accordance with 111-3-12-.04(4) .

(b) The County Program Plan shall be prepared so as to provide a logically interrelated set of policies for the local Program.

(c) The County Program Plan shall be submitted for review and approval to the governing authority of the county and to the Georgia Department of Community Health.

(3) Selection of Participating Hospitals:

(a) The County Program Plan shall contain the selection of a reasonable number of Participating Hospitals so that geographic Program Coverage will conform, in General, with the pattern of medical care for the area.

(b) In the selection of Participating Hospitals to be used by the local Program, consideration should be given to the probable needs of individual patients, the necessity for referrals between hospitals, the geographic convenience of patients, and the desires of local practicing physicians.

(c) To the fullest degree consistent with sound local Program management, the local selection of Participating Hospitals should be limited to general hospitals providing medical and surgical services.

(d) The Eugene Talmadge Memorial Hospital shall not be selected for inclusion in any County Program Plan; however, emergency or highly specialized hospital care may be authorized at this hospital.

(e) In an emergency wherein the medical condition of the patient prevents utilization of a selected participating hospital, hospitalization may be authorized in any Participating Hospital without reference to the County Program Plan.

(f) The county may amend its selection of Participating Hospitals by written notice to the Georgia Department of Community Health.

(4) Local Program Administration:

(a) The County Board of Health shall have authority to administer the local Program, including the following areas:

to make the necessary investigation for the final determination of indigency and medical indigency;
to make the final determination of the need for hospitalization;
to authorize and to approve payments for hospital care;
to maintain Program records and to prepare reports of its activities;
to properly account for funds made available to the local Program;
to maintain liaison with public and private agencies interested in the Program.

(b) The County Board of Health may delegate definable aspects of local Program administration to a governmental official, an agency, or an organization which perform a public and necessary governmental function. Any delegation must be on an annual basis and does not relieve the County Board of Health of its total Program responsibility.

(c) The County Board of Health, at its option, may elect to establish a Screening Committee to advise in local program administration.

The Act specifies that a Screening Committee, created by a County, should be delegated the function of making determinations and certifications relative to the indigency of persons applying for assistance under this Program.
Such a Screening Committee should consist of three responsible and public-minded local citizens. At least one member of a Screening Committee must be designated by the local medical society.

History

Authority: Ga. L. 1933, p. 7; O.C.G.A. § 31-8-1et seq
History. Original Rule entitled "Method of Local Administration" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-3-12-.05 Criteria for Determining Indigency {#sec-ga.-comp.-r.-regs.-r.-111-3-12-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-12-.05}

(1) General Statement on Determining Financial Eligibility:

(a) The Department of Community Health desires that each county have as much freedom as possible in determining the eligibility of its residents under the provisions of this Program.

(b) Recognizing the differences in the socio-economic level of the several counties, there shall be no rigid state-wide formula devised for determining indigency and medical indigency.

(2) A Local Policy or Standard Required:

(a) The County Board of Health shall develop a policy or standard which shall be used in determining indigency and medical indigency under the Program for the residents of that county.

(b) The local policy or standard shall be established in such a manner as to satisfy the following provisions:

It must contain reasonable assurance of a uniform basis of review for all requests for financial assistance under the Program for residents of that county.
It must contain specified standards of eligibility relative to family income, family assets, hospitalization insurance, and number of dependents.
It must contain a procedure which requires and specifies an inventory of economic resources on persons for whom assistance is requested.
It must recognize the need for a higher priority in those instances where an indigent or medically indigent resident is hospitalized outside of the county.

(3) Investigation of Individual Applicants:

(a) There shall be an investigation or review of the economic condition of each applicant to determine eligibility.

(b) Each applicant shall be required to certify that he is unable to pay for the full cost of hospital care as deemed necessary by a physician.

(c) Each applicant, from family resources or hospitalization insurance, shall be required to pay as large a share as possible of the cost of his hospitalization.

(4) Payment from Other Sources:

(a) For days of hospitalization authorized under the Program, there may be a supplemental county payment above the amount based on the official per diem rate, provided such action is based upon a contract agreement between the hospital and the governing authority of the county. There shall be no State participation in a supplemental county payment.

(b) When payment is made or expected to be made to the hospital on behalf of the patient from hospitalization insurance or family resources, the amounts so collected by or due to the hospital shall be deducted from that sum which would otherwise be payable to the hospital under the Program, except as stated in 111-3-12-.05(4)(c) .

(c) When the patient's stay in the hospital is greater than the days of hospitalization authorized under the Program, payment to the hospital from hospitalization insurance or family resources may be applied, according to the hospital's normal business practice, to those days of hospital care not authorized under the Program.

(d) After payment has been made for days of hospital care not authorized under the Program, any balance of hospitalization insurance or family resources shall be applied to days of authorized hospital care in accordance with 111-3-12-.05(4)(b) .

History

Authority: Ga. L. 1933, p. 7.; O.C.G.A. § 31-8-1et seq
History. Original Rule entitled "Criteria for Determining Indigency" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-3-12-.06 Criteria for Hospitalization {#sec-ga.-comp.-r.-regs.-r.-111-3-12-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-12-.06}

(1) Certification of Hospital Care:

(a) This Program shall provide essential hospitalization for the acutely ill or injured who are eligible otherwise under Program requirements and who are certified by the county of residency.

(b) Each Participating County has the option of including or excluding normal obstetrics as eligible under the Program.

(d) All applications for hospitalization under the Program must be initiated by a physician.

(e) Hospitalization under the Program for any one patient shall not exceed thirty days in any twelve-month period.

(f) The applicant's attending physician, in recommending hospitalization shall certify the following:

That the applicant is acutely ill or injured;
That in his professional judgment intensive care normally provided by a hospital is required;
That there is likelihood of substantial benefit from hospitalization;
That he has reason to believe that the applicant is indigent;
That he has reason to believe the applicant is NOT eligible for care under any other program.

(g) The applicant's attending physician in recommending hospitalization shall indicate, to the best of his judgment, the number of days of hospitalization required and the hospital providing the type of care needed by the applicant.

(h) The County Board of Health, or its authorized agent, shall make the final decision on the following matters:

Selection of the Hospital to be used by the applicant.
The number of hospitalization days which will be authorized.

(i) The County Board of Health, or its authorized agent, shall promptly notify the Georgia Department of Community Health regarding all hospital care authorized under the Program.

(2) Relationship with Other Medical Care Programs:

(a) The Program shall not be construed as replacing existing Federal, State or local hospital and medical care programs for the indigent but may supplement such programs.

(b) The Program may supplement other Federal or State programs in the following manner:

On proper local certification, a person who is acutely ill or injured may receive hospital care under the Program even though the person is currently eligible for or receiving care under another program for a different type of disability or illness.
After exhausting eligibility under another program and on proper local certification, a person who is acutely ill or injured may receive hospital care under the Program for an acute illness or injury normally cared for under the program of prior sponsorship.
On proper local certification, persons with diagnosed tuberculosis, who because of the critical degree of their condition cannot be safely transported to Battey State Hospital may be temporarily hospitalized under provisions of the Program.

(c) When a person receives hospitalization under both this Program and another program, the authorization under this Program shall be prepared in such a manner as to avoid an overlapping payment for hospital care received.

(3) Out-of-County Hospital Care:

(a) There shall be free movement of patients and funds between counties so that the location of hospital care may become a medical determination and that payment for such hospital care may become void of artificial barriers.

(b) Out-of-county hospital care may be a medical referral in which the patient goes from the county of residence to an out-of-county hospital after it is determined that care is needed. In this instance, the county of residency shall determine both the need for hospitalization and whether the person is eligible as indigent or as medically indigent.

(c) Out-of-county hospital care may be an emergency wherein neither the patient nor his physician would have advanced plans regarding hospitalization. In this instance, the medical staff of the hospital shall determine the need for hospitalization relating to the emergency condition, and the county of residency shall determine whether the person is eligible as indigent or medically indigent.

(d) In emergency cases, the hospital and the attending physician shall complete the appropriate parts of the application form, and such application shall be received by the patient's county of residency within five days after admission of the patient. In such instances, the hospital shall indicate its approved per diem rate when transmitting the application.

(e) In the event there is an absence of negotiations between the parties concerned regarding the financial aspect of out-of-county hospital care, the Georgia Department of Community Health may earmark and reserve that sum of State funds which it deems advisable for the purpose of payment for out-of-county hospital care.

History

Authority: Ga. L. 1933, p. 7; O.C.G.A. § 31-8-1et seq
History. Original Rule entitled "Criteria for Hospitalization" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-3-12-.07 Method for Approval of Participating Hospitals {#sec-ga.-comp.-r.-regs.-r.-111-3-12-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-12-.07}

(1) Procedure for Becoming a Participating Hospital:

(a) Prerequisite to any hospital becoming a Participating Hospital under the Program, the governing authority of the hospital must elect to participate in the Program.

(b) In expressing the desire of the hospital to participate in the Program, a responsible officer of the hospital shall complete a standard application form and shall submit such application to the Georgia Department of Community Health.

(c) A hospital once approved will continue as a Participating Hospital until it voluntarily withdraws or its approval is revoked.

(2) Requirements for Becoming a Participating Hospital:

(a) To be eligible to participate in the Program, a hospital must have a physician as chief of staff and must have been issued a current licensure permit, either annual or provisional, under authority of the Georgia Hospital Regulations Act No. 623, Georgia Laws, 1946.

(b) Any hospital electing to participate in the Program must select one of the two following methods of payment for hospital care that it renders:

A calculated per diem related to the non-profit basic cost;
A fixed sum not to exceed ten dollars ($10.00) per patient-day of care.

(c) Any hospital selecting method (b) 1. above must submit appropriate accounting data necessary to substantiate a "non-profit basic cost".

(3) Lists of Participating Hospitals. The Georgia Department of Community Health shall maintain a roster of hospitals participating in the Program and shall furnish a list of such hospitals to each County Board of Health annually or more frequently if justified by the volume of changes.

(4) Discontinuance as a Participating Hospital:

(a) A participating Hospital has the right to withdraw from the Program at any time, after proper notice of this intent to the Georgia Department of Community Health, provided that the rights of patients are not jeopardized.

(b) Should a Participating Hospital, at some future date, fail to comply with the Act and the Regulations thereunder, the Georgia Department of Community Health shall remove the hospital from the roster of participating hospitals and shall advise the hospital concerned and the County Board of Health in each participating county that the hospital is no longer a Participating Hospital under the Program.

(5) Calculating the Per Diem Rate:

(a) The non-profit basic cost shall be determined from an analysis of the hospital's financial records and reports, and all submitted cost statements must bear the certification of a qualified auditor who is not an employee of the hospital.

(b) The Georgia Department of Community Health shall establish for each Participating Hospital an official per diem rate, which shall be an established percentage of the non-profit basic cost.

(c) The method of calculation of the official per diem rate for this Program shall be in harmony with the policies of other medical care programs under the sponsorship of the State of Georgia.

(d) By electing the calculated per diem method, the hospital grants to the Georgia Department of Community Health the right to audit its financial records and the right to inform counties of its per diem rate.

(e) For any Participating Hospital, the official per diem rate shall not exceed the average patient-day income for the hospital.

History

Authority: Ga. L. 1933, p. 7; O.C.G.A. § 31-8-1et seq
History. Original Rule entitled "Method for Approval of Participating Hospitals" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-3-12-.08 General Provisions {#sec-ga.-comp.-r.-regs.-r.-111-3-12-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-12-.08}

(1) Definition of Terms. The following words, terms, or phrases when used in these Rules and Regulations, shall have the meaning ascribed to them in this section, except when the context clearly indicates a different meaning:

(a) "Program" means the Hospital Care for the Indigent Program, established by Act No. 397, Georgia Laws, 1957;

(b) "Physician" means a doctor of medicine duly licensed to practice medicine in Georgia in accordance with Section 84-901, et seq., Georgia Code Annotated.

(c) "Indigent Person" or "indigent" means any person who is ill or injured and who from his own resources or from resources of those upon whom he is legally dependent is financially unable to meet the full cost of hospital care as prescribed or ordered by a physician.

(d) "financially unable" means an economic status in which a person, who because of his level of income, property, or intrafamily assistance, is not able to pay for the cost of needed hospital care without depriving himself or his dependents of necessary food, shelter, clothing, and the other minimum necessities of life within specified limits of an economic inventory.

(e) "full cost" means the total cost of an entire period of hospitalization wherein the ill or injured person is or becomes indigent in reference to a portion of the hospital cost.

(f) "hospital care needed" means the hospital care as prescribed or ordered by a physician.

(g) "resident" means any person who is in the county for other than temporary or transitory purposes and who has lived continuously in Georgia for a period of not less than six months. The six months residency requirement may be waived when a physician certifies that the illness or injury constitutes an emergency which requires immediate hospital care.

(h) "Applicant" means a resident indigent ill or injured person who makes applications for service under this Program, according to prescribed rules and regulations.

(i) "ill or injured" means indisposed for a medical reason which requires, in the professional judgment of a physician, intensive care normally provided by a hospital, and there is a likelihood of material benefit from hospitalization.

(j) "Participating County" means a county, the governing authority of which by appropriate action has agreed to participate in the Program, has adopted the rules and regulations set forth for the administration of the Program, and is current with its prorated share of funds necessary for the hospital care of county residents.

(k) "County" means the governing or taxing authority of a county.

(l) "Participating Hospital," "Participating Hospitals," or "participating hospital" means hospitals that have agreed to cooperate with the Program and have been certified as eligible according to the eligibility criteria set forth in the Rules and Regulations.

(m) "County Board of Health" means a County Board of Health created under and by virtue of an Act of the General Assembly of Georgia (Acts of 1914, page 124-125 as amended) codified as Section 88-201 et. seq., Georgia Code Annotated; or the agency designated under the provision of 111-3-12-.02(c) of these Rules and Regulations.

(2) Appeal Procedure:

(a) An applicant, a physician, or a Participating Hospital may appeal to the County Board of Health wherein the applicant resides, if the application is not acted upon within a reasonable length of time or if the application is denied, in whole or in part, by seemingly arbitrary action.

(b) The governing authority of the county, the Count Board of Health, a Participating Hospital, or the local medical society have the right to appeal by a written request and to be granted a fair hearing by the Georgia Department of Public Health on administrative matters pertaining to local policies, procedures, or methods.

(c) The governing authority of a Participating County, or the County Board of Health have the right to ap peal by a written request and to be granted a fair hearing by the State Board of Health relative to administrative procedures and decisions of the Georgia Department of Community Health.

(3) Revision of Rules and Regulations. Within the framework and intent of the Act, these Rules and Regulations may be revised or modified from time to time by the Department of Community Health after consultation with the Hospital Care Advisory Council.

History

Authority: Ga. L. 1933, p. 7; O.C.G.A. § 31-8-1 et seq
History. Original Rule entitled "General Provisions" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-3-12-.09 Appendix {#sec-ga.-comp.-r.-regs.-r.-111-3-12-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-12-.09}

Act No.397

Georgia Laws 1957

AN ACT

To provide additional powers and duties to be vested in the State Board of Health in order to promote and preserve the life and health of the people of the State through a program for the hospital care of the indigent; to provide assistance to the several counties of the State in purchasing hospital care for citizens thereof who are in need of and are financially unable to provide such care for themselves; to appropriate funds to be used to match and supplement local, federal or other funds made available for this purpose; to provide for the administration of the Act by the State Board of Health; to authorize the appointment of a Hospital Care Council by the Governor to advise and assist in the development of rules, regulations and standards necessary and proper to the implementation and administration of this Act; to repeal conflicting laws, and for other purposes.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF GEORGIA:

SECTION 1. In order to promote and preserve the public health there is hereby established a "Hospital Care for the Indigent" program to be administered by the State Board of Health. The purpose of this program is to assist counties in the purchase of hospital care for persons who are ill or injured, and who can be helped by treatment in a hospital, and who are financially unable to meet the full cost of hospital care from their own resources or from the resources of those upon whom they are legally dependent. The purchase of such hospital care shall be limited to the non-profit basic cost of hospital care needed for the treatment of the ill or injured, as deemed necessary and ordered by the physician in charge of the case in accordance with the provisions of this Act and the rules, regulations and standards adopted and promulgated by the Board hereunder.

SECTION 2. The following words, terms and phrases, when used in this Act shall have the following meaning ascribed to them in this section, except when the context clearly indicates a different meaning:

a. Board-The State Board of Health;

b. Program-The "Hospital Care for the Indigent" program;

c. Participating Hospital-A publicly or privately owned hospital holding a valid permit issued pursuant to Section 99-1707, Georgia Code Annotated, and having a physician as chief of staff and provided further that the governing authority of the hospital elects to participate in the program in accordance with the provisions of this Act;

d. Physician-A doctor of medicine duly licensed to practice medicine in Georgia in accordance with Sections 84-901, et seq., Georgia Code Annotated;

e. Indigent Person-Any person who is ill or injured and who from his own resources or from the resources of those upon whom he is legally dependent is financially unable to meet the full cost of hospital care as prescribed or ordered by a physician;

f. Resident-Any person who is in the State of Georgia for other than temporary or transitory purposes and who has lived continuously in this State for a period of not less than six (6) months;

g. Participating County-A county, the governing authority of which, by appropriate action, has agreed to participate in the program and is current with its prorata share of funds necessary for the hospital care for its ill or injured indigent as herein defined and in accordance with the provisions of this Act.

SECTION 3. Until such time as a specific appropriation may be made to the State Board of Health for the purpose of carrying out the provisions of this Act, the Budget Bureau is hereby authorized to make an allotment to the Board in such amounts as the bureau may deem necessary and proper for such purpose in accordance with the provisions of section 40-408 of the Georgia Code of 1933.

SECTION 4. State funds appropriated to the board for the purpose of carrying out the provisions of this Act shall be expended by the board or its duly authorized agent so as to provide for the administration of this Act as it deems necessary and proper and to assist counties in providing hospital care for indigent residents. The board shall establish a graduated matching formula for the disbursement of State funds to assist counties as provided herein; provided the State share of any participating county budget shall not exceed one dollar ($1.00) per capita based on the latest official decennial population count of the United States Census Bureau. The board may establish an amount of State funds of the total State and county participating budget to provide hospital care for indigent resident patients who may be hospitalized outside of the county of residency; provided, however, that any unexpected State funds budgeted to provide hospital care for the indigent resident patient who may be hospitalized outside the county of residency may be reallocated by the board according to the matching formula.

SECTION 5. After the effective date of this Act the governing authority of the participating county shall on or before the first day of April of each year submit to the Board a Hospital Care for the Indigent budget containing an estimate and supporting data setting forth the amount of moneys needed to provide hospital care for the indigent residents for said county.

SECTION 6. Upon certification, approved by the board, any participating county may receive credit for direct expenditures made during the period covered by the budget by the county to a hospital or hospitals when such expenditures can be shown to have been made for the care of indigent residents as herein defined.

SECTION 7. The board, after consultation with the Hospital Care Council, shall adopt and promulgate such rules and regulations as it deems necessary to carry out the provisions of this Act.

SECTION 8. A person to qualify for assistance under this program must be an indigent resident of this State and hospital care is not available to the person under any other program. The six (6) months residency requirement may be waived; provided a physician certifies that the illness or injury constitutes an emergency which requires immediate hospital care.

SECTION 9. To qualify a county for assistance under this program the governing authority of said county shall have certified that:

a. The county elects to participate in the program;

b. A local budget providing the funds required by the graduated matching formula has been approved;

c. A local administrative agency or officer has been appointed;

d. A screening committee or agency has been appointed to make determinations and certifications relative indigency of persons applying for assistance as provided for in this Act.

SECTION 10. The board is authorized and empowered to enter into agreements with other State Departments, boards and agencies of the United States Government, local governmental agencies, and voluntary organizations to obtain funds for hospital care that may be available for needy persons and the board is authorized to receive and administer any funds available by such agreements in conformity with the provisions of this Act; provided, that the authority granted in this Act shall not prevent the State Department of Public Welfare from complying with the provisions of a Social Security Act Governing Medical Care (U.S.C.A. 14-701, et seq.).

SECTION 11. The board is authorized and empowered to accept and expand any and all gifts and donations that may be made available to said board for purposes of this Act.

SECTION 12. There shall be established a Hospital Care Council, the members of which shall be appointed by the Governor. The council shall advise with the board relative to policies, procedures and standards to be embodied in rules and regulations adopted and promulgated by the board. The membership of the council shall consist of two (2) county commissioners appointed from nominations made by the Association of County Commissioners of Georgia; two (2) hospital trustees appointed from nominations made by the Association of Hospital Governing Boards; two (2) physicians appointed from nominations made by the Medical Association of Georgia; two (2) hospital administrators appointed from nominations made by the Georgia Hospital Association; and three (3) citizens, not members of any of the foregoing groups, appointed by the Governor and representing the State at large, the Director of the State Department of Public Health, ex officio; and the Director of the State Department of Public Welfare, ex officio. Appointments made by the Governor as provided for above shall be from lists of nominees furnished by the Associations herein named and such lists shall contain two nominees for each appointment to be made. If any of the above named Associations ceases to function then the Governor shall make appointments for the association. When the appointments are first made one member from each of the associations shall be appointed for a term of two (2) years and one (1) member from each association shall be appointed for a term of four (4) years, and of the three members representing the State at large, one (1) shall be appointed for a term of two (2) years, one (1) for a term of three (3) years, and one (1) for a term of four (4) years. After the expiration of the first appointments all appointments shall be made for a period of four (4) years. The term of any ex officio member shall expire with his term of office and his successor in office shall succeed him as a member of the council. An ex officio member may designate a deputy to serve in his place as a member of the council. Such deputy member shall be subject to the same duties and responsibilities as would be imposed upon the ex officio member. Vacancies in the membership of said council shall be filled in the same manner as the original appointments. The council shall select one of its members to serve as chairman and one of its membership to serve as vice chairman. The council shall meet at the call of the chairman or upon written request of any seven (7) members and seven (7) members shall constitute a quorum for the transaction of business. The council is authorized to adopt such by-laws, rules and regulations as it may deem necessary for the proper conduct of its proceedings in the carrying out of its duties. The Director of the State Department of Public Health shall furnish the necessary clerical assistance from among employees of the Department of Public Health as may be required by the council.

SECTION 13. The ex officio members of the Hospital Care Council shall be paid actual and necessary travel and other expenses incurred in carrying out the functions and duties of the Council and all other members shall receive twenty dollars ($20.00) per day for each day they are engaged in their duties as members of the council, in lieu of their personal expense incurred thereby, and shall receive mileage, at the rate provided by law, to and from the place of meeting by the nearest practical route for their respective homes. All such expenses, shall be paid from the funds appropriated to the Department of Public Health. Members of the council shall receive no emoluments or compensation for their services as such members.

SECTION 14. This Act shall not be construed as replacing Federal, State or local programs for the indigent but may supplement such programs for hospital care of the indigent.

SECTION 15. Any person knowingly obtaining or attempting to obtain, or who aids or abets any other person to obtain or attempt to obtain by means of a willfully false statement or representation or impersonation, or other fraudulent device, any benefits provided by this Act, to which he is not lawfully entitled shall be deemed guilty of a misdemeanor and upon conviction thereof shall be punished as provided by law.

SECTION 16. In the event any section, subsection, sentence, clause or phrase of this Act shall be declared or adjudged invalid or unconstitutional, such adjudication shall in no manner affect the other sections, subsections, sentences, clauses or phrases of this Act, which shall be and remain in full force and effect, as if the section, subsection, sentence, clause or phrase so declared or adjudged invalid or unconstitutional was not originally a part thereof. The legislature hereby declares that it would have passed the remaining parts of this Act if it had known that such part or parts thereof would be declared or adjudged invalid or unconstitutional.

SECTION 17. This Act shall become effective when State funds become available for carrying out the provisions of this Act.

SECTION 18. All laws and parts of laws in conflict herewith are hereby repealed.

History

Authority: Ga. L. 1933, p. 7
History. Original Rule entitled "Appendix" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Subject 111-3-14 Ambulance Provider Matching Payment Program

Ga. Comp. R. & Regs. r. 111-3-14-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-3-14-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-14-.01}

As used in this Chapter 111-3-14:

(2) "Department" means the Department of Community Health established under O.C.G.A. § 31-2-1 .

(3) "Ambulance Service" for the purpose of this rule means a private entity performing services as defined in O.C.G.A. § 31-11-2(4)(A) , specifically, for providing emergency care and transportation on the public streets and highways of this state for a wounded, injured, sick, invalid, or incapacitated human being to or from a place where medical or hospital care is furnished, and where such private entity is licensed by the Department of Public Health and is a 911 responding ambulance provider, either designated as a 911 provider or providing services under a service delivery contract for a designated 911 provider.

(4) "Net Patient Revenue" means the total gross patient revenue of an Ambulance Service less contractual adjustments, charity care, bad debt, or any other write-offs.

(5) "Provider Matching Payment" means payment assessed by the Department pursuant to this Chapter on providers which operate a Private Ambulance Service.

(6) "Private Ambulance Service" means an Ambulance Service, as defined in this Chapter, other than:

(a) An Ambulance Service owned and operated by the Federal government

(b) An Ambulance Service owned and operated by a unit of State government

(7) "Segregated Account" means an account for the dedication and deposit of Provider Matching Payments which is established within the Trust Fund.

(8) "State Plan Amendment" means all documentation submitted by the Commissioner, on behalf of the Department, to and for approval by the Secretary of Health and Human Services pursuant to the Title XIX of the Federal Social Security Act of 1935, as amended.

(9) "Trust Fund" means the Indigent Care Trust Fund created by article 6 of Chapter 8 of Title 31.

(10) "Waiver" means a waiver of the requirements for permissible health care related taxes, as provided for in 42 C.F.R. § 433.68 .

History

Authority: O.C.G.A. § 31-11-31.2
History. Original Rule entitled "Definitions" adopted. F. Aug. 15, 2022; eff. Sep. 4, 2022.

Ga. Comp. R. & Regs. r. 111-3-14-.02 Payments to the Segregated Account {#sec-ga.-comp.-r.-regs.-r.-111-3-14-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-14-.02}

(1) There is established within the Trust Fund a Segregated Account for revenues raised through the imposition of the Provider Matching Payment. Any Provider Matching Payment assessed pursuant to this Chapter shall be deposited into the Segregated Account. No other funds shall be deposited into the Segregated Account. All funds shall be invested in the same manner as authorized for investing other moneys in the state treasury.

(2) Each Private Ambulance Service shall be assessed a Provider Matching Payment in an amount that shall not exceed the amount necessary for this program to obtain federal financial participation allowable under Title XIX of the Social Security Act.

(3) The Provider Matching Payment shall be paid quarterly by each Private Ambulance Service to the Department. Payment of the Provider Matching Payment shall be due on the last day of the last month of each calendar quarter; the first payment shall be due on September 30, 2022, or 30 calendar days after Board approval of this rule, whichever is later.

(4) The Department shall prepare and distribute a form on which each Ambulance Service shall submit information to comply with this Chapter.

(5) Each Ambulance Service shall keep and preserve for a period of seven (7) years such books and records as may be necessary to determine the amount for which it is liable under this Chapter. The Department shall have the authority to inspect and copy the records of an Ambulance Service for purposes of auditing the calculation of the Provider Matching Payment. All information obtained by the Department pursuant to this Chapter shall be confidential and shall not constitute a public record.

(6) The Department may impose a penalty of up to six percent (6%) for any Ambulance Service that fails to pay a Provider Matching Payment within the time required by the Department for each month or fraction thereof that the Provider Matching Payment is overdue. If a required Provider Matching Payment has not been received by the Department by the last day of the last month of the calendar quarter, the Department may withhold an amount equal to the Provider Matching Payment and penalty owed from any medical assistance payment due such Ambulance Service under the Medical program. Any Provider Payment assessed pursuant to this Chapter shall constitute a debt due the state and may be collected by civil action and the filing of tax liens in addition to such methods provided for in this Chapter. Any penalty that accrues pursuant to this Rule shall be credited to the Segregated Account.

(7) If the Department determines that an Ambulance Service has underpaid the Provider Payment, the Department shall notify the Ambulance Service of the balance of the Provider Payment that is due. Such payment shall be due within thirty (30) days of the Department's notice.

History

Authority: O.C.G.A. § 31-11-31.2
History. Original Rule entitled "Payments to the Segregated Account" adopted. F. Aug. 15, 2022; eff. Sep. 4, 2022.

Ga. Comp. R. & Regs. r. 111-3-14-.03 Use of Provider Payments {#sec-ga.-comp.-r.-regs.-r.-111-3-14-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-14-.03}

(1) The Department shall collect the Provider Matching Payments imposed pursuant to this Chapter. All revenues collected pursuant to this Chapter shall be deposited into the Segregated Account. Such funds shall be dedicated and used for the sole purpose of obtaining federal financial participation for medical assistance payments to Private Ambulance Service providers on behalf of Medicaid recipients pursuant to Article 7 of Chapter 4 of Title 49.

History

Authority: O.C.G.A. § 31-11-31.2
History. Original Rule entitled "Use of Provider Payments" adopted. F. Aug. 15, 2022; eff. Sep. 4, 2022.

Ga. Comp. R. & Regs. r. 111-3-14-.04 Effective Date {#sec-ga.-comp.-r.-regs.-r.-111-3-14-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-3-14-.04}

Upon the adoption by the Board, Chapter 111-3-14 shall become effective on July 1, 2022.

History

Authority: O.C.G.A. § 31-11-31.2
History. Original Rule entitled "Effective Date" adopted. F. Aug. 15, 2022; eff. Sep. 4, 2022.

Chapter 111-4 State Health Benefit Plan

Subject 111-4-1 State Health Benefit Plan

Ga. Comp. R. & Regs. r. 111-4-1-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.01}

(1) "Active" means that the Employee is receiving compensation or is on Approved Leave of Absence Without Pay through a department, school system, Local Employer, agency, authority, board, commission, county department of family and children services, county department of health, community service board, or Contract Employer and for whom the Employee's cost of Coverage is stated as a payroll Deduction or Reduction.

(2) "Acts" or "The Acts" or "The Health Insurance Acts" mean the legislative Acts that establish the Health Insurance Plans for State Employees, Teachers, and Public School Employees and are designated in the Official Code of Georgia Annotated as Article 1 of Chapter 18 of Title 45 and Articles 880 and 910 of Chapter 2 of Title 20.

(3) "Administrator" means the Department of Community Health or the Commissioner of the Department of Community Health.

(4) "Administrative Services" means the services that are provided by contract for a self-insured Health Benefit Plan.

(5) "Approved Leave of Absence Without Pay" means a period of time approved by the appropriate organizational official during which the Employee is absent from work and is not in pay status.

(6) "Annual Required Contribution" means an actuarially determined amount to pay for future OPEB liability over a period of years.

(7) "Beneficiary" means an Employee, Surviving Spouse, divorced or legally separated Spouse, or eligible Dependent child who loses Coverage under these regulations.

(8) "Benefits" mean the schedule of Benefits of health care services eligible for approval of payments under the Options approved by the Board.

(9) "Board of Community Health" or "Board" means the governing body authorized to exercise jurisdiction over the SHBP pursuant to O.C.G.A. § 31-2-3 .

(10) "Cafeteria Plan" means a plan which meets the requirements of the regulations of the Internal Revenue Service under Internal Revenue Code (IRC) 125.

(11) "Certificated Capacity" means the Employee holds valid certification; is not assigned to a position that requires certification as a qualification; the Employee's compensation is determined, at least in part, based upon the certificate; and the Employee is a member of the Teachers Retirement System or other Public School Teacher retirement system.

(12) "Certificated Position" means the Employee holds valid certification; is assigned to a position that requires certification as a qualification; the Employee's compensation is determined, at least in part, based upon the certificate; and the Employee is a member of the Teachers Retirement System or other Public School Teachers retirement system.

(13) "Claim" means any bill, invoice, or other written statement from a specific provider for health care services or supplies submitted in accordance with the requirements of the SHBP for a specific eligible Member.

(14) "Commissioner" means the Commissioner of the Department of Community Health as created by O.C.G.A. § 31-2-6 .

(15) "Contract Employee" means a person employed by one of the entities that contracts with the Board of Community Health to provide health benefit Coverage under the SHBP, and who is not considered to be an independent contractor.

(16) "Contract Employer" means one of the organizational entities that has elected to contract with the Board of Community Health for inclusion of their Employees in the SHBP.

(17) "Contribution" means the amount or percentage of salaries to be paid by an Employing Entity or State Department of Education for Employees and Retirees for health benefit Coverage.

(18) "Coverage" means the type, Tier, and Option of contract offered to an Enrolled Member pursuant to the Health Insurance Acts. "Coverage" does not include TRICARE Supplemental Coverage.

(19) "Covered Dependent" means any individual eligible under these regulations and for whom the Premium has been paid by the Employee, Retiree, or Extended Beneficiary.

(20) "Creditable Coverage" means health insurance that may serve to reduce a Pre-existing Condition limitation period. Creditable Coverage shall include health plan offerings under the following type plans: group health plans; individual health policies; Health Maintenance Organizations (HMOs); Medicaid; Medicare; or other governmental health programs. Disease specific policies (i.e., cancer insurance), disability insurance, and insurance that provides incidental health insurance (i.e., auto insurance) is not Creditable Coverage.

(21) "Deduction" or "Reduction" means the Premium amount to be remitted to the Administrator as the Employee's or Retiree's share of the cost of the elected Coverage.

(22) "Dependent" means any eligible Spouse, Dependent child, or Totally Disabled Child.

(23) "Employee" means any eligible, Active State Employee, Teacher, or Public School Employee.

(24) "Employing Entity" means any department, school system, Local Employer, Contract Employer, agency, authority, board, commission, county department of family and children services, county department of health, community service board or retirement system that employs or issues an annuity check to an Employee, Contract Employee or Retiree as defined in these regulations.

(25) "Enrolled Member" means the contract holder who may be the Employee, Retiree, Contract Employee, or Extended Beneficiary who is currently enrolled in Coverage and who has paid the necessary Deduction or Premium for such Coverage.

(26) "Extended Beneficiary" means the individual who was covered as an Active or Retired Employee, Employee on Approved Leave of Absence Without Pay or person who was covered as a Spouse or eligible Dependent of an Active or Retired Employee or Employee on Approved Leave of Absence Without Pay on the day SHBP Coverage was lost as a result of a Qualifying Event under the requirements of federal law and regulation known as the Consolidated Omnibus Budget Reconciliation Act (COBRA), as amended.

(27) "Fund" or "Health Benefit Fund" or "Health Insurance Fund" means the State Employees Health Insurance Fund, the Teachers Health Insurance Fund, and the Public School Employees Health Insurance Fund.

(28) "Georgia Retiree Health Benefit Fund" or "GRHBF" means the fund which provides for costs of retiree post employment health insurance benefits. The fund shall be a trust fund of public funds; the Board in its official capacity shall be the fund's trustee; and the Commissioner in his or her official capacity shall be its administrator.

(29) "Group" means all eligible Employees authorized under a specific chapter, article or part of the Official Code of Georgia Annotated for Coverage under the SHBP.

(30) "Health Maintenance Organization" or "HMO" means an organization authorized and certified to provide services under Chapter 21 of Title 33 of the Official Code of Georgia Annotated.

(31) "Local Employer" means a county or independent board of education, regional or county libraries of Georgia, the governing authority of the Georgia Military College, or Regional Educational Service Areas.

(32) "Managed Care Plan" means plans that provide health Coverage through a specified network of providers with benefit differentials in cost sharing between in-network and out-of-network providers.

(33) "Medicare Advantage" means an Option that is offered to Retirees and is approved through the Centers for Medicare and Medicaid Services (CMS) as a Medicare Advantage plan under the Medicare Prescription Drug, Improvement and Modernization Act of 2003 and federal regulations thereunder.

(34) "Member" means a benefit eligible or ineligible Employee, former Employee, Retiree, or Extended Beneficiary.

(35) "Option" means a type of benefit schedule or premium rating category that is offered to an eligible Member through the SHBP.

(36) "Other Post Employment Benefits" or "OPEB" means retiree post-employment health insurance benefits.

(37) "Partial Disability" means the Employee is unable to perform the normal, full-time duties of the individual's occupation or employment due to disability, but is certified by his/her physician to return to work on a part-time basis following a period of disability for a fixed period of time in that individual's occupation or in a modified work capacity.

(38) "Payor, Primary" means the entity which is required by contract or law to reimburse or pay for covered health services without regard to any other benefit entitlement or contractual provision.

(39) "Payor, Secondary" means the entity which does not have the primary liability for providing benefit reimbursement for covered health services.

(40) "Plan" or "Health Insurance Plan" means the insurance Options formed by the combination of Health Insurance Plans for State Employees, Teachers, and Public School Employees.

(41) "Plan Year" means the twelve-month period beginning on January 1, and ending on the following December 31. The Commissioner shall have the flexibility to modify the SHBP Plan Year.

(42) "Pre-existing Condition" is a term defined by the Health Insurance Portability and Accountability Act of 1996 and regulations thereunder. In general, it means a sickness, injury, or other condition (except for pregnancy) for which medical advice, diagnosis, care or treatment was recommended or received within the six (6) months immediately before Coverage began under the Plan.

(43) "Premium" means the Enrolled Member's cost as set by the Board of Community Health for the elected Coverage

(44) "Public School Employee" means a person who is employed by the local school system, meets the eligibility requirements under these regulations and is receiving a salary for services.

(45) "Qualifying Event" means an event as defined by federal law or regulation that authorizes:

(a) eligibility for Extended Coverageor

(b) change in coverage election under a health benefit plan. Qualifying Events include changes in employment or family status as outlined in Sections 111-4-1-.06 , 111-4-1-.07 , and 111-4-1-.08 of these regulations.

(46) "Rate" means an amount set by the Board for the Enrolled Member Premium or an amount or percentage of salary set by the Board as the Employer's Contribution.

(47) "Regular Insurance" means Options that are not Medicare Advantage Options.

(48) "Retired Employee" or "Retiree" or "Annuitant" means a former State Employee, former Teacher, or former Public School Employee who met the eligibility criteria when Active or was included by specific legislation and who receives a monthly benefit from the Employees' Retirement System, Georgia Legislative Retirement System, Teachers Retirement System, Public School Employees Retirement System, Superior Court Judges Retirement System, District Attorneys' Retirement System, or local school system retirement system and an eligible and former Employee of a county department of family and children services or county department of health who receives a monthly benefit from the Fulton County Retirement System. In the case of a county health department Employee, the Employee must have been covered as an Active Enrolled Member and continued Coverage upon receiving an annuity from the Fulton County Retirement System. Retiree shall also include Enrolled Members who remit payment directly to the SHBP and who are eligible for Coverage as a Surviving Spouse of the eligible Employee or Retiree, and Extended Beneficiary who is eligible by virtue of State law, or an Annuitant whose monthly benefit from a retirement system is insufficient to pay the Premium for the Coverage in which enrolled.

(49) "Retiring Employee" means a Enrolled Member who is eligible to receive an immediate retirement benefit payment from the Employees' Retirement System, Georgia Legislative Retirement System, Teachers Retirement System, Public School Employees Retirement System, Superior Court Judges Retirement System, District Attorneys' Retirement System or local school system retirement system or an Enrolled Member of a county department of family and children services or county department of health who is eligible to receive an immediate retirement benefit payment from the Fulton County Retirement System.

(50) "Spouse" means an individual who is not legally separated, who is of the opposite sex to the Enrolled Member and who is legally married or who submits satisfactory evidence to the Administrator of common law marriage to the Employee or Retired Employee entered into prior to January 1, 1997 and is not legally separated.

(51) "State Employee" means a person employed by the State or a community service board and who meets the eligibility definitions of these regulations and who is receiving a salary or wage for services rendered.

(52) "State Health Benefit Plan" or "SHBP" means the health benefit plan administered by the Department of Community Health covering State Employees, Public School Teachers, Public School Employees, Retirees and their eligible Dependents, and other entities under The Acts for health insurance.

(53) "Summary Plan Description" is a booklet that describes the health benefits and other provisions of the State Health Benefit Plan (SHBP) specific to the Coverage elected by the Enrolled Member.

(54) "Surviving Spouse" means the living Spouse of a deceased Enrolled Member.

(55) "Teacher" or "Public School Teacher" means a person employed by a local school system in a Certificated Position and who meets the eligibility definitions of these regulations and who is receiving a salary or wage for services rendered.

(56) "Tier" means the number and relationship to the Enrolled Member of the persons enrolled under the Member's Coverage.

(57) "Total Disability" means that the Enrolled Member is not able to perform any and every duty of the individual's occupation or employment or that the Dependent is not able to perform the normal activities of a person of like age or sex.

(58) "TPA" or "Third-party Administrator" means an approved contractor for adjudicating paying Claims, and performing other administrative processes.

(59) " TRICARE Supplemental Coverage " means insurance made available to Members who are eligible for SHBP Coverage and entitled to health care benefits under the TRICARE program, and for which premiums are collected by the Administrator and transferred to the company that sells the TRICARE Supplemental Coverage. TRICARE Supplemental Coverage provides health care benefits that are supplementary to health care benefits under TRICARE. The purchase of TRICARE Supplemental Coverage by eligible Members is facilitated by the Administrator and Employing Entities in accordance with the John Warner National Defense Authorization Act for Fiscal Year 2007 and implementing regulations. TRICARE Supplemental Coverage is a voluntary, unsubsidized benefit and is not endorsed or subsidized by the Administrator or any Employing Entity. The Administrator and Employing Entities provide minimal administrative duties with regard to TRICARE Supplemental Coverage, which duties are limited to providing information about the TRICARE Supplemental Coverage to Members and facilitating the collection of premiums for such coverage and transmittal of the premiums to the company that sells the TRICARE Supplemental Coverage. Neither the Board, nor the Administrator nor any Employing Entity provides any incentive to Members to enroll in TRICARE Supplemental Coverage. Neither the Board, nor the Administrator, nor any Employing Entity receives any compensation or consideration for offering TRICARE Supplemental Coverage. TRICARE Supplemental Coverage is not considered SHBP Coverage.

History

Authority: O.C.G.A. Secs. 20-2-881, 20-2-892, 20-2-911, 45-18-2, Health Insurance Portability and Accountability Act of 1996 (HIPAA), Consolidated Omnibus Budget Reconciliation Act (COBRA). Patient Protection and Affordable Care Act (PPACA); John Warner National Defense Authorization Act for Fiscal Year 2007
History. Original Rule entitled "Definitions" adopted. F. Apr. 18, 2005; eff. May 8, 2005.
Repealed: New Rule of same title adopted. F. Jan. 22, 2007; eff. Feb. 11, 2007.
Amended: F. Oct. 15, 2007; eff. Nov. 4, 2007.
Repealed: New Rule of same title adopted. F. Apr. 14, 2010; eff. May 4, 2010.
Amended: F. Jan. 26, 2011; eff. Feb. 16, 2011.
Amended: F. Jan. 17, 2012; eff. Feb. 6, 2012.

Ga. Comp. R. & Regs. r. 111-4-1-.02 Organizations {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.02}

(1) Functions, Duties and Responsibilities of the Board of Community Health. The Board shall provide policy direction for the operation of the State Health Benefit Plan. Other responsibilities as defined by law are:

(a) Establish and Design Plan . The Board is authorized to establish a Health Insurance Plan for group medical insurance against the financial costs of hospitalizations and medical care. The Plan may also include, but is not required to include, prescription drugs, prosthetic appliances, hospital inpatient and outpatient Benefits, dental Benefits, vision care Benefits, and other types of medical Benefits. The Plan shall be designed to:

Provide reasonable hospital, surgical, and medical benefits with cost sharing of expenses for each such type to be incurred by the Enrolled Members, Dependents and the Plan, and
Include reasonable controls, which may include deductible and reinsurance provisions applicable to some or all of the benefits, to reduce unnecessary utilization of the various hospital, surgical and medical services to be provided and to provide reasonable assurance of financial stability in future years of the Plan.

(b) Promulgate Regulations. The Board is authorized to adopt and promulgate rules and regulations for the effective administration of the SHBP; to adopt and promulgate regulations for defining the contract(s) for Retiring Employees and their Spouses and Dependent children; to adopt and promulgate regulations for prescribing the conditions under which an Employee or Retiring Employee may elect to participate in or withdraw from the SHBP; to adopt and promulgate regulations defining the conditions for covering the eligible Member's Spouse and Dependent children and for discontinuance and resumption by eligible Members of Coverage for the Spouse, Surviving Spouse, and Dependents; to adopt and promulgate regulations to establish and define terms and conditions for former and terminated eligible Member participation; adopt and promulgate rules and regulations which define the conditions under which eligible Members who originally rejected Coverage may acquire Coverage at a later date; and adopt and promulgate rules and regulations for withdrawing from the SHBP upon eligibility for the aged program of the Social Security Administration. Additionally, the Plan shall be required to establish the same eligibility requirements, unless either State or federal law, or regulations promulgated by the State of Georgia's Insurance Commissioner requires a modification.

(c) Establish Member Premium Rates. The Board shall establish Member Premium Rates for each Coverage Option. The Board shall consider the actuarial estimate of the SHBP costs and the funds appropriated to the various departments, boards, agencies, and school systems in establishing the Employee Deduction amount. Other Member Premium amounts shall be established in accordance with these regulations. All Enrolled Member Premium Rates shall be established by resolution and shall remain in effect until changed by resolution.

Tobacco Surcharge. An Enrolled Member may be charged a tobacco surcharge in an amount approved by the Board if either the Enrolled Member or any of his or her Covered Dependents have used tobacco products in the previous twelve (12) months. The surcharge amount will be added to the Enrolled Member's base monthly Premium. Any Enrolled Member who fails to answer any designated question(s) relating to the surcharge during Open Enrollment will automatically be charged a surcharge for the remainder of the Plan Year, unless the tobacco user successfully completes a tobacco cessation program, or other similar program, specifically designated by the SHBP.
Spousal Surcharge. An Enrolled Member may be charged a spousal surcharge in an amount approved by the Board if the Enrolled Member elects to cover his or her Spouse and the Spouse is eligible for health benefits through his or her employer but opts not to take those benefits. Notwithstanding the foregoing, if the Spouse is already eligible for Coverage with the SHBP through his or her employment, and the Spouse answered the surcharge question(s) on-line, the SHBP will not add the surcharge to the Premium amount. Any Enrolled Member who fails to answer any designated question(s) relating to the surcharge during Open Enrollment will automatically be charged the surcharge for the remainder of the Plan Year.

(d) Establish Employer Rates. The Board shall establish by Resolution, subject to the Governor's approval, Employer Contribution Rates. These rates may be a dollar amount for each Member, a dollar amount for each Enrolled Member, a percentage of Member salary or any other method permitted by law. If the rates are expressed as a percentage of Member salary, the requirements of (4) and (5) below apply. The Commissioner is authorized to establish necessary procedures to facilitate the receipt of Employer Contributions on a timely and accurate basis.

The Employer Contribution Rate for Teachers who retired prior to January 1, 1979 may be a dollar amount as identified in the Appropriations Act.
The State Department of Education Employer Contribution Rate for the Public School Employee Health Insurance Fund may be a dollar amount as identified in the Appropriations Act.
The local school system Employer Contribution Rate for the Public School Employee Health Insurance Fund may be a dollar amount per Enrolled Member and shall be remitted to the Administrator on a monthly basis. The Employer's Contribution amount shall be due to the Administrator on the first of the month coincident with the Employees' monthly Premium amounts.
The Employer Contribution Rate for the Teachers Health Insurance Fund may be a percentage of the salary approved by the State Board of Education under the Quality Basic Education Act for persons holding "Certificated Positions" or in a "Certificated Capacity". If it is expressed as a percentage of salary, the monthly Employer Contribution shall be a percentage of state based salaries. County or district libraries shall pay as the Employer Contribution the Board approved percentage of total salaries, exclusive of per diem and casual labor, which is defined as part-time Employees who work less than seventeen and a half (17 1/2) hours per week. The Employer's contribution amount shall be due to the Administrator on the date coincident with the Employees' monthly Premium amounts.
The Employer Contribution Rate for the State Employees Health Insurance Fund may be a percentage of the total salaries of all Members. Total salaries include temporary salaries, overtime pay, terminal leave pay, and all types of supplemental pay. If it is expressed as a percentage of salary, the monthly Employer Contribution shall be based on salaries for the previous month and shall be due on the date coincident with the Employees' monthly Premium amounts.
The Employer Contribution Rate required for coverage of local school board members shall be based on the actual claims experience of all county officers, employees, and local school board members enrolled in the SHBP.
The Contributions required from Contract Employers shall be calculated in a manner designed to ensure that Contract Employers pay the full cost of coverage for Enrolled Members, plus an administration fee.

(e) Approve Contracts. The Board is authorized to approve contracts for insurance, reinsurance, health services, and administrative services for the operation of the Plan. The Board is authorized to approve contracts as authorized by law with governments, authorities, or other organizations for inclusion in the Plan.

Insurance . The Board may execute a contract or contracts to provide the Benefits under the Plan. Such contract or contracts may be executed with one or more corporations licensed to transact accident and health insurance business in Georgia. The Board shall invite proposals from qualified insurers who, in the opinion of the Board, would desire to accept any part of the health benefit Coverage. Any contracts that the Board executes with insurers shall require compliance with O.C.G.A. § 10-1-393(b) (30.1) relating to certain unfair practices in consumer transactions. The Board may reinsure portions of a contract for the Plan. At the end of any contract year, the Board may discontinue any contract or contracts it has executed with any corporation or corporations and substitute a contract or contracts with any other corporation or corporations licensed to transact accident and health insurance business in Georgia.
Self Insurance. The Board in its discretion may establish a self-insured Plan in whole or in part. The contract for Administrative Services in connection with a self-insured health benefit plan may be executed with an insurer authorized to transact accident and sickness insurance in Georgia; with a hospital service nonprofit corporation, nonprofit medical service corporation, or health care corporation; with a professional claim Administrator authorized or licensed to transact business in Georgia; or with an independent adjusting firm with Employees who are licensed as independent adjusters pursuant to Article 2 of Chapter 23 of Title 33.
Local Governments. The Board is authorized to contract with the various counties of Georgia, the County Officers Association of Georgia, the Georgia Cooperative Services for the Blind, public and private nonprofit sheltered employment centers which contract with or employ persons within the Division of Rehabilitation Services and the Division of Mental Health and Mental Retardation of the Department of Human Resources; and to contract with the Georgia Development Authority, the Georgia Agrirama Development Authority, the Peace Officer's Annuity and Benefit Fund, the Georgia Firefighters' Pension Fund, the Sheriffs' Retirement Fund of Georgia, the Georgia Housing and Financing Authority, the Georgia-Federal State Inspection Service for the inclusion of eligible Members, retiring Enrolled Members and Dependents in the SHBP. The Board is authorized to include the Georgia-Federal State Inspection Service Employees who retired under the Employees' Retirement System of Georgia on or before July 1, 2000. The term of these contracts shall be established by the Department in accordance with these regulations and Board resolutions. The Board is authorized to contract with local boards of education for inclusion of current board members and their Dependents in the SHBP. The terms of such contracts are established by these regulations once an election for inclusion has been submitted to the Department by the local board of education. Each Contract Employer shall deduct from the Enrolled Members salary the Member's cost of Coverage. In the case of the Georgia Development Authority, the Peace Officers' Annuity and Benefit Fund, the Georgia Firefighters' Pension Fund, the Sheriffs' Retirement Fund of Georgia, the Georgia Housing Authority, and the Georgia Agrirama Development Authority, the Retiree's cost of Coverage shall be deducted from the Retired Enrolled Member's annuity payment. In addition, each Contract Employer shall make the Employer Contribution required for inclusion in the Plan and remit such payments in accordance with procedures as the Administrator may require.
Consumer Driven Health Plans (CDHPs). The Board may contract with any CDHP qualified and licensed to conduct business in Georgia pursuant to Chapter 21 of Title 33 of the Official Code of Georgia Annotated.
Other Organizations. The Board is authorized to contract with other organizations, including any public or nonprofit critical access hospital, and any federally qualified health center as defined in 42 U.S.C.A. 1395x(aa)(4) , that meets such requirements as the Administrator may establish for the inclusion of eligible Members and Dependents in the SHBP. Each Contract Employer shall deduct from the Enrolled Member's salary the Member's share of the cost of Coverage. Each Contract Employer shall remit the total Premium amount as established by the Administrator for inclusion of its Members in the Plan and in accordance with such procedures as the Administrator may require. The Board may require that specified Groups provide a bond to ensure payment performance before allowing SHBP Coverage.
Health Maintenance Organizations (HMOs) . The Board may contract with any HMO qualified and licensed to conduct business in Georgia pursuant to Chapter 21 of Title 33, relating to Health Maintenance Organizations.
Local School Systems. When a school system has elected not to participate in the SHBP for Public School Employees, the Employees may petition the local school system to contract with the Board for an Employee-Pay-Group. The local system may contract with the Board after agreeing to:

(i) Collect the Enrolled Member Premium amounts for the Rates established by the Board; and

(ii) Enroll and maintain enrollment at 75% of the eligible Public School Employees as defined in these regulations.

(2) Functions, Duties and Responsibilities of the Commissioner. The Commissioner is the chief administrative officer of the Department of Community Health. The Commissioner and Administrator as used in these regulations are synonymous. The Commissioner shall employ such personnel as may be needed to administer the SHBP, to appoint and prescribe the duties of positions, all positions of which shall be included in the classified service except as otherwise provided in the law, and may delegate administrative functions and duties at the Commissioner's discretion.

(a) Administer Regulations and Policies. The Commissioner shall administer the SHBP consistent with applicable law, Board regulation and policy.

(b) Custodian of Funds. The Commissioner shall be the custodian of the health benefit Funds and shall be responsible under a properly approved bond for all monies coming into said Funds and paid out of said Funds.

All amounts contributed to the Funds by the Member and the Employers and all other income from any source shall be credited to and constitute a part of such trust Funds. Any amounts remaining in such Fund(s) after all expenses have been paid shall be retained in such Fund(s) as a special reserve for adverse fluctuation.
The Commissioner shall establish accounting procedures for maintaining trust Funds for the Premium income, interest earned on the income and expenses and benefits paid. Any amounts remaining in each trust Fund after all expenses have been paid shall be retained wholly for the benefit of the members who are eligible and who continue to participate in each health insurance trust.
The Commissioner shall submit to the Director of the Office of Treasury and Fiscal Services any amounts available for investment, an estimate of the date such Funds shall no longer be available for investment, and when Funds are to be withdrawn. The director of the Office of Treasury and Fiscal Services shall deposit the Funds in a trust account for credit only to the Plan and shall invest the Funds subject only to the terms, conditions, limitations and restrictions imposed by the laws of Georgia upon domestic life insurance companies.
The Commissioner may administratively discharge a debt or obligation not greater than $400.00 due the Health Insurance Fund or Funds.
Accurate and Timely Payment of Employer or Employee Contributions.

(i) Payroll System and Other Supporting Documentation Required. Employing Entities that pay Employer Contributions calculated based on salaries or state based salaries must submit the documentation set forth below, in the format required by the Administrator.

(I) Annually and upon request of the Administrator, the Employing Entity must submit documentation showing that the Employing Entity's payroll software is set up to correctly reflect the salary or state-based salary used to determine the required Employer Contribution for each month. This requirement may be satisfied by the State Accounting Office on behalf of all Employing Entities that use payroll software managed by the State Accounting Office.

(II) At the time of each payment of Contributions, the Employing Entity must submit the summary page from the payroll software that displays the total salary or state-based salary used to determine the required Employer Contribution for that month, documentation showing that Employee Contributions were properly calculated and remitted, and documentation showing that Employer and Employee Contributions required for employees on unpaid leave of absence were properly calculated and remitted.

(ii) Local Employers. When a required payment from a local Board of Education, RESA, library or charter school is not received by the deadline, the Administrator shall notify the appropriate superintendent or official and the State Board of Education of the delinquency. The State Board of Education is required by law to withhold all allotments to the local Board of Education, RESA, library or charter school until the full required payment is received.

(iii) Entities Included in the SHBP Pursuant to Contract. Upon providing written notice, the Commissioner may terminate Coverage for any Group that either contracts for SHBP Coverage or is designated by applicable state law as eligible for such Coverage for failure to remit either Employee or Employer Contributions. Upon remittance of the required contributions from any Group that either contracts for SHBP Coverage or is designated by applicable state law as eligible for such Coverage, the SHBP may reinstate Coverage that has been terminated previously for failure to remit Premiums.

(c) Regulations . The Commissioner shall recommend to the Board amendments to the regulations, submit the approved regulations to appropriate filing entities, cause all regulations to be published and provide a copy to the Employing Entities.

(d) Elicit and Evaluate Proposals from Health Care Contractors and/or Administrators. As required for the appropriate administration of the Plan, the Commissioner shall cause to be prepared requests for proposals for selection of health care contractors, vendors, or administrators. Upon receipt of the proposals, the Commissioner shall secure an evaluation of the proposals and submit recommendations for the selection of health care contractors, vendors, or administrators to the Board for approval.

(e) Calculate Employer Contribution Rates . The Commissioner shall cause to be calculated Employer Contribution Rates expressed in the manner specified in Section 111-4-1-.02(d)(1) - (5) of these regulations. These Employer Contribution Rates shall be calculated and presented to the board by such time as is required for the Commissioner to meet the notification deadline set forth in (h) below.

(f) Premium Payments to a Contractor. The Commissioner shall cause to be calculated the Premium amounts due to any underwriter of insurance or re-insurance and remit payments from the appropriate trust Funds for Member Coverage.

(g) Develop and Publish Enrollment Materials, Legal Notices, and Plan Documents. The Commissioner shall cause to be developed enrollment materials, legal notices, and plan documents for Coverage Options. Plan documents shall include, for each Option, a Summary Plan Description (SPD) or Certificate of Coverage which incorporates the approved schedule of Benefits, eligibility requirements, Termination of Coverage provisions, Extended Coverage provisions, to whom benefits will be payable, to whom claims should be submitted, and other administrative requirements. The Commissioner or designee shall publish enrollment materials, legal notices and plan documents on the portion of the Department Website dedicated to the State Health Benefit Plan, and shall provide electronic versions of the enrollment materials, legal notices and plan documents to each local and state Employer for distribution to eligible Members and Enrolled Members. The Commissioner or designee shall cause to distribute the enrollment materials, legal notices and plan documents to Retired Enrolled Members and Extended Beneficiaries at their last known address.

(h) Provide Notice of Employer Contribution. The Commissioner shall provide notice and certification of the required Employer Contribution Rate to each of the Employing Entities and the Department of Education no less than thirty (30) days prior to the commencement of the plan year. The Commissioner shall notify the Employing Entities before the Rate is effective of any Rate change which may be required at times other than the beginning of a fiscal year.

(i) Provide Notice of Eligibility. The Commissioner shall develop procedures for notifying Extended Beneficiaries of the Extended Coverage provisions of Section 111-4-1-.08 of these regulations upon notification by the Employing Entity of the Enrolled Member's employment termination, death, or reduced hours or upon notification by the Member of divorce, legal separation, or child no longer meeting the definition of Dependent.

(j) Provide Certification of Creditable Coverage . The Administrator shall establish procedures for providing a Certificate of Creditable Coverage to each Enrolled Member in compliance with federal law. In general, this Certificate of Creditable Coverage must be provided at the time Coverage cancels or upon request of the Member or Covered Dependent and for a period of twenty-four (24) months after coverage cancellation. The Member may use the certification to limit a subsequent plan's imposition of a Pre-existing Condition limitation or exclusion period.

(k) Correction for Administrative Error. An administrative error is defined as any clerical error in submitting pertinent records or a delay in making any changes by the Employing Entity or Administrator that affects the Coverage for a Member or Dependent who has followed all established procedures and met the time deadlines regarding enrollment or maintenance of Coverage. If the error has placed the Member or Dependent at a substantial financial risk or risk of loss of Coverage, the facts shall be reviewed and corrective action taken. If the Administrator concludes that the Member or Dependent was substantially harmed, the Member or Dependent shall be restored to the former position or shall be granted the request in whole or in part. Any determination of an administrative error shall be left to the discretion of the Administrator and is not subject to challenge.

(l) Perform Minimal Administrative Duties and Maintain Documentation Associated with Tricare Supplemental Insurance. Any TRICARE Supplemental Insurance made available to Members shall be made available in accordance with the John Warner National Defense Authorization Act for Fiscal Year 2007 (the "DAA") and implementing regulations. The Administrator shall not endorse or subsidize TRICARE Supplemental Insurance and shall ensure that it provides only administrative support associated with enabling Members to elect TRICARE Supplemental Insurance and pay for such Insurance through salary deductions or annuity payments. The Administrator shall maintain the certification required by the DAA on behalf of all Employing Entities and provide such certification to the Department of Defense upon request. The Administrator shall take such other actions are necessary to ensure compliance with the DAA.

(3) Duties and Responsibilities of Employing Entity. Each Employing Entity is responsible for complying with these regulations. Statements made by the staff of the Employing Entities or any third party representing the Employing Entity, that are in conflict with these regulations, the Schedule of Benefits, Decision Guide, or the Summary Plan Description (SPD) shall not be binding on the Administrator. Failure of the Employing Entities to fulfill the duties and responsibilities listed in these regulations does not negate the time requirements specified throughout these regulations.

(a) Enroll Eligible Employees. Each Employing Entity shall determine which of its employees meet the SHBP eligibility requirements, which are set forth in the regulations. Each Employing Entity is solely responsible for compliance with State and federal employment laws with respect to its own employees. Each Employing Entity is solely responsible for complying with State and federal obligations to verify eligibility for receipt of health benefits that meet the definition of "public benefits" under applicable immigration laws. Each Employing Entity is solely responsible for obtaining all documentation required under applicable immigration laws, and taking all actions necessary to verify the employee's eligibility to receive "public benefits." Each Employing Entity shall provide enrollment materials, legal notices and plan documents to eligible Members and Enrolled Members, and shall instruct and assist all persons who become eligible to become Enrolled Members under these regulations how to complete the SHBP enrollment or declination process. The Employing Entity shall require each eligible new Member to complete, within thirty-one (31) calendar days of reporting to work, a form for enrolling or declining SHBP Coverage. The Employing Entity shall be responsible for collecting any Premiums due for the selected Coverage. Any penalties or claim expenses resulting from the Employing Entity's enrollment of an ineligible Member, or from the Employing Entity's failure to timely obtain the completed enrollment or declination form, or from the Employing Entity's failure to provide Plan Documents, legal notices or enrollment information to an eligible Member, shall be assessed against the Employing Entity. By facilitating the enrollment of a Member in the SHBP or communicating that a Member is eligible for the SHBP, the Employing Entity is affirming that it has taken all actions required by law for the provision of "public benefits" to that individual. Any penalties arising from the Employing Entity's failure to take such actions shall be assessed against the Employing Entity. Neither the Board nor the Administrator nor the Commissioner shall be liable for the failure of an Employing Entity to comply with employment laws or properly verify SHBP eligibility in accordance with State and federal immigration laws.

(b) Deduct Enrolled Member Premium Amounts . The Employing Entity shall withhold the Enrolled Member Premium amount as approved by the Board, or the Premium amount authorized by the applicable Georgia Code sections from earned compensation as the Enrolled Member's share of the cost of Coverage under the Plan. Any retirement system under which retired or retiring Enrolled Members may continue Coverage under the SHBP as an Annuitant shall withhold the Premium amount as approved by the Board from the annuity as the Enrolled Member's share of the cost of Coverage under the Plan.

(c) Remit Enrolled Members' Premiums and Required Employer Contributions. Employing Entities shall remit the following within five business days of the SHBP billing invoice's coverage month effective date:

Enrolled Members' premiums paid through salary deductions or annuity deductions;
Premiums collected from employees who have continued their coverage during an Approved Leave of Absence without Pay; and
Required Employer Contributions, which include contributions separately calculated for employees on an Approved Leave of Absence without Pay. For any contribution that is based on actual SHBP enrollment, each Employing Entity is responsible for reconciling any discrepancies between the billed amount and actual enrollment. All corrections to the employee coverage or deductions should be made prior to the coverage month's effective date. The Employing Entity shall follow the manner prescribed by the Administrator for both corrections and reconciliation. The amounts billed on the invoice will be considered final if reconciliations are not completed within 30 day of the billing invoice.

(d) Administer Leave Without Pay Provisions. Each Employing Entity shall administer Approved Leave of Absence Without Pay, Military Leave, and Family and Medical Leave Act Programs in compliance with the federal laws and shall provide information regarding the conditions for continuing Coverage under the SHBP to eligible Enrolled Members. Each Employing Entity shall also provide continuation of Coverage enrollment information to Members. Each Employing Entity shall insure Members on Approved Leave of Absence Without Pay are properly notified of the annual Open Enrollment period and afforded the opportunity to enroll or change Coverage. Each Employing Entity shall maintain procedures to ensure that Member Premiums are collected during these leave periods. If a Member fails to timely pay a Premium during the leave period, that failure causes a loss of eligibility for coverage unless federal law requires otherwise.

(e) Provide Member Loss of Eligibility Information to the Administrator. Each Employing Entity shall report to the Administrator the last date employed/eligible and the reason for the loss of employment/eligibility no later than thirty (30) days following the event leading to loss of eligibility to participate in the Plan. The reasons for loss of eligibility shall be limited to: failure of a Member to pay a required Premium during an approved leave of absence (unless federal law requires continuing coverage), resignation, transfer, retirement, termination of employment for gross misconduct, separation from employment for reasons other than gross misconduct, including, but not limited to loss of eligibility to work under applicable immigration laws, reduction in employment hours below the number of hours required for eligibility, lay-off, failure of an Enrolled Member to timely submit a required Premium during an approved leave of absence without pay, discontinuation, and death. Each Employing Entity is solely responsible for penalties or other liabilities arising from its failure to timely notify the Administrator of loss of eligibility for Coverage. Any claim expenses borne by the SHBP, and any penalties assessed upon the Administrator as a result of the Employing Entity's failure to timely notify the Administrator of a Member's loss of eligibility shall be billed to the respective Employing Entity. The Employing Entity shall reimburse the Administrator in full for claim liability and expenditures incurred by the Plan as a result of the Employing Entity's failure to comply with notification requirements.

(f) Protect the Privacy of Enrollment Information. The SHBP only shares enrollment information with designated employees of the Employing Entity who help with Plan enrollment. Each Employing Entity shall ensure that the SHBP is promptly notified whenever such an employee is no longer permitted to review and share enrollment information about Members with the SHBP. The Employing Entity shall ensure that designated employees are properly trained to protect the privacy and security of the enrollment information. The Employing Entity shall never use enrollment information for any purpose other than helping with enrollment in the Plan.

(g) Refrain from Endorsing TRICARE Supplemental Coverage or Providing Incentives for Members to Elect TRICARE Supplemental Coverage. If TRICARE Supplemental Insurance is made available, Employing Entities shall refrain from endorsing TRICARE Supplemental Insurance or providing any incentives to those who elect TRICARE Supplemental Insurance. Any TRICARE Supplemental Insurance is to be offered only in accordance with the requirements of the John Warner National Defense Authorization Act for Fiscal Year 2007 (the "DAA") and implementing regulations. Employing Entities shall not pay any portion of TRICARE Supplemental Coverage. Nor shall they provide any incentive to individuals who elect TRICARE Supplemental Coverage. Enrolled Members must elect TRICARE Supplemental Coverage by salary deduction or annuity deduction in the same manner they elect SHBP Coverage Options. Any penalties arising from impermissible incentives by the Employing Entity shall be assessed against the Employing Entity. Employing Entities shall provide certifications described in regulations to the Administrator or to the Department of Defense upon request.

History

Authority: O.C.G.A. Secs. 20-2-55, 20-2-881, 20-2-883 to 20-2-885, 20-2-891 to 20-2-896, 20-2-911 to 20-2-916, 20-2-918 to 20-2-922, 20-2-924, 31-5A, 45-18-1et seq., Health Insurance Portability and Accountability Act (HIPAA), Consolidated Omnibus Budget Reconciliation Act (COBRA), Family Medical Leave Act (FMLA). John Warner National Defense Authorization Act for Fiscal Year 2007; Illegal Immigration Reform and Enforcement Act of 2011; Georgia Security and Immigration Compliance Act; Personal Responsibility and Work Opportunity Reconciliation Act of 1996
History. Original Rule entitled "Organization" adopted. F. Apr. 18, 2005; eff. May 8, 2005.
Amended: F. Sept. 26, 2006; eff. Oct. 16, 2006.
Repealed: New Rule entitled "Organizations" adopted. F. Jan. 22, 2007; eff. Feb. 11, 2007.
Amended: F. May 25, 2007; eff. June 14, 2007.
Amended: F. Aug. 20, 2008; eff. Sept. 9, 2008.
Repealed: New Rule of same title adopted. F. Apr. 14, 2010; eff. May 4, 2010.
Amended: F. Jan. 26, 2011; eff. Feb. 16, 2011.
Amended: F. Jan. 17, 2012; eff. Feb. 6, 2012.

Ga. Comp. R. & Regs. r. 111-4-1-.03 General Provisions {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.03}

(1) Applicability. All Members who become eligible for Coverage under the SHBP shall be enrolled or permitted to change Coverage election only in accordance with these regulations. All Employing Entities covered by the Acts shall administer the SHBP in accordance with these regulations . All Annuitants or Extended Beneficiaries shall be enrolled or permitted to change Coverage election only in accordance with these regulations.

(2) Extension of SHBP to Eligible Groups. The Board shall review and approve provisions for extending Coverage to eligible Groups as required by law. The special provisions may include allowing Members or Beneficiaries to reenroll in the SHBP.

(3) Conformity with Federal Requirements. When federal law is enacted requiring public employers to comply with certain requirements for continued receipt of public health or other grant funds, the Commissioner shall submit proposed regulations to the Board for approval.

(4) Records. The Plan records shall be maintained in accordance with applicable State and federal law and regulations, including, but not limited to, Chapter 33 of Title 31 of the Georgia Code and the privacy regulations promulgated under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Records which are not private, confidential or otherwise excluded from disclosure shall be available for public inspection and copying, in accordance with the Georgia Open Records Act. Any medical records and other individually identifying health information presented to the Administrator or to any of the Third Party Administrators in the Claim adjudication process or medical review process shall be confidential and shall be accessible only in accordance with applicable State and federal law and regulations.

(5) Member Responsibility. The Member has responsibility for notifying the Employer and the Plan of discrepancies in the Member's Coverage records. Notwithstanding the foregoing, the requirements of this provision do not negate the Employer's responsibility. The Employing Entity must still fulfill notification and all other requirements set forth under these regulations.

(a) The Enrolled Member is responsible for assuring that the proper Premium payments are deducted or reduced from the Enrolled Member's salary or retirement benefit for the Coverage that the Enrolled Member selected. Premiums of Enrolled Members that are paid through direct pay are to be paid in accordance with their Coverage selection.

(b) The Enrolled Member is responsible for submitting such documentation as the Plan requires to verify the eligibility of Dependents to be added to Coverage within the timeframe allotted by the Plan. Any Dependents not verified within the Plan's allotted time shall not be eligible for Coverage until the next annual Open Enrollment period or subsequent Qualifying Event as described in these regulations.

(c) The Enrolled Member is responsible for updating Spouse and Dependent information and requesting appropriate changes in Coverage as the circumstances may warrant. The Enrolled Member shall reimburse the Plan in full for Claim liability and expenditures incurred by the Plan on behalf of a Dependent who does not meet the definition of an eligible Dependent under these regulations. Any refunds of Premiums (for reasons other than administrative error) will be limited to twelve (12) calendar months from the date that the Administrator receives evidence from the Enrolled Member that the Plan had no liability for additional covered persons.

(d) When the Enrolled Member desires to reduce the period under the insurance Options of limited Coverage for Pre-existing conditions which may apply to himself/herself or any Covered Dependent, the Enrolled Member shall provide the Administrator certification of prior Creditable Coverage from the appropriate health plan administrator.

(6) Gender and Number. Except when otherwise indicated by the context, any masculine terminology herein shall also include the feminine and the definition of any terms herein of the singular may also include the plural.

History

Authority: O.C.G.A. Secs. 20-2-881, 20-2-894, 20-2-897, 20-2-911, 20-2-922, 20-2-925, 45-18-1et seq., 50-18-72, 50-18-94, Health Insurance Portability and Accountability Act (HIPAA)
History. Original Rule entitled "General Provisions" adopted. F. Apr. 18, 2005; eff. May 8, 2005.
Amended: ER. 111-4-1-0.1-.03 adopted. F. June 13, 2005; eff. June 16, 2005, as specified by the Agency.
Amended: Permanent Rule adopted. F. Sept. 15, 2005; eff. Oct. 5, 2005.
Repealed: New Rule of same title adopted. F. Jan. 22, 2007; eff. Feb. 11, 2007.

Ga. Comp. R. & Regs. r. 111-4-1-.04 Eligibility for Coverage {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.04}

(1) Active Employees. Employees who are actively at work or on approved leave of absence and have not terminated their employment may participate in the SHBP if classified as the following:

(a) Full-Time.

State Employees who work a minimum of thirty (30) hours per weeks are considered full-time.
A regular full-time Employee who receives a salary or wage payment from a state department, board, agency, commission, the general assembly, a community service board, or a local government or other organization to which the Department of Community Health provides SHBP coverage through a contract authorized by the Board of Community Health; except contingent workers of the Labor Department, specially classified Employees of the Jekyll Island State Park Authority, Employees working as an independent contractor or on a temporary, seasonal, or intermittent basis and Employees whose duties are expected to require less than nine (9) months of service.
A regular full-time Employee who receives a salary or wage payment from a state authority that participates in the Employees' Retirement System;
Part-time Employees of the General Assembly who had coverage prior to January 1981, and Administrative and clerical personnel of the General Assembly;
A full-time district attorney, assistant district attorney who was appointed pursuant to O.C.G.A. § 15-18-14 , or district attorneys' investigators appointed pursuant to O.C.G.A. § 15-18-14.1 of the superior courts of this state;
A full-time Employee who receives a salary or wage payment from a county board of health or a county board of family and children services that receives financial assistance from the Department of Human Resources; except for sheltered workshop Employees;
Full-time secretaries and law clerks who are employed by district attorneys and judges and are employed under O.C.G.A. §§ 15-6-25 through 15-6-28 and O.C.G.A. §§ 15-18-17 through 15-18-19 .

(b) Teachers who are employed not less than half time, which must be at least seventeen and a half (171/2) hours per week, in the public school systems of Georgia are eligible to participate under these regulations. An eligible teacher shall not include any independent contractor, emergency or temporary person and is further defined as:

A person employed in a professionally Certificated Capacity or Position in the public school systems of Georgia;
A person employed by a regional or county library of Georgia;
A person employed in a professionally Certificated Capacity or Position in the public vocational and technical schools operated by a local school system;
A person employed in a professionally Certificated Capacity or Position in the Regional Educational Service Areas of Georgia;
A person employed in a professionally Certificated Capacity or Position in the high school program of the Georgia Military College.

(c) Public School Employees who are employed by a local school system that have elected to participate in the Plan, and are not considered independent contractors, are eligible to enroll under the conditions of these regulations.

An Employee who is eligible to participate in the Public School Employees Retirement System as defined by Paragraph (20) of O.C.G.A. § 47-4-2 may enroll, provided the Employee works the greater of at least 60 percent of the time required to carry out the duties of such position or a minimum of fifteen (15) hours per week and is not employed on an emergency or temporary basis.
An Employee who holds a non-certificated public school position and who is eligible to participate in the Teachers Retirement System (or other independent local school retirement system), provided the Employee is not employed on an emergency or temporary basis and the Employee works at least 60 percent of the time required to carry out the duties of such position or a minimum of twenty (20) hours per week, whichever is greater may enroll.

(d) Local Boards of Education that elect to provide group medical insurance for members of the local board of education, their spouses, and dependents in accordance with O.C.G.A. § 45-18-5 are eligible to enroll under the conditions of these regulations. Collection and remittance of Enrolled Member premium and employer contribution amounts shall be in accordance with O.C.G.A. § 20-2-55 and these regulations.

(2) Retired Employees. Any Employee who was eligible to participate under 111-4-1-.04(1)(a) , 111-4-1-.04(1)(b) , or 111-4-1-.04(1)(c) and who was enrolled in the Plan at the time of retirement shall be eligible to continue coverage if:

(a) The Retired Employee is eligible to immediately receive an annuity from the Employees' Retirement System, Georgia Legislative Retirement System, Judicial Retirement System, Superior Court Judges or District Attorneys' Retirement System, Teachers Retirement System, Public School Employees Retirement System, any local school system teachers retirement system, or other retirement system with which the Board is authorized to contract; or

(b) The Retired Employee as an Employee of a county department of family and children services or a county department of health is eligible to receive an annuity from the Fulton County Retirement System.

(3) Eligibility for Coverage as an Enrolled Member and a Dependent. In the situation where both husband and wife are eligible to be covered under the SHBP as an Enrolled Member, each may enroll as a Member and enroll the eligible dependents . The benefits provided under the SHBP will be coordinated in accordance with the Coordination of Benefits or the Medicare Coordination of Benefits provisions of the Summary Plan Description. In no case shall the sum of the total benefits provided by the SHBP exceed the reasonable charges for covered services.

(4) Eligibility for Coverage as an Enrolled Member Limited. In the situation where the Enrolled Member is entitled to Coverage under the SHBP as an Active Employee under a health insurance act and Retired Employee under a different health insurance act, or any combination of provisions, the Member may choose among the Active Employee provisions under which the Member will be covered, but may not choose Coverage as a Retiree or Beneficiary of a Retiree as long as the Member is eligible for Coverage under one of the Active Employee provisions. In no circumstance shall the individual be an Enrolled Member under more than one provision of these regulations.

(5) Eligibility for Coverage as an Active Employee with Two (2) Employing Entities. Dual eligibility and overlapping Coverage shall be handled as follows:

(a) Dual Eligibility. In the situation where the Enrolled Member is eligible for Coverage under the SHBP as an Active Employee of two (2) separate Employing Entities, the Employee may, during the annual Open Enrollment period, elect which Employing Entity shall deduct the Employee Premium in the upcoming Plan Year. Each Employing Entity is responsible for remitting Employer Contribution amounts in accordance with 111-4-1-.02(3)(d) of these regulations.

(b) Overlapping Coverage. In the situation where the Enrolled Member experiences a period of overlapping Coverage as a result of transferring employment between two (2) separate Employing Entities, the Coverage effective date with the second Employer shall determine the Coverage termination date with the first Employer. The Employing Entities shall be responsible under this provision for deducting or refunding Employee Premiums as appropriate.

(6) Employees on Leave Without Pay. Active Employees who are Enrolled Members of the SHBP may continue the Coverage in which enrolled during a period of "Approved Leave of Absence Without Pay", subject to the conditions in these regulations. Enrolled Employees who are on suspension or Approved Leave of Absence Without Pay who did not continue Coverage shall not be eligible to enroll or re-enroll for Coverage while on Approved Leave of Absence Without Pay under any provision of these regulations except during the annual Open Enrollment period. Except for military leave Coverage shall not be extended for an Employee who is self employed or gainfully employed by another party during a period of Approved Leave of Absence Without Pay. A request to continue Coverage while on Approved Leave Without Pay must be received by the Employing Entity within thirty-one (31) calendar days of the termination of paid Coverage through payroll Deductions. Employees who qualify for continued Coverage under multiple leave types may continue Coverage under a combination of leave types; however, the total period of Coverage on Approved Leave of Absence Without Pay shall not exceed twelve (12) calendar months, unless otherwise noted in these provisions. Premium payments must be in an amount sufficient to provide continuous Coverage between termination of paid Coverage through payroll Deductions and the beginning of Approved Leave of Absence Without Pay Coverage. When an Employee on Approved Leave of Absence Without Pay enrolls during the annual Open Enrollment, Period the twelve (12) calendar month Coverage period shall be reduced by the number of prior months of Approved Leave of Absence Without Pay during which the Employee did not elect to participate in the SHBP. Employees on Leave Without Pay must timely submit required Premiums to the Employing Entity, and the Employing Entity must timely pay required Employer Contributions associated with such Employees. An Employee's failure to timely submit a required Premium to the Employing Entity causes a loss of eligibility for Coverage, and the Employing Entity must timely notify the Administrator of loss of eligibility in accordance with these regulations.

(a) Disability Leave. A disability leave is the period of time an Approved Leave of Absence Without Pay has been granted to the Employee due to personal illness, accident or disability. Coverage may be continued under this paragraph for the period of disability, but not longer than twelve (12) consecutive calendar months. Certification of the disability period by a licensed physician shall be required to continue coverage under this provision.

(b) Reduced Working Hours Due to Partial Disability. A Partial Disability leave is the period of time during which an Employer approves an Employee's return to work on a part-time basis from a period of disability leave or paid leave if the part-time work is part of a process to gradually return the Employee to full-time work. Coverage may be continued under this provision for the period of disability approved by a licensed physician, but not longer than twelve (12) consecutive calendar months, inclusive of any time from a period of disability leave without pay. Certification of the Partial Disability period shall be required to continue coverage under this provision.

(c) Leave of Absence for the Employer's Convenience. Employer's convenience leave is a period of time during which an Approved Leave of Absence Without Pay has been granted by the appropriate organizational official due to a regular programmatic plan for Employee absence and pursuant to appropriate regulation. The Employee may continue the Coverage such leave of absence, but not longer than twelve (12) consecutive calendar months.

(d) Educational Leave. Educational leave is the period of time during which an Approved Leave of Absence Without Pay has been granted by the appropriate organizational official for educational or training purposes. The Employee may continue the Coverage under such leave for the period of absence, but not longer than twelve (12) consecutive calendar months.

(e) Family Medical Leave. Family medical leave is the period of time during which an Approved Leave of Absence Without Pay has been granted to the Employee by the appropriate organizational official for personal illness, the care of the Employee's child after birth or placement for adoption or the care of an Employee's seriously ill Spouse, child, or parent. An Employee's personal illness, if properly certified and approved may be granted under the disability leave provisions. Coverage while on Approved Leave of Absence Without Pay for family medical leave may be continued for the period of approved leave, but not longer than twelve (12) weeks in any twelve (12) consecutive month period.

(f) Military Leave. Military leave is the period of time during which an Approved Leave of Absence Without Pay has been granted by the appropriate organization official when an Employee is ordered to military duty or the period, as provided by law, during which an Employee is attending military training. Military leave also applies to an Employee who qualifies for an exigency leave or service member care leave, as defined under Federal law. The Employee may continue the Coverage under such leave for the period of absence.

(g) Suspension or Other Leave of Absence. Suspension or other leave of absence is the period of time during which suspension is in effect or an Approved Leave of Absence Without Pay has been granted by the appropriate organization official for the Employee's convenience. The Employee may continue the Coverage for the period of suspension or approved leave, but not to exceed twelve (12) calendar consecutive months, provided the Employee is not self employed or gainfully employed by another party during such leave of absence.

(h) Extensions of Leave of Absence. If the Employee is unable to return to work at the expiration of the approved leave and the maximum period has not been exhausted, a request to extend the leave of absence may be filed. The Administrator must receive the Employee's request for extension no later than thirty-one (31) calendar days following expiration of Coverage under the leave of absence. The Employing Entity must certify approval of the extension. The attending physician must complete a new disability certification for an extension of a disability leave.

(i) Sequential Periods of Leave. Health benefits may be continued during sequential types of leave, provided that continuation of health benefits during continuous, sequential periods of time shall not exceed the time limitation of the most recently approved type of leave.

(j) Premiums. Premiums for continued Coverage during a period of Approved Leave of Absence Without Pay shall be paid monthly to the Employing Entity. When establishing the monthly Premium amount to be paid by the Employee, the Board may add a processing fee. The Premium Rate, excluding the processing fee, shall be based on the type of approved leave. The Premium Rate for disability, family leave or military leave of absence shall be the same as the Employee Deduction; the Premium Rate for all other types of leave shall be the total cost of coverage as set forth in Board resolution. Failure to pay the full Premium to the Employing Entity within the allotted time shall result in loss of eligibility for Coverage.

(7) Spouse. An Active Employee shall be entitled to enroll the Employee's Spouse upon employment, during Open Enrollment, or under conditions specified in Section 111-4-1-.06 of these regulations. A Retiree shall be entitled to continue Coverage for the Spouse upon retirement or may enroll the Spouse in accordance with Section 111-4-1-.06(5) or 111-4-1-.06(6) . The Administrator shall require the Social Security Number for the Spouse as well as appropriate documentation from an Enrolled Member in order to verify a Spouse's eligibility for Coverage.

(8) Dependent Child. An Active Employee shall be entitled to enroll eligible Dependent children upon employment, during Open Enrollment, or under conditions specified in Section 111-4-1-.06 of these regulations. A Retiree shall be entitled to continue Coverage for eligible Dependent children upon retirement or may enroll eligible Dependent children in accordance with Section 111-4-1-.06(5) . The Administrator shall require the Social Security Number for every child, starting at age two, as well as appropriate documentation from an Enrolled Member in order to verify a Dependent child's eligibility for Coverage. An eligible Dependent child must meet one of the following definitions;

(a) A natural child, for which the natural guardian has not relinquished all guardianship rights through a judicial decree. Eligibility begins at birth and ends at the end of the month in which the child reaches age twenty-six (26);

(b) An adopted child. Eligibility begins on the date of legal placement for adoption and ends at the end of the month in which the child reaches age twenty-six (26);

(c) A stepchild. Eligibility begins on the date of marriage to the natural parent and ends at the end of the month in which the child reaches age twenty-six (26), or at the end of the month in which he or she loses status as the stepchild of the Enrolled Member, whichever date is earlier; or

(d) Guardianship. A child for whom the Enrolled Member is the legal guardian. Eligibility begins on the date the legal guardianship is established and ends at the end of the month in which the child reaches age twenty-six (26), or at the end of the month in which the legal guardianship terminates, whichever is earlier. Certification documentation requirements are at the discretion of the Administrator. However, a judicial decree from a court of competent jurisdiction is required unless the Administrator concludes that documentation is satisfactory to establish legal guardianship and financial dependence and that other legal papers present undue hardship on the Member or living natural parent(s).

(9) Totally Disabled Child. An Enrolled Member shall be entitled to apply for Coverage of a natural child, legally adopted child or stepchild age twenty-six (26) or older if the child was physically or mentally disabled before age twenty-six (26), continues to be physically or mentally disabled, lives with the Enrolled Member or is institutionalized and depends primarily on the Enrolled Member for support and maintenance.

(a) Application Period. The Enrolled Member may apply for Coverage during Open Enrollment, as a New Hire, or as the result of a Qualifying Event. At all other times, an Enrolled Member whose Totally Disabled Child was a covered dependent on the Member's Family Plan prior to turning age twenty-six (26) must apply for continuation of Coverage and include all supporting documentation no later than thirty-one (31) calendar days following the end of the month in which the child reaches age twenty-six (26). If the Enrolled Member fails to complete the request within the allotted time, eligibility for Coverage until the next Open Enrollment is limited to the conditions outlined for Extended Beneficiaries.

(b) Documentation and Approval. The Administrator shall require documentation as necessary to provide certification that the child was physically or mentally incapable of sustaining, self-supporting employment because of the physical or mental disability before age twenty-six (26), continues to be physically or mentally incapable of sustaining, self-supporting employment because of the physical or mental disability, and lives at the Enrolled Member's home or is institutionalized. The documentation may include but is not limited to certification from a qualified medical practitioner that outlines the physical and psychological history, diagnosis, and provides an estimate of length of time for disability, and an estimate of the child's earning capacity. If the documentation is satisfactory to substantiate the physical or mental disability as required in these regulations, the Administrator may approve Coverage for the period of incapacitation. The Administrator may require periodic recertification of the disabling condition and circumstances, provided the recertification is not more frequent than each twelve (12) calendar months or at the end of the projected disability period if that date is less than twelve (12) calendar months.

(10) Surviving Beneficiary. An Enrolled Member's Surviving Spouse and eligible Dependent children, who were included in the Coverage by the Enrolled Member immediately before death, may continue Coverage provided an application for continuing Coverage is received by the Administrator within ninety (90) calendar days following Coverage termination as a result of the death of the Enrolled Member in the situations set forth below. In the application, the Surviving Spouse shall be required to list all eligible Covered Dependents who will continue Coverage and shall not be allowed to add any future spouse or children not listed. Surviving Covered Spouses and Dependent children are entitled by federal law to continue Coverage under the Extended Beneficiary provisions set forth in Section 111-4-1-.08 . By electing to continue coverage under any of these Surviving Beneficiary provisions, the Surviving beneficiary waives rights to continuation coverage under the Extended Beneficiary provisions of Section 111-4-1-.08 .

(a) The Surviving Spouse of an Active Employee may continue Coverage for him or herself and surviving eligible Covered Dependent children if the Spouse is eligible to immediately receive a monthly benefit payment from a state supported retirement system in an amount sufficient to pay the Premium established by the Board. The Spouse must elect to continue Coverage as a Surviving Spouse under this provision or as an Employee as a result of the Spouse's own employment, and cannot elect double or dual Coverage under separate provisions of the SHBP. Eligibility of Dependent children shall terminate in accordance with provisions for Dependent children of these regulations. An election to take a lump sum distribution rather than the monthly Annuity negates eligibility to continue Coverage as a Surviving Spouse

(b) The Surviving Spouse of an Annuitant may continue Coverage for him or herself and surviving eligible Covered Dependent children if the Spouse is eligible to immediately receive a monthly benefit payment from a state supported retirement system in amount sufficient to pay the Premium established by the Board. The Surviving Spouse must elect to continue Coverage as a Surviving Spouse under this provision or as an Employee as a result of the Spouse's own employment, and cannot elect double or dual Coverage under separate provisions of the SHBP Eligibility of Dependent children shall terminate in accordance with provisions for Dependent children. An election to take a lump sum distribution rather than the monthly Annuity negates eligibility to continue Coverage as a Surviving Spouse.

(c) Upon the death of an Active Employee, an eligible Covered Dependent child who is the principal Beneficiary under one of the state supported retirement systems may continue Coverage, provided the Dependent child is not covered as a Dependent child under another contract under the SHBP, and provided the monthly benefit payment from a state supported retirement system is in an amount sufficient to pay the Premium established by the Board. Eligibility to continue Coverage shall terminate in accordance with provisions for Dependent children. An election to take a lump sum distribution rather than the monthly Annuity negates eligibility to continue Coverage under this provision.

(d) Upon the death of a Retired Employee, an eligible Covered Dependent child who is the principal beneficiary under one of the state supported retirement systems may continue Coverage, provided the Dependent child is not covered as a Dependent child under another contract under the SHBP, and provided the monthly benefit payment from a state supported retirement system is in an amount sufficient to pay the Premium established by the Board. Eligibility to continue coverage shall terminate in accordance with provisions for Dependent children. An election to take a lump sum distribution rather than the monthly Annuity negates eligibility to continue Coverage under this provision.

(e) The Surviving Spouse of a Retired Employee who is included in Coverage at the time of death of the enrolled Retiree and who will not receive a monthly annuity payment from one of the state supported retirement systems shall be eligible to continue Coverage for him or herself and any of the Retiree's Dependent children who were Covered at the time of the Retiree's death, if the following conditions are met:

The Surviving Spouse must make written application no later than ninety (90) calendar days following Coverage termination as a result of the death of the Retired Employee; and
The parties must have been married at least one full year prior to the death of the Retired Employee; and
The Surviving Spouse agrees to pay the monthly premium payment established by the Board in accordance with the established requirements; and
Coverage under this provision shall terminate for the Surviving Spouse and any enrolled Dependent children in the event the Surviving Spouse remarries.

(f) The eligible Covered Spouse and Dependent children of a Covered Active State Employee who is killed or receives injury that results in death while acting in the scope of his or her employment may continue Coverage provided the deceased Enrolled Member's Coverage was continuous during the period between injury and death. The eligible Covered Dependents may elect Coverage as a surviving Dependent or as an Employee as a result of the person's own employment, but cannot elect double or dual Coverage under separate provisions of the SHBP. Surviving Covered Dependents must agree to pay the monthly Premium payment established by the Board for Active State Employees. The Surviving Spouse may elect to continue Coverage for eligible Covered Dependent children. Eligibility of Dependent children shall terminate in accordance with provisions for Dependent children.

(11) Dependent Eligibility Unverified. The Administrator shall define the supporting documentation requirements for verifying Dependent eligibility. Coverage for Dependents whose eligibility is unverified will pend awaiting receipt and review of the documentation. When the Administrator has verified eligibility of the Dependent, the Coverage will be activated in accordance with the provisions of this Section. If the Administrator cannot verify Dependent eligibility within the allotted time, the Dependent will be ineligible for Coverage. The next opportunity to enroll the Dependent and verify the Dependent's eligibility will be the annual Open Enrollment period or subsequent Qualifying Event. Changes to a different coverage tier will not be allowed based on unverified dependent eligibility.

(12) Retired Employees Having Intermittent Periods of Active Employment. Retired Employees who are eligible to continue Coverage under these regulations may elect to return to or continue Active employment with any of the Employing Entities. In such case, the retirement benefit may be suspended or continued; however, the federal Social Security Act requires the health benefit Coverage must be purchased as an Active Employee whenever the eligibility requirements of Section 111-4-1-.04 of these regulations are met. At the point the Employee discontinues Active employment, continuous health benefit Coverage shall be reinstated with the state supported retirement system which previously collected the Premium. In no case, however is an individual who retired prior to the initial legislated funding for that Group of Employees to be entitled to enroll as a Retiree, unless the final Active service period qualifies the Employee for a retirement benefit by one of the state supported retirement systems.

(13) Judicial Reinstatement of State Employees. State Employees who are reinstated to employment by the State Personnel Board or the judiciary shall have Coverage reinstated for themselves and any eligible Dependents. If employment reinstatement occurs within twelve (12) calendar months of discharge and back-pay for continuous employment is awarded, all retroactive Premiums must be collected and remitted to the Plan before and Claims incurred during the period may be filed for reimbursement. If back-pay to provide for continuous employment is not awarded, Coverage may be reinstated with the Employee's return to work. If reinstatement occurs following a period longer than twelve (12) calendar months after the discharge, Coverage for the Employee and previously Covered Dependents will be reinstated when the Employee returns to work or in accordance with the judicial review. In any case where the reinstatement overlaps an Open Enrollment period, the Employee will be given fifteen (15) calendar days after reinstatement to modify Coverage in compliance with Open Enrollment guidelines. Pre-existing condition limitations will be waived for the reinstated Employee and all previously enrolled Dependents. Employing Entities shall be responsible for collecting and remitting any Premiums due for the selected Coverage.

(14) Contract Employees. Employees who are on approved leave of absence and/or have not terminated their employment may participate in the Plan if their Employer has contracted with the Board to provide inclusion in the SHBP. The Employee will be eligible to participate in accordance with the provisions of the contract.

History

Authority: O.C.G.A. Secs. 20-2-55, 20-2-880, 20-2-881, 20-2-885 to 20-2-887, 20-2-895, 20-2-910 to 20-2-912, 20-2-915, 20-2-916, 20-2-923, 31-3-2.1, 45-18-1et seq., 45-20-2, 47-2-313, 47-6-41, Family and Medical Leave Act of 1993 (FMLA), Social Security Act, Uniformed Services Employment & Reemployment Act, Americans With Disabilities Act (ADA). Patient Protection and Affordable Care Act (PPACA)
History. Original Rule entitled "Eligibility for Coverage" adopted. F. Apr. 18, 2005; eff. May 8, 2005.
Repealed: New Rule of same title adopted. F. Jan. 22, 2007; eff. Feb. 11, 2007.
Amended: F. May 25, 2007; eff. June 14, 2007.
Amended: F. Aug. 20, 2008; eff. Sept. 9, 2008.
Amended: F. Jan. 26, 2011; eff. Feb. 16, 2011.
Amended: F. Jan. 17, 2012; eff. Feb. 6, 2012.

Ga. Comp. R. & Regs. r. 111-4-1-.05 Effective Date of Coverage {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.05}

(1) Upon Employment. The Employee's Coverage under the SHBP shall become effective on the first of the month following employment for the full preceding calendar month if the Employee has not terminated employment on or before that date. Coverage for a transferring Employee shall be effective the first of the month following the end of Coverage under a previous Employing Entity. Coverage for eligible Dependents will become effective on the date the Employee's Coverage is effective.

(2) Upon Change in Coverage. If the Member changes Coverage to include eligible Dependents based upon acquisition of Dependent(s), Coverage for the Dependents shall become effective on the later of the first of the month following the request for Coverage, or subject to guidelines for acquisition of Dependent(s).

(3) Upon Open Enrollment Change or Enrollment. The effective date for enrollments or changes in Coverage election to add eligible dependents shall be January 1 st unless the Member no longer meets the definition of an Active Employee on or before that date. The termination date for Open Enrollment discontinuation of Coverage shall be December 31 st . Subject to the provisions of Section 111-4-1-.06 of these regulations, Coverage elections shall be binding upon the Member for the duration of the Plan Year.

(4) Upon Return from Leave Without Pay. The effective date for re-enrollments following an Approved Leave of Absence Without Pay shall be the first of the month following the return to work. The effective date for re-enrollments following a military leave without pay shall be the first of the month following the return to work or the date employment is reinstated. In all instances, the appropriate Premiums must be deducted and remitted by the Employing Entity.

(5) Upon Acquisition of a Dependent. The effective date of Coverage for acquired Dependents is subject to the requirements as outlined for the Member and shall be the later of the first of the month following the request for Coverage or:

(a) Legally Married Spouse. The effective date of Coverage shall be no earlier than the first of the month of marriage to the Member. The Plan is not responsible for payment of the Spouse's medical services incurred prior to the actual date of the marriage.

(b) Natural Children. The effective date of Coverage shall be the date of birth.

(c) Stepchildren. The effective date of Coverage shall be no earlier than the date of marriage of the Member and the natural parent of the children.

(d) Adopted Children. The effective date of Coverage shall be no earlier than the date of legal placement for adoption.

(e) Other Children. The effective date of Coverage shall be no earlier than the date that sole legal guardianship is established.

(6) Premium. The Administrator shall terminate Coverage of Enrolled Members and Covered Dependents for which the Plan has not received full payment of the required Premium prior to the first day of the Coverage month. Terminated Coverage will be reactivated upon receipt of full payment of the required monthly Premium.

History

Authority: O.C.G.A. Secs. 20-2-881, 20-2-911, 45-18-2, Health Insurance Portability and Accountability Act (HIPAA), Internal Revenue Code Section 125, Uniformed Services Employment and Reemployment Act 5. Patient Protection and Affordable Care Act (PPACA)
History. Original Rule entitled "Effective Date of Coverage" adopted. F. Apr. 18, 2005; eff. May 8, 2005.
Repealed: New Rule of same title adopted. F. Jan. 22, 2007; eff. Feb. 11, 2007.
Amended: F. May 25, 2007; eff. June 14, 2007.
Amended: F. Jan. 26, 2011; eff. Feb. 16, 2011.

Ga. Comp. R. & Regs. r. 111-4-1-.06 Changes in Coverage and Option {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.06}

(1) Open Enrollment Period and Retiree Option Change Period. The Open Enrollment period and Retiree Option change period shall be a minimum period of fifteen (15) days and shall begin no earlier than October 1 and shall end no later than November 15 of each year. The Commissioner shall announce the dates of the periods each year. Eligible Employees, enrolled Retirees and Extended Beneficiaries shall be given an opportunity to make the changes in Coverage election as reflected in the following paragraphs.

(a) Active Employees. Eligible Active Employees, eligible Employees on Approved Leave of Absence Without Pay and Extended Beneficiaries shall be given an opportunity to enroll or change Coverage during the Open Enrollment period.

(b) Retirees. During the Retiree Option Change Period, enrolled Retirees shall be given an opportunity to change Coverage Option to any Option for which the Retiree is eligible.

(2) Returning Employee from an Approved Leave of Absence. An eligible Employee who did not continue Coverage during an Approved Leave of Absence Without Pay which included the Open Enrollment period shall be offered the opportunity to enroll, discontinue, or change Coverage within fifteen (15) calendar days of the date the Employee returns to work.

(3) Qualifying Event During a Period of Ineligibility. When an Employee loses eligibility for Coverage and subsequently resumes eligibility for Coverage within the same Plan Year, and a Qualifying Event under these regulations occurs during the period of ineligibility, the Employee shall have the opportunity to request a change in Coverage election for the remainder of the Plan Year that is consistent with that Qualifying Event. The request to change Coverage election must be received by the Administrator within thirty-one (31) calendar days following the date the Employee resumes eligibility through an Employing Entity. The effective date of the requested action shall be consistent with the new employment provisions of these regulations. The Administrator shall request supporting documentation to demonstrate the Qualifying Event has occurred. Failure to fully document the occurrence of the Qualifying Event within the allotted time shall result in reversal of the new Coverage election and restoration of the Employee's former Coverage election.

(4) Retired Employee's Discontinuation of Coverage. An Enrolled Retired Employee may discontinue Coverage for him or herself at any time. A discontinuation may be made by advance notice to the Administrator or by failing to timely pay required Premiums. Once a Retired Employee discontinues Coverage for him or herself, the discontinuation is permanent except as described below.

(a) TRICARE Supplemental Coverage. If a Retired Employee discontinues SHBP Coverage and elects TRICARE Supplemental Coverage, which is offered by the Administrator, the Retired Employee may re-enroll in SHBP Coverage during the next Retiree Option Change Period as long as he or she has maintained continuous coverage under either SHBP Coverage or TRICARE Supplemental Coverage.

(b) Termination of Medicare Advantage Coverage by CMS. If a Retired Employee's Medicare Advantage coverage is terminated by CMS due to enrollment in another plan or failure to pay Medicare Part B premiums, the Retired Employee will be automatically enrolled in another SHBP Option in accordance with the procedures of the Administrator, and will be charged the required Premiums.

(c) Employment as an Active Employee. If a Retired Employee who has discontinued Coverage becomes employed as an Active Employee, he or she may re-enroll in the SHBP as an Active Employee. An Enrolled Retired Employee may discontinue Coverage for a Dependent at any time. A discontinuation of Coverage for a Dependent will be permanent except as described below.

(d) PeachCare for Kids Coverage. If a Retired Employee discontinues SHBP Coverage for a Dependent child and enrolls that Dependent child in PeachCare for Kids, the Retired Employee may re-enroll the Dependent child in SHBP Coverage during the next Retiree Option Change Period as long as the Dependent child has maintained continuous coverage under either SHBP Coverage or PeachCare for Kids.

(e) Qualifying Event. If an Enrolled Retired Employee discontinues Coverage for a Dependent and experiences a qualifying event described in Internal Revenue Service Regulation 1.125.4, subsection (6) below will apply and the Retired Employee may be able to re-enroll the Dependent.

(5) Reinstatement of Employee Across Plan Years. If an Employee was reinstated to employment for a period of time inclusive of the applicable Open Enrollment period, the Employee shall be offered the opportunity to enroll or change Coverage within fifteen (15) calendar days of the return to work.

(6) Qualifying Event Coverage Changes.

(a) A Member shall be eligible to make a change in coverage or tier on account of the qualifying events set forth, and in the manner described, in Internal Revenue Service Regulation 1.125-4, so long as the Member and the Employing Entity (if applicable) satisfy requirements established by the Administrator. This subsection does not apply to a Retired Employee who has discontinued SHBP coverage for him or herself. In general, requests to enroll, change, or discontinue coverage must be received by the Administrator no later than thirty-one (31) calendar days following the qualifying event. Requests to enroll newly eligible Dependent children must be received by the Administrator no later than ninety (90) calendar days following the qualifying event. Requests to make election changes as a result of death must be received by the Administrator no later than ninety (90) calendar days following the qualifying event. Where necessary to comply with federal law, election changes may be accepted within the deadline established by the law. The effective date of the Coverage election shall be the first of the month following receipt of the request, unless otherwise noted in Internal Revenue Service Regulation 1.125-4. The Administrator shall request supporting documentation to demonstrate the Qualifying Event has occurred. Failure to fully document the occurrence of the Qualifying Event within the allotted time shall result in reversal of the Coverage election and restoration of the Member's prior Coverage election.

(b) Additional Changes Permitted for Retirees. An enrolled Retiree may change to any Option to which the Retiree is eligible upon occurrence of one or more of the following events, provided the request is received by the Administrator within thirty-one (31) calendar days following the Qualifying Event: at the time of retirement; at the time that the annuity amount to be received from a state supported participating retirement system becomes insufficient to satisfy the Option premium; at the time that the Retired Member becomes eligible for Medicare coverage; or, subject to approval by the Centers for Medicare and Medicaid Services, at the time the enrolled Retiree requests in writing to move from his or her current Option to a Medicare Advantage plan offered by the same Third Party Administrator.

(c) Married enrolled Retirees may change Tier in order to become individual Enrolled Members at any time when no individuals other than the Spouse are enrolled in the Coverage. The change in Coverage will be effective within two (2) calendar months following the requested change.

(7) Documentation. The Administrator may require documentation that a Qualifying Event permitting enrollment, change or discontinuation of Coverage has in fact occurred outside the annual enrollment period. When required, documentation appropriate to the event will be specifically described and must be received by the Administrator within the allotted time. Failure to document appropriately or within the allotted time shall result in the reversal of the requested Coverage action and restoration of the Member's prior Coverage.

History

Authority: O.C.G.A. Secs. 20-2-295, 20-2-881, 20-2-894, 20-2-897, 20-2-911, 20-2-922, 45-18-1et seq., 50-18-72, 50-18-94, Internal Revenue Code Section 125 - Family and Medical Leave Act of 1993 (FMLA), Consolidated Omnibus Budget Reconciliation Act (COBRA), IRS Code Section 125, Health Insurance Portability and Accountability Act (HIPAA), Child Support Performance and Incentive Act, U.S.E.R.R.A
History. Original Rule entitled "Changes in Coverage and Option" adopted. F. Apr. 19, 2005; eff. May 8, 2005.
Amended: ER. 111-4-1-0.1-.06 adopted. F. June 13, 2005; eff. June 16, 2005, as specified by the Agency.
Amended: Permanent Rule adopted. F. Sept. 15, 2005; eff. Oct. 5, 2005.
Repealed: New Rule of same title adopted. F. Jan. 22, 2007; eff. Feb. 11, 2007.
Amended: F. May 25, 2007; eff. June 14, 2007.
Amended: F. May 1, 2009; eff. May 21, 2009.
Amended: F. Oct. 16, 2009; eff. Nov. 5, 2009.
Amended: F. Jan. 17, 2012; eff. Feb. 6, 2012.

Ga. Comp. R. & Regs. r. 111-4-1-.07 Extended Coverage Under State Law {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.07}

(1) Employee. Employees are permitted to continue the current Coverage under conditions outlined by State law. Application for Extended Coverage must be made to the Administrator within thirty-one (31) calendar days following Coverage termination as an Active Employee or Extended Beneficiary. Coverage election under Section 111-4-1-.08 , Extended Coverage Under Federal law, delays eligibility to enroll under State law provisions until the expiration of the Extended Beneficiary Coverage privileges, except as specifically stated in these provisions.

(a) State Employee.

Any State Employee who resigns from employment or who is not re-elected on and after July 1, 1978 and who has completed eight (8) or more years of service as an Employee, exclusive of Approved Leaves of Absence Without Pay for which health benefit Coverage may have been continued, under Section 111-4-1-.04(1)(a) shall have the privilege of continuing Coverage.
Any State Employee who has been eligible for Coverage under this Plan for a period of ten (10) years, is discharged and is appealing the discharge to the State Personnel Board shall be entitled to continue Coverage for a period required for the State Personnel Board to render a decision but no longer than six (6) calendar months. The Premium for such Coverage will be the same amount as paid by the Active Employee through payroll Deduction/Reduction. The Employing Entity must notify the Member and the Administrator of the Member's eligibility to continue Coverage. Failure to pay the full Premium within the allotted time shall result in suspension of benefit payments and/or termination of Coverage and forfeit all eligibility for continued Coverage.

(b) General Assembly Member. Any member of the General Assembly who ceases to hold office after July 1, 1981, and who was eligible to retire at the time of leaving office, except for the attainment of retirement age, pursuant to a public retirement system to which the General Assembly appropriates Funds, and who does not withdraw Employee contributions from public retirement systems shall be eligible to continue Coverage for the Enrolled Member and eligible Dependents, subject to the conditions of these regulations. The Premium shall be the same amount as an Active Employee. Coverage shall cease if the Member fails to pay the required Premium billed by the Administrator within thirty (30) calendar days following receipt of a Premium notice or the Member withdraws Employee contributions from the respective retirement system. Failure to pay the full Premium within the allotted time shall result in suspension of benefit payments and/or termination of coverage and forfeit all eligibility for continued Coverage.

(c) Teacher. Any Teacher as defined in Section 111-4-1-.04(1)(b) and any Surviving Spouse of a Teacher who died prior to January 1, 1979 who has eight (8) or more years of creditable service in a teachers retirement system in Georgia and who is not presently eligible to receive retirement benefits shall have the privilege of continuing Coverage.

(d) Public School Employee. Any Public School Employee as defined in Section 111-4-1-.04(1)(c) and who has eight (8) or more years of creditable service in a retirement system in Georgia and who is not eligible to receive retirement benefits because of age shall have the privilege of continuing Coverage. Prior to December 1, 1986, a Public School Employee whose employment terminated after January 1, 1985, and prior to July 1, 1986, under these conditions shall have the privilege of re-enrolling for Coverage by making application to the Administrator; provided that Coverage shall not become effective earlier than the first of the month in which the application for Coverage was received by the Administrator.

Correctional Officers Injured in Service. The SHBP shall provide a Coverage exception from the eight-year or more employment requirement for continued Coverage under the SHBP for a correctional officer injured by inmate violence while on duty if the correctional officer demonstrates that he or she was injured within a time period of five (5) years or less from becoming eligible for Medicare. The correctional officer must remit the Premium amount established for Active Employees. Eligibility for Coverage shall extend to an eligible correctional officer's Spouse or Dependents.

(e) Required Premiums. Except as noted in subparagraphs (a)(2) and (b), premiums for continuing Coverage under this provision shall be billed to the Enrolled Member monthly in an amount equal to the total cost for Coverage, which is the Employee's share and the Employer's cost for benefits and administration, plus processing and administrative fees where applicable. Failure to pay the full Premium within the allotted time shall result in suspension of benefit payments and/or termination of Coverage and forfeit all eligibility for continued c overage.

(f) Notice. The Administrator shall include a notice of payment requirements and penalties on application forms for continued Coverages.

(2) Pending Retiree. An Enrolled Member who has made application for disability or service retirement and who may be eligible for retirement shall have the privilege of continuing any health benefit Coverage during the period between termination of Coverage as an Active Employee and the effective date of Coverage as a Retiree, subject to conditions as outlined in these regulations. The Member may request Coverage as a Pending Retiree within thirty-one (31) calendar days following Coverage termination as an Active Employee. The Administrator shall have the option to enroll and bill the Member directly for Pending Retiree Coverage should a break in Coverage occur.

(a) Coverage as a pending Retiree must be based on a reasonable expectation that the Enrolled Member is eligible for retirement except for completion of the administrative processing to begin the annuity payments. The Administrator may define reasonable expectation; however, continuation of coverage under this provision shall not exceed six (6) calendar months, unless a decision on the retirement application has not been rendered by the respective retirement system's administrative processes. Any months of coverage as a Pending Retiree shall be inclusive of Extended Coverage provisions under Federal law.

(b) Denial of Annuity Payments. At the point that a Board of trustees or retirement Administrator denies the immediate onset of annuity payments, the separated Employee shall no longer be eligible to continue Coverage under this provision. Any Coverage under this provision is inclusive of the maximum length of time allowed under the Extended Coverage provisions that are allowed under Federal law.

(c) Reinstatement of Retiree Coverage. Upon receipt of information that the respective retirement system has reversed an earlier denial to award retirement benefits to an Employee, Coverage may be reinstated as a Retiree. Coverage reinstatement is allowed if the Retiree requests reinstatement within thirty-one (31) calendar days following the reversal of the retirement system's decision. Reinstatement shall be effective as soon as administrative processes for Deduction are completed, but no later than sixty (60) calendar days following notification to the Administrator. The Retiree and Dependents who were enrolled in the Plan will be reinstated without regard to the Pre-existing Condition limitations. The Administrator may review the circumstances and, if undue hardship will be imposed upon the Retiree, may allow retroactive coverage for up to six (6) calendar months from the date of notification that the Retiree is eligible for reinstatement.

(d) Required Premiums. Premiums for continuing coverage under this provision shall be the same as the Employee Deduction Rate plus a processing fee and shall be paid monthly. Failure to pay the full Premium within the allotted time shall result in suspension of benefit payments and/or termination of Coverage and forfeit all eligibility for continued Coverage.

(3) Retiree Retirement Benefit. If the retirement benefit to be received by a Retiree of any one of the respective retirement systems is not sufficient to pay the Premium amount by annuity Deduction, the Retiree shall be permitted to continue Coverage by paying a monthly Premium as set by the Board directly to the Plan. The Premium Rate shall be the same as the Retiree Deduction Rate plus a processing fee. Failure to pay the full Premium within the allotted time shall result in suspension of benefit payments and/or termination of Coverage and forfeit all eligibility for continued Coverage.

History

Authority: O.C.G.A. Secs. 20-2-888, 20-2-915, 20-2-915.1, 45-18-1et seq
History. Original Rule entitled "Extended Coverage Under State Law" adopted. F. Apr. 18, 2005; eff. May 8, 2005.
Amended: F. Sept. 26, 2006; eff. Oct. 16, 2006.
Repealed: New Rule of same title adopted. F. Jan. 22, 2007; eff. Feb. 11, 2007.

Ga. Comp. R. & Regs. r. 111-4-1-.08 Extended Coverage Under Federal Law (COBRA) {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.08}

(1) Extended Beneficiary. Persons who lose coverage under the Plan and who meet requirements as specified in these regulations or as specified by federal law are eligible to continue Coverage in the enrolled Option, without evidence of insurability. An Extended Beneficiary shall have the same opportunities for enrolling eligible Dependents and changing Coverage election as Active Employees. The SHBP will be administered in compliance with federal law or regulation under the Consolidated Omnibus Budget Reconciliation Act (COBRA).

(a) Terminated Employee. An enrolled Employee who terminates employment or is separated from his employment for any reason other than for gross misconduct, or whose Approved Leave Without Pay Coverage period expires shall be eligible to continue Coverage under the Plan for a period not longer than eighteen (18) calendar months following the termination of Coverage as an Employee.

(b) Reduction of Required Hours. An enrolled Employee who continues SHBP eligibility under the definition of Employee, except for working the required number of hours, shall be eligible to continue Coverage under the Plan for a period not longer than eighteen (18) calendar months following the end of the month in which the reduction of hours occurred. If the reduced hours take effect on a day other than the first work day of the month, the eighteen (18) calendar month period would begin on the first of the month following termination of Coverage through payroll Deductions.

(c) Laid-off Employee. An Enrolled Employee who is determined to be a laid-off Employee shall be eligible to continue Coverage under the Plan for a period not longer than eighteen (18) months. The extended period begins on the first of the month following termination of Coverage through payroll Deductions.

(d) Spouse of Deceased Employee. The spouse of a deceased enrolled Employee who is not eligible as a Surviving Spouse, an Employee, or an Annuitant shall be eligible to continue Coverage for the Spouse and any Covered, eligible dependents under the Plan for a period not longer than thirty-six (36) calendar months. The extended period of Coverage begins on the first of the month following termination of Coverage through the deceased Employee's payroll Deductions, or if the Employee is on an Approved Leave Without Pay, the later of the end of the month or the end of one month following the month in which the Employee died when Premium was paid in advance.

(e) Surviving Dependent Child. An eligible Dependent child of a deceased enrolled Employee who is not eligible as a Dependent of another Employee, a Surviving Beneficiary under Section 111-4-1-.04(10) , and Employee, or an Annuitant shall be eligible to continue individual Coverage under the Plan for a period not longer than thirty-six (36) calendar months following the end of the month in which death occurred. Any months for which Coverage was granted under Section 111-4-1-.04 will be included in the maximum allowance under this provision. The Extended Coverage period begins on the first of the month following termination of the deceased Employee's Coverage through payroll Deductions.

(f) Dependent Child. An eligible Dependent child of an enrolled Employee who is not eligible as an Employee or an Annuitant shall be eligible to continue Coverage under the Plan for a period not longer than thirty-six (36) calendar months following the end of the month in which the child is no longer an eligible Dependent under the Plan.

(g) Legally Separated or Divorced Spouse. A legally separated or divorced Spouse of an enrolled Employee who is not eligible as a Surviving Spouse, an Employee, or an Annuitant shall be eligible to continue Coverage for a period not longer than thirty-six (36) calendar months for the Spouse and any Covered dependents, who are no longer Covered Dependents of the Employee, under the SHBP. The Extended Coverage period begins on the first of the month following the month in which the legal separation documents were approved by a court of competent jurisdiction or the divorce was final.

(h) Disability under Social Security. An additional eleven (11) calendar months of Coverage may be provided to an Extended Beneficiary who meets the definition of disability under Title II or XVI of the Social Security Act prior to or within sixty (60) calendar days of the Qualifying Event. The eleven (11) additional months of Coverage applies to all Beneficiaries eligible under the contract. Eligibility for the additional eleven (11) months is based on the Beneficiary notifying the Administrator of the determination of disability no later than sixty (60) calendar days following the date of the determination. Such notices must be given within the initial eighteen (18) month continuation period. Additionally, the Extended Beneficiary must notify the Administrator within thirty (30) calendar days of the date of any final determination that the Beneficiary is no longer disabled. The Administrator is authorized to charge one hundred fifty percent (150%) of the applicable Premium as outlined in this section.

(i) Multiple qualifying events. If additional Qualifying Events occur which provide for a thirty-six (36) calendar month maximum period during the period when an Extended Beneficiary is covered, the maximum period of Coverage may be extended to a maximum of thirty-six (36) calendar months for Spouse or Dependent Child.

(j) Beginning of the maximum period. The maximum period of Extended Coverage as a result of one or more Qualifying Events shall begin on the day following termination of Coverage as a result of the first Qualifying Event.

(k) Limitation for Individuals Added to Coverage of Extended Beneficiary. Individuals enrolled under an Extended Beneficiary's Coverage shall not be eligible to become an Extended Beneficiary as a result of the enrollment.

(l) Payment for Extended Beneficiary Coverages. The applicable Premium for any Coverage election shall include the total Employer and Employee cost plus two percent (2%) of the total Premium cost as established by the Board for Active Employees with eligibility under this section, except that the Extended Beneficiary shall pay this Premium on a monthly basis. An additional forty eight percent (48%) of the total Premium for the Coverage election under the Plan shall be required for the eleven (11) months extension as a result of disability under the Social Security Act. One (1) advance monthly premium plus any retroactive premiums for unpaid periods of Coverage will, however, be requested as a part of the application. Failure to pay the full Premium within the allotted time shall result in suspension of benefit payments and/or termination of Coverage and forfeit all eligibility for continued Coverage.

(m) Notice Requirements. At the time of implementation of the Extended Beneficiary provisions, the Administrator shall distribute to the Employing Entities, having Active Employees, a notice of reasons for the extended eligibility. The Employing Entities shall distribute this notice to each eligible Employee. The Administrator shall incorporate the Extended Beneficiary eligibility provisions in the Employee Summary Plan Description.

The Employing Entity must notify the Administrator of the Employee's termination, death, layoff, or reduce hours within thirty (30) calendar days following the event.
The enrolled Employee or eligible Beneficiary must notify the Administrator of a Qualifying Event in case of divorce, legal separation, or the Dependent child's loss of eligibility within sixty (60) calendar days of the later of the Qualifying Event or termination of Coverage as a result of the Qualifying Event. Failure to notify the Administrator within the sixty (60) calendar days will forfeit eligibility to enroll as an Extended Beneficiary.
The Administrator shall notify the Extended Beneficiary at the known address. The Administrator shall provide notice of the continuation rights within fourteen (14) calendar days following notification from the Employing Entity of the enrolled Employee's death, termination of employment, or reduction of hours. Notice to the Employee's Spouse other than upon the Employee's termination or reduction of hours shall be deemed to be notification to all other Beneficiaries under the contract.
The Administrator shall notify the Extended Beneficiary of the continuation rights at the address specified by the Employee or Extended Beneficiary within fourteen (14) calendar days following notification from the Employee of a divorce, legal separation, or the Dependent child's Coverage ineligibility as a Dependent.
The Administrator shall notify each newly covered Spouse of the Plans Extended Beneficiary continuation rights within fourteen (14) calendar days of the Spouse's effective date.
If the Administrator fails to notify the Extended Beneficiary of the continuation rights within the required time limits as a result of failure of the Employing Entity to notify the Administrator, any penalty required of the Administrator shall be billed to the Employing Entity who failed to notify the Administrator.

(n) Extended Beneficiary's Election Period. The Extended Beneficiary may elect to continue Coverage during the later of sixty (60) calendar days following the Administrator's notification to the Extended Beneficiary or the sixty (60) calendar days following Coverage termination. Coverage will be continued from the Coverage termination date through the months for which payment is received, provided payment is received no later than forty-five (45) calendar days following the Beneficiary's election to continue Coverage.

(o) Extended Beneficiary's Independent Election. Each Beneficiary eligible for Extended Coverage shall be afforded the opportunity to make an independent election to continue Coverage in the enrolled Option, provided the Beneficiary is not enrolled under the SHBP as an Employee, Spouse, Dependent, or Annuitant. If a Beneficiary, either the Employee or Spouse of a enrolled Employee makes an election to provide Coverage for the other Extended Beneficiary, the election shall be binding on that other Beneficiary. An election on behalf of a minor child can be made by the child's parent or legal guardian. An election on behalf of an eligible Beneficiary who is incapacitated can be made by the legal representative of the Beneficiary. Except for any child who is born to or placed with an Extended Beneficiary, Dependents enrolled in the Plan during a period of Extended Coverage under federal law do not themselves become Extended Beneficiaries and may not make separate Coverage elections or participate in Open Enrollment.

(p) Required Documentation. The Administrator may require a monthly certification on the Premium billing by the Extended Beneficiary that the conditions as outlined in Section 111-4-1-.09(11) have not occurred.

(q) Recovery of Paid Benefits. The Administrator shall have the right to recover all benefit payments made on behalf of any Extended Beneficiary as a result of and after the occurrence of any of the conditions outlined in Section 111-4-1-.09(11) .

History

Authority: U.S. Internal Revenue Code and Consolidated Omnibus Budget Reconciliation Act (COBRA)
History. Original Rule entitled "Extended Coverage Under Federal Law (COBRA)" adopted. F. Apr. 18, 2005; eff. May 8, 2005.
Repealed: New Rule of same title adopted. F. Jan. 22, 2007; eff. Feb. 11, 2007.

Ga. Comp. R. & Regs. r. 111-4-1-.09 Termination of Coverage {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.09}

(1) Termination from Employment. Termination from employment includes resignation, abandonment of job, release from job, forfeiture of job, and all other types of termination. Health benefit Coverage shall terminate at the end of the month following the month of the last date of employment that was transmitted to the Administrator unless continued under the provision of Extended Coverage. This date will normally be the end of the month following the month in which separation or termination of employment occurred.

(2) Employment Layoff. Employment layoff means that the Employer has formalized a reduction in staff plan and the Employee will no longer be employed by one of the Employing Entities. Health Benefit Coverage shall terminate at the end of the month following the month of the last date of employment that was transmitted to the Administrator, unless continued under the provisions of Extended Coverage. The Coverage termination date will normally be the end of the month following the month in which the layoff occurred.

(3) Reduction of Hours. A reduction in hours worked may result in loss of eligibility to continue health benefit Coverage.

(a) If for any reason the number of worked hours is reduced for a covered State Employee to less than thirty (30) hours per week, Coverage shall terminate at the end of the month following the month in which the reduced hours took effect; unless continued under the provisions of Extended Coverage.

(b) If for any reason the number of worked hours is reduced for a covered Teacher to less than half-time or a minimum of seventeen and one-half (17 1/2) hours per week, Coverage shall terminate at the end of the month following the month in which the reduced hours took effect; unless continued under the provisions of Extended Coverage.

(c) If for any reason the number of worked hours is reduced for a covered Public School Employee to less than sixty (60) percent of that required to perform the position duties, Coverage shall terminate at the end of the month following the month in which the reduced hours took effect; unless continued under the provisions of Extended Coverage. However, the sixty (60) percent cannot be less than twenty (20) hours if the Member is a participant in the Teachers Retirement System and less than fifteen (15) hours if the member is a participant in the Public School Employees Retirement System.

(4) Failure to Return from an Approved Leave of Absence Without Pay. If an Employee on an Approved Leave of Absence Without Pay fails to return to Active employment, Coverage will terminate at the earlier of the end of the month for which the Leave Without Pay was approved or the end of the month for which a valid Premium payment has been received. Failure to return to Active employment from an Approved Leave of Absence Without Pay will be considered termination of employment for the purposes of Extended Coverage eligibility.

(5) Legal Separation or Divorce. Coverage for a legally separated or divorced Spouse will terminate at the end of the month in which the separation papers were approved by a court of competent jurisdiction or in which the divorce decree is approved by the court of competent jurisdiction unless continued as an Extended Beneficiary.

(6) Dependent Child. Coverage for an eligible Dependent child shall terminate at the end of the month in which the child reaches age twenty-six (26) unless a Qualified Medical Child Support Order (QMCSO) or other court order bears an earlier expiration date or Coverage is continued under the provisions for a Totally Disabled Child or an Extended Beneficiary.

(7) Failure to Remit Premium. Failure to remit the billed Premium amount in full within thirty (30) calendar days following the end of the month for which Coverage has been paid will result in suspension of benefit payments and will constitute forfeiture of eligibility to continue Coverage while on Approved Leave of Absence Without Pay or Extended Coverages of any kind. Coverage will not be reinstated for payments received thirty (30) calendar days following termination of Coverage for insufficient payment, unless an administrative error has been made. Failure to remit Premium will constitute a declination of eligibility to continue coverage as an Extended Beneficiary without further notice by the Administrator.

(8) Expiration of Approval Leave of Absence Without Pay. Coverage will terminate at the end of the month following expiration of the Approved Leave of Absence Without Pay period unless the leave is extended by the appropriate organizational official and such extension is approved by the Administrator or the Employee returns to work, or the Employee extends coverage under the provisions of Extended Coverage. Coverage may be terminated earlier than the expiration of such leave when the Failure to Remit Premium provisions of these regulations apply.

(9) Expiration of Coverage as a Pending Retiree. Health benefit Coverage will terminate at the end of the month following determination that the Retiree is not immediately eligible to receive an annuity under a state supported participating retirement system operated for Employees, unless the Retiree is eligible to continue Coverage under the Extended Coverage provisions of these regulations. Pending Retirees appealing a denial of retirement benefits may continue up to the maximum period outlined in Section 111-4-1-.07 .

(10) Expiration of Extended Beneficiary Coverage Privileges. Health benefit Coverage for Extended Beneficiaries will terminate at the end of the month in which the earliest of the following conditions occur:

(a) The full Premium amount is not paid within the time allowed under these regulations;

(b) The maximum Coverage period permitted under these regulations is exhausted;

(d) The Extended Beneficiary becomes covered under another group health care plan by reason of employment or marriage, and pre-existing condition exclusions are not applied under the new coverage;

(e) Cancellation of contract with an organization with whom the Board of Community Health is authorized to contract;

(f) The State Health Benefit Plan is terminated.

(11) Deceased Enrolled Member. Coverage shall terminate no later than the end of the month of death of a Member enrolled in employee only Coverage. Coverage shall terminate no later than the end of the month following the month of death of a Member when the Coverage includes Dependents. The Employing Entity, retirement system or deceased's estate shall remit the appropriate Premium. A surviving Beneficiary may continue coverage as outlined in 111-4-1-.04 , the Extended Coverage provisions of these regulations.

(12) Discontinuation of Coverage Outside Open Enrollment. Coverage shall terminate no earlier than the end of the month following receipt of the request to discontinue Coverage outside the annual Open Enrollment period. Requests to discontinue Coverage must be approved by the Administrator. The Administrator may require documentation of other Coverage.

(13) Suspension of Benefits Due to Nonpayment. If an Employing Entity fails to remit Premiums or documentation or fails to reconcile bills in the manner required by the Plan, the Plan may suspend benefit payments for Enrolled Members of the Employing Entity.

History

Authority: O.C.G.A. Secs. 20-2-881, 20-2-911, 45-18-1et seq., IRS Code Section 125. Patient Protection and Affordable Care Act (PPACA)
History. Original Rule entitled "Termination of Coverage" adopted. F. Apr. 18, 2005; eff. May 8, 2005.
Repealed: New Rule of same title adopted. F. Jan. 22, 2007; eff. Feb. 11, 2007.
Amended: F. Jan. 26, 2011; eff. Feb. 16, 2011.

Ga. Comp. R. & Regs. r. 111-4-1-.10 Plan Benefits {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.10}

(1) Creation of Benefit Schedule. The Board is authorized to establish benefit schedules for Options to be included in a health benefit plan for eligible persons as defined in Georgia law. Benefit schedules shall comply with applicable state and federal law. Benefit schedules shall further the plan design goals set forth by O.C.G.A. Sections 45-18-3 ; 20-2-883 ; 20-2-913 : "to (1) Provide a reasonable relationship between the hospital, surgical and medical benefits to be included and the expected distribution of expenses of each such type to be incurred by the covered employees and dependents; and (2) Include reasonable controls, which may include deductible and reinsurance provisions applicable to some or all of the benefits, to reduce unnecessary utilization of the various hospital, surgical, and medical services to be provided and to provide reasonable assurance of stability in the future years of the plan." Benefit schedules for Options may include a different schedule for Medicare enrolled Retirees and non-Medicare enrolled Retirees. Benefit schedules of Options shall be considered in the calculation of Employer and Employee Contribution Rates. The Regular Insurance Option benefit schedules shall be established upon approval of the Employer and Employee Contribution Rates for such Options. The Medicare Advantage Option benefit schedules shall be established upon approval of the Employer and Employee Contribution Rates for such Options. The dates of approval of Employer and Employee Contribution Rates shall be recorded in official minutes of Board meetings. Medicare Advantage Options must be developed and administered in the manner approved by the Centers for Medicare and Medicaid Services. Accordingly, the following subsections apply only to Regular Insurance Options.

(a) The Administrator shall authorize the use of established procedures by the TPA to terminate benefit payments if continuation of treatment in the mode being billed is not medically necessary. The TPA's procedures must ensure that the Member shall have the right to ask for a record review by medical consultants.

(b) The Administrator shall interpret the general schedules into specific benefit language for inclusion in the Summary Plan Description and for use by the TPA in adjudicating claim payments.

(c) The Administrator shall incorporate specific benefit language to be used by the TPA for review of utilization patterns and to implement claim cost containment features, including but not limited to, medical review of excessive utilization and audits of hospital or other claims.

(d) The Administrator shall be authorized to require pre-authorization by the TPA of any new medical service before approval for benefit payment. Generally, the service will not be considered for coverage unless medical consultants/advisors substantiate through literature research that clinical trials demonstrate the medical effectiveness of the service. Other guidelines, such as those of the Federal Drug Administration of the Centers for Medicare & Medicaid Services may also be used, at the discretion of the Administrator, in the determination of coverage.

(e) The Administrator shall authorize the use of established procedures by the TPA for obtaining additional medical information from members and from providers of medical services and supplies, in order to determine the amount and appropriateness of benefit payments.

(f) The Administrator shall establish procedures for permitting the Member to appeal an adverse determination of eligibility for Coverage or of a benefit, service, or Claim. These procedures shall be outlined in the Summary Plan Description to advise the Member of the process to initiate an appeal. However, the Administrator has delegated the final authority to the TPA for approval in accordance with the schedule of Benefits and the interpretation thereof. The Administrator shall have final authority for approval of al eligibility appeals.

(g) The Administrator may contract for or employ professionals from any medical discipline to advise the Administrator on continuing medical necessity, quality of medical care, or the level of fees charged by the providers of medical care.

(h) The Administrator is authorized to develop appropriate medical policy in conformity with the schedule of benefits and these regulations so that new procedures will be included for coverage when the new procedures are adopted as accepted medical practice and that medical procedures which are excessively used without significantly improving the treatment of an illness or injury are reviewed.

(2) Exclusions. Plan benefits shall exclude expenses incurred by or on account of an individual prior to the effective date of coverage; expenses for services received for injury or sickness due to war or any act of war, whether declared or undeclared, which war or act of war shall have occurred after the effective date of this plan; expenses for which the individual is not required to make payment; expenses to the extent of benefits provided under any employer group plan other than this plan of benefits in which the state participates in the cost thereof. In addition, for all Regular Insurance Options, the Administrator shall publish in the Summary Plan Description interpretative language showing the exclusions for the following types of charges:

(a) Charges for treatment for Pre-existing Conditions in excess of one thousand dollars ($1,000), to the extent this exclusion is permitted by federal law;

(b) Charges for treatment or supplies which are determined to be not medically necessary;

(c) Charges for treatment before the effective date of coverage or after coverage termination, except for Extended Coverage benefits;

(d) Charges other than Wellness/Preventive benefits, that are not specifically related to the care and treatment of a sickness or an injury;

(e) Charges for treatment specifically for dental or vision care;

(f) Charges for treatment for experimental or investigative services or supplies;

(g) Charges that are considered educational or treatment to restore learning capacity;

(h) Charges in connection with custodial care, extended care facilities or a nursing home;

(i) Charges in connection with rehabilitation, rehabilitation therapy, or restorative therapy when the condition is no longer expected to improve significantly in a reasonable and generally predictable period of time;

(j) Charges in connection with therapy for learning disabilities;

(k) Charges for prosthesis or equipment which are determined to be not medically necessary.

(3) Actions. In creating the SHBP, neither the Georgia General Assembly nor the Board of Community Health has waived its sovereign immunity. Thus no action either in law or in equity, can be brought or maintained against the State of Georgia, the Board of Community Health, or any other department or political subdivision of the State of Georgia to recover any money under this Plan. In like fashion, no suit may be maintained against any officials or Employees of these bodies if the ultimate financial responsibility would have to be borne by public Funds from the General Treasury, the health benefit Funds or elsewhere.

(a) The Board of Community Health, however, does reserve the right to maintain any suits, either in its own name, or through its officials, Employees, or agents, which it deems necessary to the administration of the SHBP, including actions to recover money from participants, beneficiaries, agents, Employees, officials, or any other person.

(b) The Board of Community Health reserves the right to modify its Benefits, Coverages, and eligibility requirements at any time, subject only to reasonable advance notice to its Members. When such a change is made, it will apply as of the effective date of the modification to any and all charges which are incurred by Members from that date forward, unless otherwise specified by the Board of Community Health.

(4) Non-duplication of Benefits and Subrogation. The Plan will not duplicate payments for medical expenses made under third-party personal-injury-protection contracts nor will it duplicate payments made as the result of any litigation. The Plan will be subrogated to any right of recovery that a Member has against a person or organization where medical expenses were incurred as a result of injuries suffered because of alleged negligence or misconduct. In any case where the primary plan provides for subrogation for third-party liability and this Plan would be determined to be secondary, benefits under this Plan shall be reduced to the amount that would have been paid under the secondary provisions of this Plan.

(5) Recovery of Benefit Overpayments. The Administrator shall seek repayment for any benefits paid to any individual, corporation, firm, or other entity who or which is not qualified, in the opinion of the Administrator, to receive benefits from the Plan. The Administrator shall establish procedures for collecting the overpayments, duplicate payments, or wrong payee payments. The procedures may include, but are not limited to, establishing installment payments, withholding future benefit payment, or filing suit or garnishment.

History

Authority: O.C.G.A. Secs. 20-2-881 to 20-2-885, 20-2-887, 20-2-911 to 20-2-915, 45-18-1et seq., Health Insurance Portability and Accountability Act of 1996 (HIPAA), Social Security Act
History. Original Rule entitled "Plan Benefits" adopted. F. Apr. 18, 2005; eff. May 8, 2005.
Repealed: New Rule of same title adopted. F. Jan. 22, 2007; eff. Feb. 11, 2007.
Amended: F. Sept. 28, 2007; eff. Oct. 18, 2007.
Amended: F. Aug. 20, 2008; eff. Sept. 9, 2008.
Repealed: New Rule of same title adopted. F. Apr. 14, 2010; eff. May 4, 2010.

Ga. Comp. R. & Regs. r. 111-4-1-.11 Claims {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.11}

(1) Filing Claims. The Administrator shall coordinate the procedures for filing claims with the TPA. Such procedures may not establish a liability period greater than the maximum liability period set forth below. Claim forms shall be designed and printed for the Member's and providers' use when appropriate.

(2) Maximum Liability Period. All Claims of Benefits must be presented in writing to the Administrator or TPA in accordance with the procedures established by the Administrator and the TPA, which procedures may not permit payment of claims submitted after twenty-four (24) calendar months following the month of service in which the service was rendered. If any Claim for Benefits is presented to the Administrator or TPA after two (2) years from the date the service was rendered, benefits will not be owed or paid.

(3) Unclaimed or Uncased Claim Checks. All drafts issued on behalf of the Plan shall be void if not presented and accepted by the drawer's bank within six (6) calendar months of the date the draft was drawn. If the payee or Subscriber does not present the draft or request a reissue of the draft for a period of seven (7) years from the date the draft was drawn, the draft will be void and funds retained in the appropriate trust Fund.

History

Authority: O.C.G.A. Sec. 20-2-881, 20-2-884, 20-2-890, 20-2-911, 20-2-917, 45-18-2, 45-18-6, 45-18-11
History. Original Rule entitled "Health Maintenance Organizations" adopted. F. Apr. 18, 2005; eff. May 8, 2005.
Repealed: New Rule entitled "Claims" adopted. F. Jan. 22, 2007; eff. Feb. 11, 2007.
Repealed: New Rule of same title adopted. F. Apr. 14, 2010; eff. May 4, 2010.

Ga. Comp. R. & Regs. r. 111-4-1-.12 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.12}

History

Authority: O.C.G.A. Secs. 20-2-881, 20-2-890, 20-2-911, 20-2-917, 45-18-2, 45-18-11
History. Original Rule entitled "Claims" adopted. F. Apr. 18, 2005; eff. May 8, 2005.
Repealed: F. Jan. 22, 2007; eff. Feb. 11, 2007.

Ga. Comp. R. & Regs. r. 111-4-1-.13 Georgia Retiree Health Benefit Fund {#sec-ga.-comp.-r.-regs.-r.-111-4-1-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-4-1-.13}

(1) Functions, Duties and Responsibilities of the Board of Community Health. The Board shall establish the Georgia Retiree Health Benefit Fund (GRHBF). The Board in its official capacity shall be the GRHBF's trustee. The Board shall annually review Other Post Employment Benefits (OPEB) liability. The Board shall determine Annual Required Contributions (ARC), which may not be the same as employer and employee contribution rates. The Board shall also determine annual employer and employee contribution rates. The Board shall collect employee and employer contributions and deposit the contributions into the GRHBF. The Board may utilize the investment services of the Employee Retirement System, Division of Investment Services to invest a portion of the GRHBF for long-term investments. No member of the Board or employee of the Department shall have any personal interest in the gains or profits from any investment made by the Board or use the assets of the GRHBF in any manner, directly or indirectly, except to make such payments as may be authorized by the Board or by the Commissioner as the executive officer of the Board.

(a) Establish and Design Plan. The Board is authorized to establish the GRHBF to collect employee and employer contributions for OPEB. The Board shall account for employee and employer contributions by each pension plan, as delineated at 111-4-1-.01(50) , separately.

(b) Promulgate Regulations. The Board is authorized to adopt and promulgate rules and regulations for the effective administration of the GRHBF.

(c) Establish Contributions on Behalf of Retirees. The Board shall establish by Resolution, contributions by public school teacher retirees, retired public school employees, retired State employees, and any other Annuitant listed at 111-4-1-.01(50) and shall deposit those contributions into the GRHBF. The Board shall consider the actuarial estimates of OPEB in establishing the contributions.

(d) Establish Employer Rates. The Board shall establish by Resolution, OPEB employer contribution rates and shall deposit those contributions into the GRHBF.

(2) Functions, Duties and Responsibilities of the Commissioner. The Commissioner in his or her official capacity shall be the Administrator of the GRHBF and shall be the custodian of the GRHBF.

(a) Administer Regulations and Policies. The Commissioner shall administer the GRHBF consistent with Board regulation and policy. The Department shall contract with the Division of Investment Services of the Teachers Retirement System of Georgia and the Employees' Retirement System of Georgia with respect to GRHBF investments. The Department shall maintain all necessary records regarding the GRHBF in accordance with generally accepted accounting principles. The Department shall collect all moneys due to the GRHBF and shall pay any administrative expenses necessary and appropriate for the operation of the GRHBF from the GRHBF.

(b) Annual Report. The Department shall prepare an annual report of GRHBF activities for the Board, the House Appropriations Committee, and the Senate Appropriations Committee. Such reports shall include, but not be limited to, audited financial statements. The reports shall contain the most recent information reasonably available to the Department reflecting the obligations of the GRHBF, earnings on investments, revenue and expenses by pension plan, and such other information as the Board deems necessary and appropriate. This report shall reflect activity on a state fiscal year basis. The Department shall be entitled to any information that it deems necessary and appropriate from a retirement system, as delineated at 111-4-1-.01(50) , so that the provisions of Code Section 45-18-103 may be fulfilled.

(c) Regulations. The Commissioner shall recommend to the Board amendments to the regulations, submit the approved regulations to appropriate filing entities, cause all regulations to be published, and provide a copy to the Employing Entities.

(d) Provide Notice of OPEB Employer Contribution. The Commissioner shall provide notice and certification of the required OPEB employer contribution rate to each of the Employing Entities and the Department of Education on or before June 1st of each year.

(3) Duties and Responsibilities of Employing Entity. Each Employing Entity is responsible for complying with these regulations. It shall be the responsibility of State agencies to make contributions to the GRHBF, subject to appropriations, in accordance with the OPEB employer contribution rate established by the Board. It shall be the responsibility of all other Employing Entities to make contributions to the GRHBF in accordance with the OPEB employer contribution rates established by the Board in addition to the employer contributions required to be made to the GRHBF for the health plan as determined from fiscal year to fiscal year.

(a) Deduct Enrolled Member Premium Amounts. The Employing Entity shall withhold the contribution rate as approved by the Board.

(b) Remit Employer Contributions. The Employing Entity shall calculate and remit the appropriate OPEB employer contribution.

History

Authority: O.C.G.A. Secs. 20-2-898, 20-2-926, 45-18-21, 45-18-100 to 45-18-105
History. Original Rule entitled "Georgia Retiree Health Benefit Fund" adopted. F. Oct. 15, 2007; eff. Nov. 4, 2007.

Chapter 111-5 Repealed

Subject 111-5-1 Repealed

Ga. Comp. R. & Regs. r. 111-5-1-.01 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.01}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Definitions" adopted. F. June 13, 2006; eff. July 3, 2006.
Amended: F. Aug. 26, 2009; eff. Sept. 15, 2009.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.02 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.02}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Administration of the Program" adopted. F. June 13, 2006; eff. July 3, 2006.
Amended: F. Aug. 26, 2009; eff. Sept. 15, 2009.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.03 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.03}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Health Care Provider Eligibility" adopted. F. June 13, 2006; eff. July 3, 2006.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.04 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.04}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Volunteers" adopted. F. June 13, 2006; eff. July 3, 2006.
Amended: F. Aug. 26, 2009; eff. Sept. 15, 2009.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.05 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.05}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Patient Selection and Referral" adopted. F. June 13, 2006; eff. July 3, 2006.
Amended: F. Aug. 26, 2009; eff. Sept. 15, 2009.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.06 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.06}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Eligibility" adopted. F. June 13, 2006; eff. July 3, 2006.
Amended: F. Aug. 26, 2009; eff. Sept. 15, 2009.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.07 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.07}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Covered Services" adopted. F. June 13, 2006; eff. July 3, 2006.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.08 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.08}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Contracts" adopted. F. June 13, 2006; eff. July 3, 2006.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.09 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.09}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Notice Requirements" adopted. F. June 13, 2006; eff. July 3, 2006.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.10 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.10}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Patient Records" adopted. F. June 13, 2006; eff. July 3, 2006.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.11 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.11}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Sovereign Immunity" adopted. F. June 13, 2006; eff. July 3, 2006.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.12 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.12}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Legal Actions" adopted. F. June 13, 2006; eff. July 3, 2006.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.13 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.13}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Complaints" adopted. F. June 13, 2006; eff. July 3, 2006.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Ga. Comp. R. & Regs. r. 111-5-1-.14 Repealed {#sec-ga.-comp.-r.-regs.-r.-111-5-1-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-5-1-.14}

History

Authority: O.C.G.A. § 31-2A-6
History. Original Rule entitled "Department Reports" adopted. F. June 13, 2006; eff. July 3, 2006.
Amended: F. Aug. 26, 2009; eff. Sept. 15, 2009.
Repealed: F. Sep. 20, 2013; eff. Oct. 10, 2013.

Chapter 111-8 Healthcare Facility Regulation

Subject 111-8-1 Rules and Regulations for Adult Day Centers

Ga. Comp. R. & Regs. r. 111-8-1-.01 Authority {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.01}

These rules are adopted and published pursuant to the Official Code of Georgia Annotated (O.C.G.A.) § 49-6-80et seq., the "Adult Day Center for Aging Adults Licensure Act."

History

Authority: O.C.G.A. § 49-6-80
History. Original Rule entitled "Authority" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.02 Title and Purposes {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.02}

These rules shall be known as the Rules and Regulations for Adult Day Centers. The purposes of these rules are to provide for licensing and inspection of adult day centers which provide adult day care services and/or adult day health services to three or more adults, and to establish the minimum standards for the operation of adult day centers. It is the intent of these rules to promote, safeguard and protect the well-being of adults participating in adult day care who need such services.

History

Authority: O.C.G.A. § 49-6-80
History. Original Rule entitled "Title and Purposes" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.03 Exemptions {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.03}

These rules and regulations shall not apply to the following:

(1) Individuals or organizations operating an adult day center without receiving compensation as a condition of the participant's receiving such services;

(2) Individuals or organizations that provide services for compensation to only one or two participants;

(3) Programs which provide day habilitation and treatment services exclusively for developmentally disabled persons; and

(4) Respite care services programs, provided the program meets all parts of the definition for a respite care services program as outlined in section 111-8-1-.04(hh) .

History

Authority: O.C.G.A. § 49-6-82
History. Original Rule entitled "Exemptions" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.04 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.04}

(1) In these rules, unless the context otherwise requires, the words and phrases set forth herein shall mean the following:

(a) "Abuse" means any intentional or grossly negligent act or series of acts or intentional or grossly negligent omission to act which causes injury to a participant, including but not limited to assault or battery, failure to provide treatment or care, or sexual harassment.

(b) "Activities of daily living" means bathing, shaving, brushing teeth, combing hair, toileting, dressing, eating, grooming, taking medications, and transfers and/or ambulation.

(d) "Adult day care (ADC)" means the provision of a comprehensive plan of services that meets the needs of aging adults as defined in paragraph (g) of these definitions under a social model, as defined in paragraph (ll) of these definitions. This term shall not include programs which provide day habilitation and treatment services exclusively for individuals with developmental disabilities.

(e) "Adult day center" or "center" means a facility serving aging adults that provides adult day care or adult day health services, as defined in paragraphs (d) and (f) of these definitions, for compensation to three or more persons. Adult day centers may operate in more than one location if classified and approved by the Department as a mobile adult day center. This term shall not include a respite care services program.

(f) "Adult day health services (ADHS)" means the provision of a comprehensive plan of services that meets the needs of aging adults under a medical model as defined in paragraph (v) of these definitions. This term shall not include programs which provide day habilitation and treatment services exclusively for individuals with developmental disabilities.

(g) "Aging adults" means persons 60 years of age or older or mature adults below the age of 60 whose needs and interests are substantially similar to persons 60 years of age or older who have physical or mental limitations that restrict their abilities to perform the normal activities of daily living and impede independent living.

(h) "Assistance with self-administration" means staff can provide assistance as outlined in Rule 111-8-1-.19 .

(i) "Capacity" means the number of participants for which a center has been licensed to provide care and services at any given time.

(j) "Days" means calendar days, not workdays, unless otherwise noted in the text.

(k) "Department" means the Georgia Department of Community Health.

(l) "Dietitian" means a registered dietitian, with current registration by the Commission on Dietetic Registration of the American Dietetic Association; and a licensed dietitian, with current licensure by the Georgia Board of Examiners of Licensed Dietitians.

(m) "Direct care staff" means any individual who provides direct services to participants, including, but not limited to the Director, a licensed nurse, the activities director, aides, and volunteers.

(n) "Director" means the person designated by the governing body as responsible for the overall operation of a center.

(o) "Disaster preparedness plan" means a written document which identifies potential hazards or events, that should they occur, would cause an emergency situation at the center; and proposes, for each identified emergency situation, a course of action so as to minimize the threat to health and safety of the participants.

(p) "Exploitation" means an unjust or improper use of another person or the person's property through undue influence, coercion, harassment, duress, deception, false representation, false pretense, or other similar means for one's own personal advantage.

(q) "Facility" means an adult day center, unless otherwise specified.

(r) "Governing body" means the Board of Trustees, the partnership, the corporation, the association, or the person or group of persons who maintain and control the center and who are legally responsible for the operation of the center.

(s) "Individual plan of care" means a document describing the participant's needs, services to be provided by the adult day center and, for adult day health services, identification of the therapeutic service provider who will deliver the required services, the expected outcomes and frequency of re-evaluation of the plan.

(t) "Licensed practical nurse (LPN)" means a person who provides care relating to the maintenance of health and prevention of illness under the supervision of a physician, dentist, podiatrist or registered nurse (RN).

(u) "Long-term care facility" means any skilled nursing home, intermediate care home, personal care home or assisted living community licensed by the Department.

(v) "Medical model" means a comprehensive program that provides adults with the basic social, rehabilitative, health and personal care services needed to sustain the essential activities of daily living and to restore or maintain optimal capacity for self-care. Such program of care shall be based on individual plans of care and shall be provided for less than 24 hours per day.

(w) "Mobile adult day center" means a program of services offered by an adult day center which utilizes a designated staff that travels from one central location to off-site locations to provide adult day services as described in these rules. The mobile adult day center transports the necessary staff and/or volunteers, participant records, supplies and program materials to each off-site location for the provision of services. The services offered by a mobile adult day center may either be adult day care services or adult day health services, or both, and are offered four days per week or less at any one location.

(x) "Neglect" means a failure to act or omission to act that caused or may cause physical harm, emotional injury or death.

(y) "Nurse" means a registered nurse (RN) or licensed practical nurse (LPN) licensed in the state of Georgia.

(z) "Nursing services" means services provided by licensed nursing personnel and may include therapy services. Nursing services may also include observation, promotion and maintenance of health, dressing changes, prevention of illness and disability, management of health care during acute and chronic phases of illness, guidance and counseling of individuals and participants' representatives, administration of medications and referral to physicians, other health care providers, and community resources when appropriate.

(aa) "Participant" means an adult receiving services in the adult day center.

(bb) "Physician's orders" means an order that is signed and dated by a medical doctor (MD), doctor of osteopathy (DO) or other person(s) authorized by law who is licensed to practice medicine in the state of Georgia.

(cc) "Primary caregiver" means the one identified relative or other person in a relationship of responsibility, such as an agent under a valid durable power of attorney for health care or health care agent under a valid advance directive for health care, who has assumed the primary responsibility for the provision of care needed to maintain the physical or mental health of an aging adult, who lives in the same residence with such individual, and who does not receive financial compensation for the care provided.

(dd) "Proxy caregiver" means an unlicensed person who has been determined to have the necessary knowledge and skills acquired through training by a licensed healthcare professional to perform documented health maintenance activities, including specialized procedures, for an individual with a disability who has delegated to the designated proxy caregiver the performance of such health maintenance activities through execution of a written informed consent by the individual with a disability or a person legally authorized to act on behalf of such individual with a disability.

(ee) "Registered nurse (RN)" means a person currently licensed by the Georgia Board of Nursing or successor entity to practice professional nursing.

(ff) "Representative" means anyone that the participant identifies as having authority to make decisions on his or her behalf.

(gg) "Resident" means any person receiving treatment or care in a long-term care facility.

(hh) "Respite care services program" means a program for aging adults who can function in a group setting and who can feed and toilet themselves with or without the assistance of a personal aide accompanying them and which:

Is operated by a nonprofit organization;
Provides no more than 25 hours of services per week;
Is managed by a director who has completed an adult day care services training and orientation program approved by the Department;
Is staffed primarily by volunteers; and
Has as its sole purpose to provide primary caregivers of aging adults with relief from normal caregiving duties and responsibilities.

(ii) "Restraint" means any manual or physical device, material, or equipment attached or adjacent to the participant's body that the individual cannot remove easily which restricts freedom or normal access to one's body or a drug or medication when it is used as a restriction to manage the participant's behavior or restrict the participant's freedom of movement and is not standard treatment or dosage for the participant's condition.

(jj) "Serious injury" means an injury requiring emergency medical intervention or treatment by medical personnel, either at an urgent care facility, at an emergency room or a medical office.

(kk) "Social activities" means therapeutic, educational, cultural enrichment, recreational, and other activities on site or in the community in a planned program to meet the social needs and interests of the participant.

(ll) "Social model" means a program that addresses primarily the basic social and recreational activities needed to be provided to aging adults, but also provides, as required, limited personal care assistance, supervision, or assistance essential for sustaining the activities of daily living. Such programs of care shall be based on individual plans of care and shall be provided for less than 24 hours per day.

(mm) "Staff" means, as appropriate to their roles and responsibilities, all people who provide supervision, care, treatment, and services in the center including permanent, temporary, and part-time employees, as well as contracted individuals and health profession students. The definition of staff does not include licensed independent practitioners who are not paid employees, contract employees or volunteers.

(nn) "Standard Precautions" means a system of precautions or set of guidelines designed to reduce exposure to and transmission of microorganisms from both recognized and unrecognized sources of potential infections.

(oo) "Volunteer" means an individual who performs or offers to perform a service for the center out of his/her own free will and without payment.

History

Authority: O.C.G.A. § 49-6-82et seq
History. Original Rule entitled "Definitions" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.05 Application for a License {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.05}

(1) Unless exempted in section 111-8-1-.03 , no person, partnership, entity, corporation, or association, whether operated for profit or not for profit, shall operate an adult day center without first obtaining a valid license from the Department.

(2) A license issued under these rules shall not be assignable or transferable.

(3) Unless exempted in section 111-8-1-.03 , no entity or person shall use terms in its business name or marketing materials to imply or indicate that it is an adult day center unless the entity or person holds a valid license issued by the Department.

(4) A separate application and license is required for each adult day center.

(5) During the application process, the governing body shall provide the following:

(a) A completed application for a license on forms provided by the Department.

(b) An application and license fee as approved by the Board of Community Health based upon the type of services provided;

Proof of ownership or right of occupancy may include a warranty deed, lease agreement or bill of sale; or
Written permission from the owner of the premises authorizing the adult day center to operate exclusively within a designated space is permissible where the adult day center provides services in a donated space or does not own or lease the premises where services are provided;

(d) A floor sketch of the facility showing windows, doors, room measurements, and the location of the adult day center facilities and any other services provided on the premises;

(e) A completed affidavit of personal identification;

(f) In the case of corporations, partnerships, and other entities authorized by law, the applicant shall provide a copy of its certificate of incorporation or other acceptable proof of its legal existence and authority to transact business within the State of Georgia;

(g) Documentation from the local authority having jurisdiction over fire safety or by the State Fire Marshal that the center is in compliance with all applicable fire safety regulations. Such documentation shall be dated within the six (6) months preceding the date of the application;

(h) Documentation of approval for water source and sewage disposal system from the local authority for water and/or sewage;

(i) Documentation from local zoning authorities that the center is in compliance with local zoning codes;

(j) A list of the locations of any additional adult day centers operated by the governing body;

(k) If vehicle transportation services are provided by the center, the center shall submit the following:

Proof of insurance coverage for property damage, uninsured motorists and bodily injury for the vehicle which transports participants; and
Proof of current vehicle registration.

(l) For a mobile adult day center, a list of all locations where services are provided. If the mobile adult day center provider also operates a standard freestanding adult day center, the name and address of that center shall also be included on the application.

(6) Local zoning and other local requirements regarding the proper location and establishment of adult day centers must be addressed by the applicant with the responsible local officials.

(7) All adult day centers which are required to be licensed and operating as of the effective date of these rules shall make application to the Department for a license within 90 days of the initial effective date of these rules. Such centers may continue to operate without disruption until such time as the Department has made a determination of compliance or noncompliance with these rules and regulations.

(8) A license shall be issued to the governing body of the adult day center disclosed in the application for licensure and proof of ownership documents.

(9) The adult day center shall annually submit a license renewal fee in the amount approved by the Board of Community Health.

(10) Knowingly making any verbal or written false statement of material fact in connection with the application for a license or supplying false or misleading information shall constitute grounds for denial or revocation of a license.

(11) Fees. The Department shall require the payment of application fees, license fees, license renewal fees or other similar fees relating to the licensure of adult day centers in amounts approved by the Board of Community Health. Fees are nonrefundable except as provided in Chapter 111-8-25.

(12) All application fees and license fees shall be submitted and made payable to the Department of Community Health.

(13) Mobile adult day centers .

(a) Each license issued to a mobile adult day center shall enable the licensee to provide services at no more than five (5) off-site locations.

(b) Each off-site location where the mobile adult day center provides services must be listed on the mobile adult day center's application for a license.

(c) If an applicant proposes to operate a regular adult day center as well as a mobile adult day center, there shall be a separate license fee for each type of center.

(d) Providers applying for operation of a mobile adult day center shall demonstrate compliance with all rules and regulations applicable to the types of services provided.

(e) All off-site facilities used by mobile adult day center providers shall be in compliance with all applicable regulations for physical plant and safety standards as indicated in section 111-8-1-.10 and the fire safety standards set forth in 111-8-1-.09 .

(14) Following evidence of substantial compliance with these rules and regulations and any provisions of law applicable to the operation of the adult day center, the Department may issue a license.

History

Authority: O.C.G.A. § 49-6-83
History. Original Rule entitled "Application for License" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.06 License Requirements {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.06}

(1) The governing body of each adult day center shall obtain a valid license from the Department prior to beginning operation. To be eligible for a license, the center must be in substantial compliance with the applicable rules and regulations.

(2) The adult day center's capacity shall be determined by the floor space available for participant activity, as described in 111-8-1-.10(1)(f) , and the occupancy load determined by the local authority having jurisdiction over fire safety or the State Fire Marshal. The license shall state the maximum number of participants per day who may receive services at the center. Adult day centers shall schedule and provide services to participants in such a manner that it does not exceed its licensed capacity.

(3) The license shall be displayed in a prominent place on the premises where the adult day center programs are operated.

(4) Licenses are not transferable from one governing body to another or from one adult day center location to another.

(5) A license shall no longer be valid and shall be returned to the Department when the adult day center ceases to operate, changes locations, the ownership changes, the governing body is significantly changed, or the license is suspended or revoked. At such time a license is no longer valid, it shall be returned to the Department.

(6) Each change of ownership, change of location, addition of another location, change in name, change in the maximum number of participants per day or a change in the scope of services provided shall be reported to the Department along with an application from the proposed new owners or lessees for a new license.

History

Authority: O.C.G.A. § 49-6-83
History. Original Rule entitled "License Requirements" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.07 Governing Body {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.07}

(1) Each adult day center or mobile adult day center shall have a clearly identified governing body which shall be empowered and responsible for determining all policies and procedures and ensuring compliance with these rules and regulations.

(2) The governing body shall be responsible for compliance with the requirements of O.C.G.A. §§ 49-6-81 through 49-6-86 , and with applicable administrative rules and regulations of the Department, including but not limited to all applicable statutes, rules and regulations regarding disclosure of ownership.

(3) The governing body shall certify in its application the name of the Director who has been designated as responsible for the overall management of the center and for carrying out the rules and policies adopted by the governing body.

(4) The governing body shall notify the Department in writing immediately when there is a change in the Director.

(5) Each adult day center owned or operated by the same governing body shall have a designated Director who is available on-site during operating hours.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Governing Body" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.08 Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.08}

(1) Prior to being granted a license, each adult day center shall develop written policies and procedures outlining the responsibilities of center staff, management and volunteers. The policies and procedures shall at a minimum include the following:

(a) A description of the types of services provided by the center including whether the center provides adult day care, adult day health services or both, characteristics of the participants that the center expects to serve and an Alzheimer's Disclosure Form as applicable, in compliance with O.C.G.A. § 31-8-182 , et seq.

(b) A description of the number and qualifications of staff and/or volunteers who will provide the services; and whether the services will be provided by center staff and/or volunteers or a contract provider;

(d) The center's policy for fees for service, including the daily charge; any additional fees for specific services, goods, or incidental supplies that are not included in the daily charge (e.g. personal hygiene products, transportation, bathing assistance, personal care assistance, etc.); and the method for notifying participants or their representatives of any changes or adjustments in fees;

(e) The center's policy for refunds;

(f) The center's policies and procedures for accepting voluntary contributions as compensation from or on behalf of participants;

(g) The procedure for documenting any serious or unusual incidents occurring at the center which would affect the health, safety or welfare of participants including procedures for obtaining needed care and procedures for informing participants' representatives and/or legal guardian(s), of any such incidents or major changes in general functioning or medical condition of the participant;

(h) An explanation of how emergency medical situations will be handled at the center, including how participants and representatives are informed of the procedures for dealing with emergency medical situations;

(i) The procedure for implementing standard precautions;

(j) A policy and procedure to assure that no staff member, volunteer, visitor, contractor or any other person may be on the premises of the center during the hours of operation if the person exhibits: symptoms of illness, a communicable disease transmitted by normal contact, or behavior which gives reasonable concern for the safety of the participants and others;

(k) A policy for the proper storage, handling and documentation regarding medications where assistance with self-administration is offered and/or medications are administered by a licensed nurse;

(l) A non-smoking policy or a statement that the center has designated an appropriate outside area for smoking;

(m) A description of the criteria for voluntary and involuntary discharge of a participant from the center, and the time frame for notifying the participant and/or participant's representative prior to an involuntary discharge;

(n) A policy for addressing and resolving complaints made by participants, the participant's representative, family or other interested person(s) within a reasonable time not to exceed seven (7) business days, including providing information to such person(s) about appropriate local, county and/or state agency contacts;

(2) Each center shall establish core hours and days of operation during which services are available.

(3) Each center shall maintain an organizational chart, illustrating the lines of authority and communication within the center.

(4) Each center shall ensure that participants and their representatives, if any, shall receive at least 30 days written notice prior to any substantive changes in the participant agreement or fees for service.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Administration" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.09 Disaster Preparedness, Fire Safety and Emergencies {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.09}

(1) In a format provided by the Department, each center shall complete and submit for approval a disaster preparedness plan that contains a set of procedures for responding to internal and external disasters or emergency situations.

(2) The disaster preparedness plan shall identify the staff position responsible for implementing the plan, obtaining necessary emergency medical attention or intervention for participants, and coordinating with the local emergency management agency.

(3) A standardized format shall be used throughout the plan that clearly describes how the emergency procedures should be carried out for each potential disaster. The emergency procedures should answer the questions of "who, what, when, where, and how," and allow the center to be ready to act effectively and efficiently in an emergency situation.

(4) The plan shall contain a section that outlines the frequency of rehearsal and the procedures to be followed during rehearsal. Each aspect of the plan must be rehearsed on an annual basis.

(5) Each center shall forward a copy of the plan to the local emergency management agency.

(6) Each center shall review and update its disaster preparedness plan as needed, but at a minimum on an annual basis.

(7) Each center shall maintain the following records and make them available to authorized Department employees upon request:

(a) A copy of the disaster preparedness plan and any subsequent changes thereto, which shall also be available for immediate access by center staff;

(b) Records of rehearsals of the disaster preparedness plan to include the names of all participants, staff and volunteers participating in the rehearsals; and

(c) Records of incidences, which required implementation of the disaster preparedness plan, including a written incident report and a written critique of the performance under the plan.

(8) Each center shall notify the Department within one business day when an emergency situation occurs which dictates implementation of the disaster preparedness plan. Such notification to the Department may initially be verbal and shall be followed-up in writing within three business days.

(9) Fire Safety. Adult day centers shall ensure that facilities where services are provided meet all applicable standards for fire and safety requirements. Fire safety must be observed at all times.

(a) The building must be kept in good repair; electrical, heating and cooling systems must be maintained in a safe manner. Electrical appliances, devices and lamps must be used in a manner that prevents overloaded circuits. Any extension cords in excess of six (6) feet must be shielded or protected and shall not be used in lieu of permanent wiring.

(b) Each center must develop and conspicuously post throughout the center an emergency evacuation plan.

(c) Fire drills shall be conducted at least quarterly and all staff and participants shall participate in the drills. Drills shall be held at expected and unexpected times and under varying conditions to simulate the unusual conditions that can occur in an actual emergency. Documentation of the fire drills shall be maintained by the center and shall include the date and time of such drills, the staff and participants included in the drill, and the actual evacuation time.

(d) Storage items must be arranged to minimize fire hazard. Gasoline, volatile materials, paint, and similar products must not be stored in the building housing participants unless approved in writing by the local fire marshal.

(e) Outside areas designated for smoking shall have ashtrays of noncombustible material and safe design.

(f) Portable fire extinguishers shall be maintained in operable condition at all times, inspected once a year by a qualified technician, and shall be labeled indicating the condition and date of last inspection.

(g) Each center shall be equipped with a sufficient number of smoke detectors, operated by house current or hardwired into the center's electrical service. Center staff shall consult local fire safety authorities to determine the appropriate number and placement of the smoke detectors.

(h) The use of unvented heaters, open flame heaters or portable space heaters is prohibited.

(i) The Department may require an appropriate fire safety inspection of any center at any time, including, but not limited to, when the physical plant undergoes a substantial change, such as repairs, renovations, or additions, or the Department has reason to believe that fire safety violations exist and that participants may be at risk.

(10) Emergency Procedures. Each center shall establish written emergency policies and procedures. Emergency procedures shall include at least the following:

(a) A written plan and/or agreement for emergency care;

(b) A written plan and/or agreement for emergency transportation;

Name and telephone number of the participant's physician;
Hospital preference;
Insurance information;
Medications and allergies;
Current diagnoses and history;
Name and telephone number of emergency contact;
Copy of any Georgia Advance Directive for Health Care; and
Photograph (for participant identification).

(d) A written plan for notification of local law enforcement when a participant has been missing for more than thirty (30) minutes.

(11) The Department may suspend any requirements of these rules and the enforcement of any rules where the governor of the state of Georgia has declared a public health emergency.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Disaster Preparedness, Fire Safety and Emergencies" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015

Ga. Comp. R. & Regs. r. 111-8-1-.10 Physical Plant Health and Safety Standards {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.10}

(1) General. The adult day center shall be constructed, arranged, and maintained so as to provide adequately for the health, safety, access, and well-being of the participants.

(a) Each center shall have a standard telephone, not a pay telephone or cellular telephone, on the premises which is immediately accessible during the center's hours of operation. A list of emergency telephone numbers for fire, ambulance, police, poison control and 911 shall be posted at each telephone.

(b) Each center shall provide adequate, safe and sanitary facilities appropriate for the services provided by the center and for the needs of the participants. All centers shall be accessible to and usable by physically disabled individuals and shall meet all applicable regulations for access for the handicapped.

(d) Each center shall provide adequate lighting for participant activities and safety.

(e) Each center shall be adequately ventilated at all times by either mechanical or natural means to provide fresh air and the control of unpleasant odors.

(f) There shall be adequate floor space in the center to safely and comfortably accommodate the number of participants for all activities and services provided by the center. Centers shall provide at least 35 feet of usable floor space for each participant, exclusive of passageways, bathrooms, lockers, storage rooms, staff rooms, and other areas not used for participant activities.

(2) Facilities. Center facilities shall consist of, but not be limited to, the following:

(a) Bathrooms;

(b) Dining areas;

(d) Rest area(s) as needed by the participants;

(e) Activity areas for recreation and leisure time;

(f) A private area for the provision of first aid, assistance with activities of daily living, and counseling services when provided, or as necessary for other services required by participants; and

(g) An adult day center may be co-located at a licensed long-term care facility provided that both the center and the long-term care facility are meeting the needs of the adult day participants and the long-term care facility residents, maintaining their required staffing ratios, and respecting the rights of the residents of the long-term care facility to privacy and the quiet enjoyment of their residence.

(3) Furnishings. Each center shall provide sufficient furniture for use by participants, which provide comfort and safety, and are appropriate for an adult population with physical limitations, visual and mobility limitations and cognitive impairments. Furnishings shall be maintained in good condition, intact, and functional.

(a) Each center shall provide clean, comfortable seating with support meeting the needs for each participant.

(b) Each center shall provide table space sufficient to seat all participants for dining at one time.

(d) Rest areas shall be furnished with a bed and mattress, recliner, sofa, or chair with back and arm support.

(e) Furnishings and décor shall reflect non-institutional settings.

(f) Adult day centers co-located within a licensed long-term care facility may not use residents' rooms or furnishings for adult day care participants.

(4) Bathrooms. There shall be adequate bathroom facilities to meet the needs of participants.

(a) At a minimum, there shall be not less than one toilet for every 12 participants or fraction thereof;

(b) Bathrooms and fixtures shall be accessible to participants with disabilities, function properly, and be maintained in a sanitary and odor free condition;

(d) Each bathroom shall be equipped with waste receptacles which are emptied and cleaned regularly; and

(e) Doors to all bathrooms must be equipped with closure devices which can be opened from the outside, in case a participant experiences difficulty and needs staff assistance.

(5) Bathing Facilities. A minimum of one bathing unit shall be provided in each adult day health center and in adult day care centers that provide assistance with bathing.

(a) The bathing unit, when in use, shall not interfere with the accessibility to bathroom facilities by other participants;

(b) Each tub or shower shall be in an individual room or enclosure that provides space for the private use of the bathing fixture, for bathing, drying and dressing, for the participant and staff; and

(c) Tubs and/or showers for participant use must have non-slip bottoms or floor surfaces, either installed or applied to the surface.

(6) Environment/Sanitation. The building shall be clean and in good repair, free from litter, extraneous materials, unsightly or injurious accumulations of items and free from pests and vermin.

(a) Waste, trash and garbage shall be removed from the premises at regular intervals. Excessive accumulations are not permitted.

(b) Floors, walls and ceilings must be structurally sound, maintained, cleaned, repaired and/or painted when needed.

(c) All outside refuse containers shall have tight fitting lids left in closed position. Containers shall be maintained in a clean and serviceable condition.

(7) Temperature Conditions. Each center shall provide an adequate central heating and cooling system or its equivalent at ranges that are consistent with the individual health needs and comfort of participants. The temperature range shall be maintained between 70 degrees Fahrenheit and 85 degrees Fahrenheit in all rooms used by the participants.

(8) Outdoor Areas. Adult day centers that provide outdoor activities shall have a safe, secure, and suitable outdoor recreation or relaxation area that includes a shaded area for participants that is designed to meet the needs of participants.

(a) The outdoor area shall be connected to, a part of, controlled by, and directly accessible from the center; and

(b) The outdoor area shall be suitably furnished with seating appropriate to the needs of the participants.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Physical Plant Health and Safety Standards" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.11 Supplies {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.11}

(1) Each center shall supply soap at the sinks, toilet tissue at each commode, and single use towels or mechanical hand dryers in each bathroom.

(2) Each center shall stock and maintain in a single location first aid supplies to treat minor burns, cuts, abrasions, and accidental poisonings. Staff shall assure that supplies with expiration dates are replaced in a timely manner to avoid expiration. The first aid supplies shall include the following:

(a) Thermometer;

(b) Band aids, tape and gauze;

(d) Syrup of ipecac (to be used only if so instructed by the Georgia Poison Control Center).

(3) Adult Day Health Centers. In addition to the above, adult day health care centers shall maintain the equipment and supplies listed below in a safe, clean and usable condition:

(a) Scales;

(b) Sterile dressing materials;

(d) Stethoscope;

(e) Tub-shower chair/bench;

(f) Wheelchair; and

(g) Anti-bacterial ointment or spray.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Supplies" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015

Ga. Comp. R. & Regs. r. 111-8-1-.12 Services {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.12}

(1) The scope of services provided or arranged by the center shall be based on the written description of the program.

(a) Adult day centers may provide a social model adult day care program or a medical model adult day health care program, which are differentiated by the intensity and scope of service delivery.

(b) Each model or program shall comply with all the general licensing standards as well as the program specific requirements outlined herein.

(2) Core Services. Core services provided by all centers shall include at a minimum the following:

(a) Supervision commensurate with the needs of the participants;

(b) Social and leisure activity programming which takes into consideration individual differences in health and functioning, lifestyle, ethnicity, religious affiliation, values, experiences, needs, interests, abilities and skills;

(c) Individual and group activities that encourage creativity, social interaction, and physical activity appropriate to each participant's functional status and abilities; and

(d) Nutrition, for all centers open for more than four (4) hours per day.

(3) Optional Services. Optional or additional services that may be arranged for or provided by the adult day center include the following:

(a) Transportation; and

(b) Assistance with the self-administration of medications.

(4) Adult Day Health Services. In addition to the above core services, centers that provide adult day health services shall provide an ongoing program of therapeutic activities designed to meet, in accordance with the assessment or reassessment, the physical, mental and psychosocial well-being of each participant. The activity program shall be multifaceted and reflect each individual's needs, abilities, and interests and include the following:

(a) Nursing services;

(b) Health monitoring;

(d) Physical therapy;

(e) Occupational therapy; and

(f) Speech therapy.

(5) Individual Plan of Care. The services provided by the center shall be in accordance with the participant's individual plan of care.

(a) The individual plan of care shall be completed by the Director or his/her designee, implemented within three business days of admission, and shall include the following:

Signature of the participant or representative as evidence of their involvement;
A review of the participant's functional abilities and disabilities, personal habits, likes and dislikes, medical condition and any other information helpful to developing the plan;
A statement of the activities and services the center will provide in order to meet the participant's needs and preferences;
The expected outcomes and the frequency of reevaluation of the plan;
The participant's usual travel arrangements to and from the site, the usual time for arriving and leaving, and any plan for using transportation services; and
The participant's usual times of arrival and departure not to exceed 14 hours in a 24 hour period. In addition to the above, for adult day health care centers, the individual plan of care shall also include:
The frequency and intensity of services to be provided; and
Identification of the therapeutic service provider who will provide any therapeutic services;

(b) The plan shall be reviewed and updated at least bi-annually or more often as warranted by changes in the participant's functioning, health condition, preferences or services. Changes shall be documented in the participant's record; and

(c) For adult day health services, the center shall document at least quarterly how each participant is responding to the individual plan of care.

(6) The center shall have a written agreement with any agency, program, or other service provider that provides essential services not provided directly by and otherwise the responsibility of the center. This written agreement shall include the nature and extent of the services provided and shall be updated annually. The center shall ensure that such services comply with the requirements of these rules.

(7) If the center uses animals as part of the program of activities, any such animals shall be tolerant of people on the premises, and be currently inoculated against rabies, if applicable. Documentation of immunizations for all animals that live onsite or are provided by the center shall be maintained at the center.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Services" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.13 Staffing {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.13}

(1) Core Requirements. Each adult day center shall have as many staff and/or volunteers on duty at all times as may be needed to properly safeguard the health, safety and welfare of the participants, as required by these regulations. At a minimum the following shall be observed:

(a) Each center shall have a Director who is responsible for the day to day operation of the center and in the absence of the Director, a staff member shall be designated to supervise the center.

(b) Each center shall have at least one staff member who has current certification in first aid and cardiopulmonary resuscitation ("CPR") shall be in the center at all times.

(d) Each center shall provide appropriately qualified staff and/or volunteers in sufficient number to meet the needs of the participants and implement the participant's individual plan of care. At a minimum, adult day centers shall provide a staff and/or volunteer to participant ratio of no less than 1:8. The staffing ratio refers to the staff providing direct services to participants and therefore excludes such employees as clerical or office workers and maintenance or food service staff.

(e) Each center shall maintain a monthly work schedule showing that the center has planned for adequate coverage and shall document actual coverage by date, name, and hours worked.

(f) Each center shall ensure sufficient staffing to promptly and safely evacuate all participants in the event of an emergency. The center must adjust staffing as necessary based on the number of non-ambulatory participants at the center.

(2) Adult Day Health Centers. In addition to the requirements above, adult day health centers shall provide the following staffing:

(a) A registered nurse (RN) who shall assess participant's physical and mental health needs. The RN is responsible for the development and supervision of the participant's individual plan of care within three business days of admission. If the center employs the services of a licensed practical nurse (LPN), the center shall ensure that the LPN is supervised by an RN as required by O.C.G.A. § 43-26-1et seq. The LPN shall be available by phone, pager and/or email when not on site at the center. The nurse shall:

Monitor and record participant's vital signs as needed;
Observe participant's functional levels and note any changes in physical condition;
Monitor medications brought into the center and observe participants for effectiveness and possible side effects;
Teach self-care activities and encourage participant's self-care;
Assist participants with medications when indicated;
Coordinate each participant's individual plan of care with the physician and other service agencies;
Notify the participant's primary health care provider and personal representative of changes in the participant's condition;
Supervise the provision of and teach other adult day health personnel to perform assist participants with activities of daily living; and
Document the participant's status in the participant's record.

(b) Appropriately qualified staff to perform skilled therapies, e.g. physical therapy, occupational therapy, and speech therapy, as identified in the participant's individual plan of care.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Staffing" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.14 Personnel {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.14}

(1) All adult day centers shall maintain written personnel policies and procedures which address at least the following:

(a) The hiring, training, and supervising of staff members; and

(b) The use, nature and extent of volunteer services, including a screening procedure to select volunteers with appropriate skills to work with the participants, or otherwise assist the center.

(2) Criminal History Background Checks .

(a) Criminal History Background Checks for Owners Required. Prior to the issuance of any new license, the owner of the business or agency applying for the license must comply with the requirements of the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(b) Criminal History Background Checks for Directors. The center must obtain a satisfactory fingerprint records check determination for the person being considered for employment as a director. The records check determination must be done in compliance with the Rules and 22 Regulations for Criminal Background Checks, Chapter 111-8-12.

(c) Criminal History Background Checks for Direct Access Employees Required. Prior to serving as a direct access employee, the center must obtain a satisfactory fingerprint records check determination for the person to be hired in compliance with the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(3) Training. The Director shall be responsible for ensuring that any person working in the center as an employee or under contract receives work-related training acceptable to the Department within the first ninety (90) days of employment. However, for centers providing services prior to the initial effective date of these rules, the centers shall have until March 1, 2015 to have all such staff who were hired prior to the initial effective date of these rules certified in first aid and cardiopulmonary resuscitation. The center shall ensure that at least one staff member who has completed the minimum training requirements be present in the center at all times.

(a) Work-related training for employees shall at a minimum include the following:

Orientation to the rules and regulations contained in this chapter, and to the center's policies and procedures;
Evidence of current certification in cardiopulmonary resuscitation where the training course required return demonstration of competency;
Training in standard precautions, infection control and latex safety;
Training in identifying participants who may be victims of elder abuse or self-neglect;
Training in participants' rights including the prevention and reporting of suspected abuse, neglect or exploitation;
Training in protecting the confidentiality of participant information and records;
Training on the nature of influenza and the role of vaccination in controlling its spread to those persons having direct participant contact;
Training in diversity and cultural sensitivity;
Training on Alzheimer's disease and other dementias including communicating and responding to behaviors; and
Medication training for the unlicensed staff that are providing assistance with or supervision of self-administration of medications to capable participants. The medication training must be conducted with an appropriate curriculum for providing medication assistance and include at least the following topics:

(i) The center's medication policy and procedures, including actions to take if concerns regarding participant's capacity to self-administer medications are identified;

(ii) How to read prescription labels including common abbreviations;

(iii) Providing the right medication to the right participant at the right time in the right amount and the right way including how to measure various medications;

(iv) Actions to take when concerns regarding medications are identified;

(v) Infection control procedures relative to providing assistance with medications;

(vi) Proper medication storage and disposal;

(vii) Recognition of side effects and adverse reactions for the specific medications;

(viii) Understanding the common classifications of medications, typical side effects and adverse reactions and medications for which unlicensed staff may never provide assistance with or supervision of self-administration; and

(ix) Proper documentation and record keeping using the Medication Assistance Record.

(b) Adult Day Health Centers. In addition to the training requirements above in 3(a), centers that provide adult day health services shall provide training on the laws governing administration of prescribed medications.

(c) Volunteers . The Director is responsible for ensuring that all volunteers receive training in accordance with the services they provide in the center. At a minimum, all volunteers shall receive training in the following:

Identifying abuse, neglect and exploitation and the applicable reporting requirements; and
Participant rights.

(4) Staff Records. Each center shall maintain personnel records for each employee and volunteer who provides direct care to participants. Each employee shall have access to his/her personnel record. Individual personnel records on all staff members shall contain at least the following:

(a) A complete application for employment or volunteer services;

(b) References, which may be documented as oral references or letters of reference;

(c) Copy of current license or certificate, in good standing, as required for the position, including a valid driver's license for persons providing transportation services;

(d) Staff development records, to include, but not limited to evidence of current certification in CPR and first aid as well as evidence of training for staff; and

(e) Evidence of having conducted background screenings as required by these rules in regards to the staff member or volunteer.

(5) Health of Employees.

(a) Health Screenings. Each center shall have in place a health screening program designed to identify conditions that may place participants at risk for infection, injury, or improper care. The program shall include requirements and processes for initial, regular, and targeted health screenings of employees and contractors who interact with participants or conduct other activities with environmental impact;

(b) Screening for Tuberculosis (TB). Prior to starting work, all employees must be screened for TB in accordance with CDC guidance for baseline screening and testing for health care personnel.

(6) Education/License Requirements.

(a) The adult day center shall employ staff qualified by training or experience to perform all aspects of the position for which they are hired.

(b) Adult Day Health Centers. In addition to the above, adult day health centers shall ensure the following:

Directors shall have a bachelor's degree or at least four years experience in a health or human services or related field and shall have demonstrated ability to perform all aspects of the position;
Nurses shall have a current Georgia license to practice as a nurse; and All contract professionals, i.e. social workers or occupational, physical, or speech therapists, shall be licensed or certified, as required by law.

History

Authority: O.C.G.A. §§ 49-6-80, et seq
History. Original Rule entitled "Personnel" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.
Amended: F. July 9, 2026; eff. July 29, 2026.

Ga. Comp. R. & Regs. r. 111-8-1-.15 Admission {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.15}

(1) Admission. Each adult day center shall admit individuals based on the center's comprehensive description of the types of services to be provided by the center and shall only admit individuals for whom the center can meet the participant's needs.

(2) Prior to the provision of services, the Director or his/her designee shall have at least one in-person interview with the applicant and/or representative to assess the applicant's needs and suitability of the program and shall obtain the following:

(a) A statement indicating any contraindications or limitations to the individual's participation in center activities;

(b) Evidence that the participant is free of active tuberculosis based upon the results of a negative tuberculin skin test or chest x-ray within 12 months prior to admission;

(d) Any other information as required for the participant's care.

(3) The Director or his/her designee shall search the National Sex Offender Registry website maintained through the Department of Justice and draft any resulting safety plan for participants, staff and visitors.

(4) In addition to the above, centers that provide assistance with or administration of medications shall obtain documentation of the participant's over the counter and prescription medications.

(5) Adult Day Health Centers. In addition to the above, adult day health centers shall obtain documentation of the following:

(a) A medical examination report signed by a physician, nurse practitioner or physician assistant, completed within six months prior to admission that includes recommendations for care, diet, and medical, nursing, health or supportive services which may be needed; and

(b) Physician's orders for any therapies, when applicable.

(6) At admission the center shall ensure that the participant and representative receive a copy of the following:

(a) The center's pertinent policies and procedures required to be provided in the participant agreement; and

(b) Participant's rights information.

(7) Participant Agreement. Upon admission to the center, staff shall complete and the participant or their representative shall sign a written agreement. The agreement shall include the following:

(a) A disclosure statement that describes the center's range of care and services;

(b) Specific services to be provided to the participant by the center;

(c) A current statement of all fees and daily, weekly or monthly charges and any additional fees for specific services, goods, or incidental supplies that are not included in the daily charge;

(d) Days and hours of participant attendance not to exceed 14 hours in a 24 hour period;

(e) Arrangements for reimbursement and payment;

(f) Identification of and authorization for third party payors, if applicable;

(g) Any non-financial obligations of the participant and his/her family, such as a commitment by the participant to attend the center a specified number of days per week;

(h) Admission and discharge criteria;

(i) The center's refund policy;

(j) Schedule of holidays when the center is closed; and

(k) Announcement procedures for unexpected closing of the center due to disaster or severe weather.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Admission" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.16 Records {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.16}

(1) Participant Records. An individual file for each participant shall be established and maintained at the adult day center and shall include the following:

(a) The participant's full name, address, telephone number, date of birth, marital status, and living arrangement;

(b) At least two emergency contacts to include name, address, telephone number, and relationship to participant;

(d) A signed participant agreement;

(e) Any powers of attorney, guardianship orders, or any other documents which identify authorized representatives of the participant, if applicable;

(f) All individual plans of care including updates;

(g) Copies of all signed authorizations for the center to receive and provide confidential information on the participant, if applicable;

(h) Signed authorization for the participant to receive emergency medical care from any licensed medical practitioner, if such emergency care is needed by the participant;

(i) A medical examination report conducted within six months prior to admission or within thirty (30) days after admission, and updated annually, signed by a licensed physician, physician's assistant or nurse practitioner;

(j) A statement signed by the participant or representative acknowledging receipt of center policies;

(k) An activity participation record for each participant;

(l) Medication Assistance Records; and

(m) A record of incidents, accidents, injuries, illnesses and emergencies involving the participant.

(2) Adult Day Health Centers. In addition to the above, adult day health centers shall maintain the following records:

(a) Progress notes including the written report of staff discussions, conferences, consultation with family or other interested parties; and

(b) Evaluation of a participant's progress, and any other information regarding a participant's situation.

(3) Center Records. The center shall maintain the following center records:

(a) Copies of activities schedules;

(b) Copies of menus served to participants, if applicable;

(d) A daily record of attendance of participants by name; and

(e) A written record of all serious or unusual incidents affecting participants, employees or volunteers of the center.

(4) All records shall be retained for a minimum of three years.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Records" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.17 Participant Rights {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.17}

(1) The following rights shall be guaranteed and cannot be waived by the participant or his or her representative:

(a) The right to be treated as an adult, with respect and dignity;

(b) The right to participate in a program of services and activities that promotes positive attitudes on one's usefulness and capabilities;

(d) The right to be free from actual or threatened physical or chemical restraints;

(e) The right to be encouraged and supported in maintaining 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;

(f) The right to self-determination within the day care setting, including the opportunity to:

Participate in developing one's plan of care;
Decide whether or not to participate in any given activity;
Be involved to the extent possible in program planning and operation;
Refuse to participate in treatment, activities or services at the center;
The right to be cared about in an atmosphere of sincere interest and concern in which needed support and services are provided;
The right to privacy and confidentiality;
The right to be made aware of the grievance process;
The right to file a complaint with the Healthcare Facility Regulation Division, including the complete address and phone number of the Division, whenever the participant believes that services are not being delivered in accordance with these rules;
The right to view inspection reports on the facilities compliance on the Department's web site; and
The right to review personal records.

(2) Each participant shall be provided at the time of admission a copy of the participant rights.

(3) Each participant shall receive care and services which shall be adequate, appropriate and in compliance with applicable state laws and regulations

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Nutrition" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.18 Nutrition {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.18}

(1) All adult day centers operating for more than four (4) hours a day and/or operating during regularly scheduled mealtimes shall ensure that a nutritious meal is provided to each participant in attendance.

(2) Snacks and fluids shall be available and offered to meet the participant's nutritional and fluid needs. At a minimum, a mid-morning and mid-afternoon snack shall be offered daily to participants.

(3) Meals and snacks provided by the center shall be planned to keep sugar, salt and cholesterol intake to a minimum.

(4) Adult Day Health Centers. In addition to the above, adult day health centers shall ensure the following:

(a) A meal shall meet at least one-third of an adult's daily nutritional requirement as specified by the Dietary Guidelines for Americans;

(b) A therapeutic diet shall be provided when prescribed in writing by a physician, physician's assistant or nurse practitioner;

(d) A dietitian or RN shall provide written techniques to staff on basic and special nutritional needs and proper food handling techniques and the prevention of food borne illness; and

(e) If therapeutic diets are prepared by center staff, such staff shall have training in planning and preparing therapeutic diets or shall provide documentation of previous training and education sufficient to assure ability to prepare meals in accordance with a physician's order.

(5) Food services for adult day centers licensed to care for 24 or more participants per day are subject to the provisions of the Rules and Regulations of the Department of Human Services for Food Service, Chapter 290-5-14 et seq. and any local health ordinances. Such a center must obtain a valid food service permit.

(6) Adult day centers licensed to care for fewer than 24 participants per day are not required to obtain a food service permit, but shall meet the following requirements:

(a) Each center preparing and providing meals shall have a properly equipped kitchen;

(b) Each center shall store, prepare, distribute, and serve food under sanitary conditions with generally accepted and recognized food service standards to prevent foodborne illness;

(d) All perishable foods shall be stored at such temperatures as will protect against spoilage;

(e) All foods while being stored, prepared, or served shall be protected against contamination and be safe for human consumption;

(f) All foods must be cooked, maintained, stored, and served at appropriate temperatures;

(g) Refrigerator temperatures shall be maintained at or below 41 degrees Fahrenheit and freezers at 0 degrees Fahrenheit; and

(h) Non-disposable dishes, glasses and silverware shall be properly cleaned by pre-rinsing and scraping, washing, sanitizing and drying.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Nutrition" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.19 Medications {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.19}

(1) All medications required by a participant in an adult day center that does not employ a licensed RN, LPN or proxy caregiver shall be self-administered by the participant.

(2) Centers that provide assistance with medication without employing a licensed RN, LPN or proxy caregiver may do so to the following extent:

(a) Staff may remind participants of the time to take medication;

(b) Staff may check the dosage according to the container label; and

(3) Adult day centers that employ the services of an RN, LPN or a proxy caregiver may have the RN, LPN or proxy caregiver administer medications provided such medication administration is performed in accordance with all applicable laws and regulations. For proxy caregivers, please review the Rules and Regulations for Proxy Caregivers used in Licensed Healthcare Facilities, Chapter 111-8-100.

(4) The center shall maintain a Medication Assistance Record of all medications, prescription and over-the-counter, that are supervised by staff or administered by RNs, LPNs or proxy caregivers. The Medication Assistance Record must include:

(a) The name of the medication;

(b) Dosage; and

(c) Date, time and signature of the staff person who assists the participant or administers the medications to the participant.

(5) Participants shall have the right to refuse any and all medications. The center's Director or staff providing medication assistance shall report such incidents to the participant's family and/or representative and documented on the Medication Assistance Record. The center shall record each instance of medication refusal by a participant in the participant's individual record and on the Medication Assistance Record.

(6) The center shall have the right to not accept or to discharge a participant who refuses assistance with medications if the center reasonably feels that the participant cannot safely possess and control his/her medications.

(7) All medications in the center shall be stored securely and in a manner to prevent spoilage, dosage errors, administrative errors, and inappropriate access. A participant may keep possession of medications needed for frequent or emergency use. The center shall store all medications that require refrigeration in a locked container in the refrigerator.

(8) All medications shall be in the original pharmacy-dispensed container with a proper label and directions attached.

(9) Medications by injection, including but not limited to insulin, shall be administered by a nurse or proxy caregiver if the participant is unable to self-administer the medication.

(10) A nurse in an adult day health center shall monitor the medication regimen for all participants. He/she shall:

(a) Evaluate the health status of the participant by identifying symptoms of illness and/or changes in mental and/or physical health status;

(b) Make recommendations to the family or primary health care provider regarding any medication needs or other health needs requiring follow up; and

(11) At the end of the program day, or when the shift ends, the nurse shall count all controlled substances and sign the controlled substance book. If the nurse on duty at the next shift or at the beginning of the next program day is not present during the above counts, he/she shall count all controlled substances and sign the controlled substance book immediately after beginning the work period. Any discrepancies in count shall be reported immediately to the Director.

(12) Unused or discontinued prescription medications are the property of the participant and shall be given to the participant and/or the representative, whenever possible.

(13) Any unused or discontinued prescription medications that are left with a center shall be disposed in accordance with applicable Georgia laws.

(14) The Director, the activities director or a center nurse must immediately report to the representative any unusual reactions to medications or treatments.

(15) Bio-Medical and Hazardous Waste. The storage and disposal of bio-medical and hazardous wastes must comply with applicable federal, state and local rules and/or standards.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Medications" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.20 Transportation {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.20}

(1) The center may provide transportation and/or assist in arranging transportation services for participants.

(2) When transportation is provided to participants through center-operated vehicles, the operation of each vehicle shall comply with all applicable state and federal regulations relative to both driver and vehicle.

(3) Where the center contracts for transportation services, the center shall require that the contractor provide proof of insurance and current vehicle registration.

(4) When the adult day center provides transportation, the following requirements shall be met to ensure the health and safety of the participants:

(a) Each person transported shall have a seat in the vehicle;

(b) Vehicles used to transport participants shall be equipped with seatbelts;

(d) Each vehicle shall have a first aid kit, along with fire extinguisher and safety triangles;

(e) The driver or attendant shall be trained in first aid procedures which include but are not necessarily limited to the following:

Care during a seizure;
Basic first aid; and
CPR;

(f) The driver or attendant shall have medical and emergency information in the vehicle for participants being transported;

(g) All transportation vehicles shall be equipped with a device for two-way communication;

(h) The transportation vehicle shall be in safe operating condition; and

(i) Each vehicle which transports participants shall have a trip roster which contains the addresses of the participants and the emergency contact phone numbers for each participant.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Transportation" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.21 Procedures for Change in Condition {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.21}

(1) In case of an accident or adverse change in a participant's condition or adjustment, the center shall immediately obtain needed care and notify the representative or emergency contact.

(2) The center shall immediately investigate the cause of an accident or injury involving a participant and take necessary steps to prevent recurrence.

(3) A record of incidents, accidents, injuries, illnesses and emergencies involving the participant shall be maintained in the participant's file.

(4) Accidents. In an emergency situation where the participants are subject to an imminent and substantial danger that only immediate transfer or discharge will relieve, the center shall transfer or arrange for the transfer of the participant to another health facility or call 911 for emergency medical assistance.

(5) The center shall document in the participant's file the reasons for such emergency transfer and shall immediately inform the participant's guardian and other persons of the participant's choice regarding such transfer and the place where the participant is to be transferred.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Immediate Transfer, Discharge and Death" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.22 Immediate Transfer, Discharge and Death {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.22}

(1) Immediate Transfer. In case of emergency, such as acute illness, if family or the participant's representative cannot be reached, a signed release shall be on file stating that the participant may be sent to the nearest hospital emergency room for treatment.

(2) Discharge. Each participant agreement shall include a written procedure for handling discharge of the participant that complies with these rules.

(a) Each participant and/or representative shall be given 14 days written notice if the participant is to be discharged from the center for other than emergency reasons.

(b) During a participant's placement in a center, the participant agreement required by Rule 111-8-1-.15(7) regarding plans for discharge shall be adjusted according to the participant's circumstances.

(c) Emergency discharges are authorized when the health, safety and welfare of the participant or other participants at the center may be endangered by the participant's further placement in the center.

(3) Death. Upon the death of a participant while in the center, local law enforcement shall be immediately notified in addition to the participant's representative and/or family members, other medical personnel. The Department shall be notified within 24 hours.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Immediate Transfer, Discharge and Death" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.23 Reporting Requirements {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.23}

(1) Serious Incidents. All adult day centers shall maintain records and submit on a timely basis reports required by the Department.

(2) On forms provided by the Department, no later than the next business day, the adult day center shall report whenever any of the following serious or unusual incidents involving a participant occurs or center has reasonable cause to believe that an incident involving a participant has occurred at the center or off-site during the provision of services:

(a) Any death of a participant;

(b) Any rape of a participant;

(d) Any suspected abuse, neglect or exploitation of a participant; and

(e) Any time a participant cannot be located and the participant has been missing for more than thirty (30) minutes.

(3) Reports of participant incidents shall include:

(a) The name of the adult day center, the name of the Director, and a contact telephone number for information related to the report;

(b) The date of the incident and the date the adult day center became aware of the incident;

(d) Any immediate corrective or preventive action taken by the adult day center to ensure against the replication of the incident.

(4) The adult day center shall conduct an internal investigation of any of the serious or unusual incidents listed in subparagraph (2) of this rule and shall complete and retain on-site a written report of the results of the investigation within five (5) business days of the discovery of the incident. The complete report shall be readily available to the Department for inspection and shall contain at least the following:

(a) An explanation of the circumstances surrounding the incident, including the results of a root cause analysis or any other system analysis;

(b) Any findings or conclusions associated with the review; and

(c) A summary of any actions taken to correct identified problems associated with the incident and to prevent recurrence of the incident, and also any changes in procedures or practices resulting from the investigation.

(5) Other Incidents Requiring Report.

(a) The adult day center shall report to the Department whenever any of the following events involving adult day center operations occurs or when the adult day center becomes aware that it is likely to occur, to the extent that the event is expected to cause or causes a significant disruption of care for adult day center participants:

An external disaster or other community emergency situation which causes a complete disruption in services; or
An interruption of services vital to the continued safe operation of an adult day center, such as telephone, electricity, gas, or water services.

(b) The adult day center shall make a report of the event not later than the next business day from when the reportable event occurred or from when the adult day center has reasonable cause to anticipate that the event is likely to occur. The report shall include:

The name of the adult day center, the name of the Director, and a contact telephone number for information related to the report;
The date of the event, or the anticipated date of the event, and the anticipated duration, if known;
The anticipated effect on care and services for adult day center participants; and
Any immediate plans the adult day center has made regarding participant management during the event.

(6) Where the Department determines that a rule violation related to any self-reported incident or event has occurred, the Department shall initiate a separate complaint investigation of the incident. The complaint investigation report and the report of any rule violation compiled by the Department arising either from the initial report received from the adult day center or an independent source shall be subject to disclosure in accordance with applicable laws.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Reporting Requirements" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.24 Quality Assurance {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.24 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.24}

(1) Adult day centers shall develop and implement an annual quality improvement plan to evaluate and improve the effectiveness of the program's operation and services to ensure continuous improvement in service delivery. The plan shall include the parties to be involved and the areas which will be addressed. A formal evaluation shall be conducted at regular intervals, but at least annually.

(2) The evaluation process shall include:

(a) A review of the existing program including serious incidents and corrective actions taken;

(b) Satisfaction survey results or comments and complaints received from staff, participants and/or participant's representatives;

(d) Proposed program administrative improvements.

(3) The center shall prepare a written report which summarizes the evaluation findings, improvement goals and implementation plan.

(4) Findings of the quality improvement evaluation shall be utilized to correct identified problems, revise adult day center policies, and improve the care of participants.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Quality Assurance" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.25 Infection Control {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.25 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.25}

(1) Each adult day center shall develop and implement policies and procedures that address infection control issues in all components of the adult day center. These policies and procedures shall be based on accepted standards of infection control and shall address at least the following:

(a) Hand hygiene;

(b) Cleaning, disinfecting, and sanitizing participant areas;

(d) Handling, transport, and disposal of medical waste or bodily fluids;

(e) Center requirements for communicable disease health screening, including tuberculosis surveillance and any recommended immunizations;

(f) Use of personal protective equipment and exposure reporting/follow-up;

(g) Work restrictions for staff with potentially infectious diseases;

(h) Evaluation of the participant related to infection control risks;

(i) Outbreak investigation procedures;

(j) Dietary practices;

(k) Reporting of communicable diseases, as required by law; and

(l) Standard precautions.

(2) Adult Day Health Centers. In addition to the above, adult day health center shall develop and implement policies and procedures that address infection control issues regarding the following:

(a) Wound care;

(b) Urinary tract care;

(d) Enteral therapy; and

(e) Infusion therapy.

(3) The infection control program shall be evaluated as needed, but at least annually to ensure the effectiveness of the program related to the prevention of the transmission of infections to participants and staff.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Infection Control" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.26 Inspections by Department Staff {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.26 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.26}

(1) The Department is authorized and empowered to conduct complaint investigations and periodic on-site inspections of any center when determined necessary.

(2) Prior to licensure and periodically thereafter, the Department shall inspect each adult day center to ensure that the center is providing adequate care to its participants and is in compliance with all applicable rules and regulations.

(3) An application for a license or the issuance of a license by the Department constitutes consent by the applicant, the proposed holder of the license and the owner of the premises for the Department's representative, after displaying proper identification to any center staff, to enter the premises at any time during operating hours for the purpose of inspecting the center to determine compliance with these rules.

(a) The adult day center staff, facilities, and participants shall be accessible during all hours of operation to properly identified representatives of the Department for inspections and investigations relating to the adult day center's license.

(b) For the purposes of any inspection, investigation, or survey conducted by the Department, the adult day center shall provide to properly identified representatives of the Department meaningful access to all books, records, papers, or other information related to the licensing of the adult day center.

(4) Knowingly making any verbal or written false statement of material fact in connection with any inspection or investigation or supplying false or misleading information is grounds for denial or revocation of a license.

(5) The Department may exempt a center from periodic inspections if such center has been certified or accredited by an entity recognized and approved by the Department if such entity uses standards that are substantially similar to those established by the Department. A center seeking exemption from inspection shall be required to submit to the Department documentation of certification or accreditation, including a copy of its most recent certification or accreditation inspection report, which shall be maintained by the Department as a public record.

History

Authority: O.C.G.A. § 49-6-85
History. Original Rule entitled "Inspections by Department Staff" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.27 Variances and Waivers {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.27 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.27}

(1) A center may request a waiver or variance of a specific rule by application on forms provided by the Department. The Department may grant or deny the request for waiver or variance at its discretion. If the waiver or variance is granted, the Department may establish conditions that must be met by the adult day center in order to operate under the waiver or variance. Waivers or variances may be granted with conditions of the following:

(a) Variance. A variance may be granted by the Department upon a showing by the applicant that the particular rule or regulation that is the subject of the variance request should not be applied as written because strict application would cause undue hardship. The applicant must also show that adequate standards exist for affording protection for the health, safety, and care of participants, and these existing standards would be met in lieu of the exact requirements of the rule or regulation.

(b) Waiver. The Department may dispense altogether with the enforcement of a rule or regulation by granting a waiver upon a showing by the applicant that the purpose of the rule or regulation is met through equivalent standards affording equivalent protection for the health, safety, and care of the participants, or by demonstrating that the purpose of the statute on which the underlying rule is based can be or has been achieved by other specific means and that strict application of the rule(s) would create a substantial hardship for the applicant.

(c) Experimental Waiver or Variance. The Department may grant a waiver or variance to allow experimentation and demonstration of new and innovative approaches to delivery of services upon a showing by the applicant that the intended protections afforded by the rule or regulation in question are met and that the innovative approach has the potential to improve service delivery.

(2) Waivers and variances granted by the Department shall be for a time certain, as determined by the Department.

(3) Waivers and variances granted to an adult day center shall be recorded and shall be available to the public through posting to the State's rules waiver register.

History

Authority: O.C.G.A. § 49-6-81 and § 31-2-7
History. Original Rule entitled "Variances and Waivers" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.28 Enforcement and Penalties {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.28 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.28}

An adult day center that fails to comply with licensing requirements contained in these rules, the Rules and Regulations for the Use of Proxy Caregivers, Chapter 111-8-100 as applicable and the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25, is subject to civil and administrative actions brought by the Department to enforce licensing requirements as provided by law and rules. Such actions will be initiated in compliance with the Georgia Administrative Procedures Act, O.C.G.A. § 50-13-1et seq., O.C.G.A. § 31-2-11 and the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25.

History

Authority: O.C.G.A. §§ 49-6-84, 31-2-7, 31-2-8, 43-26-12 and 50-13-1et seq
History. Original Rule entitled "Enforcement and Penalties" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Ga. Comp. R. & Regs. r. 111-8-1-.29 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-1-.29 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-1-.29}

In the event that any rule, sentence, clause, or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portion thereof. The remaining rules or portions of rules shall remain in full force and effect, as if such rule or portions thereof so determined, declared, or adjudged invalid or unconstitutional were not originally a part of these rules.

History

Authority: O.C.G.A. § 49-6-81
History. Original Rule entitled "Severability" adopted. F. Dec. 18, 2014; eff. Jan. 7, 2015.

Subject 111-8-2 Rules and Regulations for Adult Residential Mental Health Programs

Ga. Comp. R. & Regs. r. 111-8-2-.01 Authority {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.01}

The legal authority for this Chapter is found in O.C.G.A. §§ 37-3-200 et seq, and Chapter 7 of Title 31.

History

Authority: O.C.G.A. § 37-3-200, et seq.; §§ 31-2-4, 31-2-7, 31-7-2.1
History. Original Rule entitled "Authority" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.02 Purpose {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.02}

The purpose of these rules and regulations is to establish minimum standards for the licensure and operation of adult residential mental health programs.

History

Authority: O.C.G.A. § 37-3-200, et seq.; O.C.G.A. §§ 31-2-4, 31-2-7, 31-7-2.1
History. Original Rule entitled "Purpose" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.03 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.03}

In these rules, unless the context requires otherwise, the words, phrases and symbols set forth herein shall mean the following:

(1) "Adult residential mental health program" or "ARMHP" or "program" means a subacute residential alternative service of four or more residential beds authorized to provide psychiatric services for mentally ill persons 18 years of age or older that operates 24 hours per day, 7 days per week to provide intensive short-term noninstitutional treatment to clients who are temporarily in need of a 24-hour-per-day supportive therapeutic setting for prevention of or transition from or after acute psychiatric hospitalization. Such term shall not include (a) crisis stabilization units, as defined in O.C.G.A. § 37-1-29 ; (b) community living arrangements, as defined by the Department of Behavioral Health and Developmental Disabilities; (c) mental health programs conducted by accountability courts; (d) residential beds operated by a state or local public entity; or (e) hospitals licensed by the department unless the hospital is operating an adult residential mental health program that is not part of the hospital license.

(2) "Administrator" means the name of the person to whom is delegated the responsibility for the management of the program, including but not limited to, the carrying out of rules and policies adopted by the governing body.

(3) "Applicant" means any individual affiliated with the governing body submitting an application to operate a program.

(4) "Department" means the Georgia Department of Community Health.

(5) "Governing Body" means the partnership, corporation, limited liability company, association, or person or group of persons who maintains and controls the program and who is legally responsible for its operation.

(6) "Client" means a person seeking and obtaining services at a program, unless otherwise specified.

(7) "License" or "permit" means the official permit issued by the department which authorizes the holder to operate a program.

(8) "Licensee" means the holder of a program license.

(9) "Mental health professional" means a psychiatrist, psychiatric or mental health nurse practitioner, or an individual who has obtained a Doctor of Philosophy (Ph.D.) in a field of psychology or Doctor of Psychology (Psy.D.), a master's degree (M.S. or M.A.) in a mental-health related field such as psychology, counseling psychology, marriage or family therapy, or social work and is duly licensed to practice his or her profession in the State of Georgia.

(10) "Mentally ill person" means a person who has significant deficits in functioning affecting social and family relationships, work, self-care, educational goals, or legal involvements due to his or her primary diagnosis or assessment of a psychotic disorder, mood disorder, anxiety disorder, dissociative disorder, obsessive-compulsive disorder, adjustment disorder, personality disorder, or trauma and stress related disorder as listed in the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-5) or the World Health Organization's International Classification of Diseases, in effect as of July 1, 2022 and as amended from time to time.

(11) "Physician" means an individual who is currently licensed to practice medicine in the State of Georgia. These rules shall not prohibit other licensed medical professionals, such as physician assistants or advanced practice registered nurses, from performing acts required of a licensed physician under these rules where such acts are allowed and performed pursuant to applicable state scope of practice laws and regulations.

(12) "Program" means the ARHMP as defined in these rules and regulations.

(13) "Staff" means any person who performs duties in the program on behalf of the program, including but not limited to employees, contractors, administrators, on-site managers, and owners and other governing body members.

History

Authority: O.C.G.A. §§ 37-3-202, 31-2-4, 31-2-7, 31-7-2.1
History. Original Rule entitled "Definitions" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.04 Governing Body and Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.04}

(1) There shall be a governing body which assumes full legal responsibility for the overall conduct of the program and an administrator reporting to the governing body. The administrator must be at least 21 years of age and must have at least one-year of experience in managing a health care program and supervising health care staff.

(2) The governing body shall be responsible for compliance with all applicable laws and regulations pertaining to the program.

(3) The governing body shall provide the name and credentials of the administrator at the time of initial application and provide the department written notice of any change to the administrator within thirty (30) days following such change.

(4) The governing body must adopt and abide by a code of ethics pertaining to each member of the governing body and its administrator. At a minimum, the code of ethics shall include a conflict of interest policy, whistleblower policy, sexual harassment policy, discrimination policy, and other policies required for proper governance.

(5) The words "sanitorium," "sanitarium" and "hospital" shall not be used in the official title or marketing materials of any program permitted under the provisions of these rules and regulations.

(6) The governing body and administrator shall develop and implement policies, procedures and practices that support the core values of dignity, respect, choice, independence and privacy of the clients in a safe environment and in accordance with these rules. A copy of the program policies and procedures must be provided to the client upon admission, or prior to admission if requested by a client considering treatment at the program. At a minimum, such policies and procedures must comply with all these rules and regulations and provide clear instruction for the staff and clients on the following matters:

(a) The services available in the program and provide direction on how clients may access such services.

(b) Admissions, discharges and transfers which ensure that the program does not admit or retain clients who need more care than the program is authorized for or capable of providing.

(d) Payment for services, including optional services, and refund policy when a client is transferred or discharged.

(e) Training and ongoing evaluation of staff, including offerings of any specialized training.

(f) Program rules applicable to staff and clients and their enforcement.

(g) Protecting the rights of the staff and clients as set forth in these rules.

(h) Medication management, controls, procurement and the professional oversight provided for such services.

(i) Health and hygiene requirements for the program, clients, and staff, including but not limited to, issues relating to illness and infection control, work policies and return to work policies, food-borne illnesses and reportable diseases. The policy shall also include any restrictions on a client's ability to utilize designated substances, such as nicotine and caffeine, and the program's expectations regarding same.

(j) Clear instructions for method of reporting and investigation of claims of abuse, neglect, harassment, discrimination, or exploitation of clients and staff. Furthermore, the policies and procedures shall detail requirements for the reporting of accidents, injuries, voluntary discharge from the program, and changes in clients' conditions and status to family members, legal surrogates, and required parties.

(k) Discipline procedures for handling conduct which is inconsistent with the policies of the program committed by staff, and circumstances which may lead to discharge by the program.

(l) Emergency preparedness, drills and evacuation requirements.

(m) Quality assurance and peer review mechanisms to determine opportunities for improving care utilizing information acquired from reports and investigations of serious incidents, including client and family feedback.

(n) The right of clients to receive visitors and responsibilities and obligations regarding visitor access.

(o) The right of clients to use electronic equipment including but not limited to, mobile phones, computers, tablets, televisions, audio equipment, video game devices, and other equipment utilized for entertainment.

(p) The safety and security precautions that will be employed by the program to protect clients from harm from self, other clients and staff.

(q) The staffing plan which takes into account the specific needs of the clients and also includes arrangements for staffing in the absence of regularly scheduled staff.

(r) Procedures ensuring the confidentiality of client records and security measures to ensure that all client records are maintained on a confidential basis.

History

Authority: O.C.G.A. §§ 37-3-204, 31-2-4, 31-2-7, 31-7-2.1
History. Original Rule entitled "Governing Body and Administration" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.05 Application for Permit {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.05}

(1) The governing body of each program must submit to the department an application for a permit in order to operate. The application for a permit must be made on forms made available by the department and in a format acceptable to the department.

(2) No application for licensure will be acted upon by the department unless it has been determined to be complete, including all required attachments and fees due the department, as specified in the Rules and Regulations for General Licensing and Enforcement Requirements, Ga. Comp. R. & Regs. r. 111-8-25.

(3) The application must truthfully, completely, and accurately disclose required information.

(4) The name of the administrator must be included with the application for a permit. If such information is not known at the time of application, it must be provided to the department before a permit will be issued.

(5) Each application must include documentation confirming ownership or tenancy pursuant to a written lease agreement for the real property on which the program will be operated.

(6) The filing of an application for licensure constitutes a representation that the applicant is or will be in complete control of the program as of a specified date.

(7) Local zoning and other local requirements regarding the proper location and establishment of the program must be addressed by the applicant with the responsible local officials.

(8) Proof of compliance with all applicable federal and state laws for the handling and dispensing of medications, and all state and local health, safety, sanitation, building, and zoning codes shall be provided to the department as specified in the application.

(9) The application and license are subject to all requirements and obligations set forth in the department's Rules and Regulations for General Licensing and Enforcement Requirements, Ga. Comp. R. & Regs. r. 111-8-25.

(10) The application must include a copy of the program's program description and range of services which shall be reviewed by the governing body and administrator annually and updated as needed to align with the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders (DSM-5) or the World Health Organization's International Classification of Diseases, in effect as of July 1, 2022, or such other versions which may be adopted in the future.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 37-3-206, 37-3-207, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Application for Permit" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.06 License Requirements {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.06}

(1) On and after July 1, 2025, no governing body shall operate a program without having a valid license or provisional license issued pursuant to these rules.

(2) The permit must be displayed at the program in a conspicuous place that is visible to clients and visitors.

(3) Permits are not transferable from one ARMHP or program location to another.

(4) A permit is no longer valid when any of the following events occurs:

(a) The program is moved to another location which has not been licensed.

(b) The governing body changes without notification to the department required pursuant to these rules.

(5) A program must not serve more clients than its approved licensed capacity, which is listed within the permit issued by the department.

(6) A program must provide care as authorized by law and these rules.

(7) The program must provide written notice to the department and all clients of the following circumstances:

(a) a minimum of sixty (60) days written notice of any impending bankruptcy or property eviction that may force discharge or relocation of clients or otherwise adversely impact the provision of safe care and oversight; and

(b) a minimum of thirty (30) days prior written notice of any impending change of ownership. The notice to the department shall be in the form of an application for license pursuant to these rules which must be approved by the department before the permit is issued to the new owner(s).

(8) The department may accept proof of deemed status accreditation by an accreditation body or certifying authority recognized and approved by the department to demonstrate compliance with Department's licensure requirements, provided that such certification or accreditation constitutes compliance with standards that are substantially equivalent to these rules.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 37-3-206, 37-3-207, 37-3-209, 37-3-213, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "License Requirements" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.07 Provisional License; Terms {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.07}

(1) The department may issue a provisional license effective for a period not to exceed ninety (90) days to each applicant who has substantially complied with all requirements for a regular license. Provisional licenses shall be renewed at the discretion of the department only in cases of extreme hardship and in no case for longer than 90 days.

(2) The obligations and conditions of a provisional license shall be the same as those of a regular license except as otherwise provided for in these rules.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 37-3-206, 37-3-207, 37-3-208, 37-3-209, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Provisional License; Terms" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.08 Admission and Discharge, Care, and Services {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.08}

(1) Admission Criteria.

(a) Mental Illness. In order to be admitted to a program, a client must meet the definition of a mentally ill person. Mentally ill persons applying for admission and thereafter receiving services from a program are referred to within these rules and regulations as "clients," or "clients receiving services" or similar designation.

(b) Referral Required. Clients may be admitted to a program only by referral from an inpatient psychiatric hospital that is discharging a patient to a program or following a determination by a licensed psychiatrist that admission is required to provide stabilization, treatment, and care of the condition for which an inpatient admission to a psychiatric hospital is not required.

(c) Length of Stay. Length of stay shall be redetermined on a periodic basis through a mental health evaluation to include treatment goals and progress from the initial admission. Such mental health evaluation shall determine medical necessity for continued stay in the program with a maximum length of stay of six (6) months unless a client case waiver is approved by the department.

(2) Admission Agreement. Each ARMHP must utilize a written admission agreement signed by an individual with authority to bind the program and the client receiving services. The admission agreement must meet the following minimum requirements:

(a) The admission agreement is written in plain and understandable language and is consistent with the information contained in the client's clinical record.

(b) Contain a current statement of all fees and daily, weekly or monthly charges; the services covered by those basic fees and any other services which the program provides on an additional fee basis.

(c) Contain a statement that clients and their representatives or legal surrogates shall be informed, in writing, at least 30 days prior to any increase in established charges related to the provision of personal services and at least 60 days prior to any increase in charges for room and board.

(d) Contain provisions regarding the administrator's continuous assessment of the client's needs, referral for appropriate services as may be required if the client's condition changes and referral for transfer or discharge if required due to a change in the client's condition.

(e) Contain a description of how the program responds to formal complaints received from clients and their representatives and how to file a complaint within the program.

(f) Contain provisions regarding transportation of clients for shopping, recreation, rehabilitation, medical services. Such transportation service may be provided by the program as either a basic service or on a reimbursement basis, with transportation for emergency use available at all times.

(g) Contain provisions regarding the program's refund policy when a client dies, is transferred or discharged.

(h) Contain a statement that a client may not be required to perform services for the program.

(i) Contain the program policies and procedures for clients receiving treatment.

(j) Contain disclosures of how and by what level of staff medications are handled in the program. The agreement must also specify who is responsible for initial acquisition and refilling of prescribed medications utilizing unit or multidose packaging for the client. Either this responsibility will remain with the client, representative or legal surrogate, if any, or be assigned to the program operating through the administrator.

(k) The program must provide each client, representative or legal surrogate with an opportunity to read the complete agreement prior to the execution of the admissions agreement. In the event that a client, representative or legal surrogate is unable to read the agreement, the administrator or a manager must take steps to assure communication of the contents of the admission agreement to be signed. Each client, representative, or legal surrogate must be given an opportunity to ask questions prior to signing the admission agreement. The administrator or a manager must be present prior to execution to answer any questions regarding the admissions agreement.

(l) The program must provide the client and representative or legal surrogate, if any, with a signed copy of the agreement. A copy signed by both parties (client and administrator or on-site manager) must be retained in the client's file and maintained by the administrator of the program.

(m) The program must not use a written admission agreement, or any other written agreement signed by the client or the client's legal representative, which waives or attempts to waive any of the client's rights these rules protect. Any such provision of an admission agreement purporting to waive these rules is void.

(3) Nursing Assessment and Physical Examination. All clients shall be given a nursing assessment and physical examination as soon as possible but no more than 48 hours after admission to a program. The physical examination shall include a complete medical history and documentation of significant medical problems. It must contain specific descriptive terms and not the phrase, "within normal limits," or similar statement. If the client received a physical examination at an inpatient psychiatric hospital or from a psychiatrist within 72 hours prior to admission to the program, no further physical examination will be necessary unless clinically indicated or if the physical examination does not meet the requirements of this section. General findings must be written in the client's clinical record within 48 hours.

(4) Emotional and Behavioral Assessment. Upon admission to a program and on a monthly basis thereafter, an emotional and behavioral assessment shall be completed and entered into the client's clinical record. The assessment shall be made by a mental health professional. If the client received an assessment at a crisis stabilization unit or an inpatient acute care or psychiatric hospital prior to discharge to the program, another assessment is not required unless clinically indicated, the assessment does not meet the requirements of this section, or the assessment occurred more than 7 days prior to admission to the program. The assessment shall include the following:

(a) A history of previous emotional, behavioral, and substance abuse problems and treatment.

(b) An initial social assessment shall be completed upon a client's admission which must include a determination of the need for participation of family members or significant others in the client's treatment; the social, peer group, and environmental setting from which the client comes; family circumstances; current living situation; employment history; social, ethnic, cultural factors; and childhood history. Additionally, a comprehensive assessment shall be conducted within thirty days of admission by a licensed or certified staff member and reviewed by the program's multidisciplinary team and signed by a licensed or certified supervisor.

(c) A direct psychiatric evaluation of each client shall be completed by a physician or psychiatrist upon admission to include a mental status examination which includes detailed behavioral descriptions, including symptoms (not summary conclusions), and concise evaluation of cognitive functioning. A diagnosis, made by the physician or psychiatrist in accordance with the current edition of the American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders shall be recorded in the client's clinical record.

(d) Specifications of the behaviors that will be demonstrated in order for the client to return to a less restrictive setting and recommended intervention strategies.

(e) When indicated, the assessment shall also include intellectual, projective, and personality testing, and other functional evaluations of language, self-care, and social-affective and visual-motor functioning.

(f) A determination of medical necessity for continued stay in the program and treatment goals and progression.

(5) Medical Care.

(a) The program shall adopt medical care policies and procedures regarding medical care applicable to all types of mental health professionals at the program which have been approved by the medical director. The policies and procedures for medical care shall include the procedures that may be initiated by a registered nurse in order to alleviate a life-threatening situation. Medication or medical treatment shall be administered by a mental health professional with appropriate authorization and qualification, and orders for medications and treatments shall be written and signed by the physician or psychiatrist.

(b) There shall be no standing orders for any medication used primarily for the treatment of mental illness.

(c) All oral orders shall be received and recorded immediately only by a nurse with the physician's or psychiatrist's name and signed by the physician or psychiatrist within 24 hours. Such orders shall include a progress note that an order was made orally, the content of the order, justification, time, date and completion of medication reconciliation.

(d) Upon admission and as additional medication or treatment is prescribed or discontinued, the nurse, physician, psychiatrist, or other qualified staff member shall reconcile the client's medication.

(6) Treatment Plans. The program shall work with the client to develop a treatment plan which has objectives and action steps written for the client in behavioral terms. The objectives shall be related directly to one or more goals in the client's treatment plan. The treatment plan shall be initiated with documented input from the client receiving services and signed by the responsible physician or psychiatrist or other mental health professional privileged by policies and procedures within 48 hours of admission. The treatment plan shall be fully developed within 10 days of admission and must contain short-term treatment objectives stated in behavioral terms, relative to the long-term view and goals in the treatment plan, and a description of the type and frequency of services to be provided in relation to treatment objectives. The plan shall be reviewed with the client and updated at least every 30 days. A copy of the plan shall be signed by and provided to the client. A new aftercare plan shall be developed with and shared with the client prior to discharge from the program.

(7) Previous Record. For clients who enter the program following discharge from an inpatient psychiatric hospital, the previously completed intake interview, physical examination, medication log, progress notes, discharge or aftercare plan, and forms required for admission to the program attended by the client shall be made a part of the program clinical record.

(8) Required ARMHP Services.

(a) Services. Each ARMHP shall provide the following services on a 24-hour-a-day, 7-day-a-week basis:

Twenty-four hour per day supervision;
Client, group, and family counseling services directed toward alleviating the symptomatic behavior which required admission to a program;
Medical and psychiatric treatment provided by a licensed physician or psychiatrist;
Social and recreational activities, inside and outside the context of the program;
Referral arrangements with crisis stabilization units, other psychiatric treatment facilities, and hospital emergency services, which include but are not limited to, a written process and adequate staff to facilitate transfer of a client to such facilities and referral to less restrictive, nonresidential treatment services, when appropriate, and
Provision of or access to transportation in order to accomplish emergent and non-emergent transfers and to meet the service needs of clients served.

(b) Optional Services. A program may provide therapeutic modalities and complementary services beneficial to the treatment of and supports for adult mentally ill persons, as determined by the Medical Director. Notwithstanding the foregoing, such services may only be provided to a client upon the express written consent of the client or legal surrogate.

(c) Routine Activities. Basic routine activities for clients admitted to a program shall be delineated in program policies and procedures which shall be available to all staff. The daily activities shall be planned to provide a consistent, well structured, yet flexible, framework for daily living and shall be periodically reviewed and revised as the needs of clients or the group change. Basic daily routine shall be coordinated with special requirements of each treatment plan. A schedule of daily activities shall be posted or otherwise available to all clients receiving services.

(d) Laboratory Services.

(1) Requirement. Every ARMHP shall provide or contract for certified laboratory services commensurate with the client's needs.

(i) Emergency. Provision shall be made for the availability of emergency licensed laboratory services on a 24-hour-a-day, 7-day-a-week basis including holidays.

(ii) Orders. All laboratory tests and services shall be ordered by a mental health professional pursuant to authority granted by his or her scope of license.

(ii) Record. All laboratory reports shall be filed in the client's clinical record.

(iii) Specimens. Each ARMHP shall have written policies and procedures governing the collection, preservation, and transportation of specimens to ensure adequate stability of specimens.

(2) Contracts. Where the program depends on an outside laboratory for services, there shall be a written contract detailing the conditions, procedures, and availability of work performed. The contract shall be reviewed and approved by the program director or administrator.

(e) Discharge and Continuity of Care.

(1) Discharge Preparation. Prior to discharge from the program, the staff shall work with the client and, with the client's written consent, shall work with the client's support system including family, friends, employers, and case manager, as appropriate, to ensure that all efforts are made to prepare the client for returning to a less restrictive setting.

(2) Referral Services. All ARMHP facilities shall develop and maintain written referral agreements with licensed general or psychiatric hospitals. Such agreements shall ensure that referred clients are admitted as soon as necessary.

(3) Discharge Summary. The discharge summary shall include the initial formulation and diagnosis, clinical summary, final formulation, and final primary and secondary diagnoses, the psychiatric and physical categories. The final formulation shall reflect the general observations and understanding of the client's condition initially, during appraisal of the fundamental needs of the client. All relevant discharge diagnoses should be recorded and coded in the standard nomenclature of the current "Diagnostic and Statistical Manual of Mental Disorders," published by the American Psychiatric Association, and the latest edition of the "International Classification of Diseases," regardless of the use of other additional classification systems. Records of discharged clients shall be completed following discharge within a reasonable length of time, and not to exceed fifteen (15) days. In the event of death, a summation statement shall be added to the record either as a final progress note or as a separate statement. This final note shall take the form of a discharge summary and shall include circumstances leading to death. All discharge summaries must be signed by a physician who treated the client.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Admission and Discharge, Care, and Services" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.09 Minimum Building and Functional Design Standards {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.09}

(1) Required Approvals.

(a) A program shall be in compliance with all applicable local health, sanitation, building, and zoning requirements.

(b) A program shall be in compliance with all applicable laws and rules issued by the state fire marshal, the proper local fire marshal or state inspector, and shall have a certificate of occupancy if required.

(2) The program shall make reasonable efforts to ensure that the building and equipment are designed, constructed, and utilized in the interests of the safety and health of clients and staff members and in a manner that minimizes the risks of self-harm and injury. All buildings and grounds shall be constructed and maintained in a safe manner and in accordance with these rules.

(3) A program shall have appropriate and sufficient space to meet the programmatic needs of its clients and carry out the program's array of services. Such space shall include areas conducive to privacy for counseling and group activities, reception/waiting areas, and bathrooms which assure privacy for collection of urine specimens.

(4) Nurses' Station.

(a) The nurses' station shall be positioned so that the unit may be under constant surveillance. Charting and records areas shall be located in the rear of the nurses' station, and not in a separate area, so that staff on duty can readily observe the client areas.

(b) The maximum number of beds which may be served by a common nurses' station in co-located units is thirty (30).

(c) The nurses' station shall have necessary electronic assistance such as camera monitors, intercoms and remote access controls to monitor activity in more remote areas where clients may become isolated. Areas warranting visual and auditory monitoring shall include remote entrance or egress doors, isolated hallways, after hours law enforcement entrance, emergency screening area, and outdoor recreational spaces.

(5) Medication Room. The medication room shall be located near the nurses' station. The medication room shall have a sink, refrigerator, locked storage, and facilities for dispensing medication. Security against unauthorized access must be ensured. The refrigerator shall store medications and clean materials only.

(6) Sleeping Areas.

(a) For programs initially licensed or expanded after the effective date of this rule, sleeping areas shall contain not less than 60 square feet of useable floor space per client in multiple use bedroom and not less than 100 square feet of useable space in single bedrooms.

(b) Each client shall be provided with his or her own personal space and furnishings for storage of clothes and personal belongings.

(c) Each client shall be provided with his or her own personal bed and mattress. Clean sheets, pillows, and pillowcases, blankets or bed covering shall be provided and sheets and pillowcases shall be changed as needed, but at least weekly.

(d) Bedrooms shall be provided with outside ventilation by means of windows, air conditioners, or mechanical ventilation. All rooms that have windows that can be opened without special devices shall have insert window screens and the windows and screens must be in good repair.

(7) Lavatory and Bathing Facilities.

(a) There shall be at least one lavatory (water basin and toilet) with hot and cold water for every six clients or fraction thereof. Lavatories that contain more than one toilet shall contain stalls for client privacy. All lavatories shall be properly ventilated.

(b) There shall be at least one shower or bathtub with hot and cold water for every ten clients or fraction thereof. Bathtubs and shower stalls shall be equipped with non-slip surfaces.

(8) Dining Area. There shall be a separate furnished dining area for serving meals that contains not less than ten square feet of useable floor space for each client being served.

(9) Climate Control and Pest Control. A program shall be maintained at a temperature range of sixty-five degrees Fahrenheit (72 degrees if serving pregnant women) to eighty-two degrees Fahrenheit, depending on the season of the year. An effective pest control system shall be implemented and documentation on file as to actions taken.

(10) Hot and cold running water under pressure shall be readily available in all washing, bathing, food preparation and food handling areas. Hot water in client areas shall be at least 100 degrees Fahrenheit, but not exceed 120 degrees Fahrenheit.

(11) Premises. All grounds, space, and facilities, both those within the program and those regularly used by clients as an integral part of the program, shall be kept clean and free from hazards to health and safety and from litter.

(12) The program shall be designed to provide an outdoor space with secure, controlled access in an environment that makes reasonable efforts to provide privacy for the clients receiving services.

(13) Each ARMHP shall maintain laundry facilities which incorporate a flow-through design in which dirty laundry enters, is sorted, placed in the washer, dried, folded and moved out without crossing clean laundry with dirty laundry. The washing and drying units shall be equipped to sanitize clothes as a preventive measure of infection control.

(14) ARMHP furniture shall be durably constructed for heavy wear and use. Furnishings shall have finishes which are readily cleanable and shall have a flame-resistant rating.

(15) Off-site Residences. Facilities which provide off-site residences as part of the program must ensure that the residences also meet the above requirements, as well as the staffing ratios in Ga. Comp. R. & Regs. r. 111-8-2-.10(5)(d). The off-site residence must be within reasonable driving distance of the treatment location, not to exceed 5 miles.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Minimum Building and Functional Design Standards" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.10 Staff {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.10}

(1) Medical Director. Each ARMHP must have a medical director. The medical director must be a psychiatrist who is licensed to practice in this State and who is board certified by the American Board of Psychiatry and Neurology. The medical director is responsible for providing or supervising all psychiatric care and treatment at the program and shall retain responsibility for the range and quality of services provided at the program.

(2) Administrator. Each ARMHP must have an administrator. The administrator is the manager designated by the Governing Body as responsible for the day-to-day management, administration, and supervision of the program, who may also serve as the on-site manager and responsible staff person except during periods of his or her own absence. During such times of temporary absence, the administrator shall designate a responsible person to be in charge of the program.

(3) ARMHPs must designate a Food Service Manager. Such person shall be responsible for managing the preparation of meals and must enforce safe food handling practices which address basic food safety, hygiene, cross contamination, time and temperature requirements, and sanitation with staff and clients.

(4) Minimum Required Staffing. The program must provide sufficient trained staff to meet the health and safety needs of the clients. At a minimum, each ARMHP shall have the following clients on staff:

(a) Psychiatrist, or other physician when the psychiatrist is unavailable.

(b) Registered professional nurse or advanced practice nurse practitioner.

(d) Mental health technicians or similarly trained paraprofessionals or certified peer specialists.

(5) Minimum Staffing Hours.

(a) The medical director must be physically present at the program on a regular basis sufficient to maintain professional responsibility for the provision of mental health services at the program.

(b) An on-site manager must be physically present at the program at all times the program is operational. The administrator may serve as an on-site manager.

(c) A physician or qualified mental health professional must be available for client consultation at all times the program is operational.

(d) Each program must maintain a staffing ratio of not less than 1 trained staff person (mental health professional, nurse, paraprofessional or certified peer specialist) for every 12 clients at all times the program is operational.

(6) Staff subject to professional practice acts must be in compliance with the Georgia practice acts applicable to each respective professional practice.

(7) All staff are required to comply with the Georgia codes of ethics which govern their respective practices.

(8) The medical responsibility for each client will be vested in a licensed physician who oversees all medical services provided by the program.

(9) Counseling services are provided by program staff qualified by education, training, and experience to provide mental health counseling and who are licensed/certified if required by Georgia practice acts applicable to each respective professional practice.

(10) Staff Training and Orientation. Prior to working with clients, all staff who provide treatment and services shall be oriented in accordance with these rules and shall thereafter receive additional training in accordance with these rules.

(a) Orientation shall include instruction in:

The program's written policies and procedures regarding its program purpose and description; client rights, responsibilities, and complaints; confidentiality; and other policies and procedures that are relevant to the staff member's range of duties and responsibilities, including the use of universal precautions for infection control, use of behavior management and emergency safety interventions, and information about HIV/AIDS;
The staff member's assigned duties and responsibilities; and
Reporting client progress and problems to supervisory personnel and procedures for handling medical emergencies or other incidents that affect the delivery of treatment or services.
Additional training shall be provided annually for each staff member who provides treatment services to clients. Such training shall be in subjects that relate to the staff member's assigned duties and responsibilities and include a minimum of twenty (20) clock hours.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Staff" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.11 Criminal Background Checks {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.11}

(1) The Rules and Regulations for Criminal Background Checks located at Ga. Comp. R. & Regs. r. 111-8-12-.01 et seq. are incorporated herein by reference and such Rules and regulations are applicable to all governing body members, applicants, administrators, on-site managers, and other staff.

(2) A records check application shall be required for each governing body member and applicant upon application for a license or provisional license and upon a change of ownership.

(3) A records check application shall be required for each administrator, on-site manager, and direct care staff member upon application for employment or prior to placement in the position.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Criminal Background Checks" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.12 Medication {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.12}

(1) Self-Administration of Medications. Subject to discretion of the Medical Director, Clients who have the capacity to self-administer medications safely and independently without staff assistance or supervision must be allowed to store their own medications securely and self-administer medications if they so desire. Notwithstanding the foregoing, all controlled substances must be administered and stored by the program.

(2) Program's Administration of Medications. Where the clients are not capable of self-administration of medications, the program must provide medication administration services to the clients in accordance with physicians' orders, the needs of the clients and these rules. Such medications must be dispensed in accordance with Georgia law.

(3) Maintaining Records on Medication Assistance and Administration. Where the program administers medications to clients, the program must maintain a daily Medication Assistance Record (MAR) for each client receiving such service.

(a) The MAR must include the name of the specific client, any known allergies, the name and telephone number of the client's health care provider, the name, strength, route of administration and specific directions, including a summary of severe side effects and adverse reactions for use of each medication, and a chart for staff who provide assistance or administration to record initials, time and date when medications are taken, refused or a medication error is identified (e.g. missed dosage).

(b) The staff providing the assistance or administration of medications must update the MAR each time the medication is offered or taken.

(c) The program must make medication information concerning the descriptions of medication, dosing, side effects, adverse reactions and contraindications for each medication being administered to the clients immediately available for reference by staff providing medication assistance or administration.

(d) Staff providing assistance with or administration of medications must document in the client's record any unusual reactions to the medications and provide such information to the client, the client's representative and the health care provider as appropriate.

(e) Refills of prescribed medications must be obtained timely so that there is no interruption in the routine dosing. Where the program is provided with a new medication for the client, the MAR must be modified to reflect the addition of the new medication within 48 hours or sooner if the prescribing physician, advance practice registered nurse or physician assistant indicates that the medication change must be made immediately. In ARMHPs, where unit or multi-dose packaging is not available for immediate changes in medications, unit or multi-dose packaging of the medication must be obtained when the prescription is refilled.

(4) Orders Required for All Medications. A program must not allow its staff to administer medications, including over-the-counter medications, unless there is a physician, advance practice registered nurse or physician assistant's order or individualized prescription bottle, specifying clear instructions for its use on file for the client.

(5) Timely Management of Medication Procurement. The program must obtain new prescriptions within 48 hours of receipt of notice of the prescription or sooner if the prescribing physician indicates that a medication change must be made immediately. If the pharmacy does not have the medication needed for the immediate change available and has not obtained further directions from the physician, the program must notify the physician of the unavailability of the prescription and request direction.

(6) Storage of Medications.

(a) Storage of medications must be maintained in accordance with guidelines established by the United States Drug Enforcement Administration and the Georgia Board of Pharmacy.

(b) The program is responsible for having an effective system to manage the medications it receives including storing medications under lock and key, or other secure system to prevent unauthorized access, at all times, whether kept by a client or kept by the program for the client, except when required to be kept by a client on his or her person due to need for frequent or emergency use, as determined by the client's physician, advance practice registered nurse or physician assistant, or when closely attended by a staff member. Additionally, for controlled substances, the secure storage must be a locked cabinet or box of substantial construction and a log must be maintained and updated daily by the program to account for all inventory.

(c) Medication kept by a client may be stored in the client's bedroom, in a locked cabinet or other locked storage container. Single occupancy bedrooms which are kept locked at all times are acceptable. Duplicate keys for the client's locked storage container and room must be available to the client and the administrator, on-site manager or designated staff.

(d) Medications must be kept in original containers with original labels intact.

(e) A program may stock over-the-counter medications such as aspirin or acetaminophen for the convenience of clients who have PRN (as needed) orders for the specific medication and dosage. However, where the client takes an over-the-counter medication daily as prescribed in a written order by a licensed physician, nurse practitioner or physician assistant, such as vitamins or low-dose aspirins, the client must have a client bottle of the prescribed medication that is kept for the client's usage.

(f) Unused or expired medications must be properly disposed of using the current U.S. Food and Drug Administration or U.S. Environmental Protection Agency guidelines for the specific medications.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Medication" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.13 Food and Nutrition {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.13}

(1) A program shall provide each client with meals and snacks of groups and serving sizes which meet the nutritional guidelines of the United States Department of Agriculture. Meals and snacks shall be varied daily. Modified diets based on medical or religious reasons shall be served as needed.

(2) If required by the local county board of health, a residential program shall obtain a valid food service permit from the local county board of health. All ARMHPs providing food services shall meet the following requirements:

(a) Food shall be stored, prepared, and maintained in a safe and sanitary manner commensurate with generally accepted and recognized food service standards.

(b) There shall be designated and separate space for food preparation and storage.

(c) All perishable and potentially hazardous foods shall be refrigerated at a temperature of forty-five degrees Fahrenheit unless frozen. Freezer temperatures shall be maintained at zero degrees Fahrenheit or below.

(d) Food shall be in sound condition, free from spoilage and contamination and shall be safe for human consumption when served to clients.

(e) Food service equipment and preparation areas shall be kept clean and free of accumulation of dust, dirt, food particles, and grease deposits.

(f) When non-disposable dishes, glasses, and flatware are used, they shall be properly cleaned by pre-rinsing and scraping, washing, sanitizing, and drying.

(3) Where a program provides food services through contract or arranges for food services, the program shall require that food served be safe for human consumption and that the meals/snacks provided meet the nutritional guidelines of the United States Department of Agriculture.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Food and Nutrition" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.14 Disaster Preparedness Plan {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.14}

Each ARMHP shall have a Disaster Preparedness Plan which meets the requirements of Ga. Comp. R. & Regs. r. 111-8-16-.01, et seq.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Disaster Preparedness Plan" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.15 Client Rights and Grievances {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.15}

(1) Admission to a program is voluntary. A client, in the absence of a court order, may voluntarily discharge from the program at any time.

(2) The program must ensure that its clients enjoy the rights and responsibilities listed herein:

(a) Each client must receive care, and services which must be adequate, appropriate, and in compliance with applicable federal and state laws and regulations in the least restrictive environment permissible.

(b) Each client shall receive treatment without regard to race, sex, or age.

(c) Each client shall have the right to receive treatment at a program that is clean, safe, and promotes an atmosphere of recovery in support of the client's treatment goals.

(d) The program, its agents or employees, must not punish or harass the client, because of the client's efforts to enforce his or her rights.

(e) Each client must have the right to:

Exercise the constitutional rights guaranteed to citizens of this state and this country including, but not limited to, the right to vote.
Choose activities and schedules consistent with the program's treatment services and the client's interests and assessments.

(f) Each client may take part in planning his or her own treatment at the program and know the benefits, risks, and/or side effects of all medications and treatments.

(g) Each client must have the right to enjoy privacy in his or her room; program personnel and others must respect this right by knocking on the door before entering the client's room.

(h) Each client has the right to receive and refuse to receive visitors subject to reasonable safety protocols.

(i) Each client must have the right to associate and communicate freely and privately with persons and groups of the client's choice without being censored by staff subject to the limited exception in Ga. Comp. R. & Regs. r. 111-8-2-.16(d)(8).

(j) Each client must be treated with dignity, kindness, consideration and respect and be given privacy in the provision of personal care. Each client must be accorded privacy and freedom for the use of bathrooms at all hours, while accounting for client safety.

(k) No religious or spiritual belief or practice may be imposed upon any client. Clients must be free to practice their religious beliefs as they choose. Each client must have the right to participate in social, religious, and community activities that do not interfere with the rights of other clients.

(l) Each client has the right to be free from mental, verbal, sexual and physical abuse, neglect and exploitation.

(m) Each client has the right to be free from actual or threatened physical or chemical restraints unless necessary for the protection of the client, other clients or staff. Each client has the right to be free from isolation, corporal or unusual punishment and interference with the daily functions of living, such as eating or sleeping.

(n) Each client has the right to use, keep and control his or her own personal property and possessions in the immediate living quarters, except to the extent a client's use of his or her property would interfere with the safety or health of other clients or pose an immediate and serious safety risk for the client. Each client has the right to reasonable safeguards for the protection and security of his or her personal property and possessions brought into the program.

(o) Each client has a right to send and receive mail and other communications with persons outside the program.

(p) Each client must have access to a telephone and the right to have a private telephone, at the client's own expense. Telephones must be placed in areas to ensure privacy without denying accessibility.

(q) Each client has the right to manage his or her own financial affairs, including the right to keep and spend his or her own money unless that client has been adjudicated incompetent by a court of competent jurisdiction or the client has a legal surrogate handling financial affairs on their behalf.

(r) Each client has the right to receive or reject medical care, dental care, or other services except as required by law or regulations.

(s) Each client has the right to choose and retain the services of a personal physician and any other health care professional or service. No program is permitted to interfere with the client's right to receive from the client's attending physician complete and current information concerning the client's diagnosis, treatment and prognosis. Each client and his or her representative or legal surrogate, if any, has the right to be fully informed about care and of any changes in that care and the right of access to all information in medical records retained in the program.

(t) Each client has the right to fully participate in the planning of his or her care. Case discussion, consultation and examination shall be confidential and conducted discreetly. A person who is not directly involved in the client's care may be present when care is being rendered only if he or she has the client's permission.

(u) Each client shall maintain or have access to their own money and personal effects, with reasonable limitations for safety.

(v) Each client has the right to inspect and make a copy of his or her own treatment records on request consistent with State law. Each client has the right to confidential treatment of personal information in the client file.

(w) Each client who has not been committed to the program by court order or who does not have a representative or legal surrogate with specific written authority to admit, transfer or discharge, may discharge or transfer himself or herself upon notification to the program in conformance with the program's policies and procedures.

(x) Each client has the right to file a complaint with the department concerning care being provided in the program that violates these rules. The program must post the name of the department and the address and telephone number where licensing complaints are received in the common area of the program.

(y) The program shall establish a code of conduct and rights of clients in compliance with program rules and expectations which conforms with governing law and these rules and regulations. Such code of conduct shall set forth a clear and understandable review and disciplinary procedure for clients alleged to have violated the code of conduct. The code of conduct shall include the right to appeal any decision to the administrator. The program code of conduct shall also advise clients of the right to seek assistance from the Office of Disability Services Ombudsman and to report any complaints to the department, alleging violations of these rules and regulations and laws governing the program.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Client Rights and Grievances" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.16 Behavior Management and Emergency Safety Interventions {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.16}

(1) Behavior Management

(a) The program shall develop and implement policies and procedures on behavior management.

(b) Program staff shall be made aware of each client's known or apparent medical and psychological conditions and family history to ensure that the staff have adequate knowledge to deliver safe and healthy care to the client.

Behavior management principles and techniques shall be used in accordance with the client treatment plan and written policies and procedures governing service expectations, treatment goals, safety, security, and these rules and regulations.
Behavior management shall be limited to the least restrictive appropriate method, as described in the client's treatment plan and in accordance with the prohibitions as specified in these rules and regulations.

(d) Behavior management techniques shall be administered by trained staff and shall be appropriate for the client's age, intelligence, emotional makeup and past experience. The following forms of behavior management shall not be used by program staff with clients receiving services through the program:

Assignment of excessive or unreasonable work tasks;
Denial of meals and hydration;
Denial of sleep;
Denial of shelter, clothing, or essential personal needs;
Denial of essential program services;
Verbal abuse, ridicule, or humiliation;
Manual holds, chemical restraints, or mechanical restraints not used appropriately as emergency safety interventions;
Denial of communication and visits, except when a temporary peer restriction is implemented based on a clinical assessment as part of the treatment plan;
Corporal punishment; and
Seclusion or confinement of a client.

(e) Clients shall not be permitted to participate in the behavior management of other clients or to discipline other clients, except as part of an organized therapeutic self-governing program in accordance with accepted standards of clinical practice that is conducted in accordance with written policy and is supervised directly by designated staff.

(f) All forms of behavior management or emergency safety interventions used by staff shall also be documented in case records in order to ensure that such records reflect behavior management problems.

(g) The program shall take appropriate corrective action when the program staff become aware of or observe the use of prohibited forms of behavior management. Documentation of the incident and the corrective action taken by the program shall be maintained in the case records of the client.

(2) Emergency Safety Interventions .

(a) Emergency safety interventions may be used only by staff trained in the proper use of such interventions when it can be reasonably anticipated from a client's behavioral history, that a client may require the use of emergency safety interventions to keep either the client or others safe from immediate physical harm, and less restrictive means of dealing with the injurious behavior have not proven successful or may subject the client or others to greater risk of injury.

(b) Program staff working with such client shall be trained in emergency safety interventions utilizing a nationally recognized training program in emergency safety interventions which has been approved by the department.

(c) Emergency safety interventions shall not include the use of any restraint or manual hold that would potentially impair the client's ability to breathe or has been determined to be inappropriate for use on a particular client due to a documented medical or psychological condition.

(d) The program shall have written policies and procedures for the use of emergency safety interventions, a copy of which shall be provided to and discussed with each client or legal guardian, if applicable, prior to or at the time of admission. Emergency safety interventions policies and procedures shall include:

Provisions for the documentation of an assessment at admission and at each annual exam by the client's physician, a physician's assistant, or a registered nurse with advanced training working under the direction of a physician, or a public health clinic which states that there are no medical issues that would be incompatible with the appropriate use of emergency safety interventions on that client. Such assessment and documentation must be re-evaluated following any significant change in the client's medical condition; and
Provisions for the documentation of each use of an emergency safety intervention including:

(i) Date and description of the precipitating incident;

(ii) Description of the de-escalation techniques used prior to the emergency safety intervention, if applicable;

(iii) Environmental considerations;

(iv) Names of staff participating in the emergency safety intervention;

(v) Any witnesses to the precipitating incident and subsequent intervention;

(vi) Exact emergency safety intervention used;

(vii) Beginning and ending time of the intervention;

(viii) Outcome of the intervention;

(ix) Detailed description of any injury arising from the incident or intervention; and

(x) Summary of any medical care provided.

Provisions for prohibiting manual hold use by any employee not trained in prevention and use of emergency safety interventions.

(e) Emergency safety interventions may be used to prevent runaways only when the client presents an imminent threat of physical harm to self or others, or as specified in the client treatment plan.

(f) Program staff shall be aware of each client's medical and psychological conditions (e.g. obvious health issues, list of medications, history of physical abuse, etc.), as evidenced by written acknowledgement of such awareness, to ensure that the emergency safety intervention that is utilized does not pose any undue danger to the physical or mental health of the client.

(g) Clients shall not be allowed to participate in the emergency safety intervention of other clients.

(h) Immediately following the conclusion of the emergency safety intervention and hourly thereafter for a period of at least four hours where the client is with a staff member, the client's behavior will be assessed, monitored, and documented to ensure that the client does not appear to be exhibiting symptoms that would be associated with an injury.

(i) At a minimum, the emergency safety intervention program that is utilized shall include the following:

Techniques for de-escalating problem behavior including client and staff debriefings;
Appropriate use of emergency safety interventions;
Recognizing aggressive behavior that may be related to a medical condition;
Awareness of physiological impact of a restraint on the client;
Recognizing signs and symptoms of positional and compression asphyxia and restraint associated cardiac arrest;
Instructions on how to monitor the breathing, verbal responsiveness, and motor control of a client who is the subject of an emergency safety intervention;
Appropriate self-protection techniques;
Policies and procedures relating to using manual holds, including the prohibition of any technique that would potentially impair a client's ability to breathe;
Agency policies and reporting requirements;
Alternatives to restraint;
Avoiding power struggles;
Escape and evasion techniques;
Time limits for the use of restraint;
Process for obtaining approval for continual restraints;
Procedures to address problematic restraints;
Documentation;
Investigation of injuries and complaints;
Monitoring physical signs of distress and obtaining medical assistance; and
Legal issues.

(j) Emergency safety intervention training shall be in addition to the annual training required under these rules and shall be documented in the staff member's personnel record.

(k) All actions taken that involve utilizing an emergency safety intervention shall be recorded in the client's case record showing the cause for the emergency safety intervention, the emergency safety intervention used, and, if restraints are needed, approval by the medical director or other physician with responsibility for the diagnosis and treatment of the client's behavior.

(l) Programs shall submit to the department electronically in a format acceptable to the department, within 24 hours whenever the program becomes aware of an incident which results in injury to a client requiring medical treatment beyond first aid that is received by a client as a result of or in connection with any emergency safety intervention.

For any program with a licensed capacity of 20 clients or more, any 30-day period in which three or more instances of emergency safety interventions of a specific client occurred and/or whenever the program has had a total of 10 emergency safety interventions for all clients in care within the 30-day period; and
For any program with a licensed capacity of less than 20 clients, any 30-day period in which three or more instances of emergency safety interventions of a specific client occurred and/or whenever the program has had a total of five instances for all clients in care within the 30-day period.

(m) Programs shall submit a written report to the program's medical director on the use of any emergency safety intervention immediately after the conclusion of the intervention and, if the client has an assigned legal guardian, shall further notify the client's legal guardian regarding the use of the intervention. A copy of such report shall be maintained in the client's file.

(a) At least once per quarter, the program, utilizing a master agency restraint log and the client's case record, shall review the use of all emergency safety interventions for each client and staff member, including the type of intervention used and the length of time of each use, to determine whether there was a clinical basis for the intervention, whether the use of the emergency safety intervention was warranted, whether any alternatives were considered or employed, the effectiveness of the intervention or alternative, and the need for additional training. Written documentation of all such reviews shall be maintained. Where the program identifies opportunities for improvement as a result of such reviews or otherwise, the program shall implement these changes through an effective quality improvement plan.

(o) All program staff who may be involved in the use of emergency safety interventions shall have evidence of having satisfactorily completed a nationally recognized training program for emergency safety interventions to protect clients and others from injury, which has been approved by the department and taught by an appropriately certified trainer in such program.

(p) Manual Holds.

Emergency safety interventions utilizing manual holds require at least one trained staff member to carry out the hold. Emergency safety interventions utilizing prone restraints require at least two trained staff members to carry out the hold.
Emergency safety interventions shall not include the use of any restraint or manual hold that would potentially impair the client's ability to breathe or has been determined to be inappropriate for use on a particular client due to a documented medical or psychological condition.
When a manual hold is used upon any client whose primary mode of communication is sign language, the client shall be permitted to have his or her hands free from restraint for brief periods during the intervention, except when such freedom may result in physical harm to the client or others.
If the use of a manual hold exceeds 15 consecutive minutes, the medical director or his or her designee who has been fully trained in the program's emergency safety intervention plan, shall be contacted for an evaluation of whether the continuation of the manual hold is appropriate under the circumstances. Documentation of any consultations and outcomes shall be maintained for each application of a manual hold that exceeds 15 minutes. Manual holds shall not be permitted to continue if the restraint is determined to pose an undue risk to the client's health given the client's physical or mental condition.
A manual hold may not continue for more than 30 minutes at any one time without the consultation as specified in subparagraph (4) of this subparagraph, and under no circumstances may a manual hold be used for more than one hour total within a 24-hour period.
If the use of a manual hold on a client reaches a total of one hour within a 24-hour period, the staff shall reconsider alternative treatment strategies, document same, and consider notifying the authorities or transporting the client to a hospital for evaluation.
The client's breathing, verbal responsiveness, and motor control shall be continuously monitored during any manual hold. Written summaries of the monitoring by a trained staff member not currently directly involved in the manual hold shall be recorded every 15 minutes during the duration of the restraint. If only one trained staff member is involved in the restraint and no other staff member is available, written summaries of the monitoring of the manual hold shall be recorded as soon as is practicable, but no later than one hour after the conclusion of the restraint.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 37-3-212, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Behavior Management and Emergency Safety Interventions" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.17 Record Maintenance and Confidentiality Requirements {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.17}

(1) ARMHPs must maintain all records of any individual seeking treatment at the program for the required duration applicable to the types of records set forth in applicable law and regulation. In the absence of such laws and regulations, the program must maintain such records for a minimum of ten (10) years following the discharge of the client from the program.

(2) The records and name of any individual who seeks or obtains treatment, therapeutic advice, or counsel from any ARMHP shall be confidential and shall not be revealed except to the extent authorized in writing by the individual or the individual's guardian or custodian, to the extent required by applicable law, court order, and as necessary for the department to conduct its regulatory oversight functions; furthermore, any communication by such client to a staff member of a program shall be deemed confidential; provided, however, that, except for matters privileged under other laws of this state, the records of such individual and information about such individual shall be produced in response to a valid court order of any court of competent jurisdiction after a full and fair show-cause hearing and in response to a Departmental request for access for licensing purposes when such request is accompanied by a written statement that no record of client identifying information will be made. The protections in this Rule and other provisions of state or federal law or regulation of any client's identity or communications to the staff of any ARMHP shall not prohibit the use of de-identified data relating to such clients for clinical or programmatic research or education or in presentations about the programs offered by a licensee under these Rules. Subject to and in compliance with the limitations of any state or federal privacy laws or regulations, the department may require at reasonable intervals, and each licensee shall furnish, copies of summary records of each individual treated or advised pursuant to a program.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 37-3-212, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Record Maintenance and Confidentiality Requirements" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.18 Incident Reports {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.18}

(1) The staff of the program must contact the local police department with jurisdiction over the program to report any missing client from the program within 30 minutes of the staff receiving actual knowledge that such person is missing from the program.

(2) The staff of the program must immediately contact the local police department with jurisdiction over the program when it is determined that a client poses a clear and present danger to any client within the program, its staff, and/or the general public.

(3) Whenever a serious incident (as designated herein) involving a client occurs, the program must report in a format acceptable to the department either within 24 hours after the incident has occurred, or the program has reasonable cause to believe that a reportable incident involving a client has occurred. The serious incidents that must be reported to the department include the following:

(a) any death of a client seeking treatment at the program;

(b) any serious injury to a client that requires medical attention;

(c) any injury to a client that requires medical attention beyond first aid that is received by the client as a result of or in connection with any emergency safety intervention;

(d) any client that is missing from the program without notice of voluntary discharge;

(e) any rape, assault, any battery of a client;

(f) an external disaster or other emergency situation that affects the continued safe operation of the program;

(g) when an owner, director or employee acquires a criminal record; and

(h) when the program staff determines that a client poses a clear and present danger to any client within the program, its staff, and/or the general public.

(4) The incident report required by these rules must be filed with the department and must include at least:

(a) the name of the program and the name of the administrator;

(b) the date of the incident and the date the program became aware of the incident;

(d) any immediate corrective or preventative action taken by the program to ensure against the replication of the incident. Upon receipt of the incident report, the department may request additional information from the program and/or initiate a complaint investigation of the incident.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Incident Reports" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.19 Enforcement of Licensing Requirements {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.19}

(1) A program that fails to comply with licensing requirements contained in these rules and the Rules and Regulations for General Licensing and Enforcement Requirements, Ga. Comp. R. & Regs. r. 111-8-25, is subject to civil and administrative actions brought by the department to enforce licensing requirements as provided by law and rules. Such actions will be initiated in compliance with the Georgia Administrative Procedures Act, O.C.G.A. § 50-13-1 et seq., O.C.G.A. § 31-2-8 , and the Rules and Regulations for General Licensing and Enforcement Requirements, Ga. Comp. R. & Regs. r. 111-8-25-.01 et seq.

(2) The department is authorized to fine an applicant or licensee, and/or deny, suspend, or revoke a license issued under these Rules for a violation of O.C.G.A. § 37-3-200 et seq. or a rule or regulation adopted under O.C.G.A. § 37-3-200 et seq. or to take other disciplinary actions against licensees as provided in Code Section 31-2-8 and the Rules and Regulations for General Licensing and Enforcement Requirements, Ga. Comp. R. & Regs. r. 111-8-25.

(3) The denial, suspension, or revocation of a license by the department shall be a contested case for purposes of Chapter 13 of Title 50, the "Georgia Administrative Procedure Act."

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 37-3-211, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Enforcement of Licensing Requirements" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.20 Inspections {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.20}

(1) The department shall conduct periodic on-site inspection of each ARMHP. Such inspection shall include, but shall not be limited to, the premises, staff, clients, and documents pertinent to the continued licensing of such ARMHP so that the department may determine whether a program or governing body is operating in compliance with all applicable laws and regulations. Each licensee shall permit authorized Department representatives to enter upon and inspect any and all premises upon or in which a program is to be conducted, for which a license has been applied, or for which a license has been issued so that verification of compliance with all relevant laws or regulations can be made.

(2) If violations of these licensing rules are identified from an inspection, the program will be given a written report of the violation that identifies the rules violated. The program shall submit to the department a written plan of correction in response to the report of violation, which states what the program will do, and when, to correct each of the violations identified. The program may offer an explanation or dispute the findings or violations in the written plan of correction, so long as an acceptable plan of correction is submitted within ten (10) days of the program 's receipt of the written report of inspection. If the initial plan of correction is unacceptable to the department, the program will be provided with at least one (1) opportunity to revise the unacceptable plan of correction. Failure to submit an acceptable plan of correction may result in the department commencing enforcement procedures. The program shall comply with its plan of correction.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 37-3-213, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Inspections" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.21 Unlicensed Adult Residential Mental Health Programs; Penalties {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.21}

(1) A program shall be deemed to be an "unlicensed ARMHP" if it does not have a valid ARMHP license and is not exempt from licensure under these Rules and:

(a) The program is providing services; or

(b) The program represents itself as an ARMHP.

(2) Any program alleged to be operating as an unlicensed ARMHP shall be assessed by the department, after opportunity for hearing in accordance with the provisions of Chapter 13 of Title 50, the "Georgia Administrative Procedure Act," a civil penalty in the amount of $100.00 per bed per day for each day of violation. The department shall send a notice by certified mail or statutory overnight delivery stating that licensure is required and the department's intent to impose a civil penalty. Such notice shall be deemed to be constructively received on the date of the first attempt to deliver such notice by the United States Postal Service. The department shall take no action to collect such civil penalty until after opportunity for a hearing.

(3) In addition to other remedies available to the department, the civil penalty authorized by subsection (2) of this Rule shall be doubled if the owner or operator continues to operate the unlicensed program, after receipt of notice pursuant to subsection (2) of this Rule.

(4) The owner or operator of an unlicensed ARMHP who is assessed a civil penalty in accordance with this Rule may have review of such civil penalty by appeal to the superior court in the county in which the action arose or to the Superior Court of Fulton County.

(5) Any person who owns or operates a program in violation of this Rule shall be guilty of a misdemeanor for a first violation, unless such violation is in conjunction with a violation of Article 8 of Chapter 5 of Title 16, in which case such person shall be guilty of a felony and, upon conviction, shall be punished by imprisonment for not less than one nor more than five years. Upon conviction for a second or subsequent such violation, such person shall be guilty of a felony and, upon conviction, shall be punished by imprisonment for not less than one nor more than ten years.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 37-3-215, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Unlicensed Adult Residential Mental Health Programs; Penalties" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.22 Role of Disability Services Ombudsman {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.22}

The powers of the disability services ombudsman established under O.C.G.A. § 37-2-30, et seq. shall include oversight of clients at a program licensed under these Rules, with all attendant powers and functions specified by law for such ombudsman.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 37-3-215, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Role of Disability Services Ombudsman" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Ga. Comp. R. & Regs. r. 111-8-2-.23 Waivers and Variances {#sec-ga.-comp.-r.-regs.-r.-111-8-2-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-2-.23}

(1) The department may, in its discretion, grant waivers and variances of specific rules upon application or petition being filed by a program. The department may establish conditions which must be met by the program in order to operate under the waiver or variance granted. Waivers and variances may be granted in accordance with the following considerations:

(a) Variance. A variance may be granted by the department upon a showing by the applicant or petitioner that the particular rule or regulation that is the subject of the variance request should not be applied as written because strict application of the rule would cause undue hardship. The applicant or petitioner must also show that adequate standards affording protection for the health, safety and care of the clients exist and will be met in lieu of the exact requirements of the rule or regulations in question.

(b) Waiver. The department may dispense entirely with the enforcement of a rule or regulation upon a showing by the applicant or petitioner that the purpose of the rule or regulation is met through equivalent standards affording equivalent protection for the health, safety and care of clients.

(c) Experimental Variance or Waiver. The department may grant waivers and variances to allow experimentation and demonstration of new and innovative approaches to delivery of services upon a showing by the applicant or petitioner that the intended protections afforded by the rule or regulation which is the subject of the request are met and that the innovative approach has the potential to improve service delivery.

History

Authority: O.C.G.A. §§ 37-3-204, 37-3-205, 31-2-4, 31-2-7, 31-2-8, 31-7-2.1
History. Original Rule entitled "Waivers and Variances" adopted. F. Dec. 10, 2024; eff. Dec. 30, 2024.

Subject 111-8-4 Ambulatory Surgical Treatment Centers

Ga. Comp. R. & Regs. r. 111-8-4-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.01}

Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning hereinafter respectively ascribed to them:

(a) "Ambulatory Surgical Treatment Centers" means any institution, building, or facility, or part thereof, devoted primarily to the provision of surgical treatment to patients not requiring hospitalization, as provided under provisions of O.C.G.A. § 31-7-1(4)(c) . Such facilities do not admit patients for treatment which normally requires overnight stay, nor provide accommodations for treatment of patients for period of twenty-four (24) hours or longer;

(b) "Governing Body" and/or "Management" means the Board of Directors and/or Trustees, the partnership, the corporation, the association, or the person or group of persons who maintain and control the operation of the ambulatory surgical treatment center and who are legally responsible for its operation;

(d) "Board," unless otherwise indicated, shall mean the Georgia Board of Community Health;

(e) "Commissioner" means the Commissioner of the Georgia Department of Community Health or his designee;

(f) "Department" means the Georgia Department of Community Health;

(g) "General Anesthesia" means any drug, element or other material administered to eliminate all sensation and which, when administered, is accompanied by a state of unconsciousness;

(h) "Licensee" means the person or body to whom the license or permit is issued and who is held responsible for compliance with all required rules, regulations, and minimum standards;

(i) "Permit" or "license" means an authorization granted by the Department to an applicant to operate an ambulatory surgical treatment center providing one or more types or classifications of services;

(j) "Provisional Permit" means an authorization granted by the Department to an applicant to operate an ambulatory surgical treatment center on a conditional basis to allow a newly established center a reasonable but limited period of time to demonstrate that operational procedures are in satisfactory compliance with these rules and regulations, or to allow an established and operating center a specified length of time to comply with these rules and regulations, provided said center shall first present a plan of improvement which is acceptable to the Department;

(k) "Plan of Improvement" means a written plan submitted to the Department by the person or persons responsible for the center, and acceptable to the Department. The plan shall identify the existing areas of noncompliance of the facility, together with the proposed procedures, methods and period of time to correct the areas of noncompliance;

(l) "Professional Staff" means the group of persons or body appointed by the Governing Body to provide patient services, and who require special licensure or registration. Normally, the professional staff will be restricted to currently licensed medical, dental, and podiatrist practitioners. Other personnel, for example, registered nurses, may be appointed to the professional staff to assist the practitioners in the development, interpretation, and enforcement of patient care policies;

(m) "Practitioner" means a physician, dentist, or podiatrist;

(n) "Physician" means an individual who is currently licensed to practice medicine, surgery or osteopathy in the State of Georgia, under the Georgia Medical Practice Act, O.C.G.A. § 43-34-20 et seq. ;

(o) "Dentist" means any person who is currently licensed to practice dentistry in the State of Georgia, under provisions of the Georgia Dentist and Dental Hygienists Act, O.C.G.A. § 43-11-1 et seq. ;

(p) "Podiatrist" (Chiropodist) means any person who is currently licensed to practice podiatry (chiropody) in the State of Georgia, under provisions of the Georgia Podiatry Act, O.C.G.A. § 43-35-1 et seq. ;

(q) "Registered Nurse," "Registered Professional Nurse," or "R.N." means a person who is currently licensed to practice as a licensed registered nurse under provisions of O.C.G.A. § 43-26-1 et seq. ;

(r) "Licensed Practical Nurse" or "L.P.N." means a person currently licensed to practice as a licensed practical nurse under provisions of O.C.G.A.§ 43-26-30 et seq. ;

(s) "Private Office(s)," "Office(s)," and/or "Treatment Rooms" means any area or place established and maintained by a currently licensed individual practitioner, professional association, or group practice of such practitioners, in his/her/their private individual or private group practice, in which he/she/they primarily see(s), consult(s) with, examine(s), and/or treats private patients on a regular and on-going basis, and in the operation of which such currently licensed practitioners have full control of all financial, administrative, and professional arrangements with said patients;

(t) "Hospital" means any facility which meets the requirements of and is currently licensed as a hospital under Georgia Laws and rules and regulations pertaining thereto;

(u) "Procedure Room" means any room or area of the ambulatory surgical treatment center in which surgical procedures are performed;

(v) "Patient" means any individual who receives medical/surgical treatment in facilities governed by these regulations;

(w) "Qualified Counselor" means a person who assists the professional staff by talking with and informing patients regarding expectations and probable outcomes associated with services in an ambulatory surgical treatment center, and who possesses the following minimum qualifications: at least a bachelor's degree from an accredited college or university in nursing, psychology or social work, or in some related field, or who has special training in counseling which is deemed acceptable by the Department; provided, however, that any such counselor shall function only under the direct supervision of the responsible practitioner.

History

Authority: O.C.G.A. §§ 31-2-4et seq., and 31-7-1 et seq
History. Original Rule entitled "Definitions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.02 Exemptions {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.02}

The following types of health care facilities are exempt from the requirements of these regulations:

(a) currently licensed hospitals, or a facility as specified in 111-8-4-.03(12) ;

(b) a practitioner's private offices or treatment rooms in which a practitioner primarily sees, consults with, and treats patients;

History

Authority: O.C.G.A. §§ 31-2-7 and 31-7-1et seq
History. Original Rule entitled "Exemptions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.03 Organization and Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.03}

(1) Each ambulatory surgical treatment center shall be organized with an identifiable governing body that establishes the objectives, sets the policies and assumes full legal responsibilities for the overall conduct of the center and for compliance with all applicable laws and regulations pertaining to the center. The membership of the governing body shall be identified in the application to the Department for licensure.

(2) The ownership of the center shall be fully disclosed in the application to the Department. This disclosure shall include the names and addresses of all corporate officers and any person(s) having a five percent (5.0%) or more financial interest.

(3) The governing body of the center shall be responsible for appointing the professional staff and shall establish effective mechanisms for quality assurance and to ensure the accountability of the center's medical and/or dental staff and other professional personnel.

(4) The organizational objectives of the ambulatory surgical treatment center shall be clearly stated in the procedures and policies of the governing body and on the application for licensure.

(5) The governing body shall inform the Department of the name(s) of the administrator(s) to whom the responsibility for the day-to-day management of the center is delegated, including the implementation of rules and policies adopted by the governing body.

(6) Each center shall be at all times under the immediate personal and daily supervision and control of the administrator or his designated representative, whose authority, duties and responsibilities shall be defined in writing and which shall be available to the Department upon request.

(7) The Department shall be notified with a new application, or written amendment to the current application, when there are changes in location, ownership, management or operational objectives.

(8) Individual patients shall be discharged within twenty-four (24) hours of admission, in an ambulatory condition which will not endanger their continued well-being, or shall be transferred to a licensed hospital or other treatment facility. There shall be written procedures and assigned responsibilities for implementing such procedures, including provisions for transportation. Patients requiring emergency services shall be accompanied by a member of the professional staff of the center.

(9) Each center shall have an organized professional staff which is responsible for the development of patient care policies and procedures and for maintaining the level of professional performance through a continuing program of staff education, review and evaluation of patient care.

(10) Each center shall at all times have a professional director designated by the governing body, who shall be responsible for the direction and coordination of all professional aspects of the center programs.

(11) The practitioners applying for staff privileges shall be required to sign an agreement to abide by the staff bylaws and required State laws and rules and regulations.

(12) Nothing in these rules and regulations shall prevent a licensed hospital from organizing and providing an ambulatory surgical treatment service as a part of a licensed hospital under the controlling authority of a hospital board, so long as all hospital licensure standards are met and the provided services are included in the application under which the hospital license is granted.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Organization and Administration" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.04 Classification of Services {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.04}

Each ambulatory surgical center, when applying for a permit shall designate the type(s) or classification(s) of services to be provided in or by the center. These classifications may include, but are not necessarily limited to the following: general surgery; eye, ear, nose, and throat; plastic surgery; oral and maxillofacial; obstetrical-gynecological; oncological; ophthamological; and urological. Provided, however, that any facility providing labor and delivery services must meet the requirements of Rules and Regulations for Hospitals, Maternity and Obstetrical and Newborn Services, Rule 111-8-40-.34 or as later revised. The permit for a single ambulatory surgical treatment center may cover one or more types of services. Each ambulatory surgical treatment center shall provide only those services listed on the face of its permit.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Classification of Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.05 Application for Permits {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.05}

(1) Any person or persons responsible for the operation of an ambulatory surgical treatment center as defined and classified in these regulations, or who may hereafter propose to establish and operate such an institution, shall submit an application to the Department for a permit to operate said institution using forms provided by the Department. No such institution shall be operated in Georgia without a valid permit which shall be displayed in a conspicuous place within the center.

(2) The applicant for a permit to operate an ambulatory surgical treatment center shall submit a completed application with character references and a certification that the applicant is able and willing to comply with the minimum standards for an ambulatory surgical treatment center and with the rules and regulations lawfully promulgated. Each application shall be accompanied by a statement from the local (city or county) fire safety authority stating that an inspection has been made of the premises and that state and local fire safety requirements have been met.

(3) The application shall include full and complete information concerning the name and address of the applicant and the classification(s) of services to be provided; the ownership of the property and operation; in case a center is organized as a corporation, the names and addresses of each officer and director of the corporation; in case the center is organized as a partnership, the names and addresses of each partner; the identity of the professional director of the facility; the days and hours the center is normally operated; and any other information which the Department may require.

(4) Ambulatory surgical treatment centers are subject to review by the Department, pursuant to the Georgia Certificate of Need Law. Evidence of completion of this review shall be made a part of the application for a permit.

(5) Plans for ambulatory surgical treatment centers shall be submitted to the Department for review and approved in three stages of development:

(a) schematic drawings;

(b) design-development drawings; and

(6) A permit shall be issued to the person or persons named only for the premises listed on the application for licensure.

(7) Permits are not transferable or assignable.

(8) Changes in ownership shall be subject to notice requirements as specified in O.C.G.A.§ 31-6-40.1 . Each planned change of ownership or lease shall be reported to the Department thirty (30) days prior to such change with an application being submitted from the proposed new owners for a new permit.

(9) Separate applications and permits are required for centers maintained in separate premises, even though they are owned or operated by the same person(s), business or corporation, and may be doing business under the same title.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-6-40.1 and 31-7-1et seq
History. Original Rule entitled "Application for Permits" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.06 Permits {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.06}

(1) Following inspection and classification of the institution for which application for a permit has been made, the Department may issue a permit or a provisional permit or refuse to reissue or continue a permit or provisional permit. Each permit or provisional permit shall indicate the classifications of services to be provided and patient capacity of the center.

(2) Permits issued shall mean that the Department grants authorization to the governing body of the applicant institution to operate an ambulatory surgical treatment center and signifies compliance with these rules and regulations. Permits issued shall remain in force and effect until revoked or suspended.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Permits" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.07 Provisional Permits {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.07}

Provisional permits may be issued for a limited period specified by the Department based on an acceptable written plan for correcting one or more deficiencies (plan of correction) found during an inspection; provisional permits issued shall remain in force and effect for such limited period of time as specified by the Department, unless earlier revoked due to prevailing circumstances which are not acceptable to the Department. Centers which are established and operating prior to adoption of these rules and regulations may be considered for extension of a provisional permit when needed to meet physical plant standards. If the Department's decision is that a deficiency is of such nature that it would jeopardize the life of a patient, a provisional permit will not be issued.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Provisional Permits" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.08 Inspections {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.08}

(1) The ambulatory surgical treatment center shall be available at all reasonable and/or scheduled operating hours for observation and examination by properly identified representative of the Department.

(2) The governing body shall notify the Department of the anticipated opening date of a newly constructed center in order that a preopening licensure inspection of the center may be conducted to determine compliance with these rules and regulations.

(3) The administrator or his representative shall accompany the Department representative on all tours of inspection and shall sign the completed checklist.

(4) Each center shall be periodically inspected to determine whether the center is continuing to meet these requirements or is making satisfactory progress on approved plans of correction.

History

Authority: O.C.G.A. § 31-2-8
History. Original Rule entitled "Inspections" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.09 Professional Services {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.09}

(1) All services provided by or in the center shall be provided by persons who are currently licensed to perform the services they render when such services require licensure or registration under the laws of the State of Georgia. There shall be a sufficient number of qualified staff members to adequately provide for patient needs based on services provided and the number of patients served.

(2) Each center shall have a professional director who shall be a practitioner currently licensed in Georgia, and who shall be responsible for the direction and coordination of all medical aspects of the center program.

(3) General anesthesia shall be administered by an anesthesiologist, a physician anesthetist, an oral surgeon, or a certified R.N. anesthetist under the direction and responsibility of a currently licensed physician with training and experience in anesthesia, as specified in Georgia Code 84-10A. After administration of a general anesthetic, patients shall be constantly attended (at bedside) by a person qualified as above or by an R.N. until reactive and able to summon aid.

(4) All nursing services shall be under the supervision of a registered nurse (R.N.). Each center shall have a sufficient number of currently licensed nurses present and on duty to attend to patients at all times patients are receiving treatment or recovering from treatment up to and including the time of discharge. Additional staff shall be on duty and available to assist the professional staff to adequately handle routine and emergency patient needs.

(5) Each center shall establish written procedures for emergency services which will insure that a professional staff member who has been trained in emergency resuscitation procedures shall be on duty at all times when there is a patient receiving treatment or recovering from treatment, up to and including the time of discharge.

(6) The written procedures shall provide that an appropriate practitioner be designated on call and available to provide timely response to emergencies which may occur with any patient in the center.

(7) Each center shall have a hospital affiliation agreement and/or the medical staff must have admitting privileges or other acceptable documented arrangements to insure the necessary backup for medical complications. The center must have the capability to transfer a patient immediately to a hospital with adequate emergency room services.

(8) Each center will have effective policies and procedures for handling infection control and for recording complications which occur during or after surgery, which includes a reporting mechanism for patients who develop infections or postoperative complications after discharge.

(9) Either prior to, or at the time of admission, each patient who is admitted to the center without an appointment with a specified practitioner shall be provided (in writing) with the name, address and phone number of the practitioner who is serving him/her. The practitioner or a qualified counselor designated by the practitioner, shall explain the surgical and medical procedures, its potential complications, and postoperative complications and other alternatives to surgery; this shall be confirmed by the patient who shall sign an informed consent form as provided under O.C.G.A. § 31-9-1 et seq. Prior to dismissal, each patient shall be provided with both verbal and written instructions for posttreatment care and procedures for obtaining emergency care, if needed during the period of recuperation.

(10) All ancillary supportive health or medical services such as radiological services, pharmaceutical services, or clinical laboratory services provided in or by the center shall be in accordance with applicable rules and regulations of the State of Georgia.

(11) Each center shall establish policies for patient care and procedures for maintaining these policies.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Professional Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.10 Physical Plant and Operational Standards {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.10}

The following minimum physical plant and operational standards shall be met by an applicant or licensee as a prerequisite for the issuance and continuance of a permit to operate an ambulatory surgical treatment center. The failure of any licensee to comply with the minimum standards may result at any time in the denial, revocation, or suspension of licensure to operate an ambulatory surgical treatment center, pursuant to provisions of O.C.G.A. § 31-2-8, and these rules and regulations.

(a) Rooms and/or areas shall be planned and provided with sufficient space and equipment to provide for patient and visitor waiting area; presurgical examination and treatment; procedure rooms; patient recovery; and staff and administrative areas.

(b) The physical plant of the center shall meet all Federal, State and local laws, codes, ordinances, and regulations which apply to its location, construction, maintenance and operation.

(c) Equipment, electrical appliances, wiring, elevators, heating and cooling systems, surgery rooms and special service areas shall be constructed so as to assure the safety of all occupants. It shall be the responsibility of the governing body to assure that the center is in a safe condition at all times and that a fire inspection record is maintained on equipment, systems, and areas that may present a hazard to occupants.

(d) Except where additional requirements are specified herein, or are required by State or local ordinances or regulations, the construction of an ambulatory surgical treatment center shall meet the requirements for Health Care or Business Occupancies as specified in Chapter 10 and/or Chapter 13, as applicable, of the 1976 Life Safety Code, as currently adopted and amended by regulations of the Georgia Safety Fire Commissioner, Chapter 120-3-3, March 1, 1979, and subsequent revisions thereto.

(e) Entrances for patients shall be connected to the public right-of-way by a hardsurfaced, unobstructed walkway in good repair. Handicapped patients confined to a wheel chair or otherwise impaired shall be able to access the center building without climbing any stairs or steps. A ramp with handrails over existing stairs or steps may be utilized in meeting this requirement. A hard-surfaced, unobstructed road or driveway for use by ambulances or other emergency fire or police vehicles shall run from at least one entrance of the building to the public right-of-way. The doorway of such entrance shall be immediately adjacent to the road or driveway.

(f) Ambulatory surgical services provided in multistory buildings shall be accessible by an elevator of adequate size to accommodate date a standard wheeled litter patient and two attendants. A stairway or ramp of adequate dimensions shall be available for transfer of a patient in case of power failure.

(g) All procedure rooms shall be constructed, equipped, and maintained to assure the safety of patients and personnel. The following requirements shall apply within the patient treatment/procedure rooms and adjoining areas:

Procedure rooms shall be designed and located to prevent traffic through them to any other part of the center;
The walls and floors in procedure rooms shall be of material that will permit frequent washing and cleaning;
Sterilizing equipment shall be provided within the center and shall be convenient to the procedure rooms;
Staff dressing rooms and scrubup facilities shall be convenient to the procedure rooms, and shall include a knee or elbow operated scrub sink, soap dispenser, and brushes;
An equipment cleanup area with adequate plumbing, including a sink with counter, shall be provided outside the procedure room;
Enclosed storage facilities for sterile supplies and equipment shall be provided within the procedure areas;
Scrub clothing worn by personnel outside the procedure area shall be changed before returning to the procedure area;
Locations using flammable anesthetic agents shall comply with the following:

(i) Floors, furniture and equipment in operating rooms shall be of electrically conductive material. Conductive flooring shall extend into contiguous rooms and at least ten (10) feet into the entrance traffic area.

(ii) Clean conductive footwear testing device shall be maintained in the procedure rooms.

(iii) An anesthesia supply and equipment storage room shall be provided within the procedure area.

(iv) Separate storage enclosures shall be provided for flammable gases and combustion supporting gases. Such enclosures shall be constructed of building material with a fire resistive rating of at least one hour and shall not communicate directly with anesthetizing locations or each other. Air shall be adequately exhausted by gravity or spark proof forced ventilation from the flammable storage enclosure to the exterior of the building at a rate of not less than two (2) changes per hour. Storage enclosures for combustion supporting gases of less than 1500 cubic feet cylinder capacity need not be vented to the outside. Flammable materials such as fabrics, rubber and wood shall not be stored in these enclosures.

(v) Clothing generating large amounts of static electricity shall be prohibited in the procedure rooms.

Locations using flammable anesthetic agents shall be identified by prominently posted signs at all entrances to the procedure room and within the location signifying the type of anesthetics used.

(h) Toilet facilities shall be accessible to patients from the treatment, examining and recovery areas. Convenient handwashing facilities shall be provided for both staff and patients, and shall be provided with soap, disposable towels and dispensers. The use of common towels is prohibited.

(i) Emergency life support equipment shall be available for immediate use, in patient treatment areas. Such equipment shall include, but not necessarily be limited to the following: suction, IV fluids, oxygen, needles, intracatheters, medications, and ventilatory equipment such as ambu bags, oral and nasal airways and endotracheal tubes. Facilities providing general anesthesia shall also have a defibrillator and tracheotomy equipment and supplies.

(j) All medical gases shall be stored in accordance with Bulletin 56A of the National Fire Protection Association.

(k) All plumbing shall be designed and installed in accordance with State laws and local ordinances.

(l) The center shall be arranged and organized in such a manner as to ensure the comfort, safety, hygiene, privacy, and dignity of patients treated therein.

(m) Equipment for sterilizing instruments and supplies shall be conveniently located and of adequate capacity for the workload. Records shall be maintained to assure quality control, including date, time and temperature of each batch of sterilized supplies and equipment.

(n) Medicines shall be stored in a conveniently located cabinet with lock, and only licensed persons shall have access.

(o) Clean and soiled utility rooms shall be arranged and provided with equipment necessary for proper patient care, including sterilizers, storage cabinets and work counters.

(p) Each center shall provide one or more recovery rooms or areas staffed by qualified personnel. The recovery area shall be adequate for the numbers of patients scheduled. Separate recovery areas and/or cubicle curtains shall be provided for patient privacy, when appropriate.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Physical Plant and Operational Standards" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.11 Personnel {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.11}

(1) The governing body shall appoint an administrator who is responsible for the day-today management and operation of the center.

(2) The administrator shall designate an individual to act for him in his absence in order to provide the center with administrative direction at all times.

(3) All center personnel shall be currently licensed to perform the services they render when such services require licensure or registration under the laws of the State of Georgia.

(4) Each center shall require that each employee receives a health examination upon employment and a policy shall provide for follow-up examinations. The examination shall be in sufficient detail, including pertinent laboratory and x-ray data, to assure that the employee is physically and mentally qualified to perform the job to which he is assigned.

(5) There shall be a separate personnel folder maintained for each employee. This file shall contain all personnel information concerning the employee, including the application and qualifications for employment, physical examination (including laboratory and x-ray reports, if applicable), job description and attendance record.

(6) Fire and internal disaster drills shall be conducted at least quarterly and the results documented. There shall be an ongoing program of continuing education for all personnel concerning aspects of fire safety and the disaster plan for moving personnel and patients to safety, and for handling patient emergencies.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Personnel" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.12 Records {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.12}

(1) A full-time employee shall be designated responsible for establishing and maintaining medical records required to be kept by these rules and regulations.

(2) Medical records containing sufficient information to validate the diagnosis and to establish the basis upon which treatment is given shall be maintained on each patient. Contents of individual medical records shall normally contain the following at least:

(a) Admission and discharge data:

Name, address, birth date, sex, marital status, race, etc.
Date and time of admission.
Date and time of discharge.
Admitting diagnosis.
Final diagnosis.
Procedures or operations performed.
Condition on discharge.
Attending practitioner's signature.

(b) History and physical examination data:

Personal medical history (including all current medication that the patient is taking).
Family medical history.
Physical examination.
Psychiatric examination (if applicable).

Practitioner's orders.
Progress notes.
Nurse notes.
Medication.
Temperature-Pulse-Respiration (Graphic Chart; surgical purposes only).
Special examination(s) and reports (include x-ray and lab reports).
Signed informed consent form.
Operation record.
Anesthesia record (if applicable).
Consultation record (if applicable).
Tissue findings when performed.
Where dental services are rendered, a complete dental chart with dental diagnosis, treatment, prescription and progress notes shall be part of the clinical record.

(3) All orders on patients shall be signed by the practitioner giving them; admitting diagnosis (purpose of admission) shall be recorded prior to or at the time of admission.

(4) Medical records shall be preserved as original records, microfilms or other usable forms and shall be such as to afford a basis for complete audit of professional information. Centers shall retain all medical records, at least until the sixth anniversary of the patient's discharge. In the case of patients who have not attained majority at the time of the discharge, centers shall retain such records at least six (6) years after patient reaches age of majority. In the event a center shall cease operation, the Department shall be advised of the disposition and/or location of said records.

(5) The center shall collect, retrieve and annually summarize data from the medical record so that it may provide the Department with the following medical statistical information including:

(a) Number of visits by patients.

(b) Number of patients seen.

(d) Types and number of operative procedures performed.

(e) Age distribution of patients.

(f) Complications and emergencies.

(g) Number of times a patient was transferred from the center to a hospital.

(h) Pathological diagnosis.

(6) Patient records shall be current and shall be entitled to the same protection as provided for any medical records under Georgia law.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Records" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.13 Administrative Area and Waiting Rooms {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.13}

(1) Each center shall provide administrative space and facilities for admitting patients and other service, such as telephone and information office files and supplies, patients' personal belongings, medical records and files.

(2) A waiting room area shall be provided with a seating capacity to accommodate the number of patients and others of the public normally present in the facility at one time.

(3) The center shall have adequate and conveniently located toilets and handwashing facilities for its staff, employees, out-patients and visiting personnel.

History

Authority: O.G.C.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Administrative Area and Waiting Rooms" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.14 Clinical Laboratory Services {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.14}

(1) Laboratory services utilized by an ambulatory surgical treatment center shall be consistent with requirements of the Clinical Laboratory Licensure Law, O.C.G.A. § 31-22-1 et seq. , and applicable amendments and regulations, which provide for clinical laboratory services to be either licensed under Rules and Regulations of the State of Georgia, Chapter 111-8-10, or to be exempt from licensure as specified in the Clinical Laboratory Licensure Law. If exemption is claimed, the application shall state the name(s) of the practitioner(s) responsible for the operation of the clinical laboratory and there shall be an affidavit by the physician that he/she is responsible for the laboratory claims and the exemption.

(2) All removed tissues shall be examined immediately by the practitioner, whose findings shall be recorded in the patient's records, in addition to reports of pathologic examinations which may be obtained later.

(3) Laboratory services shall be provided for each patient, consistent with accepted medical practice and the conditions and needs of the patient. Laboratory reports shall be made a part of patient records.

(4) A system shall be established for the collection of information and all postoperative surgical complications and infections.

(5) The center shall report to the Department all communicable diseases detected or reported for patients.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-7-1et seq. and 31-22-1 et seq
History. Original Rule entitled "Clinical Laboratory Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.15 Housekeeping, Laundry, Maintenance and Sterile Supplies {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.15}

(1) Each center shall provide sufficient space and equipment and ensure that housekeeping and maintenance is sufficient to keep the center and equipment in a clean and tidy condition and state of good repair. Proper maintenance shall be provided as necessary to correct, prevent, or adjust faulty equipment and/or correct other undesirable conditions.

(2) Laundry service shall be provided. Separate space and facilities shall be provided for receiving, sorting and storing soiled laundry, and for sorting, storing and issuing of clean laundry, if reusable items are utilized.

(3) There shall be adequate space and facilities for receiving, packaging and proper sterilizing and storage of supplies and equipment, consistent with the services to be provided.

(4) Special precaution shall be taken to ensure that sterile instruments and supplies are kept separate from non-sterile instruments and supplies. Sterilization records shall be kept and sterile items shall be dated and utilized, based on established procedures.

(5) A recognized method of checking sterilizer performance shall be adopted.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Housekeeping, Laundry, Maintenance and Sterile Supplies" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.16 Drug Storage and Dispensing {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.16}

Each center shall provide adequate space and equipment and staff to assure that drugs are stored and administered in compliance with State and Federal laws and regulations.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Drug Storage and Dispensing" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.17 Blood Supply and Storage {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.17}

Each center which provides service for which blood is needed, shall provide separate refrigeration for the storage of blood and shall have a written agreement with a source for meeting its blood needs. If blood is retained overnight, such refrigeration shall be equipped with a temperature alarm device, and shall be tied in on an automatic emergency electrical power system. In all cases, refrigeration equipment shall be provided with a temperature recording device or the temperature shall be checked and recorded each day of use.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-7-1et seq. and 31-22-1 et seq
History. Original Rule entitled "Blood Supply and Storage" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.18 X-Ray {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.18}

All X-Ray facilities in the center shall be registered with and meet the requirements of rules and regulations of governing radiological health as promulgated by the Department. X-Rays and x-ray reports shall be made a part of the patient's record.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-7-1et seq. and 31-13-1 et seq
History. Original Rule entitled "X-Ray" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.19 Electrical Power {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.19}

(1) All electrical work and equipment shall be designed and installed in accordance with State and local laws and ordinances.

(2) All areas of the center shall have sufficient artificial lighting for designated purpose.

(3) Centers which utilize general anesthesia shall provide an emergency electrical system so controlled, that, after interruption of the normal electric power supply, an acceptable auxiliary power source is available and capable of being brought into use within ten seconds with sufficient voltage and frequency to reestablish essential in-house services and other emergency equipment needed to effect a prompt and efficient transfer of patients to an appropriate licensed hospital, when needed.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Electrical Power" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.20 Sanitation and Waste Disposal {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.20}

(1) All centers shall provide facilities for maintaining sanitary standards throughout the premises, as well as for water supply, sewerage, garbage and refuse, disposal systems. Such facilities shall meet local and State regulations.

(2) All garbage, trash and waste shall be stored and disposed of in a manner, by approved methods, that will not permit the transmission of disease, create a nuisance, or provide a breeding place for insects or rodents.

(3) Arrangements shall be made for proper disposal of all contaminate and/or infection dressings and surgical and obstetrical waste.

(4) Effective means shall be provided at all outside doors, windows and other openings to the center to prevent entrance and harborage of flies, other insects and rodents.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Sanitation and Waste Disposal" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.21 Advertising {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.21}

Any advertising of the services provided in or by ambulatory surgical treatment center shall include the full name of the center and its Georgia license number, as shown on the face of the permit.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Advertising" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.22 Waiver of Rule {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.22}

The Department may waive any rule for a stated period of time when it is shown that the specific rule is not applicable or when a waiver is needed to permit experimentation and demonstration of new and innovative approaches to the delivery of services which will not jeopardize the health and safety of the patients, staff or others utilizing the center. Results of such experimentation and demonstration projects shall be submitted to the Department as prescribed by the plan under which the waiver is approved. The Department shall maintain a record of and make available to interested persons information on all waivers granted under this rule.

History

Authority: O.C.G.A. § 31-2-7
History. Original Rule entitled "Waiver of Rule" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.23 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.23}

An ambulatory surgical treatment center which fails to comply with these rules and regulations shall be subject to revocation of its permit or provisional permit and/or other sanctions provided by law. The enforcement and administration of these rules and regulations shall be as prescribed in O.C.G.A. §§ 31-5-8, 31-5-9 and 31-2-8 which includes provision for:

(a) the misdemeanor penalty for violation of rules and regulations promulgated under this Title;

(b) injunctive relief under appropriate circumstances; and

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-7-1et seq. and 50-13-1 et seq
History. Original Rule entitled "Enforcement" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-4-.24 Applicability of Regulations {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.24 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.24}

These regulations are applicable only to ambulatory surgical treatment centers and the services provided therein, and expressly do not modify or revoke any of the provisions of the published rules of the Department of Community Health, Chapter 111-8-40 (Rules and Regulations for Hospitals) or of revisions which may be made to said regulations.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-7-1 et seq
History. Original Rule entitled "Applicability of Regulations" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Oct. 14, 2022; eff. Nov. 3, 2022.

Ga. Comp. R. & Regs. r. 111-8-4-.25 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-4-.25 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-4-.25}

In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof and such remaining rules or portions thereof shall remain in full force and effect, as if such rule or portions thereof so determined, declared or adjudged invalid or unconstitutional were not originally a part hereof. It is the intent of the Board of Community Health to establish rules and regulations that are constitutional and enforceable so as to safeguard the health and well-being of the people of the State.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Severability" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Subject 111-8-5 Anatomical Gifts

Ga. Comp. R. & Regs. r. 111-8-5-.01 Legal Authority {#sec-ga.-comp.-r.-regs.-r.-111-8-5-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-5-.01}

The legal authority for this chapter, unless otherwise noted, is "The Georgia Anatomical Gift Act," O.C.G.A. § 44-5-140.

History

Authority: O.C.G.A. §§ 31-2-5, 31-2-6, 31-2-7 and 44-5-140et seq
History. Original Rule entitled "Legal Authority" adopted. F. Feb. 19, 2013; eff. Mar. 11, 2013.

Ga. Comp. R. & Regs. r. 111-8-5-.02 Organization and Purpose {#sec-ga.-comp.-r.-regs.-r.-111-8-5-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-5-.02}

The purpose of these rules is to establish the requirements of "The Georgia Anatomical Gift Act" as it applies to the practices, procedures and criteria for making and routinely requesting anatomical gifts in hospitals.

History

Authority: O.C.G.A. § 44-5-140et seq
History. Original Rule entitled "Organization and Purpose" adopted. F. Feb. 19, 2013; eff. Mar. 11, 2013.

Ga. Comp. R. & Regs. r. 111-8-5-.03 Definitions, Unless Otherwise Indicated {#sec-ga.-comp.-r.-regs.-r.-111-8-5-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-5-.03}

(1) "Anatomical Gift" or "Gift" means a donation of all or part of a human body to take effect upon or after death.

(2) "Bank or Storage Facility" means an organ procurement organization or any other entity licensed or approved in the State of Georgia as a tissue bank, eye bank, or clinical laboratory which procures, stores, or processes human tissue designed to be used for medical purposes in human beings.

(3) "Decedent" means a deceased individual and includes a stillborn infant or fetus.

(4) "Department" means the Georgia Department of Community Health.

(5) "Document of gift" means a donor card, a statement attached to or imprinted on a motor operator's or chauffeur's license, a will, or other writing used to make an anatomical gift.

(6) "Donee" means the person that receives an anatomical gift.

(7) "Donor" means an individual who makes a gift of all or part of his body.

(8) "Enucleator" means an individual who is authorized to remove eyes.

(9) "Eye Bank" means a facility which is maintained and operated for the extraction, removal, care, storage, preservation, and use of human eyes or parts thereof for purposes of sight preservation or restoration, medical education, instruction pertaining to sight preservation, or restoration, or research and which is licensed by the Department for such purposes.

(10) "Hospital" means a hospital licensed, accredited, or approved under the laws of any state, although not required to be licensed under state laws, and includes hospitals operated by the United States government or by the state or a subdivision thereof.

(11) "Hospital Administrator" means the person in charge of a hospital.

(12) "Organ" means any heart, lung, pancreas, kidney, or liver.

(13) "Organ Procurement Organization" means an organization located in the State of Georgia that is designated by the Centers for Medicare and Medicaid Services of the federal Department of Health and Human Services under the end stage renal disease facility regulations to perform or coordinate the performance of all of the following services:

(a) procurement of donated kidneys;

(b) preservation of donated kidneys;

(d) maintenance of a system to locate prospective recipients of procured organs. An organ procurement organization may also perform those services for extrarenal vital organs and includes any organization certified by the federal Department of Health and Human Services as an organ procurement organization.

(14) "Part" means organs, tissues, eyes, bones, arteries, blood and other fluids, and any other portions of a human body. The term "part" also means a heart pacemaker.

(15) "Person" means an individual, corporation, government or governmental subdivision or agency, business trust, estate, trust partnership or association, or any other legal entity.

(16) "Physician" or "Surgeon" means a physician or surgeon licensed or authorized to practice under the laws of any state.

(17) "State" means any state, district, commonwealth, territory, insular possession, and any other area subject to the legislative authority of the United States of America.

(18) "Technician" means an individual authorized by a bank or storage facility to remove or process an anatomical gift, excluding the removal of organs for transplantation.

(19) "Tissue Bank" means a facility which provides through its ownership or operation for the storage of human or animal tissues designed to be used for medical purposes in human beings and which is licensed by the department as a clinical laboratory.

History

Authority: O.C.G.A. §§ 31-1-6, 31-22-1(2), 31-23-1(1), 44-5-140et seq
History. Original Rule entitled "Definitions, Unless Otherwise Indicated" adopted. F. Feb. 19, 2013; eff. Mar. 11, 2013.

Ga. Comp. R. & Regs. r. 111-8-5-.04 Permissible Donees and Purposes of Anatomical Gifts {#sec-ga.-comp.-r.-regs.-r.-111-8-5-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-5-.04}

The following persons may become donees of anatomical gifts for the purposes stated:

(a) Any hospital, surgeon, or physician, for medical or dental education, research, advancement of medical or dental science, therapy, or transplantation;

(b) Any accredited medical or dental school, college, or university for education, research, advancement of medical or dental science, or therapy;

(c) Any bank or storage facility, for medical or dental education, research, advancement of medical or dental science, therapy, or transplantation; or

(d) Any specified individual, for therapy or transplantation needed by him.

History

Authority: O.C.G.A. § 44-5-140et seq
History. Original Rule entitled "Permissible Donees and Purposes of Anatomical Gifts" adopted. F. Feb. 19, 2013; eff. Mar. 11, 2013.

Ga. Comp. R. & Regs. r. 111-8-5-.05 Permissible Donors {#sec-ga.-comp.-r.-regs.-r.-111-8-5-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-5-.05}

(1) Any individual who is 18 years of age or older and of sound mind may give all or any part of his body for any purposes specified in Rule .04 of this Chapter, the gift to take effect upon death.

(2) The parents, legal guardians, or other persons authorized or obligated to dispose of the body may, unless otherwise directed by a will, give all or any part of the body of a person who is under 18 years of age for any purpose specified in Rule .04 of this Chapter, the gift to take effect upon death.

(3) Persons listed at Rule .07(1)(c)1. and .07(1)(c)2. of this Chapter may give all or any part of a decedent's body for any purposes specified in Rule .04 of this Chapter.

History

Authority: O.C.G.A. § 44-5-140et seq
History. Original Rule entitled "Permissible Donors" adopted. F. Feb. 19, 2013; eff. Mar. 11, 2013.

Ga. Comp. R. & Regs. r. 111-8-5-.06 Hospital Admissions {#sec-ga.-comp.-r.-regs.-r.-111-8-5-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-5-.06}

(1) Upon admission to any hospital, a person, at his request, may make an expression of his intention regarding the disposition of his body. Such expression shall be deemed to be sufficient notice under O.C.G.A. § 44-5-140 and this Chapter not to be contravened by opposition from persons listed in Rule .07(1)(c)1. and .07(1)(c)2. of this Chapter.

(2) Hospitals shall assure that written policies and procedures are established, implemented, and maintained for recording such expressions and effective appropriate dispositions in accordance with the expressed intentions of the persons who make the requests.

History

Authority: O.C.G.A. § 44-5-140et seq
History. Original Rule entitled "Hospital Admissions" adopted. F. Feb. 19, 2013; eff. Mar. 11, 2013.

Ga. Comp. R. & Regs. r. 111-8-5-.07 Routine Requests on or Before the Occurrence of Death in Hospitals {#sec-ga.-comp.-r.-regs.-r.-111-8-5-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-5-.07}

(1) All hospitals shall establish, implement, and maintain written policies and procedures for requesting anatomical gifts on or before the occurrence of death in hospitals. The primary purpose of such policies and procedures shall be to inform persons specified in Rule .07(1)(c)1. and .07(1)(c)2. of their options of making anatomical gifts when previous expressed intentions have not been made either upon admission to the hospital or by document of gift. Such policies and procedures shall include a written agreement with a bank or storage facility and shall, at a minimum, include the following provisions:

(a) Screening and Identification of Potential Donors. Before initiating requests for anatomical gifts it must be determined that the body or parts are suitable for donation pursuant to the criteria at Rule .10 of this Chapter.

(b) Procedures for Notifying Bank or Storage Facilities of Potential Donors. If it is determined that a body or parts are suitable for donation, the hospital administrator or designated representatives shall contact the concerned bank or storage facility. However, such notification shall only be made in the absence of actual notice of contrary indications by the decedent, or in the absence of actual notice of opposition by a member of the same or prior classes specified in Rule .07(1)(c)1. and .07(1)(c)2. of this Chapter, and when persons in such prior classes are not available.

(c) Procedures for Making Requests. Actual request for donations must be made by the notified bank or storage facility and shall only be made if consent would yield a suitable donation. However, hospitals may enter into written cooperative agreements with one or more bank or storage facilities, under which agreements designated hospital staff, including physician or surgeons, may make requests as the authorized agents or representatives of the bank or storage facility. Such requests, whether made by hospital staff or the notified bank or storage facility, shall be made in the following manners:

For individuals 18 years of age or older, any of the following persons, in order of priority stated, may be requested to give all or any part of the decedent's body for any purposes specified in Rule .04 of this Chapter.

(i) any person having the power to permit an anatomical gift of all or part of the body of the decedent if such power is granted pursuant to a health care agency created under Chapter 32 of Title 31, the Georgia Advance Directive for Health Care Act.

(ii) the spouse;

(iii) an adult son or daughter;

(iv) either parent;

(v) an adult brother or sister;

(vi) a grandparent;

(vii) a guardian of the person of the decedent at the time of his death other than a guardian ad litem appointed for such purpose; or

(viii) any other person authorized or under obligation to dispose of the body.

For individuals under 18 years of age, any of the following persons, in order of priority stated, may be requested to give all or any part of the decedent's body for any purposes specified in Rule .04 of this Chapter.

(i) both parents;

(ii) if both parents are not readily available and no contrary indications of the absent parent are known, one parent;

(iii) if the parents are divorced or legally separated, the custodial parent;

(iv) in the absence of the custodial parent, when no contrary indications of the absent parent are known, the noncustodial parent;

(v) if there are no parents, any grandparent;

(vi) if there are no parents readily available or any grandparents, the legal guardian; or

(vii) any other person authorized or obligated to dispose of the body.

Consent or refusal must be obtained from persons in the highest priority class available.
Consent shall be made by a document signed by the person making the gift or by his telegraphic, recorded telephonic, or other recorded message.

(d) Recordkeeping. The hospital administrator or designated representative shall record in a book any notification to a concerned bank or storage facility about a potential donor; whether, if appropriate, a request for a consent to a gift was made; whether or not consent was granted; and the name of the person granting the consent and his or her relationship to the decedent.

(2) Persons authorized in Rule .07(1)(c)1. and .07(1)(c)2. of this Chapter may make the gift after or immediately before death.

(3) If during the process of a routine request, the donee has actual notice of contrary indications by the decedent or actual notice that a gift made by a member of a class is opposed by a member of the same or prior class listed at Rule .07(1)(c)1. and .07(1)(c)2. of this Chapter, then the donee shall not accept the gift.

(4) In the absence of a specification by a decedent or a person authorized in Rule .07(1)(c)1. and .07(1)(c)2. to give all or part of the decedent's body, any bank or storage facility that becomes the donee of any part of the decedent's body shall give preference to potential recipients of that donation of such body part, other than an organ of the decedent, who are residents of Georgia if: the donation is medically acceptable to the potential recipients who are residents of Georgia; potential recipients who are residents of other states are not in greater need of the donation than potential recipients who are residents of Georgia; and the requisite medical procedure required for the potential recipient to receive the donation will be performed in Georgia.

(5) A gift of all or part of a body authorizes any examination necessary to assure medical acceptability of the gift for the purposes intended.

(6) The rights of the donee created by the gift are paramount to the rights of others except nothing in these rules shall restrict the power of a coroner or medical examiner to limit an anatomical gift of all or part of a person's body when a medical examiner's inquiry is required of that person's death pursuant to O.C.G.A. § 45-16-24 and nothing in these rules shall restrict legal prescribing powers and duties with respect to autopsies.

History

Authority: O.C.G.A. § 44-5-140et seq
History. Original Rule entitled "Routine Request on or Before the Occurrence of Death in Hospitals" adopted. F. Feb. 19, 2013; eff. Mar. 11, 2013.

Ga. Comp. R. & Regs. r. 111-8-5-.08 Certain Physicians not to Participate in Removing or Transplanting Parts {#sec-ga.-comp.-r.-regs.-r.-111-8-5-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-5-.08}

(1) The following physicians shall not participate in the procedures for removing or transplanting parts:

(a) The physician who becomes a donee;

(b) The attending physician of the donor at his death or, if there is no attending physician, the physician who certifies the death.

(2) However, a document of gift may designate the surgeon or physician who shall carry out the appropriate procedures. In the absence of a designation or if the designee is not available, the donee or other person authorized to accept the gift may employ or authorize any surgeon or physician for the purpose. A physician or surgeon so designated, employed, or authorized to carry out such procedures may authorize any other person to perform such procedures if such person is:

(a) so trained in those procedures;

(b) so authorized by the appropriate bank or storage facility to perform those procedures; and

a physician's assistant;
a registered professional nurse;
a licensed professional nurse;
a technician; or
when the procedure involves only the human eye, an enucleator.

History

Authority: O.C.G.A. § 44-5-140et seq
History. Original Rule entitled "Certain Physicians Not to Participate in Removing or Transplanting Parts" adopted. F. Feb. 19, 2013; eff. Mar. 11, 2013.

Ga. Comp. R. & Regs. r. 111-8-5-.09 Delivery of Donations from Receiving Hospitals to Permissible Donees {#sec-ga.-comp.-r.-regs.-r.-111-8-5-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-5-.09}

Hospitals shall establish, implement, and maintain appropriate hospital policies and procedures for assisting bank or storage facilities or other permissible donees in the delivery of donations to potential recipients. Such assistance shall include the use of available hospital services, equipment, and supplies. Hospitals shall be reimbursed by the donee for reasonable charges incurred in the provision of such assistance.

History

Authority: O.C.G.A. § 44-5-140et seq
History. Original Rule entitled "Delivery of Donations from Receiving Hospitals to Potential Recipients" adopted. F. Feb. 19, 2013; eff. Mar. 11, 2013.

Ga. Comp. R. & Regs. r. 111-8-5-.10 Suitability of Anatomical Gifts {#sec-ga.-comp.-r.-regs.-r.-111-8-5-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-5-.10}

(1) A gift authorizes any examination necessary to assure medical suitability of the gift for the intended purposes. The suitability of anatomical gifts shall be determined by attending physicians or surgeons and may be made in conjunction with applicable types of banks or storage facilities. Factors which must be considered in determining suitability shall include age, etiology of death, length of cardiac arrest, and infection or disease. All determinations shall be based upon existing, acceptable medical criteria related to the specific donation and its purpose, as established by the United Network for Organ Sharing, the Southeastern Organ Procurement Foundation, the Organ Procurement and Transplant Network, the American Association of Tissue Banks, and the Eye Bank Association of America, respectively. Hospitals shall be reimbursed by the donee for reasonable charges incurred in doing necessary laboratory work for donor evaluations and suitability determinations when the donee has requested the laboratory work, regardless of whether the donee receives an anatomical gift.

(2) Any permissible donee shall subject or have subjected all human body parts, or the potential donors of such parts, to a HIV test prior to making such parts available for use in the body of another human being. No parts found to be infected or no other parts of a donor found to be infected shall be used in the body of another human.

(3) Unless used for medical research, all HIV infected tissue or organs retrieved from a donor shall be incinerated.

(4) When a human body part or a donor is determined to be HIV infected, the permissible donee that provided or provided for the testing shall:

(a) Provide personal and confidential notification to a living donor from whose body the part was removed if the donee's records identify where the donor is located.

(b) Provide personal and confidential notification to any known physician licensed in Georgia of a deceased donor; such physician shall then have the sole discretion to determine whether to notify the persons who executed the gift or any other persons who were at risk of being infected with HIV by the decedent.

(5) In a medical emergency constituting a serious threat to the life of a potential recipient of blood, if blood that has been subjected to the HIV testing as required by Rule .10(2) is not available, the testing otherwise required by Rule .10(2) shall not be required regarding such blood.

History

Authority: O.C.G.A. § 44-5-140et seq
History. Original Rule entitled "Suitability of Anatomical Gifts" adopted. F. Feb. 19, 2013; eff. Mar. 11, 2013.

Ga. Comp. R. & Regs. r. 111-8-5-.11 Training {#sec-ga.-comp.-r.-regs.-r.-111-8-5-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-5-.11}

(1) Persons making requests for anatomical gifts shall relate to donors and families in a sensitive and caring manner and shall have received suitable training in the following areas:

(a) psychological and emotional considerations when dealing with bereaved families;

(b) social, cultural, ethical and religious factors affecting attitudes toward donations;

(c) procedures for declaring death and collecting and preserving organs, tissues and/or other body parts, and how these procedures are to be explained to decedents' families.

(d) general medical concepts and issues in organ, tissue, and eye donations;

(e) procedures for notifying and involving banks or storage facilities;

(f) procedures for recording the outcome of requests.

(2) Any cooperative agreement between a hospital and bank or storage facility developed in accordance with Rule .07(1) of this Chapter shall include provisions for suitable training of appropriate hospital staff by the bank or storage facility. Such training shall be provided to any staff members designated to request anatomical gifts.

History

Authority: O.C.G.A. § 44-5-140et seq
History. Original Rule entitled "Training" adopted. F. Feb. 19, 2013; eff. Mar. 11, 2013.

Subject 111-8-7 Rules and Regulations for Birth Centers

Ga. Comp. R. & Regs. r. 111-8-7-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.01}

Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning hereinafter respectively ascribed to them:

(a) "Administrator" means the individual who is responsible for the day to day management of the center.

(b) "Birth Center", "Birthing Center" or "Center" means a facility, other than the laboring woman's legal residence, which admits persons for the purpose of childbearing and which facility has not been classified and licensed by the Department as a hospital.

(d) "Certified Nurse Midwife" means an individual who is a Registered Nurse currently licensed in the State of Georgia and who is also certified by the American College of Nurse Midwives.

(e) "Department" means the Georgia Department of Community Health.

(f) "General Anesthesia" means any drug, element or other material which is administered to eliminate all sensation and which, when administered, is accompanied by a state of unconsciousness.

(g) "Governing Body" or "Management" means the board of directors, trustees, partnership, corporation, association, or person or group of persons who maintain and control the operation of the center and who are legally responsible for its operation.

(h) "Hospital" means any facility which meets the requirements of and is currently licensed as a hospital under the provisions of OCGA Chapter 31-7, Article 1, and is in compliance with all rules and regulation of the Department pertaining to Maternity, Obstetrics and Newborn services.

(i) "Local Anesthesia" means any drug which, when administered, provides localized temporary loss of sensation, but not accompanied by a state of unconsciousness.

(j) "Low Risk Patient" means an individual who:

is in general good health with uncomplicated prenatal course;
is participating in an ongoing prenatal care and education program;
has no major medical problems;
has no significant signs or symptoms of hypertension, toxemia, hydramnios, abruptio placenta, chorioamnionitis, malformed fetus, multiple gestation, intrauterine growth retardation, fetal meconium, fetal distress, alcoholism, or drug addiction, Rh or other blood group antigen sensitization;
has no history of fetal wastage or premature delivery;
has no previous significant obstetrical complications likely to recur, nor previous uterine wall surgery or Caesarean section;
has parity under six unless a justification for a variation is documented by clinical staff;
is not a nullipara of greater than thirty six years of age;
is not less than sixteen years of age at onset of pregnancy;
is appropriate for a setting where anesthesia is limited to local infiltration of the perineum, or a pudendal block, and analgesia is limited;
while in active labor:

(i) demonstrates no significant signs, or symptoms, or evidence of anemia, significant hypertension, placenta previa, malpositioned fetus or breech;

(ii) is progressing normally;

(iii) is without prolonged ruptured membranes; and

(iv) is not in premature labor.

is not postmature.

(k) "Patient" means any woman who receives antepartum, intrapartum and postpartum care, or any newborn who receives medical care, in facilities governed by these regulations.

(l) "Permit" or "License" means an authorization granted by the Department to the Governing Board to operate a birth center.

(m) "Physician" means an individual who is currently licensed to practice medicine in the State of Georgia and is board certified or board eligible in obstetrics, family practice or pediatrics.

(n) "Plan of Correction" means an acceptable written plan submitted to the Department by the person or persons responsible for the center and which states proposed procedures and methods to correct the areas of non-compliance within an acceptable time frame.

(o) "Practitioner" means a physician or a certified nurse midwife.

(p) "Professional Staff" means the group of physicians, certified nurse midwives, other registered nurses, licensed practical nurses and other health professionals who require special licensure, certification or registration, who provide patient services at the center.

(q) "Provisional Permit" means an authorization granted by the Department to operate a birth center on a conditional basis in order to allow a newly established center a reasonable but limited period of time, as determined by the Department, to demonstrate that operational procedures are in satisfactory compliance with these rules and regulations, or to allow an established and operating center a specific length of time to comply with these regulations, provided said center shall first present an acceptable plan of correction.

(r) "Regional Anesthesia" means any drug, element or other material which, when administered, is accompanied by temporary sectional loss of sensation.

(s) "Special Care Capability" means availability of on-site equipment for use in providing emergency care to adult and newborn patients.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Definitions" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.02 Application for Permits {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.02}

(1) The governing body shall submit an application to the Department for a permit using forms provided by the Department. No center shall be operated in Georgia without a valid permit which shall be displayed in a conspicuous place within the center. Failure or refusal by the governing body of any facility existing at the time these rules become effective to file an application for a permit within ninety (90) days shall constitute a violation of law and shall be dealt with as provided by law.

(2) The applicant for a permit to operate a birth center shall submit a completed application and a certification that the applicant is able and willing to comply with the minimum standards for a birth center and with the rules and regulations lawfully promulgated. Each applicant shall be responsible for complying with applicable fire safety laws and shall present evidence of such compliance, prior to receiving a permit.

(3) The application shall include complete information concerning the name and address of the applicant and the services to be provided; the ownership of the property and operation; if organized as a corporation, the names and addresses of each officer and members of the board of directors of the corporation; if organized as a partnership, the names and addresses of each partner; the identity of the medical director of the facility; and any other information which the Department may require.

(4) The applicant shall submit evidence of approval from the State Health Planning and Development Agency, as a part of the application to the Department for a permit.

(5) Plans for birth centers shall be submitted to the Department for review and approval in two stages of development:

(a) schematic drawings; and

(b) final working drawings and specifications.

(6) A permit shall be issued to the person or persons named only for the premises listed on the application for licensure.

(7) Permits are not transferable or assignable.

(8) Changes in ownership shall be subject to prior review and approval as required by the Department. Each planned change of ownership or lease shall be reported to the Department at least sixty (60) days prior to such change along with an application from the proposed new owners for a new permit.

(9) The Center shall file a new application, prior to change in ownership or location. A written amendment to the current application shall be filed when there is a change in management or operational objectives.

(10) Separate applications and permits are required for centers maintained in separate premises, even though they are owned or operated by the same person(s), business or corporation, and may be doing business under the same title.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Application for Permits" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.03 Permits {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.03}

(1) Following inspection and evidence of compliance with these regulations, the Department may issue a permit. Each permit shall indicate the classifications of services to be provided and patient capacity of the center.

(2) Permits issued shall remain in force and effect until revoked or suspended for failure to comply with these rules and regulations.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Permits" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.04 Provisional Permits {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.04}

Provisional permits may be issued by the Department for a time specific period based on an acceptable written plan for correcting deficiencies (plan of correction) found during an inspection. Provisional permits may be revoked by the Department due to prevailing circumstances which are not acceptable to the Department. Centers which are established and operating prior to adoption of these rules and regulations may be issued provisional permits when additional time is needed to meet physical plant standards.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Provisional Permits" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.05 Inspections {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.05}

(1) The center shall be open at all reasonable hours for observation and examination by properly identified representatives of the Department.

(2) The governing body shall notify the Department of the anticipated opening date of a newly constructed center in order that a pre-opening licensure inspection of the center may be conducted to determine compliance with these rules and regulations.

(3) The administrator (or a designated representative) shall accompany the Department representative on all tours of inspection and shall sign the completed inspection report.

(4) The center may be inspected at the discretion of the Department to determine whether it is continuing to meet these requirements or is making satisfactory progress in accordance with approved plans of correction.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-5-21; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Inspections" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.06 Organization and Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.06}

(1) The birth center shall be organized with an identifiable governing body which is responsible for establishing objectives and policies and which assumes full legal responsibilities for the overall conduct of the center, including compliance with laws and regulations pertaining to the center. The governing body and its membership shall be identified in the application for licensure.

(2) The ownership of the center shall be fully disclosed in the application. This disclosure shall include the names and addresses of all corporate officers and any person(s) having a five percent (5.0%) or more financial interest in the center.

(3) The governing body shall be responsible for professional staff appointments, shall establish effective mechanisms for quality assurance, and shall ensure the accountability of the professional staff.

(4) The organizational objectives of the center shall be clearly stated in the policies and procedures of the center.

(5) The governing body shall appoint an administrator and shall notify the Department of such person's name.

(6) The center shall be at all times under the personal and daily supervision and control of the administrator (or a designated representative) whose authority, duties and responsibilities shall be defined in writing. This information shall be available to the Department on request.

(7) The center shall be available for occupancy twenty-four (24) hours per day, with professional staff on call at all times.

(8) Criteria for admission to the center shall be clearly identified in the center's policies. The admission policy shall be submitted with the application for licensure. At a minimum, admission criteria shall include a provision that only low-risk patients will be admitted and that there will be no discrimination according to race.

(9) Each patient shall be provided with a copy of the fee schedule and policy regarding payment.

(10) Admissions to the center shall be restricted to low-risk patients who have received antepartum care in accordance with the facility's policies. The center's policies and procedures regarding management of complications shall be explained by a staff physician or certified nurse midwife.

(11) The center shall have written policies and procedures for antepartum, intrapartum, postpartum and newborn care including physician consultation, referral, transfer and transport to the hospital and registration of vital records. A written procedure shall be established to maintain these policies.

(12) The center shall have a written policy regarding visitation or attendance during the birth process.

(13) The mother and newborn shall be discharged within twenty-four (24) hours after delivery, in a condition which will not endanger the well-being of either the mother or newborn, or shall be transferred to a licensed hospital. The mother and newborn will be discharged in the care of another responsible adult who will assist in their transport from the birth center.

(14) The center shall have an organized professional staff which is responsible for the development of patient care policies and procedures and for maintaining the level of professional performance through a continuing program of staff education, and review and evaluation of care. Records of staff attendance at educational programs shall be maintained.

(15) The center shall have a medical director who is a physician, designated by the governing body, who shall be responsible for the direction and coordination of all professional aspects of the center's program.

(16) Practitioners applying for center privileges shall sign an agreement to abide by the center's policies and procedures.

(17) The center shall have specific policies and procedures for infection control, which include a mechanism for reporting to the Department those infections which develop within six (6) weeks after discharge of the patient from the center, using forms provided by the Department.

(18) The center shall submit annually to the Department a statistical summary of morbidity and mortality data on forms supplied by the Department.

(19) Nothing in these rules and regulations shall prevent a licensed hospital from organizing and providing a birth center as an integral part of its facility, so long as the provided services are included in the application under which the hospital license is granted.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Organization and Administration" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.07 Transfer and Transport Capability {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.07}

(1) Each birth center shall have a written hospital affiliation agreement with an acute care hospital with at least Level III perinatal services within a reasonable distance from the birth center or the medical staff at the birth center shall have admitting privileges or other acceptable documented arrangements with such acute care hospital to ensure the necessary backup for the birth center for medical complications.

(2) Each birth center shall have a written agreement with the acute care hospital for acceptance and examination of laboratory specimens to expedite treatment, prior to formal admission procedures.

(3) The center shall have the capability to transfer and transport the adult and/or newborn patients immediately to the acute care hospital within a reasonable distance from the birth center. Documentation of each transfer shall be maintained by the center to substantiate to the Department that it has met this requirement.

(4) The center shall have a written contract with a licensed ambulance service which will assure timely response.

History

Authority: O.C.G.A. §§ 31-2-4, 31-7-1, Chapter 31-7, Article 1
History. Original Rule entitled "Transfer and Transport Capability" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.
Amended: F. Apr. 21, 2026; eff. May 11, 2026.

Ga. Comp. R. & Regs. r. 111-8-7-.08 Professional Services {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.08}

(1) All services provided by or in the center shall be performed by persons who are appropriately licensed or certified to perform such services in accordance with the laws of the State of Georgia. There shall be qualified staff members to provide for patient needs. At least one physician, certified nurse midwife or registered nurse shall be present at all times that the facility is open whenever a patient (mother or new born) is in the facility.

(2) All services shall occur within a health care system which provides for medical consultation, collaborative management or referral.

(3) All intrapartal services shall be under the direct supervision of a physician or a certified nurse midwife. At least one other member of the professional staff shall also be present at each delivery.

(4) The center shall establish written policies and procedures for emergency services to patients and shall require each professional staff member to receive instruction in emergency treatment of adult and infant patients, upon employment and at least annually thereafter.

(5) Each medical staff member shall have admitting privileges or a written agreement with a staff physician to provide services at the contract hospital. Documentation to show compliance with this requirement shall be maintained in the center.

(6) Definite means of identification shall be applied to every infant immediately after birth. Such identification shall remain on the infant until discharged. The permanent records of each newborn shall include footprints.

(7) The center shall have written policies and procedures to ensure (a) metabolic screening of all newborns within one week of age, (b) assessment of newborn status, including Apgar score at one and five minutes, (c) prevention of eye infection, (d) umbilical cord care, and (e) periodic observation and assessment after birth until the infant's condition is stable. These policies shall be developed in consultation with a pediatrician.

(8) Policies, procedures and facilities shall be provided for proper collection, storage and laboratory testing of cord blood for necessary studies on Rh Negative and O Positive mothers and a supply of Rhogam or other appropriate treatment material shall be readily available for use when needed.

(9) Prior to discharge, each newborn shall be examined by a physician.

(10) Verbal and written instructions shall be provided for observation and care of both the mother and newborn after discharge.

(11) A joint conference involving physicians, nurses, representatives of administration and other health personnel responsible for obstetric and newborn care shall be conducted at least quarterly to discuss morbidity and mortality. All fetal and newborn deaths and transfers occurring within the interval since the previous conference shall be reviewed. Minutes shall be kept of the meetings and shall be available to the Department.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Professional Services" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.09 Personnel {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.09}

(1) The center shall require that each employee receives a health examination up on employment. The examination shall be in sufficient detail, including pertinent laboratory and tuberculosis screening, to assure that the employee is able to perform assigned tasks. The center shall have a policy for monitoring the health status of employees.

(2) There shall be a separate personnel folder maintained for each employee. This personnel file shall contain all pertinent information concerning the employee, including the application for employment and qualifications for employment, verifications of physical examinations, job description and a copy of current Georgia license for those required to be licensed.

(3) There shall be an on-going program of continuing education for all personnel. This shall include aspects of fire safety and the disaster plan for moving personnel and patients to safety and for handling patient emergencies.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Personnel" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.10 Health Services Information System {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.10}

(1) The birth center shall establish and maintain an organized health services information system for the collection, processing, maintenance, storage and retrieval of information concerning health services received by the patient.

(2) An individual medical record shall be maintained within the system for each patient, and shall include the following data:

(a) Identification-name, address, identifying number, date of first visit, age or birth date, sex, marital status, occupation, telephone number, and name and telephone number of a person to contact in event of an emergency;

(b) An initial health evaluation including a chronological record of past medical history, drug use profile, personal and family history and results of physical examinations, including laboratory and x-ray reports;

(d) Clinical diagnosis or impression, studies ordered, treatment given, disposition, recommendations, and instructions to patient, complete with a progress note for each follow-up visit.

(3) The system shall be kept current and available to staff or agencies authorized to use the system.

(4) Medical records shall be preserved as original records, microfilms or other usable forms and shall be such as to afford a basis for complete audit of professional information. Centers shall retain all medical records or shall assure that they are maintained in a manner acceptable to the Department at least until the sixth anniversary of the patient's discharge. In the case of patients who have not attained majority at the time of the discharge, centers shall retain such records for at least six (6) years after the patient reaches age of majority. In the event a center shall cease operation, the Department shall be advised of the location of said records.

(5) Sufficient space and equipment for record processing, storage and retrieval shall be provided.

(6) Policies and procedures shall be written and implemented to assure organization and continuous maintenance of the health information system.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Health Services Information System" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.11 Clinical Laboratory Services {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.11}

If laboratory services are provided on site, the laboratory shall be licensed under the provisions of the Georgia Laboratory Licensure Law of 1970, O.C.G.A. Chapter 31-22, and applicable rules and regulations.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1; O.C.G.A. Chapter 31-22
History. Original Rule entitled "Clinical Laboratory Services" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.12 Drug Storage and Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.12}

(1) Each center shall provide adequate space and equipment and staff to assure that drugs are stored and administered in compliance with State and Federal laws and regulations.

(2) No drugs shall be dispensed at the facility unless pharmacy regulations are met.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Drug Storage and Administration" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.13 Food Service {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.13}

If food services are provided, the facility must comply with Georgia Laws and Food Services Rules and Regulations of the Department.

History

Authority: O.C.G.A. Chapter 26-2, Article 13; O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Food Service" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.14 Anesthesia {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.14}

General or regional anesthesia shall not be utilized in a birth center. Local or pudendal anesthesia is permitted.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Anesthesia" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.15 Physical Plant and Operational Standards {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.15}

The following minimum physical plant and operational standards shall be met:

(a) The center shall provide sufficient space and equipment for patient and visitor waiting area, examination and treatment rooms, birth rooms, special care capability, and for staff and administrative areas. Birthrooms shall each have at least 100 square feet of area, exclusive of bathroom, toilet or entry way, and be designed and located to prevent traffic through them to any other part of the center.

(b) The Department may deny the center a permit if it does not comply with Federal, State and local laws, codes, ordinances, and regulations which apply to its location, construction, maintenance and operation.

(c) It shall be the responsibility of the governing body to assure that the center is in a safe condition at all times, and that a fire inspection record is maintained on equipment, systems, and areas that may present a hazard to occupants.

(d) Fire and internal disaster drills shall be conducted at least quarterly and the time of the drill and results documented.

(e) In addition to requirements specified herein, and those required by local ordinances or regulations, the construction of a birth center shall meet the requirements of the Georgia Safety Fire Commissioner, Chapter 120-3-3,* March 1, 1979, and subsequent revisions thereto. Applications for licensure shall be accompanied by written evidence that these requirements have been met.

(f) Entrances for patients shall be connected to the public right-of-way by a hard-surfaced, unobstructed walkway in good repair. Access for handicapped individuals shall be provided at a minimum of one entrance. A hard-surfaced, unobstructed road or driveway for use by ambulances or other emergency vehicles shall run from at least one entrance of the building to the public right-of-way. The doorway of such entrance shall be immediately adjacent to the road or driveway. If such doorway is not on the same level as the road, a ramp shall provide a continuous, unobstructed plane to the entrance.

(g) Services provided in multi-story buildings shall be accessible by an elevator of adequate size to accommodate a standard wheeled litter patient and two attendants. Multi-story buildings will be considered to have met this requirement when patients are located only on ground level floors with outside exits. A stairway or ramp of adequate dimensions shall be available for transfer of patients in case of power failure. *EDITORIAL NOTE: A copy of said Chapter 120-3-3, Rules and Regulations of the Safety Fire Commissioner, was filed with former Chapter 290-5-41 and is on file with same in the Office of Secretary of State.

(h) The birth center shall be constructed, equipped, and maintained to assure the safety of patients and personnel. The following requirements shall apply within the center:

Birth rooms shall be designed and located to prevent traffic through them to any other part of the center.
The walls and floors of birth rooms, examination rooms and staff dressing and scrub areas shall be of material that will permit frequent washing and cleaning.
Staff dressing rooms and scrub facilities shall be convenient to the birth rooms, and shall include a knee, elbow, wrist or foot operated sink soap dispenser and brushes.
Toilet and handwashing facilities shall be accessible to patients from the birth room. Convenient handwashing facilities shall be provided for both staff and patient and shall be provided with soap dispenser and individual or disposable towels. The use of common towels is prohibited
The center shall be arranged and organized in such a manner as to ensure the comfort, safety, hygiene, privacy and dignity of patients treated therein.
A clean up room for equipment shall be provided.
The center shall have an audible alarm system with control switches in all birth rooms which can be activated during an emergency.
The center shall have special care capability which includes but is not necessarily limited to the following, for both adults and infants: resuscitation equipment, intravenous solutions, drugs, oxygen, suction, infant stethoscope and transfer isolette. Such emergency equipment shall be provided on each floor on which patients are served.
Each birth room shall have an infant resuscitation tray with a laryngoscope, positive pressure bag and mask and endotracheal tubes.

(i) The center shall provide space and facilities for administrative activities, including offices, medical records and other files and storage of supplies.

(j) A waiting room and patient admissions area(s) shall be provided. There shall also be space for storage of personal belongings of staff, patients and visitors.

(k) The center shall have adequate and conveniently located toilets and handwashing facilities for its staff, employees, patients and visitors.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Physical Plant and Operational Standards" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.16 Housekeeping, Laundry, Maintenance and Sterile Supplies {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.16}

(1) The center shall ensure that housekeeping and maintenance is adequate to maintain the center and equipment in a clean condition and state of good repair. An equipment clean-up area with adequate plumbing, including a sink with counter, shall be provided within the center.

(2) Laundry service shall be provided either in house or by contractual arrangement. Separate space and facilities shall be provided for receiving, sorting and storing soiled laundry and for the sorting, storing and issuing of clean laundry, if reusable items are utilized.

(3) There shall be adequate space and facilities for receiving, packaging and proper sterilization end storage of supplies and equipment consistent with the services to be provided.

(4) Special precaution shall be taken to ensure that sterile instruments and supplies are kept separate from nonsterile instruments and supplies. Equipment for sterilization of instruments and supplies shall be conveniently located and of adequate capacity for the workload. Records shall be maintained to assure quality control, including, date, time and temperature of each batch of sterilized supplies and equipment. Sterilization performance shall be checked and records shall be kept. Sterile items shall be dated and utilized, based on established procedures.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Housekeeping, Laundry, Maintenance and Sterile Supplies" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.17 Electrical Power {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.17}

(1) All electrical work and equipment shall be designed and installed in accordance with State and local laws and ordinances.

(2) All areas of the center shall have sufficient artificial lighting, for designated purposes.

(3) All centers shall have an alternative lighting source for emergency use in the event of a power failure.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Electrical Power" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.18 Sanitation and Waste Disposal {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.18}

(1) The center shall maintain sanitary conditions throughout the premises. This shall include the water supply, sewerage, and solid waste disposal systems. Such facilities shall meet local and State regulations.

(2) All garbage, trash and waste shall be stored and disposed of in a manner that will not permit the transmission of disease, create a nuisance, or provide a breeding place for insects or rodents.

(3) Obstetrical wastes and contaminated materials shall be disposed of by incineration or other means acceptable to the Department.

(4) Effective means shall be provided at all outside doors, windows and other openings to the center to prevent the entrance and harborage of flies, other insects and rodents.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Sanitation and Waste Disposal" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.19 Advertising {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.19}

Any advertising of the services provided in or by a birth center shall be truthful and shall include the full name of the center and its Georgia license number, as shown on the face of the permit.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Advertising" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.20 Waivers and Variances {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.20}

(1) The Department upon application may grant variances or waivers of specific rules and regulations as provided for in O.C.G.A. Section 31-2-7(b) , when it has been shown that the rule or regulation is not applicable or to allow experimentation and demonstration of new and innovative approaches to delivery of services.

(2) The Department may exempt classes of facilities from regulation as provided for in O.C.G.A. Section 31-2-7(c) , when regulation would not permit the purpose intended or the class of facilities is subject to similar requirements under other rules and regulations.

History

Authority: O.C.G.A. § 31-2-7; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Waivers and Variances" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.21 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.21}

A birth center which fails to comply with these rules and regulations shall be subject to denial of a permit, revocation of its permit or provisional permit and other sanctions provided by law. The enforcement and administration of the rules and regulations: shall be as prescribed in O.C.G.A. Chapter 31-7, Enforcement and Administrative Procedure, which includes provision for:

(a) the misdemeanor penalty for violation of rules and regulations promulgated under this Title;

(b) injunctive relief under appropriate circumstances;

(d) the due process requirements of notice, hearing and appeals.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. Chapter 31-5; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1; O.C.G.A. Chapter 50-13
History. Original Rule entitled "Enforcement" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-7-.22 Applicability of Regulations {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.22}

These regulations are applicable to any building or facility which is or shall be classified by the Department of Community Health as a birth center and the services provided there in, and expressly do not modify or revoke any of the provisions of the published rules of the Department of Community Health, Chapter 111-8-40 (Rules and Regulations for Hospitals) or of revisions which may be made to said regulations.

History

Authority: O.C.G.A. §§ 31-2-4, 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Applicability of Regulations" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.
Amended: F. Oct. 14, 2022; eff. Nov. 3, 2022.

Ga. Comp. R. & Regs. r. 111-8-7-.23 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-7-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-7-.23}

In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof and such remaining rules or portions there of shall remain of full force and effect, as if such rule or portions thereof so determined, declared or adjudged invalid or unconstitutional were not originally a part hereof. It is the intent of the Board of Human Resources to establish rules and regulations that are constitutional and enforceable so as to safeguard the health and well-being of the people of the State.

History

Authority: O.C.G.A. § 31-2-4; O.C.G.A. § 31-7-1; O.C.G.A. Chapter 31-7, Article 1
History. Original Rule entitled "Severability" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Subject 111-8-9 Blood Labeling

Ga. Comp. R. & Regs. r. 111-8-9-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-9-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-9-.01}

Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning hereinafter respectively ascribed to them:

(a) "Act" means "The Blood Labeling Act" (O.C.G.A. § 31-24-1 et seq. );

(b) "Person" means any individual, blood bank, clinical laboratory, hospital, firm, corporation or any other entity;

(d) "Board" means the Board of Community Health;

(e) "Clinical Laboratory" means a single facility for the biological, microbiological, serological, immunological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body, for the diagnosis of, recommendation of treatment of, or for the purpose of providing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, man; the term "clinical laboratory" shall include blood banks which provide through their ownership or operation a system for the collection, processing, or storage of human blood and its component parts as well as tissue banks which store human or animal tissues designed to be used for medical purposes in human beings.

(f) "Director" means a person who is responsible for the administration of the technical and scientific operation of a clinical laboratory, including supervision of procedures for testing and the reporting of results;

(g) "Blood" means whole human blood, packed red blood cells, blood platelets, concentrated leukocytes, and blood plasma. It does not include blood derivatives manufactured or processed for industrial use.

(h) "Donation" means any transaction involving the person from whom blood is withdrawn, whether he presents himself for the withdrawal of blood on his own initiative or on the initiative of another person, in which he receives no consideration other than credit through blood assurance programs or other intangible benefits.

(i) "Purchase" means any transaction involving the person from whom blood is withdrawn, whether he presents himself for the withdrawal of blood on his own initiative or on the initiative of another person, in which he receives a monetary consideration in any form. Time off from work granted by an employer for the purpose of giving blood shall not be considered a direct monetary consideration.

(j) "Industrial use" means a use of blood in which the blood is modified by physical or chemical means to produce derivatives for therapeutic or pharmaceutic biologicals and laboratory reagents or controls.

(k) "Transfusion" means a use of blood in which the blood is administered to a human being for treatment of sickness or injury.

History

Authority: O.C.G.A. §§ 31-2-5, 31-2-7 and 31-24-1et seq
History. Original Rule entitled "Definitions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-9-.02 Criteria for Donor Selection {#sec-ga.-comp.-r.-regs.-r.-111-8-9-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-9-.02}

No blood may be withdrawn from any individual in this State for transfusion or industrial use unless he qualifies to be a blood donor under the laws of this State. Criteria for donor selection shall conform to those required in accordance with provisions of the act providing for the control and operation of clinical laboratories (O.C.G.A. § 31-22-1et seq.) and the Rules and Regulations as adopted and promulgated thereunder entitled "Rules and Regulations for Licensure of Clinical Laboratories".

History

Authority: O.C.G.A. §§ 31-2-3, 31-2-5 and 31-2-7
History. Original Rule entitled "Criteria for Donor Selection" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-9-.03 Labeling for Containers of Blood; Certificates for Out-of-State Blood {#sec-ga.-comp.-r.-regs.-r.-111-8-9-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-9-.03}

(1) It shall be the responsibility of the licensed laboratory director to assure the legal requirement that every unit of blood drawn from an individual and any components derived by physical processes (including plasmapheresis for transfusions and blood for auto transfusions), shall have affixed to each container of such blood or components, a label which indicates whether the blood was obtained by purchase or donation. The label must be affixed prior to bleeding of the donor. The label shall meet the following specifications:

(a) Labels shall state that content is "Blood From Paid Donor" or "Blood From Volunteer Donor".

(b) Labels must be affixed in a prominent position, in such manner as not to obscure any other necessary identifying labels, and using non-toxic permanent type adhesive which is non-leachable through plastic blood bag.

(c) If incorporated into the product label, the wording must be easily read, with block lettering in size described below:

(d) If a separate label is used, such label must be:

No less than 3/8 inch by 11/4 inch in overall size;
With black letters on an orange background; and
Using bold Helvetica or similar block letters, capital height no less than five (5) points in size. See example below. BLOOD FROM VOLUNTEER DONOR BLOOD FROM PAID DONOR

(e) If blood is received from out-of-state with individual labels which meets the above specifications, it need not have an additional label applied.

(2) The director of any blood bank who receives blood from a federally licensed blood bank in another state shall be responsible for acquiring a certificate from the out-of-state blood bank certified by its director, indicating which blood units in each shipment were acquired by "donation" or "purchase" as defined in these regulations. If he holds a certificate which certifies that the blood was received by donation, he may label such blood as donated blood. If he cannot obtain such a certificate, he shall label each unit of blood as blood acquired by purchase. In those instances where the supplying out-of-state blood bank draws blood exclusively from volunteer donors, only one certificate per year, acquired in advance, will be required.

(3) The certificate accompanying each shipment of blood or the single annual certificate shall be signed by the Director in whose name the blood bank is federally licensed or an individual authorized by him and so recorded.

(4) All certificates from out-of-state blood banks shall be retained by the receiving Georgia bank for at least five years.

(5) All costs for both certificates and labels shall be borne by the blood bank involved.

History

Authority: O.C.G.A. §§ 31-2-5, 31-2-7 and 31-24-1et seq
History. Original Rule entitled "Labeling of Containers of Blood; Certificates for Out-of-State Blood" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-9-.04 Unlabeled Blood, Medical Record, Removal of Label {#sec-ga.-comp.-r.-regs.-r.-111-8-9-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-9-.04}

(1) No person may administer blood, transfer, or offer to transfer, blood or blood components for transfusion purposes by any type of transaction unless the container of such blood is labeled as required by these regulations. The label may not be removed before or during the administration of the blood or blood components.

(2) A record must be maintained in the blood bank to identify the source of each unit as by "donation" or "purchase".

(3) The identification numbers of the unit(s) of blood transfused shall be recorded in the patient's medical record by the person authorized to administer the blood. Records accompanying each unit of blood or blood products leaving a Blood Bank shall indicate whether such unit was acquired by donation or purchase.

History

Authority: O.C.G.A. §§ 31-2-5, 31-2-7 and 31-24-5
History. Original Rule entitled "Unlabeled Blood, Medical Record, Removal of Label" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-9-.05 Blood and Blood Components: Industrial Uses {#sec-ga.-comp.-r.-regs.-r.-111-8-9-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-9-.05}

Blood and blood components, including salvage plasma, may be used and transferred for industrial uses without regard to whether its original acquisition was by purchase or donation.

History

Authority: O.C.G.A. §§ 31-2-5, 31-2-7 and 31-24-5
History. Original Rule entitled "Blood and Blood ComponentsIndustrial Uses" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-9-.06 Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-9-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-9-.06}

Determination of fulfillment of these requirements shall be made by the Department of Community Health as a part of, and using the procedures of the Act providing for the control and operation of clinical laboratories (O.C.G.A. § 31-22-1et seq.).

History

Authority: O.C.G.A. §§ 31-2-5, 31-2-7 and 31-24-7
History. Original Rule entitled "Administration" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-9-.07 Punishment for Violations {#sec-ga.-comp.-r.-regs.-r.-111-8-9-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-9-.07}

Any person violating the provisions of the Act on which these Rules are based shall be guilty of a misdemeanor and upon conviction thereof shall be punished as for a misdemeanor.

History

Authority: O.C.G.A. §§ 31-2-5, 31-2-7 and 31-24-8
History. Original Rule entitled "Punishment for Violations" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-9-.08 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-9-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-9-.08}

The administration and enforcement of these rules and regulations shall be in accordance with the provisions of the Act providing for the control and operation of clinical laboratories (O.C.G.A. § 31-22-1et seq.), and in compliance with the applicable minimum requirements as prescribed by the Georgia Administrative Procedure Act (O.C.G.A. § 50-13-1et seq.).

History

Authority: O.C.G.A. §§ 31-2-5, 31-2-7, 31-2-8 and 50-13-1et seq
History. Original Rule entitled "Enforcement" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Subject 111-8-10 Licensure of Clinical Laboratories

Ga. Comp. R. & Regs. r. 111-8-10-.01 Legal Authority {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.01}

The legal authority for this chapter is found in Chapters 2, 7 and 22 of Title 31 of the Official Code of Georgia Annotated.

History

Authority: O.C.G.A. §§ 31-2-5et seq., 31-7-1et seq. and 31-22-1 et seq
History. Original Rule entitled "Legal Authority" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.02 Purpose {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.02}

The purpose of these rules is to implement the requirements of Chapter 22 of Title 31 of the Official Code of Georgia Annotated pertaining to the licensure of clinical laboratories and the qualifications and performances of laboratory personnel.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Purpose" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.03 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.03}

Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning here in after respectively ascribed to them:

(a) Analyte means a substance or constituent for which the laboratory conducts testing;

(b) Board means the Board of Community Health of the State of Georgia;

(c) Clinical Laboratory means a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the diagnosis of, recommendation of, treatment of, or for the purposes of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings; the term "Clinical Laboratory" shall include specimen collection stations and blood banks which provide through their ownership or operation a system for the collection, processing, or storage of human blood and its component parts unless such human blood and its component parts are intended as source material for the manufacture of biological products and regulated by the Center for Biologics Evaluation and Research (CBER) within the federal Food and Drug Administration; the term "Clinical Laboratory" shall include tissue banks which procure, store, or process human or animal tissues designed to be used for medical purposes in human beings. The term 'clinical laboratory' shall not include laboratories which are nondiagnostic only and regulated pursuant to the federal Clinical Laboratory Improvement Amendments (CLIA) whose sole function is to perform examination of human blood or blood components intended as source material for the manufacture of biological products.

(d) CLIA-exempt state means a state where the Centers for Medicare & Medicaid Services (CMS) has determined that the state has enacted laws/rules relating to laboratory requirements that are equal to or more stringent than CLIA requirements. All laboratories subject to state licensure will be considered as "CLIA exempt" where the state has been determined to be CLIA exempt;

(e) Commissioner means the Commissioner of the Department of Community Health of the State of Georgia;

(f) Department means the Georgia Department of Community Health;

(g) Director means a person who is responsible for the administration of the technical and scientific operation of a clinical laboratory, including supervision of procedures for testing and the reporting of results;

(h) Evaluation Program means a state-conducted or state-approved proficiency testing program;

(i) Facility means a building, structure, institution, place, or entity, which may be fixed or mobile;

(j) Laboratory Advisory Council means the Clinical Laboratory, Blood Bank and Tissue Bank Committee authorized and required by law and appointed by the Board;

(k) Laboratory Test means any examination and/or manipulation performed on a specimen produced by the human body, by procedures such as phlebotomy or blood diverted from a normal or life-sustaining circulatory path, or in vivo testing of body fluids for the purpose of diagnosis, treatment, monitoring or the assessment of the health of human beings;

(l) Limited specialty laboratory or limited laboratory specialty means a clinical laboratory, or part of a clinical laboratory, in which testing is restricted (limited) to a designated category or subcategory, including but not necessarily limited to the following examples: cytology, histology, tissue banking, special chemistries (radio bioassay, blood gases, toxicology, etc.), cytogenetics and histocompatibility;

(m) Other Personnel means non-technical personnel who may be employed in the laboratory such as aides, clerks, etc. These persons may assist laboratory technical staff, but do not themselves qualify as technical staff or perform tests;

(n) Person means any individual, firm, partnership, association, corporation, the State or any municipality or other subdivision thereof, or any other entity whether organized for profit or not;

(o) Pertinent Laboratory Experience means full time or equivalent work in a clinical laboratory, directing, supervising or performing tests in all categories, or, when limited to laboratory specialty(ies), work is restricted to that category/subcategory;

(p) Plan of Correction means a written plan submitted by the laboratory director, owner, or other controlling authority, for approval by the Department. The plan shall identify the existing noncompliance of the laboratory and the proposed procedures, methods, means and reasonable period of time needed to correct the noncompliance;

(q) Point of Care Technician means a medical professional person subject to these rules, who has received special training in point of care testing as defined by these rules. Medical professional staff authorized to perform point of care testing are limited to registered professional nurses, certified nurse practitioners, licensed practical nurses, certified respiratory care professionals, physician assistants, certified paramedics, certified emergency medical technicians, perfusionists, laboratory technologists, laboratory technicians and certified cardiovascular technologists, radiologic technologists certified by a professional credentialing organization approved by the Department, and phlebotomists, certified by a professional credentialing organization approved by the Department;

(r) Point of Care Testing means testing performed in the immediate proximity of the patient. All point of care testing must be approved by and under the supervision of a Georgia-licensed laboratory, unless the test site meets the requirements for exemption. All such point of care testing shall be approved only in the specialties for which the laboratory holds a license. Testing shall be limited to procedures which meet all current Georgia rules for quality control, quality assurance and Point of Care Testing personnel requirements. Point of Care Testing is exclusive of screening and monitoring tests;

(s) Quality Assurance means a comprehensive process used by the laboratory to prevent and control errors that may occur at any interval from the time a test is ordered until it is reported and charted;

(t) Quality Control Program means those quality control requirements established for clinical laboratories as provided in applicable federal law and regulations and in Georgia law and regulations;

(u) Screening and Monitoring Tests. Screening tests mean those simple laboratory tests, approved by the Board as screening tests, used to aid in the detection of previously undiagnosed conditions. Monitoring tests mean those simple laboratory tests, approved by the Board as monitoring tests, with performance characteristics (accuracy and precision) that allow the tests to be used for evaluation of the status of previously diagnosed conditions and/or for evaluation of response to medical management;

(v) Specimen Collection Station means a place or entity, without regard to location, that either collects specimens directly from patients or brings specimens together after collection for the purpose of forwarding them either intrastate or interstate to a licensed/certified clinical laboratory for examination;

(w) Specimen Collector and/or Phlebotomist means any person who has been trained in procedures requiring understanding and skills in the procurement of specimens for clinical laboratory analysis in Clinical Chemistry, Hematology, Immunohematology, Microbiology, and Immunology/Serology and who works under the general supervision of the laboratory director, supervisor or technologist;

(x) Supervisor means an assistant to the director and a person with special scientific skills, who, under the general supervision of a clinical laboratory director, supervises technical personnel;

(y) Technician means any person other than the clinical laboratory director, supervisor, technologist, or trainee who functions under the supervision of a clinical laboratory director, supervisor, or technologist and performs only those clinical laboratory procedures which require limited skill and responsibility and a minimal exercise of independent judgment as described in 111-8-10-.06(5)(a) . The degree of supervision by the clinical laboratory director, supervisor, or technologist of a technician shall be determined by the director, supervisor, or technologist based on:

The complexity of the procedure to be performed;
The training and capability of the technician; and
The demonstrated competence of the technician in the procedure being performed;

(z) Technologist means a person who performs clinical laboratory procedures which require the exercise of independent judgment and responsibility, with minimal supervision by the director or supervisor, in only those specialties or subspecialties in which they are qualified by education, training, experience, and certification.

(aa) Trainee means a person who is enrolled in an accredited training program or who, in a limited laboratory specialty(ies) for which there is no accredited training program available, trains under the supervision of a director, supervisor, or technologist qualified in the specialty(ies), but does not report actual patient test results without prior supervisory approval.

History

Authority: O.C.G.A. § 31-22-1 et seq
History. Original Rule entitled "Definitions. Amended" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Jan. 27, 2017; eff. Feb. 16, 2017.
Amended: F. Mar. 19, 2018; eff. Apr. 8, 2018.

Ga. Comp. R. & Regs. r. 111-8-10-.04 License {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.04}

(1) Clinical Laboratory License.

(a) No clinical laboratory shall be operated without a license issued pursuant to these rules and regulations and without a licensed director. All laboratory activities, which are not specifically exempted by these regulations, must be performed in a license laboratory. Provided, however, a facility or part of a facility in which laboratory testing is done may qualify for exemption from personnel requirements when only specific tests or techniques, designated by the Department and used for screening and monitoring purposes only, are performed, and the facility or part of the facility is under the supervision of the laboratory as outlined in Rule 111-8-10-.16 .

(b) A license shall be issued by the Department to a clinical laboratory after all requirements for licensure are met.

(c) A provisional license may be issued as an authorization to operate a clinical laboratory for a limited and specified period of time under the following conditions:

After a review of an application and on-site inspection of a new laboratory has indicated that the laboratory has the potential to meet required standards and appears to be in substantial compliance with the requirements of these rules and regulations; or
An inspection or review of a licensed laboratory reveals only correctable deficiencies for which an acceptable plan of correction has been provided to Licensure of Clinical Laboratories Chapter 111-8-10 the Department and where the deficiencies do not constitute imminent hazards to patients or to laboratory personnel.

(d) A license shall authorize the performance of one or more categories, subcategories and/or test procedures and shall be valid for one year from the date of issue unless sooner canceled, suspended or revoked. Renewal of a license is subject to continued conformance with all rules and regulations.

(e) A license shall specify the names of the owner and director, categories and subcategories of tests, and the location of the laboratory. The laboratory license must be displayed at all times in view of the public.

(f) A license shall be valid only for the clinical laboratory (as defined at 111-8-10-.03(c) ) at the stated location and shall not be subject of sale or transfer to any premises other than those for which it was issued. Should the laboratory change its location, or ownership, a new application shall be made.

(g) Laboratory licenses shall be maintained current and changes in categories/subcatogories of tests or off site locations shall not be implemented without prior notification to and approval by the Department.

(h) Specimen collection stations which have a parent clinical laboratory which is licensed by the State of Georgia may be considered by the Department to be a part of that laboratory; but subject to all other applicable regulations.

(2) Director's License.

(a) A director's license shall be issued by the Department to persons meeting the requirements stated in these rules and regulations. Applications for licensure or renewal as a director shall be made on a form provided by the Department accompanied by the non-refundable fee, and provide pertinent information as deemed necessary by the Department.

(b) The director's license shall be maintained current and changes in the required information shall be reported to the Department when they occur. Application shall be made and approved by the Department prior to assumption of duties as a laboratory director.

(c) Any licensed laboratory director who is convicted, pleads guilty or nolo contendere or receives first offender treatment under the laws of this state, the United States, or any other state of any criminal offense involving the manufacture, distribution, trafficking, sale, or possession of a controlled substance or marijuana shall notify the Department of the conviction within ten days following the conviction, plea or first offender treatment.

History

Authority: O.C.G.A. §§ 16-13-111 and 31-22-1et seq
History. Original Rule entitled "License" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.05 Fees {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.05}

(1) Each original application for licensure and each application for annual renewal for a clinical laboratory shall be accompanied by the non-refundable fee set by the Board. These fees as determined by the Board shall be applicable to a ll laboratories. Each screening and monitoring approval shall pay a non-refundable processing and inspection fee as set by the Board.

(2) A non-refundable fee set by the Board shall accompany each application and renewal for licensure as a clinical laboratory director. Each license or renewal shall be valid for two years, unless suspended or revoked, or voluntarily terminated.

(3) Changes in fees and/or development of additional fee schedules may be established by the Board, without formal change in the rules and regulations.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Fees" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.06 Laboratory Personnel Requirements, Personnel Qualifications and Personnel Records {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.06}

(1) Laboratory Personnel Requirements :

(a) General . The laboratory shall perform tests in only those categories, subcategories or procedures for which it is licensed and for which there is either a director, supervisor, or technologist having minimum qualifications as outlined for Clinical Laboratory Technologists in Rule 111-8-10-.06(4) . (Special personnel requirements for donor screening and plasmapheresis and whole blood donor centers are outlined in Rule 111-8-10-.28 ). In addition, the following criteria shall be minimum personnel qualifications for the supervision of the categories and subcategories below:

Clinical Chemistry, Hematology, Immunohematology, Microbiology, Clinical Immunology and Serology: Supervisory requirements for these categories are those requirements for Clinical Laboratory Supervisor, outlined in Rule 111-8-10-.06(3) .
Exfoliative Cytology. For the purpose of these rules, exfoliative cytology is defined as that part of laboratory science dealing with the examination of cells obtained from human body fluids, surfaces, tissues, and other sources. This service must be provided by either a licensed physician who is certified or eligible for certification in anatomic pathology or cytopathology by the American Board of Pathology or the American Osteopathic Board of Pathology or by applicants who have a doctoral degree and whose special field is cytology. Unless the physician/Ph.D. also serves as cytology general supervisor, the supervisor must meet the minimum qualifications outlined in Rule 111-8-10-.06(3)(b)5 or current federal regulations of § 353 of the Public Health Service Act and Title 42 U.S.C. 263 a, whichever is more stringent.
Anatomic Pathology. For the purpose of these rules, anatomic pathology is defined as the examination and diagnosis of human tissues whether removed during life or after death. It deals with the morphologic study of normal or abnormal structure of tissues. For the purpose of these rules, this definition includes performance of all autopsies including medical-legal, and forensic autopsies. The laboratory director, if not so qualified, shall engage the services of a licensed physician who is certified or eligible for certification in an anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.
Oral Pathology. For the purpose of these rules, oral pathology is defined as a branch of anatomic pathology (see (a)3. above). The laboratory director, if not qualified in oral pathology, shall engage the services of a licensed physician who is certified or eligible for certification in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or those of a dentist, licensed in the State of Georgia, who is certified or eligible for certification by the American Board of Oral Pathology.
Radiobioassay. For the purposes of these rules, radiobioassay is defined as the diagnostic in vivo study involving administration of radioactive materials to a human subject (with the exclusion of organ scanning). Laboratories performing tests in radiobioassay must have a director or supervisor who is a physician working in Georgia in the field of radiobioassay at the time of the adoption of these rules and regulations or is qualified and trained in nuclear medicine or radioisotopic pathology and/or is certified or eligible for certification by the American Board of Nuclear Medicine or the subspecialty of radioisotopic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology. If not so qualified, the laboratory must engage the services of one so qualified:

(i) In vitro studies of organs, tissues, or fluids, using radioactive materials are considered in the licensed category of Clinical Chemistry (special) and may be handled by those appropriately qualified in this area.

(ii) For both in vivo and in vitro studies, all users of radioactive material must comply with Georgia "Rules and Regulations for Radioactive Material", Chapter 290-5-23.

Qualifications for test areas not included in above general categories may be established as Department policy.

(b) Directors . Each licensed laboratory shall be under the direction of a licensed laboratory director whose responsibilities and qualifications are outlined in Rule 111-8-10-.06(2) . The director may delegate Point of Care Testing oversight to qualified laboratory supervisors; however, such delegation must be in writing. In addition, delegation of authority does not relieve director of responsibilities as outlined in these regulations regarding Point of Care Testing.

(c) Supervisors. With the exception of a laboratory in which the director also qualifies and serves as supervisor, each laboratory shall have one or more supervisors who serve as assistants to the laboratory director and whose responsibilities are outlined in Rule 111-8-10-.06(3) . Such personnel must spend an adequate amount of time in the laboratory to supervise the performance of the work in the laboratory and must be readily available at other times for on-site or telephone consultation.

(d) Technologists and Technicians . Each laboratory shall engage the services of a sufficient number of clinical laboratory technologists, and/or clinical laboratory technicians to meet the workload demands including prompt performance, reporting and record-keeping of test results, quality control and proficiency testing.

(e) Point of Care Technicians. Each point of care testing site subject to state licensure shall utilize medical professional staff, as defined in these rules to perform such testing.

(f) Specimen Collectors and Phlebotomists. A laboratory may employ specimen collectors and/or phlebotomists whose responsibilities are outlined in Rule 111-8-10-.06(7) .

(g) Other Personnel. No person may perform laboratory tests within a licensed laboratory unless they qualify as a trainee, technician, technologist, supervisor, or director as defined in these rules. Other personnel may be employed in the laboratory such as aides, clerks, etc. These persons may assist the laboratory technical staff, but do not themselves qualify as technical staff, perform patient testing or operate clinical analyzers.

(h) Personnel Records:

Personnel records shall be kept current. They shall include a complete resume of each employee's training, experience, duties, competency evaluation and date or dates of employment. Personnel forms shall be submitted to the Department in a timely manner.
The laboratory is responsible for maintaining written documentation (in the personnel file of each employee performing testing) which demonstrates that the employee meets the personnel qualifications as set forth in these rules.

(2) Licensed Laboratory Directors.

(a) Responsibilities and general requirements:

Each licensed clinical laboratory shall be under the direction of a licensed laboratory director who is responsible for the operation of the laboratory at all times, who must spend an adequate amount of time in the laboratory to administer the technical and scientific operation of the laboratory, is responsible for the proper performance and reporting of laboratory findings, and is responsible for adequate staffing by qualified laboratory personnel, their in-service training and work assignment.

(i) There must be documentation completed by the laboratory director or supervisor, of competency to perform testing by an individual initially before patient testing is performed and not less than annually, thereafter, unless test methods or instruments change, in which case the director or supervisor is responsible for completing a new competency validation on the individual(s) before test results can be reported. Competency is to be measured against an established performance standard as defined by the laboratory director. Methods for validation of competency for each procedure must include:

(I) Direct observation of test performance through the testing of previously analyzed specimens and internal blind samples or external proficiency testing samples previously run and recorded. Testing samples may not be labeled as competency evaluation material, but must be treated as patient samples for routine processing;

(II) Review of test results from tests performed as a part of the competency assessment;

(III) Assessment of response to problems or situations related to the procedure;

(IV) Review of documentation of critical incidents related to the individual's performance of the procedure;

(V) Response to written or oral questions related to the procedures and, if applicable to the individual's responsibilities;

(VI) Assessment of the performance of calibration, and review of records pertaining to quality control and instrument maintenance.

(ii) The laboratory director may delegate the responsibility for competency assessment to other directors or supervisors in the laboratory meeting the qualifications described in 111-8-10-.06(2) and 111-8-10-.06(3) .

(iii) The licensed laboratory director shall ensure that no individual performs any laboratory procedure independently without first having demonstrated competency for the procedure as described above in 111-8-10-.06(2)(a)1. (i) .

(iv) When a director will be continuously absent for more than four weeks, arrangements must be made for a qualified substitute licensed director.

In addition to responsibilities outlined at 111-8-10-.06(8)(a) and (b) of these rules, the director is responsible for ensuring that all testing is instituted and conducted in a manner that complies with all applicable rules. The director, in consultation with appropriate medical staff, shall prepare an internal needs assessment for point of care testing which shall include evaluation of patient benefits and criteria for establishing the necessity of such testing. The assessment shall also include an evaluation of proposed methodologies for tests to be performed. The director is responsible for terminating testing in cases where there is consistent non-compliance with applicable rules or substandard performance.
There must be a written plan of action for how patient testing and reporting is handled when either laboratory or point of care testing fails. The director must ensure that, when recommended by the manufacturer, all screening tests performed must have confirmatory tests performed in a timely manner. The director must also ensure that the laboratory is enrolled and successfully participates in an approved proficiency testing program and that each Point of Care Testing area either enroll and successfully participate in an approved proficiency testing program or successfully participate in an approved program subscribed to by the responsible laboratory. Point of Care Testing methods, analyzers, or test areas must be challenged the number of times a year as is consistent with the requirement for clinical laboratories under state and/or current federal regulations. The director may delegate his or her authority, to assure that all applicable state regulations are met, to a supervisor that is qualified as defined in these rules and regulations.
Each licensed clinical laboratory must be served by a licensed clinical laboratory director, (permitted to direct no more than five clinical laboratories at a given time), on a full time or regular part-time basis. However, no licensed clinical director (Restricted) shall be permitted to direct more than one clinical laboratory at a given time.

(b) Qualifications:

Each licensed clinical laboratory in Georgia shall be directed by a licensed clinical laboratory director who qualifies under either (i), (ii), (iii), (iv), or (v) below, and whose practice is to be restricted according to the subparagraph under which he/she qualifies.

(i) Licensed Clinical Laboratory Director. A licensed clinical laboratory director must hold a license to practice medicine and surgery pursuant to Chapter 34 of Title 43 of the Official Code of Georgia Annotated, or a Georgia license to practice dentistry, or hold an earned doctoral degree in biology, microbiology, chemistry or related fields, and must either be certified or eligible for certification by one of the following:

(I) The American Board of Pathology or the American Board of Osteopathic Pathology in Clinical and/or Anatomic Pathology;

(II) The American Board of Oral Pathology;

(III) The American Board of Medical Microbiology;

(IV) The American Board of Clinical Chemistry;

(V) The American Board of Bioanalysists [Clinical Laboratory Director (CLD) and/or Bioanalyst Clinical Laboratory Director (BCLD)]; or

(VI) The American Board of Medical Laboratory Immunology; or

(VII) Qualified by other combinations of pertinent laboratory training and experience, in one or more of limited laboratory specialties, which are acceptable to the Department.

(ii) Licensed Clinical Laboratory Director (Restricted ). In recognition that certain laboratories, due to varying circumstances, have difficulty providing a laboratory director qualified under the requirements above, the clinical laboratory director's license (restricted) is authorized for issuance to new applicants who are physicians or possess an earned doctoral degree and who are qualified as laboratory supervisors under Rule 111-8-10-.06(3)(b)1. or (b)2. , and who meet the following requirements:

(I) The person will serve as director of only one laboratory at a given time;

(II) The served laboratory employs not more than ten full-time technical employees (supervisors, technologists, and technicians) or equivalent number of part-time technical employees; and

(III) The laboratory must also employ a qualified full-time or regular part-time clinical laboratory supervisor or pathologist.

(iii) Licensed Clinical Laboratory Director (Plasmapheresis and/or Whole Blood Donor Centers). The director of a plasmapheresis and/or whole blood donor center shall be a physician licensed in Georgia, who is qualified by training and/or experience in blood banking and/or plasmapheresis procedures and who shall be responsible for the medical, technical and clerical services, including special services such as phlebotomy for autologous transfusion, and special pheresis technique.

(iv) Licensed Clinical Laboratory Director (Specimen Collection Station). Each specimen collection station which is not a part of a parent clinical laboratory that is licensed by the State of Georgia must have a licensed clinical laboratory director. The director of a Specimen Collection Station shall be a person who is licensed to practice medicine in Georgia, or who holds an earned doctoral degree in biology, microbiology, chemistry or a related field and have pertinent clinical laboratory experience related to specimen collection.

(v) A person, who at the time of adoption of these regulations holds a current Georgia license as a clinical laboratory director, may renew the license and continue to function with same or similar duties and responsibilities upon application and payment of license fee. Persons who qualify under this provision but who are inactive for two (2) consecutive years must meet current requirements. Provided, further, that individuals and laboratories so concerned must meet all other standards of performance required by law and accompanying rules and regulations.

In addition to the directorship of the clinical laboratory, the director may participate in actual laboratory work only in those areas in which qualified by training and experience. For those categories in which the director is not qualified, a supervisor must be employed who is qualified in accordance with Rule 111-8-10-.06(3) to perform and/or supervise those procedures independently.
The person serving as a hospital laboratory director must be a member of the hospital medical staff.

(3) Laboratory Supervisor .

(a) Responsibilities and general requirements. With the exception of a laboratory in which the director also serves as supervisor, each laboratory must have an adequate number of qualified personnel who are assistants to the director, and who, under his/her general direction may function as supervisors, depending upon the size of the laboratory and diversity of the laboratory testing. A supervisor must be available for two-way communication within 30 minutes during all hours of operation, for the purpose of supervising technical personnel. For Point of Care Testing areas, the responsible supervisor must be qualified at a minimum under subparagraph (3)(b)4 of this rule. In addition, the supervisor of the testing area must be available for two-way communication within 30 minutes during all hours of operation. The supervisor is responsible for developing a quality control and quality assurance program for each test area that is equal to or more stringent than current federal and applicable state requirements. No Point of Care Testing area may be operated without a qualified supervisor.

(b) Qualifications. A supervisor shall meet one of the following minimum requirements:

Hold a license to practice medicine and surgery pursuant to Chapter 34 of Title 43 of the Official Code of Georgia Annotated and have at least two years of pertinent laboratory experience; or
Hold a doctoral degree from an accredited institution with a chemical, physical, or biological science as the major subject and have at least two years of pertinent laboratory experience; or
Hold a master's degree from an accredited institution with a major in one of the chemical, physical or biological sciences, allied health science or laboratory management, and have at least three years of pertinent laboratory experience as a technologist as outlined in Rule 111-8-10-.06(4)(b) of these rules and regulations; or
Qualify as a clinical laboratory technologist under Rules 111-8-10-.06(4)(b)1. , 2., 3. or 4. and have at least four years of pertinent laboratory experience as a technologist as outlined in Rule 111-8-10-.06(4)(b) ; or
In the limited specialty laboratory or limited laboratory specialty(ies), the supervisor must meet one of the above conditions or, if restricted to the category or subcategory, must meet one of the following:

(i) Hold a master's degree with a major in a chemical, physical, or biological science, allied health science, or laboratory management; be a graduate of an accredited program in the specialty and have at least two years pertinent laboratory experience in the specialty as technologist; or

(ii) Hold a bachelor's degree in the specialty; or a degree with a major in chemical, physical, or biological sciences and be a graduate of a program in the specialty accredited by an agency accepted by the Department, or have one year of training in a clinical laboratory environment; and have at least three years of pertinent laboratory experience in the specialty as a technologist; or

(iii) Qualify as a technologist under Rule 111-8-10-.06(4)(b)6. (i) and have at least four years of pertinent laboratory experience in the specialty as a technologist.

(iv) A cytology supervisor must be a physician licensed to practice medicine in Georgia, and be certified in anatomic pathology by the American Board of Pathology, or the American Osteopathic Board of Pathology, and be licensed by the Department as a laboratory director.

(v) A cytotechnologist general supervisor must meet the requirements of Rule 111-8-10-4(b)6. (iii) and have 3 years full time experience as a cytotechnologist in a clinical laboratory.

(vi) A histocompatibility supervisor must be a pathologist who is board certified in anatomical and clinical pathology, a licensed physician or doctor of osteopathy with four years experience in histocompatibility, or a Ph.D. with two years general immunology and two years histocompatibility experience.

(vii) The histopathology supervisor must be a licensed physician or doctor of osteopathy, and be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology, and licensed by the Department as a laboratory director.

(viii) The histotechnologist general supervisor must have formal training, be certified by an approved crediting agency and have two years of pertinent experience.

Persons who have been continuously engaged as laboratory supervisors in Georgia since July 1, 1970, are exempt from the personnel qualifications listed above. Persons who initially qualified under this provision and who become inactive for two (2) consecutive years for any reason must meet current requirements. Provided, further, individuals and laboratories so concerned must meet all other standards of performance required by this law and applicable rules and regulations.

(4) Technologist.

(a) Responsibilities and general requirements. Technologists, under general supervision, exercise independent judgment to perform and report findings proficiently for clinical laboratory tests. In the case of technologists who are qualified only in limited laboratory specialties, work as a technologist shall be limited to those respective specialties in which qualified.

(b) Qualifications. Each technologist shall successfully complete a certification examination from the American Society for Clinical Pathology (ASCP), the American Medical Technologists (AMT), the National Credentialing Agency for Laboratory Personnel (NCA), the American Association of Bioanalysts (AAB), or another agency approved by the Department, and shall meet one of the following requirements, listed in 1. through 7. below:

Successful completion of a full course of study which meets all academic requirements for a bachelor's degree in medical technology from an accredited college or university; or
Successful completion of three years of academic study (a minimum of 135 quarter hours or equivalent) in an accredited college or university and the successful completion of a course of training of at least 12 months in a school of medical technology accredited by an agency recognized by the Council for Higher Education Accreditation (CHEA) or the U.S. Department of Education; or
Successful completion in an accredited college or university of a course of study which meets all academic requirements for a bachelor's degree in one of the chemical, physical, or biological sciences, and have at least one year of pertinent laboratory experience or training accepted by the Department; or
Successful completion of 135 quarter hours in an accredited college or university, including 24 quarter hours of chemistry, 24 quarter hours of biology, and 5 quarter hours of mathematics, (thirty quarter hours of the total, with a minimum of fifteen in science, must be at the third or fourth year level), and have at least two years of pertinent laboratory experience; or
Successful completion of a full course of study which meets all academic requirements for an associate's degree in medical technology from an accredited college or university, or successful completion of two years of academic study (a minimum of 90 quarter hours or equivalent) in an accredited college or university which included at least 20 quarter hours of lecture and laboratory courses in chemical, physical, or biological sciences acceptable toward a major in science, with at least three years of pertinent laboratory experience; or graduation from high school and successful completion of a formal technician training course which is accredited by an accrediting agency accepted by the Department with at least four years of pertinent laboratory experience; or
In the limited specialty laboratory or limited laboratory specialty(ies), a technologist is restricted to the category or subcategory of testing authorized to be performed in the limited laboratory, and must have satisfactorily completed either:

(i) Ninety (90) quarter hours in an accredited college or university with at least 20 quarter hours in science and one year of pertinent laboratory experience or training accepted by the Department; or

(ii) At least two years of pertinent laboratory experience as a technician under the supervision of a director qualified in the specialty, or a one-year formal training program accepted by the Department in the specialty; or

(iii) Cytotechnologists must be certified by specialty examination by the American Society for Clinical Pathology (ASCP), or another agency approved by the Department; or

(iv) Histotechnologists must have formal training and specialty certification by the American Society for Clinical Pathology (ASCP) or another agency acceptable to the Department.

Persons who possess the technologist qualifications under provisions (b)1. through 6. above and have recently moved into the state or have recently completed the academic and training/experience requirements may be temporarily classified once as technologists for eighteen (18) months to afford the persons an opportunity to successfully complete an approved qualifying examination.
Persons who have been continuously engaged as technologists in Georgia since July 1, 1970, are exempt from the personnel qualifications listed above. Persons who initially qualified under this provision but become inactive for two consecutive years must meet current requirements. Provided further, that individuals and laboratories so concerned must meet all other standards of performance required by this law and applicable rules and regulations.

(c) Technologist allowable testing. Technologists shall be permitted to independently perform all laboratory procedures for which the technologist has been trained and demonstrated competency as described under 111-8-10-.06(2)(a)1. (i) . Where the technologist chooses to delegate the performance of any test requiring more than limited skill and responsibility and exercise of independent judgment as described in 111-8-10-.06(5)(c) :

The delegating technologist shall ensure that the individual to whom the testing has been delegated meets at a minimum the qualifications described in 111-8-10-.06(5)(b) and has documented competency for performance of the test as described in 111-8-10-.06(2)(a)1. (i) ;
The delegating technologist shall be responsible for the accuracy of the test results; and
The delegating technologist shall ensure that a qualified technologist is available onsite or by telephone for consultation regarding the testing or for review of results; and
In those cases where a qualified technologist is not available on site during the performance of the delegated test, but is only available on call, the performance of those tests shall only be delegated to an individual who has completed a technician-level certification test approved by the Department, has completed a full course of study which meets all academic requirements for an associate's degree in medical technology from an accredited college or university, and has completed a minimum of two years of pertinent full time laboratory experience, one year of which experience has been obtained in the laboratory where they will be performing the delegated test.

(5) Technician .

(a) Responsibilities and general requirements. The laboratory must employ a sufficient number of qualified technicians to meet the workload demands, and they must function under the direct supervision of a technologist, supervisor or director. The decision regarding the degree of supervision necessary shall be determined by consideration of the complexity of the procedure, the training and capability of the technician, and the demonstrated competency of the technician in the procedure to be performed. The determination of the degree of supervision under which the technician performs any type of laboratory testing must be documented in the technician's job description and personnel record. In the case of technicians who are qualified only in limited laboratory specialties, work as a technician shall be limited to those respective specialties in which qualified.

For any testing performed by a technician, there must be documentation in the technician's personnel record of training and competency testing of the technician to perform the test.
Documentation of the test and reporting of results must be retained, for the purpose of supervisory review, for all testing performed independently by a technician.

(b) Qualifications. Each technician shall successfully complete a certification examination from the American Society for Clinical Pathology (ASCP), the American Medical Technologists (AMT), the National Credentialing Agency for Laboratory Personnel (NCA), the American Association of Bioanalysts (ABB), or another agency approved by the Department and shall meet one of the following requirements listed in 1. through 4. below:

Has earned an associate's degree in medical laboratory technology; or successful completion of two years of academic study (a minimum of 90 quarter hours or equivalent) in an accredited college or university which included at least 20 quarter hours of lecture and laboratory courses in chemical, physical, or biological sciences acceptable toward a major in science and have at least one year of pertinent laboratory experience or training accepted by the Department; or
Graduation from high school and successful completion of a formal technician training course which is accredited by an accrediting agency accepted by the Department; or
Graduation from high school and subsequent to graduation has obtained two years of pertinent laboratory experience in a clinical laboratory of a hospital, a health department, university, or in an independent clinical laboratory; or
For persons who possess the technician qualifications under provisions above and have recently moved into the state or completed the academic and/or training requirements, they may be temporarily classified once as technicians for eighteen (18) months to afford them an opportunity to successfully complete an approved qualifying examination.
Persons who have been continuously engaged as technicians in Georgia since July 1, 1970 are exempt from personnel qualifications listed above. Persons who initially qualified under this provision but become inactive for two consecutive years for any reason must meet current requirements. Provided, further, individuals and laboratories so concerned must meet all other standards of performance required by this law and applicable rules and regulations.

(c) Technician allowable testing. Technicians shall be permitted to perform tests requiring limited skill and responsibility and a minimal exercise of independent judgment, and for which the technician has demonstrated competency as described in 111-8-10-.06(2)(a)1. (i) , to include:

CLIA waived tests;
Complete blood count (CBC) utilizing automated/semi-automated methods with internal support systems;
Routine chemistries utilizing automated/semi-automated methods with internal support systems; and
Coagulation studies utilizing automated methods.

(6) Trainee . A trainee is a person who is enrolled in an accredited training program, or who, in a limited laboratory specialty(ies) for which there is no accredited training program, works and trains under the direct supervision of a qualified director, supervisor, or technologist qualified in the specialty(ies), but does not report actual patient test results without prior supervisory review. A person may function as a trainee for the duration of the formal approved training program or for a maximum period of 24 months.

(7) Specimen Collector and/or Phlebotomist. The laboratory may employ specimen collectors, qualified by training and/or experience approved by the laboratory director, to perform, under general supervision, collection procedures requiring understanding and skills in the procurement of specimens for clinical laboratory analysis. Documentation of qualifying training and/or experience must be available in the laboratory's personnel files. The collector may also perform exempt screening and monitoring tests as outlined in Rule 111-8-10-.16 of these regulations. Phlebotomists certified by the American Society for Clinical Pathologists (ASCP), the American Medical Technologists (AMT), the National Healthcareer Association (NHA), the National Center for Competency Testing (NCCT), the American Association of Bioanalysts (ABB), or another professional credentialing organization that has been approved by the Department, may perform Point of Care Testing in accordance with these rules.

(8) Point of Care Technician.

(a) Responsibilities and general requirements. Point of Care technicians must function under the supervision of a laboratory director and/or supervisor appointed by the director. These technicians must complete all training requirements as outlined in subparagraph (b) of this rule.

(b) Qualifications:

Professional background. Point of Care technicians must have one of the following medical professional backgrounds: licensed registered nurse, certified nurse practitioner, licensed practical nurse, certified respiratory care professional, physician assistant, perfusionist, certified paramedic or certified emergency medical technician, radiologic technologist, certified cardiovascular technologist certified by a professional credentialing organization approved by the Department, medical technologist and medical technician qualified by these rules, or a phlebotomist certified by a professional credentialing organization approved by the Department.
Training. The laboratory director is responsible for determining and maintaining documentation of an individual's credentials which qualify him or her to perform Point of Care Testing. The director may delegate this responsibility to a qualified supervisor. The documentation of qualifications to perform point of care testing must include the following: training, licensure, certification or other medical professional background information as well as competency certification documentation. In all cases, an individual must be trained and his or her competency verified prior to the director or supervisor allowing the individual to perform patient testing. Such training must include, at a minimum, proper specimen collection and handling, proper use of test instruments, proper storage, handling and preparation of test kits/reagents, quality control, quality assurance, remedial action and record keeping. Training must also include troubleshooting to the extent that results will not be reported when instrument or quality control problems arise.

(9) Other Personnel. Other personnel may be employed in the laboratory, such as aides, clerks, etc. These persons may assist laboratory technical staff in the performance of non-clinical tasks, but do not qualify as technical staff, perform technical tests or operate testing devices.

History

Authority: O.C.G.A. § 31-22-1 et seq
History. Original Rule entitled "Laboratory Personnel Requirements, Personnel Qualifications and Personnel Records" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-10-.07 Application {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.07}

(1) Applications for licensure of clinical laboratories shall be made on forms provided by the Department and shall indicate from the following list, those categories, subcategories and/or procedures for which the facility requests licensure:

(a) Clinical Chemistry;

Routine;
Urinalysis;
Special (includes Radiobioassay, Blood Gases, Medical Toxicology, Therapeutic Drug Monitoring, Immunohistochemistry, etc.)

(b) Hematology;

(c) Immunohematology (including Group/Type/Crossmatch, Antibody Screen/Identification, Storage, Transfusion Services, Pheresis/ Components, Donor Services (autologous, general), Histocompatibility.

(d) Microbiology;

Bacteriology (Level I - Direct microscopic examination of smears; Level II - Primary culture, report no growth and refer growth for identification; Level III - Culture and Identification and/ or Sensitivity Testing);
Mycobacteriology (Level I - Direct microscopic examination of smears for acid fast organisms; Level II - Primary culture, report no growth and refer growth for identification; Level III - Culture, Identification and/or Sensitivity Testing);
Mycology (Level I - Direct microscopic examination for fungi; Level II - Primary culture, report no growth and refer growth for identification; Level III - Culture, Identification and/or Sensitivity Testing);
Parasitology; and
Virology.

(e) Clinical Immunology and Serology:

Syphilis;
Non-syphilis;
Viral Serology;
HIV (Screening/Confirmation).

(f) Pathology;

Exfoliative Cytology;
Anatomic Pathology; and
Oral Pathology.

(g) Radiobioassay.

(h) Tissue Banking.

(i) Cytogenetics.

(j) Inherited Metabolic Disorder Testing of Newborns.

(k) Specimen Collection Station(s).

(l) Point of Care Testing.

(m) Other: (ART, andrology, molecular genetics).

(2) If a facility provides any laboratory testing services it must apply for and obtain one or more appropriate laboratory licenses (or screening and monitoring approvals) as needed to cover all laboratory services provided and must meet all requirements of these regulations. Where testing beyond the scope of authorized laboratory services is performed, these additional tests must be obtained from a duly licensed laboratory that meets all requirements of these regulations or from an out-of-state laboratory holding a current federal certificate for laboratory testing.

(3) The application for licensure in the category of specimen collection station shall be made on forms provided by the Department, and shall indicate the name and address of the laboratory or laboratories to which specimens are submitted for testing.

(4) Application for screening and monitoring approvals shall be made on forms provided by the Department and shall provide pertinent information as deemed necessary by the Department.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Application" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.08 Sanitation and Safety {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.08}

(1) General. All laboratories shall be well lighted, maintained in a clean, neat, orderly and professional manner, and operated in a manner which will prevent undue physical, chemical, or biological hazards to its employees or other members of the community, and shall meet local and state sanitation and safety regulations:

(a) Adequate lighting shall be provided for the work area at bench top level.

(b) Syringes, needles, lancets, or other bloodletting devices capable of transmitting infection from one person to another shall be of a disposable type or shall be cleaned and sterilized before use, in accordance with accepted sterilization procedures.

(2) Sanitary Facilities. All laboratories shall have suitable sanitary facilities, including toilet and hand washing facilities, within the premises. New installations and major renovations completed after the effective date of these rules shall include hand washing and toilet facilities for visitors and patients, separate from those provided for employees.

(3) Garbage and Rubbish Disposal. All laboratories shall provide facilities for maintaining sanitary standards, including water supply, sewage, garbage and refuse disposal, throughout the laboratory structure and premises. Such facilities shall meet local and state regulations, and shall be maintained in a clean and orderly manner. Cultures and specimens shall be discarded in an appropriate manner.

(4) Safety. Laboratory locations and facilities must conform to local and state building and safety and fire codes and ordinances where applicable. There shall be sufficient space, equipment and facilities to perform the services provided by the laboratory with reasonable accuracy and safety:

(a) Work involving the licensed subcategories of mycobacteriology (Levels II or III), mycology (Levels II or III), and appropriate virology shall be performed under a biological safety cabinet with a rating of Class IIA/B3. Safety cabinets shall exhaust filtered air directly to the outside when a recirculation air conditioning system is used. Laboratories utilizing a single pass ventilation system with their safety cabinet may exhaust air back into the laboratory. All laboratory procedures which involve liberation of large amounts of toxic, corrosive or explosive substances shall be performed under a fume hood that has a face velocity of 100 feet per minute and an independent exhaust system;

(b) Cylinders of compressed gas shall be properly secured by restraining chains, brackets or other materials that are sufficiently strong to support the weight of the cylinder;

(c) Flammable or combustible liquids shall be in containers not larger than one liter, in safety cans, in cabinets suitable for storage of flammable or combustible liquids or must otherwise comply with the requirements established by the state fire marshal; flammable liquids requiring refrigeration shall be stored in an Underwriters' Laboratory labeled explosion-proof refrigerator or otherwise comply with the requirements established by the state fire marshal;

(d) Laboratories utilizing corrosive materials or solutions shall have an appropriately located safety spray hose or shower;

(e) Each plumbing fixture shall be provided with air gap or vacuum breaker where necessary to eliminate back-siphoning hazards.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Sanitation and Safety" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.09 General Quality Control Requirements {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.09}

Each laboratory shall establish and follow written policies and procedures for a quality assurance program, comprehensive in scope and specific to that laboratory. The program shall monitor and evaluate the ongoing and overall quality of the total testing process from specimen collection to reporting of test results. The program shall identify and correct problems, assure the accurate, reliable and prompt reporting of test results and assure adequacy and competency of laboratory staff. Written procedures shall be revised when evaluation results indicate the need. There must be documentation of the ongoing quality assurance program as well as corrective action taken when necessary. The laboratory director is responsible for ensuring that the following quality controls are employed for all clinical testing authorized under the laboratory's license:

(a) Preventive maintenance, periodic inspection or testing for proper operation of equipment and instruments, based on but not limited to manufacturers' instructions. The laboratory must confirm the effectiveness of its preventive maintenance program;

(b) Each quantitative method shall be validated prior to placing into routine use. Such validation shall include reportable range, sensitivity, specificity, accuracy and precision. Documentation of validation shall be maintained for the period the method is used, or for at least two years, whichever is longer;

(d) Maintenance of documentation verifying that test systems perform according to laboratory specification; such documentation must be available to the authorized persons ordering or receiving test results, and to the Department; the laboratory must establish its reference range for each method before reporting patient test results;

(e) Establishment and employment of policies/procedures for remedial action to be taken in response to quality control outside acceptable limits, equipment or methodology performance outside established operating limits, test results outside acceptable limits, tests not performed within laboratory established time frames, proficiency test results outside acceptable limits or errors detected in reported patient results;

(f) Adequacy of space, ventilation, facilities, equipment, instruments, and methods of performance of the procedures or categories of procedures for which a license application is filed or granted; proper lighting for accuracy and precision; convenient location of essential utilities; monitoring of temperature controlled spaces and equipment to assure proper performance of equipment and storage of specimens, tissues, reagents and supplies; the evaluation of analytical measuring devices, with respect to all critical operating characteristics, and the laboratory shall not report test results unless such operating characteristics are within defined acceptable ranges;

(g) Labeling of all reagents and solutions to indicate identity, and when significant, titer, strength or concentration, recommended storage and preparation or expiration date, and other pertinent information. Material of substandard reactivity, expired, or deteriorated materials may not be used;

(h) Availability at all times, in the immediate bench area of personnel engaged in examining specimens and performing related procedures within a category, of laboratory manuals or other complete written descriptions and instructions (properly designated and dated to reflect an initial and periodic review by the current director) relating to the current analytical methods, specimen processing procedures, reagents, control and calibration procedures, microscopic examinations, remedial action procedures, limitations in methodologies, pertinent literature references and the date each procedure was placed into use. Textbooks may be used as supplements to such written descriptions but may not be used in lieu thereof;

(i) Written approval by the director of any and all changes in laboratory procedures; a copy of each procedure must be retained for two years after the procedure has been discontinued;

(j) Maintenance and availability to laboratory personnel, and to the Department, of records, reflecting dates, and where appropriate, the nature of inspection, validation, remedial action, monitoring, evaluation, and alternative test methods;

(k) Written materials designed to provide instruction for proper collection, labeling, preservation and transportation of specimens to assure accurate results suitable for clinical interpretation.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "General Quality Control Requirements" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.10 Quality Control for Microbiology {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.10}

Chemical or biological solutions, reagents, and antiserum shall be tested and inspected as prescribed by the Department for reactivity and deterioration. Discs and systems used in antibiotic susceptibility testing are checked for deterioration and proper reactivity, using approved reference organisms.

(a) Bacteriology, Mycobacteriology and Mycology. Staining material shall be tested for intended reactivity by weekly application to smears of microorganisms with predictable staining characteristics, with the exception of fluorochrome acid fast stains, which must be checked each day of use. Each batch of media shall be tested before or concurrently with use with selected organisms to confirm required growth characteristics selectivity, enrichment, and biochemical response. The laboratory may use commercial manufacturers' quality control checks of media if the laboratory has documentation to verify that the manufacturer meets the National Committee for Clinical Laboratory Standards (NCCLS) requirements for media quality control. Each day of use the laboratory must test direct antigen detection systems using positive and negative control organisms that evaluate both the extraction and reaction phases.

(b) Parasitology. A reference collection of slides, photographs, or gross specimens of identified parasites shall be available in the laboratory for the appropriate comparison with diagnostic specimens. A calibrated ocular micrometer shall be used for determining the size of ova and parasites, if size is a critical factor. Staining material shall be tested for intended reactivity, using a fecal sample control that will demonstrate staining characteristics, whenever a new lot number of reagent is opened or once a month, whichever comes first;

Systems for the isolation of viruses and reagents for their identification shall be available to cover the entire range of viruses that are etiologically related to clinical diseases for which services are offered.
Records shall be maintained which reflect the systems used, and the reactions observed. In tests for the identification of viruses, controls shall be employed which will identify erroneous results.
Physical facilities and safety cabinets must be adequate and appropriate for the extent of testing offered.
There must be a written procedure in place and utilized by the laboratory for the proper disposal of infectious materials and biohazardous waste.
Host systems must be checked for sensitivity to viral agents and sterility.
Continuous cell lines must be checked for bacterial/fungal contamination as appropriate.
Storage requirements and expiration dates must be observed and recorded.
Diluents must be checked for sterility and pH.
Records must be kept of cell types, passage number, source, lot numbers and media used for growth and maintenance.
In tests for the identification of viruses, the laboratory must simultaneously culture uninoculated cells or cell substrate controls as a negative control to detect erroneous identification results.
Inoculated cultures must be checked for cytopathic effect at appropriate intervals.
Records must be kept of all quality control and quality assurance for as long as required under current federal regulations or not less than two years, whichever is more stringent.
If serodiagnostic tests for viral diseases are performed, requirements for quality control as specified for serology and immunology shall apply as listed at 111-8-10-.09(4) .

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Quality Control for Microbiology" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.11 Quality Control for Serology/Immunology {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.11}

(1) Serologic and immunologic tests on unknown specimens shall be run concurrently with a positive control serum of known titer or controls of graded reactivity plus a negative control in order to detect variations in reactivity levels. Controls for all test components shall be employed to ensure reactivity and uniform dosage. Test results shall not be reported unless the redetermined pattern of the control is obtained.

(2) Each new lot of reagent shall be tested with one of known acceptable reactivity, or with known control sera before or concurrent with the new lot of reagent being placed into routine use.

(3) Equipment, glassware, reagents, controls and techniques for tests for syphilis shall conform to manufacturers' specifications, where applicable.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Quality Control for Serology/Immunology" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.12 Quality Control for Clinical Chemistry {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.12}

(1) The laboratory must verify (validate) that each method or testing system functions in the laboratory as specified by the manufacturer. Verification includes reportable range, accuracy, sensitivity and specificity. Verification studies must be done upon introduction of a new methodology; a laboratory may not report test results beyond or below its own established range.

(2) Calibration, or calibration verification must be performed:

(a) According to manufacturer specifications, or every six months, whichever is sooner;

(b) When a complete change of reagents (except where all reagents are packaged together) occurs;

(d) When controls begin to reflect an unusual trend or are consistently outside acceptable ranges; or

(e) At least every six months.

(3) Each quantitative assay procedure shall be rechecked at least once each day of testing (24-hour period) except for blood gases, which must be rechecked each shift (see (7) below); rechecks must be conducted using two levels of calibrators, controls, standards, or a combination of these materials.

(4) Limits for standards and reference samples shall be recorded and shall include the course of action to be instituted when the results are outside the acceptable limits for each lot number of controls. Manufacturer's limits may be used only if they are verified by the laboratory.

(5) For urinalysis, the laboratory shall use a positive control each day of patient testing, which checks the reactivity of each constituent for which qualitative tests are reported.

(6) Counting equipment used for in vitro radioassay determination shall be checked for stability at least once each day of use with radioactive standards or reference sources. Records which document the routine precision of each method, automated or manual, and its recalibration scheduled, shall be maintained. At least one standard and one reference sample (control) shall be included with each run (ad defined by guidelines) of unknown specimens.

(7) For blood gas analysis, a two point calibration must be performed and documented each shift; a third point verification must be run using a separate material from that used in the two point check; for blood gas analyzers which include other chemistries (electrolytes, glucose, bun, etc.) the quality control requirements are outlined under Rule 111-8-10-.09 and .09(5) .

(8) For co-oximetry, preventive maintenance shall follow manufacturer's guide lines except where regulations are more stringent; a hemoglobin control shall be performed each day of testing. The calibration of the instrument shall be checked weekly unless required more frequently by the manufacturer.

(9) Drug screens for medical purposes must contain a standard which contains all drugs to be identified by the method used, or for which the laboratory reports, per each plate or run. The control must go through all phases of testing including extraction, unless technology that is more current has been approved by the Department. Positive qualitative tests must be confirmed by a quantitative method, if required or recommended by the manufacturer.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Quality Control for Clinical Chemistry" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.13 Quality Control for Immunohematology {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.13}

Those clinical laboratories which provide for the collection, processing or storage of human blood and its components shall provide methods for the selection of blood and component donors as well as for the collection, storage, processing and transfusion of blood and its components, and shall ensure that the blood and component donation will not be detrimental to the donor and also protect, as far as possible, the recipient of the human blood or any of its components from infectious disease known to be transmissible by blood. The methods used shall conform to the following:

(a) Selection of donor:

On the day of donation, the donor shall be evaluated in order to protect the donor and the recipient of the donation. At a minimum, the following shall be used in the evaluation of the donor and records shall be retained.
The minimum age for donation is seventeen (17) years; the maximum age for a donor is left to the discretion of the director of the facility providing the donor is in good health.
Minimum weight for routine donation shall not be less than 110 lbs. (50 kg) with a maximum of 525 ml. of blood removed per donation; individuals weighing less than 110 lb. (50 kg) may donate relative to the volume collected; in this event, the volume of anticoagulant must be considered. Any recent unexplained weight loss (e.g., more than 4.5 gk. or 10 lbs) should be evaluated by the donor's physician.
The volume of donation shall not exceed 545 ml in an eight week period; donation of whole blood must be deferred for at least 48 hours after apheresis.
The systolic blood pressure shall be no higher than 180mm of mercury, and the diastolic blood pressure must be no higher than 90 mm of mercury.
Pulse rate shall be between 50 and 100 beats per minute. Prospective donors with pathogenic cardiac irregularities must be deferred.
Donor hemogoblin or hematocrit must be determined prior to donation by a method acceptable to the Department; donors with a hemoglobin less than 12,5g/dL or a hematocrit less than 38% must not be considered for donation.
Prospective donors with chronic or acute illness must be evaluated by a physician prior to donation.
Routine donation must be deferred for six months after the conclusion of a pregnancy.
Prospective donors on therapeutic drugs must be evaluated by a physician prior to donation to protect the donor and the recipient.
The donor temperature (oral) shall not exceed 37.5 degrees C. (99.6 degrees F.).

(b) Donor deferral:

Abnormal behavior: a prospective donor shall not appear to be under the influence of alcohol or any illegal substance.
The site of venipuncture shall be free of lesions; evidence of drug abuse shall indefinitely exclude the potential donor. At a minimum, both arms shall be inspected for parenteral drug use.
A history of syphilis or gonorrhea shall exclude the potential donor for a period of not less than six months after treatment of the disease.
Potential donors who have received blood, blood components, derivatives, or other human tissue known to be a possible source of blood borne pathogens shall be excluded as donors for a period of not less than 12 months.
Potential donors who have taken medication known to alter platelet function within the previous three days, shall be evaluated as to the impact on the patient who is to receive the platelets from this donor and that such donor is to be the sole source of the platelets.
Immunizations and vaccinations: Donors shall be evaluated for the impact of the immunizations and vaccinations on the donation in accordance with general accepted standards of practice. At a minimum the following actions shall be taken:

(i) Potential donors who have received toxoids and killed viral, bacterial, and rickettsial immunizations and/or vaccinations may be considered as a donor if symptom-free and afebrile.

(ii) Potential donors who received human diploid cell rabies shots may be considered if symptom-free and afebrile, unless the vaccine was given following an animal bite; the exclusion period for this event shall be no less than one year.

(iii) Potential donors shall be deferred after receiving the following vaccinations:

(I) Live attenuated viruses such as measles, rubella(a), mumps (oral), or yellow fever shall be deferred for a period of not less than two weeks.

(II) German measles (rubella) shall be deferred for a period of not less than four weeks.

(III) Hepatitis B Immune Globulin (HBIG) shall be deferred for a period of not less than twelve months.

Infectious diseases requiring indefinite deferral:

(i) Those potential donors with a history of hepatitis B after the age of eleven, or those who have been confirmed positive for hepatitis B surface antigen (HBsAg) or those who have had a repeatedly reactive test for antibodies to hepatitis B core (anti-HCc) on more than one occurrence.

(ii) Those potential donors with a present or past clinical history of infection with hepatitis C virus (HCV), human T-cell lymphatic virus (HTLV) or human immunodeficiency virus (HIV);

(iii) Those potential donors (male) who have had sex with another male since 1977;

(iv) Those potential donors who have had sex for money;

(v) Those potential donors who were born or emigrated from a country where heterosexual activity is thought to play a major role in the transmission of HIV-2 infection.

Deferral of potential donors having had contact with potential viral pathogens, application of a tattoo, mucus membrane exposure to blood, exposure to blood or other body fluid through non-sterile skin penetration, non-casual contact with another person positive for hepatitis B surface antigen (HGsAg) or HIV, or being incarcerated in a correctional institution for more than 72 hours, shall be not less than twelve months.
Malaria:

(i) Potential donors diagnosed as having malaria must be excluded for a period of not less than 3 years after becoming asymptomatic;

(ii) A potential donor coming from a country considered endemic for malaria must be excluded for a period of not less than 3 years;

(iii) Potential donors who are permanent residents of a country in which malaria is not considered endemic, but who has traveled to a malaria endemic country must be excluded for a period of not less than 12 months, and they must be asymptomatic at the time of donation;

(iv) Malaria restrictions may not apply, if the donor is only donating plasma and the red cells are not used for transfusion purposes.

Other protozoan diseases: Potential donors with a history of Babesios is or Chagas' disease shall be deferred indefinitely.

(c) Donor Information. Potential donors must be informed and sign a consent form. This information/form must contain, at least, information relative to the potential danger of donation, the significance of blood-borne pathogens, and post-phlebotomy care. The donor must be given the opportunity to confidentially request that his/ her donation not be used for transfusion. A physician associated with the collecting facility must establish a means to notify donors of any significant abnormality detected during predonation evaluation or laboratory test results.

(d) Autologous donor blood. If a donation is only for autologous purposes, the donor requirements may be reduced, however, no donation shall be collected for an individual with a systemic infection. The unit must be labeled "autologous use only". Autologous units must be stored under the same requirements as banked blood. However, the autologous units must be segregated from the regular banked blood and blood components. The facility must be licensed by the FDA for the collection and storage of autologous donations.

The facility must have policies and procedures for the selection of donors, the collection, processing (testing), storage and disposition of autologous donations.
The ABO group and Rh type on these units to be transfused must be determined.
Test for HBsAg, HIV-1, anti-HIV-1, anti-HIV-2, anti-HCV, anti-Hbc and a serological test for syphilis must be performed by the collecting facility prior to being transfused in another facility. The unit must be labeled positive for any positive test results.
The transfusing facility and the physician must be informed of any abnormal test results. Prior to autotranfusion, the ABO group and Rh type of the donor and recipient must be confirmed.
Autologous units must be labe led "autologous donor" and "for autologous use only".

(e) Therapeutic donations:

Therapeutic bleeding, to include hemapheresis, can only be performed with the written approval of the patient's physician and must be approved by the director of the laboratory.
There shall be written policies and procedures for performing the phlebotomy.
Records must be retained to document patient identification, diagnosis, and type of therapeutic procedure performed, extracorporeal blood volume, nature and volume of component removed, quality control of measuring device, any occurrence of adverse reactions to medication, disposition of the blood, and the unit shall be labeled "not for transfusion".

(f) Reagent quality control. All reagents must conform to FDA regulations and manufacturer's instructions must be followed.

ABO antisera must be quality controlled with a positive control each day of use.
Rh antisera and reagent cells must be quality controlled with a negative control each day of use; the negative control may be deleted if indicated by the manufacturer.
Other antisera must be quality controlled with a positive and negative control each day of use.
Anti human globulin sera must be quality controlled with a positive and negative control each day of use.
Antibody screening cells must be quality controlled with a positive control each day of use.
Each bottle of reagents used in testing must be evaluated in the quality control program on the day of use.

(g) Transfusion services. It is the responsibility of the laboratory director to assure that the needs of the physicians responsible for the diagnosis, management, and treatment of patients are met in reference to blood, blood components, blood products and blood bank testing services.

(h) Preparation of blood components. The process of component preparation must be sterile and a closed system is preferred.

If a closed system is not employed or the seal is broken, components stored between 1- 6° C shall have an expiration date of 24 hours.
All components must be traceable through identification numbers and lot numbers.
For red blood cells, the unit must contain the type of anticoagulant/ preservative used in the collection.

(i) Red blood cells and deglycerolized red cells designated for freezing, must be frozen within six days of collection.

(ii) Rejuvenated red blood cells: following rejuvenation, the cells may be washed and transfused within 24 hours or deglycerolized and frozen; the label on the unit of blood after rejuvenation must indicate the rejuvenating solutions.

(iii) Irradiated red blood cells: for red blood cells which have received at least 500 cGy irradiation, the dose shall be a minimum of 2,500 cGy targeted to the midpoint of the canister; if free-standing irradiation is used, or to the center midplane of an irradiation field if a respiratory instrument is used; the method used for irradiation must be monitored at least annually to verify the delivered cGy.

Plasma components. Fresh frozen plasma - removed from a single donor must be stored at -18° C; if collected in CPD, CPD.2, OR CPDA-1, the plasma must be frozen within 8 hours of collection; if collected in ACD, the plasma must be frozen within 6 hours of collection. The freezing process must protect the plasma from chemical alteration.

(i) Cryoprecipated antihemophilic factor (AHF) must be thawed at 1-6° C, separated from the plasma and stored frozen within one hour; there must be a method to monitor the amount of AHF and fibrinogen harvested. For platelets and platelet pheresis, a method to determine the concentration of platelets must be established and followed. When leukocyte reduction is a consideration, there shall be a method to determine the leukocyte contamination.

(ii) For granulocyte pheresis, a method shall be established and followed to monitor the concentration of the component.

(iii) When any blood components are mixed/pooled, any plasma alloantibodies must be compatible with red cell antigens.

(i) Testing of donor blood. Prior to transfusion, the testing laboratory must perform, at a minimum, the following tests on donor blood:

ABO group must be performed by testing the red cells with anti-A and anti-B, and by testing the serum or plasma for expected antibodies to A1 and B red blood cells.
Rh type must be determined with anti-D; if the anti-D is negative, a test for weak D must be performed; both tests must be negative in order for the unit to be labeled D negative; the donor's previous record must be checked relative to ABO and Rh, and any discrepancy must be resolved.
Testing for unexpected red cell antibodies: serum or plasma from donors with a history of transfusion or pregnancy must be tested for the presence of clinically significant antibodies; if any such antibody(s) is detected, it must be identified, if the blood is to be transfused, and the blood and its components labeled with the identity of the antibody(s).
Testing to prevent disease transmission: All blood for transfusion must be tested for HBsAg, anti-HBC, anti-HTLV, HIV-1-Ag, anti-HIV-1, anti-HIV-2, anti-HCV, and with a serological test for syphilis; blood should not be transfused prior to completion of testing; in the event of prior transfusion, follow up investigation must be documented and the recipient's physician must be notified if the unit was found to be positive for any or all of those markers.

(j) Blood labeling. The label on a unit of blood or blood component must identify the original unit and any component, or component modification; the label must be clear, eye-readable, and may be machine readable; handwritten labels must be legible and in permanent ink; prior to labeling, a review to reveal units not to be issued shall be completed; the labeling process must include a second check to determine if an error has occurred in the labeling; this check must verify ABO, expiration date, and other appropriate labels on the unit as well as components. An appropriate label must be affixed, should modification be made to the component.

Unit identification. A unique identifier must be assigned to each unit by the collection facility; such identification may not be removed or altered by subsequent facilities; other facilities may affix another unique identifier which must identify the facility; no more than two unit identifications may appear on the unit at a given time.
Labeling at collection or preparation. At the time of collection for whole blood, and at the time of preparation for components, the unit must be labeled as to whether it is whole blood, a component, or an intended component, unique identification, type of anticoagulant (not required for frozen, deglycerolized, rejuvenated, or washed blood cells); for platelets, low volume red blood cells, fresh frozen plasma, pooled components, or components prepared by apheresis, the approximate volume must appear on the container, sedimenting agent (if any), and the identification of any facility collecting or modifying the blood component.
Labeling prior to use. The final container label must indicate at least the following information:

(i) Temperature of storage, expiration date/time, if appropriate, identification of the facility preparing the final component, ABO group, Rh type and interpretation of unexpected antibody test, when positive, and instructions for the transfusionist, at a minimum; to properly identify intended recipient, the statement "This product may transmit infectious agents. Caution: Federal law prohibits dispensing without a prescription."

(ii) The type of donor: i.e., volunteer, paid or autologous.

(iii) Name of anticoagulant, except for components, prepared by hemapheresis, and type of cells, i.e., frozen, deglycerolized, rejuvenated or washed red cells.

Irradiated blood and components must be labeled as such, along with the name of the facility performing the irradiation.
CMV negative red blood cells or cellular components to be issued to a CMV negative recipient must be labeled CMV-negative.
Labeling for pooled components: In addition to the labeling requirements under "labeling at collection or preparation" and "prior to use", the label for pooled components must contain the following: name of pooled component, final volume of pooled component, name of facility preparing the pooled component, and unique identification of pooled component. The following information must appear either on the label or on the attached tag:

(i) Number of units in the pool.

(ii) ABO group and Rh type in the pool (-Rh is not required for cryoprecipitate).

(iii) The record must contain the unique identification for each unit in the pool as well as the collecting facility.

Labeling of blood bags must meet FDA regulations (21 CFR 606 Subpart G).

(k) Storage. Refrigerators in which blood and blood components are stored must provide a uniform temperature. Blood and blood components must be stored within an acceptable temperature range.

Refrigerators, freezers, incubators, and other storage areas must have a continuously monitored record of the temperature; in those areas not continuously monitored, the temperature must be monitored and documented each four hours of storage.
Refrigerators and freezers used for the storage of blood and blood components must be equipped with an audible alarm, set to activate at a temperature to allow proper action to be taken before the blood and components reach unacceptable temperatures.
The alarm system used with liquid nitrogen storage must be set in such a manner as to alert personnel of an unsafe level of liquid nitrogen.
Blood and red blood cells must be transported in a manner to ensure a temperature of 1-10°C.
Components stored at 20-24° C.
Components stored in a frozen state must be transported to assure that they remain in the frozen state.

(l) Expiration of blood and blood components. Provided that FDA approved collection methods, solutions, labeling practices, storage, transportation and equipment are used, the expiration date that appears on the label must be followed under ordinary situations. In order to consider this the expiration date, the closed system under which the unit was collected must not have been compromised; dating periods must follow FDA regulations (21 CFR 610.5B).

(m) Apheresis. At a minimum, the following policies and procedures must be available and followed when blood or a blood component is to be returned to the donor in a timely manner to assure that only the donor's blood or blood component is re infused to the donor:

Only 0.9% USE injectable sodium chloride may be mixed with the blood as a diluent.
Donor must provide an informed consent.
A licensed physician must be responsible for the apheresis procedure and must assure donor care.
Only sterile, pyrogen-free, non-toxic containers and additives which are compatible with the contents may be employed (those approved by the FDA).
For apheresis performed for the purpose of transfusion (i.e., platelet, AHF, granulocytes), there must be policies and procedures to evaluate the recovery with the recipient's needs considered; those products not meeting the established criteria must not be transfused without additional evaluation.
The procedures employed must assure the safe reinfusion of blood and avoid possible air embolism.
Any adverse reactions must be documented and medical advice must be rendered.

(n) Plasmapheresis. The donor criteria for an occasional (not to exceed one donation in a four-week period) donation shall be the same as those for a whole blood donor.

When plasmapheresis occurs more frequently than once every four weeks, FDA regulations 21 CFR 600- 660 must be followed; for those donations not following this regulation, the donor must have a physical on the day of donation and a physician must request the donation and take responsibility for any undesirable outcome.
Cells shall be returned to the donor before collecting a second unit or within 2 hours of the initial phlebotomy; no more than 500 ml. of whole blood shall be removed at one time, or 1000 ml. for transfusion (or within 24 hours), unless, the donor's weight exceeds 176 lbs., in which case the amount shall be 600 ml. or 1200 ml. respectively.
If the pheresis is performed using an automated instrument, the amount of plasma collected shall not exceed the amount approved by the FDA for the instrument in use.

(o) Compatibility Testing. Requests for transfusion and samples from the recipient must contain sufficient information for positive identification of the recipient; the facility must establish policies to determine minimum criteria for recipient identification; these policies and procedures must contain provisions for emergency situations; the minimum acceptable information must be the patient's name (first and last) and an identification number, if not addressed in the emergency policy; any discrepancy must be resolved prior to testing. The facility must do the following as appropriate:

Recipient specimen labeling policies and procedures must be established by the facility. These policies and procedures must provide a method of positive recipient identification on the specimen, a unique identification between the recipient, the specimen(s), and the blood or components to be prepared for the patient, assure that the specimen is labeled at the time of collection in the presence of the recipient, and assure a method to identify and document the specific identity of the individual collecting the specimen. Should there by any discrepancy in the specific identification system, it must be resolved prior to testing.
The transfusion service must confirm the ABO group of all whole blood and red blood cells as well as the Rh type using a sample obtained from the attached segment. Any discrepancy in group and/or type must be reported to the collecting facility and the unit must be quarantined until notification from the collecting agency. This verification must be completed prior to release for transfusion. A label must be affixed to the unit indicating group and type confirmation.
Each blood specimen consisting of one or more tubes to be used in testing for the transfusion of whole blood and/or red blood cells must be tested for ABO group and Rh type. A screen for unexpected antibodies to red blood cell antigens must be performed. If the transfusion is to take place more than three days in the future, the specimen must be recollected and re-screened for antibodies to red blood cell antigens if:

(i) The patient has been transfused in the preceding three months with blood or components containing red blood cells;

(ii) The patient has been pregnant in the preceding three months or;

(iii) The patient history is not certain or unavailable.

ABO group must be determined using the red cells with anti-A and anti-B reagents. The serum or plasma must be tested using known A1 and B cells to determine the presence of expected antibodies to A1 and B cells. Any discrepancy must be resolved.
Rh typing must be determined using anti-D reagents. A control system must be employed, if indicated by the manufacturer of the anti-D reagent.
Screening for unexpected antibodies in the recipient's specimen must be conducted. This screen must be capable of detecting clinically significant antibodies and must include a 37º that are not pooled. With documentation of equivalent sensitivity, an alternative screening method may be employed. A control system using red blood cells sensitized with IgG must be applied to each test interpreted as negative. When a licensed test system is employed that does not allow the addition of IgG-sensitized cells, controls shall be used as recommended by the manufacturer.
Prior to release for transfusion of whole blood or red blood cells, the transfusion history or the patient must be reviewed in order to detect a possible error.
Except in cases of emergency, a sample of the recipient's serum or plasma must be crossmatched against a sample from the donor cells from a specimen attached to the unit of whole blood or red blood cells. The crossmatch must have the ability to demonstrate ABO incompatibility and clinically significant antibodies to red blood cell antigens and must include an antiglobulin test. If no clinically significant antibodies to red blood cell antigens are detected and the patient's history does not indicate a clinically significant antibody, then only serologic testing to detect ABO incompatibility is required.
A computer system that has been validated by the facility to prevent the release of ABO incompatible blood and blood components, may be used in place of a serologic crossmatch, provided that the system contains donor information to include the donor number, the component name, ABO group, and Rh type of the component and the interpretation of the ABO confirmatory test. The system must contain the recipient's ABO group and Rh type.

(i) There must be a method to verify correct entry of data prior to release of blood or components. The system must alert the user to discrepancies between the donor unit labeling and the blood group confirmatory test interpretation and to ABO incompatibilities between the recipient and the donor unit.

(ii) There must be documentation of initial training for those individuals using the system, and of annual training thereafter. After initial training, annual training may be limited to upgrades and/or changes in the computerized system. The facility must maintain a back-up program to implement in the event of failure or malfunction of the computerized system to assure uninterrupted service.

(q) Selection of blood and blood components for transfusion:

Recipients should receive ABO group specific whole blood of ABO group compatible red blood cells.
Whole blood and red blood cells must lack the red blood cell antigen when the recipient demonstrates the presence of a clinically significant, unexpected antibody(s) to a specific red blood cell antigen(s). In addition, the donor unit must lack the red blood cell antigen(s) when the recipient's history indicates the presence of a clinically significant antibody(s) directed toward a specific antigen.
Fresh frozen plasma should be ABO compatible, whenever possible.
The donor plasma in platelet preparations must be ABO compatible when the recipient is an infant. Red blood cells and granulocytes shall be ABO compatible with the recipient's plasma.
Each facility must have written and utilized policies and procedures for the release of blood and blood components for transfusion purposes.
When a recipient has received a volume of blood approximating his/her total blood volume in a 24-hour period, the compatibility testing procedure may be abbreviated. This is at the discretion of the director of the laboratory. There must be written policies and procedures for the laboratory personnel to follow.
Where recipients are under four months of age, the ABO group, using anti-A, anti-B, and the Rh type, using anti-D must be performed on the infant. For the antibody screen, serum or plasma from the infant or infant's mother may be used. If the initial red blood cell antibody screen is negative, it is not required to crossmatch donor red blood cells for the initial or subsequent transfusions for the duration of that hospitalization. If the initial antibody screen is positive for clinically significant red blood cell antibodies, the infant must be transfused with red blood cells that are negative for the corresponding antigen or are compatible by antiglobulin crossmatch.
In the case of massive or exchange transfusion, only blood drawn to be hemoglobin S negative should be transfused.

(q) Issuance and transfusion of blood and blood components. At the time of release for transfusion, the donor unit must be labeled as specified in the facility's policy. The information must include, at a minimum, the recipient's name (first and last), identification number, donor unit number, and compatibility test interpretation, if performed. There must be a mechanism to identify the intended recipient and requested blood component at the time of issue. The transfusion record for each unit of blood, blood component or pooled component must contain the intended recipient's name, identification number, ABO group, and if required, the Rh type, the interpretation of the compatibility tests, if performed, and the date of transfusion. Following the transfusion, the record must be made part of the patient's medical record. A sealed specimen from the recipient and the donor must be maintained at 1- 6ºC for a period of seven days post transfusion.

Blood must be inspected immediately before issuance. If it appears abnormal, the unit must not be transfused.
Blood that has been returned to the blood bank must not be reissued unless the container closure has not been disturbed, and blood has not been allowed to warm above place and followed to assure that temperature ranges are not exceeded. The record must indicate that the blood has been reissued, and that it has been inspected prior to being reissued.
At least one sealed segment of integral donor tubing must remain attached to the container. Those segments removed may be reattached, if the identification number on them are identical to the segment(s) that remain attached.
When the requesting physician indicated with a signed statement, that a delay in transfusion could be detrimental to the patient, the blood may be released prior to the completion of the tests that are performed to reduce the transmission of infectious diseases as well as the compatibility testing. In that event, recipients whose ABO group can be determined (excluding the recipients' history) may receive ABO group specific or ABO group compatible red blood cells or whole blood. The unit must be labeled in a conspicuous manner to indicate that the compatibility testing was not performed at the time of release. Standard compatibility tests should be completed promptly on those units signed out as "uncrossmatched". All requirements relative to the labeling of specimens to assure positive identification must not be ignored during the collection, release, or the transfusion of blood during an emergency. After completion of required testing, the laboratory must notify the recipient's phys icia n and the laboratory director, if a test result could effect the health and safety of the recipient.

(r) Transfusion complications. The facility must establish policies and procedures to assure that any transfusion complication is investigated. These policies and procedures must have a mechanism to detect errors in reporting, and evaluation of suspected complications of transfusion. All such investigations must be evaluated with a written interpretation by the laboratory director. The collection facility must be notified, if the complication appears to be attributed to the donor or the processing of the unit. Fatal transfusion reactions must be reported to the FDA, the collecting facility, and the Department.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Quality Control for Immunohematology" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.14 Quality Control for Hematology {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.14}

Instruments used in hematological examination of specimens shall be recalibrated, retested or reinspected, as appropriate, each day of use. Each procedure shall be recalibrated or rechecked each shift of use with standards or controls covering the entire range of expected values, unless required more frequently by the manufacturer or federal laboratory regulations. Tests such as the hematocrit and one-stage prothrombin time test shall be run in duplicate except as specified in published guidelines. Standard deviation, coefficient of variation, or other statistical estimates of precision shall be determined by the laboratory. All control materials used to satisfy the control requirement must have documented established limits.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Quality Control for Hematology" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.15 Quality Control for Exfoliative Cytology; Histopathology; and oral Pathology {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.15}

(1) Exfoliative Cytology.

(a) The laboratory must establish and document an annual evaluation of the number of cytology cases examined, the number of specimens processed by type, the number of cases reported by diagnosis, including the number of cases reported as unsatisfactory for diagnosis, the number of gynecologic cases where cytology and available histology are discrepant, and the number of cases where histology results were unavailable for comparison. The evaluation must also include the number of gynecologic cases where the rescreen of a negative or normal test results in a reclassification to a premalignant or malignant diagnosis.

(b) The laboratory must evaluate the case reviews of each person examining slides against the overall statistical values, document the reasons for deviations, and corrective actions taken, if needed.

(c) The laboratory must develop and implement procedures to detect inadequately prepared slides, assuring no diagnosis is reported on such cases. Such procedures must include a plan for promptly notifying referring physicians of inadequately prepared slides. The report must clearly distinguish specimens, or smears, or both, that are unsatisfactory for diagnosis interpretation. Documentation of unsatisfactory specimens and notifications must be retained by the laboratory for a minimum of five years.

(d) The laboratory director or supervisor qualified in cytology or cytotechnology shall rescreen for proper staining and correct interpretation at least a ten percent random sample of gynecological smears which have been interpreted to be in one of the benign categories by personnel not processing director or supervisor qualifications. The review must include negative cases selected at random from the total caseload and from patients or groups of patients that are identified as having a high probability of developing cervical cancer, based on available patient information. Records of initial examination and rescreening must be available. Rescreening must be performed prior to reporting.

(e) No laboratory shall assign or permit an individual engaged in the evaluation of cytology preparations by non-automated microscopic technique to examine more than one hundred (one patient per slide, gynecologic or non-gynecologic, or both) slides in a twenty-four hour period. This limit represents an absolute maximum number of slides in any twenty-four hour period, unless slide preparations are made using automated, semiautomated, or other liquid-based slide preparatory techniques resulting in cell dispersion over one-half or less of the slide area, in which case the slide counts as one-half slide, if examined by nonautomated microscopic technique. The maximum number of one hundred slides shall be examined in not less than an eight-hour period. Recognizing individual differences in abilities, the laboratory must establish the maximum number of slides (not to exceed the 100 slide limit) each individual may screen in a twenty-four hour period, and records must be available to document that each individual's workload limit is reassessed at least every six months and adjusted, when necessary. For the purposes of establishing workload limits for individuals examining slides by nonautomated microscopic technique on other than an eight hour workday basis, a period of eight hours must be used to prorate the number of slides that may be examined by using the following formula: number of hours examining slides X 100 / 8

(f) Records shall be maintained by the laboratory of the total number of slides examined by cytotechnologist during each twenty-four and eight hour period. It shall be the responsibility of each laboratory to maintain records of the number of slides read on and off the premises of the laboratory by cytotechnologists when such slides are assigned by that laboratory. All slides must be read on the premises of the licensed laboratory unless referred to another licensed laboratory.

(g) All gynecological smears interpreted to be in the "suspicious" or "positive" categories by cytotechnologists shall be confirmed by the laboratory director or supervisor, who is qualified in Exfoliative Cytology as specified in Rule 111-8-10-.06(1)(a)2. or (3)(b) , and who shall personally sign all such suspicious or positive reports. All nongynecological cytological preparations, positive and negative, shall be reviewed by such a director or supervisor qualified in cytology. All slides for exfoliative cytology must be retained as long as required by applicable federal law and regulations, but not less than five years from the date of examination.

(h) The laboratory must review, for each patient with premalignant or malignant gynecologic cytology results, all gynecologic cytology specimens received within the previous five years, if available. If significant discrepancies are found that would affect patient care, the laboratory must notify the patient's physician and issue an amended report.

(2) Histopathology and Oral Pathology. Special stains on tissue sections must be checked for intended reactivity by use of positive preparations, and results of reactions must be documented. Stained slides and tissue blocks shall be retained as long as required by applicable federal law and regulations, but not less than ten years for slides or two years for tissue blocks. Remnants of tissue specimens shall be retained in a fixative solution until those portions submitted for microscopy have been examined and a diagnosis made by a pathologist.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Quality Control for Exfoliative Cytology; Histopathology; and Oral Pathology" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.16 Quality Control for Tissue Banks {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.16}

Tissue banks which procure, store, or process human or animal tissue designed to be used for medical purposes in human beings shall conform to the procurement, storage and processing requirements listed in this section. The tissue bank must maintain donor and patient recipient records and communications. These records must be retained for not less than seven years after the distribution of the tissue material. These records shall be evaluated and reviewed by the director to ensure the suitability of the donated tissue for its intended use. Records must include the following:

(a) Each step in collection, preparation, testing, storage and distribution of the tissue must be documented concurrent with the performance of each step.

(b) Records must be legible and indelible and must include dates of testing, testing results, interpretations, assigned expiration date, if applicable, and the identity of the person performing the work.

(c) Donor identification and documentation of the pathological and microbiological evaluation of the donor shall be recorded.

(d) Each tissue and any component must be given a generic designation and a unique identification number which shall be used as the lot number throughout the collection, processing, distribution and utilization processes.

(e) All records concerning donor history, tissue processing and any other details deemed necessary (within the bounds of medical-legal and donor confidentiality) shall be available to authorized personnel upon request.

An adverse reaction file must be maintained.
An accurate inventory of all tissues (unprocessed, processed, and distributed) must be maintained.
There must be verification of step by step procedures under which tissue is procured, processed, tested and stored. Final disposition of the transplanted tissue must be recorded.

(f) Air drains, surfaces and water faucets shall include periodic sampling to ensure the tissue bank environment is maintained.

(g) The tissue bank shall have a system to prevent unauthorized entry either by physical configuration and/or an adequate security system.

(h) Procedures for recruiting donors shall be established and approved by appropriate officials.

(i) Permission to obtain tissues from living or non-living donors shall be documented through informed consent. Tissue banks must comply with Georgia Rules and Regulations for Anatomical Gifts, Chapter 111-8-5, as may be applicable.

(j) Tissues shall be processed by procedures which are appropriate for the type of tissue and the manner in which it is retrieved. Processing shall not change the physical properties of the tissues.

(k) Tissue preservation and types of storage containers shall ensure that the biological and biochemical properties are retained.

(l) Tissues shall be sent only to licensed and approved facilities that have accepted responsibility for proper handling and use. There shall be an agreement for notifications of the tissue bank if tissues are received in defective packaging, have been removed from sterile containers but not used, or have been lost. The following criteria for distribution must be met:

Transportation methods shall maintain proper environmental conditions during transit.
Excess product remaining after use shall be discarded unless the tissue bank retains control of the product and the product remains sterile.
Upon receipt of tissue, a record shall be made of its description, date received, and the tissue supplier and, if applicable, expiration dates.
Tissue shall not be dispensed without a documented order from the physician or other authorized health professional, and records of the person to whom this tissue was dispensed, and the integrity of the container and label.

(m) Records must be retained indefinitely to permit tracing of any tissue from the donor to all recipients or other final dispositions. Records must include the following:

Receipt, storage, and transportation information;
Identity of the source facility;
Type of tissue and the numeric or alphanumeric identification;
Name(s) of the recipient(s);
Personnel who prepared the tissue for dispensing;
Personnel who dispensed the tissue;
Personnel who accepted the tissue for use;
Dates of dispensing and transportation;
Identification of the ordering physician or other authorized health professional;

(n) Storage temperature records must be retained for five years.

(o) Container labels must include:

Name of product;
Name and address of tissue bank; and
Tissue identification number.

(p) Package labels must include:

Product name;
Name and address of the tissue bank;
Unique tissue identification number;
Expiration date of contents, if applicable;
Method of sterilization, if applicable;
Preservation and concentration or "no preservative" if preservative presents a safety factor;
Number of containers, if applicable;
Amount of product by weight;
Storage and handling instructions, including recommended storage temperature and special handling instructions relative to the product;
Sensitizing substances known to be present;
Antibiotics added during processing: type and calculated amount;
Product source, if a factor in safety of administration; and
A statement that the tissue donor was tested for HIV antibody and Hepatitis B surface antigen (HBsAg) using FDA approved tests and found to be nonreactive.

(q) Final container shall be packaged in a manner that ensures the integrity and sterility of the contents.

(r) A product insert must accompany all tissues.

(s) There shall be written procedures for tissue recall and notification of recipient centers of possible tissue contamination, errors detected in the processing, preparation or distribution process or other factors which may render the tissue unsuitable for its intended application.

(t) Standard nomenclature and units of measure shall be used to describe tissues and the processing they have undergone.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Quality Control for Tissue Banks" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.17 Quality Control for Sperm Banks/Embryology and Assisted Reproductive Technology (ART) {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.17}

(1) Sperm Banks. Facilities collecting semen specimens shall comply with the following:

(a) Sperm banks shall be staffed with personnel trained in the most current methods of cryobanking and who meet the personnel requirements of these rules.

(b) Records must contain a donor release and a complete history.

(c) Donor semen shall have specific identification codes for use during the freezing and storage processes. Codes shall in no way be linked to the donor or the recipient.

(d) Donor history shall include the following:

Interview;
Examination including personal, physical, sexual and genetic histories;
Examination of semen to ensure viability and motility, freedom from infection and/or foreign cells and freezing survival capabilities.

(e) Semen specimens shall be collected at the sperm bank and processing shall be initiated within one hour of collection. Test results and measurements shall be initiated within one hour of collection. Test results and measurements shall be documented concurrent with evaluation.

(f) An appropriate method of cryopreservation shall be chosen which ensures maximum viability and freedom from contamination. Documentation shall be available which validates the method chosen.

(g) Storage and handling instructions shall be made available to the requesting physician. Such instructions shall include handling and disposition of unused specimen. Donor semen shall not be refrozen or redistributed.

(2) Assisted Reproductive Technology (ART). Facilities providing ART shall comply with the following:

(a) The laboratory director must meet requirements at Rule 111-8-10-.06(2)(b) of these regulations; in addition, the director must have two years of documented experience in a laboratory performing ART procedures, have documented training of at least six months in an embryo laboratory which includes performing, at a minimum, each ART laboratory procedure 60 times. Included in the responsibilities of the director of the laboratory performing these procedures shall be:

To establish and monitor a program to ensure that aseptic conditions are maintained in the laboratory;
To assure that procedure manuals meet requirements at Rule 111-8-10-.09(2)(h) ;
Establish and monitor a quality assurance program that meets requirements at Rule 111-8-10-.06(3)(a) , as applicable.

(b) An ART supervisor shall meet the requirements at Rule 111-8-10-.06(3)(b)1. , 2., 3., or .06(4)(b)1., or 3., and have documented training which includes performing, at a minimum, each ART laboratory procedure sixty (60) times.

An ART supervisor must be accessible to laboratory personnel when ART procedures are performed, either on-site or via electronic means; and
An ART supervisor may perform director responsibilities as authorized, in writing, by the director.

Requirements at Rule 111-8-10-.06(4)(b)1. , or 3.;
Have documented ART training for laboratory procedures; and
Training must include the performance of ART procedures at least 30 times under director and constant supervision.

(d) In addition to meeting all safety requirements at Rule 111-8-10-.08 , an ART laboratory must also:

Be located in a secure place with access limited to authorized personnel;
Conduct laboratory activities under aseptic conditions; and
Use no radioisotopes in the laboratory where ART procedures are performed.

(e) In addition to meeting all quality assurance requirements at Rule 111-8-10-.09 , an ART laboratory must also:

Verify that materials which come in contact with sperm, oocytes, and embryos have been tested and found to be non-toxic to the sperm, oocytes and embryos;
Ensure patient confidentiality throughout the testing phase; and
Require that an authorized person's request for testing must be written or electronic; and that an oral request must be followed within 24 hours by a written or electronic request.

(f) In addition to meeting all quality control requirements, as applicable, at Rule 111-8-10-.09 , an ART laboratory must also:

Have documented criteria for assessment of oocyte morphology, maturity, fertilization, and embryo quality;
Document the insemination schedule relative to oocyte maturity;
Document volume, numbers, and quality of sperm used for insemination of each oocyte;
Document disposition of oocytes with an abnormal number of pronuclei; disposition of excess oocytes; and
Document critical time periods for various procedures.

(g) In addition to meeting specimen, reporting and records requirements at Rules 111-8-10-.11 , .12 , and .13 , an ART laboratory must also:

Keep records for the pre- and post-washing and concentration for insemination, the outcome of insemination and culture, and quality of all embryos at transfer, and the identity of testing personnel;
Use a reliable tracking method for cryopreserved specimens;
Use permanent labeling of containers; and
Assure that records are indelible and legible, retained for two years on-site and for ten years beyond the date of final disposition or disposal of all specimens obtained during each patient's ART cycle.

(h) If the ART laboratory ceases operation, it must make provisions for records to be maintained for the required time frames.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Quality Control for Sperm Banks/Embryology and Assisted Reproductive Technology (ART)" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.18 Quality Control for Specimen Collection Stations {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.18}

(1) A laboratory supervisor or designated supervisory qualified staff must make monthly on-site visits to specimen collection stations.

(2) Collection stations drawing specimens must have a written agreement with a designated person possessing medical emergency treatment skills to be available/on call during all hours of specimen collection.

(3) Procedure manuals for specimen collection stations must include procedures for:

(a) Proper collection of specimen;

(b) Types of specimens collected;

(d) Proper identification and labeling of specimens;

(e) Instructing facilities forwarding specimens to the collection station, including criteria for unsatisfactory specimens; and

(f) Forwarding reports to the appropriate physician when reports are returned to the collection station.

(4) Accession records for specimen collection stations shall indicate the following:

(a) Patient name;

(b) Requesting physician;

(d) Date of specimen collection;

(e) Date of referral to testing laboratory; and

(f) Date results are received back from reference laboratory.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Quality Control for Specimen Collection Stations" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.19 Quality Control for Cytogenetics {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.19}

(1) Each laboratory performing cytogenetics procedures shall engage the services of a sufficient number of testing personnel who meet the requirements as noted in Rule 111-8-10-.06 . In addition, the laboratory must document the competency of testing personnel in the areas of collection, handling, preparation and processing of various specimens, appropriate culture techniques for specimens submitted, proper techniques for setting up cell cultures and harvesting specimens, proper techniques of chromosome banding and staining, maintenance and use of microscopes, photographic and computer-generated imaging techniques and equipment, chromosome analysis including knowledge of normal and abnormal morphology, general laboratory skills, quality control, and understanding of general principles of genetics.

(2) Each cytogenetics laboratory must comply, at a minimum, with ma nfacturers' instructions except where applicable regulations are more stringent, when using reagents and equipment and must document all quality control activities.

(a) The laboratory must define and follow specific criteria for receiving specimens and for handling unacceptable specimens.

(b) The laboratory must establish and follow a maintenance schedule and must document routine maintenance and function checks on all instruments. Microscopes must have a sufficiently high resolution for examination of slides. The hoods used for processing and handling cultures must be designed to keep contaminants out, checked periodically to ensure that the filters are functioning properly and that the airflow meets specifications and protect employees.

(c) The laboratory must perform an acceptable quality control performance check on routine and fluorescent stains (the method must check the timing that is critical to the staining process). Corrective action must be documented, if staining time has to be adjusted. Reagents (purchased, made in-house or aliquoted) must be properly labeled, and include content and quantity, concentration or titer, storage requirements, date prepared or received, date placed in service and expiration date.

(d) For in-house culture media, an acceptable method of checking the pH, sterility, contamination and ability to support growth must be in place. The sterility of each lot or shipment of commercial media must be checked when received.

(e) The laboratory must establish procedures and follow the appropriate incubation period for cell cultures to achieve active cell division. Incubation time may vary for each diagnostic area. There must be a monitoring system in place to detect power failure which may affect the incubation phase.

(f) The laboratory must define and document chromosome analysis failure rates, maintain records of causes of failures and investigate cultures that failed.

(g) The laboratory must establish (based on standardized methods) the minimum number of cells examined for X and Y chromatin counts, fragile X, complete metaphases or other applicable analysis performed.

(h) Critical limits must be established for appropriate tests and records must identify the appropriate person to be notified if results do not fall within established limits.

(3) The laboratory must maintain records that indicate the media used, reactions observed, number of chromosomes counted for each metaphase spread, quality of banding, and resolution to support the final results and number of karyotypes for each individual. Records must also be maintained of confirmatory testing on all atypical results, of at least two cells karotyped for each use, and two cultures for each specimen type.

(4) The laboratory must establish guidelines, based on appropriate standards for setting time limits on signing out final reports. Preliminary reports must be submitted within a reasonable length of time as established by the laboratory. Laboratory reports must include type of banding used, number of cells counted and analyzed microscopically, number of cells from which photographic or computerized karotypes were prepared, band resolution, preliminary report results, a narrative report of clinical pathology interpretation of the laboratory findings, diagnosis and identification of testing personnel. The current International System of Human Cytogenetic Nomenclature (ISCN) or other standard nomenclature recognized industrywide, must be used correctly in the final report. The results of tests performed must be reviewed and signed out by the director.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Quality Control for Cytogenetics" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.20 Quality Control for Screening and Monitoring Tests {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.20}

(1) Facilities performing only screening and monitoring tests shall establish a training program with written guidelines and must keep documentation of the training of those personnel designated for performance of specific tests.

(2) Quality control procedures for screening and monitoring tests shall be performed for each test, if available. Controls and control frequency shall be according to published guidelines. Only tests approved by the Department may be performed; a list of approved tests shall be available from the Department. Proficiency testing is required for all tests, where such is available and graded.

(3) Results of exempt screening and monitoring tests, including all quality control records, shall be maintained separate from the patient's medical record for two years. The records must include the test date, time, patient's first and last name or unique identifier, test site, control/calibration results, lot numbers of reagents/controls, and identification of testing personnel.

(4) Reports of test results provided to non-physicians shall contain a statement which recommends that the results of the test be reviewed by a physician or that medical advice be obtained.

(5) The results of the tests shall be clearly identified as being performed by a nonlicensed facility and shall be displayed in a manner which will clearly differentiate them from results of a licensed laboratory.

(6) Screening test results which indicate abnormal conditions shall be noted with a recommendation that the abnormal results be confirmed by a definitive laboratory test performed in a licensed laboratory.

(7) Safety instruction using CDC's universal precaution guide lines for handling blood and instructions for packaging, labeling and disposal of potentially infectious waste materials and sharps, must be available to and practiced by the facility personnel.

(8) Each facility, performing whole blood cholesterol, HDL or other approved screening procedures, shall establish a training program with written guidelines and retain documentation of the training of those personnel designated for performing these procedures. The training shall include all areas of the testing process including the use of the instrument.

(a) Prior to performing cholesterol testing, the facility must evaluate the procedure for accuracy and precision. Maintenance and testing for proper operation of any analyzers shall be performed with the frequency specified by the manufacturer.

(b) Two levels of control must be performed at the beginning of each day of testing and one level of control must be performed if testing equipment is moved from site to site.

(c) Maintenance, quality control, current procedure manuals and test participant records shall be available at each test site or with each instrument in use.

(d) The screening facility shall recommend referrals for further cholesterol testing in accordance with the National Cholesterol Education Program (NCEP) published guidelines.

(e) Reports shall show the name, telephone number, street address, city and state of the screening facility/agency. The screening facility/agency shall provide privacy for blood sampling and confidential counseling about test results.

(f) Each screening entity shall have a medical review officer who is licensed to practice medicine in Georgia. This officer may authorize testing.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Quality Control for Screening and Monitoring Tests" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.21 Quality Control for Histocompatibility {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.21}

(1) Mechanical refrigerators and freezers with recording thermometers must have an audible alarm that is monitored 24 hours a day. If liquid nitrogen is used for storage of frozen cells, the level of liquid nitrogen in the cell freezers must be monitored periodically. Sera and reagents must be stored at an acceptable temperature range. Reagents, solutions, culture media, controls, calibrators or other materials must be labeled to indicate identity and when significant, titer, strength or concentration, recommended storage requirements, preparation and expiration date and other pertinent information. Reagents typing area (locally constructed trays) must indicate source, bleeding date, identification number and volume remaining.

(2) The laboratory must have available and follow written policies and procedures regarding specimen collection:

(a) Requisitions must include patient's first and last name or unique identifier, name and address of the authorized person who ordered the test, date and time of specimen collection and source of specimen.

(b) All specimens must be properly identified and easily retrievable. Blood samples must be labeled with the patient's first and last name or unique identifier, date of collection, and must be obtained in a manner which does not compromise aseptic techniques.

(3) The laboratory must maintain a system to ensure reliable specimen identification and document each step in the processing and testing of patient specimens. If "chain of custody" is a requirement, the laboratory must maintain records of the "chain of custody" of the sample, the phlebotomist who collected the sample, documentation to identify each specimen, and a signature to verify information submitted.

(a) Computer assisted analysis and all reports must be reviewed and verified by the supervisor or director. Records may be saved in a computer file if back-up files are maintained to ensure against loss of data.

(b) The laboratory must, at least once a month, give each individual performing tests a characterized specimen as an unknown to verify his or her ability to reproduce results.

(4) Records of the results for each individual must be maintained for a minimum of two (2) years. In addition, the laboratory must participate in at least one national or regional cell exchange program, if available, or develop an exchange system with another licensed/ certified laboratory in order to validate interlaboratory reproducibility.

(a) The laboratory must maintain records of each result, including preliminary reports, for at least two (2) years. Worksheets must clearly identify the subject whose cells were tested, the typing sera used, date of test and the person performing the test. For each cellserum combination, the results must be recorded in a manner which indicates the approximate percent of cells killed.

(b) Membranes or autoradiography from nucleic acid analysis must be retained as a permanent record.

(c) For marrow transplantation, the donor must give his/her informed consent before blood is taken for typing and before the donor is placed on a list of donors available to be called. Donor records for marrow transplantation must be maintained so that donors can be rapidly retrieved according to HLA type. The report must contain the date of collection, name, street address, city and state of the testing facility, patient's name or unique identifier, date of testing, date of final report, test results, control values and normal ranges where appropriate, interpretation, and signature of the director or his/her designee.

(5) Renal and Bone Marrow Transplantation. The laboratory must have established policies for selecting appropriate patient samples for crossmatching, preparing donor lymphocytes for crossmatching, and reporting crossmatch results; having available results of final crossmatches before an organ or tissue is transplanted, documenting efforts to obtain specimens for all potential transplant recipients at initial typing, for periodic screening, for pre-transplantation crossmatch and following sensitizing events such as transfusion and transplant loss. If transplantation is deferred, a new serum sample must be obtained from the patient at monthly intervals, screened for antibodies and stored in the frozen state for possible use in crossmatch tests. Serum used for crossmatching must be tested undiluted and with one or more dilutions. Crossmatching must use techniques documented to have increased sensitivity in comparison with the basic microlymphocytotoxicity test such as prolonged incubation, washing or augmentation with antiglobulin or flow cytometry. Final crossmatches performed prior to transplantation must utilize a serum sample collected within the past 48 hours before transplant if the recipient has class I lymphocytotoxic antibodies or has had a recent sensitizing event, otherwise, a serum collected within seven days may be used. Donors and recipients must be ABO and Rh typed according to blood bank standards.

(a) The laboratory must HLA type all potential transplant recipients and organ donors, and follow a policy that establishes when antigen redefinition and retyping are required.

(b) The laboratory must have and follow criteria for the preparation of lymphocytes for HLA-A, B and DR typing; select typing reagents which are made in-house or purchased commercially, assignment of HLA antigens and assure that reagents used for typing recipients and donors are adequate to define all major and International Workshops HLAA, B and DR specificities for which reagents are readily available.

(6) Potential transplant sera must be screened for HLA-A, B and DR antibodies with a suitable lymphocyte panel on sera collected, at the time of the recipient's initial HLA typing and thereafter, following sensitizing events and upon request. A suitable cell panel, which contains all the major HLA specificities and common splits for screening patient sera, must be used.

(7) Transfusion and Non-Renal Transplantation. All requirements specified in (5)(a) must be met.

(a) The laboratory must check each typing tray using positive and negative control sera and must use positive controls for specific cell types (i.e., T cells, B cells and monocytes) when applicable. Controls must be used to monitor the test components and each phase of the test system to ensure an acceptable performance for each compatibility test, i.e., mixed lymphocyte cultures, homozygous typing cells for DNA analysis.

(b) Compatibility tests for cellularly-defined antigens must use techniques such as the mixed lymphocyte culture test, or homozygous typing cells for DNA analysis. If the laboratory uses immunologic reagents such as antibodies or complement to remove contaminating cells during the isolation of lymphocytes or lymphocyte subsets, the methods must be verified with appropriate controls.

(8) Non-Renal Solid Organ Transplantation. The results of final crossmatches must be available before transplantation when the recipient has demonstrated presensitization by prior screening, except for emergency situations. The laboratory must document the circumstances, if known, under which emergency transplants are performed, and records must reflect any information concerning the transplant provide d by the patient's physician to the laboratory.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Quality Control for Histocompatibility" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.22 Quality Control for Flow Cytometry {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.22}

(1) A standard, consisting of latex beads or other uniform particles, shall be run to insure proper focusing and alignment of all lenses in the path, and for both the existing light source and signal (light scatter, fluorescence, etc.) detectors. The results of optical focusing/ alignment must be recorded each day.

(2) A threshold value for acceptable optical standardization shall be established for all relevant signals for each instrument and the focusing procedure repeated until these values are achieved or surpassed. If a particular threshold value cannot be attained, a written protocol for instituting corrective action must be available and used.

(3) A fluorescent standard, for each fluorochrome to be used, shall be run to insure adequate amplification of the fluorescent signal(s) each day of use and after any maintenance or adjustment of the instrument. This standard may be incorporated in the beads or other particles used for optical standardization or may be a separate bead of fixed cell preparation. If acceptable fluorescence separation cannot be attained, a written protocol instituting corrective action must be available and used.

(4) When performing analyses using two or more fluorochromes simultaneously, an appropriate procedure must be used to compensate for "spill over" into the other fluorescence detectors.

(5) For laser based instruments, the current input (amps) and laser light output (milliwatts), at the normal operating wavelength measured after the laser is peaked and normal operating power set, must be recorded as part of a daily quality control record.

(6) The use time of instruments with mercury fluorescent lamps must be recorded. Lamps must be replaced when the allowable use limit has been reached.

(7) The laboratory must run a positive and negative control each day of patient testing. The negative controls should include normal serum from a healthy individual. The positive control (using appropriate dilutions) should react with cells representing all HLA types (i.e., pulled high PRA sera).

(8) Each laboratory must establish and document its own threshold with multiple normal sera for discriminating positive crossmatches. For significant change in protocol, instrumentation, or software, the characterization of the positive threshold must be repeated.

(9) For internal labeling, the method used to allow fluorochrome labeled antibodies to penetrate the cell membrane must be documented as effective.

(10) Whether analyzed directly or fixed prior to analysis, labeled cells must be analyzed within a time period demonstrated by the laboratory to avoid significant loss of any cell sub-population or total cell numbers. Test samples must be analyzed within the same period, after staining, as the control samples.

(11) If analysis will be based on a population of cells selected by flow cytometry "gating" on size or density parameters, or selected depletion or enrichment techniques, control stains must be run for each test individual to detect the presence of contaminating cells in the selected population (i.e., monocyte contamination of lymphocytes gated by forward angle or forward angle vs. 90 degree light scatter must be detected with a monocyte specific marker antibody). For cell surface labeling, a method must be used to determine the proportion of viable cells in the population of counted cells (i.e., thidium bromide staining, CD45 staining). If this value falls below an established laboratory threshold, an appropriate reanalysis of specific measurements must be done.

(12) Conclusions about abnormal proportions of abnormal cell surface marker shall only be drawn in comparison with local control data obtained with the same instrument, reagents and techniques. Conclusions about leukemia/lymphoma classification shall be based on local or published reference data. Determination of percent positives must take into consideration the results of the negative control reagent.

(13) The specificity of monoclonal antibodies shall be verified by the published and/or manufacturer's documentation and, whenever possible, verified locally through tests with appropriate control cells prepared and tested by the same analysis. The quantities of reagents used for each test sample must be determined by the manufacturers from published data and, whenever possible, should be verified locally by appropriate titration procedures.

(14) Terminology used must be defined and/or must conform to nomenclature recommended/approved by the most recent International Workshop of Differentiation Antigens of Human Leukocytes or other appropriate scientific organizations.

History

Authority: O.C.G.A. §§ 31-22-1, 31-22-4
History. Original Rule entitled "Quality Control for Flow Cytometry" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.23 Evaluation {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.23}

The Department shall conduct a clinical laboratory performance evaluation (proficiency testing) program with the following requirements:

(a) All clinical laboratories shall enroll and successfully participate in a Department approved proficiency testing program. Point of Care testing areas shall be enrolled or participate in approved proficiency testing programs subscribed to by the responsible laboratory. No proficiency testing agency will be Department-approved unless it meets current requirements found in Title 42 U.S.C. Section 263 a.

(b) In addition, the Department may require the clinical laboratory to analyze test samples submitted or authorized by the Department and to report on the results of such analysis.

(c) Laboratories shall enroll in one or more representative segments of approved proficiency testing programs, if available, based upon the categories, subcategories and/or procedures for which a license is issued, and shall have copies of the results sent to the Department. External proficiency testing is not required for blood, tissue, and/or plasmapheresis donor screening procedures.

(d) Proficiency testing must be conducted in the laboratory being evaluated, by regular employees of that laboratory and in the same manner as patient testing. If a laboratory is found to have intentionally sent proficiency testing samples to another laboratory for analysis prior to receiving results back from the testing agency, it shall have its license revoked for a minimum of one year or a period that is equal to or more stringent than current federal law and regulations and, shall be subject to other appropriate sanctions as provided for in Chapter 111-8-25 of the Georgia Rules and Regulations for General Licensing and Enforcement Requirements; all records of proficiency testing must be retained and available for inspection for a period of not less than two years.

(e) Proficiency testing performance standards must be consistent with current federal requirements unless the Department elects to require more stringent standards.

History

Authority: O.C.G.A. §§ 31-2-8 and 31-22-1et seq
History. Original Rule entitled "Evaluation" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.24 Specimens Examined {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.24 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.24}

(1) A licensed clinical laboratory shall examine human specimens only at the request of a licensed physician, dentist or other person authorized by law to use the findings of laboratory examinations.

(2) All specimens accepted by a licensed laboratory shall be tested on the premises, unless forwarded to another licensed clinical laboratory.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Specimens Examined" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.25 Reporting {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.25 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.25}

The results of a test performed by a licensed clinical laboratory shall be reported only to (or as directed by) a licensed physician, dentist, or other authorized person requesting the test. Such reports shall include the name of the director and the name and street address of the clinical laboratory in which the test was performed. When a test is performed in a reference laboratory, the director, name and address of the laboratory performing the test must be clearly identified in the report.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Reporting" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.26 Records {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.26 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.26}

Records of all clinical laboratory services, including records of laboratory test requests and reports, shall be retained by the laboratory for as long as required by federal law and regulations, and:

(a) For general laboratory records and quality control records, kept at least two (2) years,

(b) For records of immunohematology and cytology, kept at least five (5) years, and

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Records" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.27 Reports to the Department {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.27 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.27}

(1) Clinical laboratories shall report to the Department evidence of selected infectious diseases on forms provided by the Department.

(2) Clinical laboratories making such reports concerning infectious diseases shall not be held liable for having violated a trust or confidential relationship. The reports shall be deemed confidential and not subject to public inspection.

(3) Reports of Serious Incidents/Events. The laboratory shall report to the Department the following incidents:

(a) Fatal transfusion reactions or transfusion complications affecting the patients;

(b) Laboratory testing errors which have resulted in the death or serious injury to a patient or employee;

(c) Significant interruptions in service vital to the continued safe operation of the facility, such as the loss of electricity, gas or water services.

(4) The laboratory shall make the initial report of the serious incident/ event within twenty-four (24) hours or by the next regular business day from when the reportable event occurred, or from when the laboratory has reasonable cause to believe that the reportable event has occurred. The initial report shall be received by the Department in confidence and shall include at least the following:

(a) The name of the laboratory;

(b) The date of the event or the anticipated event and the duration of the incident, if known;

(5) Within forty-five (45) days following the resolution of the event, the laboratory shall prepare a written report which includes a root cause analysis on systems and processes associated with the event to identify those improvements that are within the control of the laboratory that will be made to help prevent similar occurrences. The complete report shall be available to the Department for inspection at the facility. The laboratory is not required to complete a written report or a root cause analysis on interruptions in service for which the laboratory did nothing that contributed to the interruption in service.

(6) The Department will hold the initial self-report concerning the reportable serious incident/event in confidence and not release it to the public. However, where the Department determines that a rule violation related to the reported serious incident/event has occurred, the Department will initiate a separate complaint investigation of the incident. The separate complaint investigation report and survey results concerning the serious incident/event will not be kept confidential.

(7) Where a licensed laboratory is operated as an organized service of the licensed hospital, the laboratory may comply with the requirements for reporting serious incidents/events set forth in this rule by submitting its reports to the Department through the hospital- wide peer review committee, so long as the reports are made in a timely manner. Only one self-report of each serious incident/event is required to be made for the licensed laboratory that is operating within a licensed hospital.

History

Authority: O.C.G.A. §§ 31-7-15 and 31-22-1et seq
History. Original Rule entitled "Reports to the Department" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.28 Plasmapheresis and Whole Blood Donor Centers {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.28 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.28}

Clinical laboratories, including independent plasmapheresis and whole blood donor centers, which provide a system for the collection, processing or storage of human blood and/or its components shall provide methods for the selection of donors as well as methods for the collection, storage, processing, and transfusion, which shall ensure that the donation will not be detrimental to the donor and also protect (as far as possible) the recipient of human blood or any of its components from infectious disease known to be transmissible by blood.

(a) Special Personnel Requirements. In addition to the general personnel requirements outlined elsewhere in these Rules and Regulations, the following special personnel requirements are established:

Requirements for Directors and/or Physicians:

(i) In a whole blood, plasmapheresis or other blood component donor center, the director shall meet at least the requirements of Rule 111-8-10-.06(2)(b)1.

(ii) In a whole blood, plasmapheresis or other blood component donor center, the director and any other physician employed must be licensed in the State of Georgia and comply with all provisions of the Georgia Laboratory Licensure Law and associated regulations, and with all applicable federal regulations, specifically those provisions regarding physician requirements. The director shall be responsible, at all times, for all phases of operation.

Requirements for Other Personnel:

(i) Donor Selection (Screening) Area. The donor screening area shall be staffed with trained personnel with no lesser qualification than that of Licensed practical Nurse (LPN), Clinical Laboratory Technician or an equivalent level of training or experience. Every screener must be trained to recognize abnormalities, (i.e., blood pressure, pulse, etc.). Careful evaluation must be conducted by a skilled interviewer (based on the outline for donor selection published by the American Association of Blood Banks) to eliminate most donor reactions. A Clinical Laboratory Technologist or a licensed Registered Nurse (RN) must be assigned responsibility for supervision of the screening area, including such procedures as total protein, hemoglobin and hematocrit testing performed there.

(ii) Blood Collection (Phlebotomy) Area.

(I) The supervisors in the phlebotomy area must be persons who have a minimum of three months training and experience in a plasmapheresis or blood donor center and who are qualified as either a Registered Nurse or a Clinical Laboratory Technologist, Licensed Practical Nurse, or a Certified Physician's Assistant. One person of such qualifications must be employed for one (1) to twelve (12) donors being processed at one time.

(II) The phlebotomists in the phlebotomy area must be persons who have a minimum of one month training in a plasmapheresis or blood donor center and who meet no lesser qualifications in phlebotomy and/or reinfusion than that of Licensed Practical Nurse (LPN), Clinical Laboratory Technician, or equivalent level of training and/or experience. A phlebotomist must be employed for one to six donors being processed on automated equipment, for manual processing there must be one phlebotomist for one to four donors being processed at a time, with a minimum of two phlebotomists in the phlebotomy area whenever any donors are processed. (The phlebotomy supervisors may also serve as phlebotomists).

(iii) Laboratory Testing Area. Personnel in the laboratory area of all whole blood, plasmapheresis or other blood component donor centers must meet qualifications required for any licensed clinical laboratory.

(iv) Other Personnel. Other personnel may be employed or used in the center, such as aides, clerks, volunteer workers, etc. These persons may assist technical staff, but shall not themselves perform technical laboratory duties.

(b) Proficiency Testing Requirements. Rule 111-8-10-.23 outlines proficiency testing requirements for hematology, immunohematology, syphilis serology, HIV testing and hepatitis testing. External proficiency testing is not required for blood, tissue and/or plasmapheresis donor screening procedures such as specific gravity, hematocrits, dipstick tests and serum proteins. This exemption from external proficiency testing does not, however, exempt such facilities from quality control requirements, inspection and licensure.

(c) Documentation of Reactions. The records system of the facility must maintain documentation of all reactions. Adequate reporting and recording forms must be available and used.

(d) Blood Labeling and Associated Records. In addition to labeling required as a part of good laboratory practices, it shall be the responsibility of the licensed laboratory director to comply with Chapter 24 of Title 31 of the Official Code of Georgia Annotated and Rules and Regulations for Blood Labeling, Chapter 111-8-9.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Plasmapheresis and Whole Blood Donor Centers" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.29 Exemption of Specific Screening and Monitoring Tests {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.29 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.29}

A facility or part of a facility in which laboratory testing is performed may apply and qualify for exemption from personnel requirements for specific screening and monitoring tests or techniques, as approved and published by the Board.

(a) The Department shall establish guidelines for the exempted screening and monitoring tests, which shall include adequate provisions for (1) personnel, (2) quality control, (3) reporting, (4) record keeping and (5) safety. The guidelines and list of tests or techniques will be periodically reviewed and published by the Department.

(b) Screening and monitoring approvals shall be issued by the Department and shall be valid for one year or a limited and specified time.

(c) Approvals, renewal of approvals or continuation of approvals are subject to continued conformance with the published guidelines, as determined by the Department. If approval is not granted, the laboratory testing is subject to clinical laboratory licensure.

History

Authority: O.C.G.A. §§ 31-2-7 and 31-22-1et seq
History. Original Rule entitled "Exemption of Specific Screening and Monitoring" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.30 Inspection and Plans of Correction {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.30 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.30}

(1) Employees and agents of the Department shall have the right of entry into the premises of the laboratory during all hours of operation and full access to all records, reports and documents relevant to the licensure status of the laboratory as determined by the Department.

(2) Licensed laboratories shall submit to inspection by CMS or CMS agents as a condition of licensure, and failure to submit to such inspection shall constitute grounds for suspension or denial of the State license.

(3) A laboratory subject to CMS inspection is authorized and required by the Department to release to CMS or CMS agents all records and information required by CMS in the course of the inspection.

(4) The Department shall make periodic inspections of every clinical laboratory, at its discretion. The frequency of inspection shall take into consideration the compliance record of the laboratories, e.g., the laboratory personnel, proficiency testing performance, and the number or seriousness of deficiencies reported on or since the last on-site inspection.

(5) The director or the laboratory supervisor in charge of the laboratory in the director's absence shall be present during each inspection of the laboratory. In the case of hospital laboratories, the hospital administrator or the administrator's designee shall be available for interview at the opening and close of inspection.

(6) None of the inspections performed by the Department nor any reports generated by the Department shall relieve the licensee from its duty to maintain the safety of its equipment, the work place, or to ensure safe and accurate laboratory testing.

(7) Plan of Correction. If as a result of an inspection, violations of these licensing rules are identified; the laboratory will be given a written report of the inspection which identifies the rules violated. The laboratory shall submit to the Department a written plan of correction in response to the report of inspection, which states what the laboratory will do, and when, to correct each of the violations identified. The laboratory may offer an explanation or dispute the findings or violations in the written plan of correction, so long as an acceptable plan of correction is submitted within ten days of the facility's receipt of the written report of inspection. The laboratory shall comply with its plan of correction.

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Inspections and Plans of Correction" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.31 Exemptions {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.31 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.31}

These rules and regulations shall not apply to:

(a) Clinical laboratories operated by the Medical College of Georgia, the Emory University School of Medicine, Mercer University School of Medicine, Morehouse School of Medicine, or any other medical schools in Georgia, or the United States Government;

(b) Clinical laboratories operated and maintained exclusively for research and teaching purposes involving no patient or public health services;

(c) Clinical laboratories operated by duly licensed physicians exclusively in connection with the diagnosis and treatment of their own patients; or

(d) Pharmacists duly licensed in Georgia practicing in accordance with O.C.G.A. § 26-4-4 as it pertains to the performing or capillary blood tests and the interpretation of the results of those tests as a means to screen for or monitor disease risk factors and facilitate patient education. The capillary blood tests allowed under this exemption shall be limited to those capillary blood tests available to and for use by the public without licensure of the user of the test.

History

Authority: O.C.G.A. §§ 26-4-4 and 31-22-9
History. Original Rule entitled "Exemptions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.32 Variances and Waivers {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.32 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.32}

The Department, upon application or petition, may grant variances and waivers to these rules and regulations (after review and advice of Laboratory Advisory Council) when it is shown that the rule and regulation should not be applied as written, because strict application would cause undue hardship and that adequate standards affording protection of health, safety and care exist and will be met in lieu of the exact requirements, or that the purpose of the rule is met through equivalent standards affording equivalent protection of health, safety and care, or to allow experimentation or demonstration of new and innovative approaches to delivery of services, where the approach has the potential to improve service delivery and the intended protections afforded by the rule are being met.

History

Authority: O.C.G.A. § 31-2-7
History. Original Rule entitled "Variances and Waivers" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.33 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.33 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.33}

(1) The administration and enforcement of these rules and regulations shall be in accordance with Chapters 2, 5 and 22 of Title 31 of the Official Code of Georgia Annotated and Chapter 13 of Title 50 of the Official Code of Georgia Annotated and the Rules and Regulations General Licensing and Enforcement Requirements, Chapter 111-8-25.

(2) A Clinical Laboratory and/or Clinical Laboratory Director License may be denied, revoked, suspended, limited or renewal denied for:

(a) Making false statements of material information on an application for a license or any other documents required by the Department;

(b) Permitting unauthorized persons to perform technical procedures or to issue or sign reports;

(d) Performing a test for or rendering a report to a person not authorized by law to receive such services;

(e) Referring a specimen for examination to a clinical laboratory in this state which has not been licensed or exempted under Chapter 22 of Title 31 of the Official Code of Georgia Annotated or, if not in this state, certified under all applicable federal law and associated rules and regulations;

(f) Making a report on clinical laboratory work actually performed in another clinical laboratory without designating the director and the name and address of the clinical laboratory in which the test was performed.

(g) Lending the use of the name of the licensed clinical laboratory or its personnel to an unlicensed clinical laboratory;

(h) Violating or aiding in the violation of any provision of Chapter 22 of Title 31 of the Official Code of Georgia Annotated, or these rules and regulations;

(i) Violating any other provisions of law applicable to the proper operation of a clinical laboratory.

(3) Upon being notified of a conviction, plea, or first offender treatment of a licensed laboratory director involving the manufacture, distribution, trafficking, sale, or possession of a controlled substance or marijuana, the Department shall suspend or revoke the license of such individual as follows:

(a) Upon the first conviction, the licensed individual shall have his or her license to direct a clinical laboratory suspended for a period of not less than three months, provided, however, that in the case of a first conviction, plea, or first offender treatment for a misdemeanor the Department shall be authorized to impose a lesser sanction or no sanction upon the licensed individual, and

(b) Upon the second or subsequent conviction, the licensed individual shall have his or her license to direct a clinical laboratory revoked. The failure of a licensed laboratory director to notify the Department of a conviction as required in subsection C of Rule 111-8-10-.04(2) shall be considered grounds for revocation of his or her license to direct a clinical laboratory.

(c) A licensed laboratory director sanctioned under the foregoing subsections (a) or (b) may be entitled to reinstatement of his or her license to direct a clinical laboratory upon successful completion of a drug abuse treatment and education program approved by the Department.

(4) The operation or maintenance of an unlicensed clinical laboratory in violation of Chapter 22 of Title 31 of the Official Code of Georgia Annotated and these rules may be declared a nuisance, inimical to the public health, welfare, and safety. The Commissioner may bring an action for an injunction to restrain such violation or to enjoin the future operation or maintenance of any such clinical laboratory until compliance with Chapter 22 of Title 31 of the Official Code of Georgia Annotated and these rules has been demonstrated to the satisfaction of the Department. (5) Any person who violates any provision of Chapter 22 of Title 31 of the Official Code of Georgia Annotated or any of the rules and regulations promulgated thereto shall be guilty of a misdemeanor.

History

Authority: O.C.G.A. §§ 16-13-110et seq., 31-2-8 and 31-22-1et seq
History. Original Rule entitled "Enforcement" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-10-.34 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-10-.34 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-10-.34}

History

Authority: O.C.G.A. § 31-22-1et seq
History. Original Rule entitled "Severability" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Subject 111-8-12 Rules and Regulations for Criminal Background Checks

Ga. Comp. R. & Regs. r. 111-8-12-.01 Legal Authority {#sec-ga.-comp.-r.-regs.-r.-111-8-12-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-12-.01}

These rules are adopted and published pursuant to the Official Code of Georgia Annotated (O.C.G.A.) § 31-7-350 et seq. (effective Oct. 1, 2019).

History

Authority: O.C.G.A. §§ 31-2-5, 31-2-7, 31-7-360
History. Original Rule entitled "Legal Authority" adopted. F. Aug. 14, 2019; eff. Sept. 3, 2019.

Ga. Comp. R. & Regs. r. 111-8-12-.02 Title and Purpose {#sec-ga.-comp.-r.-regs.-r.-111-8-12-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-12-.02}

These rules, known as the Rules and Regulations for Criminal Background Checks, establish the minimum standards for the Georgia Long-term Care Background Check Program for conducting criminal background checks of owners, applicants for employment, administrators, onsite managers, directors and direct access employees at certain facilities.

History

Authority: O.C.G.A. § 31-7-350 et seq
History. Original Rule entitled "Title and Purpose" adopted. F. Aug. 14, 2019; eff. Sept. 3, 2019.

Ga. Comp. R. & Regs. r. 111-8-12-.03 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-12-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-12-.03}

In these rules, unless the context otherwise requires, the terms set forth herein shall mean the following:

(1) "Abuse" means the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain, or mental anguish. Such term includes the deprivation by an individual of goods or services that are necessary to attain or maintain physical, mental, and psychosocial well-being. Such term includes verbal abuse, sexual abuse, physical abuse, and mental abuse, including abuse facilitated or enabled through the use of technology.

(2) "Conviction" means a finding or verdict of guilty or a plea of guilty regardless of whether an appeal of the conviction has been sought.

(3) "Crime" means commission of:

(a) Any of the following offenses:

A violation of O.C.G.A. § 16-5-70 ;
A violation of O.C.G.A. § 16-5-101 ;
A violation of O.C.G.A. § 16-5-102 ;
A violation of O.C.G.A. § 16-6-4 ;
A violation of O.C.G.A. § 16-6-5 ;
A violation of O.C.G.A. § 16-6-5.1 ; or
A violation of O.C.G.A. § 30-5-8 ;

(b) A felony violation of:

Chapter 5, 6, 8, 9, or 13 of O.C.G.A. Title 16;
O.C.G.A. § 16-4-1 ;
O.C.G.A. § 16-7-2 ; or
O.C.G.A. § 31-7-12.1 ; or

(c) Any other offense committed in another jurisdiction which, if committed in this state, would be deemed to constitute an offense identified in this paragraph without regard to its designation elsewhere.

(4) "Criminal background check" means a search of the criminal records maintained by the Georgia Crime Information Center and the Federal Bureau of Investigation to determine whether an owner, applicant for employment, or employee has a criminal record.

(5) "Criminal record" means any of the following:

(a) Conviction of a crime;

(b) Arrest, charge, and sentencing for a crime when:

A plea of nolo contendere was entered to the crime;
First offender treatment without adjudication of guilt was granted to the crime; or
Arrested and charged for a crime if the charge is pending, unless the time for prosecuting such crime has expired pursuant to Chapter 3 of Title 17;

(c) Such term shall not include an owner, applicant for employment, or employee for which at least ten years have elapsed from the date of his or her criminal background check since the completion of all of the terms of his or her sentence; provided, however, that such ten-year period or exemption shall never apply to any crime identified in subsection 0) of O.C.G.A. § 42-8-60 .

(6) "Department" means the Department of Community Health of the State of Georgia, its agents and employees.

(7) "Direct access" means having, or expecting to have, duties that involve routine personal contact with a patient, resident, or client, including face-to-face contact, hands-on physical assistance, verbal cuing, reminding, standing by or monitoring or activities that require the person to be routinely alone with the patient's, resident's, or client's property or access to such property or financial information such as the patient's, resident's, or client's checkbook, debit and credit cards, resident trust funds, banking records, stock accounts, or brokerage accounts.

(8) "Employee" means any individual who has direct access and who is hired by a facility through employment, or through a contract with such facility, including, but not limited to, housekeepers, maintenance personnel, dieticians, and any volunteer who has duties that are equivalent to the duties of an employee providing such services. Such term shall not include an individual who contracts with the facility, whether personally or through a company, to provide utility, construction, communications, accounting, quality assurance, human resource management, information technology, legal, or other services if the contracted services are not directly related to providing services to a patient, resident, or client of the facility. Such term shall not include any licensed healthcare provider, including, but not limited to physicians, dentists, nurses, and pharmacists who are licensed by the Georgia Composite Medical Board, the Georgia Board of Dentistry, the Georgia Board of Nursing, or the State Board of Pharmacy.

(9) "Facility" means:

(a) A personal care home required to be licensed pursuant to O.C.G.A. § 31-7-12 ;

(b) An assisted living community required to be licensed pursuant to O.C.G.A. § 31-7-12.2 ;

(d) A home health agency required to be licensed pursuant to O.C.G.A. § 31-7-151 ;

(e) A hospice required to be licensed pursuant to O.C.G.A. § 31-7-173 ;

(f) A nursing home, skilled nursing facility, or intermediate care home required to be licensed pursuant to O.C.G.A. § 31-7-1 et seq.;

(g) An adult day center required to be licensed pursuant to O.C.G.A. § 49-6-83 ; or

(h) An adult residential mental health program required to be licensed pursuant to O.C.G.A. § 37-3-206 .

(10) "Fingerprint records check determination" means a satisfactory or unsatisfactory determination by the department based upon fingerprint based national criminal history information.

(11) "GCIC" means the Georgia Crime Information Center established under Article 2 of Chapter 3 of Title 35.

(12) "License" or "Permit" means the document issued by the department to authorize a facility to operate.

(13) "Owner" in the context of a nursing home or intermediate care home means an individual who is not an "excluded party" as such term is defined in O.C.G.A. § 31-7-3.3 , otherwise such term means an individual or any person affiliated with a corporation, partnership, or association, who has 10 percent or greater ownership interest in a facility and who performs one or more of the following:

(a) Purports to or exercises authority of a facility;

(b) Applies to operate or operates a facility;

(d) Resides at a facility;

(e) Has direct access at a facility;

(f) Provides direct personal supervision of facility personnel by being immediately available to provide assistance and direction when such facility services are being provided; or

(g) Enters into a contract to acquire ownership of a facility.

(14) "Records check application" means fingerprints in such form and of such quality as prescribed by GCIC under standards adopted by the Federal Bureau of Investigation and a records search fee to be established by the department by rule and regulation, payable in such form as the department may direct to cover the cost of obtaining a criminal background check.

(15) "Registry check" means a review of the nurse aide registry provided for in O.C.G.A. § 31-2-14 , the state sexual offender registry, and the List of Excluded Individuals and Entities as authorized in Sections 1128 and 1156 of the federal Social Security Act, as it existed on February 1, 2018, or any other registry useful for the administration of, or mandated under, these rules.

(16) "Satisfactory determination" means a written determination that an individual for whom a criminal background check was performed was found to have no criminal record.

(17) "Unsatisfactory determination" means a written determination that an individual for whom a criminal background check was performed was found to have a criminal record.

(18) "Willful" means acting deliberately, not that there is an intention to inflict injury or harm.

History

Authority: O.C.G.A. §§ 31-7-351, 31-7-355
History. Original Rule entitled "Definitions" adopted. F. Aug. 14, 2019; eff. Sept. 3, 2019.
Amended: F. Feb. 20, 2025; eff. Mar. 12, 2025.

Ga. Comp. R. & Regs. r. 111-8-12-.04 Registry and Professional Licensing Board Checks {#sec-ga.-comp.-r.-regs.-r.-111-8-12-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-12-.04}

(1) Prior to a criminal background check required by these rules, the facility shall perform a registry check of the owner, administrator, onsite manager, director, and employees. If an individual has not resided in this state for at least two years, the facility shall conduct registry checks of each state in which the individual resided for the previous two years, as represented by such individual or as otherwise determined by the facility.

(2) If the subject of the criminal background check is a licensed healthcare professional or is required to hold a professional license as a qualification for the position, a query of available information maintained by the Georgia Composite Medical Board, the Secretary of State, or other applicable licensing boards shall be conducted prior to a criminal background check to determine that such individual has a professional license and is in good standing.

(3) If the individual appears on a registry or has a professional license that is not in good standing, the facility must comply with the Rule 111-8-12-.06 .

(4) Except as provided in subsection (c) of O.C.G.A. § 31-7-359 , nothing in these rules shall be construed to limit the responsibility or ability of a facility to screen owners, applicants for employment, administrators, onsite managers, directors or employees through additional methods.

History

Authority: O.C.G.A. §§ 31-7-352, 31-7-354
History. Original Rule entitled "Registry and Professional Licensing Board Checks" adopted. F. Aug. 14, 2019; eff. Sept. 3, 2019.

Ga. Comp. R. & Regs. r. 111-8-12-.05 Records Check Application {#sec-ga.-comp.-r.-regs.-r.-111-8-12-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-12-.05}

(1) A records check application shall be required:

(a) For each owner, upon application for a new license;

(b) For each owner, upon application for a change of ownership;

(c) For each administrator, onsite manager or director of a facility, upon application for employment or prior to placement in the position;

(d) For each direct access employee, upon application for employment or prior to placement in the position; and

(e) For existing owners, administrators, onsite managers, directors and direct access employees, on or before January 1, 2021.

(2) In lieu of a records check application, the facility may submit documentation, satisfactory to the department, that the individual has received a satisfactory determination within the immediately preceding 12 months (provided the prior satisfactory determination was issued on or after October 1, 2019) or at any time prior if the individual's fingerprints have been retained under authority of O.C.G.A. § 35-33-3(a)(1)(f).

History

Authority: O.C.G.A. §§ 31-7-353, 31-7-354
History. Original Rule entitled "Records Check Application" adopted. F. Aug. 14, 2019; eff. Sept. 3, 2019.

Ga. Comp. R. & Regs. r. 111-8-12-.06 Employment Prohibition; Grace Period; Personnel Files; Notice {#sec-ga.-comp.-r.-regs.-r.-111-8-12-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-12-.06}

(1) Except for the Grace Period described in paragraph (3) below, an individual required to submit to a registry check and criminal background check shall not be employed by, contracted with, or allowed to work as an employee at a facility, or to serve as an administrator, onsite manager or director of the facility, if:

(a) The individual appears on a registry check;

(b) There is a substantiated finding of neglect, abuse, or misappropriation of property by a state or federal agency pursuant to an investigation conducted in accordance with 42 U.S.C. Section 1395i-3 or 1396r as it existed on February 1, 2018;

(d) The facility receives notice from the department that the individual has been found to have an unsatisfactory determination as a result of a criminal background check.

(2) An individual whose professional license is not in good standing may be employed by a facility in a position wherein his or her duties do not require professional licensure, so long as he or she has a satisfactory determination.

(3) Grace Period

(a) During pending criminal background checks. While a criminal background check is pending, the facility may permit an individual to have direct access to residents for a period not to exceed 30 days, provided that the individual is under the direct supervision of a staff member who has a satisfactory determination or otherwise meets the requirements of these rules. At the end of 30 days, if no background check determination has been issued by the department and the individual is working at the facility, the facility shall ensure that the individual does not have direct access to residents. The 30-day grace period shall not apply to placement of an administrator, onsite manager or director; the facility shall not appoint any individual to serve as an administrator, onsite manager or director while the background check for that individual is pending. In order for facilities subject to federal regulations that require background screening before employment to utilize the 30-day grace period, the facility first must obtain a GCIC state criminal history record check comparison of data with information other than fingerprints in order to verify that the individual has not been found guilty of abuse, neglect, exploitation, misappropriation of property, or mistreatment by a court of law.

(b) During administrative appeals. Unless prohibited under federal regulations, the facility may retain a current director, administrator, onsite manager or employee who has an unsatisfactory determination during the period of his or her administrative appeal.

(4) Personnel file. A personnel file for each employee shall be maintained by the facility. Such files shall be available for inspection by the department but shall otherwise be maintained to protect the confidentiality of the information contained therein and shall include, but not be limited to, evidence of each employee's satisfactory determination, registry check, and licensure check, if applicable.

(5) Notice to applicants. Each application form provided by a facility to an applicant for employment shall conspicuously state the following: "FOR THIS TYPE OF EMPLOYMENT, STATE LAW REQUIRES A NATIONAL AND STATE BACKGROUND CHECK AS A CONDITION OF EMPLOYMENT."

History

Authority: O.C.G.A. §§ 31-7-354; 31-7-355, 31-7-357
History. Original Rule entitled "Employment Prohibition; Grace Period; Personnel Files; Notice" adopted. F. Aug. 14, 2019; eff. Sept. 3, 2019.

Ga. Comp. R. & Regs. r. 111-8-12-.07 Ownership Prohibition {#sec-ga.-comp.-r.-regs.-r.-111-8-12-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-12-.07}

When the department determines that an owner has an unsatisfactory determination as a result of a criminal background check or has appeared on a registry check, the department shall notify such owner of the ineligible status for ownership and shall take the necessary steps to revoke the facility's license or refuse to issue a license if an application is pending.

History

Authority: O.C.G.A. § 31-7-358
History. Original Rule entitled "Ownership Prohibition" adopted. F. Aug. 14, 2019; eff. Sept. 3, 2019.

Ga. Comp. R. & Regs. r. 111-8-12-.08 Background Checks Initiated by the Department {#sec-ga.-comp.-r.-regs.-r.-111-8-12-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-12-.08}

The department may require a criminal background check on any facility owner, administrator, onsite manager, director or employee during the course of an abuse investigation involving such individual or if the department receives information that such individual was arrested for a crime. In such instances, the department shall require the owner or employee to furnish two full sets of fingerprints which the department shall submit to GCIC together with appropriate fees collected from the owner or employee.

History

Authority: O.C.G.A. § 31-7-355
History. Original Rule entitled "Background Checks Initiated by the Department" adopted. F. Aug. 14, 2019; eff. Sept. 3, 2019.

Ga. Comp. R. & Regs. r. 111-8-12-.09 Enforcement and Penalties {#sec-ga.-comp.-r.-regs.-r.-111-8-12-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-12-.09}

The department shall impose a civil monetary penalty fine in the amount of the lesser of $10,000.00 or $500.00 for each day that a violation of these rules occurs. The daily civil monetary penalty fine shall be imposed only from the time the facility knew or should have known that it employed an individual with a criminal record and until the date such individual's employment is terminated.

History

Authority: O.C.G.A. § 31-7-356
History. Original Rule entitled "Enforcement and Penalties" adopted. F. Aug. 14, 2019; eff. Sept. 3, 2019.

Ga. Comp. R. & Regs. r. 111-8-12-.10 Contested Results and Appeals {#sec-ga.-comp.-r.-regs.-r.-111-8-12-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-12-.10}

(1) An owner, applicant for employment, employee, administrator, onsite manager or director may:

(a) Obtain information concerning the accuracy of his or her criminal record, and the department shall refer such individual to the appropriate state or federal law enforcement agency that was involved in the arrest or conviction;

(b) Challenge the finding that he or she is the true subject of the results from a registry check, and the department shall refer such individual to the agency responsible for maintaining such registry; and

(2) Applicants for employment, employees, administrators, onsite managers or directors who received an unsatisfactory determination or whose name appears on a registry check conducted pursuant to these rules shall be eligible to appeal such determination pursuant to Chapter 13 of title 50, the "Georgia Administrative Procedure Act." In a hearing held pursuant to this paragraph, the hearing officer shall consider in mitigation the length of time since the crime was committed, the absence of additional criminal charges, the circumstances surrounding the commission of the crime, and other indicia of rehabilitation.

(3) Owners

(a) The department's unsatisfactory determination of an owner or any action by the department revoking or refusing to grant a license based on such determination, shall constitute a contested case for purposes of Chapter 13 of Title 50, the "Georgia Administrative Procedure Act," except that any hearing required to be held pursuant thereto may be held reasonably expeditiously after such determination or action by the department.

(b) In a hearing held pursuant to subparagraph (1)(c) above, the hearing officer shall consider in mitigation the length of time since the crime was committed, the absence of additional criminal charges, the circumstances surrounding the commission of the crime, other indicia of rehabilitation, the facility's history of compliance with the regulations, and the owner's involvement with the licensed facility in arriving at a decision as to whether the criminal record requires the denial or revocation of the license to operate the facility. When a hearing is required, at least 30 days prior to such hearing, the hearing officer shall notify the office of the prosecuting attorney who initiated the prosecution of the crime in question in order to allow the prosecuting attorney to object to a possible determination that the conviction would not be a bar for the grant or continuation of a license as contemplated under these rules. If objections are made, the hearing officer shall take such objections into consideration.

History

Authority: O.C.G.A. §§ 31-7-354, 358
History. Original Rule entitled "Contested Results and Appeals" adopted. F. Aug. 14, 2019; eff. Sept. 3, 2019.

Ga. Comp. R. & Regs. r. 111-8-12-.11 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-12-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-12-.11}

In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof. The remaining rules or portions thereof shall remain in full force and effect as if such rule or portions thereof so determined, declared or adjudicated invalid or unconstitutional were not originally part of these rules.

History

Authority: O.C.G.A. §§ 31-2-5, 31-2-7, 31-7-360
History. Original Rule entitled "Severability" adopted. F. Aug. 14, 2019; eff. Sept. 3, 2019.

Subject 111-8-13 Rules and Regulations for the Georgia Caregiver Registry

Ga. Comp. R. & Regs. r. 111-8-13-.01 Legal Authority {#sec-ga.-comp.-r.-regs.-r.-111-8-13-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-13-.01}

These rules are adopted and published pursuant to the Official Code of Georgia Annotated §§ 31-7-380 et seq.

History

Authority: O.C.G.A. §§ 31-7-380 et seq
History. Original Rule entitled "Legal Authority" adopted. F. Nov. 30, 2021; eff. Dec. 20, 2021.

Ga. Comp. R. & Regs. r. 111-8-13-.02 Title and Purpose {#sec-ga.-comp.-r.-regs.-r.-111-8-13-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-13-.02}

These rules, known as the Rules and Regulations for the Georgia Caregiver Registry, establish the minimum standards for the Georgia Caregiver Registry which allows employers who are family members or guardians of elderly persons to conduct an employment eligibility determination for an applicant or employee who will provide personal care services for the employer's family members or wards.

History

Authority: O.C.G.A. § 31-7-380
History. Original Rule entitled "Title and Purpose" adopted. F. Nov. 30, 2021; eff. Dec. 20, 2021.

Ga. Comp. R. & Regs. r. 111-8-13-.03 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-13-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-13-.03}

In these rules, unless the context otherwise requires, the terms set forth herein shall mean the following:

(a) "Applicant" means an individual applying to provide personal care services to an elderly person in a residence or location not licensed by the Department.

(b) "Caregiver Registry" means the database established by the Department to provide private family employers with access to employee or applicant eligibility determinations.

(c) "Criminal Background Check" means a search of the criminal records maintained by the Georgia Crime Information Center (GCIC) and the Federal Bureau of Investigation to determine whether an applicant or employee has a criminal record.

(d) "Department" means the Department of Community Health.

(e) "Elderly Person" means an individual who is 65 years of age or older.

(f) "Employee" means any individual who is providing personal care services to an elderly person in a residence or location not licensed by the Department.

(g) "Employer" means an individual who is considering an applicant or has hired an employee for a family member or ward.

(h) "Family Member" means an individual with a close familial relationship, including, but not limited to, a spouse, parent, sibling, or grandparent.

(i) "Personal care services" means home care, health care, companionship, or transportation and includes, but is not limited to, providing assistance with bathing, eating, dressing, walking, shopping, fixing meals, and housework.

(j) "Records Check Application" means fingerprints in such form and of such quality as prescribed by GCIC under standards adopted by the FBI and a records search fee, payable in such form as the Department may direct to cover the cost of obtaining a criminal background check.

(k) "Registry Check" means a review of the nurse aide registry provided in O.C.G.A § 31-2-14 , the state sexual offender registry, and the List of Excluded Individuals and Entities as authorized in Sections 1128 and 1156 of the federal Social Security Act, as it existed on February 1, 2018, or other registry useful for the administration of these rules as specified by the Department.

(l) "Ward" means an elderly person for whom a guardian has been appointed pursuant to O.C.G.A. § 29-1-1 et seq.

History

Authority: O.C.G.A §§ 31-7-381, 31-7-386
History. Original Rule entitled "Definitions" adopted. F. Nov. 30, 2021; eff. Dec. 20, 2021.

Ga. Comp. R. & Regs. r. 111-8-13-.04 Use of the Georgia Caregiver Registry {#sec-ga.-comp.-r.-regs.-r.-111-8-13-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-13-.04}

(1) The Georgia Caregiver Registry will enable employers who are family members or guardians of elderly persons in Georgia to obtain an employment eligibility determination for applicants or employees who are providing personal care services to the employer's family members or wards.

(2) The Caregiver Registry shall be used solely for those applicants or employees that offer personal care related services to an elderly person that is an employer's family member or ward in the State of Georgia. Personal care services performed pursuant to these rules shall not be performed at facilities licensed by the Department.

(3) The use of the Georgia Caregiver Registry is voluntary and not required by state or federal law.

(4) The Georgia Caregiver Registry shall not be used by facilities licensed by the Department, or other entities, or individuals who are not employers, as defined in this rule, to determine a person's employment status or for any other purpose.

(5) DCH will allow employers to use the Georgia Caregiver Registry to inquire about the eligibility status of an applicant or current employee as if they were applying to work or working in one of the facilities licensed under O.C.G.A. § 31-7-351(8) if the following requirements are met:

(a) the applicant or employee agrees to such request,

(b) the applicant or employee provides his or her fingerprints as set forth in O.C.G.A. Article 14, Chapter 7, Title 31; and

(c) the applicant or employee provides written consent to the inclusion of the results in the Georgia Caregiver Registry.

(6) If the requirements in Section 111-8-13-.04(5)(a)-(c) are satisfied, DCH shall issue a written eligibility determination to the applicant or employee. The employer shall be responsible for all employment decisions made based on the eligible or ineligible employment determination. Any fees associated with such check shall be paid by the employer, applicant, or employee.

(7) Should the applicant or employee refuse to include the results of their criminal background check into the Georgia Caregiver Registry then the Department shall not issue a determination as defined in O.C.G.A. §§ 31-7-351(15) and (16) .

History

Authority: O.C.G.A. §§ 31-7-380, 31-7-382, 31-7-383
History. Original Rule entitled "Use of the Georgia Caregiver Registry" adopted. F. Nov. 30, 2021; eff. Dec. 20, 2021.

Ga. Comp. R. & Regs. r. 111-8-13-.05 Appeals of Ineligibility Determinations {#sec-ga.-comp.-r.-regs.-r.-111-8-13-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-13-.05}

(1) If an applicant or employee receives an ineligible determination notice by the Department and wishes to appeal the ineligible determination, the applicant or employee must appeal by requesting an appeal in writing within ten (10) days of receipt of the notice. The applicant or employee must submit their request in writing for the Department at via submission of the Request for Administrative Appeal form located at the Department's website at https://dch.georgia.gov/divisionsoffices/hfrd/facility-licensure/georgia-criminal-history-check-system-gchexs/request (or such other location as indicated on the Department's webpage) or via mail to the Georgia Department of Community Health, Office of Inspector General, 19 th Floor, 2 M.L.K. Jr. Drive, SW, Atlanta, GA 30334, or such other mailing address listed for the Department's headquarters as set forth on its website located at www.dch.ga.gov.

(2) An applicant or employee who receives an ineligible determination or whose name appears on a registry check conducted pursuant to these rules shall be eligible to appeal such determination pursuant to Chapter 13 of Title 50, the "Georgia Administrative Procedure Act." In a hearing held pursuant to this paragraph, the hearing officer shall consider in mitigation the length of time since the crime was committed, the absence of additional criminal charges, the circumstances surrounding the commission of the crime, and other indicia or rehabilitation.

History

Authority: O.C.G.A. §§ 31-7-360, 31-7-384
History. Original Rule entitled "Appeals of Ineligibility Determinations" adopted. F. Nov. 30, 2021; eff. Dec. 20, 2021.
Amended: F. June 9, 2023; eff. June 29, 2023.

Ga. Comp. R. & Regs. r. 111-8-13-.06 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-13-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-13-.06}

In the event that any rule, sentence, clause, or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof. The remaining rules or portions of rules shall remain in full force and effect, as if such rule or portions thereof so determined, declared, or adjudged invalid or unconstitutional were not originally a part of these rules.

History

Authority: O.C.G.A. §§ 31-2-5, 31-2-7, 31-7-386
History. Original Rule entitled "Severability" adopted. F. Nov. 30, 2021; eff. Dec. 20, 2021.

Subject 111-8-16 Disaster Preparedness Plans

Ga. Comp. R. & Regs. r. 111-8-16-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-16-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-16-.01}

Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning hereinafter respectively ascribed to them:

(a) "Approved Plan" means a Disaster Preparedness Plan which has been found by the Department to meet the requirements of these regulations;

(b) "Board" means the Georgia Board of Community Health;

(d) "Commissioner" means the Commissioner of the Georgia Department of Community Health or his designee;

(e) "COVID-19" means coronavirus disease 2019;

(f) "Department" means the Georgia Department of Community Health;

(g) "Direct care staff person" means any employee, facility volunteer, or contract staff who provides to residents:

Any personal services, including but not limited to, medication administration or assistance, assistance with ambulation and transfer, and essential activities of daily living such as eating, bathing, grooming, dressing, and toileting; or
Any other limited nursing services, as defined in subsection (b) of Code Section 31-7-12 .

(h) "Disaster Preparedness Plan" or "Plan" means a written document which identifies, (1) potential hazards or events, that should they occur, would cause an emergency situation at the facility; and (2) proposes, for each identified emergency situation, a course of action so as to minimize the threat to health and safety of the patients or residents;

(i) "Facility" means any institution subject to licensure under the provisions of O.C.G.A. Chapter 31-7, Article 1; which is not exempted from the requirements of these rules and regulations;

(j) "Governing Body" means the Board of Directors or trustees, partnership, corporation, association, person or persons who are legally responsible for the facility's operation.

(k) "Long-term care facility" means a personal care home with 25 or more beds, an assisted living community, or a nursing home licensed by the Department.

(l) "SARS CoV-2" means Severe Acute Respiratory Syndrome Coronavirus 2, the strain of coronavirus that causes the COVID-19 disease.

History

Authority: O.C.G.A. §§ 31-7-3(c), 31-7-12
History. Original Rule entitled "Definitions" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Mar. 19, 2018; eff. Apr. 8, 2018.
Amended: F. Oct. 19, 2020; eff. Nov. 8, 2020.

Ga. Comp. R. & Regs. r. 111-8-16-.02 Exemptions {#sec-ga.-comp.-r.-regs.-r.-111-8-16-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-16-.02}

The following facilities are exempt from these rules and regulations:

(a) Facilities classified and licensed by the Department as: "Family Personal Care Homes", "Freestanding Emergency Care Centers", "Home Health Agencies", and "Specimen Collection Center" or "Health Testing Facilities."

(b) Institutions operated exclusively by the federal government or by any of its agencies.

(d) Health care facilities, other than nursing homes, which are certified by the Centers for Medicare and Medicaid Services (CMS) for participation in the Medicare program. All licensed nursing homes shall remain subject to these rules.

(e) Any health care facility accredited by a CMS-approved Accreditation Organization (AO), as long as the facility's accreditation status is maintained. Facilities losing accreditation shall immediately be subject to these rules.

History

Authority: O.C.G.A. §§ 31-2-4 (1982 Supp); 31-7, Article 1
History. Original Rule entitled "Exemptions" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Mar. 19, 2018; eff. Apr. 8, 2018.
Amended: F. Oct. 19, 2020; eff. Nov. 8, 2020.

Ga. Comp. R. & Regs. r. 111-8-16-.03 Disaster Preparedness Plan {#sec-ga.-comp.-r.-regs.-r.-111-8-16-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-16-.03}

(1) Unless specifically exempted in Rule 111-8-16-.02 every facility shall have a Disaster Preparedness Plan which meets the requirements of Rule 111-8-16-.04 . Disaster Preparedness Plan rehearsals shall be regularly conducted with a minimum of two rehearsals in each calendar year.

(2) The governing body shall be responsible for the development of the plan. The governing body shall designate those individual(s) within the facility who have primary responsibility for rehearsal and implementation of the plan.

(3) The facility shall designate staff to participate in the healthcare coalition for their region, as designated by the Department of Public Health (DPH). Participation in the coalition shall include:

(a) Initiation and maintenance of an account with the web-based emergency operations center managed by DPH or its contractor, agent or designee;

(b) Evidence of participation, at least annually, in communication drills with the coalition and/or attendance at coalition meetings; and

(c) Evidence of contact, at least annually, with the local emergency management agency coordinator for the area in which the facility is located.

(4) The facility shall review the plan at least annually and make appropriate updates. The Department shall require a revised plan under the following circumstances:

(a) A 10% or greater increase in the number of patients or residents at the facility;

(b) A change in evacuation strategy that requires different contractual arrangements for the facility;

(d) Technological advancements which provide new warning and communications systems or sources.

History

Authority: O.C.G.A. § 31-7-3(c)
History. Original Rule entitled "Disaster Preparedness Plan" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Mar. 19, 2018; eff. Apr. 8, 2018.

Ga. Comp. R. & Regs. r. 111-8-16-.04 Content of Plan {#sec-ga.-comp.-r.-regs.-r.-111-8-16-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-16-.04}

(1) The plan shall contain a section in which the unique needs of the facility's residents are identified and assessed.

(2) The plan shall contain a section which identifies the emergency situations to be addressed by the plan. As a minimum the following emergency situations shall be addressed:

(a) fire;

(b) explosion;

(d) loss of air conditioning or heat; and

(e) damage to physical plant resulting from severe weather, i.e., tornadoes, ice or snowstorms, etc. Other emergencies or hazards may be included in the plan.

(3) For each of the emergencies identified in subsection (2) above, the plan shall include a set of emergency guidelines or procedures. A standardized format should be used throughout the plan that clearly describes how the emergency procedures should be carried out. The emergency procedures should answer the questions of "who, what, when, where, and how", and allow the facility to be ready to act effectively and efficiently in an emergency situation.

(4) The written procedures referred to in subsection (3) above should address as a minimum: assignment of responsibility to staff members; care of the residents; notification of attending physicians and other persons responsible for the resident; arrangements for transportation and hospitalization; availability of appropriate records; alternate living arrangements; and emergency energy sources.

(5) The plan must contain a section that outlines the frequency of rehearsal and the procedures to be followed during rehearsal. The rehearsal should be as realistic as possible and designed to check the following:

(a) knowledge of facility staff regarding their responsibility under the plan;

(b) the reliability of individuals or community agencies or services that are listed in the plan as resources to be called upon in the event of an emergency. However, the quest for realism in the rehearsal of the plan should not require the actual movement of non-ambulatory patients/residents nor those whose physical or mental condition would be aggravated by a move.

(6) When portions of the facility's plan are contingent on services or resources of another agency, facility, or institution, the facility shall execute a written agreement with the other party or parties acknowledging their participation in the plan. Such agreement(s) shall be made a part of the plan.

(7) Long-term care facilities shall include in the plan a pandemic plan for influenza and other infectious diseases which conforms to CDC standards and contains the following minimum elements:

(a) Protocols for surveillance and detection of epidemic and pandemic diseases in residents and staff;

(b) A communication plan for sharing information with public health authorities, residents, residents' representatives or their legal surrogates, and staff;

(d) An infection control plan that addresses visitation, cohorting measures, sick leave and return-to-work policies, and testing and immunization policies; and

(e) A surge capacity plan that addresses protocols for contingency staffing and supply shortages.

History

Authority: O.C.G.A. §§ 31-7-3(c), 31-7-12.5
History. Original Rule entitled "Content of Plan" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Oct. 19, 2020; eff. Nov. 8, 2020.

Ga. Comp. R. & Regs. r. 111-8-16-.05 Special Requirements for Long-Term Care Facilities {#sec-ga.-comp.-r.-regs.-r.-111-8-16-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-16-.05}

Each Long-term care facility shall:

(1) Inform its residents and their representatives or legal surrogates by 5:00 P.M. the next calendar day following the occurrence of either a single confirmed infection of COVID-19 or another airborne infectious disease identified by the department or the CDC as a threat to public health, or three or more residents or staff with new-onset of respiratory symptoms occurring within hours of each other. Such information shall:

(a) Not include personally identifiable information;

(b) Include information on mitigating actions implemented to prevent or reduce the risk of transmission, including if normal operations of the facility will be altered; and

(c) Include any cumulative updates for residents and their representatives or legal surrogates at least weekly or by 5:00 P.M. the next calendar day following the occurrence of any subsequent confirmed infection of COVID-19, or whenever three or more residents or staff with new onset of respiratory symptoms occurs within 72 hours of each other;

(2) Maintain a minimum of a seven-day supply of protective masks, surgical gowns, eye protection, and gloves sufficient to protect all residents and staff based on CDC guidance and with consideration given to any widespread supply shortages documented by the facility or known to the department;

(3) Maintain and publish for its residents and their representatives or legal surrogates policies and procedures pertaining to infection control and mitigation within their facilities and update such policies and procedures annually; and

(4) On or before September 28, 2020, ensure that each resident and direct care staff person has received an initial baseline molecular SARS CoV-2 test as outlined by the CDC.

History

Authority: O.C.G.A. §§ 31-7-3(c), 31-7-12.5, 31-7-12.6
History. Original Rule entitled "Records" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013
Amended: New title "Special Requirements for Long-term Care Facilities." F. Oct. 19, 2020; eff. Nov. 8, 2020.

Ga. Comp. R. & Regs. r. 111-8-16-.06 Records {#sec-ga.-comp.-r.-regs.-r.-111-8-16-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-16-.06}

The facility shall maintain the following records and make them available to authorized Department employees upon request:

(a) a copy of the plan and any subsequent changes thereto;

(b) records of rehearsals of the plan;

History

Authority: O.C.G.A. § 31-7-3(c)
History. Original Rule entitled "Scope of Regulations" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: New title "Records." F. Oct. 19, 2020; eff. Nov. 8, 2020.

Ga. Comp. R. & Regs. r. 111-8-16-.07 Scope of Regulations {#sec-ga.-comp.-r.-regs.-r.-111-8-16-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-16-.07}

The rules as contained in this chapter expressly do not modify or revoke the provisions of any of the other rules of the Department of Community Health which have been or will be promulgated under the authority of O.C.G.A. Chapter 31-7, Article 1.

History

Authority: O.C.G.A. §31-7, Article 1
History. Original Rule entitled "Notice to the Department" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: New title "Scope of Regulations." F. Oct. 19, 2020; eff. Nov. 8, 2020.

Ga. Comp. R. & Regs. r. 111-8-16-.08 Notice to the Department {#sec-ga.-comp.-r.-regs.-r.-111-8-16-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-16-.08}

When an emergency situation occurs which dictates implementation of the plan and results in injury or loss of life, the Department shall be notified within 24 hours. Such notification may be verbal. In other emergency situations which dictate implementation of the plan a record shall be made including a written incident report and a written critique of the performance under the plan. These records shall be filed with the plan and made available to the Department during inspections of the facility.

History

Authority: O.C.G.A. § 31-7-3(c)
History. Original Rule entitled "Waivers and Variances" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: New title "Notice to the Department." F. Oct. 19, 2020; eff. Nov. 8, 2020.

Ga. Comp. R. & Regs. r. 111-8-16-.09 Waivers and Variances {#sec-ga.-comp.-r.-regs.-r.-111-8-16-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-16-.09}

The Department, upon petition, may grant variances or waivers of specific rules and regulations as provided for in O.C.G.A. § 31-2-7 when it has been shown that the rule or regulation is not applicable or to allow experimentation and demonstration of new and innovative approaches to the delivery of services, or the center has met the intended purpose of the rule through equivalent standards, provided that the granting of the variance or waiver will not jeopardize the health, safety or care of the residents. The Department may establish conditions which must be met by the facility in order to operate under the variance or waiver.

History

Authority: O.C.G.A. §§ 31-2-7, 31-7-3(c)
History. Original Rule entitled "Enforcement" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: New title "Waivers and Variances." F. Oct. 19, 2020; eff. Nov. 8, 2020.

Ga. Comp. R. & Regs. r. 111-8-16-.10 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-16-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-16-.10}

A facility which fails to comply with these rules and regulations shall be subject to revocation of its permit or provisional permit and/or other sanctions provided by law. The enforcement and administration of these rules and regulations shall be as prescribed in O.C.G.A. Chapter 31-5, Enforcement and Administrative Procedure, which includes provisions for:

(a) the misdemeanor penalty for violation of rules and regulations promulgated under Title 31;

(b) injunctive relief under appropriate circumstances; and

History

Authority: O.C.G.A. §§31-5, 31-7, Article 1
History. Original Rule entitled "Severability" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: New title "Enforcement." F. Oct. 19, 2020; eff. Nov. 8, 2020.

Ga. Comp. R. & Regs. r. 111-8-16-.11 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-16-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-16-.11}

In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof, and such remaining rules or portions thereof shall remain of full force and effect, as if such rules or portions thereof so determined, declared or adjudged invalid or unconstitutional were not originally a part hereof. It is the intent of the Board of Community Health to establish rules and regulations that are constitutional and enforceable so as to safeguard the health and well-being of the people of the State.

History

Authority: O.C.G.A. § 31-7-3(c)
History. Original Rule entitled "Severability" adopted. F. Oct. 19, 2020; eff. Nov. 8, 2020.

Subject 111-8-19 Rules and Regulations for Drug Abuse Treatment and Education Programs

Ga. Comp. R. & Regs. r. 111-8-19-.01 Legal Authority {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.01}

These rules are adopted and published pursuant to the Official Code of Georgia Annotated (O.C.G.A.) Sec. 26-5-1et seq.

History

Authority: O.C.G.A. § 26-5-1et seq
History. Original Rule entitled "Legal Authority" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.02 Title and Purposes {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.02}

These rules shall be known as the Rules and Regulations for Drug Abuse Treatment and Education Programs. The purpose of these rules is to provide minimal requirements for the licensing and inspection of drug abuse treatment and education programs, not subject to regulation as licensed hospitals, or approved Emergency, Receiving, Evaluation and/or Treatment (ERET) services or licensed Narcotic Treatment Programs monitored by the State Methadone Authority.

History

Authority: O.C.G.A. § 26-5-1et seq
History. Original Rule entitled "Title and Purposes" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.03 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.03}

In these rules, unless the context otherwise requires, the words and phrases set forth herein shall mean the following:

(a) "Ambulatory Detoxification Program" means a program for the medical management and other support for processes associated with the physical process of withdrawal from drugs in a non-residential setting. Persons treated in this setting are without unusual or significant medical risks or behavioral problems.

(b) "Behavior management" means those principles and techniques used by a facility to assist a client in facilitating self-control, addressing inappropriate behavior, and achieving positive outcomes in a constructive and safe manner. Behavior management principles and techniques shall be used in accordance with the client's treatment plan, written policies and procedures governing service expectations, treatment goals, safety, security, and these rules and regulations.

(c) "Branch" means a part-time (operating less than five days per week) substance abuse program at a site or location different from the location of the licensed program, yet which is operated as a part of the licensed program and is not separately licensed.

(d) "Department" means the Department of Community Health, acting through the Division of Healthcare Facility Regulation, or its successor.

(e) "Drug abuse treatment and education program" or "program" means any system of treatment or therapeutic advice or counsel provided for the rehabilitation of drug dependent persons and shall include programs offered in residential and/or nonresidential settings.

(f) "Drug dependent person" means a person who is in imminent danger of becoming dependent upon or addicted to the use of drugs or who habitually lacks self-control as to the use of drugs or who uses drugs to the extent that his health is substantially impaired or endangered or his social or economic function is substantially disrupted.

(g) "Drugs" means any substance defined as a drug by federal or Georgia law or any other chemical substance which may be used in lieu of a drug to obtain similar effects, with the exception of alcohol and its derivative.

(h) "Emergency safety interventions" means those behavioral intervention techniques that are authorized under an approved emergency safety intervention plan and are utilized by properly trained staff in an urgent situation to prevent a client from doing immediate harm to self or others.

(i) "Emergency safety intervention plan" means the plan developed by the facility utilizing a nationally recognized, department-approved, evidence-based, training program for emergency safety intervention. The plan shall clearly identify the emergency safety interventions staff may utilize and those that may never be used.

(j) "Final Adverse Finding" means

the issuance of a ruling by the Commissioner of the Department of Community Health on any appeal from a decision of a state administrative law judge or hearing examiner pursuant to a contested case involving the imposition of a sanction;
when a decision of the state administrative law judge or hearing examiner becomes final by operation of law because no appeal is made to the Commissioner of the Department of Community Health;
where the parties to a contested case dispose of the case by settlement; or
where a facility does not contest within the allotted time period a sanction imposed by the department.

(k) "Governing body" means the county board of health, the partnership, the corporation, the association, or the person or group of persons who maintains and controls the program and who is legally responsible for the operation.

(l) "Inspection" means any examination by the department or its representatives of a provider, including but not necessarily limited to the premises, staff, persons in care, and documents pertinent to initial and continued licensing so that the department may determine whether a provider is operating in compliance with licensing requirements or has violated any licensing requirements. The term inspection includes any survey, monitoring visit, complaint investigation, or other inquiry conducted for the purposes of making a compliance determination with respect to licensing requirements. Such examinations are generally unannounced.

(m) "License" means the official permit issued by the department which authorizes the holder to operate a drug abuse treatment and education program for the term provided therein.

(n) "Manual hold" means the application of physical force, without the use of any device, for the purpose of restricting the free movement of a client's body. A manual hold does not include briefly holding the client without undue force to calm or comfort the client, holding the client by the hand or by the shoulders or back to walk the client safely from one are to another where the client is not forcefully resisting the assistance, or assisting the client in voluntarily participating in activities of daily living.

(o) "Mechanical restraint" means a device attached or adjacent to the client's body that is not a prescribed and approved medical protection device, and that he or she cannot easily remove, that restricts freedom of movement or normal access to his or her body.

(p) "Narcotic Treatment Program" means a program for chronic heroin or opiate-like drug users that administers narcotic drugs under physicians' orders either for detoxification purposes or for maintenance treatment in a rehabilitative context. This program is licensed according to rules promulgated by the department.

(q) "Outpatient Drug Treatment Program" means a non-residential program staffed by professional and paraprofessional persons that provides drug treatment or therapeutic services, primarily counseling and other supportive services for drug dependent persons, and is not classified as an ambulatory detoxification program or Specialized Day Treatment Program.

(r) "Parent program" means the licensed program that develops and maintains administrative controls of Subunits and Branches of the program.

(s) "Residential Sub-Acute Detoxification Program" means a residential program for drug dependent persons which includes the medical management and other support for processes associated with the physical withdrawal from drugs in a residential setting, staffed by professional and paraprofessional persons, which is not in a licensed hospital or approved ERET facility.

(t) "Residential Intensive Treatment Program" means a residential program staffed by professional and paraprofessional persons which provide highly structured treatment and therapeutic activities that focus on stabilization, abstinence, and skills required for recovery; are not classified as a residential sub-acute detoxification program.

(u) "Residential Transitional Treatment Program" means a residential program which provides therapeutic services to drug dependent persons, who are transitioning to the community or to other treatment modalities, and who, typically, lack a stable living situation and require variable levels of therapeutic services.

(v) "Seclusion" means the involuntary confinement of a client away from other clients, due to imminent risk of harm to self or others, in a room or an area from which the client is physically prevented from leaving.

(w) "Specialized Day Treatment Program" means a non-residential program for drug dependent persons staffed by professional and paraprofessional persons that provides structured treatment or therapeutic services, utilizing activity schedules as part of its operational method; it is not classified as an ambulatory detoxification or outpatient drug treatment program.

(x) "Special Program" means a program that provides therapeutic services to drug dependent persons which does not fit into existing program classifications.

(y) "Subunit" means a full-time program for drug dependent persons operated semiautonomously in a different location from the Parent program, which may provide different modalities of services, and must independently meet the licensing requirements and shall be separately licensed.

(z) "Time out" means a behavior management technique that involves the brief separation of a client from the group or setting where the client is experiencing some behavioral or emotional distress, not to exceed twenty (20) minutes, designed to de-escalate the emotionally charged condition of the client. During "time-out" a client's physical freedom of movement is not restricted.

History

Authority: O.C.G.A. § 26-5-1et seq
History. Original Rule entitled "Definitions" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.04 Governing Body {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.04}

Each licensed program shall have a clearly identified governing body. The chairperson or chief executive officer of the governing body shall complete a statement of responsibility on behalf of the governing body acknowledging the governing body's responsibility for the operation of the program in accordance with these rules in connection with any application for a license on a form provided by the department. If a program is individually owned, then the owner(s) will complete the statement of responsibility.

History

Authority: O.C.G.A. § 26-5-1et seq
History. Original Rule entitled "Governing Body" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.05 Licenses {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.05}

No governing body shall operate a drug abuse treatment and education program in the state without first obtaining a license or provisional license. A licensed program may offer one or more of the program services described in these rules.

(a) License. A license will be issued, upon presentation of evidence satisfactory to the department, that the program is in compliance with these rules and all applicable federal and state laws for the handling and dispensing of drugs, and all state and local health, safety, (including fire, sanitation, building) and zoning requirements. A license shall remain in force and effect for a period determined by the department unless sooner suspended or revoked by the department. Such license shall describe each type of service and program that the licensee is authorized to provide. Any changes in authorized services and programs shall be reported to the department. The department will determine whether a new license is required.

(b) Provisional license. A provisional license may be issued for a period not to exceed 90 days to a program that has substantially complied with all requirements for a regular license. Provisional licenses shall be renewed at the discretion of the department only in cases of extreme hardship and in no case for longer than 90 days. The obligations and conditions of a provisional license shall be the same as those of a license unless otherwise provided for by the department. Such provisional license shall describe each type of service and program that the licensee is authorized to provide. Any changes in authorized services and programs shall be reported to the department. The department will determine whether a new license is required.

(c) Qualifications Requirement. In order to obtain or retain a license or provisional license, the administrator of the program and its employees must be qualified, as defined in these rules, to administer or work in a program. However, the department may require additional reasonable verification of the qualifications of the administrator and employees either at the time of application for a license or provisional license or at any time during the license period whenever the department has reason to believe that an administrator or employee is not qualified under these rules to administer or work in a program.

(d) License is nontransferable. A license or provisional license to operate a program is nontransferable for a change of location or governing body. Each license or provisional license shall be returned to the department in the following cases: changes in location, governing body, program closure or the license is suspended or revoked.

(e) Exclusions. The following types of entities are not subject to these specific rules:

Narcotic Treatment Programs which are licensed/monitored by the State Methadone Authority;
Licensed hospitals not operating separate and distinct drug abuse treatment programs as classified by the department;
Approved Emergency Receiving, Evaluation and/or Treatment (ERET) facilities which have been licensed or approved by the department and are not operating drug abuse treatment programs as classified by the department;
Licensed individual professionals operating in compliance with their state practice acts but do not offer or purport to offer "Drug Abuse Treatment and Education Programs.
Organizations or persons that provide supportive services (i.e. residence, transportation, and etc.) to drug dependent persons but do not offer or purport to offer "Drug Abuse Treatment and Educational Programs." Support services under the direct control of licensed programs must be a part of the licensed program.

History

Authority: O.C.G.A. §§ 26-5-6 to 26-5-11, 26-5-14, 31-2-4
History. Original Rule entitled "Licenses" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.06 Accreditation {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.06}

The department may issue a license to a program that provides proof of accreditation by an accreditation agency approved by the department, if the accreditation agency's requirements are substantially equivalent or more stringent than the requirements of these rules. The license may be issued without an on-site visit by the department, however, the department reserves the right to inspect accredited programs on a sample validation basis or whenever there is reason to believe that the requirements of these rules are not being met. Provided however, any denial, suspension, or revocation of such accreditation shall result in similar licensure actions, and the governing body shall be required to apply for a new license. For purpose of this rule, proof of accreditation shall require a copy of the program's most recent accreditation report together with any supplemental recommendations or reports. Such reports shall be submitted to the department whenever received by a program or whenever requested by the department.

History

Authority: O.C.G.A. §§ 26-5-6, 26-5-10, 31-2-4, 37-1-22, 37-7-3
History. Original Rule entitled "Accreditation" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.07 Applications {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.07}

(1) An application for a license to operate a drug abuse treatment and education program shall be submitted to the department on forms provided by the department, as well as requested updating information, and shall include assurances satisfactory to the department that the program is in compliance with all applicable federal and state laws for the handling and dispensing of drugs, with professional practice acts, and all state and local health, safety, sanitation, building, and zoning requirements.

(2) False or Misleading Information. An application for a license must be truthfully and fully completed. In the event that the department has reason to believe that an application has not been completed truthfully, the department may require additional verification of the facts alleged. The department may refuse to issue a license where false statements have been made in connection with an application or any other documents required by the department.

History

Authority: O.C.G.A. §§ 26-5-6, 26-5-8
History. Original Rule entitled "Applications" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.08 Inspections and Plans of Corrections {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.08}

(1) The department is authorized and empowered to conduct onsite inspections of any program to verify compliance with these rules. A program shall permit any authorized department representative to enter upon and inspect any and all program premises which, for the purposes of these rules, shall include access to all parts of the facility, staff, persons in care, and documents pertinent to initial and continued licensure, including but not limited to all clinical records maintained on clients. Failure to permit entry and inspection shall constitute noncompliance or violation of this rule and, subject to notice of an opportunity for a hearing, may result in the denial of any license applied for or the suspension or revocation of a license or provisional license. Inspections are generally unannounced, and may occur at any time the department deems necessary.

(2) If as a result of an inspection, violations of these licensing rules are identified, the program will be given a written report of the inspection which identifies the rules violated. The program must submit a written plan of correction in response to the report of inspection which states what the program will do when to correct each of the violations identified. The program may offer any explanation or dispute the findings of violations in the written plan of correction so long as an acceptable plan of correction is submitted within ten days of the receipt of the written report of inspection. Failure to submit an acceptable plan of correction may constitute cause for the department to deny a license or suspend or revoke a license.

History

Authority: O.C.G.A. §§ 26-5-6, 26-5-13, 26-5-14
History. Original Rule entitled "Inspections and Plans of Corrections" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013

Ga. Comp. R. & Regs. r. 111-8-19-.09 Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.09}

(1) Program Purpose. A licensed program shall develop and implement written policies and procedures that specify its philosophy, purpose, and program orientation. Such policies and procedures shall identify the types of drug abusers and the ages of the clients that it serves, including referral sources. When the program serves persons with special needs, the description shall explain how these special needs will be met.

(2) Program Operations. A licensed program shall develop and implement written policies and procedures for operations to include:

(a) A description of the range of treatment and services provided by the program to be reviewed annually and updated as needed, specifying which American Society of Addiction Medicine (ASAM) levels of care will be offered, what services will be provided directly by the program, and what services are provided in cooperation with available community or contract resources;

(b) The process for intake, assessment, admission, treatment planning, and evaluation of treatment;

(d) The protection of client's rights and confidentiality of client records;

(e) The appropriate use of behavior management and emergency safety interventions; and

(f) When the program administers medications, policies and procedures related to medication administration.

(3) Administrator. The governing body of the program shall designate an administrator who shall be authorized to manage the program. The clinical director may serve as the administrator.

(4) Clinical Director. The governing body of the program shall designate a clinical director who is responsible for all treatment services provided.

(5) Finances. The governing body shall provide for the preparation of an annual budget and approve such budget. Copies of the current year's budget and expenditure records shall be maintained for examination and review by the department.

(a) The administrator and all persons authorized to receive and disburse operating funds shall be authorized by the governing body to do so.

(b) The program shall develop and implement a written schedule of client fees. The schedule shall identify all fees which are chargeable to clients and a copy of the schedule shall be provided to the client, or parent, or guardian, or responsible party upon request, during the admission process and subsequently upon request.

(c) A financial audit shall be completed annually by a certified public accountant or other qualified audit approved by the governing body.

(6) Client Records. A written record of each client assessed and each client admitted to the program must be maintained by the program.

(a) Contents. Each client record shall include all information necessary to monitor the client's condition and contain at least the following information:

Basic identifying information including name, address, telephone number, date of birth, sex, and race;
If applicable, the names, addresses, and telephone numbers of parents, or guardians, or responsible parties;
Persons to notify in case of an emergency if different from above;
The name of the client's attending physician, if any;
All records of screening and assessment, including a comprehensive psychosocial history;
If applicable, documentation of why the client was not admitted for treatment and suggested referrals given to client;
Written consent as required in rule .13(c)1.;
Documentation of orientation as required in rule .13(c)2.;
Rights of the client (State and Federal) including confidentiality and signed by the client;
Individualized treatment plan and treatment notes (including drug administration records if applicable);
Results of laboratory tests, as appropriate;
Discharge summary and aftercare plan;
Any other records relating to the client's treatment and stay in the program such as written grievances, reports about discipline to include any use of emergency safety interventions if an incident resulting in injury occurs while the patient is at the program location, observations, etc.

(b) Confidentiality and Retention of Client Records. Written policies and procedures shall be established and implemented for the maintenance and security of client records specifying who shall supervise the maintenance of such records, who shall have custody of such records, and to whom records may be released, how they may be released and for what purposes they may be released. The department shall have access to all client clinical records for the purpose of determining compliance with licensure requirements. Confidentiality, release, and retention of client records must comply with 42 CFR, Part 2 Confidentiality of Alcohol and Drug Abuse Patient Records.

(7) Personnel Records. A program shall maintain written records for each employee and the administrator. Each individual file shall include:

(a) Identifying information such as name, address, telephone number, emergency contact person(s);

(b) A ten year employment history or a complete employment history if the person has not worked ten years;

(d) Date of employment;

(e) The person's job description or statements of the person's duties and responsibilities;

(f) Documentation of training and orientation required by these rules;

(g) Any records relevant to the employee's performance including at least annual performance evaluations; and

(h) The results of employment and criminal background checks conducted by the program prior to employment indicating that the employee has no history of violence or abuse which would pose a risk to clients receiving services through the treatment program.

(8) Emergency Services. During non-operating hours, the program must make provisions for 24 hour emergency services or a telephone "hot line" to assist a client in a crisis situation. This information must be provided to the client upon admission.

(9) HIV/AIDS. A licensed program shall provide HIV/AIDS education, risk assessment and the provision of HIV counseling and testing, either directly or by referral.

(10) Priority Access. Written policies and procedures must be developed for providing priority in access to services and admissions to programs for drug dependent pregnant females.

(11) Drug-free work place. Written policies and procedures shall be established and implemented to provide for a drug-free work place. Pre-employment and ongoing random urine drug screens shall be utilized for all program employees. Each sample collected shall be screened for opiates, methadone, amphetamines, cocaine, benzodiazepines, THC and other drugs either as indicated by the department or the employer.

(12) Referral to Other Programs. Each program shall have a formal plan of cooperation with other programs in the state for referral of clients to allow for continuity of care for drug dependent persons or for emergency hospitalization. The licensed programs must have identified resources that would be available to continue the drug dependent person's care and to have worked out referral/transfer arrangements where appropriate.

(13) Reporting. Written summary reports shall be made to the department, in a form acceptable to the department within 24 hours (with a detailed investigative report to follow in five work days if not provided initially) regarding serious occurrences involving clients that happened either at the facility or were connected with the care that the client received at the facility, such as accidents or injuries requiring medical treatment and/or hospitalization; death; emergency safety interventions resulting in any injury requiring medical treatment beyond first aid; or any incident which results in any federal, state, or private legal action by or against the facility which affects any child or the conduct of the facility. However, legal action involving the juvenile justice system is not required to be reported.

(14) Child Abuse Reports. Whenever the program has reason to believe that a client who is a minor in care has been subjected to child abuse it shall cause a report of such abuse to be made to the child welfare agency providing protective services as designated by the Department of Human Services (Division of Family and Children Services) or in the absence of such an agency to an appropriate police authority or district attorney in accordance with the requirements of O.C.G.A. Sec. 19-7-5 . A copy of such report shall also be filed with the department.

History

Authority: O.C.G.A. §§ 19-7-5, 26-5-5, 26-5-6
History. Original Rule entitled "Administration" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013

Ga. Comp. R. & Regs. r. 111-8-19-.10 Staffing {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.10}

(1) The program shall have sufficient types and numbers of staff as required by these rules to provide the treatment and services offered to clients and outlined in its program description.

(2) Staff subject to professional practice acts must be in compliance with the state practice acts.

(3) Counseling services are provided by individuals qualified by education, training, and experience to provide substance abuse counseling and who are licensed/certified if required by state practice acts.

(4) The medical responsibility for each client will be vested in a licensed physician who oversees all medical services provided by the program. Physician assistants or nurse practitioners may be utilized to the extent allowed by state practice acts.

(5) Each program shall have available professional mental health consultation to review selected cases and to provide assistance to the staff in client management or for referral for psychiatric services.

(6) The clinical director must be either a doctor of medicine licensed to practice in this state, or a licensed practitioner who is licensed to provide treatment, therapeutic advice or counsel for the rehabilitation of drug dependent persons in compliance with state practice acts, or a certified addiction counselor.

(7) For any employee hired after the effective date of these rules, employment and criminal background checks shall be conducted prior to employment, and only persons with no history of violence or abuse which would pose a risk to the clients in treatment shall be employed by the program.

(8) Staff Training and Orientation. Prior to working with clients, all staff who provide treatment and services shall be oriented in accordance with these rules and shall thereafter receive additional training in accordance with these rules.

(a) Orientation shall include instruction in:

The program's written policies and procedures regarding its program purpose and description; client rights, responsibilities, and complaints; confidentiality; and other policies and procedures that are relevant to the employee's range of duties and responsibilities, including the use of universal precautions for infection control, use of behavior management and emergency safety interventions, and information about HIV/AIDS;
The employee's assigned duties and responsibilities; and
Reporting client progress and problems to supervisory personnel and procedures for handling medical emergencies or other incidents that affect the delivery of treatment or services.

(b) Additional training consisting of a minimum of thirty (30) clock hours of training or instruction shall be provided annually for each staff member who provides treatment services to clients. Such training shall be in subjects that relate to the employee's assigned duties and responsibilities.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6
History. Original Rule entitled "Staffing" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.11 Physical Plant and Safety {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.11}

(1) Required Approvals.

(a) A program shall be in compliance with all applicable local health, sanitation, building, and zoning requirements.

(b) A program shall be in compliance with all applicable laws and rules issued by the state fire Marshall, the proper local fire marshal or state inspector, and shall have a certificate of occupancy if required.

(2) All buildings and grounds shall be constructed and maintained in a safe manner and in accordance with these rules.

(3) A program shall have appropriate and sufficient space to meet the programmatic needs of its clients, and carry out the program's array of services. Such space shall include areas conducive to privacy for counseling and group activities, reception/waiting areas, and bathrooms which assure privacy for collection of urine specimens.

(4) Sleeping Areas - Residential Programs.

(a) For residential programs initially licensed or expanded after the effective date of this rule, sleeping areas shall contain not less than 60 square feet of useable floor space per resident in multiple use bedroom and not less than 100 square feet of useable space in single bedrooms.

(b) Each resident shall be provided with his or her own personal space and furnishings for storage of clothes and personal belongings.

(c) Each resident shall be provided with his or her own personal bed and mattress. Clean sheets, pillows, and pillow cases, blankets or bed covering shall be provided and sheets and pillow cases shall be changed as needed, but at least weekly.

(5) Lavatory and Bathing Facilities - Residential Programs.

(a) For residential programs initially licensed or expanded after the effective date of this rule, there shall be at least one lavatory (water basin and toilet) with hot and cold water for every six residents or fraction thereof. Lavatories that contain more than one toilet shall contain stalls for individual privacy. All lavatories shall be properly ventilated.

(b) For residential programs initially licensed or expanded after the effective date of this rule, there shall be at least one shower or bathtub with hot and cold water for every ten residents or fraction thereof. Bathtubs and shower stalls shall be equipped with non-slip surfaces.

(6) Dining Area - Residential Programs. There shall be a separate furnished dining area for serving meals that contains not less than ten square feet of useable floor space for each resident being served.

(7) Climate Control and Pest Control - Residential Programs. A program shall be maintained at a temperature range of sixty-five degrees Fahrenheit (72 degrees if serving pregnant women, infants or small children) to eighty-two degrees Fahrenheit, depending on the season of the year. An effective pest control system shall be implemented and documentation on file as to actions taken.

(8) Off-site Residences. Programs which provide off-site residences as a part of their programs must ensure that the residences also meet the above requirements.

(9) Premises. All grounds, space, and facilities, both those within the program and those regularly used by residents as an integral part of the program, shall be kept clean and free from hazards to health and safety and from litter.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6
History. Original Rule entitled "Physical Plant and Safety" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.12 Food Service {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.12}

(1) A residential program which provides food service shall provide each resident with meals and snacks of food groups and serving sizes which meet the nutritional guidelines of the United States Department of Agriculture. Meals and snacks shall be varied daily. Modified diets based on medical or religious reasons shall be served as needed.

(2) If required by the local county board of health, a residential program shall obtain a valid food service permit from the local county board of health. All residential programs providing food services shall meet the following requirements:

(a) Food shall be stored, prepared, and maintained in a safe and sanitary manner commensurate with generally accepted and recognized food service standards.

(b) There shall be designated and separate space for food preparation and storage.

(d) Food shall be in sound condition, free from spoilage and contamination and shall be safe for human consumption when served to residents.

(e) Food service equipment and preparation areas shall be kept clean and free of accumulation of dust, dirt, food particles, and grease deposits.

(f) When non-disposable dishes, glasses, and flatware are used, they shall be properly cleaned by pre-rinsing and scraping, washing, sanitizing, and drying.

(3) Where a residential program provides food services through contract or arranges for food services, the residential program shall require that food served be safe for human consumption and that the meals/snacks provided meet the nutritional guidelines of the United States Department of Agriculture.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6, 26-5-8
History. Original Rule entitled "Food Service" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.13 Client Referral, Intake, Assessment, and Admission {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.13}

(1) A program shall only accept referrals and shall only admit and retain clients whose known needs can be met by the program in accordance with its program purpose and description. Written policies and procedures for client referral, intake, assessment, and admission shall be established and implemented and shall include the following:

(a) Screening. All persons referred to the program or who present themselves for services shall be initially screened to determine if the prospective client appears to meet the program's admission criteria. Such screenings shall be done by a staff person who has been determined to be qualified by education, training, experience, and who are licensed/certified if required by state practice acts to perform such screenings. Screenings shall constitute an initial appraisal of the clients' dysfunctions and the types of services that appear needed. Persons whose needs cannot be met by the program shall not be admitted and should be referred to other programs that provide appropriate services. A record (log) will be kept of persons not admitted and reason(s) for not admitting. The program has the discretion to use information on clinical evaluations done within thirty days.

(b) Assessment. All clients admitted to the program shall be evaluated by a staff person who has been determined to be qualified by education, training, and experience and who are licensed/certified if required by state practice acts to perform or coordinate the provision of such assessments. Such evaluations shall include a comprehensive assessment of the client's physical, emotional, behavioral, social, recreational, and educational status and needs. The program has the discretion to use current clinical information concerning a transitioning client from another licensed program, licensed hospital, or a state or federal agency, if there has not been a discontinuance in treatment.

Physical Assessment. At the time of admission, a preliminary physical assessment shall be done, at a minimum, by a Registered Nurse or Licensed Practical Nurse under the supervision of a RN or physician and shall include documentation of vital signs, appropriate screening tests for STD and TB, urine drug screens, a determination of whether the client requires a physical or psychiatric examination by a physician according to established protocols, and laboratory tests as clinically indicated. Laboratory tests required upon admission for clients in each program modality, in addition to those tests required for all modalities, will be determined by the programs and documented in their policy and procedures as to the criteria used to determine and specify which minimum lab tests are to be done for each modality. Other lab tests may be required by the physician as clinically indicated. If an examination by a physician is indicated, arrangements shall be made for such an examination as appropriate. The assessment shall also include circumstances leading to admission, mental status, support system, psychiatric and medical history, risk assessment for HIV, history of use of drugs, including the age of onset, duration, patterns, and consequences of use, family history of drug use, route of administration and previous treatment. If a client has been referred for treatment from another facility, the results of a physical examination and laboratory tests from the other facility may be documented and used to assess physical status, provided that such physical examination was done within six months of admission, and there has been no significant change in the physical status of the client. Further assessments or laboratory tests may be required depending upon the modality of treatment needed or the client's changing condition.
Psycho-social assessment. At the time of admission or as soon as clinically appropriate (but no longer than ten working days), a comprehensive psycho-social assessment shall be done and shall document personal and social history, including current relationships, educational status, living arrangements, social habits, employment status, legal status and related areas.

Consent. Except as otherwise authorized by law, no person shall be admitted for treatment without written authorization from the client and parent, guardian, or responsible party, if applicable. The following information must be explained by a trained staff person to the client and other consenters, and documented in the client's file.

(i) The program's services and treatment;

(ii) The specific condition that will be treated;

(iii) The expected charges for services including any charges that might be billed separately;

(iv) The Client's Rights and Responsibilities;

(v) The rights of consenters to obtain information about the client's treatment, etc.; and

(vi) The procedures for complaint and question resolution.

Orientation. The program shall provide orientation to clients admitted for treatment within 24 hours of admission or at such time that the client appears able to hear and respond to requests, but in no event later than 72 hours after admission. Orientation shall be done by a staff person who has been determined to be qualified by education, training, and experience to perform the task. The following information must be explained to the client, and documented in the client's file.

(i) The expected benefits of the treatment that the client is expected to receive;

(ii) An explanation of individualized treatment planning;

(iii) The client's responsibilities for adhering to the treatment plan and the consequences of non-adherence;

(iv) The identification of the staff person that is expected to provide treatment or coordinate the treatment;

(v) Program rules including requirements for conduct and the consequences of infractions;

(vi) Client's Rights, Responsibilities, and Complaints;

(vii) The program's policies for use of behavior management and emergency safety interventions when necessary; and

(viii) Policies and procedures for visiting hours and communications with persons outside the program, if a residential program.

(2) Drug dependent pregnant females shall be given priority for admission and services when a program has a waiting list for admissions.

History

Authority: O.C.G.A. §§ 26-5-2, 26-5-5, 26-5-6
History. Original Rule entitled "Client Referral, Intake, Assessment, and Admission" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.14 Individual Treatment Planning {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.14}

A program must develop and implement a complete individualized treatment plan for each client. Such treatment plans shall be modified and updated as necessary, depending upon the clients' needs.

(a) Preliminary Treatment Plan. An initial treatment plan will be formulated at the time of admission after assessment (within a minimum of ten working days) and will include the initial treatment recommendation for the client. The initial treatment plan may be documented in the program notes.

(b) Complete Treatment Plan. The complete treatment plan must be comprehensive, formulated by a multi-disciplinary team with the input of the client, approved by the clinical director, completed within thirty days from admission, and shall contain sufficient information about the client's expected treatment including:

Descriptions of the client's problems and needs;
Measurable goals and desired outcomes that are to be attained by the client, which include both long term goals and short term objectives leading to these goals;
The interventions and services that the program will provide to help the client achieve the individual goals and desired outcomes;
The expected course of treatment; and
Identification of the staff person who will provide treatment or coordinate the treatment.

(c) Progress Notes. A program shall document the services received by the client and document chronologically observations of the client's clinical course of treatment which includes the client's response to treatment and progress towards achieving individual goals and desired outcomes. Progress notes shall be documented by the staff members assigned primary responsibility for the client's care, and shall be legible and recorded in the client's plan. Progress notes shall be recorded as applicable;

At the end of each shift in the client's medical record for residential detoxification programs;
Following any contact with a client undergoing ambulatory detoxification or narcotic treatment;
At least weekly for substance abuse treatment residences;
Daily for day treatment programs;
Whenever there are face-to-face contacts with the client for outpatient drug treatment programs;
Whenever the client is observed to engage in a behavior which may effect a change in the treatment plan; and
Immediately following the use of any emergency safety intervention with the client.

(d) Random urine drug screens are required for each client, the frequency of which is determined by the program in order to determine its effectiveness. Clinical directors electing to rely upon presumptive urinalysis results for client management must demonstrate adequate access to definitive qualitative laboratory analysis for use when necessary.

(e) Plan Reviews. Plans shall be reviewed and updated, as needed, by the staff member who has primary responsibility for coordinating or providing for the care of the client. Reviews shall be done whenever necessary as indicated by the client's needs or at least every thirty (30) days for residential and sixty (60) days for outpatient.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6
History. Original Rule entitled "Individual Treatment Planning" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.15 Medications {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.15}

If a program administers medications, written policies and procedures for prescription, administration and security of medications shall be established and implemented. Such policies and procedures shall include the following:

(a) Medications are prescribed by a physician, and/or other practitioners as allowed by state law, and the risks and benefits of the prescribed medication are explained to the client (and parent, guardian, or responsible party if applicable) by the physician or a staff person who has been delegated responsibility in writing by the physician to explain the risks and benefits. Documentation of such explanations of risks and benefits must be maintained by the program.

(b) The program may have written pre-medication screening protocols which are completed and approved by the physician. Such protocols shall include an assessment as required in rule .13(1)(b).

(d) Any medications prescribed, administered or self-administered under supervision are documented on an individual medication administration record that is filed with the individual treatment plan, unless maintained as a clinical record at the client's bedside or in the medication room in a residential detoxification setting. The record must include:

Name of medication;
Date prescribed;
Dosage;
Frequency;
Route of administration;
Date and time administered; and
Documentation of staff administering medication or supervising self-administration.

(e) Adverse drug reaction and errors are reported to a physician immediately and corrective action is initiated. The adverse reaction or error is recorded in the drug administration record and the individual treatment plan, and all persons who are authorized to administer medication or supervise self-medication are alerted.

(f) All medications shall be stored under lock and key when not being administered or self- administered.

(g) Program staff shall adhere to all federal and state laws and rules regarding controlled substances.

History

Authority: O.C.G.A. § 26-5-6
History. Original Rule entitled "Medications" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.16 Quality Assurance {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.16}

Written policies and procedures for an ongoing quality assurance process shall be established and implemented. Such process shall identify areas of treatment or treatment problems to be addressed; establish and monitor criteria by which the quality and appropriateness of the treatment are to be measured; analyze the outcomes; make recommendations for change, as needed; and monitor changes to ensure problem resolution. Responsibility for administering and coordinating the quality assurance process shall be delegated to a staff person who has been determined to be qualified by education, training, and experience to perform such tasks. If the program provides medical services, the medical director shall be actively involved in the process.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6
History. Original Rule entitled "Quality Assurance" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.17 Discharge Summaries and Aftercare Plans {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.17}

A program must complete an individualized discharge summary for all clients discharged and also an aftercare plan for continuing services and support for those clients who complete their course of treatment.

(a) Discharge Summary. A discharge summary shall be completed within seven working days of discharge for clients who leave the program before completing treatment. A summary shall be completed by the person who has primary responsibility for coordinating or providing for the care of the client, and it shall include a final assessment of the client's status at the time of discharge, summary of progress towards treatment goals, and the reasons the client was discharged prior to completing treatment. For those who complete treatment, the discharge summary must be completed within ten working days and must include aftercare plans.

(b) Aftercare Plans. Aftercare plans for continuing services and support shall be developed and completed prior to discharge for clients who complete treatment. The plan shall be completed by the person who has primary responsibility for coordinating or providing for the care of the client, and it shall include a final assessment of the client's status at the time of discharge, summary of progress towards treatment goals, a description of what services and supports the client is expected to need following discharge, and a description of potential barriers to overcome to maintain a drug free life style. The client must participate in aftercare planning, and if applicable, parents, or guardians, or responsible persons must participate whenever feasible.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6
History. Original Rule entitled "Discharge Summaries and Aftercare Plans" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.18 Residential Sub-acute Detoxification Programs {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.18}

Programs offering residential sub-acute detoxification programs must meet the rules listed in this subsection (.18), in addition to the general rules set forth.

(a) The program shall establish and implement written policies and procedures that address how the program manages the medical and detoxification services that it provides. The program shall operate 24 hours a day.

(b) Staffing. Treatment is provided by qualified medical staff and other professionals who are qualified by education, training, experience, and who are licensed/certified if required by state practice acts to perform detoxification services that meet the needs of clients.

Medical Staff. The medical staff is headed by a medical director who is licensed to practice medicine in Georgia, and all other medical staff are licensed to practice in Georgia. The medical director must approve all medical policies and procedures, including assessment tools, treatment protocols, and emergency procedures. Such policies and procedures shall include provisions for an effective infection control program.
Director of Nursing. A licensed registered nurse determined qualified by education, training, and experience to supervise nursing services for detoxification shall be designated as the Director of Nursing.
Medical Coverage.

(i) Physician coverage shall be provided in accordance with the treatment protocol. At a minimum, there shall be on call physician coverage 24 hours a day, and a physician must be on site daily as medically indicated.

(ii) Nursing coverage shall be provided in accordance with clients needs as determined by the number and condition of client population. At a minimum, there shall be one registered or licensed practical nurse awake and on duty on premises 24 hours per day to respond to client needs.

Other Medical Services.

(i) Diagnostic Services. Clinical laboratory services and x-ray services shall be provided in accordance with the Department of Community Health's Rules for Licensure of Clinical Laboratories, Chapter 111-8-10, and Rules for X-Ray, Chapter 290-5-22.

(ii) Emergency Medical Services. The program's medical policies and procedures include provisions for the delivery of emergency, medical services, which services are either provided directly or through an established procedure specifying how emergency services will be accessed.

(iii) Pharmaceutical Services. Pharmaceutical services are offered through a licensed pharmacy service in the community or by the program's own licensed pharmacist.

(c) Treatment - Assessment. Admission Assessment of clients shall be performed by a physician, nurse practitioner, physician's assistant, or registered nurse. If an assessment is done by other than a physician, then the assessment must be communicated to physician by telephone prior to the client's admission. The assessment must include:

Drug history including past detoxification episodes, and current use of drugs and medications;
Causes that triggered the present need for services;
Descriptions of medical risks and any behavioral or emotional problems.
Taking and documentation of vital signs; and
Determination of whether or not a physical and/or psychiatric examination by a physician is needed immediately and arrangements for such examination, if the assessment was done by a registered nurse. If the assessment is done by a physician, nurse practitioner or physician's assistant, it will include a physical examination.
Laboratory tests will be ordered as indicated, but at a minimum will include: CBC, RPR, urinalysis (routine and microscopic). TB screening and urine drug screens.

(d) Treatment - Admission. Clients are admitted to treatment by physician's orders only following assessment and determination that the medical, emotional, and behavioral status of the client justifies admission. The initial detoxification care plan must be documented in the record and may be initiated by the order of the physician following admission.

(e) Treatment.

Within twenty-four hours of admission, or the next normal business day if admission occurred on a weekend or holiday, the client must be seen by a physician, nurse practitioner, or physician's assistant if the assessment required by rule .13(1)(b) and subparagraph (3) above was done by a registered nurse. If a physical examination is needed, such examination shall be done at that time.
Within 48 hours of admission, a complete Detoxification Care Plan shall be developed by a registered nurse, physician's assistant, or physician. If not done by a physician, the development of the plan shall be supervised and signed by a physician. Any changes to the plan must be documented in the plan and reviewed and signed by the physician. The plan shall address the nursing and medical procedures needed to stabilize the client and to manage the withdrawal.
In addition to medical management, the program shall provide the client substance abuse counseling and support by staff who are determined qualified by training, education, experience, and who are licensed/certified if required by state practice acts to provide such services. Such services shall be provided to clients as soon as it is determined that they can benefit from such services but no later than within three work days of admission.
A discharge summary and aftercare plan, if applicable, shall be completed in accordance with rule .17.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6
History. Original Rule entitled "Residential Sub-acute Detoxification Programs" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.19 Ambulatory Detoxification Programs {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.19}

Programs offering outpatient ambulatory detoxification services must meet the rules listed in this subsection (.19) in addition to the general rules set forth.

Medical Staff. The medical staff is headed by a medical director who is licensed to practice medicine in Georgia, and all other medical staff are licensed to practice in Georgia. The medical director must approve all medical policies and procedures, including assessment tools, treatment protocols, and emergency procedures.
Medical Coverage. There shall be a physician, nurse practitioner, physician's assistant, registered nurse, or licensed practical nurse with at least two years of substance abuse experience under RN supervision on duty during all hours of operation to provide or supervise client treatment and assess individual clients as needed. Each physician employed by the program is determined qualified by training, education, and experience to manage detoxification treatment and assumes responsibility for the medical services provided by the staff.
On-Call Coverage. A staff physician shall provide 24-hour, on-call coverage when the program is closed or a physician is not present on the premises.
Other Medical Services.

(i) Diagnostic Services. Clinical laboratory services and x-ray services shall be provided in accordance with the Department of Community Health's' Rules for Licensure of Clinical Laboratories, Chapter 111-8-10, and Rules for X-Ray, Chapter 290-5-22.

(ii) Emergency Medical Services. The program's medical policies and procedures include arrangements for the delivery of emergency medical services.

(iii) Pharmacy Services. Pharmaceutical services are provided through a licensed pharmacy in the community or the program's own licensed pharmacist.

(c) Treatment - Assessment. Admission Assessment of client shall be performed by a physician, nurse practitioner, physician's assistant or a registered nurse. If an assessment is done by other than a physician, then the assessment must be communicated to a physician by telephone prior to the client's admission. The assessment must include:

Drug history including past detoxification episodes, and current use of drugs and medications;
Causes that triggered the present need for services;
Descriptions of medical risks and any behavioral or emotional problems;
Taking and documentation of vital signs;
Determination of whether or not a physical and/or psychiatric examination by a physician is needed immediately, and arrangements for such examinations, if indicated, if the assessment was done by a registered nurse; and
Determination that the prospective client appears to have the needed support and supervision from family members and others to benefit from ambulatory treatment.
Laboratory tests will be ordered as indicated, but at a minimum will include: CBC, RPR, urinalysis (routine and microscopic), TB screening and urine drug screens.

(d) Treatment - Admission. Clients are admitted to treatment by physicians' orders only following assessment and determination that the medical, emotional, and behavioral status of the client and his or her support systems are adequate to justify admission to an ambulatory program. Persons treated in ambulatory detoxification settings are without unusual or significant medical or behavioral problems that would pose a significant risk to the safe completion of an ambulatory detoxification program. The initial detoxification care plan must be documented in the record and may be initiated by the order of the physician following admission.

(e) Treatment.

Within twenty-four hours of admission, or the next normal business day if admission occurred on a weekend or holiday, the client must be seen by the physician, nurse practitioner, or physicians assistant if the assessment required by rule .13(1)(b) and subparagraph (3) above was done by a registered nurse. If a physical examination is needed, such examination shall be done at that time.
Within 48 hours of admission, a Detoxification Care Plan shall be developed by a registered nurse, physician's assistant, or the physician. If not done by a physician, the development of the plan shall be supervised and signed by a physician. Any changes to the plan must be documented in the plan and reviewed and signed by the physician. The plan shall address the nursing and medical procedures and monitoring activity needed to stabilize the client and to manage the withdrawal.
For the length of the detoxification care plan and while on medication, the client shall be required to visit the program at least once a business day for a check of vital signs and monitoring of medication by one of the medical staff.
In addition to medical management services, the program shall provide the client counseling and support by staff who are determined qualified by training, education, experience, and who are licensed/certified if required by state practice acts to provide such services. Such services shall be provided to clients as soon as it is determined that they can benefit from such services but no later than within three work days of admission.
A discharge summary and an aftercare plan, if applicable, shall be completed in accordance with rule .17.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6
History. Original Rule entitled "Ambulatory Detoxification Programs" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.20 Residential Intensive Treatment Programs {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.20}

Such residences provide services for clients with significant substance abuse impairment, and who, typically, have not progressed in a less intensive setting, or lack supports and require a highly structured and specialized environment, or are transitioning from detoxification. In addition to the general rules set forth, programs offering residential intensive treatment programs shall meet the requirements of this subsection (.20).

(a) Client intake, assessment, and admission; individual treatment planning; and discharge and aftercare, if applicable, shall be done in accordance with rules .13, .14, and .17. Additional admission requirements, including laboratory tests, may be required by facility policy and/or determination of the medical/clinical director.

(b) A program shall provide a minimum of eight hours per day of various therapeutic services designed to enable the client to function without substance abuse. Such services shall be provided by persons who have been determined qualified by education, training, experience, and who are licensed/certified if required by state practice acts to render such services that meet the needs of clients.

(c) There shall be sufficient types and numbers of staff members on duty in the residence to provide for safe supervision of clients whenever clients are present.

(d) Provisions shall be made for mandatory education of children in care in accordance with O.C.G.A. Sections 20-2-690 et seq. or its successor statute.

(e) A program shall have a written agreement with a physician for the provision of medical care.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6
History. Original Rule entitled "Residential Intensive Treatment Programs" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.21 Residential Transitional Treatment Programs {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.21}

Such residences provide services on an intermediate basis for clients characterized as chronic substance abusers who are transitioning to the community or to other treatment modalities, and who, typically, lack a stable living situation and require variable levels of therapeutic services. Facilities that only provide housing for persons, such as half-way houses or temporary shelters, are not subject to licensure as residential transitional treatment programs, unless the residence offers treatment services or is a supportive service owned and/or controlled by a licensed program. In addition to the general rules set forth, programs offering residential transitional treatment programs shall meet the requirements of this subsection (.21).

(a) Client intake, assessment, and admission; individual treatment planning; and discharge and aftercare shall be done in accordance with rules .13, .14 and .17. Additional admissions requirements, including laboratory tests, may be required by facility policy and/or determination of the medical/clinical director. The program has the discretion to use physical and psycho-social assessment information from another licensed program, licensed hospital, or a state or federal agency, if the client is transitioning directly from another program.

(b) The program shall provide at least five or more hours per week of therapeutic services designed to enable the client to function without substance abuse. Such services shall be rendered by persons who have been determined qualified by training, education, experience, and who are licensed/certified if required by state practice acts to render such services.

(c) There shall be sufficient types and numbers of staff members on duty in the residence to provide for safe supervision of clients whenever clients are present.

(d) Provisions shall be made for mandatory education of children in care in accordance with O.C.G.A. Sections 20-2-690 et seq. or its successor statute.

(e) A program shall have a written agreement with a physician for the provision of medical care.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6
History. Original Rule entitled "Residential Transitional Treatment Programs" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013

Ga. Comp. R. & Regs. r. 111-8-19-.22 Specialized Day Treatment Programs {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.22}

Specialized day treatment programs emphasize continued abstinence, development of social support network and necessary lifestyle changes, educational skills, vocational skills, social and interpersonal skills, the understanding of addictive disease, and the continued commitment to a recovery program. The program provides structured treatment or therapeutic services, utilizing activity schedules as part of its operational method, i.e. plans or schedules of days or times of day for certain activities. The programs utilize methods, materials, settings, and outside resources that are appropriate to the development levels and ages of clients, and, age appropriate. These programs are provided over a period of several weeks or months and often follow detoxification or residential services. They may also utilize group and/or individual counseling and/or therapy. Such programs shall provide:

(a) Client intake, assessment, and admission; individual treatment planning; and discharge and aftercare shall be done in accordance with rules .13, .14, and .17. Additional admissions requirements, including laboratory tests, may be required by facility policy and/or determination of the medical/clinical director.

(b) Treatment must be provided by persons determined to be qualified by training, education, experience, and who are licensed/certified if required by state practice acts to render such services that meet the needs of the clients.

(c) Provisions shall be made for mandatory education of children in care in accordance with O.C.G.A. § 20-2-690 et seq. or its successor statute.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6
History. Original Rule entitled "Specialized Day Treatment Programs" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013

Ga. Comp. R. & Regs. r. 111-8-19-.23 Outpatient Drug Treatment Programs {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.23}

Outpatient drug treatment programs provide a variety of treatment and therapeutic services intended to enable clients to function drug free and to learn social and psychological skills. Typically, these include services such as psychosocial assessment; group, individual, and family counseling; supportive counseling; substance abuse education; and therapeutic recreational activities. Such services shall be provided in part outside normal business hours so that clients who work or go to school can attend. Such programs shall provide:

(a) Client intake, assessment, and admission; individual treatment planning; and discharge and aftercare shall be done in accordance with rules .13, .14, and .17.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6
History. Original Rule entitled "Outpatient Drug Treatment Programs" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.24 Special Programs {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.24 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.24}

Structured programs that do not fit into existing program classifications but meet the requirements of these rules will be licensed as Special Programs. These programs may be part of other licensed programs or may be individually licensed.

History

Authority: O.C.G.A. §§ 26-5-5, 26-5-6
History. Original Rule entitled "Special Programs" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.25 Client's Rights, Responsibilities, and Complaints {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.25 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.25}

A program shall establish and implement written policies and procedures regarding the rights and responsibilities of clients, and the handling and resolution of complaints. At a minimum, the program must ensure that its clients enjoy the rights and responsibilities listed herein.

(a) Such policies and procedures shall include a written notice of rights and responsibilities which shall be provided to each client and parent, guardian, or responsible party, if applicable, when the client receives orientation. The required notice shall contain the following items:

Right to a humane treatment or habilitation environment that affords reasonable protection from harm, exploitation, and coercion;
Right to be free from physical and verbal abuse;
Right to be free from the use of physical restraints and seclusion unless it is determined that there are no less restrictive methods of controlling behavior to reasonably insure the safety of the client and other persons:
Right to be informed about plan of treatment and to participate in the planning, as able;
Right to be promptly and fully informed of any changes in the plan of treatment;
Right to accept or refuse treatment, unless it is determined through established authorized legal processes that the client is un-able to care for himself or is dangerous to himself;
Right to be fully informed of the charges for treatment;
Right to confidentiality of client records;
Right to have and retain personal property which does not jeopardize the safety of the client or other clients or staff and have such property treated with respect;
Right to converse privately, have convenient and reasonable access to the telephone and mails, and to see visitors, unless denial is necessary for treatment and the reasons are documented in the client's treatment plan;
Right to be informed of the program's complaint policy and procedures and the right to submit complaints without fear of discrimination or retaliation and to have them investigated by the program within a reasonable period of time;
Right to have access to their own client records and to obtain necessary copies when needed;
Right to receive a written notice of the address and telephone number of that state licensing authority, i.e. the department, which further explains the responsibilities of licensing the program and investigating client complaints which appear to violate licensing rules;
Right to obtain a copy of the program's most recent completed report of licensing inspection from the program upon written request. The program is not required to release a report until the program has had the opportunity to file a written plan of correction for the violations as provided for in these rules; and

(b) Such policies and procedures shall also include provisions for clients and others to present complaints, either orally or in writing, and to have their complaints addressed and resolved as appropriate in a timely manner.

History

Authority: O.C.G.A. § 26-5-6
History. Original Rule entitled "Client's Rights, Responsibilities, and Complaints" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.26 Behavior Management and Emergency Safety Interventions {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.26 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.26}

(1) Behavior Management.

(a) The program shall develop and implement policies and procedures on behavior management. Such policies and procedures shall set forth the types of clients served in accordance with its program purpose, the anticipated behavioral problems of the clients, and appropriate techniques of behavior management for dealing with such behaviors.

(b) Program staff shall be made aware of each client's known or apparent medical and psychological conditions and family history, as evidenced by written acknowledgement of such awareness, to ensure that the staff have adequate knowledge to deliver safe and healthy care to the client.

Behavior management principles and techniques shall be used in accordance with the individual treatment plan and written policies and procedures governing service expectations, treatment goals, safety, security, and these rules and regulations.
Behavior management shall be limited to the least restrictive appropriate method, as described in the client's treatment plan pursuant to Rule .14(a),(b)1. -5. and in accordance with the prohibitions as specified in these rules and regulations.

(b) Behavior management techniques shall be administered by trained staff and shall be appropriate for the client's age, intelligence, emotional makeup and past experience. The following forms of behavior management s hall not be used by program staff with client's receiving services through the program:

Assignment of excessive or unreasonable work tasks;
Denial of meals and hydration;
Denial of sleep;
Denial of shelter, clothing, or essential personal needs;
Denial of essential program services;
Verbal abuse, ridicule, or humiliation;
Manual holds, chemical restraints, or mechanical restraints not used appropriately as emergency safety interventions;
Denial of communication and visits unless restricted in accordance with Rule .13(2);
Corporal punishment;
Seclusion or confinement of a client in a room or area which may reasonably be expected to cause physical or emotional damage to the client; or not used appropriately as an emergency safety intervention; and
Seclusion or confinement of a client to a room or area for periods longer than those appropriate to the client's age, intelligence, emotional make up and previous experience, or confinement to a room or area without the supervision or monitoring necessary to ensure the client's safety and well-being.

(f) Programs shall submit to the department electronically or by facsimile a report within 24 hours whenever the program becomes aware of an incident which results in any injury to a client requiring medical treatment beyond first aid that is received by a client as a result of or in connection with any behavior management.

(g) All forms of behavior management or emergency safety interventions used by staff shall also be documented in case records in order to ensure that such records reflect behavior management problems.

(h) The program shall take appropriate corrective action when the program staff become aware of or observe the use of prohibited forms of behavior management, as specified in sections .26(1)(d)1. through 10. Documentation of the incident and the corrective action taken by the program shall be maintained in the case records of the client.

(2) Emergency Safety Interventions.

(c) Emergency safety interventions shall not include the use of any restraint or manual hold that would potentially impair the client's ability to breathe or has been determine d to be inappropriate for use on a particular client due to a documented medical or psychological condition.

(d) The program shall have written policies and procedures for the use of emergency safety interventions, a copy of which shall be provided to and discussed with each client (as appropriate taking into account the client's age and intellectual development) and the client's parents and/or legal guardians prior to or at the time of admission. Emergency safety interventions policies and procedures shall include:

Provisions for the documentation of an assessment at admission and at each annual exam by the client's physician, a physician's assistant, or a registered nurse with advanced training working under the direction of a physician, or a public health clinic which states that there are no medical issues that would be incompatible with the appropriate use of emergency safety interventions on that client. Such assessment and documentation must be re-evaluated following any significant change in the client's medical condition; and
Provisions for the documentation of each use of an emergency safety intervention including:

(i) Date and description of the precipitating incident;

(ii) Description of the de-escalation techniques used prior to the emergency safety intervention, if applicable;

(iii) Environmental considerations;

(iv) Names of staff participating in the emergency safety intervention;

(v) Any witnesses to the precipitating incident and subsequent intervention;

(vi) Exact emergency safety intervention used;

(vii) Documentation of the 15 minute interval visual monitoring of a client in seclusion;

(viii) Beginning and ending time of the intervention;

(ix) Outcome of the intervention;

(x) Detailed description of any injury arising from the incident or intervention; and

(xi) Summary of any medical care provided.

Provisions for prohibiting manual hold use by any employee not trained in prevention and use of emergency safety interventions.

(e) Emergency safety interventions may be used to prevent runaways only when the client presents an imminent threat of physical harm to self or others, or as specified in the individual treatment plan.

(g) Clients shall not be allowed to participate in the emergency safety intervention of other clients.

(i) At a minimum, the emergency safety intervention program that is utilized shall include the following:

Techniques for de-escalating problem behavior including client and staff debriefings;
Appropriate use of emergency safety interventions;
Recognizing aggressive behavior that may be related to a medical condition;
Awareness of physiological impact of a restraint on the client;
Recognizing signs and symptoms of positional and compression asphyxia and restraint associated cardiac arrest;
Instructions on how to monitor the breathing, verbal responsiveness, and motor control of a client who is the subject of an emergency safety intervention;
Appropriate self-protection techniques;
Policies and procedures relating to using manual holds, including the prohibition of any technique that would potentially impair a client's ability to breathe;
Agency policies and reporting requirements;
Alternatives to restraint;
Avoiding power struggles;
Escape and evasion techniques;
Time limits for the use of restraint and seclusion;
Process for obtaining approval for continual restraints and seclusion;
Procedures to address problematic restraints;
Documentation;
Investigation of injuries and complaints;
Monitoring physical signs of distress and obtaining medical assistance; and
Legal issues.

(j) Emergency safety intervention training shall be in addition to the annual training required in Rule .10(8)(b) and shall be documented in the staff member's personnel record.

(j) All actions taken that involve utilizing an emergency safety intervention shall be recorded in the client's case record showing the cause for the emergency safety intervention, the emergency safety intervention used, and, if needed, approval by the clinical director, the staff member in charge of casework services, and the physician who has responsibility for the diagnosis and treatment of the client's behavior.

(l) Programs shall submit to the department electronically or by facsimile a report, in a format acceptable to the department, within 24 hours whenever the program becomes aware of an incident which results in injury to a client requiring medical treatment beyond first aid that is received by a client as a result of or in connection with any emergency safety intervention.

For any program with a licensed capacity of 20 clients or more, any 30-day period in which three or more instances of emergency safety interventions of a specific client occurred and/or whenever the program has had a total of 10 emergency safety interventions for all clients in care within the 30-day period; and
For any program with a licensed capacity of less than 20 clients, any 30-day period in which three or more instances of emergency safety interventions of a specific client occurred and/or whenever the program has had a total of five instances for all clients in care within the 30-day period.

(m) Programs shall submit a written report to the program's clinical director on the use of any emergency safety intervention immediately after the conclusion of the intervention and, if the client is a child or has an assigned legal guardian, shall further notify the client's parents or legal guardians regarding the use of the intervention. A copy of such report shall be maintained in the client's file.

(n) At least once per quarter, the program, utilizing a master agency restraint log and the client's case record, shall review the use of all emergency safety interventions for each client and staff member, including the type of intervention used and the length of time of each use, to determine whether there was a clinical basis for the intervention, whether the use of the emergency safety intervention was warranted, whether any alternatives were considered or employed, the effectiveness of the intervention or alternative, and the need for additional training. Written documentation of all such reviews shall be maintained. Where the program identifies opportunities for improvement as a result of such reviews or otherwise, the program shall implement these changes through an effective quality improvement plan.

(o) No later than March 31, 2007 and ongoing thereafter, all program staff who may be involved in the use of emergency safety interventions, shall have evidence of having satisfactorily completed a nationally recognized training program for emergency safety interventions to protect clients and others from injury, which has been approved by the department and taught by an appropriately certified trainer in such program.

(p) Manual Holds.

Emergency safety interventions utilizing manual holds require at least one trained staff member to carry out the hold. Emergency safety interventions utilizing prone restraints require at least two trained staff members to carry out the hold.
Emergency safety interventions shall not include the use of any restraint or manual hold that would potentially impair the client's ability to breathe or has been determine d to be inappropriate for use on a particular client due to a documented medical or psychological condition.
When a manual hold is used upon any client whose primary mode of communication is sign language, the client shall be permitted to have his or her hands free from restraint for brief periods during the intervention, except when such freedom may result in physical harm to the client or others.
If the use of a manual hold exceeds 15 consecutive minutes, the clinical director or his or her designee, who possesses at least the qualifications of the clinical director and has been fully trained in the program's emergency safety intervention plan, shall be contacted by a two-way communications device or in person and determine that the continuation of the manual hold is appropriate under the circumstances. Documentation of any consultations and outcomes shall be maintained for each application of a manual hold that exceeds 15 minutes. Manual holds shall not be permitted to continue if the restraint is determined to pose an undue risk to the client's health given the client's physical or mental condition.
A manual hold may not continue for more than 30 minutes at any one time without the consultation as specified in subparagraph (4) of this subparagraph, and under no circumstances may a manual hold be used for more than one hour total within a 24-hour period.
If the use of a manual hold on a client reaches a total of one hour within a 24-hour period, the staff shall reconsider alternative treatment strategies, document same, and consider notifying the authorities or transporting the client to a hospital or mental health facility for evaluation.
The client's breathing, verbal responsiveness, and motor control shall be continuously monitored during any manual hold. Written summaries of the monitoring by a trained staff member not currently directly involved in the manual hold shall be recorded every 15 minutes during the duration of the restraint. If only one trained staff member is involved in the restraint and no other staff member is available, written summaries of the monitoring of the manual hold shall be recorded as soon as is practicable, but no later than one hour after the conclusion of the restraint.

(q) Seclusion.

If used, seclusion procedures in excess of thirty (30) minutes must be approved by the clinical director or designee. No client shall be placed in a seclusion room in excess of one (1) hour within any twenty-four (24) hour period without obtaining authorization for continuing such seclusion from the client's physician, psychiatrist, or licensed psychologist and documenting such authorization in the client's record.
A seclusion room shall only be used if a client is in danger of harming himself or herself or others.
A client placed in a seclusion room shall be visually monitored at least every fifteen (15) minutes.
A room used for the purposes of seclusion must meet the following criteria:

(i) The room shall be constructed and used in such ways that the risk of harm to the client is minimized;

(ii) The room shall be equipped with a viewing window on the door so that staff can monitor the client;

(iii) The room shall be lighted and well-ventilated;

(iv) The room shall be a minimum fifty (50) square feet in area; and

(v) The room must be free of any item that may be used by the client to cause physical harm to himself/herself or others.

No more than one client shall be placed in the seclusion room at a time.
A seclusion room monitoring log shall be maintained and used to record the following information:

(i) Name of the secluded client;

(ii) Reason for client's seclusion;

(iii) Time of client's placement in the seclusion room;

(iv) Name and signature of the staff member that conducted visual monitoring;

(v) Signed observation notes; and

(vi) Time of the client's removal from the seclusion room.

History

Authority: O.C.G.A. §§ 26-5-14, 26-5-15, 26-5-16, 50-13-18
History. Original Rule entitled "Behavior Management and Emergency Safety Interventions" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.27 Enforcement and Penalties {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.27 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.27}

(1) When the department finds that any applicant for any license fails to fulfill the requirements of these rules, the department may, subject to notice and opportunity for a hearing, refuse to grant any license (denial); provided, however, that the department shall not be required to hold a hearing prior to taking such action.

(2) When the department finds that any licensed program violates any requirements of this chapter, the department may, subject to notice and opportunity for a hearing, suspend or revoke any license.

(a) The department may suspend any license for a definite period calculated by it as the period necessary for the facility to implement long-term corrective measures and for the facility to be deterred from lapsing into noncompliance in the future. As an alternative to suspending a license for a definite period, the department may suspend the license for an indefinite period in connection with the imposition of any condition or conditions reasonably calculated to elicit long-term compliance with licensing requirements which the program must meet and demonstrate before it may regain its license.

(b) The department may revoke any license, subject to notice and opportunity for hearing, when it determines that the facility is non-compliant with rules and regulations or sanctions previously imposed. If the sanction of license revocation is finally imposed, as defined by a final adverse finding, the department shall effectuate it by requiring the program to return its license to the department.

Notification of Action: The program shall notify clients and clients' representatives and family units of the department's actions to revoke the license or seek an emergency suspension of the program's license to operate.
The official notice of the revocation or emergency suspension action and any final resolution, together with the department's complaint intake phone number and website address, shall be provided to current and prospective clients and to their representatives and family units.
The program shall ensure the posting of the official notice at the program location in an area that is visible to the clients and to the clients' family units and representatives.
The program shall ensure that the official notice continues to be visible to the clients and to the clients' representatives and family units throughout the pendency of the revocation and emergency suspension actions, including any appeals.
The program shall have posted at the program location in an area that is readily visible to the clients and to the clients' representatives and family units any inspection reports that are prepared by the department during the pendency of any revocation or emergency suspension action.
It shall be a violation of these rules for the program to permit the removal or obliteration of any posted notices of revocation, emergency suspension action, resolution, or inspection survey during the pendency of any revocation or emergency suspension action.
The department may post an official notice of the revocation or emergency suspension action on its website or share the notice of the revocation or emergency suspension action and any information pertaining thereto with any other agencies that may have an interest in the welfare of the patients in care at the program.
If the sanction of license suspension is finally imposed, as defined by a final adverse findings, the department shall effectuate it by requiring the program to return its license to the department. Upon the expiration of any period of suspension, and upon a showing by the program that it has achieved compliance with licensing requirements, the department shall reissue the program a license. Where the license was suspended for an indefinite period in connection with conditions for the reissuance of a license, once the program can show that any and all conditions imposed by the department have been met, the department shall reissue the program a license.

(3) If the department identifies a violation of these rules, where an opportunity to correct is permissible, the department shall provide written notice specifying the rule(s) violated and setting a time, not to exceed ten (10) working days, within which a program may file an acceptable written plan of correction. If such plan of correction is determined not acceptable to the department because it does not adequately correct the identified violation, the department will advise the program that the plan of correction is not acceptable. The department may permit the program to submit a revised plan of correction.

(a) The program shall comply with an accepted plan of correction.

(b) Where the department determines that either the program has not filed an acceptable plan of correction or has not complied with the accepted plan of correction, the department may initiate an adverse action to enforce these rules.

(4) All actions to enforce the Rules and Regulations for Drug Abuse Treatment and Education Programs shall be administered in accordance with Chapter 13 of Title 50 of the Official Code of Georgia Annotated, the "Georgia Administrative Procedure Act," the Rules and Regulations for Enforcement of General Licensing and Enforcement Requirements, Chapter 111-8-25, and O.C.G.A. § 26-5-1 et seq. Any request for a hearing in response to any enforcement action undertaken pursuant to this chapter shall be in writing and must be submitted to the department no later than ten (10) calendar days from the date of receipt of any written notice of intent by the department to impose an enforcement action setting forth the proposed action or actions and the basis therefore. The department's notice of intent to impose an enforcement action shall be made within ninety days after an application is submitted or within 90 days of when the grounds for the actions are discovered.

(5) The department may suspend any requirements of these rules and the enforcement of any rules where the Governor of the State of Georgia has declared a public health emergency.

History

Authority: O.C.G.A. §§ 26-5-6, 26-5-14 to 26-5-16, 31-2-8, 50-13-18
History. Original Rule entitled "Enforcement and Penalties" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.28 Waivers and Variances {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.28 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.28}

The department may, in its discretion, grant waivers and variances of specific rules upon application or petition being filed on forms provided by the department. The department may establish conditions which must be met by the program in order to operate under the waiver or variance granted. Waivers and variances may be granted in accordance with the following considerations:

(a) Variance. A variance may be granted by the department upon a showing by the applicant or petitioner that the particular rule or regulation that is the subject of the variance request should not be applied as written because strict application of the rule would cause undue hardship. The applicant or petitioner must also show that adequate standards affording protection for the health, safety and care of clients exist and will be met in lieu of the exact requirements of the rule or regulations in question.

(b) Waiver. The department may dispense entirely with the enforcement of a rule or regulation by granting a waiver upon a showing by the applicant or petitioner that the purpose of the rule or regulation is met through equivalent standards affording equivalent protection for the health, safety and care of clients.

History

Authority: O.C.G.A. §§ 26-5-6, 31-2-7
History. Original Rule entitled "Waivers and Variances" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-19-.29 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-19-.29 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-19-.29}

In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof. The remaining rules or portions thereof shall remain in full force and effect, as if such rule or portions thereof so determined, declared or adjudged invalid or unconstitutional were not originally a part of these rules.

History

Authority: O.C.G.A. § 26-5-6
History. Original Rule entitled "Severability" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Subject 111-8-22 End Stage Renal Disease Facilities

Ga. Comp. R. & Regs. r. 111-8-22-.01 Purposes of This Chapter {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.01}

These rules and regulations establish minimum standards for the operation of end state renal disease facilities in order to ensure the health, safety, and protection of the patients served, and establish procedures and requirements for the licensing of such facilities.

History

Authority: O.C.G.A. §§ 31-2-4, 31-2-5, 31-2-7 and 31-44-3
History. Original Rule entitled "Purposes of This Chapter" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-22-.02 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.02}

Unless another meaning is specifically indicated by context, these selected terms shall have the following definitions when used in these rules and regulations:

(a) Applicant means a person, business entity, corporation, partnership or association applying for a license to operate an end stage renal disease facility in Georgia;

(b) Department means the Department of Community Health of the state of Georgia;

(c) Dialysis means a process by which dissolved substances are removed from a patient's body by diffusion, osmosis, and convection (ultrafiltration) from one fluid compartment to another across a semi-permeable membrane;

(d) Dialysis technician means an individual who is not a registered nurse or physician and who provides dialysis care under the supervision of a registered nurse or physician;

(e) End stage renal disease means that stage of renal impairment that appears irreversible and permanent and that requires a regular course of dialysis or kidney transplantation to maintain life;

(f) End stage renal disease facility means a facility that provides dialysis treatment, home dialysis training, and support services, or any combination of such services, to individuals with end stage renal disease;

(g) Equipment technician means an individual who performs the required tasks for the maintenance, monitoring, and repair of dialysis, reuse processing, and water treatment systems and equipment at the facility;

(h) Facility means an end stage renal disease facility;

(i) Healthcare personnel means any person providing healthcare services directly to patients at the facility, including but not limited to the provision of medical or nursing care;

(j) Initial license means the first license issued by the Department for a particular end-stage renal disease facility, with subsequent licenses requiring review for renewal;

(k) Nurse responsible for nursing services means the Georgia licensed registered nurse who has at least 12 months of experience in clinical nursing, and an additional 6 months of experience in nursing care of the patient with permanent kidney failure or undergoing kidney transplantation, including training in and experience with the dialysis process or has 18 months of experience in nursing care of the patient on maintenance dialysis, or the nursing care of the patient with a kidney transplant, including training in and experience with the dialysis process. Where the nurse responsible for nursing services is also in charge of self-care dialysis training, at least 3 months of the total required dialysis experience is in training patients in self-care;

(l) Physician means an individual who is licensed to practice medicine in Georgia under O.C.G.A. Chapter 43-34;

(m) Preceptor means an individual who provides direct supervision of the provision of patient care by trainees who are in the process of completing training as dialysis technicians, and who:

Is a licensed nurse or a dialysis technician with at least twelve months experience in hemodialysis, and
Has authorization from a supervising nurse or the medical director of the facility to be preceptor;

(n) Reuse technician means an individual who is not a registered nurse or licensed physician who performs the procedures necessary to clean and properly prepare kidney dialyzers for use for multiple treatments;

(o) Special purpose facility means an end stage renal dialysis facility providing dialysis services at special locations on a short-term basis to a group of dialysis patients who would otherwise be unable to obtain treatment in that special location; and

(p) Temporary provisional license means a license to provide end stage renal care for patients for a limited time period, not to exceed six months.

History

Authority: O.C.G.A. § 31-44-1
History. Original Rule entitled "Definitions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-22-.03 License Requirements and Exemptions {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.03}

(1) License Requirements. Unless specifically exempted under 111-8-22-.03(2) , no person, business entity, association, partnership, or corporation shall operate an end stage renal disease facility in Georgia without having first obtained a license from the Department.

(a) A license issued by the Department is required prior to the initiation of dialysis or dialysis support services for patients.

(b) A facility is required to have a separate license for each physical address. Separate applications and licenses are required for facilities maintained separately, even if they are owned or operated by the same person(s), business, partnership, or corporation, and may be doing business under the same trade name.

(c) The license shall be effective for twelve (12) months following the date of issue; the temporary provisional license shall be effective for a maximum of six (6) months. If the facility applies for renewal as required by these regulations, the existing license shall remain in effect until the inspection for renewal is completed.

(d) The facility license is not transferable. A new license is required for any change in physical location, operational or trade name, or facility ownership. An application for a new license must be submitted at least 30 days prior to the change. The former license shall be considered revoked upon issuance of the new license, and shall be returned to the Department.

(e) The facility license shall be prominently displayed in a public area of the facility at all times of operation.

(f) If the facility anticipates that it will close or cease to operate, the governing body shall notify the Department and the patients at least thirty (30) days prior to the anticipated date of closure.

With the notification of intent to close, the facility shall submit a written plan for the orderly transfer of care of the facility's patients and their clinical records.
Upon closure, the facility shall return the existing license to the Department. The license shall be considered revoked, unless the facility has been placed on temporary inactive status as described in these rules.

(2) Exempt Facilities. The following facilities are not required to have a license:

(a) Any hospital permitted under O.C.G.A. 31-7 as a hospital that provides dialysis to individuals receiving services from the hospital;

(b) The office of a physician unless the office is used primarily as an end stage renal disease facility; and

(d) Non-profit camps operating for eight (8) days or less which do not charge a fee to the campers or their families and which provide dialysis services through the use of staff who possess the same minimum qualifications as required of staff providing services under these rules.

History

Authority: O.C.G.A. § 31-44-5
History. Original Rule entitled "License Requirements and Exemptions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-22-.04 Application for a License and License Renewal {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.04}

(1) All applications for licenses shall be submitted on forms provided by the Department.

(2) No application shall be considered by the Department unless it is complete, and is accompanied by all required attachments and fee payments.

(3) The Department shall issue an annual license to an applicant if it is determined that the applicant and the facility meet the requirements of these rules.

(4) Initial License.

(a) Application for Initial License. The application for the initial license shall be submitted to the Department not later than thirty (30) days prior to the anticipated date of the opening and initiation of operations by the facility, shall be signed by the executive officer of the facility's governing body, and shall be accompanied by:

The nonrefundable application fee;
The initial license fee as designated on the fee schedule;
A narrative description of the services to be offered at the facility, including the number of dialysis stations;
The name and contact information of the facility administrator as appointed by the facility's governing body;
Evidence that the facility has sufficient staff, qualified as required by these regulations, to meet the needs of patients, with a description of the organizational structure of the staffing; and
Proof of facility ownership:

(i) If ownership is a corporation, the application shall be accompanied by a copy of the Certificate of Existence (Good Standing) from the Office of the Secretary of State of Georgia.

(ii) If the facility is non-profit, the application shall be accompanied by legal proof of the organization and the names and addresses of all trustees.

(iii) If ownership is neither a corporation nor a non-profit organization, the name and address of each person with ownership in the facility shall be submitted with the application.

(b) Temporary Provisional License. The Department may at its discretion issue a temporary provisional license to the facility. The temporary provisional license shall be effective for a period of no more than six (6) months.

A temporary provisional license shall be considered for only the following situations:

(i) The facility has applied for an initial license or renewal of a license and cannot demonstrate full compliance with these rules, but has demonstrated satisfactory evidence that it is making progress toward meeting these rules and has submitted an acceptable plan of correction; or

(ii) The facility has applied for a license in order to function as a special purpose facility, meeting the requirements of these rules, with intended operation of no more than the six month period of effectiveness of the license.

A temporary provisional license may be issued by the Department only when the facility has demonstrated sufficient compliance with these rules that the health and safety of patients will not be endangered.
A 12-month license issued during the period of temporary provisional licensure shall not require an additional license fee.

(c) An end stage renal disease facility in operation at the time these rules initially become effective, and holding certification for participation in the federal Medicare program, shall be granted an initial license upon payment of the applicable license fee, without requiring inspection. This initial license shall be effective for a period of twelve (12) months, unless suspended or revoked as a result of an adverse action, and shall be subject to the renewal process.

(5) Application for a New Annual License Due to Change in Facility Name, Facility Location, or Facility Ownership.

(a) At least 30 days prior to the change in the facility's name, location, or ownership, a new application for license shall be submitted which shall contain the new name, location, proof of ownership, any changes in the official mailing address and contact telephone numbers, and a description of any organizational changes or changes in key personnel.

(b) The Department, at its discretion, may require an inspection of the facility prior to approval of the new license.

(c) The facility shall return to the Department the license issued under the prior name, location, or ownership, immediately upon the change of same, and it shall be considered revoked.

(6) Renewal of License. At least 30 days, but no more than 90 days, prior to the expiration of the license, the facility shall submit an application for license renewal on forms provided by the Department, with the applicable renewal fee.

(a) The Department shall conduct an inspection of the facility prior to renewal of the facility license, to ensure continued compliance with these rules and regulations.

(b) The facility shall be permitted to continue operation under the existing license until such time as the inspection has been completed and the renewal of the annual license is issued or denied.

(c) The renewed annual license shall have an effective date at the date of issue or at the expiration date of the previous license, whichever is later, and shall be effective for twelve (12) months from the effective date.

(7) Denial of License Application or Renewal Application. The Department may refuse to grant a license within the parameters described in "General Licensing and Enforcement Requirements", Chapter 111-8-25.

(a) The Department may refuse to grant an initial annual license without the requirement of holding a hearing prior to the action.

(b) Denial of an application for a new or renewal license from a facility shall be subject to notice and opportunity for a hearing.

The facility has failed to demonstrate compliance with these rules and regulations;
The applicant has had a license denied, revoked, or suspended within one year of the date of a new application;
The applicant has transferred ownership of a facility within one year of the date of a new application in order to avert denial, suspension, or revocation of a permit; or
The applicant has knowingly made any verbal or written false statement of material fact in connection with the application for the license.

(8) Request for Approval for Addition of Services. A facility shall obtain written approval from the Department prior to any addition of services or increase in number of dialysis stations.

(a) At least thirty (30) days prior to the anticipated date of the addition of a new service or an increase in the number of dialysis stations, the facility shall submit a request for approval. The facility shall submit with the request:

A description of any modifications to the facility's physical plant to accommodate the change; and
Evidence that the facility has reviewed staffing availability and added staff positions if indicated to accommodate the change.

(b) The Department may at its discretion conduct an inspection of the facility prior to action on the request for change.

(c) The Department shall notify the facility of the approval of the request for change, or the reason for disapproval. If disapproved, the Department shall indicate the action or information required for approval of the change.

(9) Notification of the Discontinuation of a Service. At least thirty (30) days prior to the discontinuation of a facility service, the facility shall notify the Department of the planned discontinuation, and shall provide a description of impact of the change on the care of patients currently served. The facility shall also notify the patients of its planned discontinuation of a facility service.

(10) Temporary Inactive Status. If the facility is closing temporarily, and plans to reopen under the same ownership and name, the facility may request to have the license placed on temporary inactive status.

(a) Temporary inactive status shall be granted initially for a period of no more than ninety (90) days, and may be granted upon request for only one additional period of ninety (90) days at the discretion of the Department.

(b) When placed on temporary inactive status, the license shall be returned to the Department, and the facility shall not operate until the license has been reactivated.

(c) The facility shall request in writing that the permit be reactivated at least thirty (30) days prior to the desired date of re-opening. Prior to reactivation of the license, the facility shall be subject to inspection by the Department. If the license is not reactivated within six (6) months, the license shall be considered revoked.

History

*Authority: O.C.G.A. §§ 31-44-2, 31-44-6 and 31-44-11. *
History. Original Rule entitled "Application for a License and License Renewal" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-22-.05 Facility Inspections {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.05}

(1) The facility shall be available during all hours of operation for observation and examination of the facility and the entirety of its administrative and service operations, by representatives of the Department. If dialyzers are reused for dialysis at the facility, the reprocessing of the dialyzers shall be subject to inspection.

(2) Initial Inspections.

(a) There shall be an initial inspection of a facility prior to the opening date in order to determine that the facility is in compliance with these rules. At the time of the initial inspection the facility shall be ready to operate in compliance with these rules, and shall have available for review:

A copy of the Certificate of Occupancy as required by law;
Written operational policies and procedures for all services described in the application, and for all support and monitoring functions as required by these rules;
Documentation of any agreements with hospitals or other service providers;
Evidence of satisfactory water culture results and water chemical analysis; and
Documentation of qualifications of staff.

(b) During the period of temporary provisional license, and following the initiation of patient treatment services, the Department shall inspect the facility to determine eligibility for the annual license.

(3) Periodic Inspections. Prior to renewal of the license, and periodically as deemed necessary by the Department, the facility shall be subject to periodic inspections to determine that there is continued compliance with these rules.

(a) Upon receipt of a complaint alleging a rule violation by the facility, or if the Department has a reason to suspect there has been a rule violation, the facility shall be subject to inspection.

(b) If the facility is requesting addition of services or dialysis stations, the facility shall be subject to inspection.

(4) Plans of Correction. If as a result of an inspection violations of these licensing rules are identified, the facility will be given a written report of the inspection which identifies the rules violated. The facility shall submit to the Department a written plan of correction in response to the report of inspection, which states what the facility will do, and when, to correct each of the violations identified. The plan of correction shall be submitted within ten calendar days of the facility's receipt of the written report of inspection.

History

Authority: O.C.G.A. § 31-44-10
History. Original Rule entitled "Facility Inspection" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-22-.06 Facility Organization and Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.06}

(1) Governing Body . The facility shall function under the control of an identifiable governing body, which has full legal authority for the governance and operation of the facility.

(a) The governing body shall specify in writing the operational objectives of the facility, including which services are to be offered.

(b) The governing body shall be responsible for the establishment, adoption, and annual review of administrative rules and regulations and facility policies and procedures, and for ensuring that they are in accordance with accepted standards of practice and safeguard the health and safety of patients.

(c) The governing body shall be responsible for ensuring that the facility's design and operation are in compliance with all relevant federal, state, and local legal requirements.

(d) The governing body shall adopt for the facility admission criteria that ensure equitable access to services for individuals needing care for end stage renal disease.

(e) The governing body shall designate sufficient staff and allocate sufficient staff time to implement the facility's quality management program and shall provide for leadership support of the program.

(f) The governing body shall establish and implement written policies regarding the determination, selection, or privileging of medical staff for the facility.

(g) The governing body shall appoint a facility administrator to be responsible for the administrative management of the facility and the enforcement of adopted rules and regulations.

The governing body shall delineate the responsibilities of the facility administrator in writing and shall ensure that the administrator is sufficiently free of other duties to provide effective management of the facility.
The governing body of the facility shall notify the Department of a change in the administrator of the facility and shall at that time provide the name and contact numbers of the new administrator.

(2) Facility Administrator.

(a) The facility administrator may serve on a full-time or part-time basis, but shall serve sufficient time to plan, organize, and direct the overall function of the facility, and to carry out those responsibilities as assigned by the governing body. The facility administrator shall meet one of the following qualifications:

Holds at least a baccalaureate degree and has at least one (1) year experience in an end stage renal disease facility; or
Meets the qualifications for a physician director or a nurse responsible for nursing services for an end stage renal disease facility as described in these rules; or
As of the first effective date of these rules, has been acting for at least two years as a facility administrator for an end stage renal disease facility which has been certified for a federal Medicare program.

(b) The facility administrator shall be responsible for:

Management of the facility's fiscal affairs, including maintenance of financial records and generating regular reports of expenses and revenues for review by the governing body;
Implementing the policies and procedures of the facility as approved by the governing body, and ensuring that all personnel at the facility are familiar with applicable policies as well as applicable state and federal regulations;
Coordinating the provision of services at the facility, including establishing clear lines of authority and accountability for those involved in patient care;
Ensuring that the facility employs sufficient qualified staff to provide patient care services, and adequately orients staff to their work responsibilities while meeting the following minimum staffing ratios:

(i) There must be one (1) licensed and qualified nurse for every twelve (12) patients receiving dialysis care and one qualified dialysis care giver for each four (4) patients present in the immediate clinical care area. At least one licensed and qualified registered nurse shall be available in the immediate clinical care area to provide nursing care whenever patients are being dialyzed.

(ii) Trainees may not be counted in the staff:patient ratios.

Maintaining facility records, including a chronological record of patient care services provided, and submitting reports on facility functions and operations as required by the governing body or the Department.

(c) The facility administrator shall serve as the liaison between the governing body and the medical staff and other healthcare workers at the facility.

(d) The facility administrator shall designate in writing a qualified individual to act on his/her behalf in the event of his/her absence.

(e) The facility administrator shall be responsible for ensuring that the care of dialysis patients of the facility is coordinated appropriately when a patient is being transferred to a hospital or another dialysis provider or being received back by the facility.

History

Authority: O.C.G.A. §§ 31-2-5, 31-2-7, 31-44-3
History. Original Rule entitled "Facility Organization and Administration" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Mar. 15, 2023; eff. Apr. 4, 2023.

Ga. Comp. R. & Regs. r. 111-8-22-.07 Facility Communication Responsibilities {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.07}

(1) The facility shall develop, adopt, implement, and enforce policies and procedures to ensure that each patient is:

(a) Provided communication of information in a manner effective for the patient, which may include the services of an interpreter or written form, as appropriate;

(b) Fully advised of their medical condition in terms that they understand, or, if they are unable to understand, their representative is so advised;

(c) Informed of all treatment modalities and settings for the treatment of end stage renal disease, and of the criteria for suitability for each treatment modality and setting;

(d) Informed about, and given the opportunity to participate in, all decisions about care, including the right to refuse treatment and the medical consequences of refusal;

(e) Informed about all services provided by the facility, the qualifications and training of staff providing services, and the charges for services provided;

(f) Informed of the facility's reprocessing of dialyzers or bloodlines, if supplies are reused;

(g) Transferred or discharged only for medical reasons, for the welfare of the patient, other patients, or staff, or for on payment of fees, and given at least thirty (30) days advance notice of the transfer or discharge unless such delay presents significant risk to the patient or others, and that there is documentation of efforts to resolve issues leading to discharge when the discharge is against the patient's wishes;

(h) Provided information about, and allowed to formulate, advance directives and have them honored in accordance with current statutes; and

(i) Informed of the facility's internal mechanisms for receiving and responding to complaints from patients and others regarding services, and the mechanisms for filing a grievance or complaint against the facility through the licensing agency, without fear of denial of services or retaliation by the facility.

(2) The facility shall inform each patient upon admission of their responsibilities in the treatment process, and of the facility's rules regarding patient conduct.

(3) The facility shall report to the Department whenever any of the following incidents involving patients receiving dialysis services through the facility occurs:

(a) Any unanticipated patient death not related to the natural course of the illness or the patient's underlying condition occurring at the facility or as a direct result of treatment received in the facility;

(b) Any serious injury resulting from the malfunction or intentional or accidental misuse of patient care equipment;

(d) Any patient dialyzed with another patient's dialyzer where the facility reuses the hemodialyzers;

(e) Any deviation in fulfilling the patient prescription which results in a significant adverse patient outcome;

(f) Any sexual or physical assault of or by a patient which is alleged to have occurred in the facility.

(4) The facility shall make an initial report of the incident within twenty-four (24) hours or by the next business day from when the incident occurred, or from when the facility has reasonable cause to suspect a reportable incident. The initial report shall be received by the Department in confidence, and shall include at least:

(a) The name of the facility;

(b) The date of the incident and that date that the facility became aware that a possible reportable incident may have occurred;

(d) The type of incident suspected, with a brief description of the incident; and

(e) Any immediate corrective action or preventative action taken by the facility to ensure against the replication of the incident prior to the completion of the facility investigation.

(5) The facility is required to conduct an investigation of any of the incidents listed above and to complete and retain on site a written report of the results of the investigation within forty-five (45) days of the discovery of the incident. The complete report of the investigation shall be available to the Department for inspection at the facility, and shall contain at least the following:

(a) An explanation of the circumstances surrounding the incident, including the results of a root cause analysis or other appropriate quality improvement process or tool;

(b) Any findings and conclusions associated with the review; and

(c) A summary of any actions taken to correct identified problems associated with the incident, and to reduce the potential for recurrence of the incident.

History

Authority: O.C.G.A. §§ 31-44-3, 31-5-5, 31-7-131 and 31-7-133
History. Original Rule entitled "Facility Communication Responsibilities" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-22-.08 Continuous Quality Improvement {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.08}

(1) Through the facility administration, the medical director, and the medical and nursing staff, the facility shall develop and implement a facility-wide continuous quality improvement program, specific to the facility and designed to perform a systematic, ongoing, concurrent, and comprehensive review of the patient care provided, both in-facility and through the home dialysis program, if provided.

(2) All facility staff shall be involved in the continuous quality improvement program.

(3) Policies and procedures for the continuous quality improvement program shall include the use of a defined methodology for implementation. The methodology selected must include components for measuring the facility's performance, identifying opportunities for improvement through the use of such quality improvement tools as root cause analyses, setting priorities, and identifying expected outcomes. Reporting mechanisms shall be established, including at least a quarterly review of the continuous quality improvement activities.

(4) The continuous quality improvement program shall continuously monitor at a minimum:

(a) Morbidity and mortality;

(b) Hemodialyzer reuse, if applicable;

(d) Preventable maintenance of facility equipment;

(e) Clinical outcomes, including but not limited to adequacy of dialysis and anemia management;

(f) Critical incidents;

(g) Patient complaints;

(h) Infection control; and

(i) Vascular access preservation and complications.

(5) The results of continuous quality improvement activities and monitoring shall be disseminated to the governing body, the medical director, the medical staff, and any service staff impacted by the results.

(6) The facility shall take and document remedial action to address service deficiencies identified through the continuous quality improvement program.

History

Authority: O.C.G.A. § 31-44-3
History. Original Rule entitled "Continuous Quality Improvement" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-22-.09 Medical Staff and Medical Services {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.09}

(1) Medical Director. Any medical director beginning such a function for the first time in Georgia at any facility on or after July 1, 2002 shall be a licensed physician who is board-certified in nephrology. However, a physician who has completed a fellowship in nephrology after July 1, 2002 may direct a dialysis facility in a medically- underserved area for a maximum of two years provided that the physician obtains board certification as a nephrologist by the end of the two-year period. Any physician functioning as a facility medical director at the implementation date of these rules shall be board-eligible or board-certified in nephrology, internal medicine, or pediatrics, and shall have at least one year experience in the care of patients at an end stage renal disease facility.

(a) The medical director shall participate in the development of all patient care policies at the facility.

(b) The facility shall have mechanisms in place for communication of essential patient care issues and information to the medical director.

(c) The medical director shall be responsible for the daily clinical operations of the facility, and for the execution of patient care policies and procedures.

(d) The medical director shall be permitted to provide direct patient care services at the facility, in addition to the duties as the medical director.

(2) Medical Services. The medical director shall ensure that each patient at the facility receives medical care and supervision appropriate to the patient's dialysis needs.

(a) Each patient shall have an attending physician who is responsible on a continuing basis for the patient's medical care. Each patient's records shall clearly indicate the name and contact number for the patient's physician.

The facility shall require a history and physical examination of each patient following admission, prior to the development of the patient's care plan, and at least annually thereafter.
The facility shall require each patient to have a medical plan of care, prescribed by a physician, to include indicated dialysis or related treatments, dialysis orders, medications, diet, criteria for discharge and any other special services needed.
The facility shall require that the patient's physician participates in the development of the care plan for the patient, and shall assure that the plan for the patient's medical care is based on the assessment of the patient's individual needs.
The facility shall require and the medical director shall ensure that the patient's medical progress at the facility is monitored by a physician on-site at least monthly. The facility shall require that each patient have a scheduled opportunity to see a physician at least once per month. Medical patient monitoring and physician visits shall be documented by progress note entries in the patient's medical record.
The facility shall require and the medical director shall ensure that any adverse medical patient outcomes are communicated to the patient's physician, and that the facility takes appropriate corrective action.

(b) The medical director shall ensure that there is medical care available at all times for managing emergency situations, for both in-center and home dialysis patients. There shall be posted at each nursing/monitoring station a roster of physicians on-call for the provision of emergency care. The roster shall specify when each physician is available and how they can be reached.

(c) The facility shall ensure that each patient, or each patient's responsible party, is aware of how to access medical care in an emergency, as appropriate to the patient's age and abilities.

History

Authority: O.C.G.A. § 31-44-3
History. Original Rule entitled "Medical Staff and Medical Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. May 9, 2017; eff. May 29, 2017.

Ga. Comp. R. & Regs. r. 111-8-22-.10 Staff Qualifications, Training, and Supervision and Staff Records {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.10}

(1) Staff Orientation .

(a) The facility shall provide a facility orientation program for all staff, approved by the medical director, to include at least:

A review of the services provided by the facility;
A review of facility policies and procedures, including general infection control procedures and use of universal precautions;
The facility's emergency procedures and disaster preparedness plans;
The facility's continuous quality improvement program; and
Documentation and records requirements.

(b) The facility shall document that each staff member has attended the orientation program.

(2) Nursing Staff .

(a) Minimum Education and Experience Qualifications for Nursing Staff.

Any registered nurse or licensed practical nurse providing services in the facility shall have and maintain a current Georgia license to practice nursing.
Registered nurses in charge of the training of patients in self-care, involving either home hemodialysis or peritoneal dialysis, shall have a minimum of three months of experience working with dialysis self-care patients.
Prior to providing dialysis care, all nursing staff shall demonstrate satisfactory completion of either the training program or educational equivalency and the competency skills assessment checklist as required for dialysis technicians.

(b) Supervision of Nursing Staff.

The nurse responsible for nursing services shall ensure that the licensed practical nurses participating in the provision of appropriate nursing services are familiar with protocols established by the medical staff as necessary for patient care during dialysis treatment. At all times, a registered nurse must be in the patient care area while patient care is being provided.
Any registered nurse or licensed practical nurse who is employed without previous experience in the dialysis process, and who has not yet successfully completed the skills competency checklist, shall be directly supervised when engaged in dialysis treatment activities with patients by a staff member who has demonstrated skills competency for dialysis treatment as required by these rules.

When a facility hires a registered nurse who has not had previous dialysis experience, the facility shall conduct and document a training needs assessment to identify training needs specific to care for the dialysis patient, and shall document the provision of such training by an instructor meeting the qualifications for training dialysis technicians as indicated by the needs assessment, together with satisfactory completion of a skills competency checklist.
Licensed practical nurses providing dialysis care shall meet the same training and competency requirements, including the documentation of such training and competency, as required by these rules for dialysis technicians.
The facility shall require and maintain adequate documentation for all nursing staff of a minimum of twelve (12) clock hours per year of continuing education related to end stage renal disease treatment.

(d) Competency Evaluation for Nurses. The facility shall document for each licensed nurse the satisfactory completion of a skills competency checklist in dialysis treatment, signed by the registered nurse responsible for nursing services at the facility, or qualified instructor under these rules, prior to the unsupervised provision of hemodialysis or peritoneal dialysis treatment to patients and thereafter at least annually. The competency skills assessment shall reflect those patient care activities provided by the nurse and shall include age-specific competencies when applicable.

(3) Dialysis Technicians.

(a) An individual may not function as or be represented to be a dialysis technician unless that individual has satisfied the training and competency requirements of these rules. The individual in the process of completing training as a dialysis technician shall be identified as a trainee when present in any patient area of the facility.

(b) Minimum Qualifications for Dialysis Technicians. Persons first employed by the facility as dialysis technicians after the effective date of these rules shall meet or exceed the following criteria:

A high school diploma or equivalent;
Documentation of the satisfactory completion of a training program with a curriculum equivalent to or exceeding the curriculum required by these rules for dialysis technicians; and
Documentation of the satisfactory completion within the past twelve months of a skills competency checklist equivalent to or exceeding the competencies required by these rules for dialysis technicians, administered at the current employment facility.

A training program curriculum for dialysis technicians shall be approved by the medical director of the facility, and shall include minimally the following educational and clinical components, defined in written form with objectives for each component:

(i) Understanding of the individual with end stage renal disease, to include:

(I) Basic renal anatomy, physiology, and pathophysiology;

(II) The effect of renal failure on other body systems;

(III) Signs and symptoms of the uremic state;

(IV) Basic renal nutrition;

(V) Basic psychosocial aspects of end stage renal disease; and

(VI) Medications commonly administered to patients with end stage renal disease, and side effects, toxicity, and other common problems associated with medications;

(ii) Introduction to dialysis treatments and options including a history of dialysis and definitions and terminologies used;

(iii) Principles of hemodialysis to include at least:

(I) The use of osmosis and diffusion for blood cleaning;

(II) Access to the circulatory system; and

(III) Anticoagultion and the role of local anesthetics and normal saline;

(iv) Hemodialysis procedures to include at least:

(I) Using aseptic technique;

(II) Technical aspects of operation and monitoring of dialysis equipment, and of the initiation and termination of dialysis;

(III) Delivery of an adequate dialysis treatment and factors which may result in inadequate treatment;

(IV) Observation and reporting of patient reactions to treatment;

(V) Glucose monitoring, dialysis adequacy monitoring, and hemoglobin/ hematocrit monitoring; and

(VI) Emergency procedures and responses such as cardiopulmonary resuscitation, air embolism management, management of hypo and hypertensive crises, response to line separation during hemodialysis, calling an ambulance, and handling patient death;

(v) Hemodialysis equipment to include at least:

(I) Theory and practice of conventional, high efficiency, and high flux dialysis;

(II) Dialysate composition, options, indications, complications, and safety;

(III) Safe equipment operation and monitoring; and

(IV) Equipment disinfection;

(vi) Water treatment to include:

(I) Standards for water treatment used for dialysis as described in the current American National Standard, Hemodialysis Systems, published by the Association for the Advancement of Medical Instrumentation (AAMI);

(II) Water treatment systems and devices;

(III) Monitoring of water; and

(IV) Risks to patients of unsafe water;

(vii) Reprocessing, if the facility practices dialyzer reuse, to include at least:

(I) Principles of reuse;

(II) Safety, quality control, universal precautions, and water treatment in reprocessing; and

(III) Standards for reprocessing of dialyzers for reuse, as described in the current American National Standard, Reuse of Hemodialyzers, published by the Association for the Advancement of Medical Instrumentation (AAMI);

(viii) Patient teaching, to include at least the role of the technician in supporting patient education goals;

(ix) Infection control during dialysis and in the dialysis environment, to include at least:

(I) Risks to patients of nosocomial infections, accidents, and errors in treatment;

(II) Sterile techniques and specimen handling;

(III) Basic bacteriology and epidemiology;

(IV) Risks to employees of blood and chemical exposure; and

(V) The importance of ongoing quality control activities in assuring safe dialysis treatments are provided to patients;

(x) The facility's grievance policies and the handling of patient complaints.

If the dialysis technician is to participate in training or treatment with peritoneal dialysis patients, the following components must be included in the training curriculum in addition to those components listed above:

(i) Principles of peritoneal dialysis;

(ii) Sterile technique for peritoneal dialysis;

(iii) Peritoneal dialysis delivery systems;

(iv) Symptoms of peritonitis; and

(v) Complications of peritoneal dialysis.

If the dialysis technician is to cannulate the access site, the training curriculum shall include, in addition to those components listed under 111-8-22-.10(3)(c)1. above, training in accessing the circulatory system, including at least:

(i) The creation and development of a fistula, needle placement for access, and prevention of complications;

(ii) The materials used and creation of grafts, needle placement for access in a graft, and prevention of complications; and

(iii) Identification of signs and symptoms of complications when cannulating access.

The trainee shall independently complete a written examination at the completion of the training program, which shall encompass the content of the curriculum in subsection 1. of this section, and, as applicable, subsection 2. and/or 3. The trainee shall be required to obtain a passing score of 80% or greater on the written examination. Current certification as a dialysis technician by a nationally recognized certification organization or satisfactory evidence of having successfully passed a nationally standardized test of competency for dialysis care technicians approved by the Department may exempt an individual from the requirement of the training program and written examination, if permitted by facility policy.
The curriculum for the training program shall be:

(i) Reviewed at least annually by the medical director, and updated as needed by changes in the facility's equipment and/or procedures;

(ii) Administered under conditions that do not compromise the integrity of each individual assessment required for competency tests and the completion of skills checklists; and

(iii) Where the Department determines that the facility's training program does not appear to provide adequate evidence of training in accordance with these requirements as a result of the identification of rule violations associated with the quality of care being provided by dialysis technicians and/or the facility's performance falls below acceptable levels on at least three patient care quality indicators, such as mortality rate, hospitalization rate, catheter rates, fistula rates, hematocrit levels and urea reduction rates and the Department so notifies the facility, the facility will be required to utilize a nationally standardized competency test approved by the Department. The facility shall have one year from the date of the Department's notification to have all its dialysis care technicians providing care having passed an approved nationally standardized competency test for dialysis care technicians, and must continue using the nationally standardized competency test for all new hires. No dialysis care technician hired after the facility has received notice of that nationally standardized competency test is being required by the Department shall be permitted to continue in employment at the facility for more than one (1 year without having satisfactorily completed a nationally standardized test of competency approved by the Department.

Instructors . Instructors for the training program for dialysis technicians shall have passed the training and clinic skills competency checklist for dialysis technicians. All instructors providing training for dialysis technicians two years from the effective date of these rules and thereafter shall have passed a nationally recognized and standardized examination for the provision of dialysis care as approved by the Department.

(i) For the two years immediately following the adoption of these rules, a registered nurse or licensed practical nurse with at least twelve months of experience in hemodialysis, and at least three months experience in peritoneal dialysis, if applicable to the facility program, or an instructor qualified by education and training providing a dialysis technician training course through an accredited college or university may serve as an instructor of dialysis technicians.

(ii) Adjunct Instructors . With twelve (12) months experience in a dialysis setting, licensed dietitians, licensed social workers or qualified dialysis technicians providing training on water reuse or equipment maintenance may provide those components of the training program within their specific areas of expertise under the supervision of the instructor.

(d) Clinical Supervision of Dialysis Technicians and Trainees .

Trainees who are in the process of completing a dialysis technician training program shall provide patient care only as a part of the training program, and only under the immediate and direct monitoring of either:

(i) A licensed nurse meeting the qualifications of this chapter, or

(ii) An assigned preceptor, who is either a licensed practical nurse or a dialysis technician with at least one year of dialysis experience and a current satisfactory skills competency checklist as required of a dialysis technician on file at the facility.

The facility shall define by written policy the hours of directly monitored clinical patient care activities required for the completion of the training program for staff coming into the facility with credentials demonstrating appropriated competencies. At a minimum, facility policy must provide for 40 hours of monitored clinical patient care activities and completion of a skills checklist. For the first forty (40) hours of monitored patient care activities, this staff may not be counted in the staff: patient care ratio.
A licensed facility utilizing a temporary employment agency to provide patient care services must have a written agreement with the temporary agency that specifies that the staff the agency sends to provide patient care services to the facility must meet the staff qualification set forth in these rules. The facility will monitor contract performance to ensure that the agency staff providing patient care services in the facility are competent to perform the assigned patient care tasks and that the agency staff have been familiarized with the particular facility's environment and procedures for handling emergencies prior to caring for patients at the facility.
Dialysis technicians who have completed an acceptable training program and skills competency checklist shall be supervised by a registered nurse. A licensed registered nurse shall be immediately available in the dialysis area to monitor the care being provided by the dialysis technician to the patient.

(e) Competency Evaluation for Dialysis Technicians. In addition to the satisfactory completion of the required training program and written examination, the dialysis technician trainee, each dialysis technician newly employed, and each dialysis technician at least annually, shall be required to demonstrate satisfactory clinical patient care performance through a skills competency evaluation.

A licensed nurse who qualifies as an instructor in these rules shall administer to each trainee or technician an assessment of skills through a skills competency checklist which covers at least the following acts:

(i) Assembling necessary supplies for hemodialysis;

(ii) Preparing dialysate according to procedures and dialysis prescription;

(iii) Assembling and preparing the dialysis extracorporeal circuit correctly;

(iv) Securing the correct dialyzer for the specific patient;

(v) Installing and rinsing the dialyzer and all necessary tubing;

(vi) Testing monitors and alarms, conductivity, and (if applicable) presence and absence of residual sterilants;

(vii) Setting monitors and alarms according to facility and manufacturer protocols;

(viii) Obtaining predialysis vital signs, weight, and temperature according to facility protocol and informing the registered nurse of unusual findings;

(ix) Inspecting access for patency and, after cannulation is performed and heparin administered, initiating dialysis according to the patient's prescription, observing universal precautions, and reporting unusual findings to a licensed nurse;

(x) Adjusting blood flow rates according to established protocols and the patient's prescription;

(xi) Calculating and setting the dialysis machine to allow fluid removal rates according to established protocols and the patient's prescription;

(xii) Monitoring the patient and equipment during treatment, responding appropriately to patient needs and machine alarms, and reporting unusual occurrences to a licensed nurse;

(xiii) Monitoring patient blood pressure and taking appropriate actions related to blood pressure according to facility protocol;

(xiv) Documenting findings and actions according to facility protocol;

(xv) Describing indicators and appropriate response to dialysis-related emergencies such as cardiac or respiratory arrest, needle displacement, or infiltration, clotting, blood leaks, or air emboli and to nonmedical emergencies such as power outages or equipment failure;

(xvi) Discontinuing dialysis and establishing hemostasis, to include at least:

(I) Inspecting, cleaning, and dressing the access site according to facility protocol; and

(II) Identifying and reporting unusual findings to a licensed nurse.

(xvii) Obtaining and recording post-dialysis vital signs, temperature, and weight and reporting unusual findings to a licensed nurse;

(xviii) Discarding supplies and sanitizing equipment and treatment chair according to facility protocol;

(xix) Communicating the patient's emotional, medical, psychological, and nutritional concerns to a licensed nurse;

(xx) Maintaining professional conduct, good communication skills, and attention to privacy and confidentiality during the care of the patient;

(xxi) For the dialysis technician trainee who will be assisting with training or treatment of peritoneal dialysis patients:

(I) Assisting patients in ordering supplies for dialysis;

(II) Making a dialysate exchange (draining and refilling the peritoneal space with dialysate) to include continuous ambulatory peritoneal dialysis exchange procedures and initiation or discontinuation of continuous cycling peritoneal dialysis;

(III) Observing peritoneal effluent and identifying significant factors;

(IV) Collecting dialysate specimen;

(V) Performing a transfer tubing change; and

(VI) Setting up and operating continuous cycling peritoneal dialysis equipment.

(xxii) For the dialysis technician trainee who will be cannulating dialysis access, the performance of cannulation, to include:

(I) Inspecting the site for access;

(II) Preparing the skin;

(III) Using aseptic technique;

(IV) Placing and securing needles correctly;

(V) Establishing blood access;

(VI) Replacing needles; and

(VII) Recognizing problems and the need to call for assistance; and

(xxiii) For the licensed practical nurse functioning as a dialysis technician, the skills competency checklist shall include, in addition to the above, the protocols for administering medications and intravenous fluids, including but not limited to normal saline, heparin and subcutaneous lidocaine, during the dialysis treatment.

For any items failed during the administration of the skills competency checklist, the facility shall document additional training for the trainee or technician in the area(s) of failure, and the trainee or technician shall not be permitted to provide patient care without direct supervision until all checklist items have been demonstrated satisfactorily.

(f) Verification and Demonstration of Completion of the Training Program and Competency Assessment for Dialysis Technicians . When a trainee completes a dialysis technician training program at the facility, the facility shall issue and provide to the dialysis technician a document verifying completion of the training requirements under this chapter. This document may be accepted as proof of completion of training by another facility that later employs the dialysis technician, provided that the dialysis technician is able to satisfactorily complete a skills competency checklist administered by the new place of employment.

(g) Dialysis Acts Permitted for Dialysis Technicians to Perform . A dialysis technician who has successfully completed the training program outlined herein and the skills competency checklist may perform the following actions under the supervision of a licensed registered nurse:

Initiate routine dialysis treatments for those patients whom the technicians are not prohibited from dialyzing as outlined in section (h) below.
Administer normal saline via the extracorporeal circuit during the initiation and discontinuation of the dialysis treatment and during dialysis treatment according to specified written protocols established by the medical director. At the time that the technician administers normal saline during the course of the dialysis treatment, the technician shall immediately notify the nurse responsible for that patient.
Monitor patients during their dialysis treatment and make adjustments in rate of treatment in accordance with established protocols and instructions.
Discontinue routine dialysis treatment and establish hemostasis for those patients whom the technician is not prohibited from dialyzing as outlined in section (h) below.

(h) Dialysis Acts Prohibited for the Dialysis Technician . A dialysis technician who is not a licensed practical nurse shall not:

Initiate or discontinue hemodialysis via a central catheter, manipulate a central catheter, or change dressings for a central catheter;
Administer controlled substances or dangerous drugs to patients at any time, including those medication which may be required during routine dialysis treatment, except for normal saline as provided in paragraph (g)2. above.
Administer blood or blood products;
Perform non-access site arterial puncture;
Accept physician orders; or
Provide hemodialysis treatments to pediatric patients under fourteen (14) years of age or under 35 kilograms weight.

(4) Reuse Technicians .

(a) Minimum Qualifications for Reuse Technicians . Persons first hired after the effective date of these rules to process kidney dialyzers for reuse at the facility shall meet or exceed the following criteria:

A high school diploma or equivalency,
Documentation of the satisfactory completion of a training program with a curriculum equivalent to or exceeding the curriculum required by these rules for reuse technicians, and
Documentation of the satisfactory completion within the past twelve months of a skills competency checklist equivalent to or exceeding the competencies required by these rules for reuse technicians, administered at the facility where currently employed.

(b) Required Training for Reuse Technicians .

A training program curriculum for reuse technicians shall be approved by the medical director of the facility, and shall include minimally the following educational and technical components, defined in written form, with objectives for each component which comply with the American National Standard for Reuse of Hemodialyzers, published by the Association for the Advancement of Medical Instrumentation (AAMI) and herein incorporated by reference:

(i) The basic principles of hemodialysis, emphasizing the role of the dialyzer;

(ii) The rationale for and importance of the use of treated water in dialysis and dialyzer processing, including the risks of using untreated water;

(iii) The facility's protocols for the reprocessing dialyzers and the rationale for each step of the procedure;

(iv) The operation and maintenance of the equipment used by the facility in the reprocessing program;

(v) Infection control procedures; and the importance of infection control in the handling of dialyzers and reprocessing equipment and materials;

(vi) The risks of cross-contamination, and the methods to prevent it;

(vii) The disinfection procedures, including safe handling of disinfectants, cleaning spills and disposing of toxic substances, the importance of protective equipment and ventilation in the reprocessing area, and the procedures for testing for residual disinfectant in the dialyzer;

(viii) Documentation procedures and procedures for labeling dialyzers during and after reprocessing; and

(ix) Criterion for determining when a dialyzer should not be reused, and proper disposal of used dialyzers.

Instructor. An instructor for a reuse technician training program shall be a licensed nurse or trained reuse technician who has successfully completed the skills competency checklist for reuse technicians within the past year.
Prior to completion of the training program and satisfactory demonstration of competency, the reuse technician trainee or newly employed reuse technician shall not engage in any part of dialyzer reprocessing except as a part of the training program and under the direct supervision of an instructor as defined in 111-8-22-.10(4)(b)2.

(c) Competency Evaluation for the Reuse Technician . The reuse technician trainee, any newly employed reuse technician, and each reuse technician at least annually, shall be required to demonstrate satisfactory performance of reprocessing tasks through a skills competency evaluation administered by a qualified instructor as defined in 111-8-22-.10(4)(b)2.

The competency skills checklist for reuse technicians shall include at least the following:

(i) Performance of all steps of the facility's protocols for reprocessing dialyzers, including receiving and transporting, rinsing and cleaning, disinfecting, storage, and setup for reuse, and observance of required procedures to control risk of infection and cross-contamination.

(ii) Monitoring and documentation of air and water quality;

(iii) Monitoring and documentation of equipment function;

(iv) Handling of toxic substances and use of protective equipment and clothing, including management of spills;

(v) Labeling of dialyzers; and

(vi) Documentation of reprocessing for each dialyzer, and completion of required logs and forms.

For any items failed during the administration of the skills competency checklist, the facility shall document additional training for the trainee or technician in the area(s) of failure, and the trainee or technician shall not be permitted to reprocess dialyzers without direct supervision until all checklist items have been demonstrated satisfactorily.

(d) Verification and Documentation of Completion of the Training Program and Competency Evaluation for Reuse Technicians . When a trainee completes a reuse technician training program at the facility, the facility medical director shall issue and provide to the reuse technician a document verifying completion of the training requirements under this chapter. This document may be accepted as documentation of completion of training by another facility that later employs the reuse technician, provided that the reuse technician is able to satisfactorily complete a skills competency checklist administered at the new place of employment.

(5) Water Treatment System Technician .

(a) Minimum Qualifications for Water Treatment Systems Technicians . Individuals first hired after the effective date of these rules who are assigned responsibility for the operation and monitoring of the water treatment system shall meet or exceed the following criteria:

A high school diploma or equivalency;
Documentation of completion of an on-site training program in the principles and fundamentals of water treatment and the operation and maintenance of the equipment currently used by the facility, or a training program which covered the same material as provided in the on-site program prior to employment. An on-site training program, if provided, shall be approved by the medical director, and shall include the current standards and procedures for water treatment recommended by the Association for the Advancement of Medical Instrumentation (AAMI), under the title "Hemodialysis Systems", herein incorporated by reference.
Demonstration of an understanding of the risks of patients exposed to water which has not been treated to remove contaminants and impurities, and documentation of satisfactory completion of a skills competency checklist at least annually, to include at least the following:

(i) Basic operation and use of the facility's water treatment system, according to the manufacturer's protocols, at a minimum, from the water source through the water delivery system;

(ii) Monitoring and testing for water quality and treatment system performance, and documentation of such monitoring, as required by facility protocol;

(iii) Adherence to cleaning and disinfection schedules and procedures for the water treatment equipment;

(iv) Calibration of measurement and monitoring instruments;

(v) Troubleshooting for equipment malfunctions; and

(vi) Procedures to be followed if abnormal findings are discovered during water quality monitoring.

(b) All water treatment technicians, regardless of the date of hire, must successfully complete a skills competency checklist annually for all water treatment procedures which meets or exceeds the skills competency checklist for new trainees.

(6) Equipment Technicians . An individual first hired after the effective date of these rules who functions as an equipment technician shall have at least the following minimum qualifications:

(a) High school diploma or equivalency;

(b) Completion of a training program approved by the medical director of the facility, which includes at least an overview of mechanical and equipment systems at the facility, electrical safety (including lockout) and safety requirements of dialysate delivery systems, standards and protocols for monitoring water bacteriology, both in dialysate and water used for reprocessing;

(c) Prior to being assigned responsibility for performing any equipment-related maintenance and repairs, the facility must ensure that the technician has completed training in machine maintenance and repairs for the equipment used at the facility for dialysis, reprocessing, and water treatment for which the technician may be responsible for, as provided by the equipment manufacturer(s) or other qualified staff certified by the equipment manufacturer and must complete satisfactorily an appropriate skills competency checklist administered by staff qualified to judge the required job competencies.

(d) All equipment technicians, whether hired before or after the effective date of these rules, must satisfactorily complete at least annually a skills competency checklist covering all assigned duties administered by staff qualified to judge the required job competencies.

(7) Dietitian . Any dietitian employed by the facility shall hold a current license in the state of Georgia to practice as a dietitian.

(8) Social Worker . The social worker employed by the facility shall hold a current license in the state of Georgia as either a Master's Social Worker or a Licensed Clinical Social Worker.

(9) Continuing Education . Facility staff providing patient care shall attend a minimum of twelve clock hours of continuing education activities related to end stage renal disease and treatment within twelve months of the effective date of these rules and annually thereafter. Continuing education activities may consist of, but are not limited to, seminars, lectures, and educational workshops, or one-on-one training. Continuing education provided at the facility, including technician training programs, shall be accepted toward satisfaction of this requirement. The facility orientation program shall not be accepted for satisfaction of this requirement. Documentation of attendance at continuing education activities shall be kept in the personnel file for each staff member.

(10) Staff Records .

(a) The facility shall compile and maintain a personnel record for each staff member which include documentation of at least:

The staff member's employment history;
The staff member's job description;
The results of annual competency evaluations and job performance evaluations; and
Verification of the current status of any professional licenses or certifications, as applicable to the staff member's job functions.

(b) The facility shall maintain for each staff member a record of any health screenings required under 111-8-22-.16(3) and (4) .

History

Authority: O.C.G.A. §§ 31-44-3, 31-44-8, 31-44-9
History. Original Rule entitled "Quality Qualifications, Training and Supervision and Staff Records" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Aug. 14, 2026; eff. Sep. 3, 2026.

Ga. Comp. R. & Regs. r. 111-8-22-.11 Patient Care Services {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.11}

(1) Nursing Services.

(a) Nursing services shall be provided in accordance with current standards of practice as defined by Georgia law.

(b) The facility shall employ a full-time registered nurse to be the nurse responsible for nursing services, and to supervise the provision of patient care by licensed practical nurses and unlicensed personnel.

(d) The facility shall ensure the following patient care activities are assigned to and performed by appropriately licensed nurses:

Conducting nursing assessments on admission and when indicated by an observed or reported change in the patients' health status;
Provision of nursing input for the team review of a patient's progress;
Recommending to the team changes in treatment suggested by the patient's needs;
Administration of medications, including the introduction of intravenous saline;
Initiation and discontinuation of hemodialysis via a central catheter, and manipulation of a central catheter or change of dressing for a central catheter;
Administration of blood or blood products;
The facilitation of communication between the patient, the patient's family, and other members of the treatment team; and
Provision of oversight and supervision for dialysis technician trainees, dialysis technicians, and other unlicensed personnel involved in patient care activities, including the recording of treatment observations and interventions in progress notes, as qualified for such oversight and supervision by the rules contained in this chapter.

(e) Dialysis treatments for pediatric patients under fourteen years of age or under 35 kilograms in weight shall be performed by a licensed registered nurse with experience in pediatric dialysis.

(2) Nutrition Services. The facility shall provide nutrition services to the patients and the patients' families and caregivers, which are designed to maximize the patient's nutritional status. Services shall be provided by a qualified dietitian, as defined by these rules, and shall include at a minimum:

(a) Basic nutritional education must be initiated within two weeks of admission by the nursing or dietary staff. A comprehensive nutritional assessment report with recommendations for patient education will be completed within thirty days of admission and at least annually thereafter;

(b) Participation as a member of the interdisciplinary treatment team in the development of each patient's plan(s) of care and review of that plan;

(c) Availability of a qualified dietitian to provide counseling and assistance to patients during regular treatment times;

(d) Recommendations of therapeutic diets specific to each patient's needs, counseling and training for patients related to the dietary recommendations, and monitoring of nutritional status and adherence to dietary requirements by objective and subjective means, with timely intervention when changes are indicated; and

(e) Regular recording in the patient's medical record of the patient's nutritional status, monitoring data, and progress in meeting nutritional goals.

(3) Social Work Services. The facility shall provide social services which are directed toward supporting and maximizing the patient's social functioning and adjustment to management of end stage renal disease. Services shall be provided by a qualified social worker, as defined by these rules, and shall include at a minimum:

(a) Psychosocial evaluation of each patient, completed within thirty (30) days of admission and at least annually thereafter;

(b) Participation as a member of the interdisciplinary treatment team in the development of each patient's plan(s) of care and review of that plan;

(d) The provision of case work and group work services to patients and their families in dealing with the problems and complications associated with end stage renal disease and dialysis;

(e) Identification of community service agencies and other support resources, and facilitation of patients' access to those resources;

(f) Provision of access to social work services during times of patient treatment; and

(g) Regular reporting of the patient's contact with the social worker in the patient's medical record.

(4) Laboratory Services. The facility shall provide or arrange for the laboratory services needed for safe and effective patient treatment.

(a) If the facility provides its own laboratory services:

The facility shall have current Georgia licensure and federal certification as required for the tests performed, or a waiver for the tests performed if licensure and certification are not required.
The facility performing waived tests shall have policies and procedures for obtaining samples, performing tests, and reporting results, which conform to current standards of practice and the manufacturer's specifications.

(b) If the facility receives services from an outside laboratory, such arrangements shall be made by written contract, which shall ensure that the laboratory meets all applicable state and federal licensing and certification requirements for the tests performed, and which ensures the provision of test results in a timely manner.

(5) Administration and Storage of Controlled Substances and Dangerous Drugs.

(a) Controlled substances and dangerous drugs shall be administered to patients only with an order from a licensed physician or from a physician's assistant or nurse practitioner as permitted by Georgia law.

(b) Controlled substances and dangerous drugs shall be administered to patients only by those persons authorized under Georgia law to administer medications. However, trained and competent dialysis technicians are permitted to administer saline via the extracorporeal circuit as provided under Section 111-8-22-.10(3)(g)2.

(d) Medications not given immediately shall be labeled with the patient's name, the name of the medication, and the dosage, and the date and time opened, and initialed by the person preparing the medication. All medications shall be administered by the individual who prepares them.

(e) The facility shall establish and implement procedures for limiting access to medications by unauthorized personnel.

(f) Medications requiring refrigeration shall be stored in refrigerators used only for that purpose and stored at appropriate temperatures.

(g) The facility shall regularly inventory controlled substances and dangerous drugs and medication supplies to ensure that outdated supplies are immediately disposed of in an appropriate manner, and that sufficient supplies of usable controlled substances and dangerous drugs are available to meet patient needs.

(h) Controlled substances shall be stored and dispensed in accordance with the provisions of the Georgia Pharmacy Practice Act and the Georgia Controlled Substance Act.

(6) Home Training Services for Hemodialysis or Peritoneal Dialysis.

(a) If the facility provides services for training and support of home dialysis, the facility shall meet the requirements for care plans for those patients, to include interdisciplinary conferences.

(b) In addition to other facility services and support requirements, the facility shall provide for home dialysis patients:

A written outline of the home dialysis training program, including didactic and practice components, including the performance of dialysis treatments by patients and/or their assisting partner and the requirements for facility surveillance of the patient's home adaptation and water quality, with the requirement that each patient (and their assisting partner, if applicable), satisfactorily complete the training program before beginning home dialysis;
Sufficient teaching materials available for patient use during and after home dialysis training;
A program for surveillance of the patient's home adaptation, to include an initial visit in the patient's home and subsequent supervisory visits by a licensed registered nurse, as indicated by the patient's medical status and training needs or at least annually, with documentation of all home visits in the patient's medical record;
A procedure for continuous re-evaluation of the suitability of home dialysis for the patient, to include evaluation of the adherence of the patient to physician's orders and policies and procedures of the facility, and the adequacy of the dialysis performed in the home;
Provision of supplies for the home sufficient to sustain dialysis treatment;
Routine transfer set changes, where applicable, for peritoneal dialysis patients at least every six (6) months and as needed;
Installation and maintenance of dialysis equipment in the home, including training for the patient in identifying equipment malfunctions and mechanisms for accessing equipment service; and
A system for routine monitoring, culturing, and disinfection of the water in the home of each hemodialysis patient, to ensure that the water quality meets the standards recommended by the Association for the Advancement of Medical Instrumentation (AAMI).

(c) The facility shall provide dialysis services at the facility or arrange for the provision of services at a site mutually agreeable to the facility and the patient for the home dialysis patient on those occasions when the home dialysis patient is unable to perform safe and adequate dialysis in the home.

History

Authority: O.C.G.A. § 31-44-3
History. Original Rule entitled "Patient Care Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. May 9, 2017; eff. May 29, 2017.

Ga. Comp. R. & Regs. r. 111-8-22-.12 Patient Care Plans {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.12}

(1) The facility shall coordinate services for each patient through an interdisciplinary treatment team approach. An interdisciplinary treatment team shall be identified at the time of admission for each patient and shall consist of at least:

(a) The patient and any family member(s) or other(s) designated as a representative of the patient who wishes to participate and is invited by the patient to participate;

(b) Either the patient's attending physician or the medical director of the end stage renal disease facility;

(d) A licensed social worker;

(e) A licensed dietitian; and

(f) A transplant surgeon or surgeon-designee.

(2) There shall be documentation of the participation of the patient (or their representative) in the development and review of the patient's plan of care, with consideration given to the patient's preferences. If participation is declined, the declination shall be documented, and there shall be evidence that the content of the plan(s) or decisions were reviewed with the patient or their representative.

(3) The treatment team shall develop a written, individualized plan of care for each patient, designating a selected treatment modality and a selected setting for treatment.

(a) The care plan shall be developed within 30 days of admission to the facility.

(b) All suitable treatment modalities shall be considered by the treatment team, regardless of their availability at the current facility, and there shall be consideration of the patient's preferences as well as clinical and psychosocial needs.

(c) The care plan for patients deemed unsuitable for transplant shall indicate the specific rationale for the unsuitability.

(d) For patients for whom transplant referral has been selected, educational and rehabilitation needs shall be addressed as a part of the care plan.

(e) The care plan shall be reviewed and updated at least annually, or sooner if there has been a change in the selected treatment modality or setting.

History

Authority: O.C.G.A. § 31-44-3
History. Original Rule entitled "Patient Care Plans" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. May 9, 2017; eff. May 29, 2017.

Ga. Comp. R. & Regs. r. 111-8-22-.13 Hemodialyzer Reuse {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.13}

(a) Facilities processing dialyzers for reuse shall adhere to the current American National Standard, Reuse of Hemodialyzers, published by the Association for the Advancement of Medical Instrumentation (AAMI), which are incorporated herein by reference.

(2) The facility practicing reuse shall provide each patient with information regarding the reuse practice at the facility and an opportunity to ask questions regarding the reprocessing of dialyzers, and shall obtain written informed consent from the patient, or the patient's representative, if applicable, for the use of a reprocessed dialyzer for the patient's hemodialysis.

(3) The facility shall develop and implement policies and procedures for dialyzer reprocessing which include but are not limited to criteria for determining the safe and useful life of a dialyzer, procedures for documenting the reprocessing history of each dialyzer, and procedures for documenting maintenance and monitoring of the functioning of the reprocessing equipment. If the facility uses an offsite reprocessing service, the facility shall have policies and procedures regarding the coordination of this service with the handling of dialyzers within the facility, to ensure adequate documentation of the storage and transport of the dialyzers from the time they are re- moved from the dialysis machine to the time they are returned to the facility.

(4) The facility shall limit access to the reprocessing room to authorized personnel.

(5) The reprocessing room shall have a ventilation system, which is connected to an exhaust system vented to the outside, with a fan at the outside end to direct discharge of air outward. The exhaust outlet shall be arranged to minimize recirculation of the exhausted air into the building.

(6) The system providing water for reprocessing must meet all the requirements for pressure, flow rate, bacteriological and pyrogenic contamination, and other requirements for operating the reprocessing equipment under minimal and peak load conditions.

(7) If a facility utilizes an off-site reprocessing service, the facility shall be responsible and accountable for the safety and effectiveness of the reprocessing of the dialyzers. Such arrangements must be by written contract requiring that:

(a) The reprocessing services comply with the American National Standard, Reuse of Hemodialyzers, published by the Association for the Advancement of Medical Instrumentation (AAMI), in its current edition:

(b) The individuals performing the reprocessing meet training and competency standards equivalent to or exceeding those required for reuse technicians at the end stage renal disease facility;

(c) The service implements a continuous quality improvement program to monitor the effectiveness and safety of reprocessing procedures;

(d) There are provisions for transport of the dialyzers to and from the reprocessing site which are adequate to prevent contamination or deterioration; and

(e) The off-site reprocessing location shall be available during regular business hours for inspection of reprocessing procedures by representatives of the Department.

History

Authority: O.C.G.A. § 31-44-3
History. Original Rule entitled "Hemodialyzer Reuse" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-22-.14 Medical Records {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.14}

(1) A current and complete medical record shall be maintained for each patient.

(2) The facility shall designate a supervisor for the medical records who shall be responsible for the organization, proper documentation, completion and preservation of the facility's medical records.

(3) The medical records shall be organized in a manner to facilitate the completion and retrieval of information.

(4) Patients' medical records for the most recent two years shall be kept on site. The remainder of the patient's medical record may be stored off-site if the record is readily available. Medical records shall be retained for at least five years following the date of death or discharge. For pediatric patients, the records shall be retained for three years after the patient reaches the age of majority, or at least five years, whichever is longer.

(5) Medical records shall be available for inspection only to members of the professional staff, the patient, representatives of the Department acting in an official capacity, or persons authorized in writing by the patient to have access to the medical record.

(a) The facility shall release copies of all or part of a patient's medical record to an authorized representative of the Department at no cost to the Department when the Department determines that said records are necessary in connection with the Department's licensing and certification responsibilities of a facility.

(b) The facility shall arrange for the prompt transfer of a courtesy copy of the following parts of the patient's medical record to the receiving facility: the patient's care plan, the last two weeks of run sheets and flow charts, a list of current medications, current treatment orders and the last three months of clinical laboratory test results to the receiving facility.

(c) The facility shall have a mechanism to release copies of all or part of a patient's medical records to the patient or to others with the written consent of the patient or the patient's legal guardian and to others where required by law. The facility may charge a reasonable fee for the copies so produced.

(d) The medical record for each patient shall contain at a minimum:

Patient identifying information (name, address, age, sex, marital status);
Dates of admission, transfer, and discharge, as applicable;
Names of referring and attending physicians;
Evaluation and assessment reports, including the history and physical examination administered prior to the initial treatment;
Reports from any special examinations and consultations, and laboratory and x-ray results;
Physician's orders;
Care plans;
Signed consent forms, as applicable;
Progress notes, including dialysis flow sheets; and
The discharge summary, including cause of death, if applicable.

(e) All entries in the medical records shall be permanent, accurate, dated with the actual date of entry, and signed by the individual making the entry. Late entries shall be labeled as late entries.

(f) Verbal or telephone orders, if allowed by facility policy, may only be entered by Georgia-licensed personnel, and must be authenticated by the ordering physician or individual taking responsibility for the order at the next patient visit or sooner as required by facility policy.

(g) All medical record entries shall be legible.

(h) Medical records shall be completed within forty-five (45) days after the patient's discharge.

History

Authority: O.C.G.A. § 31-44-3
History. Original Rule entitled "Medical Records" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. May 9, 2017; eff. May 29, 2017.

Ga. Comp. R. & Regs. r. 111-8-22-.15 Environment of Care {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.15}

(1) Safety. The facility shall have sufficient staff, systems and equipment in place to provide a safe environment for patients, staff, and visitors, to include at least:

(a) A system for patients and staff to summon assistance, when needed, from treatment areas and bathrooms;

(b) An incident reporting and monitoring system that promptly identifies, investigates, and takes corrective action regarding all incidents that involve injury to patients or visitors, that involve damage to property, or which have the potential to cause such injury or damage if not corrected;

(c) Policies and procedures to prohibit and prevent verbal or physical abuse or neglect of patients while they are receiving services from the facility;

(d) A program which requires and documents the inspection, monitoring, and maintenance of biomedical equipment, electrical equipment, and any emergency power systems;

(e) An environment free of physical hazards such as broken or torn furniture, loose floors or wet flooring, or holes in walls, windows, or ceilings;

(f) Procedures, supplies, and equipment for the management of biomedical waste and the disposal of sharps in accordance with current accepted standards of practice;

(g) Adequate supplies of protective equipment for staff involved with patient care; and

(h) A working telephone on the premises accessible to the patients.

(2) Cleanliness and Sanitation. The facility premises and equipment shall be maintained in a clean and orderly condition. There must be evidence that the facility has systems that satisfactorily address at least the following:

(a) The description and performance of effective daily, interim, and terminal cleaning routines for all areas;

(b) Procedures, supplies, and facilities for the management of linens which include separate storage areas and separate transport containers for clean and dirty linens, separate storage areas for patient property if permitted by facility policy, and the requirement that no dirty linens or sanitation equipment shall be stored in a water treatment room or reuse room;

(d) Facilities and supplies for convenient and effective handwashing throughout the facility, including but not limited to:

For facilities newly constructed or undergoing major renovation after the effective date of these rules, at least one handwashing sink in the dialysis area for each eight dialysis stations;
If the facility conducts reuse hemodialysis, a separate handwashing sink in the reuse room;
If the facility provides on-site peritoneal dialysis, a handwashing sink in the room used for peritoneal dialysis which is separate from any facilities for disposal of effluent (peritoneal dialysis drainage); and
Hot and cold running water at each sink, with soap or sanitizing solution for washing hands, and clean disposable materials or air dryers for drying hands.

(e) Sufficient equipment and systems for prevention of infestation by insects, rodents, or other vermin or vectors;

(f) Systems for the storage and disposal of trash, garbage, and waste in a manner that will not permit the transmission of disease, create a nuisance, or provide a breeding place for insects or rodents; and

(g) Floor coverings that are intact, with no reservoirs or cracks in the surface where pathogens and standing water may accumulate.

(3) Space and Equipment. The facility shall provide adequate space and equipment to provide the scope of services offered, while ensuring the health and safety of patients and staff.

(a) For a facility constructed or undergoing renovation after the effective date of these rules, the facility shall have a minimum of 70 square feet of floor space at each treatment station, with the smallest dimension being 7 feet.

The 70 square feet may include counters, sinks, and aisles.
There shall be access to both sides of the patient bed/chair at each treatment station, with ease of passage for staff or a wheelchair.

(b) Public hallways, doorways, and elevators should be of sufficient size so as to accommodate passage of a wheelchair or ambulance gurney or stretcher.

(c) If the facility provides on-site peritoneal dialysis, there shall be a separate room for the peritoneal dialysis treatment.

(d) The facility shall have a private area for meetings with patients or family members, separate from the treatment areas.

(e) The facility shall have an examination room, equipped with a door that closes, an examining table, a readily accessible handwashing sink, and adequate floor space to accommodate the patient's treatment needs.

(f) If the facility offers services to patients with infectious diseases, the facility shall provide treatment for those patients in accordance with recommendations from the Centers for Disease Control. Some infectious diseases will require the use of isolation rooms and separate dialyzer equipment.

(g) There shall be sufficient office space for physicians, nurses, social services, administration, and dietetic and other ancillary services to work and meet, physically separated from the patient treatment area(s).

(h) The facility shall have at least one toilet facility with handwashing sink for patient use, which is accessible for a patient in a wheelchair.

(4) Water Treatment System.

(a) The facility shall operate a system for the analysis and treatment of water to ensure a continuous water supply sufficient in quantity and quality to conduct dialysis in accordance with accepted standards of practice.

Responsibility for the effective operation of the water treatment system shall be assigned to the medical director of the facility.
Policies and procedures shall be developed and implemented to govern all staff actions relative to water treatment; and
Systems for water treatment, water monitoring, water delivery, and water disposal shall adhere to the current standards for water treatment as described in the American National Standard,"Hemodialysis Systems", published by the Association for the Advancement of Medical Instrumentation (AAMI), herein incorporated by reference.

(b) The area used for water treatment shall be separate from the area(s) used for dialysis treatment, dialyzer reprocessing, or other activities and purposes at the facility. Mixing of dialysate may be performed in the area used or water treatment, if there is sufficient space for both functions.

(c) The facility's water treatment system shall be continuously monitored during patient treatment, and shall be equipped with a functional audible and visible alarm system to alert staff if there is a failure of the system.

(d) Staff assigned to the operation and monitoring of the water treatment system shall meet the training and competency qualifications for water treatment technicians required under this chapter.

(e) Staff shall maintain a written log of the operation of the water treatment system throughout each treatment day. Entries into the log shall be current and legible, and shall indicate that each component of the system is operating within required parameters or shall describe actions taken when operation is outside required parameters.

(f) Monthly testing of product water from selected sample sites within the system shall be conducted to assess compliance with AAMI water quality standards. In addition, a sample of product water shall be submitted for chemical analysis every six months, or sooner if there have been changes to the system or if the monthly results indicate there may have been a significant change in quality. Reports of all water testing shall be reviewed and signed by the medical director.

History

Authority: O.C.G.A. § 31-44-3
History. Original Rule entitled "Environment of Care" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-22-.16 Infection Control {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.16}

(1) The facility shall have an infection control committee composed of at least the facility administrator, a physician, and a registered nurse. The infection control committee shall develop and implement policies and procedures for preventing and controlling hepatitis and other infections at the facility, including but not limited to:

(a) Operational procedures for the prevention of the spread of infectious diseases, including identification of job classifications or work areas or tasks requiring the use of protective barriers and other universal precautions as recommended by the Centers for Disease Control;

(b) Procedures for facility-wide surveillance and reporting of infections, to include mechanisms for tracking infection rates and suspected pyrogenic reactions;

(d) Specific procedures for the sterilization and disinfection of equipment, including dialysis machines;

(e) Procedures for maintaining a safe and clean physical environment;

(f) Procedures for the prevention of contamination by blood and other body fluids of facility areas outside the dialysis and dialyzer reprocessing areas;

(g) Procedures for prevention of cross-contamination in storage and treatment areas and in the dialyzer reprocessing area, if applicable;

(h) Procedures for providing dialysis for patients testing positive for hepatitis B surface antigen or other bloodborne infectious diseases as outlined by the CDC in its current guidelines for infection control in dialysis centers, including reservation or special disinfection of dialysis equipment;

(i) Procedures for providing dialysis for patients with active pulmonary tuberculosis or other active airborne infectious disease;

(j) Procedures for the protection of patient clothing, blankets, or other personal articles during the time when blood lines are opened or needles inserted or withdrawn; and

(k) Procedures for the investigation of infections.

(2) Reports of infections such as bacteremia, septicemia, hepatitis, any wound that may allow for cross-contamination of patients and any suspected pyrogenic reactions and other communicable diseases of patients shall be made to the infection control committee through established mechanisms and noted in patient files. Reports maintained by the infection control committee shall include documentation of efforts to determine the origin of the infection, and, where the dialysis procedure or environment was found to be related to the transmission of the infection, shall include documentation of the actions taken to prevent recurrence.

(3) Health Screenings. Each facility shall have in place a health screening program designed to identify conditions that may place patients at risk for infection, injury, or improper care. The program shall include requirements and processes for initial, routine, and targeted health screenings for employees and contractors who interact with patients or conduct other activities with environmental impact.

(4) Screening for Tuberculosis (TB). Prior to starting work, all employees must be screened for TB in accordance with Centers for Disease Control and Prevention (CDC) guidelines for baseline screening and testing for health care personnel.

(5) Records. Copies or certificates of the health screenings shall be kept in the employee's personnel folder.

(6) Dialysis patients shall be tested initially and at least annually for the presence of Hepatitis B surface antigen, and for tuberculosis and any other infectious diseases which the Centers for Disease Control have deemed to be endemic to the area served, to determine the need for special treatment precautions and surveillance of the infection. Results of the screenings, as well as any refusals to submit to such testing signed by the patient, shall be included in the patient's medical record.

History

Authority: O.C.G.A. § 31-44-3; 42 CFR § 494.30
History. Original Rule entitled "Infection Control" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Aug. 14, 2026; eff. Sep. 3, 2026.

Ga. Comp. R. & Regs. r. 111-8-22-.17 Emergency and Disaster Preparedness {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.17}

(1) The facility shall establish and implement procedures that describe staff and patient actions in medical and non-medical emergencies, including at least fire, equipment failure, power outages, medical emergencies, unscheduled facility closing, and natural disasters which are likely to threaten the health and safety of patients or staff.

(2) The facility shall provide training for staff and patients in where to go, what to do, and whom to contact if a medical or non-medical emergency occurs. Patient training in the handling of emergencies shall be documented in the patient's medical record and review with the patient at least annually.

(3) The facility plan shall include method of access to community emergency services. Contact numbers for emergency needs, shall be conspicuously posted near a telephone readily available to the clinical treatment area.

(4) The facility shall have and maintain appropriate equipment and supplies, in ready-to-operate condition, for managing medical emergencies, in a location accessible by all healthcare personnel. By October 1, 2002, all licensed facilities shall have an automatic external defibrillator. Emergency trays or carts shall include at least:

(a) Emergency drugs and supplies for administering treatment;

(b) Oxygen or compressed air for respiratory support;

(d) Oral airway access-devices and suctioning equipment.

(5) The facility shall establish and implement a plan for management of staff and patients in the event of a fire and provide for patient education on emergency evacuation.

(a) Evacuation routes shall be posted in all treatment areas, and patients shall be informed of these routes.

(b) The facility shall conduct and document regular fire and/or disaster drills for all shifts of service provision. Fire and/or disaster drills shall be conducted at least every six months.

(d) All facility staff shall be trained in the operation of emergency equipment, as appropriate to their qualifications and licensure.

(e) All staff shall be knowledgeable of emergency procedures and their role in the event of an emergency or disaster situation.

(f) All personnel at the facility who provide direct healthcare services for patients must maintain current certification in Basic Cardiopulmonary Life Support (BCLS) and the use of the automatic external defibrillator when the facility acquires one.

(g) The facility shall prepare a plan for procedures in the event of a natural or other disaster which may affect the facility's ability to provide patient treatment.

The disaster preparedness plan shall include at a minimum plans for the following emergency situations:

(i) Local or widespread weather emergencies or natural disasters, such as tornadoes, hurricanes, earthquakes, ice or snow storms, or floods;

(ii) Unanticipated interruption of service of utilities, including water, gas, or electricity, either within the facility or within a local or widespread area;

(iii) Loss of heat or air conditioning;

(iv) Fire, explosion, or other physical damage to the facility.

The facility shall have a written agreement with at least one other licensed facility that can provide dialysis services, to assure that the facility's patients will be treated in the event that an emergency situation at the facility renders it unable to provide scheduled dialysis services.
The facility shall have an emergency lighting system sufficient to allow for safe discontinuation of treatments and evacuation of the facility in the event of power failure.
The facility's disaster preparedness plan shall be made available to the Department for inspection upon request.

History

Authority: O.C.G.A. § 31-44-3
History. Original Rule entitled "Emergency and Disaster Preparedness" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-22-.18 Requests for Waiver or Variance {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.18}

(1) A facility may request a waiver or variance of a specific rule by application on forms provided by the Department.

(2) The Department may grant or deny the request for waiver or variance at its discretion. If the waiver or variance is granted, the Department may establish conditions, which must be met by the facility in order to operate under the waiver or variance. Waivers or variances may be granted with consideration of the following:

(a) Variance. A variance may be granted by the Department upon a showing by the applicant that the particular rule or regulation that is the subject of the variance request should not be applied as written because strict application would cause undue hardship. The applicant must also show that adequate standards exist for affording protection for the health, safety, and care of patients, and these existing standards would be met in lieu of the exact requirements of the rule or regulation.

(b) Waiver. The Department may dispense altogether with the enforcement of a rule or regulation by granting a waiver, upon a showing by the applicant that the purpose of the rule or regulation is met through equivalent standards affording equivalent protection for the health, safety, and care of the patients.

(3) Experimental Waiver or Variance. The Department may grant a waiver or variance to allow experimentation and demonstration of new and innovative approaches to delivery of services, upon a showing by the applicant that the intended protections afforded by the rule or regulation in question are met and that the innovative approach has the potential to improve service delivery.

(4) Waivers and variances granted by the Department shall be for a time certain, as determined by the Department.

History

Authority: O.C.G.A. § 31-2-47
History. Original Rule entitled "Requests for Waiver or Variance" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-22-.19 Enforcement of Rules and Regulations {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.19}

(1) An end stage renal disease facility that fails to comply with these rules and regulations shall be subject to sanctions and/or license revocation as provided by law.

(2) The Department may take actions to enforce these rules and regulations as prescribed in the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25, pursuant to O.C.G.A. § 31-2-8 , and/or by appointment of a temporary manager as described in these rules.

(3) Voluntary Appointment of a Temporary Manager. A person holding a controlling interest in an end stage renal disease facility may, at any time, request the Department to assume the management of the facility through the appointment of a temporary manager.

(a) If the Department considers the appointment appropriate for the protection of the health and safety of patients, the Department may enter into an agreement providing for the appointment of the temporary manager to manage the facility under conditions agreed upon by both parties.

The agreement shall specify all terms and conditions of the temporary manager's appointment and authority.
The agreement shall preserve all rights granted by law to patients of the facility.

(b) The primary duty of the temporary manager shall be to ensure that adequate and safe services are provided to patients until temporary management ceases.

(4) Involuntary Appointment of a Temporary Manager. The Department may request that the state Attorney General bring an action for the appointment of a temporary manager to manage the facility, if:

(a) The facility is operating without a license;

(b) The Department has denied, suspended, or revoked the facility's license but the facility continues to operate;

(c) License denial, suspension, or revocation proceedings against the facility are pending and the Department determines that there exists an imminent or reasonable foreseeable threat to the health and safety of a patient of the facility;

(d) The Department determines that an emergency exists that presents an immediate threat to the health and safety of a patient of the facility; or

(e) The facility is closing and arrangements for the care of patients by other licensed facilities have not been made before closure.

(5) A temporary manager appointed under either voluntary or involuntary condition shall be entitled to a reasonable fee as determined by the court. The fee shall be paid by the facility.

(6) A temporary manager appointed voluntarily may petition the court to order the release of any payment owed to him/her for care and services provided to patients at the facility if the payment has been withheld before or during the period of appointment, including any Medicaid, Medicare, or insurance payment, or payment from another third party.

History

Authority: O.C.G.A. §§ 31-2-8 and 31-44-13et seq
History. Original Rule entitled "Enforcement of Rules and Regulations" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-22-.20 Severability of These Rules {#sec-ga.-comp.-r.-regs.-r.-111-8-22-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-22-.20}

In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court or competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof. The remaining rule or portions of rules shall remain in full force and effect, as if such rule or portions thereof so determined, declared, or adjudged invalid or unconstitutional were not originally a part of these rules.

History

Authority: O.C.G.A. §§ 31-2-4, 31-2-7 and 31-44-1et seq
History. Original Rule entitled "Severability of These Rules" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Subject 111-8-25 General Licensing and Enforcement Requirements

Ga. Comp. R. & Regs. r. 111-8-25-.01 Legal Authority, Title and Purpose {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.01}

These rules shall be known as the Rules and Regulations for Enforcement of General Licensing and Enforcement Requirements. The purposes of these rules are to provide for general licensing and enforcement actions requirements by the department with respect to violations of licensing requirements by certain applicants or licensees operating facilities subject to regulation by the department as set forth under Chapters 7, 13, 22, 23 and 44 of Title 31, Chapter 5 of Title 26, paragraph (8) of subsection (d) of Code § 31-2-4 and Article 7 of Chapter 5 of Title 49; to provide for licensing, payment of licensing activities fees, inspections, investigations and examinations of such facilities; compliance with plans of correction; and to provide that certain facilities give notice of violations giving rise to the receipt of notice of the imposition of any sanction under federal or state laws or regulations. These rules are adopted and published pursuant to the Official Code of Georgia Annotated (O.C.G.A.) §§ 31-2-4, 31-2-9, 31-2-11 and 31-7-2.2.

History

Authority: O.C.G.A. Secs. 31-2-4, 31-2-9, 31-2-11, 31-7-2.2
History. Original Rule entitled "Legal Authority" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.
Repealed: New Rule entitled "Legal Authority, Title and Purpose" adopted. F. July 14, 2010; eff. August 3, 2010.

Ga. Comp. R. & Regs. r. 111-8-25-.02 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.02}

(1) "Administrative action" means the initiation of a contested case as defined in the Georgia Administrative Procedures Act (APA), O.C.G.A. § 50-13-2(2) .

(2) "Alter ego" means a person who acts pursuant to the control or influence of another while purporting to act independently.

(3) "Commissioner" means the Commissioner of the Department of Community Health.

(4) "Department" means the Department of Community Health, its agents and employees.

(5) "Document" means any book, record, paper, or other information related to initial and continued licensing.

(6) "Facility" means any agency, institution, entity or person subject to regulation by the department under Chapters 7, 13, 22, 23, 44 of Title 31, paragraph (8) of subsection (d) of Code § 31-2-4 , Chapter 5 of Title 26, and Article 7 of Chapter 6 of Title 49 of the Official Code of Georgia Annotated.

(7) "Final Adverse Finding" means

(a) the issuance of a ruling by the Commissioner on any appeal from a decision of a hearing officer or hearing examiner pursuant to a contested case involving the imposition of a sanction;

(b) when a decision of the hearing officers or hearing examiner becomes final by operation of law because no appeal is made to the Commissioner;

(d) where a facility does not contest within the allotted time period a sanction imposed by the department.

(8) "Formal Order" means any ruling following an administrative or judicial hearing or an emergency directive issued by the Commissioner as authorized by law related to the initial or continued licensing of a facility which requires the facility to take or refrain from taking specified action. Formal orders include, but are not limited necessarily to final administrative hearing decisions and settlement agreements between the department and facilities. Additionally, formal orders, as defined herein, may include any orders issued by the Commissioner as authorized by law, such as but not limited to O.C.G.A. § 31-7-2.2 or as authorized by similar statues enacted after the effective date of these rules.

(9) "Inspection" means any examination by the department or its representatives of a facility, including but not necessarily limited to the premises, and staff, persons in care, and documents pertinent to initial and continued licensing so that the department may determine whether a facility is operating in compliance with licensing requirements. The term "inspection" includes any survey, monitoring visit, or other inquiry conducted for the purpose of making a compliance determination with respect to licensing requirements.

(10) "Investigation" means any examination, conducted in response to an allegation or allegations of noncompliance, by the department or its representative of a facility, including but not necessarily limited to the premises, and staff, persons in care, and documents pertinent to initial and continued licensing so that the department may determine whether a facility has violated any licensing requirement.

(11) "License" means the official authorization granted by the department pursuant to any of the provisions of law cited in Rule 111-8-25-.01 to operate a facility physically located in Georgia. The term "license" includes any permit, registration, commission, or similar designation reflecting such authorization.

(12) "Licensee" means any person holding a license.

(13) "Licensing requirements" means any provisions of law, rule, regulation, or formal order of the department which apply to facilities with respect to initial or continued authority to operate.

(14) "Long-term care facility" means a licensed adult day center, assisted living community, home health agency, hospice, intermediate care home, nursing home, personal care home or private home care provider.

(15) "Management or Control", for the purpose of imposing the sanction pursuant to Rule 111-8-25-.04(1)(c) or 111-8-25-.04(2)(b) , means the exercise of or authority to exercise direction, administration, or oversight over a facility's operations by certain persons which include owners, directors, or administrators.

(16) "Memory Care Certificate" means a certificate issued by the department to a licensed assisted living community or personal care home to authorize the operation of a memory care center.

(17) "Person" means any individual, agent, representative, governing authority, firm, organization, partnership, agency, association, corporation, facility, or other entity.

History

Authority: O.C.G.A. §§. 31-2-9, 31-7-2.1, 31-7-2.2, 31-7-3.2, 31-7-12.4
History. Original Rule entitled "Title and Purposes" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.
Repealed: New Rule entitled "Definitions" adopted. F. July 14, 2010; eff. August 3, 2010.
Amended: F. Apr. 16, 2021; eff. May 6, 2021.

Ga. Comp. R. & Regs. r. 111-8-25-.03 General Licensing Requirements and Fee Schedules {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.03}

(1) No facility shall offer or provide services which are required to be licensed under rules enforced by the department without a current license issued by the department.

(2) No license shall be issued by the department unless the facility is in compliance with applicable rules set forth in these rules, specific rules applicable to the particular facility type and all licensure activity fees due the department have been paid.

(3) Fees will be assessed to facilities and applicants for licensure for the following licensure activities: processing applications for a new license or a change in ownership, initial license fees, annual licensure activity fees to maintain current license, follow-up visits to periodic inspections, training materials, returned check and mail processing charges and civil monetary penalties.

(4) Application for License. An application for a license to provide regulated services shall be submitted on forms made available by the department in a format acceptable to the department. No application shall be acted upon by the department until the application is determined complete by the department with all required attachments and applicable fees submitted.

(5) Where the department denies an initial license for non-payment of fees or any other reason, such action may be taken by the department prior to an administrative hearing on the denial being held. The applicant whose license has been denied may obtain an administrative hearing, subsequent to the decision to deny the license, as authorized under Georgia law.

(6) Ongoing Licensure Activity Fees. All licenses issued by the department require payment of ongoing licensure activity fees as calculated by the department each state fiscal year, including the state fiscal year that these rules take effect. For annual licenses, such licensure activity fees will be due on the anniversary date of the issuance of the previous year's license. For continuing licenses, such ongoing licensing activity fees will be due October 31st of each state fiscal year. The annual fees shall include the base licensure activity fee and any additional fees incurred during the previous year. Such fees are due and payable to the department within thirty (30) days of receipt of the licensure activity fee invoice. Fees will be calculated by the department in a manner so as to help defray the direct and indirect costs incurred by the department in providing such licensure activities for all programs, but in no event shall exceed such costs.

(7) Effective January 31, 2011, the department may revoke any license if the facility has failed to pay the annually recurring licensure activity fees within sixty (60) days of receipt of a written invoice from the department. The revocation action is subject to written notice of the proposed revocation and a right to receive an administrative hearing on the amount past due and owing prior to the revocation action becoming final.

(8) Schedule of Fees. Fees collected by the department are not refundable, except in extraordinary circumstances as determined by the department in its sole discretion. The decision of the department as to whether to refund a payment is final and may not be appealed. Payment of fees must be in a form of payment accepted by the department. Some forms of electronic payment may result in an additional convenience charge being added to the licensing fee that is due. Any convenience charge for which the user is responsible must be disclosed to the potential user before completion of the transaction. No cash payments are accepted by the Department. The following schedule of fees applies for the listed licensure activities: Licensure Activity Fee Fee Frequency Application Processing Fee, Change in Ownership, Change in Service Level (requiring on site visit), Name Change - Any Program $300 Upon submission Initial Provisional or Regular License (Same as annual licensure activity fee for each program type) Varies by program Submitted with application processing fee Involuntary Application Processing Fee subsequent to unlicensed complaint investigation $550 Follow-up Visit to Periodic Inspection - Any Program $250 License renewal date Licenses and Certificates Adult Day Centers ** $250 (social) $350 (medical) Annually Adult Residential Mental Health Programs** $800 Annually Ambulatory Surgical Treatment Centers ** $750 Annually Assisted Living Communities ** (see Personal Care Homes) Birthing Centers ** $250 Annually Clinical Laboratories ** $500 Annually Community Living Arrangements ** $350 Annually Drug Abuse Treatment Programs ** $500 Annually End Stage Renal Disease Centers ** Annually 1-12 stations $600 Annually 13-24 stations $1,000 Annually 25 or more $1,100 Annually Stand Alone ESRD Facilities Offering Peritoneal Dialysis Only $800 Annually Eye Banks $250 Annually HMOs (if subject to licensure) $2,000 Annually Home Health Agencies ** $1,000 Annually Hospices ** $1,000 Annually Hospitals ** Annually CAHS < 25 beds $250 Annually 25 =< 50 beds $750 Annually >50 beds $1,500 Annually Imaging Centers (rules to be developed) ** $3,000 Annually Infirmaries $250 Annually Intermediate Care Facilities/MR (private) ** $250 Annually Memory Care Certificate ** $200 Annually Narcotic Treatment Programs ** $1,500 Annually Nursing Homes ** Annually 1 =< 99 $500 Annually >99 $750 Annually Personal Care Homes ** Annually < 25 beds $350 Annually 25 =< 50 beds $750 Annually >50 beds $1,500 Annually Private Home Care Providers ** Annually For each service offered: Companion Sitter, Personal Care and/or Nursing Maximum of $750 $250 (per service) Annually Traumatic Brain Injury Facilities $250 Annually X-Ray Facilities (per machine) $300 Annually Miscellaneous Fees Civil monetary penalties as finally determined Case-by-case basis Late Fee: Sixty (60) days past due $150 Per instance Lists of Facilities by license type (electronic only) $25 Per request Replacement of Lost Permit $50 Per request Returned check charge - as assessed by bank <$50 Per instance Special handling charges when required (special courier/mailing costs) Cost Per instance Training materials - cost to reproduce for participant $.25 per page, $5 per disc Per participant ** Eligible for a 25% discount if currently accredited by a nationally recognized accreditation organization approved by the department as having standards comparable to specific state licensure requirements, and complete copy of current decision is submitted to the department at the time of renewal or is already on file with the department.

History

Authority: O.C.G.A. §§ 31-2-4, 31-2-7, 31-2-8, 31-7-3
History. Original Rule entitled "Definitions" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.
Repealed: New Rule entitled "General Licensing Requirements and Fee Schedules" adopted. F. July 14, 2010; eff. August 3, 2010.
Amended: F. Aug. 22, 2012; eff. Sept. 11, 2012.
Amended: F. Apr. 16, 2021; eff. May 6, 2021.
Amended: F. Feb. 18, 2025; eff. Mar. 10, 2025.

Ga. Comp. R. & Regs. r. 111-8-25-.04 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.04}

The department shall have the authority to impose any one or more of the sanctions enumerated in paragraphs (1), (2) and (3) of Rule 111-8-25-.05 upon a finding that an applicant or licensee has:

(a) Knowingly made any verbal or written false statement of material fact either in connection with the application for a license; or on documents submitted to the department as part of any inspection or investigation; or in the falsification or alteration of facility records made or maintained by the facility;

(b) Failed or refused, without legal cause, to provide the department with access to the premises subject to regulation or information pertinent to the initial and continued licensing of the facility.

(d) Failed to comply with the provisions of O.C.G.A. § 31-2-11 or with the provisions of these rules.

History

Authority: O.C.G.A. Sec. 31-2-11
History. Original Rule entitled "Enforcement" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.

Ga. Comp. R. & Regs. r. 111-8-25-.05 Sanctions {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.05}

(1) Sanctions against Licensees. When the department finds that any licensee has violated any provision of Rule 111-8-25-.04 , Enforcement, the department, subject to notice and opportunity for a hearing, may impose any one or more of the sanctions in subparagraphs (a) through (f) below.

(a) Administer a Public Reprimand. If the sanction of public reprimand is finally imposed, as defined by a final adverse finding, the public reprimand shall consist of a notice prepared by the department that the facility has been reprimanded; such notice shall include a written report of the department's findings along with the facility's response and corrective action plan.

Location of Notice. The facility shall post the public reprimand in places readily accessible and continuously visible to persons in care and their representatives. Additionally, if the facility maintains a website, it shall post a web link in a prominent location on the main page of the website that provides access to a copy of the public reprimand.
Timing of Notice. The facility shall post the public reprimand on the day the public reprimand is received by the facility and such reprimand shall remain posted for a period of ninety (90) days.
Notice for Service Inquiries. During any period that the reprimand is required to be posted, the facility shall advise persons seeking services and representatives of persons seeking services of the reprimand. In response to a notice by the department of the imposition of a public reprimand, a facility may request that the department not require the facility to advise persons seeking services and representatives of persons seeking services of the reprimand if such requirement would compromise its ability to provide services and is not feasible given the facility's range of services and the ways its services are provided. Such request must be made within ten (10) calendar days from receipt of the notice from the department. The department upon such a convincing showing, as well as a showing that the correction of the violation has been achieved and will be sustained by the facility, may elect not to enforce this requirement. If the department elects to enforce the requirement and the facility appeals the imposition of the sanction, the issue of this requirement may become an issue for consideration by the hearing examiner at any hearing held on the sanction, unless waived by the facility.

(b) Suspend any License. The department may suspend for a definite period or for an indefinite period in connection with any condition which may be attached to the restoration of said license.

The department may impose the sanction of suspension for a definite period calculated by it as the period necessary for the facility to implement long-term corrective measures and for the facility to be deterred from lapsing into noncompliance in the future. As an alternative to suspending a license for a definite period, the department may suspend the license for an indefinite period in connection with the imposition of any condition or conditions reasonably calculated to elicit long-term compliance with licensing requirements which the facility must meet and demonstrate before it may regain its license.
If the sanction of license suspension is finally imposed, as defined by a final adverse finding, the department shall effectuate it by requiring the facility to return its license to the department. Upon the expiration of any period of suspension, and upon a showing by the facility that it has achieved compliance with licensing requirements, the department shall reissue the facility a license. Where the license was suspended for an indefinite period in connection with conditions for the re-issuance of a license, once the facility can show that any and all conditions imposed by the department have been met, the department shall reissue the facility a license.

(c) Prohibit Persons in Management or Control. The department may prohibit a licensee from allowing a person who previously was involved in the management or control of any facility which has had its license revoked or application denied within the past twelve (12) months to be involved in the management or control of such facility. Any such person found by the department to have acted diligently and in good faith to ensure correction of violations in a facility which has had its license revoked or denied, however, shall not be subject to this prohibition if that person became involved in the management or control of the facility after the facility was notified by the department of violations of licensing requirements giving rise to a revocation or denial action. This subparagraph shall not be construed to require the department to obtain any information that is not readily available to it regarding any person's involvement with a facility. For the purpose of this Rule, the twelve (12) month period will begin to run from the date of any final adverse finding or the date that any stay of enforcement ceased, whichever first occurs.

(d) Revoke any License. The department may revoke any license. If the sanction of license revocation is finally imposed, as defined by a final adverse finding, the department shall effectuate it by requiring the facility to return its license to the department.

(e) Impose a Civil Penalty Fine. The department may impose a civil penalty fine of up to $2,000 per day for each violation of a law, rule, regulation, or formal order related to the initial or continued licensing of a facility; provided, however, that no such fines shall exceed $40,000 for violations found during the same inspection. If a violation is found on two (2) consecutive inspections, there shall exist a rebuttable presumption that the violation continued throughout the period of time between each inspection.

Categories of Violations. Violations shall be assigned a category based upon the following criteria:

(i) Category I ($1,201-$2,000 per violation per day): A violation or combination of violations of licensing requirements which has caused death or serious physical or emotional harm to a person or persons in care or poses an imminent and serious threat or hazard to the physical or emotional health and safety of one or more persons in care;

(ii) Category II ($601-$1,200 per violation per day): A violation or combination of violations of licensing requirements which has direct adverse effect on the physical or emotional health and safety of a person or persons in care; and

(iii) Category III ($100-$600 per violation per day): A violation or combination of violations of licensing requirements which indirectly or over a period of time has or is likely to have an adverse effect on the physical or emotional health and safety of a person or persons in care, or a violation or violations of administrative, reporting, or notice requirements.

Fine Amounts. The specific amount of the fine for each violation in each category shall be determined based upon whether and when the particular or similar rule, law, or order, or the act, omission, incident, circumstance, or conduct giving rise to the violation of the same regulatory requirement, or one substantially similar thereto, has been cited by the department previously. In no case, however, shall a facility be sanctioned for a violation characterized as a subsequent or repeat violation unless the time frame identified in the acceptable plan of correction has passed and the facility nonetheless has failed to attain or maintain correction.

(i) Initial Violation. If the same or a substantially similar violation has not been cited previously by the department within the past twenty-four (24) months against the facility, it shall be considered to be an initial violation. The fine amount for initial violations shall be the bottom figure in the appropriate category.

(ii) Subsequent Violation. If the present violation or a substantially similar violation had been found and cited by the department as the result of the last inspection of the facility, or as the result of any one other inspection during the previous twenty-four (24) months, the violations shall be considered to be a subsequent violation. The fine amount for subsequent violations shall be in the range between the top and bottom figures of the appropriate category and other factors, such as the existence of mitigating or aggravating circumstances, shall be considered in determining the fine amount within the range.

(iii) Repeat Violation. If the present violation or a substantially similar violation also had been found and cited any two (2) other times during the past twenty-four (24) months, it shall be considered to be a repeat violation. The fine amount for repeat violations shall be the top figure in the category.

Limitation of Fines. A single act, omission, incident, circumstance, or conduct shall not give rise to the imposition of more than one fine even though such act, omission, incident, circumstance, or conduct may have violated more than one licensing requirement. In such a case, the fine shall be based upon the highest category in which any one violation resulting from the same act, omission, incident, circumstance, or conduct falls. Correction by the facility of cited violations tolls the continuation of the assessment of the daily fine, provided, however, that the department shall confirm that such cited violations were corrected.
Financial Hardships. In response to a notice by the department of the imposition a fine, a facility may request that the department reduce the fine amount if the fine would cause significant financial hardship that would compromise its ability to provide care or services in compliance with licensing requirements. The department, in its discretion, upon such a convincing showing as well as a showing that correction of the violation has been achieved and will be sustained by the facility, may reduce the amount of the fine. If the department proceeds with the imposition of the fine as proposed, the issue of significant financial hardship may become an issue for consideration by the hearing examiner at any hearing held on the sanction, unless waived by the facility.
Mandatory Fines. The Department shall impose mandatory fines in the following circumstances:

(i) Long-Term Care Facilities . The Department shall impose a mandatory fine of no less than $5,000.00 for a violation of a law, rule, regulation, or formal order related to the initial or ongoing licensing of a long-term care facility which has caused the death of or serious physical harm to a resident in such facility. For purposes of this subparagraph, the term 'serious physical harm' means an injury which causes any significant impairment of the physical condition of the resident as determined by qualified medical personnel which may be proven by testimony or by submission of the medical record. Any mandatory fine imposed by the Department may not be reduced on the basis of financial hardship. Mandatory fines for nursing homes related to closure, change of ownership or other material changes are set forth in Rule 111-8-56-.20(5) .

(ii) Hospitals and Related Institutions . The Department shall impose a mandatory fine of no less than $5,000.00 for a violation of O.C.G.A. § 31-7-3.5 .

Federal Preemption. No fine, whether discretionary or mandatory, may be imposed against any nursing facility, nursing home, or intermediate care facility which is subject to intermediate sanctions under the provisions of 42 U.S.C. § 1396r(h)(2)(A) , as amended, whether or not those sanctions actually are imposed.

(f) Limit or Restrict any License. The department may limit or restrict any license as the department deems necessary for the protection of the public (a provisional or temporary time-limited license granted by the department shall not be considered to be a limited or restricted license).

Limitation or restriction of a license may occur to:

(i) prohibit the provision of a particular service or services when a facility is unable or unwilling to render or perform the service or services in compliance with licensing requirements;

(ii) restrict the authorized number of persons cared for by a facility when the facility is unable or unwilling to render care in compliance with licensing requirements; and/or

(iii) prohibit a facility from caring for persons with specific types or degrees of needs that the facility is not capable of meeting in compliance with licensing requirements.

If the sanction of license limitation or restriction is finally imposed, as defined by a final adverse finding, the department shall effectuate it by sending the facility a restricted or limited license. Upon receipt of the restricted or limited license, the facility shall return to the department its original license. Upon expiration of the restriction or limitation period, and upon proof by the facility that it has taken effective corrective action and has sustained that action during the period of the sanction, the department shall fully restore the facility's license. The department shall take any steps it deems necessary to verify compliance prior to the expiration of the sanction period so that a compliant facility is restored its license without delay.

(2) Sanctions against Applicants. When the department finds that any applicant for a license has violated any provision of Rule 111-8-25-.04 , Enforcement, the department, subject to notice and opportunity for a hearing, may impose any one or more of the following sanctions in subparagraphs (a) through (c) below.

(a) Refuse to Grant License. The department may refuse to grant (deny) a license; provided, however, that the department may refuse to grant an initial license without holding a hearing prior to taking such action.

The department may deny an application for a license where the facility has failed to demonstrate compliance with licensing requirements. Additionally, the department may deny an application for a license where the applicant or alter ego of the applicant has had a license denied, revoked, or suspended within one year of the date of an application, or where the applicant has surrendered the license or transferred ownership or governing authority of a facility within one year of the date of a new application when such surrender or transfer was made in order to avert denial, revocation, or suspension of a license or payment of fines. For the purpose of determining the one-year denial period, the period shall begin to run from the date of the final adverse finding, or the date any stay of enforcement ceased, whichever first occurs. In further determining whether to grant or deny a license, the department may consider the applicant's overall record of compliance with licensing requirements.

(b) Prohibit Persons in Management or Control. The department may prohibit an applicant from allowing a person who previously was involved in the management or control of any facility which has had its license revoked or application denied within the past twelve (12) months to be involved in the management or control of such facility. Any such person found by the department to have acted diligently and in good faith to ensure correction of violations in a facility which has had its license revoked or denied, however, shall not be subject to this prohibition if that person became involved in the management or control of the facility after the facility was notified by the department of violations of licensing requirements giving rise to denial action. This subparagraph shall not be construed to require the department to obtain any information that is not readily available to it regarding any person's involvement with a facility. For the purpose of this rule, the twelve (12) month period will begin to run from the date of any final adverse finding or the date that any stay of enforcement ceased, whichever first occurs.

(c) Limit or Restrict any License. The department may limit or restrict any license as it deems necessary for the protection of the public (a provisional or temporary time-limited license granted by the department shall not be considered to be a limited or restricted license).

Limitations or restrictions of a license may include any or all of the following as determined necessary by the department:

(i) prohibiting the provision of a particular service or services when a facility is unable or unwilling to render or perform the service or services in compliance with licensing requirements;

(ii) restricting the authorized number of persons cared for by a facility when the facility is unable or unwilling to render care in compliance with licensing requirements; and

(iii) prohibiting a facility from caring for persons with specific types or degrees of needs that the facility is not capable of meeting in compliance with licensing requirements.

The department may restrict a license where any applicant or alter ego of the applicant has had a license denied, revoked, or suspended within one (1) year of the date of an application, or where the applicant has surrendered the license or transferred ownership of governing authority of a facility within one (1) year of the date of a new application when such surrender or transfer was made in order to avert denial, revocation, suspension of a license, or payment of fines. For the purpose of determining the one (1) year denial period, the period shall begin to run from the date of the final adverse finding or the date any stay of enforcement ceased, whichever occurs first.
If the sanction of license limitation or restriction is finally imposed, as defined by a final adverse finding, the department shall effectuate it by sending the facility a restricted or limited license. Upon receipt of the restricted or limited license, the facility shall return to the department its original license if one was granted. Upon expiration of the restriction or limitation period, and upon proof by the facility that it has taken effective corrective action and has sustained that action during the period of the sanction, the department may issue the facility a license. The department shall take any steps it deems necessary to verify compliance prior to the expiration of the sanction period so that a compliant facility may be issued a license without delay.

(3) Extraordinary Sanctions Where Imminent and Substantial Danger. Where the Commissioner of the department determines that the patients or residents in the care of an institution, community living arrangement or drug abuse treatment program subject to licensure are subject to an imminent and substantial danger, the Commissioner may order any of the extraordinary sanctions listed in subsections (b), (c), (d) and (e), of this rule, 111-8-25-.05(3) , to take effect immediately unless otherwise specified in the order, without notice and opportunity for hearing prior to the order taking effect.

(a) Content of the Order. The order shall contain the following:

the scope of the order;
reasons for the issuance of the order;
effective date of the order if other than the date the order is issued;
person to whom questions concerning the order are to be addressed; and
notice of the right to obtain after the issuance of the order, a preliminary hearing and an administrative hearing regarding the emergency order as a contested case.

(b) Emergency Relocation. The Commissioner may order emergency relocation of the patients or residents of any institution, community living arrangement or drug abuse treatment program subject to licensure to the nearest appropriate institution, community living arrangement or drug abuse treatment program. Prior to issuing an emergency order, the Commissioner may consult with persons knowledgeable in the field of medical care and a representative of the facility to determine if there is a potential for greater adverse effects on patient or resident care as a result of the proposed issuance of an emergency order. The Commissioner shall provide for notice to the patient or resident, his or her next of kin or guardian and his or her physician of the emergency relocation and the reasons therefore; relocation to the nearest appropriate institution, community living arrangement or drug abuse treatment and education program and other protection designed to ensure the welfare and, when possible, the desires of the patient or resident.

When provided with the notice of the execution of the emergency relocation order, the institution, community living arrangement or drug abuse treatment program shall make patient/resident information available to the department in usable formats.
The institution, community living arrangement or drug abuse treatment program that is the subject of the emergency relocation order shall not impede in any way the Department's communications with the patients/residents, next of kin or guardians of the patients/residents and attending physicians.
The institution, community living arrangement or drug abuse treatment program shall continue to provide care and services to the patients/residents and shall prepare records required by the receiving facility which are necessary to facilitate continuity of patient/resident care for the patients/residents to be relocated.
The institution, community living arrangement or drug abuse treatment program shall make any personal property, such as but not limited to patient/resident funds, available to the receiving facility at the time of transfer.

(c) Emergency Placement of Monitor. The Commissioner may order the emergency placement of a monitor in an institution community living arrangement or drug abuse treatment program subject to licensure when conditions at the facility require immediate oversight for the safety of the patients or residents.

Conditions. The placement of a monitor may be required when one or more of the following circumstances are present:

(i) the institution, community living arrangement or drug abuse treatment program is operating without a permit or license;

(ii) the department has denied the application for a permit or a license or has initiated an action to revoke the existing permit or license of the institution, community living arrangement or drug abuse treatment program;

(iii) the institution, community living arrangement or drug abuse treatment program is closing or plans to close and adequate arrangement for the relocation of the patients or residents have not been made at thirty (30) days before the date of closure; or

(iv) the health, safety, security, rights or welfare of the patients or residents cannot be adequately assured by the institution, community living arrangement or drug abuse treatment program. For example, the department is informed that essential service vendors (electricity, gas, water, food or pharmacy) have not been paid and anticipate discontinuing service and the institution, community living arrangement or drug abuse treatment program does not have a signed contract with another vendor establishing that there will be no disruption in service.

Role of Monitor. The monitor may be placed in the institution, community living arrangement or drug abuse treatment program for no more than ten (10) days during which time the monitor shall observe conditions and compliance with remedial action recommended by the department. The monitor shall not assume any administrative responsibility for the institution, community living arrangement or drug abuse treatment program, nor shall the monitor be liable for any of the actions of the institution, community living arrangement or drug abuse treatment program.
Cost of Monitor. The institution, community living arrangement or drug abuse treatment program shall pay the costs associated with the placement of the monitor unless the Commissioner's order placing the monitor is determined to be invalid in a contested case proceeding under the Georgia Administrative Procedure Act, Chapter 13 of Title 50.

(d) Emergency Prohibition of Admissions. The Commissioner may order the emergency prohibition of admissions to an institution, community living arrangement or drug abuse treatment program when such facility has failed to correct a violation of departmental permit rules within a reasonable period of time, as specified in the department's corrective order, and the violation could either jeopardize the health and safety of the residents/patients if allowed to remain uncorrected or is a repeat violation over a twelve (12) month period, which is intentional or due to gross negligence.

(e) Emergency Suspension of Admissions. The Commissioner may order admissions to an institution, community living or drug abuse treatment program, may be suspended until the department has determined that the violation has been corrected or until the department has determined that the facility has undertaken the action necessary to effect correction of the violation.

(f) Preliminary Hearing. The institution, community living arrangement or drug abuse treatment program affected by the Commissioner's emergency order, may request that the department hold a preliminary hearing within the department on the validity of the order and the need for its continuation. Such hearing shall occur within ten (10) days following the request.

A request for a preliminary hearing shall be made in writing to the representative of the department designated in the emergency order. Unless a request is made to appear in person, the preliminary hearing shall consist of an administrative review of the record, written evidence submitted by the institution affected, and a preliminary written argument in support of its contentions.
If a request is made to appear in person at the preliminary hearing, the following information shall be included in the request, or provided prior to the hearing:

(i) the name and address of person or persons, if any, who will be representing the institution in the preliminary hearing;

(ii) the names and titles of all other persons who will attend the preliminary hearing; and

(iii) any additional evidence the institution wishes to submit for consideration at the hearing.

Upon receipt of a request for a preliminary hearing, the department shall set and give notice of the date, time, and location of the preliminary hearing. The preliminary hearing shall be held within ten (10) calendar days of receipt of the request.
If a personal appearance is requested, the preliminary hearing shall consist of a review of the evidence in the record; any additional evidence introduced at the hearing; and any arguments made. A sound recording shall be made of the hearing.
Within seven (7) calendar days of the close of the preliminary hearing, the department shall render a written decision. The decision shall be divided as follows:

(i) description of additional evidence submitted by the affected institution;

(ii) summary of the arguments and/or brief submitted by the institution in support of its contention that the emergency order is invalid;

(iii) a statement as to whether the emergency order issued by the department is found valid and the reasons therefore; and

(iv) notice of the affected institution's right to obtain an administrative hearing regarding the Commissioner's emergency order pursuant to O.C.G.A. § 50-13-13 , if the emergency order is found valid as a result of the department's preliminary hearing.

Pending final appeal of the validity of any emergency order issued as provided herein through the administrative hearing process, such emergency order shall remain in full effect until vacated or rescinded by the Commissioner.

(g) Cumulative Remedy. The department is not limited to a single emergency action under these rules, nor is the department precluded from other actions permitted by other law or regulations during the time an emergency order is in force.

(4) Standards for Taking Sanctions. In taking any of the actions pursuant to subparagraphs (1), (2) or (3) of this rule, the department shall consider the seriousness of the violation or violations, including the circumstances, extent, and gravity of the prohibited act or acts or failure to act, and the hazard or potential hazard created to the physical or emotional health and safety of the public.

(5) Non-Compliance with Sanctions. Failure on the part of any facility to abide by any sanction, including payment of a fine, which is finally imposed against it, shall constitute grounds for the imposition of additional sanctions, including revocation.

(6) Settlements. With regard to any contested case instituted by the department pursuant to this Chapter or other provisions of law or regulation which may now or hereafter authorize remedial or disciplinary grounds and action, the department may, in its discretion, dispose of the action so instituted by settlement. In such cases, the department, the facility, and those persons deemed by the department to be successors in interest to any settlement agreement, shall be bound by the terms specified therein. Violation thereof by any applicant or licensee, their agents, employees, or others acting on their behalf, shall constitute grounds for the imposition of any sanctions enumerated in this Chapter, including revocation.

(7) Sanctions for Nursing Facilities. With respect to any facility classified as a nursing facility, nursing home, or intermediate care home, the department may not take an action to fine or restrict the license of any such facility based on the same act, occurrence, or omission for which: the facility has received an intermediate sanction under the provisions of 42 U.S.C. § 1396r(h)(2)(A) , as amended, or 42 U.S.C. § 1395i - 3(h)(2)(B); or such facility has been served formal notice of intent to take such a sanction which the Division of Medical Assistance, based on administrative review, or any other appropriate body, based on administrative or judicial review, determines not to impose, provided however, that nothing in this subparagraph shall prohibit the department from using the provisions authorized by law in paragraph (5) above.

History

Authority: O.C.G.A. §§ 31-2-8, 31-7-2.2, 31-7-4, 31-7-3.5
History. Original Rule entitled "Sanctions" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.
Repealed: New Rule entitled "Sanctions" adopted. F. July 14, 2010; eff. August 3, 2010.
Amended: F. Apr. 16, 2021; eff. May 6, 2021.
Amended: F. Sept. 22, 2023; eff. Oct. 12, 2023.

Ga. Comp. R. & Regs. r. 111-8-25-.06 Investigations, Inspections and Plans of Correction {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.06}

(1) Authority to Investigate. The department shall have the authority to make public or private investigations inside or outside this state. Such investigations may be initiated at any time, in the discretion of the department, and may continue during the pendency of any action initiated by the department pursuant to Rule 111-8-25-.05 of this Chapter.

(2) Consent to Entry and Access. An application for a license or the issuance of the same by the department constitutes consent by the applicant or licensee and the owner of the premises for the department's representatives, after displaying identification to any facility staff, to enter the facility for the purpose of conducting an investigation or an inspection.

(a) Department representatives shall be allowed reasonable and meaningful access to the facility's premises, and information pertinent to licensure including staff and persons in care. The department shall have the authority to require the production of any documents related to the initial and continued licensing of any facility.

(3) Cooperation with Inspection. Facility staff shall cooperate with any inspection or investigation conducted by the department and shall provide, without unreasonable delay, any documents which the department is entitled hereunder.

(4) Assessment of Expenses. Pursuant to the inspection, investigation, and enforcement powers given to the department by O.C.G.A. § 31-2-11 and other applicable laws, and the provisions of this Chapter, the department may assess against a facility reasonable and necessary expenses incurred by the department pursuant to any administrative or legal actions required by the failure of a facility to fully comply with licensing requirements. Such expenses may be assessed only pursuant to the initiation of sanction actions under this Chapter and may only be collected if such actions result in final adverse findings. A facility shall be notified of the department's action to assess expenses when the department sends a facility a notice of the sanction. If the sanction is appealed, the assessment may become an issue for consideration by the hearing examiner at any hearing held on the sanction.

(a) Reasonable and Necessary Expenses. Reasonable and necessary expenses, as used in this subparagraph, shall include, but not necessarily be limited to: hourly compensation of department representatives, commuting expenses (including mileage at the current state reimbursement rate), and lodging and meal expenses (at the rate approved for reimbursement by the state) associated with overnight out-of-town travel; and other similar costs. Assessments shall not include attorney's fees and expenses of litigation, shall not exceed actual expenses, and shall be made only if inspections, investigations, or enforcement actions result in final adverse findings.

(b) Payment of Assessed Expenses. Expenses assessed against a facility shall be paid within thirty (30) days of receipt of a statement of expenses. In response to an assessment, a facility may request that the department reduce the assessment or agree to a payment plan if full payment within thirty (30) days would cause significant financial hardship that would compromise its ability to provide care or services in compliance with licensing requirements. The issue of significant financial hardship caused by the assessment may become an issue for consideration by the hearing examiner at any hearing held on the sanction.

(5) Outcome of Investigation Available. When an investigation is initiated due to an allegation of noncompliance by any person acting on his or her own or another's behalf, the outcome of the investigation shall be provided by the department to that person and to the facility upon request after the investigation is completed; provided however, that the names and identifying information regarding the complainants are classified as confidential. Nothing in this rule shall be construed to require the department to release the name or identifying information regarding a complainant without first obtaining proper authorization from such complainant. Nor shall this rule be construed to require the department to release any other confidential or privileged information without first obtaining proper authorization.

(6) Compliance with Plan of Correction . If violations of any licensing rules are identified, the facility will be given a written report of the violation that identifies the rule violated. The facility shall submit a written plan of correction in response to the report of violation, which stats what the facility will do, and when, to correct each of the violations identified. The facility may offer an explanation or dispute the findings of violations in the written plan of correction, so long as an acceptable plan of correction is submitted within ten (10) days of the facility's receipt of the written report of inspection. If the initial plan of correction is unacceptable to the department, the facility will be provided with at least one (1) opportunity to revise the unacceptable plan of correction. The facility shall comply with the plan of correction accepted by the department.

History

Authority: O.C.G.A. Secs. 31-2-11, 31-5-5, 31-7-2.2, 31-7-4
History. Original Rule entitled "Investigations and Inspections" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.
Repealed: New Rule entitled "Investigations, Inspections and Plans of Correction" adopted. F. July 14, 2010; eff. August 3, 2010.

Ga. Comp. R. & Regs. r. 111-8-25-.07 Immunity {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.07}

For any action taken or any proceeding held under this Chapter or under color of law, except for gross negligence or willful or wanton misconduct, the department, when acting in its official capacity, shall be immune from liability and suit to the same extent that any judge of any court of general jurisdiction in this state would be immune.

History

Authority: O.C.G.A. Sec. 31-2-11
History. Original Rule entitled "Immunity" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.

Ga. Comp. R. & Regs. r. 111-8-25-.08 Exemptions {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.08}

In an administrative or legal proceeding under this Chapter, a person claiming an exemption or an exception granted by law, rule, regulation, or formal order has the burden of proving this exemption or exception.

History

Authority: O.C.G.A. Sec. 31-2-11
History. Original Rule entitled "Exemptions" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.

Ga. Comp. R. & Regs. r. 111-8-25-.09 Applicability of Administrative Procedures Act {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.09}

This Chapter and all sanction actions resulting from its provisions shall be administered in accordance with Chapter 13 of Title 50 of the Official Code of Georgia Annotated, the Georgia Administrative Procedure Act. Any request for hearing in response to any sanction action undertaken pursuant to this Chapter shall be in writing and shall be submitted to the department no later than 10 calendar days from the date of receipt of any notice of intent by the department to impose a sanction setting forth the proposed sanction or sanctions and the basis therefore.

History

Authority: O.C.G.A. Secs. 31-2-11, 50-13-18
History. Original Rule entitled "Applicability of Administrative Procedures Act" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.

Ga. Comp. R. & Regs. r. 111-8-25-.10 Notice of Violations {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.10}

(1) Where a nursing home or intermediate care home is required by the provisions of O.C.G.A. § 31-7-3.2 to give notice of violations giving rise to the imposition of any sanction, the notice shall contain the information required by that code section and shall conform to the following requirements:

(a) Size and Format of Notice. The facility may post the Report of Licensure Inspection and Medicare/Medicaid Statement of Deficiencies, along with the notices by the department, the department's Division of Medical Assistance and/or the Center for Medicare and Medicaid Services of intent to impose any sanction. These may be posted in their original forms as the notice required by O.C.G.A. § 31-7-3.2(a)and(b) . If the facility chooses to post the notice of the agency taking the action and the Report of Licensure Inspection and Statement of Deficiencies, there shall be a conspicuous heading clearly visible from at least twenty feet away, calling the attention of the observer to them. As an alternative, the facility may post its own notice which accurately and thoroughly reflects the violations found which give rise to the sanctions imposed or proposed and which describes each sanction or notice of sanction issued by any of the above-described agencies. Any such notice shall be at least 11 1/2 inches by 17 1/2 inches in size. Words and letters shall be in bold print and shall be at least one centimeter in size;

(b) Location of Notice. The facility shall post the notice in a place readily accessible and continuously visible to persons in care and their representatives;

(c) Timing of Notice. The facility shall post the notices within fourteen days after it receives notification of the imposition of a sanction for a violation which requires the notice. The notices shall remain in place until the department has determined that cited violations no longer exist, at which time the notice may be removed; and

(d) Mailing of Notices. Where any person has made a written request for a copy of the notice or notices, the facility shall mail the same to the requester within 5 business days of receipt of the request when such request is accompanied by a postage paid self addressed envelope.

History

Authority: O.C.G.A. Secs. 31-2-11, 31-7-2.1, 31-7-3.2
History. Original Rule entitled "Notice of Violations" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.

Ga. Comp. R. & Regs. r. 111-8-25-.11 Applicability of Other Laws {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.11}

The provisions of this Chapter shall be supplemental to and shall not operate to prohibit the department from acting pursuant to those provisions of law which may now or hereafter authorize remedial or disciplinary grounds and action for the department. In cases where those other provisions of law so authorize other disciplinary grounds and actions, but this Chapter limits such grounds or actions, those other provisions shall apply.

History

Authority: O.C.G.A. Sec. 31-2-11
History. Original Rule entitled "Applicability of Other Laws" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.

Ga. Comp. R. & Regs. r. 111-8-25-.12 Inspection Warrants {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.12}

In addition to the enforcement actions authorized by this Chapter with respect to refusal to provide the department with access to a facility, the department may make application to a court of competent jurisdiction for an inspection warrant if its representatives are denied meaningful access to the premises, staff, persons in care, and documents or other information of a licensed facility or of a facility which the department believes is required to have a license but which does not have one. Upon the grant of such a warrant, the department may gain entry and meaningful access to such facility, its staff, and persons in care therein, facility documents, and other information deemed pertinent by the department to making a compliance determination, unless the warrant specifically limits the entry or access allowed to department representatives. This rule shall not be construed to require the department to seek entry and be denied the same before it may apply for an inspection warrant.

History

Authority: O.C.G.A. Secs. 31-2-11, 31-5-20et seq
History. Original Rule entitled "Inspection Warrants" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.

Ga. Comp. R. & Regs. r. 111-8-25-.13 Injunctive Relief {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.13}

The department may, without regard to the availability of other remedies, including the remedies set forth in this Chapter, seek an injunction against the continued operation of a facility without a license. The department likewise may seek injunctive relief against the continued operation of a facility in violation of licensing requirements.

History

Authority: O.C.G.A. Secs. 31-2-11, 31-5-9
History. Original Rule entitled "Injunctive Relief" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.

Ga. Comp. R. & Regs. r. 111-8-25-.14 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-25-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-25-.14}

In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof. The remaining rules or portions thereof shall remain in full force and effect as if such rule or portions thereof so determined, declared or adjudicated invalid or unconstitutional were not originally part of these rules.

History

Authority: O.C.G.A. Sec. 31-2-11
History. Original Rule entitled "Severability" adopted. F. Mar. 17, 2010; eff. Apr. 6, 2010.

Subject 111-8-28 Eye Banks

Ga. Comp. R. & Regs. r. 111-8-28-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.01}

Unless a different meaning is required by the context, the following terms as used in these regulations shall have the meaning hereinafter respectively ascribed to them:

(a) "Eye bank" means a facility which is maintained and operated for the extraction, removal, care, storage, preservation, and/or use of human eyes or parts thereof for purposes of sight preservation or restoration, medical education, instruction pertaining to sight preservation or restoration, or research.

(b) "Person" or "persons" means any individual, firm, partnership, corporation, trustee, association, or combination thereof.

(d) "Medical Director" means a physician who has specialized in the field of ophthalmology, is certified by the American Board of Ophthalmology and is responsible for the medical supervision of the eye bank.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-23-1 et seq
History. Original Rule entitled "Definitions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.02 Application {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.02}

Any person or persons desiring to establish an eye bank shall apply in writing to the Department for a permit. The application shall include the following information:

(a) Name of hospital or medical school;

(b) Name and qualifications of medical director of the proposed eye bank;

(d) Address of the eye bank;

(e) Brief description of equipment and facilities;

(f) Concise description of scope of service to be offered;

(g) Proof of tax-exempt and non-profit status.

History

Authority: O.C.G.A. §§ 31-2-4 and 31-23-1et seq
History. Original Rule entitled "Application" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.03 Approval {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.03}

(1) Upon compliance with all of the requirements for establishing an eye bank the governing authority for establishing said eye bank shall be issued a permit by the Department.

(2) It shall be unlawful to establish and operate an eye bank without a permit.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-23-1 et seq
History. Original Rule entitled "Approval" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.04 Inspection {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.04}

Inspections of facilities, equipment and operational procedures of the eye bank shall be made by the Department. If the eye bank is found to be deficient in any point in these rules and regulations, notice of these deficiencies will be given to the eye bank. Correction of such deficiencies must be accomplished for continuation of licensure.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-23-1 et seq
History. Original Rule entitled "Inspection" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.05 National Standards {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.05}

In addition to the requirements of these regulations, the eye bank shall meet the current medical standards approved by the Eye Bank Association of America.

History

Authority: O.C.G.A. §§ 31-2-4 and 31-23-1et seq
History. Original Rule entitled "National Standards" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.06 Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.06}

(1) The eye bank shall be under the control of a hospital or medical school's governing authority. This control may be shared through contractual agreement with other charitable institutions.

(2) The eye bank shall have a medical director.

(3) The eye bank may receive gifts, donations and bequests for purposes stated under the law.

(4) The eye bank shall be non-profit.

(5) The eye bank shall offer, on an as-needed basis, an appropriate course in eye extractions for embalmers.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-23-1 et seq
History. Original Rule entitled "Administration" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.07 Records {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.07}

(1) All records of the eye bank shall be confidential and shall be made available only to duly authorized persons.

(2) The following records shall be kept by each eye bank:

(a) donor record; the signed and witnessed duplicate donor card of every intended donor as well as the consent form for every eye received in the eye bank must be kept on file. The consent form shall be witnessed by two (2) persons of legal majority.

(b) history record; this shall be a record of the enucleation, identification and condition of the eye or eyes. It shall include a full medical history, the cause of death, time of death, recorded time of enucleation, and when available, gross and slit lamp examination of the enucleated eye.

(3) These records shall be retained for a minimum of six (6) years.

(4) If the eye bank ceases operation, provision must be made for the retention of records in a manner acceptable to the Department.

History

Authority: O.C.G.A. §§ 31-2-4 and 31-23-1et seq
History. Original Rule entitled "Records" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

(1) In any case in which a donor is having an autopsy performed, the following consent requirements shall be met prior to enucleation:

(a) A decedent who may provide a suitable eye for the transplant is under the jurisdiction of a coroner or medical examiner and an autopsy is required in accordance with O.C.G.A. § 45-16-20 et seq. ; or the physician has been requested, as provided by law, to perform an autopsy on a decedent who may provide a suitable eye for the transplant:

(b) The express written consent to the removal of the eye is given by the next of kin of the decedent; and

(2) For corneal excision the following consent requirements shall be met:

(a) The decedent from whom the tissue is to be taken is under the jurisdiction of a coroner or medical examiner pursuant to O.C.G.A. § 45-16-25 ;

(b) No objection by the decedent during his lifetime or after his death, by the appropriate person listed in paragraph (d) of this subsection is known to the coroner, medical examiner, or authorized official acting for the coroner at the time the tissue is removed;

(c) The person designated by the eye bank to remove the tissue is a person authorized to do so under O.C.G.A. § 31-23-5 .

(d) Objection to the removal of corneal tissue may be made known to the coroner, medical examiner, hospital, funeral director, or authorized official acting for the coroner by the decedent during his lifetime or by the following persons after the decedent's death:

The decedent's spouse;
f no spouse survives him, any of the decedent's adult children;
If no adult children or spouse survive him, either of the decedent's parents;
If no parents, adult children, or spouse survive him, any of the decedent's brothers or sisters; or
If none of the foregoing survive him, the decedent's next of kin.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-23-1 et seq
History. Original Rule entitled "Consent Requirements in Coroner or Medical Examiner Cases" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Standard hospital and/or eye bank consent requirements shall be met.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-7-1et seq. and 31-23-1
History. Original Rule entitled "Consent Requirements in Non-Coroner or Non-Medical Examiner Cases" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.10 Persons Authorized to Extract Eyes {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.10}

Eye banks may authorize the following persons to perform eye extractions:

(a) Any physician;

(b) any embalmer licensed by the state of Georgia who has completed a course in eye extraction approved by the Department;

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-23-1 et seq
History. Original Rule entitled "Person Authorized to Extract Eyes" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.11 Medical and Surgical Procedures {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.11}

Procedures involved in the enucleation, transportation, and storage of eye tissue shall comply with the eye bank's policies for such procedures. These procedures shall conform to the current prevailing medical standards.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-23-1 et seq
History. Original Rule entitled "Medical and Surgical Procedures" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.12 Shipment {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.12}

(1) Shipping of eyes shall be the fastest and most convenient transportation methods.

(2) Eyes used for transplanting purposes shall be shipped in sturdy, insulated shipping containers that will maintain a maximum temperature of 4°C. for at least 36 hours.

(3) A shipping carton, for the transportation of eyes, shall be supplied to the participating physicians by the Eye Bank and shall contain for each donated eye:

(a) a sterile storage chamber with cotton balls.

(b) history record card;

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-23-1 et seq
History. Original Rule entitled "Shipment" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.13 Publicity {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.13}

All publicity, with the objective of informing and educating the general public to take an active part in the eye donor program, all fund raising activities, and the solicitation of donor eye pledges, must be done by the most dignified means. Such activities shall conform to prevailing medical ethics and at a minimum provide that:

(a) Eye tissue shall neither be bought nor sold.

(b) Eye tissue shall be distributed without discrimination based on race, creed, color, or national origin.

(c) Eye tissue shall be distributed only to qualified opthalmologists on a first come, first served basis, except in an emergency.

(d) The wishes of the immediate family shall be respected in carrying out the donor's eye pledge.

(e) The names of donor and recipient shall not be disclosed without written consent.

(f) Eye pledges shall be solicited in a dignified manner.

(g) Fund raising shall be ethically conducted.

(h) Eye banks shall not compete with one another.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-23-1 et seq
History. Original Rule entitled "Publicity" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.14 Penalty {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.14}

(1) It shall be unlawful:

(a) for any person to sell either his eyes or any parts thereof or the eyes or any parts thereof of another person or to receive any remuneration for the giving of a human eye or any part thereof;

(b) for the person or persons operating and maintaining any eye bank to sell any donated eye or donated part thereof or knowingly to extract, remove, or take possession of any human eye or part thereof for which any person received compensation or remuneration;

(c) for any person or persons to establish or operate any eye bank without approval of the Department or otherwise not in accordance with this chapter.

(2) Any person who violates any provision of O.C.G.A. § 31-23-9 shall be guilty of a misdemeanor.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-23-9
History. Original Rule entitled "Penalty" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.15 Waivers, Variances, Exemptions {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.15}

(1) The Department upon petition may grant variances or waivers of specific rules and regulations as provided for in O.C.G.A. § 31-2-7 , when it has been shown that the rule or regulation is not applicable or to allow experimentation and demonstration of new and innovative approaches to delivery of services.

(2) The Department may exempt classes of facilities from regulation as provided for in O.C.G.A. § 31-2-7 , when regulation would not permit the purpose intended or the class of facilities is subject to similar requirements under other rules and regulations.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-23-1 et seq
History. Original Rule entitled "Waivers, Variances, Exemptions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-28-.16 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-28-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-28-.16}

The administration and enforcement of these rules and regulations shall be as prescribed in O.C.G.A. § 31-2-8 and as prescribed by the Georgia Administrative Procedure Act, O.C.G.A. § 50-13-1et seq.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-23-1et seq. and 50-13-1 et seq
History. Original Rule entitled "Enforcement" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Subject 111-8-29 Rules and Regulations for Health Maintenance Organizations

Ga. Comp. R. & Regs. r. 111-8-29-.01 Introduction and Purpose {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.01}

(1) The Department of Community Health is authorized by the Georgia Health Maintenance Organization Act of 1979, Ga. Laws of 1979, p. 1148, et seq., (Ga. Insurance Code Chapter 56-36) to promulgate rules and regulations necessary to establish and control the standards of health care which any Health Maintenance Organization (HMO)created under that Act shall be required to maintain. Before the Insurance Commissioner may issue a Certificate of Authority to operate an HMO, the Commissioner of the Department of Community Health must certify to the Insurance Commissioner that the standards of health care are met by the applicant HMO.

(2) The purpose of these rules and regulations is to establish the standards of health care which will be required by the Department of Community Health of HMOs. Minimum parameters of operation for the clinical staff and management of HMOs and components thereof will also be set. In recognition that HMOs are intended to be a cost effective alternative for the delivery of health care services, the Department is supportive of efforts to assure their availability to all citizens. It is the intent of the Department to assist the growth and development of HMO programs in Georgia and to aid in providing technical assistance needed for their efficient and effective utilization.

(3) HMOs are subject to review by the Office of Health Planning, pursuant to the Georgia Certificate of Need Law and 1122 of the Social Security amendment (where applicable). Evidence of completion of this review shall be Submitted to the Department of Community Health as a documentation requirement during the Certificate of Authority process.

(4) Copies of these rules and regulations shall be available within the HMO, and employees shall be fully informed and instructed with reference to their requirements.

History

Authority: Ga. L. 1964, pp. 499, 507, 523; Ga. L. 1979, p. 1148 et seq.; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Introduction and Purpose" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.02 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.02}

Unless a different meaning is required or given in the context, the following terms as used in these rules and regulations shall have the meaning hereinafter respectively ascribed to them:

(a) "Basic Health Care Services" means healthcare services which an enrolled population might reasonably require in order to be maintained in good health, including as a minimum but not restricted to, preventive care, emergency care, inpatient hospital and physician care, and outpatient medical services;

(b) "Commissioner" means the Commissioner of the Georgia Department of Community Health or his designee;

(c) "Complaint" means a written expression of concern by an enrollee or provider regarding the provision of health care services by the HMO or a condition in the operation of an HMO which affects an enrollee or provider to such an extent as to be viewed by such as deserving of formal redress;

(d) "Department" means the Georgia Department of Community Health (DCH);

(e) "Enrollee" means an individual person who is enrolled in a health benefits plan;

(f) "Governing Body" means the person or persons, natural or corporate, in which the ultimate responsibility, authority and accountability for the conduct of the HMO is vested;

(g) "Health Benefits Plan" means any arrangement whereby any person undertakes to provide, arrange for, pay for, or reimburse any part of the cost of any health care services and at least part of such arrangement consists of arranging for or the provision of health care services, as distinguished from an arrangement which provides only for indemnification against the cost of such services, on a prepaid basis through insurance or otherwise;

(h) "Health Care Services" means any services included in the furnishing to any individual of medical or dental care, or hospitalization or incident to the furnishing of such care or hospitalization, as well as the furnishing to any person of any and all other services for the purpose of preventing, alleviating, curing, or healing human illness or injury;

(i) "Health Education" means the provision of health information and the use of educational techniques to modify an individual's or family's knowledge and/or behavior to achieve and maintain optimum physical and mental health and to prevent illness, injury, chronicity, or unnecessary disability;

(j) "Health Maintenance Organization" or "HMO" means any legal entity subject to the provisions of the Georgia Health Maintenance Organization Act;

(k) "Health Professional" means those professionals engaged in the delivery of health services who are currently licensed to practice in the State of Georgia, or provide services authorized under an institutional license, or are certified, or practice under authority consistent with Georgia laws;

(l) "In-Area" means the geographical area defined by the health maintenance organization as its service area in which it provides health services to its enrollees directly through its own resources or through arrangements with other providers in the area;

(m) "Insurance Commissioner" means the Insurance Commissioner of the State of Georgia or his designee;

(n) "Medical Audit" means the retrospective examination and evaluation of the documentation of clinical application of medical knowledge as revealed inpatient health records for the purposes of education, accountability, and quality assurance;

(o) "Out-of-Area" means that area outside of the geographical area defined by the health maintenance organization as its service area;

(p) "Physician" means an individual who is currently licensed to practice medicine, surgery, or osteopathy in the State of Georgia, under the Georgia Medical Practice Act, Chapter 84-9, Georgia Laws Ann.;

(q) "Primary Care Physician" means the physician responsible for the management of medical care and coordination of health care services of an enrollee;

(r) "Provider" means any physician, hospital, or other person or facility which is licensed or otherwise authorized in this State to furnish health care services;

(s) "Peer Review" means professional evaluation by currently licensed professional persons in the same category as those being reviewed, of the performance of individuals in the medical and related health care fields for the purpose of achieving and maintaining high standards of care and professional practice;

(t) "Person" means any individual, institution, partnership, association, corporation, the State, or any municipalities or subdivision thereof, or any other entity whether organized for profit or not;

(u) "Quality Assurance Program" means the planned systematic medical and/or management actions which assure consistent rendering of high quality health care services through the use of monitoring and evaluation techniques;

(v) "Service Area" means the defined geographical area (i.e., boundaries of political subdivisions, census tracts, Area Planning and Development Commissions or Health System's Agencies, etc.) in which HMO services are available and readily accessible to enrollees;

(w) "Subscriber" means an enrollee who has entered into a contractual relationship for the provision of/or arrangement of health care services from an HMO for himself and/or his dependents;

(x) "Supplemental Health Services" means those health services offered in addition to "Basic Health Care Services."

History

Authority: Ga. L. 1964, pp. 499, 507, 523; Ga. L. 1979, p. 1148 et seq.; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Definitions" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.03 Basic Health Care Services {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.03}

An HMO shall provide or arrange for the provision of basic health care services to its enrollees as needed and without limitations as to time, cost, type of service, or waiting period, e.g. maternity benefits, except as otherwise provided for in these rules and regulations. Provided, however, that such persons or institutions shall not be required to provide or receive services which conflict with their religious belief or moral objection. Exemptions claimed under this provision must be fully disclosed in the health benefits plan. Upon the determination of necessity, the HMO shall be responsible for medically necessary emergency care 24-hours per day, seven days per week, during the time of an existing contract. The HMO is responsible to provide or arrange for the provision of nonemergency care during reasonable and customary working hours and days. An HMO must provide the basic health care services listed herein and may not provide less service, nor may the HMO withhold a basic health care service because of an enrollee's known or unknown health condition. An HMO may provide one or more health benefits plans which exceed the basic health care services by including one or more supplemental health services. The basic health care services are:

(a) Preventive Care Services (including family planning services and services for the detection of asymptomatic diseases). The following services will be provided on a periodic basis, as specified in the plan:

The full range of family planning services;
Services for infertility;
Preventive eye/ear examinations by a physician, optometrist, or other qualified health professional to determine the need for correction, for children through age seventeen (17). The cost of corrective appliances and/or artificial aids shall not be included as a basic service unless otherwise specified in the health benefits plan;
Pediatric and adult immunizations in accordance with the Immunization Program of the Georgia Department of Public Health;
Periodic health examinations with appropriate protocols for specific age and sex groups, which may include pelvic and breast examinations and pap smears for women and other special diagnostic and screening procedures for enrollees considered to be at risk for specific disease states (e.g., obesity, hypertension, diabetes, glaucoma, cardiovascular disorders, lung diseases, cancer, sickle cell disease, etc.);
Well-child care services aimed at preventing problems and promoting the well-being of the child according to an established schedule of examinations and services planned for early detection and treatment of disorders for the promotion of healthy growth and development (e.g., health assessments, nutrition counseling, immunizations, screening, health education, etc.); and
Health education activities (including nutritional education and counseling). Health education activities shall state in writing the targeted population, purposes and techniques to be utilized in the program and the evaluation of results.

(b) Emergency Care.

Medically necessary emergency care service is medical care rendered by affiliated or non-affiliated providers, whether in or out of the service area, under unforeseen conditions requiring services necessary for the repair of accidental injury, relief of acute pain and/or infection, protection of the person's health, or the amelioration of illness which, if not immediately diagnosed and treated, would result in physical or mental impairment or loss of life. Outpatient and inpatient in-area medically necessary emergency health services shall be available 24-hours a day, seven days a week. Emergency health services shall include in-area ambulance services to the nearest facility designated by the HMO plan. The HMO shall have a plan for coverage of out-of-area emergencies; the plan shall cover ambulance service. An HMO associated physician or other delegated health professional shall authorize the use of nonemergency ambulance services.
Medically necessary emergency services shall include psychiatric emergency care provided in an emergency room. Such care shall not be considered among the limited short-term outpatient mental health visits.
Emergency care related to alcohol use and abuse shall include:

(i) immediate medical evaluation and care;

(ii) medical management of intoxicated persons until they are no longer incapacitated by the effects of alcohol; and/or

(iii) initiation of other appropriate health services needed for continuity of care.

Emergency care related to drug abuse and addiction shall include treatment for overdose and adverse reactions to psychotropic substances such as barbiturates, amphetamines, hallucinogens (including marijuana), tranquilizers and narcotics.

Outpatient medical services shall include diagnostic or treatment services or both for patients who are ambulatory and may be provided in a non-hospital-based health care facility or in a hospital.
Inpatient hospital services shall include, but not be limited to room (private, if determined medically necessary by the physician) and board, general nursing care, meals and special diets when medically necessary, use of operating room and related facilities, intensive care unit and services, x-ray, laboratory and other diagnostic tests, drugs, medications, biologicals, anesthesia and oxygen services, special duty nursing when medically necessary, physical therapy, respiratory therapy, radiation therapy, administration of whole blood and blood products (or components) and derivatives, other diagnostic therapeutic and rehabilitative services as needed, and coordinated discharge planning including the planning of such continuing care as may be necessary both medically and as a means of preventing possible early rehospitalization.
Outpatient medical services and inpatient hospital services shall include appropriate short-term rehabilitative services. The HMO must clearly define and make known its policy to enrollees.
Prenatal, intrapartum and postnatal maternity care shall be covered. This shall include complications of pregnancy of the mother and care with respect to the newborn child from the moment of birth; and necessary care and treatment of illness, injury, and congenital defects of the infant.
Medically necessary plastic surgery shall be provided as needed for the purpose of improving function by anatomic alterations. The HMO has flexibility to determine a policy for elective plastic surgery and must clearly define and make known its policy to enrollees.
Prescribed drug(s) and/or injection(s) may be provided to an enrollee at the time of outpatient care as a basic healthcare service. The HMO must clearly define and make known its policy to enrollees.
Experimental procedures or biomedical clinical research investigations undertaken by the HMO or by health professionals associated with the HMO which involve HMO enrollees must comply with all current Federal and State regulations, especially with regard to informed patient consent, peer review, and the rights of human subjects.
The HMO shall provide outpatient evaluative and crisis intervention mental health services. These basic mental health services may be provided through lesser or longer time periods if enrollees are equitably assured the equivalency of twenty full 50-55 minute session visits per enrollee per year. Modifications of the standard therapeutic full session shall be fully and fairly disclosed to enrollees of the HMO.
Diagnosis and medical treatment for the abuse of or addiction to alcohol and drugs includes detoxification on either an outpatient or inpatient basis, whichever is medically determined to be appropriate, in addition to treatment for other medical conditions.
Alcohol and drug referral services may be for either medical or for nonmedical ancillary services. Medical services shall be a part of basic health services; nonmedical ancillary services need not be a part of basic health services.
Diagnostic laboratory and diagnostic and therapeutic radiology services shall include, but are not to be limited to clinical and anatomic pathology, and diagnostic radiology, including special procedures, therapeutic radiology, nuclear medicine, electrocardiography, electroencephalography, and other generally accepted diagnostic and therapeutic technology. Laboratory and diagnostic radiology services necessary for the care and management of a condition of an enrollee shall be readily accessible.
Home health services are services which are provided at an enrollee's home by health care personnel, as prescribed or directed by the primary care physician. Home health services may include such rehabilitative therapy as medical social services and home health aide services. Homemaker services are not a required basic health service.

(d) Physician Care. Physician services (including consultant and referral services by a physician) shall be provided by or at the direction of a currently licensed physician.

Consultant services are defined as those services requiring the skills of a physician or other licensed health professional who by training and experience has acquired or demonstrated proficiency in specialized clinical areas. Coordination of patient care shall continue to be the responsibility of the primary care physician associated with the HMO.
Referral services are defined as those health and medical services provided directly to an enrollee by another health professional or health agency. Referrals shall be authorized and coordinated through the enrollee's primary care physician.

History

Authority: Ga. L. 1964, pp. 499, 507, 523; Ga. L. 1979, p. 1148 et seq.; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Basic Health Care Services" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.04 Supplemental Health Services {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.04}

(1) An HMO may provide or arrange for the provision of supplemental health services for which the enrollee has contracted and for which the required health manpower is available.

(2) An HMO must define the level and scope of each supplemental benefit to be offered, i.e., covered days of care, number of visits, or other specific units of service to be offered. Health service facilities, type of health professionals and range of specific services, and the capabilities made available under each benefit, shall be fully disclosed to enrollees and kept current and updated.

History

Authority: Ga. L. 1964, pp. 499, 507, 523; Ga. L. 1979, p. 1148 et seq.; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Supplemental Health Services" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.05 Health Services Information System {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.05}

(1) The HMO and/or its providers shall establish and maintain an organized health services information system for the collection, processing, maintenance, storage and retrieval of information concerning health services received by HMO enrollees.

(2) An individual record shall be maintained within the system for each enrollee to include the following minimum data:

(a) Identification - name; address; identifying number; enrollment date; age and birthdate; sex; marital status; occupation; and telephone number;

(b) An initial health evaluation including a chronological record of past medical history, drug use profile, personal and social history, family history and results of physical examinations, including laboratory and x-ray reports;

(c) A health care plan which identifies enrollee problem(s) and need(s) and the service(s) that will be provided for the enrollee's health maintenance, including revisions as indicated;

(d) The chief complaint and purpose of each visit; clinical diagnosis or impression; studies ordered; treatment given; disposition, recommendations, and instruction to patient; and a progress note for each follow-up visit;

(e) Copies of all consultation and/or referral requests and responses from other health care providers within and without of the organization, which shall be entered into the health record within 14 calendar days following the completion of services by the provider; and

(f) Other records, such as laboratory, x-ray and other test reports, vision/hearing records, immunization records, prenatal/postnatal records, copies of discharge summaries from inpatient health facilities, etc.

(3) The system shall be kept current and available to staff or agencies authorized to use the system.

(4) Health services information shall be retained for a period of six years after the last patient encounter for adults, and for six years after a minor reaches the age of majority. This information may be retained as originals, microfilms, or other usable forms and shall afford a basis for complete audit of professional information. If the HMO dissolves or changes ownership, the plan for retention shall be placed into effect and the Department shall be advised of the disposition and/or location of said records.

(5) Sufficient space and equipment for record processing, storage and retrieval shall be provided.

(6) Policies and procedures shall be written and implemented to assure organization and continuous maintenance of the health services information system.

History

Authority: Ga. L. 1964, pp. 499, 507, 523; Ga. L. 1979, p. 1148 et seq.; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Health Services Information System" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.06 Confidentiality of Medical Information {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.06}

Any data or information pertaining to the diagnosis, treatment, or health of any enrollee obtained from such person or from any provider by any HMO shall be held in confidence and shall not be disclosed to any person except to the extent that it may be necessary to carry out the purposes of these regulations; or upon the express consent of the enrollee; or pursuant to statute or court order for the production of evidence or the discovery thereof or in the event of claim or litigation between such person and the HMO wherein such data or information is pertinent. An HMO shall be entitled to claim any statutory privileges against such disclosure which the provider who furnished such information to the HMO is entitled to claim.

History

Authority: Ga. L. 1979, pp. 1148, 1171, 1172; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Confidentiality of Medical Information" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.07 Quality Assurance {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.07}

(1) Program Planning and Evaluation. The HMO shall have a formal organized plan for an ongoing quality assurance program. The purpose of the quality assurance plan is to assure that the quality of health care services is continually monitored, reviewed and evaluated for appropriate resource utilization, cost containment, and improvement of healthcare delivery. The written plan shall be approved by the governing body and implemented under the direction of the medical director of the HMO or the medical group. At a minimum, the plan shall include:

(a) The role and responsibilities of the medical director;

(b) An organizational structure created for the purpose of monitoring, reviewing, and evaluating the quality of health care services provided and appropriate resource utilization and cost containment;

(c) Mechanisms to collect data; identify problem areas and make recommendations for changes or improvements; develop plans for correction of identified problems; and follow-up;

(d) Arrangements for routine reporting of results of quality assurance program activities to the governing body and administration;

(e) Provision for maintenance of minutes and records of quality assurance program activities; and

(f) A peer review process which will evaluate and document the internal quality assurance program and the professional standards and practices of the providers, and services provided.

(2) Accessibility and Availability of Services.

(a) Basic health care services and supplemental health services for which enrollees have contracted shall be accessible (capable of being reached) to each enrollee and shall be readily available (present or ready for immediate use), within the defined service area of the HMO.

(b) An HMO shall provide or arrange for regular and reasonable hours during which an enrollee may receive services. An orderly system for scheduling services to enrollees is required and shall take into account the immediacy of the need for service.

(c) The HMO shall have a physician available or arrange for physician services to be available at all times to provide diagnostic and treatment services. The HMO shall assure that every enrollee seen for a medical complaint is evaluated by a physician or other qualified health professional pursuant to Georgia law. Each enrollee shall have the opportunity to select his primary care physician from among those available at the HMO.

(d) Medically necessary emergency services shall be available and accessible within the service area 24-hours a day, seven days a week.

(e) The ratio of enrollees to staff, including health professionals, administrative and other supporting staff, directly or through referrals, shall be such as to reasonably assume that all services offered by the HMO will be accessible without delays detrimental to the health of the enrollees. The HMO shall demonstrate an adequate ratio of primary care physicians to enrollees.

(f) The HMO shall provide for the availability and accessibility to services of medical specialists as determined to be medically necessary for the enrollee.

(g) Each HMO shall have a procedure for monitoring and evaluating availability and accessibility of its services, including a system for addressing problems that develop.

(3) Continuity of Care.

(a) Each provider shall establish and maintain an individual health record on each enrollee served, which shall contain information relating to the health care of that enrollee. These records shall be available to accommodate the flow of pertinent information to and from primary care physicians, as needed to assure continuity of care.

(b) The HMO shall offer counseling in dealing with the physical, emotional, and economic impact of illness and disability through services such as pre- and post-hospitalization planning, referral to services provided through community health, social and welfare agencies for family counseling, home health services, mental health services, health education, etc.

(4) Personnel.

(a) All HMO personnel and providers of services shall be currently licensed to perform the services they provide, when such services require licensure or registration under applicable State laws.

(b) The HMO shall assure that there is a sufficient number of health professionals to meet the needs of its enrollees. The specialty mix of licensed physicians shall be consistent with the projected health needs of the enrolled population. Emphasis shall be placed on having an adequate number of primary health care physicians.

(c) The HMO shall arrange for programs of continuing education for its staff and providers, either internally or by external organizations or agencies, to maintain and update skills and to assure quality of health care services.

(d) The HMO shall maintain an individual personnel folder on each employee and/or provider. This file shall include all personal information concerning the employee and/or provider, including applications and qualifications for employment. The employee's and/or provider's current license or registration number shall be included, if applicable.

(5) Facilities and Equipment.

(a) All facilities and equipment used for and in the delivery of services which are required to be licensed and/or certified by law, shall be so licensed and/or certified. This includes but is not necessarily limited to hospitals, nursing and intermediate care homes, clinical laboratories, pharmacies, psychiatric hospitals, and state- operated facilities.

(b) Providers shall have a functional, sanitary, and comfortable environment for patients, personnel, and the public. At all times the privacy and dignity of patients will be upheld.

(c) There shall be an adequate amount of space for services provided and disabilities treated, including waiting and reception areas, staff space, examining rooms, treatment areas, and storage.

History

Authority: Ga. L. 1964, pp. 499, 507, 523; Ga. L. 1979, p. 1148 et seq.; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Quality Assurance" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.08 Policies and Procedures of the HMO {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.08}

The HMO shall have written policies and procedures governing the provision of services which are based on the stated objectives of the HMO. Policies and procedures shall be approved by the governing body and reviewed and updated at least annually. All policies/procedures shall be available for review by staff, enrollees, and providers. Policies and procedures shall include the following subjects:

(a) Administrative Policies:

Advisory Panels. Enrollees shall be afforded an opportunity to participate in health care matters of policy and operation through the establishment of advisory panels, by the use of advisory referenda on major policy decision, or through the use of other mechanisms;
Complaint System. The HMO shall establish and maintain a complaint system approved by the Insurance Commissioner after consultation with the Commissioner;
Annual Report. The HMO shall annually, on/or before the first day of March, file with the Insurance Commissioner's Office an annual statement as of December 31st of the preceding year which has been certified by at least two principal officers of said HMO. This report shall include summary information and statistics relating to the quality of health care, cost of operations, the pattern of utilization of services, availability and accessibility to services, use of the complaint system, and such other matters as may be required by the Commissioner;
Separation of Medical Decisions. The HMO plan shall be able to demonstrate through its quality assurance program and utilization review process that medical decisions are not hindered by fiscal and administrative management;
Service Area. The HMO shall maintain a current, explicit, definition of its service area and a statement of any restrictions or limitations on out-of-area health care.

(b) Policies Related to Professional Services:

Physician Services. The enrollee shall have a choice of any of the primary care physicians under contract to the HMO subject to availability;
Other Services. A system shall be established for referral, consultant, and other services not directly provided by the HMO to ensure continuity and availability of care;
Inpatient Admission and Discharge Policies. The HMO shall have policies and procedures for inpatient health facility utilization and utilization review.

History

Authority: Ga. L. 1964, pp. 499, 507, 523; Ga. L. 1979, pp. 1148, 1153, 1157, 1159, 1160, 1161; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Policies and Procedures of the HMO" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.09 Statistical Information {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.09}

(1) The HMO shall develop, compile, evaluate, and report statistics to the Department as requested relating to the cost of its operations, the pattern of utilization of its services, and the availability and accessibility of its services. The HMO shall provide the Department with full access to all operational and statistical data to enable the Department to verify the HMO's compliance.

(2) The annual statistical report shall contain the following information and shall be made on forms to be provided by the Commissioner. (Federally qualified HMO's may substitute for this annual statistical report, a copy of their four (4) most recent quarterly reports under the National Data Reporting Requirements).

(a) Enrollee statistics:

Number of employer contracts and total number of enrollees served by the contracts;
Number of subscriber contracts and total number of enrollees served by the contracts;
Number of enrollees at the beginning of the reporting year, and number of enrollees at the end of the reporting year, additions during the reporting year, losses during the reporting year;
Number of Medicaid and Medicare enrollees.

(b) Provider contracts:

Number by type of provider (i.e. physician, dentist, hospital, etc.);
Additions during the year;
Number of terminations during the year.

Inpatient services;
Ambulatory care;
Preventive health care services.

(d) Other relevant information as determined by the Commissioner.

History

Authority: Ga. L. 1964, pp. 499, 507, 523; Ga. L. 1979, pp. 1153, 1159, 1160, 1161; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Statistical Information" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.10 Examinations {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.10}

(1) The HMO shall be available at all reasonable and/or scheduled operating hours for observation and examination by properly identified representatives of the Department. These examinations shall pertain to all matters relating to the quality of healthcare services of the HMO and all providers with whom such HMO has contracts, agreements, or other arrangements pursuant to its health benefits plan, as often as the Commissioner shall deem it necessary for the protection of the interests of the people of the State, but not less than once every five years. Such examinations may include any accounts, records, documents and files in the possession or control of the HMO, its officers, employees, representatives and providers, which relate to the subject of the examination. An HMO shall be entitled to claim any statutory privileges against such disclosure which the provider who furnished such information to the HMO is entitled to claim.

(2) The administrator or his representative shall accompany the Department representative on all tours of inspection and shall sign the completed checklist.

(3) Each HMO shall be periodically inspected to determine whether it is continuing to meet these requirements or is making satisfactory progress on approved plans of correction.

History

Authority: Ga. L. 1964, pp. 499, 505, 507, 523; Ga. L. 1979, pp. 1148, 1164, 1165; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Examinations" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.11 Regulatory Process {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.11}

Upon certification to the Insurance Commissioner's Office that the HMO does not meet the requirements of Section 56-3603(1) (b) of the HMO Act of Georgia; or the HMO is unable to fulfill its obligations to furnish health care services as required under its health benefits plan(s); or the HMO has violated any provision of the rules and regulations of the Department, the HMO shall be subject to the regulatory process as prescribed by the HMO Act of Georgia.

History

Authority: Ga. L. 1979, pp. 1148, 1166, 1167, 1168; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Regulatory Process" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.12 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.12}

(1) Informal Procedure. If the Commissioner shall for any reason have cause to believe that any violation of these rules and regulations or of the Georgia Laws governing HMO's has occurred or is threatened, the Commissioner may give notice to the HMO and to its representatives, or to other persons who appear to be involved in the suspected violation, to arrange a conference with the alleged violators or their authorized representatives for the purpose of ascertaining the facts relating to each suspected violation. In the event it appears that any violation has occurred or is threatened, the conferees may determine an adequate and effective means of correcting or preventing such violation. The proceedings under this subsection may be conducted in the manner deemed appropriate by the Commissioner under the particular circumstances.

(2) Formal Regulatory Process. In the event the Department does not choose to use the informal procedure set out above, or if an HMO does not correct or prevent the alleged violations as required by the Commissioner when the Department finds an HMO does not meet the requirements of these regulations or an HMO is unable to fulfill its obligations to furnish health care services as required under its health benefits plan, the Department shall so certify to the Insurance Commissioner for enforcement proceeding by that Department.

History

Authority: Ga. L. 1979, pp. 1170, 1171; O.C.G.A. § 33-21-1 et seq
History. Original Rule entitled "Enforcement" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.13 Applicability of Regulations {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.13}

These regulations are applicable only to HMO's and the services provided therein, and do not modify or revoke any of the provisions of other published rules of DCH.

History

Authority: Ga. L. 1964, p. 499 et seq; Ga. L. 1979, p. 1148 et seq.; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Applicability of Regulations" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Ga. Comp. R. & Regs. r. 111-8-29-.14 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-29-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-29-.14}

In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof and such remaining rules or portions thereof shall remain of full force and effect, as if such rule or portions thereof so determined, declared or adjudged invalid or unconstitutional were not originally a part hereof. It is the intent of the Board of Community Health to establish rules and regulations that are constitutional and enforceable so as to safeguard the health and well-being of the people of the State.

History

Authority: Ga. L. 1979, p. 1172; O.C.G.A. § 33-21-1et seq
History. Original Rule entitled "Severability" adopted. F. Oct. 9, 2020; eff. Oct. 29, 2020.

Subject 111-8-31 Home Health Agencies

Ga. Comp. R. & Regs. r. 111-8-31-.01 Purpose {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.01}

Under the authority of O.C.G.A. § 31-7-150, the Department of Community Health is authorized and required to establish the licensing procedures and standards of operation for home health agencies operating in this State. These rules and regulations are provided for this purpose.

History

Authority: O.C.G.A. § 31-7-150et seq
History. Original Rule entitled "Purpose" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-31-.02 Applications and Licenses {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.02}

Each person, private or public organization, political subdivision, or other governmental agency desiring to operate a home health agency, as defined herein, must first apply for and obtain a license using the forms furnished by the Department of Community Health. A license is not assignable or transferable and is subject to suspension or revocation at any time for failure to comply with these rules and regulations.

(a) Applications.

The governing body of the home health agency shall submit to the Department an application for a license of each agency and/or subunit. Such application(s) shall be signed by the executive officer of the governing body.
The application for a license shall be filed at least thirty (30) days prior to the anticipated date of opening and commencement of operation of a new home health agency.
Corporations shall submit a copy of their charter and the name and address of all owners with five percent or more of the stock and shall identify each corporate officer.
An application for a change in service(s) or service area(s) which is subject to review under O.C.G.A. § 31-6-1 et seq. and applicable rules shall be accompanied by a letter of approval from the Office of Health Planning within the Division of Healthcare Facility Regulation, Department of Community Health.

(b) Licenses.

To be eligible for a license, the home health agency must be in satisfactory compliance with these rules and regulations and other applicable Federal, State and local laws.
The license shall be returned to the Department when the home health agency ceases to operate, or is leased, or is moved to another location, or the ownership changes, or the license is suspended or revoked.
Any person or agency wishing to appeal the denial, suspension or revocation of a license is entitled to request a hearing under the provisions of the "Georgia Administrative Procedure Act."
Licenses will be renewed on an annual basis.
The license shall be prominently and appropriately displayed.

History

Authority: O.C.G.A. §§ 31-6-1et seq., 31-7-150et seq. and 50-13-13 et seq
History. Original Rule entitled "Applications and Licenses" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-31-.03 Certificate of Need Review {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.03}

Home health agencies which are required by state laws to obtain a certificate of need shall submit evidence that such requirements have been met when applying for a license.

History

Authority: O.C.G.A. §§ 31-6-1et seq. and 31-7-155
History. Original Rule entitled "Certificate of Need Review" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-31-.04 Exemptions {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.04}

These rules and regulations shall not apply to services which are provided under the following conditions:

(a) Persons who provide personal or paraprofessional health services, either with or without compensation when there is no claim that the service is provided as a part of a licensed home health agency;

(b) Persons who provide professional services for which they are duly licensed under Georgia laws, when there is no claim that the service is provided as a part of a licensed home health agency;

(c) Services provided under the provisions of any other license issued by the State of Georgia when there is no claim that the service is provided as a part of a licensed or certified home health agency;

(d) Any home health agency certified in a federal program for reimbursement of Medicare or Medicaid services shall be exempt from an additional on-site licensure inspection upon presentation of evidence of such certification.

History

Authority: O.C.G.A. §§ 31-2-7 and 31-7-150et seq
History. Original Rule entitled "Exemptions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-31-.05 Inspections {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.05}

For the purpose of insuring compliance with these rules and regulations, each home health agency shall be subjected to periodic inspections by an authorized representative of the Department. Such inspections shall take place during reasonable hours and, if possible, during scheduled operating hours. The administrator or his representative shall accompany the Department representative on tours of inspection and shall sign the completed checklist.

History

Authority: O.C.G.A. § 31-7-150et seq
History. Original Rule entitled "Inspections" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-31-.06 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.06}

Unless a different meaning is required or given in the context, the following terms as used in these rules and regulations shall have the meaning respectively ascribed to them:

(a) "Administrator" means the full-time person by whatever title used, to whom the governing body has delegated the responsibility for day-to-day administration of the home health agency, including the implementation of the rules and policies adopted by the governing body, and who:

is a licensed physician; or
is a registered nurse; or
has training and experience in health service administration and at least one (1) year of supervisory or administrative experience in home health care or related health programs.

(b) "Board" means the Board of Community Health.

(c) "Branch Office" means a location or site identified in the application or endorsement thereto from which a home health agency provides services within a portion of the total geographic area served by the parent agency. The branch office is part of the home health agency and is located sufficiently close to share administration, supervision, and services in a manner that renders it unnecessary for the branch independently to meet the requirements of these rules and regulations.

(d) "By-Laws" means a set of rules adopted by a home health agency for governing the agency's operation.

(e) "Certificate of Need" shall have that meaning as defined in O.C.G.A. § 31-6-1 et seq. and applicable rules.

(f) "Clinical Note" means a dated and signed written notation by the providing member of the health team of a contact with a patient containing a description of signs and symptoms, treatment and drug given, the patient's reaction, and any changes in physical or emotional condition.

(g) "Department" means the Georgia Department of Community Health.

(h) "Governing Body" means the person or persons, natural or corporate, in which the ultimate responsibility, authority and accountability for the conduct of the home health agency is vested.

(i) "Health Professionals" means those professionals engaged in the delivery of health services Who are currently licensed to practice in the State of Georgia, or are certified, or practice under authority consistent with Georgia laws.

(j) "Home Health Agency" means: a public, non-profit, or proprietary organization; whether owned or operated by one or more persons or legal entities, which is engaged in providing home health services.

(k) "Home Health Services" means those items and services provided to an individual, according to a written plan of treatment signed by the patient's physician, by a home health agency or others under arrangement with the home health agency on a visit or hourly basis, in a place of temporary or permanent residence used as the individual's home as follows:

part-time or intermittent skilled nursing care as ordered by a physician and provided by or under the supervision of a registered nurse and at least one other service listed below;
physical, occupational, or speech therapy;
medical social services;
home health aide services.

(l) "License" means a license issued by the Department.

(m) "Licensee" means the individual, corporation, or public entity with whom rests the ultimate responsibility for maintaining approved standards for the home health agency.

(n) "Licensed Practical Nurse or LPN" means an individual who is currently licensed as a licensed practical nurse in Georgia.

(o) "Occupational Therapist" means a qualified individual who:

Is currently licensed as an occupational therapist in Georgia; and
Meets the federal conditions for participation.

(p) "Occupational Therapy Assistant" means a qualified individual who:

Is currently licensed as an occupational therapy assistant in Georgia and assists in the practice of occupational therapy under the supervision and direction of a Georgia licensed occupational therapist; and
Meets the federal conditions for participation.

(q) "Parent Home Health Agency" means the agency that develops and maintains administrative controls of subunits or branch offices.

(r) "Physical Therapist" means a qualified individual who:

Is currently licensed as a physical therapist in Georgia; and
Meets the federal conditions for participation.

(s) "Physical Therapy Assistant" means a qualified individual who:

Is currently licensed as a physical therapy assistant in Georgia and assists in the practice of physical therapy under the supervision and direction of a Georgia licensed physical therapist; and
Meets the federal conditions for participation.

(t) "Physician" means an individual who is currently licensed or authorized to practice medicine and surgery in Georgia.

(u) "Plan of Treatment" means an individual plan written, signed, and reviewed at least every sixty days by the patient's physician prescribing items and services for the patient's condition.

(v) "Primary Home Health Agency" means the agency (parent or subunit) that is responsible for the service rendered to patients and for implementation of the plan of treatment.

(w) "Progress Note" means a dated and signed written notation by the providing member of the health team, summarizing facts about care and the patient's response during a given period of time.

(x) "Registered Nurse or RN" means an individual who is currently licensed as a registered professional nurse in Georgia.

(y) "Service Area" means the geographical area in which a home health agency provides services, as defined by the State Health Planning and Development unit of the Department.

(z) "Social Work Assistant" means an individual who meets the federal conditions of participation and applicable Georgia laws.

(aa) "Social Worker" means an individual who meets the federal conditions of participation and applicable Georgia laws.

(bb) "Speech Pathologist" and/or "Audiologist" means a qualified individual who:

Is currently licensed as a speech pathologist and/or audiologist in Georgia; and
Meets the federal conditions of participation.

(cc) "Subunit" means a semiautonomous organization, which serves patients in a geographic area different from that of the parent agency. The subunit by virtue of the distance between it and the parent agency is judged incapable of sharing administration, supervision, and services on a daily basis with the parent agency, and must, therefore, independently meet the licensing requirements for a home health agency, and shall be separately licensed.

(dd) "Supervision" means authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic inspection of the actual act of accomplishing the function or activity.

Ga. Comp. R. & Regs. r. 111-8-31-.07 Administrative Standards {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.07}

(1) Organizations, Services, Administration. Organizations, services provided, administrative control, and lines of authority for the delegation of responsibility down to the patient care level shall be clearly set forth in written policies and procedures. Administrative and supervisory functions shall not be delegated to another agency or organization. Services not provided directly shall be monitored and controlled by the primary agency, including services provided through subunits of the parent agency. If an agency has subunits, appropriate administrative records shall be maintained for each subunit.

(2) Governing Body. There shall be a governing body which assumes full legal authority and responsibility for the operation of each home health agency. The governing body shall appoint a qualified administrator, arrange for professional advice, adopt and periodically review written bylaws and oversee the management and fiscal affairs of the agency. The name and address of each officer, directors, and owner shall be disclosed to the Department. If the agency is a corporation, all ownership interests of five (5) percent or more (direct or indirect) shall also be disclosed.

(3) Group of Professional Personnel.

(a) A group of professional personnel, which shall include at least one physician and one registered nurse, with appropriate representation from other professional disciplines, shall establish and annually review the policies of each home health agency governing scope of services offered, admission and discharge policies, medical supervision and plans of treatment, emergency care, clinical records, personnel qualifications, and program evaluation. There must be at least one member of the group who is neither an owner nor an employee of the agency.

(b) The group of professional personnel shall meet at least once per quarter unless circumstances require more often to advise the agency on professional issues, to participate in the evaluation of the agency's program, and to assist the agency in maintaining liaison with other health care providers in the community and in its community information program. The minutes shall be documented by dated minutes.

(4) Administrator. The administrator (who may also be the supervising physician or registered nurse), is responsible for organizing and directing the agency's ongoing functions; maintaining ongoing liaison among the governing body, the group of professional personnel, and the staff; employing qualified personnel and ensuring adequate staff education and evaluations; ensuring the accuracy of public information, materials and activities; and implementing an effective budgeting and accounting system. A qualified person shall be authorized in writing to act in the absence of the administrator.

(5) Supervising Physician or Registered Nurse. Skilled nursing and other therapeutic services provided shall be under the supervision and direction of a physician or a registered nurse. This person or similarly qualified alternate shall be available at all times during operating hours and: participate in all activities relevant to the professional services provided, including the developing of qualifications and assignments of personnel.

(6) Personnel Policies. Personnel practices shall be supported by appropriate, written personnel policies. Individual personnel records shall include job descriptions, qualifications, licenses, performance evaluations, and health examinations, and shall be kept current. If personnel under hourly or per visit contracts are utilized by the home health agency, there shall be a written contract between such personnel and the agency clearly designating:

(a) that patients are accepted for care only by the primary home health agency;

(b) the services to be provided;

(d) the responsibility for participating in developing plans of treatment;

(e) the manner in which services will be controlled, coordinated, and evaluated by the primary agency;

(f) the procedures for submitting clinical and progress notes, scheduling of visits, periodic patient evaluation; and

(g) the procedure for determining charges and reimbursement.

(7) Planning and Budget. A home health agency, under the direction of the governing body, shall prepare an overall plan and budget which provides for an annual operating budget. If capital expenditures are anticipated, a three-year capital expenditure plan shall be provided and updated annually. The overall plan, budget and capital expenditure plan shall be reviewed and updated at least annually.

(8) Evaluation.

(a) A home health agency shall have written policies requiring an overall evaluation of the agency's total program at least once a year by the group of professional personnel (or a committee of this group), home health agency staff, and consumers; or by professional people outside the agency working in conjunction with consumers. The evaluation shall consist of an overall policy and administrative review and a clinical record review. The evaluation shall assess the extent to which the agency's program is appropriate, adequate, effective and efficient. Results of the evaluation shall be reported to the governing body and maintained separately as administrative records. Mechanisms shall be established in writing for the collection of pertinent data to assist in this evaluation. This data to be considered may include but is not limited to:

number of patients receiving each service offered;
number of patient visits;
reasons for discharge;
breakdown by diagnosis;
sources of referral;
number of patients not accepted with reasons; and
total staff days for each service offered.

(b) At least quarterly, appropriate health professionals representing at least the scope of the program, shall review a sample of both active and closed clinical records to assure that established policies are followed in providing services (direct services as well as services under arrangement). Evidence of this review shall be documented by dated minutes.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-150 et seq
History. Original Rule entitled "Administrative Standards" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-31-.08 Scope of Services {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.08}

A home health agency shall provide part-time or intermittent skilled nursing services and at least one other therapeutic service, e.g., physical, speech, or occupational therapy; medical social services; or home health aide services. Services shall be made available on a visiting basis, in a place of residence, as a patient's home.

(a) Nursing Services. A home health agency shall provide skilled nursing service by or under the supervision of a registered nurse and in accordance with the plan of treatment.

Duties of the Registered Nurse (RN). A registered nurse shall make the initial evaluation visit, regularly reevaluate the patient's nursing needs, initiate the plan of treatment and necessary revisions, provide those services requiring substantial specialized nursing skill, initiate appropriate preventive and rehabilitative nursing procedures, prepare clinical and progress notes, coordinate services inform the physician and other personnel of changes in the patient's condition and needs, counsel the patient and family in meeting nursing and related needs, participate in inservice programs, and supervise and teach other personnel.
Duties of the Licensed Practical Nurse (LPN). The licensed practical nurse shall provide services in accordance with agency policies, prepare clinical and progress notes, assist the physician and/or registered nurse in performing specialized procedures, prepare equipment and materials for treatments observing aseptic technique as required and assist the patient in learning appropriate self-care techniques.

(b) Therapy Services. All therapy services offered by the home health agency directly or under arrangement shall be given by a qualified therapist in accordance with the plan of treatment. The qualified therapist shall assist the physician in evaluating level of function, help develop the plan of treatment (revising as necessary), prepare clinical and progress notes, advise and consult with the family and other agency personnel, and participate in inservice programs. Therapy services include, but are not limited to:

Physical Therapy;
Occupational Therapy;
Speech Therapy;
Audiology.

(c) Medical Social Services. Medical social services, when provided, shall be given by a qualified social worker in accordance with the plan of treatment. The social worker shall assist the physician and other team members in understanding the significant social and emotional factors related to the health problems, participate in the development of the plan of treatment, prepare clinical and progress notes, work with the family, utilize appropriate community resources, participate in discharge planning and inservice programs, and act as a consultant to other agency personnel.

(d) Home Health Aide Services.

Home health aides shall be selected on the basis of such factors as a sympathetic attitude toward the care of the sick; ability to read, write, and carry out directions; and maturity and ability to deal effectively with the demands of the job. Aides shall be carefully trained in at least the following areas: methods of assisting patients to achieve maximum self-reliance, principles of nutrition and meal preparation, the aging process and emotional problems of illness, procedures for maintaining a clean, healthful, and pleasant environment, recognizing changes in a patient's condition that should be reported, work of the agency and the health team; ethics, confidentiality, and recordkeeping. Aides shall be closely supervised to assure their competence in providing care.
A home health aide shall be assigned to a particular patient by a registered nurse. Written instructions for patient care shall be prepared by a registered nurse or therapist as appropriate. Home health aide duties shall be limited to the performance of simple procedures such as an extension of therapy services, personal care, ambulation and exercise, household services essential to health care at home, assistance with medications that are ordinarily self-administered, reporting changes in the patient's condition and needs, and completing appropriate records.
A registered nurse, or other appropriate professional staff member, if other services are provided, shall make a supervisory visit to the patient's residence at least every two weeks, either when the aide is present to observe and assist, or when an aide is absent, to assess relationships and determine whether goals are being met. A record of the supervisory visit shall be dated and documented by a clinical note in the patient clinical record.

(e) Coordination of Patient Services. All personnel providing services shall maintain a liaison with the home health agency to assure that their efforts effectively complement one another and sup- port the objectives outlined in the plan of treatment. The clinical record shall contain dated minutes of case conferences verifying that effective interchange, reporting, and coordinated patient evaluation does occur. A written summary report of clinical and progress notes for each patient shall be sent to the attending physician at least every sixty (60) days and upon discharge. A copy of these reports shall become a permanent part of the patient's clinical record.

(f) Services Under Arrangements. All services provided under arrangements shall be subject to a written contract. Contracts for home health services shall conform with the specific requirements of Rule 111-8-31.07(6)(a)through(g) .

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-150 et seq
History. Original Rule entitled "Scope of Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-31-.09 Standards for Patient Care {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.09}

Patients shall be accepted for treatment on the basis of a reasonable expectation that the patient's medical, nursing, and social needs can be met adequately by the agency in the patient's place of residence. Patients shall not be denied services because of their age, sex, race, religion, or national origin. Care shall follow a written plan of treatment established and periodically reviewed by a physician, and shall continue under the supervision of a physician.

(a) Plan of Treatment. An individual plan of treatment shall be developed for each patient in consultation with agency staff, and shall cover all pertinent diagnosis, including mental status, types of services and equipment required, frequency of visits, prognosis, rehabilitation potential, functional limitations, activities permitted, nutritional requirements, medications and treatments, safety measures to protect against injury, instructions for timely discharge or referral, and other appropriate items. If a physician refers a patient under a plan of treatment which cannot be completed until after an evaluation visit, the physician shall be consulted to approve additions or modifications to the original plan. Orders for therapy services shall specify the procedures and modalities to be used, and the amount, frequency, and duration.

(b) Periodic Review of Plan of Treatment. The total plan of treatment shall be reviewed by the attending physician and home health agency personnel as often as the severity of the patient's condition requires, but at least once every sixty (60) days. Date of the review and approval of the plan shall be documented by the physician's signature. Agency professional staff shall promptly alert the physician to any changes that suggest a need to alter the plan of treatment.

(c) Conformance with Physician's Orders. Drugs and treatment shall be administered by agency staff only as ordered by the physician. The nurse or therapist shall immediately record and sign oral orders and forward the written order within five (5) business days to the physician for countersignature. Documentation of the physician's countersignature must appear in the patient's medical record within thirty (30) days of the verbal order. Professional agency staff shall check all medicines a patient may be taking to identify possible ineffective drug therapy or adverse reactions, significant side effects, drug allergies, and contraindicated medication, and shall promptly report any problems to the physician.

(d) Clinical Records.

A clinical record shall be established and maintained on each patient in accordance with accepted professional standards and shall contain:

(i) pertinent past and current findings;

(ii) plan of treatment;

(iii) appropriate identifying information;

(iv) name of physician;

(v) drug, dietary, treatment and activity orders;

(vi) signed and dated clinical and progress notes (clinical notes are written the day service is rendered by the providing member of the health team and incorporated no less often than weekly);

(vii) copies of case conferences;

(viii) copies of summary reports sent to the physician; and

(ix) a discharge summary.

If a patient transfers to another home health agency or a health facility, a copy of the record or abstract shall be furnished to accompany the patient.
Sufficient space and equipment for record processing, storage and retrieval shall be provided.
Policies and procedures shall be written and implemented to assure organization and continuous maintenance of the clinical records system.

(e) Retention of Records. Clinical records shall be retained for a period of six years after the last patient encounter for adults, and for six years after a minor reaches the age of majority. These records may be retained as originals, microfilms, or other usable forms and shall afford a basis for complete audit of professional information. If the home health agency dissolves or changes ownership, a plan for record retention shall be developed and placed into effect. The Department shall be advised of the disposition and/or location of said records.

(f) Protection of Records. Clinical record information shall be safeguarded against loss or unauthorized use. Written procedures shall govern the use and removal of records and conditions for release of information. A patient's written consent is required for release of information not authorized by law.

History

Authority: O.C.G.A. § 31-7-150et seq
History. Original Rule entitled "Standards for Patient Care" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-31-.10 Penalties {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.10}

Any person who operates a home health agency without first obtaining a license pursuant to the provisions of the Georgia Home Health Agency Act shall be deemed guilty of a misdemeanor, and upon conviction shall be fined not to exceed $500.00 or imprisoned for a period not to exceed six months or both.

History

Authority: O.C.G.A. § 31-7-158
History. Original Rule entitled "Penalties" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-31-.11 Fees {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.11}

Each application for initial and annual renewal licenses shall be accompanied by a fee as prescribed by the Department.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-150 et seq
History. Original Rule entitled "Fees" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-31-.12 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.12}

The administration and enforcement of these rules and regulations shall be as prescribed in the "Georgia Administrative Procedure Act," O.C.G.A. § 50-13-1et seq.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 50-13-1 et seq
History. Original Rule entitled "Enforcement" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-31-.13 Applicability of Regulations {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.13}

These regulations are applicable only to home health agencies as defined herein and the services they provide, and do not modify or revoke any of the provisions of other published rules of the Department.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-150 et seq
History. Original Rule entitled "Applicability of Regulations" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-31-.14 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-31-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-31-.14}

In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof and such remaining rules or portions thereof shall remain of full force and effect, as if such rule or portions thereof so determined, declared or adjudged invalid or unconstitutional were not originally a part hereof. It is the intent of the Board of Community Health to establish rules and regulations that are constitutional and enforceable so as to safeguard the health and well being of the people of the State.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-150 et seq
History. Original Rule entitled "Severability" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Subject 111-8-37 Rule and Regulations for Hospices

Ga. Comp. R. & Regs. r. 111-8-37-.01 Title and Purpose {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.01}

These rules shall be known as the Rules and Regulations for Hospices. The purpose of these rules is to provide for the inspection and issuance of licenses for hospices and to establish minimum requirements for facilities operating under hospice licenses.

History

Authority: O.C.G.A. § 31-7-170et seq
History. Original Rule entitled "Title and Purpose" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.02 Authority {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.02}

The legal authority for this Chapter is O.C.G.A § 31-7-170et seq., the "Georgia Hospice Law" and O.C.G.A. § 31-2-4et seq.

History

Authority: O.CG.A. §§ 31-2-4 and 31-7-170et seq
History. Original Rule entitled "Authority" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.03 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.03}

(1) Unless the context otherwise requires, these identified terms mean the following when used in these rules:

(a) "Administrator" means the person, by whatever title used, to whom the governing body has delegated the responsibility for the day-to-day administration of the hospice, including the implementation of the policies and procedures adopted by the governing body.

(b) "Advanced and progressive disease" means a serious life-threatening medical condition which is irreversible and which will continue indefinitely, where there is no reasonable hope of recovery, but where the patient's medical prognosis is one in which there is a life expectancy of up to two years. The term does not include terminally ill patients as defined in paragraph (ee) of this rule.

(c) "Attending physician" means the physician identified by the hospice patient or the patient's representative as having primary responsibility for the hospice patient's medical care and who is licensed to practice medicine in this state.

(d) "Bereavement services" means the supportive services provided to the family unit to assist it in coping with the patient's death, including follow-up assessment and assistance through the first year after death.

(e) "Clergy" means an individual representative of a specific spiritual belief who has documentation of ordination or commission by a recognized faith group and who has completed at least one unit of clinical pastoral education from a nationally recognized provider.

(f) "Counseling" means those techniques used to help persons learn how to solve problems and make decisions related to personal growth, vocation, family, social, and other interpersonal concerns.

(g) "Department" means the Georgia Department of Community Health.

(h) "Dietitian" means a specialist in the study of nutrition who is licensed as required by O.C.G.A. § 43-11A-1 et seq. , the "Dietetics Practice Act."

(i) "Family unit" means the terminally ill person or person with an advanced and progressive disease and his or her family, which may include spouse, children, siblings, parents, and other relatives with significant personal ties to the patient.

(j) "Governing body" means the board of directors, trustees, partnership, corporation, association, or person or group of persons who maintain and control the operation of the hospice and who are legally responsible for its operation.

(k) "Home care" means hospice care primarily delivered in the residence of the hospice patient, whether that place is the patient's permanent or temporary residence. A hospice patient who considers his or her residence to be a licensed assisted living community, licensed nursing home, licensed intermediate care home, licensed personal care home, or residential hospice setting is considered to be receiving home care while a resident of that facility.

(l) "Hospice" means a public agency or private organization or unit of either providing to persons terminally ill and to their families, regardless of ability to pay, a centrally administered and autonomous continuum of palliative and supportive care, directed and coordinated by the hospice care team primarily in the patient's home but also on an outpatient and short-term inpatient basis and which is classified as a hospice by the Department. In addition, such public agency or private organization or unit of either may also provide palliative care to persons with advanced and progressive diseases and to their families, directed and coordinated by the hospice care team.

(m) "Hospice care" means both regularly scheduled care and care available on a 24 hour on-call basis, consisting of medical, nursing, social, spiritual, volunteer, and bereavement services substantially all of which are provided to the patient and to the patient's family regardless of ability to pay under a written care plan established and periodically reviewed by the patient's attending physician, by the medical director of the hospice program, and by the hospice care team.

(n) "Hospice care team" means an interdisciplinary working unit composed of members of the various helping professions (who may donate their professional services), including but not limited to: a physician licensed or authorized to practice in this state, a registered professional nurse, a social worker, a member of the clergy or other counselors, and volunteers who provide hospice care.

(o) "Inpatient care" means short-term, 24-hour medically supervised care for the purpose of adjusting and monitoring the terminally ill patient's medications for pain control or managing acute or chronic symptoms that cannot be managed in another setting. Inpatient care is provided within the confines of a licensed hospital, a licensed skilled nursing facility, or a licensed inpatient hospice facility.

(p) "Inpatient hospice facility" means a facility that is licensed to provide acute inpatient care for hospice patients in beds that are not included in the certified bed capacity of another licensed facility.

(q) "License" means a license issued by the Department to the governing body to operate a hospice.

(r) "Medical director" means a physician licensed in this state who is a member of the hospice care team and is responsible for the direction and quality of the medical component of the care rendered by the hospice to patients.

(s) "Palliative care" means those interventions by the hospice care team which are intended to achieve relief from, reduction of, or elimination of pain and of other physical, emotional, social, or spiritual symptoms of distress to achieve the best quality of life for the patients and their families.

(t) "Patient" means a terminally ill individual receiving the hospice continuum of services, regardless of ability to pay and also means an individual with an advanced and progressive disease.

(u) "Patient representative" means an individual who, under applicable laws, has the authority to act on behalf of the patient where the patient is incapable of making decisions related to health care.

(v) "Personal care services" means assistance with activities of daily living, personal care, ambulation and exercise; provision of household services essential to health care at home; assistance with self-administration of medication; and preparation of meals.

(w) "Physician" means an individual who is licensed to practice medicine in this state by the Georgia Composite Medical Board.

(x) "Primary caregiver" means a person or entity designated in writing by the patient or the patient's representative who agrees to give and/or arrange for continuing support and care and who may advocate on behalf of the patient.

(y) "Professional counselor" means a person licensed or certified as a professional counselor or associate professional counselor as required by O.C.G.A. § 43-10A-1 et seq. , the "Professional Counselors, Social Workers, and Marriage and Family Therapists Licensing Law."

(z) "Registered nurse" means an individual who is currently licensed to practice nursing under the provisions of Article 1 of Chapter 26 of Title 43 of the Official Code of Georgia Annotated.

(aa) "Residential hospice facility" means a small home-like residential facility or unit that is a part of a licensed hospice program, designed, staffed, and organized to provide non-acute hospice care, 24-hours per day, seven days per week, under the supervision of the hospice physician and hospice registered nurses to terminally ill hospice patients and their family units.

(bb) "Respite care" means short-term inpatient or residential care provided for the patient to provide relief for that patient's family unit from the stress of providing care.

(cc) "Restraint" means any manual, physical, or mechanical method, device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body or head freely, not including devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm (this does not include a physical escort); or 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.

(dd) "Social worker" means an individual who is qualified by education, training, and experience and licensed as required by law to perform social work for hospice patients and their family units.

(ee) "Terminally ill" means that the individual is experiencing an illness for which therapeutic intervention directed toward cure of the disease is no longer appropriate, and the patient's medical prognosis is one in which there is a life expectancy of six months or less.

(ff) "Volunteer" means a lay or professional person who provides, without compensation, support and assistance to the patient and the patient's family under the supervision of a member of the hospice staff unit in accordance with the plan of care developed by the hospice care team.

(2) As used in these rules and regulations, the singular indicates the plural and the plural the singular when consistent with the intent of these rules.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Definitions" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.04 Licensure Procedures {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.04}

(1) Operating, establishing or maintaining a hospice in the State of Georgia without first obtaining a valid license from the Department is prohibited.

(2) Use of the term "hospice" to imply or indicate that a person or entity is providing hospice services to patients and their families unless the person or entity holds a valid license to provide hospice care is prohibited.

(3) A governing body desiring to operate a hospice must file with the Department an initial application on forms prescribed and made available by the Department. The application must be complete, accurate, and signed by the hospice administrator or the executive officer of the hospice's governing body and must include:

(a) The applicant's name, address, phone number, and business e-mail address for receiving inspection reports and communications concerning the license from the Department.

(b) Proof of ownership. In the case of corporations, partnerships, and other entities authorized by law, the applicant must provide a copy of its certificate of incorporation or other acceptable proof of its legal existence and authority to transact business within the state;

(d) A list of the locations of any additional hospice care facilities operated by the hospice on separate premises, as applicable, and the number of beds at such facilities.

(4) Knowingly supplying materially false, incomplete, or misleading information is grounds for denial or revocation of a license.

(5) Following evidence of substantial compliance with these rules and regulations and any provisions of law as applicable to the construction and operation of the hospice, the Department may issue a license to provide hospice services primarily to terminally ill patients in their own homes.

(6) An initial license may be issued for a period of six months to allow a new hospice to demonstrate its ability to comply with these rules and regulations. After becoming fully operational and demonstrating substantial compliance with the rules and regulations, the hospice shall become eligible for a regular license.

(7) Inpatient and residential services and palliative care services are not eligible to be licensed separately from hospice home care services.

(8) The license must be displayed in a prominent place in the hospice's administrative offices.

(9) Licenses are not transferable from one governing body to another or from one hospice location to another.

(10) Each planned change of ownership or lease or change of location must be disclosed to the Department at least 30 days prior to such change by submitting an application and the required fees from the proposed new owners or lessees for a new license.

(11) Changes in the hospice that require the submission of a new application and the issuance of a new license include a change in name, the addition of another service location, a change in the number of licensed beds if residential services are provided or a change in the scope of services provided. The new application that reflects the proposed change must be filed at least 30 days prior to the proposed change. Hospices licensed before the effective date of these rules desiring to change their scope of service solely to include palliative care to patients with advanced and progressive diseases who are not terminally ill, will not be required to pay an application change processing fee to add palliative care if the Department receives the palliative care change request within 180 days of these rules taking effect.

(12) A license is no longer valid and must be returned to the Department when the hospice ceases to operate, changes locations, is issued a new license or the license is suspended or revoked. The facility must notify referring individuals and entities of the closure and patients' families regarding the location of medical records.

(13) Temporary Inactive Status. If the hospice is closing for a period of less than 12 months, and plans to reopen under the same ownership, governing body, and name, the hospice may request to have the license placed on temporary inactive status. The hospice must submit its request in writing and provide a written plan for notifying referring individuals and entities of the closure and patients' families regarding the location of medical records.

(a) When placed on temporary inactive status, the license must be returned to the Department within 10 days of closure and the hospice must not operate until the license has been reactivated.

(b) The hospice must request in writing that the permit be reactivated at least 30 days prior to the desired date of reopening. Prior to reactivation of the license, the hospice may be subject to inspection by the Department. If the license is not reactivated within 12 months, the license is void.

(14) Multiple Hospice Locations. Separate applications and licenses are required for hospices operated at separate locations; however, the Department has the option of approving a single license for multiple hospice locations based on evidence that the hospice meets all of the following requirements:

(a) All locations are owned and operated by the same governing body and conduct business under the same set of by-laws and the same trade name;

(b) Each location is responsible to the same governing body and central administration managed together under the same set of policies and procedures;

(c) The governing body and central administration demonstrate the capacity to adequately manage all locations and ensure the quality of care at all locations as evidenced by a prior history of satisfactory compliance with hospice regulations and appropriate staffing;

(d) Supervision and oversight at additional locations is sufficient to ensure that hospice care and services meet the needs of patients and the patients' family units;

(e) The medical director assumes responsibility for the medical component of the hospice's patient care at all locations;

(f) Additional locations provide the same full range of services and the same level and quality of care including timely responses, that is provided by the primary location;

(g) Each patient is assigned to a specific hospice care team responsible for ongoing assessment, planning, monitoring, coordination, and provision of care, which has ready access to the patient's clinical record;

(h) All hospice patients' clinical records that are requested by the Department at the time of inspection must be available at the hospice's primary location; and

(i) All locations maintain the same Medicare provider number, as applicable.

(15) Hospice Care Facilities. Hospices desiring to provide facilities for residential and/or acute inpatient hospice services as a part of the licensed hospice must submit an application to the Department requesting a change in service level. The Department will not approve the change in service level that includes residential and/or inpatient hospice services, unless the hospice:

(a) Is licensed and in substantial compliance with these rules and regulations that apply to home care hospice services;

(b) Submits a copy of the certificate of occupancy issued by local building officials for the facility or unit;

(c) submits evidence of compliance with the applicable provisions of the Life Safety Code®, as enforced by the state fire marshal ;

(d) Provides evidence to the Department of compliance or ability to comply with all the applicable requirements of paragraph (14) of this rule relating to multiple hospice locations; and

(e) Demonstrates substantial compliance with all the applicable requirements of Rule 111-8-37-.24 , Hospice Care Facilities, as evidenced by an on-site inspection by the Department.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Licensure Procedures" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.05 Inspections and Investigations {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.05}

(1) The hospice staff, any facilities where hospice care is being delivered, and the hospice patients must be accessible during all hours of operation to properly identified representatives of the Department for inspections and investigations relating to the hospice's license.

(2) The Department will periodically inspect each hospice to ensure that the licensee is providing quality care to its patients; provided, however, that a hospice is exempt from routine periodicon-site licensure inspection if it is certified as a hospice in accordance with federal regulations. Where the Department receives or becomes aware of a complaint alleging that the hospice is not acting in compliance with the requirements of these rules, the Department may conduct an inspection at any time to determine whether the licensed hospice is in compliance with these rules.

(3) For the purposes of any inspection, investigation, or survey conducted by the Department, the hospice must provide to properly identified representatives of the Department meaningful access to all books, records, papers, or other information related to the initial or continued licensing of the hospice.

(4) The hospice must submit to the Department, in a format acceptable to the Department, a written plan of correction in response to any inspection report of violations identified by the Department. The plan of correction must specify what the hospice will do by a date certain to correct each of the violations identified. The plan of correction must be submitted within 10 days of the hospice's receipt of the inspection report of violations. A plan of correction must be determined to be acceptable by the Department. Hospices may be allowed an additional 48 hours to revise any plan of correction deemed unacceptable by the Department. Failure to submit an acceptable plan of correction may result in the Department commencing enforcement procedures. The hospice must correct all violations cited.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Inspections and Investigations" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.06 Reports to the Department {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.06}

(1) Patient Incidents Requiring Report. The hospice must report to the Department, on forms made available by the Department, within 24 hours or the next business day, whenever any of the following incidents involving patients occurs or the hospice has reasonable cause to believe that an incident involving a patient has occurred:

(a) Any death of a hospice patient not related to the natural course of the patient's terminal illness or advanced and progressive disease, or any identified underlying condition;

(b) Any rape, assault, or any abuse, neglect or exploitation of a patient; and

(c) Any time a patient, who is admitted to a residential or inpatient hospice facility cannot be located, where there are circumstances that place the health, safety, or welfare of the patient or others at risk and the patient has been missing for more than eight hours.

(2) Where the hospice staff has reasonable cause to believe that a disabled adult or elder person has been the victim of abuse, other than by accidental means, or has been neglected or exploited, the hospice must report such information to an adult protection agency providing protective services as designated by the Department and to an appropriate law enforcement agency or prosecuting attorney.

(3) The hospice, through its peer review committee, must submit the reports of patient incidents listed in subparagraph (1)(a) through (c) of this rule. The Department will receive and retain such peer review reports concerning the listed incidents in confidence.

(4) Reports of patient incidents made through the peer review process must include:

(a) The name of the hospice, the name of the administrator or site manager, and a contact telephone number for information related to the report;

(b) The date of the incident and the date the hospice became aware of the incident;

(d) Any immediate corrective or preventative action taken by the hospice to ensure against the replication of the incident.

(5) The hospice must conduct an internal investigation of any of the patient incidents listed in subparagraph (1)(a) through (c) and must complete and retain on-site a written report of the results of the investigation within 45 days of the discovery of the incident. The complete report must be made available to the Department for inspection at the hospice office and contain at least:

(a) An explanation of the circumstances surrounding the incident, including the results of a root cause analysis or any other detailed system analysis;

(b) Any findings or conclusions associated with the review; and

(6) The hospice must report to the Department any pending involuntary discharge of a hospice patient initiated by the hospice. The report must be made no later than the time of notification to the patient of the pending discharge.

(7) Other Events Requiring Report.

(a) The hospice must report in an acceptable format to the Department whenever any of the following events involving hospice operations occur or when the hospice becomes aware that any such events are likely to occur, to the extent that such events are expected to cause or cause a significant disruption of care for hospice patients:

An external disaster or other community emergency situation; or
An interruption of services vital to the continued safe operation of a hospice facility, such as telephone, electricity, gas, or water services.

(b) The hospice must make a report of the event within twenty-four hours or by the next regular business day from when the reportable event occurred or from when the hospice has reasonable cause to anticipate that the event is likely to occur. The report must include:

The name of the hospice, the name of the hospice administrator or site manager, and a contact telephone number for information related to the report;
The date of the event, or the anticipated date of the event, and the anticipated duration, if known;
The anticipated effect on care and services for hospice patients; and
Any immediate plans the hospice has made regarding patient management during the event.

(c) Within 45 days of the discovery of the event, the hospice must complete an internal evaluation of the hospice's response to the event where opportunities for improvement related to the hospice's disaster preparedness plan were identified. The hospice must make changes to the disaster preparedness plan as appropriate. The complete report must be available to the Department for inspection at the hospice office.

(8) While self-reported incidents made through the hospice's peer review process are received by the Department in confidence and not considered open records, where the Department's internal review determines that a rule violation related to any self-reported incident or event has occurred, the Department shall initiate a separate complaint investigation of the incident. The complaint investigation report and the report of any rule violation compiled by the Department arising either from the initial report received from the hospice or an independent source shall be subject to disclosure in accordance with applicable laws.

History

Authority: O.C.G.A. §§ 31-7-130et seq., 31-7-170et seq
History. Original Rule entitled "Reports to the Department" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.07 Governing Body {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.07}

(1) The hospice must have an established and functioning governing body that is responsible for the conduct of the hospice and that provides for effective hospice governance, management, and budget planning.

(2) The governing body must appoint an administrator and delegate to the administrator the authority to operate the hospice in accordance with these rules and management policies established and approved by the governing body.

(3) The governing body must appoint a medical director and delegate to the medical director the authority to establish and approve, in accordance with current accepted standards of care, all patient care policies related to medical care.

(4) The governing body must ensure that no member of the governing body, administration, staff associated or affiliated with the hospice, or family member of staff causes, encourages or coerces any patient or family member of a patient to:

(a) name any person associated or affiliated with the hospice as a beneficiary under a will, trust, or life insurance policy;

(b) take out or otherwise secures a life insurance policy on any patient; or

(c) give or loan anything of value to a member of the governing body, administration, staff associated or affiliated with the hospice or family member of staff.

(5) The governing body must be responsible for determining, implementing, and monitoring the overall operation of the hospice, including the quality of care and services, management, and budget planning. The governing body must:

(a) Be responsible for ensuring the hospice functions within the limits of its current license granted by the Department;

(b) Ensure that the hospice provides coordinated care that includes at a minimum medical, nursing, social, spiritual, volunteer, and bereavement services that meet the needs of the patients;

(c) Ensure that the hospice is staffed and equipped adequately to provide the services it offers to patients, whether the services are provided directly by the hospice or under contract;

(d) Develop and make available to patients and their families, a description of services offered by the hospice, including patient eligibility for the various services and whether the hospice provides palliative care to patients who have not been determined to be terminally ill but have been diagnosed with an advanced and progressive disease;

(e) Ensure the development and implementation of effective policies and procedures that address the management, operation, and evaluation of the hospice, including all patient care services and those services provided by independent contractors;

(f) Ensure there is an individual authorized in writing to act for the administrator during any period the administrator is absent;

(g) Appoint an individual to assume overall responsibility for a quality assurance, utilization, and peer review program for monitoring and evaluating the quality and level of patient care in the hospice on an ongoing basis;

(h) Ensure that hospice advertisements are factual and do not contain any element that might be considered coercive or misleading;

(i) Ensure that hospice care to patients who have been determined to be terminally ill is provided regardless of the patient or the family unit's ability to pay; and

(j) Ensure that there are policies and procedures in place that specify the manner in which transitions across care sites and providers (e.g. hospital to home hospice) will be handled to ensure that communications are effective to address continuity of care issues for the patient.

(6) The governing body shall comply with the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12, as applicable.

History

Authority: O.C.G.A. §§ 31-7-170 et seq., 31-7-350 et seq
History. Original Rule entitled "Governing Body" adopted. F. May 26, 2015; eff. June 15, 2015.
Amended: F. Feb. 28, 2020; eff. Mar. 19, 2020.

Ga. Comp. R. & Regs. r. 111-8-37-.08 Administrator {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.08}

(1) Each hospice must have a qualified administrator, designated by the governing body, who must be responsible for the ongoing and day-to-day operation of the hospice.

(2) The hospice administrator must be either a Georgia-licensed health care professional, who has at least one year of supervisory or management experience in a hospice setting or an individual with education, training and experience in health services administration and at least two years of supervisory or management experience in a hospice setting. The term, licensed health care professional, includes the following who hold Georgia licenses: physicians, nurse practitioners, physicians' assistants, registered professional nurses, clinical social workers, physical therapists and psychologists, but does not include practical nurses.

(3) The hospice administrator must ensure that the hospice:

(a) Implements policies and procedures for the provision of hospice care and palliative care to persons with advanced and progressive diseases, if it offers such services, which have been developed with interdisciplinary participation from the hospice care team;

(b) Employs qualified staff, including physicians, practitioners, nurses, social workers, clergy, volunteers, or other persons providing services at the hospice;

(c) Has implemented policies and procedures related to the management, operation, and evaluation of the overall performance of the hospice;

(d) Has a qualified director of nursing services along with sufficient qualified staff to meet the needs of patients admitted for hospice care and palliative care, if offered to persons with advanced and progressive diseases but who have not been determined to be terminally ill, and as outlined in the patients' plans of care;

(e) Provides an orientation, training, and supervision program for every employee and volunteer that addresses hospice care and palliative care for persons with advanced and progressive diseases, when offered, and the performance of the specific job to which the employee or volunteer is assigned;

(f) Ensures that the staff members complete their annual training and education program; and

(g) Ensures that there are effective mechanisms to facilitate communication among the hospice staff, hospice care team, and patients, their family units, and their legal guardians, if any.

(4) The hospice administrator shall comply with the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12, as applicable.

History

Authority: O.C.G.A. §§ 31-7-170 et seq., 31-7-350 et seq
History. Original Rule entitled "Administrator" adopted. F. May 26, 2015; eff. June 15, 2015.
Amended: F. Feb. 28, 2020; eff. Mar. 19, 2020.

Ga. Comp. R. & Regs. r. 111-8-37-.09 Quality Management {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.09}

(1) The hospice must appoint an interdisciplinary quality management committee that reflects the hospice's scope of services. The committee must develop and implement a comprehensive, effective and ongoing quality management, utilization, and peer review program that evaluates, maintains and improves the quality of patient care provided, including the appropriateness of the level of service received by patients, and submits required patient incident reports to the Department.

(2) The quality management, utilization, and peer review program must establish and use written criteria as the basis to evaluate the provision of patient care. The written criteria must be based on accepted standards of care and must include, at a minimum, systematic reviews of:

(a) Appropriateness of admissions, continued stay, and discharge;

(b) Appropriateness of professional services and level of care provided;

(d) Patient injuries, such as those related to falls, accidents, and restraint use;

(e) Errors in medication administration, procedures, or practices that compromise patient safety;

(f) Infection control practices and surveillance data;

(g) Patient and family complaints and on-call logs;

(h) Inpatient hospitalizations;

(i) Staff adherence to the patients' plans of care; and

(j) Appropriateness of treatment.

(3) Findings of the quality management utilization, and peer review program must be utilized to correct identified problems, revise hospice policies, and improve the care of patients.

(4) There must be an ongoing evaluation of the quality management, utilization, and peer review committee to determine its effectiveness, with the results of the evaluation presented at least annually for review and appropriate action to the medical staff and the governing body.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Quality Management" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.10 Patient and Family Rights {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.10}

(1) The hospice must ensure that patients and their families receive hospice care and palliative care for persons with advanced and progressive diseases, when offered, in a manner that respects and protects their dignity and ensures all patients' rights to:

(a) Participate in the hospice voluntarily and sever the relationship with the hospice at any time;

(b) Receive only the care and services to which the patient and/or the patient's family have consented;

(c) Receive care in a setting and manner that preserves the patient's dignity, privacy, and safety to the maximum extent possible;

(d) Receive hospice care in a manner that neither physically nor emotionally abuses the patient, nor neglects the patient's needs;

(e) Receive care free from unnecessary use of restraints;

(f) Receive education in the availability and use of the hospice's grievance process for all patients;

(g) Communicate grievances, concerns or complaints to the hospice for prompt resolution;

(h) Refuse any specific treatment from the hospice without severing the relationship with the hospice;

(i) Choose their own private attending physician, so long as the physician agrees to abide by the policies and procedures of the hospice;

(j) Exercise the religious beliefs and generally recognized customs of their choice, not in conflict with health and safety standards, during the course of their hospice treatment and exclude religion from their treatment if they so choose;

(k) Have their family unit, legal guardian, if any, and their patient representative present any time during an inpatient stay, unless the presence of the family unit, legal guardian, if any, or patient representative poses a risk to the patient or others;

(l) Participate in the development of the patient's plan of care and any changes to that plan;

(m) Have maintained as confidential any medical or personal information about the patient;

(n) Continue hospice care and not be discharged from the hospice during periods of coordinated or approved appropriate hospital admissions;

(o) Be provided with a description of the hospice care provided and levels of care to which the patient is entitled depending upon whether the patient is terminally ill or suffering from an advanced and progressive disease, and any charges associated with such services;

(p) Review, upon request, copies of any inspection report completed by the Department within the two years preceding the request;

(q) Make self-determinations concerning medical care, which encompass the right to make choices regarding life-sustaining treatment, including resuscitative services;

(r) Continue to receive appropriate hospice care when terminally ill without regard for the ability to pay for such care; and

(s) Have communication of information provided in a method that is effective for the patient. If the hospice cannot provide communications in a method that is effective for the patient, attempts to provide such shall be documented in the patient's medical record.

(2) The hospice must provide to the patient, the patient's representative, and/or the patient's legal guardian oral and written explanations of the rights of the patient and the patient's family unit while receiving hospice care for the terminally ill and palliative care for persons with advanced and progressive diseases. The explanation of rights must be provided at the time of admission into the hospice.

(3) At the time of admission, the hospice must provide to the patient, the patient's representative, and the patient's legal guardian the contact information, including the website address of the Department, for reporting complaints about hospice care to the Department.

(4) The hospice shall post the following information in a public area at the facility:

(a) A copy of the patient rights as outlined in Rule 111-8-37-.10(1) in a public area at the facility; and

(b) Contact information, including the website address of the Department, for reporting complaints about hospice care to the Department.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Patient and Family Rights" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.11 Disaster Preparedness {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.11}

(1) Every hospice must have a current disaster preparedness plan that addresses potential situations where services to patients may be disrupted and outlines appropriate courses of action in the event a local or widespread disaster occurs including communications with patients and their families and emergency management agencies.

(2) The disaster preparedness plan must include at a minimum plan for the following emergency situations:

(a) Local and widespread severe weather emergencies or natural disasters, such as floods, ice or snowstorms, tornados, hurricanes, and earthquakes;

(b) Interruption of service of utilities, including water, gas, or electricity, either within the facility or patients' homes or within a local or widespread area; and

(3) If the hospice offers residential and/or inpatient services, in addition to the procedures specified in paragraph (2) of this rule, the plan must also include:

(a) Fire safety and evacuation procedures and procedures for the provision of emergency power, heat, air conditioning, food, and water; and

(b) Plans for the emergency transport or relocation of all or a portion of the hospice patients, should it be necessary, in vehicles appropriate to the patients' conditions when possible, including written agreements with any facilities which have agreed to receive the hospice's patients in such situations, and notification of the patients' representatives.

(4) The hospice must have plans to ensure sufficient staffing and supplies to maintain safe patient care during the emergency situation.

(5) The plan must be reviewed and revised annually, as appropriate, including any related written agreements.

(6) Disaster preparedness plans for hospice care facilities must be rehearsed at least annually. Rehearsals must be documented to include staff and patient participants, a summary of any problems identified, and the effectiveness of the rehearsal. In the event an actual disaster occurs in any given year, the hospice may substitute the actual disaster's response in place of that year's rehearsal.

(7) Hospices must include emergency management agencies in the development and maintenance of their disaster preparedness plans and also provide copies of such plans to those agencies as requested.

(8) The Department may suspend any requirements of these rules and the enforcement of any rules where the Governor of the State of Georgia has declared that a state of emergency or disaster exists as a result of a public health emergency.

History

Authority: O.C.G.A. §§ 31-7-170 et seq., 50-13-4
History. Original Rule entitled "Disaster Preparedness" adopted. F. May 26, 2015; eff. June 15, 2015.
Amended: F. Feb. 28, 2020; eff. Mar. 19, 2020.

Ga. Comp. R. & Regs. r. 111-8-37-.12 Infection Control {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.12}

The hospice must have an effective infection control program designed to reduce the transmission of infections in patients, health care workers, caregivers, families, visitors and volunteers.

(a) The hospice must develop an infection control surveillance plan that is tailored to meet the needs of the hospice and the hospice patients and includes both outcome and process surveillance.

(b) The hospice must develop and implement effective policies and procedures that address infection control issues in all components of the hospice. These policies and procedures shall be based on accepted standards of infection control, approved by the administrator and the medical director, and shall address at least the following:

Hand hygiene;
Wound care;
Urinary tract care;
Respiratory therapy;
Enteral therapy;
Infusion therapy;
Cleaning, disinfecting, and sterilizing patient care equipment;
Isolation precautions;
Handling, transport, and disposal of medical waste and laboratory specimens;
Requirements for initial and annual health screenings for staff, including tuberculosis surveillance and required immunizations;
Use of personal protective equipment and exposure reporting/follow-up;
Work restrictions for staff with potentially infectious diseases;
Evaluation of the patient and the home environment related to infection control risks;
Outbreak investigation procedures;
Dietary practices in hospice care facilities; and
Reporting of communicable diseases, as required by law.

(c) The infection control program must be evaluated at least annually to ensure effectiveness of the program related to the prevention of the transmission of infections to patients, health care workers, caregivers, families, visitors and volunteers.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Infection Control" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.13 Human Resources {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.13}

(1) All persons providing services for a hospice must be qualified by education, training, and experience to carry out all duties and responsibilities assigned to them.

(2) All persons providing services for a hospice must receive an orientation to the hospice to include, but not be limited to:

(a) Hospice concepts and philosophy;

(b) Patient rights including abuse reporting requirements; and

(c) Hospice policies and procedures, including, but not limited to, disaster preparedness, fire safety and emergency evacuations, and reporting abuse and neglect.

(3) Where a patient does not have a do-not-resuscitate order, the hospice must ensure that all persons providing hands-on care directly to that patient on behalf of the licensed hospice have current certification in basic cardiac life support (BCLS) or cardiopulmonary resuscitation.

(4) The hospice must have an effective annual training and education program for all staff and volunteers who provide hands-on care to patients that addresses at a minimum:

(a) Emerging trends in infection control;

(b) Recognizing abuse and neglect and reporting requirements;

(d) Palliative care.

(5) The administrator and each staff member and volunteer who has direct contact with patients or their family units must receive an initial and annual health screening evaluation, performed by a licensed health care professional in accordance with accepted standards of practice, sufficient in scope to ensure that the staff and volunteers screened are free of communicable and health diseases that pose potential risks to patients, their family units, and other staff and volunteers.

(6) Human resource files must be maintained for the following individuals delivering any services associated with the written plan of care: each staff member, independent contractor, and volunteer. The files must contain the person's application, employment history, emergency contact information, evidence of qualifications, job description, evidence of initial and annual health screening, yearly skills competency assessments, evidence of verified licensure or certification, and criminal record check as appropriate, and evidence of orientation, education, and training. These files must be available for inspection by the appropriate enforcement authorities on the premises.

(7) Where the hospice contracts with a staffing agency to provide any services specified in a plan of care, the written contract must require the contracting agency to verify licensing credentials, where applicable, of contract workers to ensure that such workers meet the same qualifications and licensure requirements as specified for hospice employees providing such services directly. The hospice must retain a copy of the contract.

(8) The hospice must comply with the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12, with respect to direct access employees and maintain documentation of a satisfactory fingerprint criminal record check determination in the individual's personnel file.

History

Authority: O.C.G.A. §§ 31-7-170 et seq., 31-7-350 et seq
History. Original Rule entitled "Human Resources" adopted. F. May 26, 2015; eff. June 15, 2015.
Amended: F. Feb. 28, 2020; eff. Mar. 19, 2020.

Ga. Comp. R. & Regs. r. 111-8-37-.14 Admissions, Discharges, and Transfers {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.14}

(1) Admissions. The hospice must not admit any patients unless the hospice believes that it is capable of meeting the care needs of the patients. The hospice must have written criteria that address the eligibility for admission into home hospice care, residential, or inpatient hospice care and palliative care for persons with advanced and progressive diseases, if such palliative care is offered.

(2) Terminally Ill Patient Admissions for Home Care . The hospice program offered to terminally ill patients in their homes must admit only patients that meet the following minimum criteria:

(a) The patient has a referral from a physician who has personally evaluated the patient and diagnosed the patient as terminally ill, where the medical prognosis is less than six months of life if the terminal illness takes its normal course, and in need of hospice care;

(b) The patient has received from the hospice an initial assessment, performed by an appropriate representative of the hospice care team, that reflects a reasonable expectation that the patient's medical, nursing, and psychological needs can be met adequately by the hospice and further reflects that the patient has a need for and can benefit from hospice care;

(c) The patient has been given a description of the scope of services and has personally or through an authorized patient representative given informed consent in writing to receive hospice care;

(d) The patient has been certified in writing by the hospice to have an anticipated life expectancy of six months or less if the terminal illness takes its normal course;

(e) The patient lives within the hospices service area; and

(f) The patient has identified a primary caregiver. In the absence of a primary caregiver, the hospice must develop a detailed plan for meeting the daily care and safety needs of the patient.

(g) The hospice must ensure the development of an initial plan of care, within 24 hours of admission to the hospice, based on the initial assessment and with appropriate input from a physician or registered nurse to meet the immediate needs of the patient.

(h) The hospice must ensure that no terminally ill patient is excluded from participation in or denied benefits of any hospice care because of an inability to pay for such hospice care.

(3) Inpatient Hospice Admissions. Hospices must admit to acute inpatient hospice care only those terminally ill patients who meet the following criteria:

(a) The patient has an order from a physician to be transferred to inpatient status and requires any of the following:

Nursing care supervised by a registered nurse that cannot feasibly be provided in another hospice setting;
Procedures that are necessary for pain control or acute or chronic symptom management;
Medication adjustment, observation, or other stabilizing treatment; or
Psycho-social monitoring; or

(b) Respite care.

(4) Residential Hospice Admissions. In addition to the home care admissions, hospices that elect to offer residential services must admit to a residential facility only those terminally ill patients who do not require acute management of symptoms or stabilization in an inpatient care setting and who meet the following criteria:

(a) The patient lacks a sufficient number of capable and willing caregivers; or

(b) The patient's care needs are too complex and difficult for non-medical caregivers to perform confidently; or

(c) The patient's primary home is not suitable or available and/or the home cannot be adapted to meet the patient's needs; or

(d) The patient has no other home available or desires not to live at home.

(5) Palliative Care Admission Requirements . Hospices that elect to provide palliative care to persons with advanced and progressive diseases in any setting, other than an inpatient or residential hospice, must admit only those persons who meet the following criteria:

(a) have an order from a physician indicating the patient has an advanced and progressive disease;

(b) request the intervention of a hospice care team to alleviate suffering and achieve relief from physical, emotional or spiritual symptoms of distress to achieve the best quality of life for the person and his or her family; and

(6) Discharge Requirements.

(a) Once a hospice admits a patient who is terminally ill for hospice care, the hospice at its discretion must not discharge the patient unless either the patient freely and voluntary requests the discharge or the hospice determines that an involuntary discharge is necessary in accordance with these rules.

(b) No hospice is permitted to require or demand that a terminally ill patient request voluntary discharge from the hospice or require or demand a hospice patient to execute a request for voluntary discharge from the hospice as a condition for admission or continued care.

(c) In situations where the hospice identifies issues where the safety of the terminally ill patient, the patient's family unit, or a hospice staff member or volunteer is compromised, the hospice must make every effort to resolve the issues before considering the option of involuntary discharge.

All such efforts for resolution by the hospice must be documented in the patient's record.
If involuntary discharge is the elected option, the hospice must give no less than 14 days' notice of discharge to the terminally ill patient and the patient's representative, except in cases of imminent danger or immediate peril to the terminally ill patient, other terminally ill patients, or staff.
The hospice must notify the Department of the pending involuntary discharge of a terminally ill patient at the time of patient notification.

(d) No terminally ill patient receiving hospice care may be discharged due to inability to pay for the hospice services.

(e) No hospice is permitted to discontinue hospice care for a terminally ill patient, nor discharge or transfer the patient, during a period of coordinated or approved appropriate hospital admission for the treatment of conditions related to the patient's terminal illness or any other condition.

(f) Hospices must assist in coordinating continued care should any hospice patient be transferred or discharged from the hospice.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Admissions, Discharges, and Transfers" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.15 Assessment and Plan of Care {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.15}

(1) The hospice must designate a hospice care team for each patient admitted by the hospice. The hospice care team must be composed of individuals who provide or supervise the care and services offered by the hospice.

(2) The hospice care team must include at least the following individuals:

(a) A physician;

(b) A registered nurse;

(d) A member of the clergy or other counselors; and

(e) Volunteers.

(3) The appropriate members of the hospice care team must provide a comprehensive assessment, as dictated by the identified needs of the patient, no later than five days after admission that includes at least medical, nursing, psychosocial, and spiritual evaluations of the patient, as well as the capability of the family unit in meeting the care needs of the patient and the need for bereavement services.

(a) The assessment must be designed to trigger identification of any referral needed by the patient for additional services, including at a minimum:

Professional counseling;
Spiritual counseling by a member of the clergy or other counselor;
Bereavement services;
Dietitian services; and
Other therapeutic services, as needed.

(b) If additional services are identified for a terminally ill patient, the hospice must ensure that those services are provided by qualified individuals who must be added to the patient's hospice care team. Such qualified individuals include, but are not limited to:

Other appropriately licensed counselors, as applicable to the patient's needs; and
Volunteers who provide services for the patient.

(4) Based on the results of the assessment of the patient, the hospice care team must:

(a) Establish the plan of care; and

(b) Provide and supervise hospice care and services in accordance with accepted standards of care and the plan of care.

(5) The hospice care team must establish and maintain a written plan of care for each patient prior to providing care.

(a) The plan of care must be developed with the input of the patient, the patient's family unit if designated by the patient, the patient's caregivers where the patient resides in a licensed facility, and the patient's representative, if any.

(b) The plan of care must detail the scope and frequency of services to be provided to meet the needs of the patient and the patient's family unit.

(c) The hospice care team must meet as a group to review each terminally ill patient's plan of care. The plan of care must be reviewed and updated as the patient's condition changes and as additional service needs are identified. The plan of care for terminally ill patients must be reviewed and updated at intervals of no more than 15 days. All reviews and updates shall be documented in the patient's medical record. Plans of care for patients receiving palliative care who have not been determined to be terminally ill will be reviewed and updated as the patient's condition changes or the patient requests additional services.

(d) Documentation of plan of care review for the terminally ill patient must include a record of those participating and must also include evidence of the attending physician's opportunity to review and approve of any revised plans of care. In the absence of the attending physician's written approval of the revised plan of care, the revised plan of care must have the written approval of the medical director.

(6) The hospice care team must ensure that the patient receives treatment free from restraints, unless use of such restraints has been determined by a physician to be necessary for a temporary period to protect the patient from injury.

(a) Prior to using any restraint with a patient, the hospice care team must attempt less restrictive measures to accomplish the patient's treatment while affording the patient the maximum amount of personal freedom possible. The hospice must document the attempts at use of such less restrictive measures in the patient's medical record.

(b) If it is determined that restraints are necessary to prevent patient injury:

The hospice must obtain and document consent, specific to the type of restraint proposed, from the patient and/or the patient's representative for use of the restraint and such consent shall be obtained prior to the use of the restraint;
There must be a physician's order for the restraint, specifying the type of restraint to be used and the circumstances under which the restraint is to be applied, which is subject to the following conditions:

(a) The physicians order must be time limited; and

(ii) The order for the restraint must be re-evaluated prior to subsequent orders for the restraint;

The plan of care for the patient must include the plan and standard of care for use of the restraint, including the type and frequency of monitoring of the patient when the restraint is used. The plan must include maximum duration for each restraint application, with mandatory release at least every two hours, and a requirement that time, date, and duration of each restraint application are recorded and documented;
The plan of care must include procedures to ensure that the patient's comfort and safety needs are addressed during any period of restraint use;
The hospice must ensure safe and proper application and monitoring of the use of the restraint by adequately training staff and evaluating competency of each staff member treating patients in the use of the restraint and by directly observing staff performance with patients; and
The hospice staff must provide training to other patient caregivers in safe and proper use and monitoring of the restraint. Such training must be documented in the patient's medical record.

(c) A positioning or securing device utilized during medical treatment procedures to temporarily maintain the patient's position or immobilize the patient will not be considered a restraint, provided such necessity is documented in the patient's plan of care and the physician orders it. Such devices must only be applied by trained nursing or medical personnel and the plan of care must require monitoring sufficient to ensure the patient's safety.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Assessment and Plan of Care" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.16 Home Care {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.16}

(1) The hospice must provide home care services to patients primarily in the patients' home. At least 51 percent of the total of all hospice care days, delivered by the hospice in the fiscal year to terminally ill patients must be delivered in the homes of the terminally ill patients.

(2) During home care visits, the hospice employee must provide continuing education for the patient and the patient's primary caregiver regarding the progression of the patient's illness and the patient's care needs.

(3) If, during the home care visit, there are observed or communicated significant changes in the patient's condition or needs, or if the hospice employee or volunteer observes that the patient's primary caregiver cannot provide the continuing support and care the patient requires, such findings must be communicated to the patient's hospice care team in a sufficiently timely manner to ensure that the patient's care and safety needs are addressed.

(4) When hospice services are provided to a patient who is a resident of a licensed nursing home, licensed intermediate care home, licensed personal care home or licensed assisted living community, or another licensed hospice operating an inpatient unit, there must be written communication evidencing an understanding between the hospice and the licensed facility that makes clear that the hospice takes full responsibility for professional management of the patient's hospice care and that the licensed nursing home, licensed intermediate care home, licensed personal care home or licensed assisted living community takes responsibility for the other services the patient needs or receives that the licensed facility is authorized to provide.

(a) The written communication must clearly specify the patient-care activities and responsibilities that will be performed by the hospice employees and volunteers and those patient care tasks that will be performed by employees of the facility where the hospice patient resides. Hospice employees and volunteers must provide those services for which they are assigned responsibility in the hospice's plan of care for the patient.

(b) The written communication must specify an individual from the hospice and an individual from the facility where the patient resides who shall be responsible for communication between services providers regarding each patient's treatment and condition and for addressing any care issues. Such communication must be ongoing throughout the period of hospice service provision and must be documented in the patient's hospice medical record.

(c) The hospice must provide a copy of any self-determination documentation to the licensed nursing home, licensed intermediate care home, licensed personal care home or licensed assisted living community where the patient resides and must communicate with the facility as to the procedure for the appropriate implementation of any advance directive or physician's order for life sustaining treatment.

(5) If the hospice does not offer inpatient services directly, the hospice must have a contractual agreement with a licensed hospital, a licensed skilled nursing facility, or a licensed inpatient hospice for the provision of short-term, acute inpatient care and respite care for hospice patients.

(6) The hospice must arrange for transport services when necessary to transport hospice patients to and from inpatient hospice care.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Home Care" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.17 Medical Services {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.17}

(1) Medical services must be under the direction of the medical director. In addition to palliation and management of the terminal illness and related conditions, physicians of the hospice, including the physician members of the hospice care team, must also address the basic medical needs of the patients to the extent that such needs are not met by each patient's attending physician or other physician of the patient's choice.

(2) Medical Director. The medical director for the hospice must be a physician licensed to practice in this state and must have at least one year of documented experience on a hospice care team or in another setting managing the care of terminally ill patients. The medical director must:

(a) Be either an employee of the hospice or work under a written agreement with the hospice;

(b) Have admission privileges at one or more hospitals commonly serving patients in the hospice's geographical area;

(c) Be responsible for the direction and quality of the medical component of the care provided to patients by the hospice care team, including designating a licensed physician, employed by the hospice or working under a written agreement, to act on his or her behalf in the medical director's absence;

(d) Participate in the interdisciplinary plan of care reviews, patient case review conferences, comprehensive patient assessment and reassessment, and the quality improvement and utilization reviews;

(e) Review the clinical material of the patient's attending physician that documents basic disease process, prescribed medicines, assessment of patient's health at time of entry and the drug regimen;

(f) Ensure that each terminally ill patient receives a face-to-face assessment, by either the medical director or the terminally ill patient's attending physician, or is measured by a generally accepted life-expectancy predictability scale for continued admission eligibility at least every six months, as documented by a written certification from the medical director or the terminally ill patient's attending physician that includes:

The statement that the terminally ill patient's medical prognosis is for a life expectancy of six months or less if the terminal illness runs its natural course;
The specific current clinical finding and other documentation supporting a life expectancy of six months or less if the illness takes its natural course for the terminally ill patient; and
The signature of the physician.

(g) Communicate with each patient's attending physician and act as a consultant to attending physicians and other members of the hospice care team;

(h) Help to develop and review policies and procedures for delivering care and services to the patients and their family units;

(i) Serve on appropriate committees and report regularly to the hospice administrator regarding the quality and appropriateness of medical care;

(j) Ensure written protocols for symptom control and medication management are available; and

(k) Assist the administrator in developing, documenting and implementing a policy for discharge of patients from hospice care.

(3) In addition to the hospice medical director, the hospice may appoint additional hospice physicians who shall assist the medical director in the performance of his or her duties, as prescribed by the hospice.

(4) The medical director must assist the administrator in developing, documenting, and implementing effective policies and procedures for the delivery of physicians' services, for orientation of new hospice physicians, and for continuing training and support of hospice physicians. These policies and procedures must:

(a) Ensure that a hospice physician is on-call 24 hours a day, seven days a week; and

(b) Provide for the review and evaluation of clinical practices within home care, residential, and inpatient hospices in coordination with the quality management, utilization, and peer review committee.

(5) Verbal orders for medications and controlled substances shall only be given to appropriately licensed staff members, acting within the scope of their licenses, and must be immediately recorded, signed, and dated by the licensed staff member receiving such order.

(a) The individual receiving the order shall immediately repeat the order and the prescribing physician must verify that the repeated order is correct. The individual receiving the order must document in the patient's medical record that the order was "repeated and verified."

(b) The hospice must provide a written copy of the order to the prescribing physician within 24 hours of such order or by the end of the next business day.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Medical Services" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.18 Nursing Services {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.18}

(1) The hospice shall have a system to make available nursing services 24-hours a day, seven days a week to meet the needs of the patients.

(a) A registered nurse must be available at all times to provide or supervise the provision of nursing care.

(b) On-site nursing services must be made available within one hour of notification where the terminally ill patient and the patient with an advanced and progressive disease who has contracted for nursing services experiences a symptom-management crisis situation.

(c) The hospice must maintain an on-call log for all calls received after normal business hours, the records of which shall be kept for a period of two years.

(2) The hospice must designate a director of nursing who must be a Georgia-licensed registered nurse and who must be responsible for implementing a system for delivery, supervision, and evaluation of nursing and personal care services.

(a) The director of nursing must establish and implement effective policies and procedures for nursing and personal care services based on generally accepted standards of nursing practice.

(b) The director of nursing must ensure that nursing personnel are oriented to nursing policies and procedures and are qualified and competent for their assigned duties.

(c) The director of nursing must ensure the types and numbers of nursing personnel necessary to provide appropriate nursing care for each patient in the hospice.

(d) The director of nursing must ensure patient assignments are made that reflect a consideration of patient needs as well as nursing staff qualifications and competencies.

(3) Nursing staff must administer medications and other treatments in accordance with the physicians' orders, generally accepted standards of practice, and any federal and state laws pertaining to medication administration.

(4) When a patient who is terminally ill or whose death is anticipated and who is receiving hospice care from a licensed hospice dies, a physician assistant, a nurse practitioner, or a registered professional nurse licensed in this state and employed by the hospice at the time of the apparent death of such person, may make the determination and pronouncement of the patient's death in the absence of an attending physician. Such determination or pronouncement shall be made in writing on a form approved by the Department.

(5) Personal Care Services. Personal care services must be available and provided in all components of the hospice to meet the needs of patients. The hospice may utilize licensed nurses or qualified personal care aides for the provision of personal care services.

(a) Personal care aides considered qualified by training and experience to provide services to patients include:

Georgia Certified Nursing Aides with current certification as such; or
Individuals who have completed and can provide validation or documentation of completion of a home health aide training and competency evaluation program conducted in a Medicare-certified home health agency; or
Individuals who have successfully completed a personal care aide-training program, provided by the hospice under the direction of a registered nurse, which meets the following requirements:

(i) The personal care aide-training program must be conducted through classroom and supervised practical training totaling at least 75 hours;

(ii) At least 16 of the 75 hours of training shall be devoted to supervised practical training;

(iii) The individual being trained must complete at least 16 hours of classroom training before beginning the supervised practical training;

(iv) Supervised practical training must be provided either in a laboratory setting or in one of the components of the hospice in which the trainee demonstrates knowledge while performing tasks on an individual or patient under the direct supervision of a registered nurse or licensed practical nurse; and

(v) The personal care aide-training program must address each of the following subject areas:

(I) Communications skills;

(II) Observation, reporting, and documentation of patient status and the care or service furnished;

(III) Reading and recording temperature, pulse, and respiration;

(IV) Basic infection control procedures;

(V) Basic elements of body functioning and changes in body function that must be reported to an aide's supervisor;

(VI) Maintenance of a clean, safe, and healthy environment;

(VII) Recognizing emergencies and knowledge of emergency procedures;

(VIII) The physical, emotional, and developmental needs of and ways to work with the populations served by the hospice, including the need for respect for the patient, the patient's privacy, and the patient's property;

(IX) Appropriate and safe techniques in personal hygiene and grooming that include:

I. Bed bath;

II. Sponge, tub, or shower bath;

III. Shampooing in the sink, tub, or bed;

IV. Nail and skin care;

V. Oral hygiene; and

VI. Toileting and elimination;

(X) Safe transfer techniques and ambulation;

(XI) Normal range of motion and positioning;

(XII) Adequate nutrition and fluid intake, including preparing and assisting with eating;

(XIII) Any other task that the hospice may choose to have the personal care aide perform, as authorized by law; and

(XIV) Patient rights, including effectuating advance directives and abuse reporting requirements.

(b) Prior to providing care independently to patients, a registered nurse must observe personal care aides actually delivering care to patients and complete an initial competency evaluation for all personal care tasks assigned to the aide.

(c) Personal care aides must receive at least 12 hours of continuing education annually regarding applicable aspects of hospice care and services.

(d) A registered nurse must prepare for each personal care aide written instructions for patient care that are consistent with the interdisciplinary plan of care and must make and document supervisory visits to the terminally ill patient's residence or living facility at least every two weeks to assess the performance of the personal care aide services.

(e) At least annually, there must be written evidence for each personal care aide that reflects that the personal care aide's performance of required job tasks was directly observed by a registered nurse and such performance was determined to be competent for all job tasks required to be performed.

History

Authority: O.C.G.A. §§ 31-2-4, 31-7-170et seq
History. Original Rule entitled "Nursing Services" adopted. F. May 26, 2015; eff. June 15, 2015.
Amended: F. Mar. 19, 2018; eff. Apr. 8, 2018.

Ga. Comp. R. & Regs. r. 111-8-37-.19 Other Services {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.19}

Hospices must make supportive services available to both the patient and the patient's family unit, including, but not limited to, bereavement services provided both prior to and after the patient's death, as well as spiritual counseling and any other counseling services identified in the interdisciplinary plan of care for the patient and the patient's family unit.

(a) Bereavement Services. Hospices must have an organized program for the provision of bereavement services under the supervision of a licensed professional counselor or licensed social worker or other professional determined, in compliance with applicable laws, to be qualified by training and education to provide the required supportive services. Bereavement services must be a part of the interdisciplinary plan of care and shall address the needs of the patient and the patient's family unit, the services to be provided, and the frequency of services. Bereavement services, including educational and spiritual materials and individual and group support services, must be available to the terminally ill patient's family unit for a period of at least one year following the terminally ill patient's death. Hospices must maintain documentation of all bereavement services.

(b) Spiritual Counseling. Hospices must make available spiritual counseling and must notify patients and patients' family units as to the availability of clergy. In the delivery of spiritual counseling services, hospices must not impose any value or belief system on the patient or the patient's family unit.

(c) Other Counseling. Additional counseling for the patient or the patient's family unit may be provided by other qualified members of the hospice care team as well as by other qualified professionals in accordance with state practice acts. Such counseling includes, but is not limited to, access to a licensed clinical social worker or professional counselor for the provision of counseling to the patient or the patient's family unit or primary caregiver on a short-term basis to resolve assessed clear or direct impediments to the treatment of the patient's medical condition.

(d) Physical Therapy, Occupational Therapy, and Speech Language Pathology Services. Physical therapy services, occupational therapy services, and speech language pathology services must be available to the patient and, when provided, offered by qualified personnel, in accordance with state practice acts, in a manner consistent with accepted standards of practice.

(e) Dietary and Nutritional Services. Dietary and nutritional services, as required, must be available to all patients in all components of hospice care and provided or supervised by a licensed dietitian. Hospices must develop, document, and implement effective written policies and procedures for dietary and nutritional services.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Other Services" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.20 Volunteer Services {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.20}

(1) The hospice must establish a program that utilizes volunteers to provide services to terminally ill patients and family units in accordance with patients' plans of care and/or to provide administrative support services for the hospice.

(2) The hospice must designate a coordinator of volunteer services who assists the administrator in developing, documenting, and implementing a volunteer services program.

(3) The hospice volunteer coordinator must establish and implement effective written policies and procedures relating to volunteer services. These policies and procedures must address at a minimum:

(a) Recruitment and retention;

(b) Screening;

(d) Scope of function;

(e) Supervision;

(f) Basic infection control;

(g) Ongoing training and support; and

(h) Documentation of volunteer activities; and

(i) Patient rights and reporting abuse and other serious incidents.

(4) Volunteer services must be provided without compensation.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Volunteer Services" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.21 Pharmaceutical Services {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.21}

(1) The hospice must provide for the procurement, storage, administration, and destruction of drugs and biologicals utilized for hospice care in accordance with accepted professional principles and in compliance with all applicable state and federal laws.

(2) The hospice must:

(a) Ensure medication and pharmacy procedures are approved by a licensed pharmacist who is either employed directly or has a formal arrangement with the hospice;

(b) Ensure the availability of a licensed pharmacist on a 24-hour per day basis to advise the hospice staff regarding medication issues and to dispense medications;

(c) Ensure that any emergency drug kit placed in the hospice is in accordance with all applicable laws and rules and regulations:

(d) Ensure that drugs and biologicals are labeled in accordance with current accepted standards of practice;

(e) Ensure effective procedures for control and accountability of all drugs and biologicals throughout the hospice, including records of receipt, disposition, destruction, and reconciliation of all controlled substances and dangerous drugs; and

(f) Ensure that only licensed nurses or physicians, acting within the scope of their licenses, administer medications on behalf of the hospice, except for liquid morphine administered in accordance with O.C.G.A. § 31-7-12.2(g)(7)(G) .

(3) In the event of special circumstances under which the hospice is unavailable to administer liquid morphine to a hospice patient residing in an assisted living community, the hospice may train a certified medication aide at the community to administer the medication, subject to the following requirements:

(a) The patient is under a physician's written order that contains specific instructions for indication, dosage, frequency and route of administration;

(b) The initial dose is administered by a licensed hospice health care professional;

(c) The hospice provides adequate training to ensure that the medication aide who will be administering the liquid morphine can do so safely and properly;

(d) The morphine administration training is repeated at least on an annual basis to ensure continuing competency; and

(e) The hospice maintains documentation of compliance with these requirements.

History

Authority: O.C.G.A. §§ 31-7-170 et seq., 31-7-12.2(g)(7)(G)
History. Original Rule entitled "Pharmaceutical Services" adopted. F. May 26, 2015; eff. June 15, 2015.
Amended: F. Feb. 28, 2020; eff. Mar. 19, 2020.

Ga. Comp. R. & Regs. r. 111-8-37-.22 Medical Supplies {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.22}

The hospice must make available sufficient medical supplies and equipment for the palliative care and management of the illness or conditions directly attributable to the terminal diagnosis of terminally ill patients.

(a) If the hospice directly provides medical supplies and equipment, the hospice must:

Develop and implement effective policies and procedures to maintain the supplies and equipment in good working order per the manufacturers' recommendations;
Ensure the safe handling and storage of supplies and equipment to ensure function and cleanliness;
Instruct the caregiver on the use and maintenance of the equipment; and
Replace supplies and equipment as essential for the care of terminally ill patients.

(b) If the hospice contracts for medical supplies and equipment services, the hospice must ensure that contract agreements include requirements consistent with subparagraph (a) of this rule and must ensure that contractors adhere to such agreements.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Medical Supplies" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.23 Medical Records {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.23}

(1) In accordance with accepted standards of practice, the hospice must establish and maintain a medical record for every patient admitted for care and services. The medical record must be complete, promptly and accurately documented, readily accessible, and systematically organized to facilitate retrieval and to support the provision of patient care.

(2) Entries must be made for all services provided and must be signed and dated on the day of delivery by the individual providing the services for inclusion in the patient's medical record within seven days. The record must include all services whether furnished directly or under arrangements made by the hospice.

(3) Each patient's medical record must contain:

(a) Identification data;

(b) The initial and subsequent assessments;

(d) Consent and authorization forms;

(e) The interdisciplinary plan of care;

(f) The name of the patient's attending physician; and

(g) Complete documentation of all services and events, including evaluations, treatments, progress notes, transfers, discharges, etc.

(4) The hospice must have the patient's medical record readily accessible and must safeguard the medical record against loss, destruction, and unauthorized use.

(5) Medical records must be preserved as original records, microfilms, or other usable forms and must be such as to afford a basis for complete audit of professional information. Hospices must retain all medical records at least until the sixth anniversary of the patient's death or discharge, and as otherwise required by law. If the patient is a minor, medical records must be retained for at least five years past the age of majority or, in the event the minor patient dies, for at least five years past the year in which the patient would have reached the age of majority. In the event the hospice ceases operation, the hospice must provide prior notice to the local community, referring providers and the Department of the location of the medical records and how such records may be retrieved.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Medical Records" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.24 Hospice Care Facilities {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.24 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.24}

(1) Hospices providing home care services may establish, as optional services, small home-like residential facilities or units, in order to provide 24-hour non-acute palliative hospice care, and/or inpatient units, in order to provide short-term, 24-hour acute hospice care to terminally ill hospice patients. Residential hospices built, or undergoing major renovations after the effective date of these rules must meet the Facility Guidelines Institute, Guidelines for Design and Construction of Residential Health, Care, and Support Facilities, including the provisions specifically applicable to hospices.

(2) The environment of the hospice care facility must be designed, equipped, and maintained in accordance with applicable life safety code requirements to provide for the comfort, privacy, and safety of no more than 25 patients and family members in any one self-contained, home-like unit. A hospice may operate multiple self-contained, home-like units of no more than 25 beds each, either at the same location or separate locations, provided that each unit is fully staffed to meet the needs of the hospice patients in that unit, the locations are within 35 miles of the principal location and the governing body does not have a history of poor compliance with licensure requirements. Hospice care facilities, whether residential, inpatient, or residential and inpatient facilities, must provide:

(a) An emergency power source capable of providing electrical service for communication systems, alarm systems, egress lighting, and patient care areas;

(b) Décor and room configuration that is home-like in design and function;

(d) Accommodations for at least one family member to remain with the patient throughout the night;

(e) Separate restrooms for staff and public use;

(f) A program to inspect, monitor and maintain biomedical, electrical equipment in proper and safe working order;

(g) Procedures that prevent infestations of insects, rodents, or other vermin or vectors;

(h) Security procedures sufficient for the protection of patients;

(i) Procedures for the safe management of medical gases;

(j) Procedures for infection control, including isolation of patients, in accordance with accepted standards;

(k) An environment that is clean, in good repair, and designed and equipped to minimize the spread of infection;

(l) Adequate lighting, ventilation, and control of temperature and air humidity; and

(m) An alternative power source to support the needs of the patients.

(3) Patient rooms and bathrooms must be designed and equipped to allow for easy access to the patient and for the comfort and safety of patients.

(4) Each residential and/or inpatient hospice care facility must provide rooms that:

(a) Measure at least 100 square feet for a single patient room or 80 square feet for each patient for a multi-patient room;

(b) Are private rooms, unless consent for a roommate is obtained and then only if the following requirements are met:

The hospice must provide an alternative temporary accommodation for a patient whose roommate is in a crisis situation;
In no case shall more than two patients share a room;

(c) Are equipped with a bathroom with an adequate supply of hot water and with automatically regulated temperature control of the hot water;

(d) Are at or above grade level and have a window to the outside;

(e) Contain a suitable bed and mattress for each patient, suitable furniture that allows family to remain in the room overnight, chairs for seating, and closets or furniture for storage of personal belongings;

(f) Are equipped with a system for patients to summon for assistance when needed;

(g) Are equipped with a telephone in each room or telephones located in private areas convenient to bedrooms; and

(h) Have an adequate amount of clean bed linens, towels, and washcloths.

(5) In addition to complying with all other requirements of these rules and regulations, each facility that is newly constructed or expands its existing facility after the date these rules and regulations take effect shall also provide a tub or shower in each patient room.

(6) In addition to the hospice's applicable home-care policies and procedures, hospice care facilities must develop and implement additional policies and procedures for post-mortem care and for pronouncement of deaths, in accordance with applicable law.

(7) Hospice care facilities must have policies regarding smoking which apply to employees, volunteers, patients, and visitors.

(8) Hospice care facilities must ensure adequate staff are on duty at all times in order to meet the needs of patients, in accordance with patients' plans of care and in accordance with accepted standards of nursing and hospice care. Residential and/or inpatient hospice care facilities must provide:

(a) At least two staff members on duty 24 hours per day, seven days per week, with additional staff as needed to meet the needs of patients; and

(b) A registered nurse must direct and supervise all patient care in accordance with the needs of patients and the individual plans of care.

Residential hospice care facilities may utilize licensed practical nurses for patient care provided that a registered nurse supervises the care and is available on call at all times.
Inpatient hospice care facilities must have a registered nurse present during each shift who provides direct patient care.

(9) Meals must be provided in accordance with established dietary practice and the dietary needs and wishes of patients. The hospice must:

(a) Serve three meals a day with not more than 14 hours between a substantial evening meal and breakfast, unless medically contraindicated;

(b) Have a system for providing meals for patients outside the normal meal service hours, when requested;

(d) Purchase, store, prepare, and serve food in a manner that prevents food borne illness;

(e) Ensure patient diets follow the orders of physicians;

(f) Ensure that a qualified staff member plans and supervises meals to ensure meals meet patient's nutritional needs and to ensure meals follow recommended dietary allowances and menu plans; and

(g) Ensure the services of a licensed dietitian to review meal plans and to consult in practical freedom of choice diets to ensure that patients' favorite foods are included in their diets whenever possible.

History

Authority: O.C.G.A. §§ 31-7-170et seq
History. Original Rule entitled "Hospice Care Facilities" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.25 Waivers and Variances {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.25 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.25}

(1) A hospice may request a waiver or variance of a specific rule by application on forms provided by the Department.

(2) The Department may grant or deny the request for waiver or variance at its discretion. If the waiver or variance is granted, the Department may establish conditions that must be met by the hospice in order to operate under the waiver or variance. Waivers or variances may be granted with consideration of the following:

(a) Variance. A variance may be granted by the Department, at its discretion, upon a showing by the applicant that the particular rule or regulation that is the subject of the variance request should not be applied as written because strict application would cause undue hardship. The applicant must also show that adequate standards exist for affording protection for the health, safety, and care of patients, and these existing standards would be met in lieu of the exact requirements of the rule or regulation.

(b) Waiver. The Department may, at its discretion, dispense altogether with the enforcement of a rule or regulation by granting a waiver upon a showing by the applicant that the purpose of the rule or regulation is met through equivalent standards affording equivalent protection for the health, safety, and care of the patients.

(c) Experimental Waiver or Variance. The Department may grant a waiver or variance, at its discretion, to allow experimentation and demonstration of new and innovative approaches to delivery of services upon a showing by the applicant that the intended protections afforded by the rule or regulation in question are met and that the innovative approach has the potential to improve service delivery.

(3) Waivers and variances granted by the Department must be for a time certain, as determined by the Department.

(4) The hospice may request a final review of the initial waiver or variance decision made by program staff to the chief of the Division of Healthcare Facility Regulation by filing a written request for review of the initial decision and providing any additional information which supports the request for review. The chief of the Division will issue a final decision on behalf of the Department.

(5) Where the Department has denied the application for a waiver or variance in writing, the Department will not consider a subsequent application for the same waiver or variance from the same hospice unless the applicant includes new evidence of a substantial change in the circumstances which formed the basis for the initial request.

History

Authority: O.C.G.A. §§ 31-2-4 7 and 31-7-170 et seq
History. Original Rule entitled "Waivers and Variances" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.26 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.26 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.26}

A hospice that fails to comply with licensing requirements as contained in the Rules and Regulations for Hospices, Chapter 111-8-37 and the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25, is subject to civil and administrative actions brought by the Department to enforce licensing requirements as provided by applicable laws and rules. Such actions will be initiated in compliance with the Georgia Administrative Procedures Act, O.C.G.A. §§ 50-13-1et seq., 31-2-8 and the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25.

However, the Department may suspend any requirements of these rules and the enforcement of any rules when the Governor of the State of Georgia has declared a public health emergency.

History

Authority: O.C.G.A. §§ 31-2-8, 31-7-170et seq. and 50-13-1 et seq
History. Original Rule entitled "Enforcement" adopted. F. May 26, 2015; eff. June 15, 2015.

Ga. Comp. R. & Regs. r. 111-8-37-.27 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-37-.27 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-37-.27}

History

Authority: O.C.G.A. §§ 31-2-4 and 31-7-170et seq
History. Original Rule entitled "Severability" adopted. F. May 26, 2015; eff. June 15, 2015.

Subject 111-8-40 Rules and Regulations for Hospitals

Ga. Comp. R. & Regs. r. 111-8-40-.01 Title and Purpose {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.01}

These rules shall be known as the Rules and Regulations for Hospitals. The purpose of these rules is to provide for the inspection and issuance of permits for hospitals and to establish minimum requirements for facilities operating under a hospital permit.

History

Authority: O.C.G.A. §§ 31-2-4, 31-2-5, 31-7-2.1 and 31-7-3
History. Original Rule entitled "Title and Purpose" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.02 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.02}

Unless a context otherwise requires, these identified terms mean the following when used in these rules:

(a) Board certified means current certification of a licensed physician by a specialty board recognized by the American Board of Medical Specialties (ABMS) or American Osteopathic Association (AOA) or other nationally recognized specialty's certifying board.

(b) Board eligible means a licensed physician who meets the criteria for examination for the designated specialty as published by that nationally recognized specialty's certifying board.

(c) Bylaws means a set of laws or rules formally adopted internally by the facility, organization, or specified group of persons to govern internal functions or practices within that group, facility, or organization.

(d) Department means the Department of Community Health of the State of Georgia.

(e) Governing body means the hospital authority, board of trustees or directors, partnership, corporation, entity, person, or group of persons who maintain and control the hospital.

(f) Hospital means any building, facility, or place in which are provided two (2) or more beads and other facilities and services that are used for persons received for examination, diagnosis, treatment, surgery, or maternity care for periods continuing for twenty-four (24) hours or longer and which is classified by the department as a hospital.

(g) Inpatient means a person admitted to a hospital for an intended length of stay of twenty-four (24) hours or longer.

(h) Rural Free Standing Emergency Department means any hospital that downgrades its existing scope of services to meet all of the following conditions:

(i) is currently licensed by the Department as a hospital or was previously licensed by the Department as a hospital and such license expired within the previous 12 months;

(ii) is located in a rural county as defined by O.C.G.A. § 31-6-2(32) ;

(iii) is located no more than 35 miles from a licensed general hospital;

(iv) is open 7 days a week, 24 hours a day;

(v) provides non-elective emergency treatment and procedures for periods continuing less than 24 hours;

(vi) may provide elective, out-patient surgical treatment and procedures for periods continuing less than 24 hours;

(vii) may provide basic obstetrics and gynecology treatment and procedures for periods continuing less than 24 hours; and

(viii) is classified by the department, as provided for in this chapter, as a Rural Free Standing Emergency Department. Rural Free Standing Emergency Departments may provide elective endoscopy or other elective treatment and procedures which are not performed in an operating room environment.

(i) Medical record means the written or electronic collection of diagnostic and/or treatment information and data pertaining to the patient, including but not limited to identifying information and, as applicable, medical orders, assessment findings, diagnostic test results, progress notes, x-rays films, monitoring data, and details of treatment.

(j) Medical staff means the body of licensed physicians, dentists, and/or podiatrists, appointed or approved by the governing body, to which the governing body has assigned responsibility and accountability for the patient care provided at the hospital.

(k) Organized service(s) means any inpatient or outpatient service offered by the hospital which functions as an administrative or operational unit under the governing body of the hospital.

(l) Outpatient means a person who presents to a hospital for diagnostic or treatment services and who is not admitted to the hospital as an inpatient by a member of the medical staff.

(m) Patient means any person presenting at a hospital for the purpose of evaluation, diagnosis, monitoring, or treatment of a medical condition, mental condition, disease, or injury.

(n) Peer review means the procedure by which professional health care providers evaluate the quality and efficiency of services ordered or performed by other professional health care providers in the hospital for the purposes of fostering safe and adequate treatment of the patients and compliance with standards set by an association of health care providers and with the laws, rules, and regulations applicable to hospitals.

(o) Permit means the authorization granted by the Department to a hospital governing body to operate the hospital's authorized services.

(p) Physical restraint means any manual method or physical or mechanical device used with a patient such that the patient's freedom of movement or access to his/her own body is restricted.

(q) Physician means any person who is licensed to practice medicine in this state by the Georgia Composite State Board of Medical Examiners.

(r) Practitioner means any individual engaged in the practice of the profession for which they are licensed, certified, or otherwise qualified or authorized to practice.

(s) Professional staff means a person or persons licensed by the state of Georgia to practice a specified health profession and employed by or contracting with the hospital for the practice of that profession.

(t) Rules and regulations means the set of rules formally adopted internally by a specified hospital body to provide guidance for internal functions or practices.

(u) Seclusion means the confinement of a person to a room or an area where the person is prevented from leaving.

(v) Surveillance means the systematic method of collecting, consolidating, and analyzing data concerning the distribution and determinants of a given disease or medical event, followed by the dissemination of that information to those who can improve the outcomes.

(w) The singular indicates the plural, the plural indicates the singular, and the masculine the feminine, when consistent with the intent of these rules.

History

Authority: O.C.G.A. §§ 31-7-1, 31-7-2.1, 31-7-15 and 31-7-131
History. Original Rule entitled "Definitions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Apr. 29, 2014; eff. May 19, 2014.

Ga. Comp. R. & Regs. r. 111-8-40-.03 Hospital Permit Requirement {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.03}

No person, corporation, association, or other entity shall establish, operate, or maintain a hospital in Georgia without a permit or provisional permit.

(a) A permit is required for each hospital. Multi-building hospitals may request a single permit to include all buildings provided that the hospital buildings are in close proximity to each other, the facilities serve patients in the same geographical area, and the facilities are operated under the same ownership, control, and bylaws.

Services offered in separate buildings or on separate premises, which do not by themselves meet the definition of a hospital, including, but not limited to, satellite urgent care centers, outpatient or mammography clinics, or hospital-owned physicians' offices, shall be considered organized services of the hospital for the purposes of these rules.
Only those services operated by the hospital under the permit as approved by the Department shall be presented to the public as a service of the hospital.

(b) A permit, either continuing or provisional, is required prior to the admission of any patients or initiation of any patient care services in the hospital. A provisional permit may be issued for a limited time to a newly established hospital to allow the hospital to demonstrate that its operational procedures equal standards specified by the rules.

(c) The permit shall designate the classification of the hospital as determined by the Department following evaluation of the hospital's services and in accordance with the Certificate of Need.

The classification shall be one of the following:

(i) Classification as a general hospital means a facility meets the definition of a hospital and provides continuous care for a variety of patients who have a variety of medical conditions. A critical access hospital shall fall under the general hospital classification;

(ii) Classification as a specialized hospital means a facility that meets the definition of a hospital and provides care to a specialized or specified group of patients and/or patients who have specified conditions. The type of specialization shall be designated on the hospital permit; or

(iii) Classification as a Rural Free Standing Emergency Department.

If changes occur in the organized services offered by the hospital, including the addition of any services requiring CON review or off-campus service locations, the hospital's administrator or governing body shall submit to the Department a new description of services at least thirty (30) days prior to the change. Change in the classification of the hospital shall require application for a new permit.

(d) To be eligible for a permit the hospital shall be in substantial compliance with these rules and regulations and any provisions of law as applicable to the construction and operation of the hospital. In its discretion, the Department may issue a provisional permit for a limited time to a new or existing hospital to allow the hospital a reasonable length of time to come into compliance with these rules provided the Department has received an acceptable plan of correction.

(e) The permit issued to the hospital shall be prominently displayed in a public area of the hospital at all times.

(f) A permit is not transferable from one governing body to another nor from one hospital location to another.

(g) If the hospital anticipates that it will close or cease to operate, the governing body shall notify the Department at least thirty (30) days prior to the anticipated closure.

Prior to hospital closure, the hospital shall inform the Department of the planned storage location for patients' medical records, medical staff information, and other critical information after closure. The hospital shall publish in a widely circulated newspaper(s) in the hospital's service area a notice indicating where medical records and other critical information can be retrieved and shall notify the Department of Transportation of the anticipated date of closure for removal of the hospital locator signs. Following closure, the Department shall be notified of any change in location of the patients' medical records, medical staff information, and other critical information from the published location.
When the hospital ceases to operate, the permit shall be returned to the Department within ten (10) days of closure. The permit shall be considered revoked, unless placed on inactive status as described in these rules.
If the hospital is closing for a period of less than twelve (12) months, and plans to reopen under the same ownership, name, classification, and bed capacity, the hospital may request to have the permit placed on temporary inactive status.

(i) When placed on temporary inactive status, the permit shall be returned to the Department within ten (10) days of closure and the hospital shall not operate until the permit has been reactivated. The hospital shall notify the Department of Transportation of the intended closure.

(ii) The hospital shall request in writing that the permit be reactivated at least thirty (30) days prior to the desired date of reopening. Prior to reactivation of the permit, the hospital may be subject to inspection by the Department. If the permit is not reactivated within twelve (12) months, the permit shall be considered revoked.

(h) A new permit may be obtained by application to the Department and is required if the hospital is moved to another location, has a change in operational or trade name, has a change in ownership or classification, or has a change in the authorized bed capacity. The former permit shall be considered revoked upon the issue of a new permit and the former permit shall be returned to the Department.

(i) A permit shall remain in effect unless suspended or revoked or otherwise rescinded or removed as provided in these rules.

History

Authority: O.C.G.A. §§ 31-7-1, 31-7-2, 31-7-2.1 and 31-7-3
History. Original Rule entitled "Hospital Permit Requirement" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Apr. 29, 2014; eff. May 19, 2014.

Ga. Comp. R. & Regs. r. 111-8-40-.04 Facilities Exempt from These Rules {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.04}

The following classes of hospitals are exempt from these rules:

(1) Federally owned and/or operated hospitals. Hospitals owned or operated by the federal government are exempt from these rules and the requirement for a Georgia hospital permit; and

(2) Residential Mental Health Facilities for Children and Youth. A sub-classification of specialized hospitals which are licensed to provide twenty-four (24) hour care and have as their primary function the diagnosing and treating patients to age twenty-one (21) with psychiatric disorders are exempt from these rules in lieu of meeting the specific regulations under Chapter 111-8-68.

History

Authority: O.C.G.A. §§ 31-2-7, 31-7-2 and 31-7-5
History. Original Rule entitled "Facilities Exempt from These Rules" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.05 Application for a Permit {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.05}

An application for a permit to operate a hospital shall be submitted on forms provided by the Department. The application submitted to the Department shall be an original document. No application shall be considered by the Department unless it is complete and accompanied by all required attachments.

(a) Application for Initial Permit. The application for an initial permit shall be submitted to the Department not later than thirty (30) days prior to the anticipated date of the opening and initiation of operations by the hospital. The application shall be signed by the hospital administrator or the executive officer of the hospital's governing body and shall include:

A listing of the services provided:
Proof of hospital ownership. In the case of corporations, partnerships, and other entities authorized by law, the applicant shall provide a copy of its certificate of incorporation, or other acceptable proof of its legal existence together with the names and addresses of all persons owning five (5) percent or more;
A list of the locations of any services offered by the hospital on separate premises; and
A copy of the Certificate of Need (CON) from the Department.

(b) Application Due to a Change in Name, Location, or Bed Capacity of a Hospital. The application for a new permit due to a change in name, location, or authorized bed capacity of a hospital shall be submitted at least thirty (30) days prior to the proposed effective date of the change.

(c) Application Due to a Change in Classification of the Hospital. The application for a new permit due to a change in the classification for the hospital shall be submitted at least thirty (30) days prior to the proposed effective date of the change. The application shall be signed by the hospital administrator or the executive officer of the governing body and shall include:

A listing of the service(s) to be provided; and
A copy of the required Certificate of Need (CON) from the Department, if applicable.

(d) Application Due to a Change in Ownership. The application for a new permit due to a change in ownership shall be submitted at least thirty (30) days prior to the change whenever possible. Proof of ownership documents, as required with the application for the initial permit and any other approvals required by state law, shall be submitted upon the completion of the transaction changing ownership.

History

Authority: O.C.G.A. § 31-7-3
History. Original Rule entitled "Application for a Permit" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.06 Permit Denial and Sanctions {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.06}

The Department may refuse to grant an initial permit, revoke a current permit, or impose other sanctions as described herein and in the rules for the "General Licensing and Enforcement Requirements," Chapter 111-8-25.

(a) Denial of an Application for a Permit. The Department may refuse to grant an initial permit or provisional permit without the requirement of holding a hearing prior to the action. Denial of an application for a change to a permit from an existing facility shall be subject to notice and opportunity for a hearing following the denial. An application may be refused or denied if:

The hospital has failed to demonstrate compliance with these rules and regulations;
The applicant or alter ego of the applicant has had a permit denied, revoked, or suspended within one (1) year of the date of a new application;
The applicant has transferred ownership or governing authority of a hospital within one (1) year of the date of the new application when such transfer was made in order to avert denial, suspension, or revocation of a permit; or
The applicant has knowingly made any verbal or written false statement(s) of material fact in connection with the application for the permit or on documents submitted to the Department as part of any inspection or investigation or in the falsification or alteration of facility records made or maintained by the hospital.

(b) Sanction of a Permit.

The Department may take an action to sanction the hospital permit holder, subject to notice and opportunity for a hearing, where the Department finds that the hospital has:

(i) Knowingly made any verbal or written false statement of material fact either in connection with the application for the permit or on documents submitted to the Department as part of any inspection or investigation or in the falsification or alteration of hospital records made or maintained by the hospital;

(ii) Failed or refused, without legal cause, to provide the Department with access to the premises subject to regulation or information pertinent to the initial and continued licensing of the hospital;

(iii) Failed to comply with the licensing requirements of this state; or

(iv) Failed to comply with the provisions of O.C.G.A. § 31-2-8 or Rules for General Licensing and Enforcement Requirements, Chapter 111-8-25.

Such sanctions may include any one or more of the following:

(i) Administration of a public reprimand;

(ii) Suspension of the permit;

(iii) Prohibition of persons in management or control;

(iv) Imposition of civil penalties as provided by law; and

(v) Revocation of the permit.

History

Authority: O.C.G.A. §§ 31-2-8 and 31-7-1et seq., and the Rules for General Licensing and Enforcement Requirements, Chapter 111-8-25
History. Original Rule entitled "Permit Denial and Sanctions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.07 Hospital Inspections and Required Reports to the Department {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.07}

(1) Inspections by the Department. The hospital shall be available during all hours of operation for observation and examination by properly identified representatives of the Department.

(a) Initial Inspection. There shall be an initial inspection of a hospital prior to the opening date in order to determine that the hospital is in substantial compliance with these rules. Prior to this initial inspection, the hospital shall submit to the Department:

A copy of the certificate of occupancy;
Verification of building safety and fire safety from local and state authorities; and
Evidence of appropriate approvals by the state architect.

(b) Periodic Inspections. The hospital shall be subject to periodic inspections to determine that there is continued compliance with these rules, as deemed necessary by the Department.

(c) Random Inspections. The hospital may be subject to additional or more frequent inspections by the Department where the Department receives a complaint alleging a ruleviolation by the hospital or the Department has reason to believe that the hospital is in violation of these rules.

(d) Plans of Correction. If violations of these licensing rules are identified, the hospital will be given a written report of the violation that identifies the rules violated. The hospital shall submit to the Department a written plan of correction in response to the report of violation, which states what the hospital will do, and when, to correct each of the violations identified. The hospital may offer an explanation or dispute the findings or violations in the written plan of correction, so long as an acceptable plan of correction is submitted within ten (10) days of the hospital's receipt of the written report of inspection. If the initial plan of correction is unacceptable to the department, the hospital will be provided with at least one (1) opportunity to revise the unacceptable plan of correction. The hospital shall comply with its plan of correction.

(e) Accreditation in Place of Periodic Inspection. The Department may accept the accreditation of a hospital by the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO), the American Osteopathy Association (AOA), or other approved accrediting body, in accordance with specific standards determined by the Department to be substantially equivalent to state standards, as representation that the hospital is or remains in compliance with these rules.

Hospitals accredited by an approved accrediting body shall present to the Department a copy of the full certification or accreditation report each time there is an inspection by the accreditation body and a copy of any reports related to the hospital's accreditation status within thirty (30) days of receipt of the final report of the inspection.
Hospitals accredited by an approved accrediting body are excused from periodic inspections. However, these hospitals may be subjected to random inspections by the Department for continuation of the permit when:

(i) A validation study of the accreditation process is necessary;

(ii) There has been a complaint alleging a rule violation which the Department determines requires investigation;

(iii) The Department has reason to believe that there is a patient incident or situation in the hospital that presents a possible threat to the health or safety of patients; or

(iv) There are additions to the services previously offered by the hospital which the Department determines requires an on-site visit.

(2) Required Reports to the Department.

(a) Patient Incidents Requiring Report.

The hospital's duly constituted peer review committee(s) shall report to the Department, as required below, whenever any of the following incidents involving hospital patients occursor the hospital has reasonable cause to believe that a reportable incident involving a hospital patient has occurred:

(i) Any unanticipated patient death not related to the natural course of the patient's illness or underlying condition;

(ii) Any rape which occurs in a hospital;

(iii) Any surgery on the wrong patient or the wrong body part of the patient; and

(iv) Effective three (3) months after the Department provides written notification to all hospitals the hospital's duly constituted peer review committee(s) shall also report to the Department, whenever any of the following incidents involving hospital patients occurs or the hospital has reasonable cause to believe that a reportable incident involving a hospital patient has occurred:

(I) Any patient injury which is unrelated to the patient's illness or underlying condition and results in a permanent loss of limb or function;

(II) Second or third degree burns involving twenty (20) percent or more of the body surface of an adult patientor fifteen (15) percent or more of the body surface of a child which burns were acquired by the patient in the hospital;

(III) Serious injury to a patient resulting from the malfunction or intentional or accidental misuse of patient care equipment;

(IV) Discharge of an infant to the wrong family;

(V) Any time an inpatient, or a patient under observation status, cannot be located, where there are circumstances that place the health, safety, or welfare of the patient or others at risk and the patient has been missing for more than eight (8) hours;and

(VI) Any assault on a patient, which results in an injury that requires treatment.

The hospital's peer review committee(s) shall make the self-report of the incident within twenty-four (24) hours or by the next regular business day from when the hospital has reasonable cause to believe an incident has occurred. Theself-report shall be received by the Department in confidence and shall include at least:

(i) The name of the hospital;

(ii) The date of the incident and the date the hospital became aware that a reportable incident may have occurred;

(iii) The medical record number of any affected patient(s);

(iv) The type of reportable incident suspected, with a brief description of the incident; and

(v) Any immediate corrective or preventative action taken by the hospital to ensure against the replication of the incident prior to the completion of the hospital's investigation.

The hospital's peer review committee(s) shall conduct an investigation of any of the incidents listed above and complete and retain on site a written report of the results of the investigation within forty-five (45) days of the discovery of the incident. The complete report of the investigation shall be available to the Department for inspection at the facility and shall contain at least:

(i) An explanation of the circumstances surrounding the incident, including the results of a root cause analysisor other systematic analysis;

(ii) Any findings or conclusions associated with the review; and

(iii) A summary of any actions taken to correct identified problems associated with the incident and to prevent recurrence of the incident and also any changes in procedures or practices resulting from the internal evaluation using the hospital's peer review and quality management processes.

The Department shall hold the self-report made through the hospital's peer review committee(s) concerning a reportable patient incident in confidence as a peer review document or report and not release the self-report to the public. However, where the Department determines that a rule violation related to the reported patient incident has occurred, the Department will initiate a separate complaint investigation of the incident. The Department's complaint investigation and the Department's report of any rule violation(s) arising either from the initial self-report received from the hospital or an independent source shall be public records.

(b) Other Events/Incidents Requiring Report.

The hospital shall report to the Department whenever any of the following events involving hospital operations occurs or when the hospital becomes aware it is likely to occur, to the extent that the event is expected to cause or causes a significant disruption of patient care:

(i) A labor strike, walk-out, or sick-out;

(ii) An external disaster or other community emergency situation; and

(iii) Aninterruption of services vital to the continued safe operation of the facility, such as telephone, electricity, gas, or water services.

The hospital shall make a report of the event within twenty-four (24) hours or by the next regular business day from when the reportable event occurred or from when the hospital has reasonable cause to anticipate that the event is likely to occur. The report shall include:

(i) The name of the hospital;

(ii) The date of the event, or the anticipated date of the event, and the anticipated duration, if known;

(iii) The anticipated effect on patient care services, including any need for relocation of patients; and

(iv) Any immediate plans the hospital had made regarding patient management during the event.

Within forty-five (45) days following the discovery of the event, the hospital shall complete an internal evaluation of the hospital's response to the event where opportunities for improvement relating to the emergency disaster preparedness plan were identified. The hospital shall make changes in the emergency disaster preparedness plan as appropriate. The complete report of the evaluation shall be available to the Department for inspection at the facility.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-8, 31-7-2.1, 31-7-15, 31-7-133, 31-7-140 and 50-18-72
History. Original Rule entitled "Hospital Inspections and Required Reports to the Department" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.08 Hospital Ownership {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.08}

There shall be full disclosure of hospital ownership to the Department at the time of the initial application and when requested. In the case of corporations and partnerships, the names of all corporate officers, partners, and all others owning five (5) percent or more of corporate stock or ownership shall be made known to the Department.

History

Authority: O.C.G.A. § 31-7-3
History. Original Rule entitled "Hospital Ownership" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.09 Governing Body and Hospital Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.09}

The hospital shall have an established and functioning governing body that is responsible for the conduct of the hospital as an institution and that provides for effective hospital governance, management, and budget planning.

(a) The governing body shall be organized under bylaws and shall be responsible for ensuring the hospital functions within the classification for which it is permitted by the Department.

(b) The governing body shall appoint members of the medical staff within a reasonable period of time after considering the recommendations of the medical staff, if any, and shall ensure the following:

That every inpatient is under the care of a qualified member of the medical staff;
That the medical staff is organized and operates under medical staff bylaws and medical staff rules and regulations, which shall become effective when approved by the governing body; and
That the medical staff is responsible to the governing body for the quality of all medical care provided to patients in the hospital and for the ethical and professional practices of its members while exercising their hospital privileges.

(c) If the hospital does not provide emergency services as an organized service, the governing body shall ensure that the hospital has written policies and procedures approved by the medical staff for the appraisal of emergencies, the initial treatment of emergencies, and the referral for emergency patients as appropriate.

(d) The governing body shall identify an administrator or chief executive officer who is responsible for the overall management of the hospital. The administrator or chief executive officer shall:

Ensure that there are effective mechanisms in the hospital's organization to facilitate communication between the governing body, the medical staff, the nursing staff, and other departments of the hospital;
Ensure that patients receive the same quality of care throughout the hospital; and
Be responsible for reporting to the appropriate licensing board any member of the medical staff whose privileges at the hospital have been denied, restricted, or revoked, or who has resigned from practice at the hospital, to the extent required by state law.

(e) The hospital shall advise the Department immediately and in writing of a change in the designation of the administrator or chief executive officer.

(f) The governing body shall ensure that the hospital is staffed and equipped adequately to provide the services it offers to patients, whether the services are provided within the facility or under contract. All organized services providing patient care shall be under the supervision of qualified practitioners.

(g) The governing body shall be responsible for compliance with all applicable laws and regulations pertaining to the hospital.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Governing Body and Hospital Administration" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.10 Hospital-Patient Communications {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.10}

The hospital shall develop, implement, and enforce policies and procedures to ensure that each patient is:

(a) Informed about the hospital's grievance process, including whom to contact to file a grievance or complaint with the hospital and that individual's telephone number, and the name, address, and telephone number of the state regulatory agency;

(b) Provided an opportunity to give informed consent, or have the patient's legally authorized representative give informed consent, as required by state law, with documentation of provision of such opportunity in the patient's medical record;

(d) Have advance directives honored in accordance with the law and afforded the opportunity to issue advance directives if admitted on inpatient status;

(e) Provided, upon request, a written summary of hospital charge rates, per service, sufficient and timely enough to allow the patient to compare charges and make cost-effective decisions in the purchase of hospital services;

(f) Provided an itemized statement of all charges for which the patient or third-party payer is being billed; and

(g) Provided communication of information in a method that is effective for the recipient, whether the recipient is the patient or the patient's designated representative. If the hospital cannot provide communications in a method that is effective for the recipient, attempts to provide such shall be documented in the patient's medical record.

History

Authority: O.C.G.A. §§ 10-1-393, 31-7-2.1, 31-7-11, 31-9-2, 31-9-7, 31-11-82, 31-32-1et seq., 31-33-2, 31-33-3
History. Original Rule entitled "Hospital-Patient Communications" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.11 Medical Staff {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.11}

Each hospital shall have an organized medical staff that operates under bylaws adopted by the medical staff and approved by the governing body. The bylaws may provide for the exercise of the medical staff's authority through committees.

(a) Organization of the Medical Staff. The medical staff shall be organized and may operate through defined committees as appropriate.

Any physician, podiatrist, or dentist providing patient care, whether directly or by contract with the hospital, shall obtain clinical privileges through the hospital's medical staff credentialing process.
The medical staff shall be responsible for the examination of credentials of any candidate for medical staff membership and for any other individuals seeking clinical privileges and for the recommendations to the governing body concerning appointment of such candidates. Minimum requirements for medical staff appointments and clinical privileges shall include:

(i) Valid and current Georgia license to practice the respective profession;

(ii) Confirmed educational qualifications for the position of appointment;

(iii) References for practice and performance background;

(iv) Current health and mental status sufficient to perform medical and professional duties;

(v) Current Drug Enforcement Agency registration; if applicable;

(vi) Evidence of inquiry through relevant practitioner databases, such as databases maintained by licensing boards and the National Practitioner Data Bank; and

(vii) Congruity of the qualifications and/or training requirements with the privilege requested.

The medical staff shall evaluate at least biennially the credentials and professional performance of any individual granted clinical privileges for consideration for reappointment.
The medical staff shall establish a system for the approval of temporary or emergency staff privileges when needed.

(b) Medical Staff Accountability. The medical staff shall be accountable to the governing body for the quality of medical care provided to all patients.

The medical staff shall require that all individuals granted clinical privileges comply with generally accepted standards of practice.
The medical staff shall implement measures, including peer review, to monitor the on-going performance of the delivery of patient care by those granted clinical privileges, including monitoring of compliance with the medical staff bylaws, rules and regulations, and hospital policies and procedures.
The medical staff shall establish effective systems of accountability for any hospital services ordered by physicians and other practitioners.
The medical staff shall review and, when appropriate, recommend to the governing body denial, limitation, suspension, or revocation of the privileges of any practitioner who does not practice in compliance with the scope of privileges, the medical staff bylaws, rules and regulations, generally accepted standards of practice, or hospital policies and procedures.

(c) Medical Staff Bylaws and Rules and Regulations. The medical staff of the hospital shall adopt and enforce bylaws and rules and regulations which provide for the self-governance of medical staff activities and accountability to the governing body for the quality of care provided to all patients. The bylaws and rules and regulations shall become effective when approved by the governing body and shall include at a minimum:

A mechanism for participation of medical staff in policy decisions related to patient care in all areas of the hospital;
A plan for administrative organization of the medical staff and committees thereof, which clearly delineates lines of authority, delegation, and responsibility for various tasks and functions;
Description of the qualifications and performance to be met by a candidate in order for the medical staff to recommend appointment or reappointment by the governing body;
Criteria and procedures for recommending the privileges to be granted to individual physicians, dentists, or podiatrists;
A requirement that members of the medical staff comply with ethical and professional standards;
Requirements for regular health screenings for all active members of the medical staff that are developed in consultation with hospital administration, occupational health, and infection control/ safety staff. The health screenings shall be sufficient to identify conditions which may place patients or other personnel at risk for infection, injury, or improper care. There shall be a mechanism for the reporting of the screening results to the hospital, either through the medical staff or otherwise;
A mechanism for ensuring physician response to inpatient emergencies twenty-four (24) hours per day;
A mechanism for physician coverage of the emergency department and designation of who is qualified to conduct an emergency medical screening examination where emergency services are provided;
A requirement that referral for consultations will be provided to patients when a patient's physical or mental condition exceeds the clinical expertise of the attending member of the medical staff;
The requirements for the patient's history and physical examination, which must be performed either within twenty-four (24) hours after admission or within the thirty (30) days prior to admission and updated upon admission. See Rule 111-8-40-.28(a)(2) for history and physical requirements when surgery is being performed;
Establishment of procedures for the choice and control of all drugs in the hospital;
The requirements for the completion of medical records;
The requirements for verbal/telephone orders, to include which Georgia-licensed or Georgia-certified personnel or other qualified individuals may receive verbal/telephone orders, and the acceptable timeline for authentication of the orders, not to exceed the timeline requirements of these rules;
A mechanism for peer review of the quality of patient care, which includes, but is not limited to, the investigation of reportable patient incidents involving patient care as described in Rule 111-8-40-.07(2)(a) ; and
A procedure for review and/or update of the bylaws and rules and regulations as necessary, but at least once every three (3) years.

(d) Other Medical Staff Policies. If not addressed through the medical staff bylaws or rules and regulations, the medical staff shall develop and implement policies to address, at a minimum:

Criteria for when an autopsy shall be sought and a requirement that the attending physician be notified when an autopsy is performed; and
A requirement that every member of the medical staff provide appropriate medical care for each of their patients until the patient is stable for discharge or until care of the patient has been transferred to another member of the medical staff or to another facility.

History

Authority: O.C.G.A. §§ 31-7-2.1 and 31-7-15
History. Original Rule entitled "Medical Staff" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.12 Human Resources Management {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.12}

The hospital shall select and organize sufficient qualified and competent personnel to meet patients' needs and in a manner appropriate to the scope and complexity of the services offered.

(a) The hospital shall establish and implement human resources policies and procedures to include at least:

Procedures for selecting qualified personnel;
A system for documenting the current licensure and/or certification status for those personnel whose positions or functions require such licensure or certification;
A system for assessing competency of all personnel providing health care services, on a time schedule defined by hospital policy; and
Policies and procedures regarding the hospital-approved method for identification of personnel to patients, other staff, and visitors.

(b) Written Job Descriptions. The hospital shall have a written description of responsibilities and job duties, with qualification requirements, for each position or job title at the hospital.

(c) Health Screenings. The hospital shall have in place a mechanism and requirement for initial, regular, and targeted health screenings of personnel who are employed or under contract with the hospital or providing patient care services within the hospital setting. The screening shall be sufficient in scope to identify conditions that may place patients or other personnel at risk for infection, injury, or improper care. The health-screening program shall be developed in consultation with hospital administration, medical staff, occupational health, and infection control/safety staff.

(d) Personnel Training Programs. The hospital shall have and implement a planned program of training for personnel to include at least:

Hospital policies and procedures;
Fire safety, hazardous materials handling and disposal, and disaster preparedness;
Policies and procedures for maintaining patients' medical records;
The infection control program and procedures; and
The updating of job-specific skills or knowledge.

(e) Personnel records shall be maintained for each employee of the hospital and shall contain, at a minimum:

The employment application or resume;
Dates of hire and position changes since hiring;
The job or position description(s) for the employee;
All evaluations of performance or competencies for the employee since the date of hire or at least the last five (5) years;
Credible evidence of current registration, licensure, or certification as required for that position by state law;
Evidence of completion of in-service training as required by hospital policy; and
Evidence of completion of any requirements of the occupational health program at the hospital.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Human Resources Management" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.13 Quality Management {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.13}

The governing body shall establish and approve a plan for a hospital-wide quality management program, which includes the use of peer review committees. The purpose of the quality management program is to measure, evaluate, and improve the provision of patient care.

(a) The scope and organization of the quality management program shall be defined and shall include all patient services and clinical support services, contracted services, and patient care services provided by the medical staff.

(b) The hospital's quality management program shall be designed to systematically collect and assess performance data, prioritize data, and take appropriate action on important processes or outcomes related to patient care, including but not limited to:

Operative procedures and other invasive and non-invasive procedures that place patients at risk;
Nosocomial infection rates;
Patient mortality;
Medication use;
Patient injuries, such as, but not limited to, those related to falls and restraint use;
Errors in procedures or practices which could compromise patient safety ("near-miss" events);
Discrepancies or patterns of discrepancies between preoperative and postoperative diagnosis, including those identified during the pathologic review of specimens removed during surgical or invasive procedures;
Significant adverse drug reactions (as identified by the hospital);
Adverse events or patterns of adverse events during anesthesia;
Equipment malfunctions, for equipment used for patient care; and
Reportable patient incidents as required under Rule 111-8-40-.07 .

(c) The quality management program shall utilize a defined methodology for implementation, including at least mechanisms and methodology for:

Performance measurement including consideration of scope of services;
Monitoring, evaluating, and assessing accountability;
Setting priorities;
Root cause analyses, as appropriate, of problems identified;
Process improvement;
Identification of expected outcomes;
Reporting mechanisms; and
Authority for problem resolution.

(d) Results or findings from quality management activities shall be disseminated to the governing body, the medical staff, and any services impacted by the results.

(e) The hospital shall take and document action to address opportunities for improvement identified through the quality management program.

(f) There shall be an on-going evaluation of the quality management program to determine its effectiveness, which shall be presented at least annually for review and appropriate action to the medical staff and governing body.

History

Authority: O.C.G.A. §§ 31-7-2.1 and 31-7-15
History. Original Rule entitled "Quality Management" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.14 Physical Environment {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.14}

The hospital shall be equipped and maintained to provide a clean and safe environment for patients, employees, and visitors.

(a) Safety. The hospital shall develop and implement an effective hospital-wide safety program that includes the following components:

A fire safety program including compliance with the applicable provisions of the Life Safety Code (NFPA 101), as enforced by the state fire marshal;
An incident monitoring system that promptly identifies, investigates, and takes effective action regarding all incidents that involve injury to patients, employees, or visitors or that involve significant damage to property;
A program to inspect, monitor, and maintain biomedical equipment, electrical equipment, and emergency power generators;
A program for the monitoring and maintenance of electrical safety;
Security procedures for controlling access to sensitive areas, as defined by the hospital, for patients, employees, and visitors;
Procedures for the safe management of medical gases;
A system for patients or staff to summon assistance, when needed, from patient rooms, bathrooms, and treatment areas;
Policies regarding smoking which apply to employees, patients, and visitors; and
Procedures for storage and disposal of biohazardous medical waste in accordance with applicable laws.

(b) Cleanliness and Sanitation. The hospital shall maintain an environment that is clean and in good repair, through a program that establishes and maintains:

Standardized daily, interim, and terminal cleaning routines for all areas;
Facilities for convenient and effective hand washing throughout the hospital;
Systems for management of linens, including collection, sorting, transport, and washing of soiled linens, and storage and distribution of clean linens;

(i) Collection and sorting procedures shall be designed to prevent contamination of the environment and personnel. Collection procedures shall include bagging of soiled linen at site of use. Sorting and rinsing of soiled linens shall not take place in patient care areas;

(ii) Clean and soiled linens shall be transported in separate containers or carts;

(iii) The laundering process for soiled linens shall be sufficient to remove organic soil and render the linen incapable of causing human illness; and

(iv) Any soiled linen processing area shall be separate from the area used for clean linen storage, from patient care areas, and from areas where clean or sterilized supplies and equipment are stored;

Standards regarding the use of hospital disinfectants;
Systems for the storage and disposal of garbage, trash, and waste in a manner that will not permit the transmission of disease, create a nuisance, or provide a breeding place for insects or rodents; and
Procedures for the prevention of infestation by insects, rodents, or other vermin or vectors.

(c) Light, Temperature, and Ventilation. The hospital shall provide adequate lighting, ventilation, and control of temperature and air humidity for optimal patient care and safety of the hospital's patients and staff and shall monitor and maintain such systems to function at least minimally to the design standards current at the time of approved facility construction or renovation.

(d) Space. The hospital shall provide sufficient space and equipment for the scope and complexity of services offered.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Physical Environment" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.15 Disaster Preparedness {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.15}

The hospital shall prepare for potential emergency situations that may affect patient care by the development of an effective disaster preparedness plan that identifies emergency situations and outlines an appropriate course of action. The plan must be reviewed and revised annually, as appropriate, including any related written agreements.

(a) The disaster preparedness plan shall include at a minimum plans for the following emergency situations:

Local and widespread weather emergencies or natural disasters, such as tornadoes, hurricanes, earthquakes, ice or snowstorms, or floods;
Manmade disasters such as acts of terrorism and hazardous materials spills;
Unanticipated interruption of service of utilities, including water, gas, or electricity, either within the facility or within a local or widespread area;
Loss of heat or air conditioning;
Fire, explosion, or other physical damage to the hospital; and
Pandemics or other situations where the community's need for services exceeds the availability of beds and services regularly offered by the hospital.

(b) There shall be plans to ensure sufficient staffing and supplies to maintain safe patient care during the emergency situation.

(c) There shall be plans for the emergency transport or relocation of all or a portion of the hospital patients, should it be necessary, in vehicles appropriate to the patient's condition(s) when possible, including written agreements with any facilities which have agreed to receive the hospital's patients in these situations.

(d) The hospital shall document participation of all areas of the hospital in quarterly fire drills.

(e) In addition to fire drills, the hospital shall have its staff rehearse portions of the disaster preparedness plan, with a minimum of two (2) rehearsals each calendar year either in response to an emergency or through planned drills, with coordination of the drills with the local Emergency Management Agency (EMA) whenever possible.

(f) The plan shall include the notification to the Department of the emergency situation as required by these rules.

(g) The hospital shall provide a copy of the internal disaster preparedness plan to the local Emergency Management Agency (EMA) and shall include the local EMA in development of the hospital's plan for the management of external disasters.

(h) The hospital's disaster preparedness plan shall be made available to the Department for inspection upon request.

(i) The Department may suspend any requirements of these rules and the enforcement of any rules where the Governor of the State of Georgia has declared a public health emergency.

History

Authority: O.C.G.A. §§ 31-7-2.1, 31-7-3 and 31-12-2.1
History. Original Rule entitled "Disaster Preparedness" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.16 Infection Control {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.16}

The hospital shall have an effective infection control system to reduce the risks of nosocomial infections in patients, health care workers, volunteers, and visitors.

(a) The hospital shall designate qualified infection control staff to coordinate the infection control program.

(b) The administrative and medical staff of the hospital, as well as staff from appropriate organized services, shall participate in the infection control program.

(c) The infection control program shall function from a well-designed surveillance plan that is based on accepted epidemiological principles, is tailored to meet the needs of the hospital, and includes both outcome and process surveillance methodologies.

(d) The surveillance plan shall require collection of sufficient baseline data on the incidence of nosocomial infections in order that outbreaks can be identified.

(e) The infection control methodologies for effective investigation and control of outbreaks, once identified, shall include at least:

The availability of microbiology laboratory capacity to detect and investigate outbreaks;
A system for obtaining appropriate clinical specimens for culture;
Access to necessary information in order to investigate infectious outbreaks; and
Administrative, physician, and nursing support to direct hospital changes to achieve immediate control of outbreaks and for implementation of corrective actions.

(f) The program shall specify policies and procedures for infection control that apply to all areas of the hospital, and these shall include at least the following:

The approved hospital isolation system;
The approved procedures for handling and disposing of hazardous waste products;
The standards for approved cleaning, disinfection, and sterilization of all areas of the hospital;
The standards for hand washing and hand antisepsis; and
A communicable disease health-screening plan for the hospital that includes required communicable disease activities, immunizations, exposure evaluations, tuberculosis surveillance, and work restrictions. There shall be evidence that the plan was developed in consultation with hospital administration, medical staff, and safety staff.

(g) The infection control program shall have an organized and effective on-going education plan for hospital health care workers and volunteers that includes at least:

An orientation plan;
A plan for on-going training on isolation precautions, aseptic practices, and prevention of blood and body fluid exposure; and
Provision of specially designed training programs that result from outcome and process surveillance data.

(h) The hospital shall designate which departments are responsible for the reporting of communicable diseases as required by law.

(i) The infection control program shall be evaluated at least annually to determine the effectiveness of the program at lowering the risks and improving the trends of nosocomial infections in patients, health care workers, and volunteers. Changes in the infection control program shall reflect consideration of the results of the evaluations.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Infection Control" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.17 Sterile Processing Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.17}

Each hospital shall designate a sterile processing service area designated for the decontamination, cleaning, sterilizing of reusable equipment, instruments, and supplies.

(a) With the collaboration of the infection control program, the staff providing sterile processing services shall develop and implement standardized policies and procedures that conform to generally accepted standards of practice for:

Decontamination and cleaning of instruments and other items and description of reprocessing protocols for contaminated patient equipment;
Disinfecting and/or sterilizing equipment and other items;
Monitoring of the systems used for sterilization;
Procedures for ensuring the sterility of packaged instruments and supplies;
Recall of items; and
Mechanisms for protection of workers from exposure to blood and other potentially infectious materials and environmental hazards.

(b) The sterile processing service shall be staffed by qualified personnel.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Sterile Processing Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.18 Medical Records {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.18}

(1) Management of Patients' Medical Records. The hospital shall have an efficient and organized medical records service that establishes the policies and procedures for the maintenance of the medical records for all patients and that is administratively responsible for the management of those records.

(a) The medical records service shall maintain a list of accepted abbreviations, symbols, and medical terminology to be utilized by persons making entries into patients' medical records.

(b) The medical records service shall utilize systems to verify the author(s) of entries in the patients' medical records. Delegation of use of computer codes, signature stamps, or other authentication systems, to persons other than the author of the entry, is prohibited.

(c) The hospital shall utilize systems defined by hospital policies and procedures to ensure that patients' medical records are kept confidential. Medical records shall be accessible only to hospital and medical staff involved in treating the patient and to other individuals as permitted by federal and state laws. The Department, in exercising its licensing authority, shall have the right to review and copy any patients' medical records.

(d) At any time during or after their course of treatment, patients shall be provided with copies of their medical records upon their written requests or the written requests of their authorized representatives in accordance with state law. Copies shall be provided within a reasonable time period not to exceed thirty (30) days after the request, unless the patient agrees to a lengthier delivery time. Copies of records shall be provided to patients for a reasonable fee in accordance with applicable laws.

(e) Copies of the patient's medical records shall be released to persons other than the patient or the patient's legally authorized representative either at the written request of the patient or as otherwise allowed by law. If the individual designated to receive a copy of the record is a health care provider, the copy of the record shall be released by the hospital in a timely manner so as not to interfere with the continuation of the patient's treatment.

(f) Patients' medical records shall be coded and indexed in a manner that allows for timely retrieval by diagnosis or procedure when necessary.

(g) The hospital shall utilize an effective process to ensure that patients' medical records are completed within thirty (30) days after the patients are discharged from the hospital. Records of other parts of patients' records that are not within the control of the hospital or its medical staff shall be added to the patients' records as soon as they become available to the hospital.

(h) The hospital shall retain all patients' medical records at least until the fifth anniversary of the patients' discharges. If the patient is a minor, the records must be retained for at least five (5) years past the age of majority. Records may be preserved in the hospital's format of choice, including but not limited to paper or electronic format, so long as the records are readable and capable of being reproduced in paper format upon request.

(i) Medical records shall be secured in such a manner as to provide protection from damage or unauthorized access.

(2) Entries in the Medical Record. All entries in the patient's medical records shall be accurate and legible and shall contain sufficient information to support the diagnosis and to describe the treatment provided and the patient's progress and response to medications and treatments. Inpatient records shall also contain sufficient information to justify admission and continued hospitalization.

(a) The date of the entry and the signature of the person making the entry, shall accompany all entries in the patient's medical record. Late entries shall be labeled as late entries.

(b) The hospital, through its medical staff policies, shall appropriately limit the use of verbal/telephone orders. Verbal/telephone orders shall be used only in situations where immediate written or electronic communication is not feasible and the patient's condition is determined to warrant immediate action for the benefit of the patient. Verbal/telephone orders shall be received by an appropriately license or otherwise qualified individual as determined by the medical staff in accordance with state law.

(c) The individual receiving the verbal/telephone order shall immediately enter the order into the medical record, sign and date the order, with the time noted, and, where applicable, enter the dose to be administered.

(d) The individual receiving the order shall immediately repeat the order and the prescribing physician or other authorized practitioner shall verify that the repeated order is correct. The individual receiving the order shall document, in the patient's medical record, that the order was "repeated and verified."

(e) The verbal/telephone order shall be authenticated by the physician or other authorized practitioner giving the order, or by a physician or other authorized practitioner taking responsibility for the order, in accordance with hospital and medical staff policies.

Where the procedures outlined in subparagraph (2)(d) of this rule are followed, the hospital shall require authentication of all verbal/telephone orders no later than thirty (30) days after the patient's discharge.
As an alternative to meeting the requirements set forth in subparagraph (2)(d) of this rule, the hospital shall require that verbal/ telephone orders be authenticated within forty-eight (48) hours, except where the patient is discharged within forty-eight (48) hours of the time the verbal/telephone order was given, in which case authentication shall occur within thirty (30) days after the patient's discharge.

(f) The hospital's quality improvement plan shall include monitoring of the appropriate use of verbal/telephone orders in accordance with these rules and hospital policy and taking appropriate corrective action as necessary.

(3) Minimum Requirements for Patients' Medical Records. Upon completion, medical records for inpatients and outpatients shall contain, at minimum, the documents as specified below. Records for patients at the hospital for other specialized services, such as emergency services or surgical services, shall contain such additional documentation as required for those services.

(a) Inpatient Records. Medical records for inpatients shall contain at least the following:

A unique identifying number and a patient identification form, which includes the following when available: name, address, date of birth, sex, and person to be notified in an emergency;
The date and time of the patient's admission;
The admitting diagnosis and clinical symptoms;
The name of the attending physician;
Any patient allergies;
Documentation regarding advanced directives;
The report from the history and physical examination;
The report of the nursing assessment performed after admission;
Laboratory, radiological, electrocardiogram, and other diagnostic assessment data or reports as indicated;
Reports from any consultations;
The patient's plan of care;
Physician's orders or orders from another practitioner authorized by law to give medical or treatment orders;
Progress notes from staff members involved in the patient's care, which describe the patient's response to medications, treatment, procedures, anesthesia, and surgeries;
Data, or summary data where appropriate, from routine or special monitoring;
Medication, anesthesia, surgical, and treatment records;
Documentation that the patient has been offered the opportunity to consent to procedures for which consent is required by law;
Date and time of discharge;
Description of condition, final diagnosis, and disposition on discharge or transfer;
Discharge summary with a summary of the hospitalization and results of treatment; and
If applicable, the report of autopsy results.

(b) Outpatient Records. Medical reports for outpatients shall contain at least the following:

A unique identifying number and a patient identification form, which includes the following if available: name, address, date of birth, sex, and person to be notified in an emergency;
Diagnosis of the patient's condition;
The name of the physician ordering treatment or procedures;
Patient allergies;
Physician's orders or orders from another practitioner authorized by law to give medical or treatment orders as applicable;
Documentation that the patient has been offered the opportunity to consent to procedures for which consent is required by law;
Reports from any diagnostic testing; and
Sufficient information to justify any treatment or procedure provided, report of outcomes of treatment or procedures, and, as appropriate, progress notes and the disposition of the patient after treatment.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Medical Records" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.19 Patient Assessment and Treatment {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.19}

All patient care services provided by the hospital shall be under the direction of a member of the medical staff or a licensed physician, dentist, osteopath, or podiatrist who has been granted hospital privileges.

(a) Patient Assessment/Screening on Admission. The hospital shall provide each inpatient with an appropriate assessment of the patient's condition and needs at the time of admission. Such assessments shall be provided by personnel authorized by hospital policy or the medical staff bylaws and/or rules and regulations and shall be designed to trigger referral for further assessment needs.

A history and physical examination shall be completed within the first twenty-four (24) hours after admission. A history and physical examination completed by either the patient's physician or the appropriate practitioner operating under the direction of the physician as authorized by law no more than thirty (30) days prior to the admission may be accepted but must be updated to reflect the patient's condition at the time of admission. Where the patient is admitted solely for oromaxillofacial surgery, such history and physical may be completed by the oromaxillofacial surgeon.
A basic nursing assessment to include at least evaluation of physical and psychological status sufficient to develop an initial plan of care shall be completed within the first twelve (12) hours after admission. Within twenty-four (24) hours after admission, a comprehensive nursing assessment will be completed to include at least:

(i) Screening and referral for further assessment of patient needs related to social, nutritional, and functional status; and

(ii) Screening of educational and potential post-hospitalization needs.

Inquiry as to the status of any advance directives for the patient shall be made at the time of admission.

(i) If a patient has an advance directive in place that the patient wishes to invoke, but the written directive is not available at the time of admission, there shall be a mechanism in place to trigger a recheck by hospital personnel for the document within a reasonable period of time.

(ii) If the patient does not have an advance directive in place, admissions procedures shall require that designated hospital personnel will offer information regarding advance directives according to hospital policy and timelines.

(b) Patient's Plan of Care.

On admission, the plan of care shall be initiated by the designated hospital staff for each patient to meet the needs identified by the initial assessments. The initial plan of care shall be placed in the patient's record within twelve (12) hours of admission.
As the patient's treatment progresses, the plan of care shall be updated to reflect any changes necessary to address new or changing needs.

(c) Reassessments of the Patient's Condition. Reassessment of the patient's condition shall be performed periodically at appropriate intervals and defined in hospital policy. In addition, reassessments shall occur at least as follows:

During and following an invasive procedure;
Following a change in the patient's condition or leve l of care;
During and following the administration of blood and blood products;
Following any adverse drug reaction or allergic reaction; and
During and following any use of physical restraints or seclusion.

(d) Other Treatment Requirements.

All patients shall be given the opportunity to participate, or have a designated representative participate, in decisions regarding their care.
Patients shall be provided treatment free from physical restraints or involuntary seclusion, unless utilized solely for protection during brief transport to a specified destination or authorized by a physician's order, for a limited period of time, to protect the patient or others from injury. Policies and procedures shall be in place to require that a patient's physical comfort and safety needs are addressed during any period of required physical restraint or confinement. A positioning or securing device used to maintain the position, limit mobility, or temporarily immobilize during medical, dental, diagnostic, or surgical procedures is not considered a restraint.
Patients shall receive care in a manner free from all forms of abuse or neglect.
Patients shall receive treatment in an environment that respects their personal privacy, both of their physical person and their treatment information.
The hospital shall establish and enforce policies and procedures that require that all personnel providing direct care to the patient identify themselves to the patient by name and title or function.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Patient Assessment and Treatment" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.20 Discharge Planning and Transfers for Inpatients {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.20}

The hospital shall utilize an effective and on-going discharge planning process that identifies post-hospital needs of inpatients and arranges for appropriate resource referral and follow-up care.

(a) On admission, the nursing assessment shall identify patients who are likely to suffer adverse consequences upon discharge in the absence of adequate discharge planning.

(b) For those patients identified as needing a discharge plan, designated qualified staff shall complete an evaluation of post-hospital needs and shall develop a plan for meeting those needs. The discharge plan shall be revised as needed with changes in the patient's condition.

(c) The hospital shall provide education to patients, and their family members or interested persons as necessary or as requested by the patient, to prepare them for the patient's post-hospital care.

(d) The hospital shall arrange for the initial implementation of any discharge plan, including, as applicable, any transfer or referral of the patient to appropriate facilities, agencies, or outpatient services for follow-up or ancillary care. The hospital shall be responsible for the transfer of any necessary medical information to other facilities for the purpose of post-hospital care.

(e) The hospital shall regularly reassess the discharge planning process to ensure that it is responsive to patients' discharge needs.

(f) The hospital shall adopt and enforce a policy requiring annually during influenza season (inclusive of at least October 1st through March 1st) and prior to discharge, any inpatient 65 years of age or older shall be offered vaccinations for the influenza virus and pneumococcal disease unless contraindicated and contingent on availability.

The hospital policy may authorize such vaccinations to be administered per hospital medical staff approved standing order and protocol following an assessment for contraindications.
The hospital policy must also require the inpatient's medical record, where such vaccination is administered, to contain an assessment for contraindications, the date of such administration and patient response.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Discharge Planning and Transfers for Inpatients" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.21 Nursing Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.21}

The hospital shall have an organized nursing service that provides twenty-four (24) hour nursing care to meet the needs of patients. Critical access hospitals are exempted from providing on-site twenty-four (24) hour nursing care when there are no hospitalized patients.

(a) Organization of Nursing Services. The hospital's nursing services shall be directed by a licensed registered nurse who shall be responsible for implementing a system for supervision and evaluation of nursing clinical activities.

The chief nurse executive shall establish and implement policies and procedures for nursing services based on generally accepted standards of practice including the evaluation of the effectiveness of the services in coordination with the hospital's quality management program.
The chief nurse executive shall be responsible for ensuring that nursing personnel are oriented to nursing policies and procedures.
Nursing services shall have and follow a written plan for organization, administrative authority, delineation of responsibilities for patient care, and staff qualifications and competencies.

(i) The nursing service plan shall include the types and numbers of nursing personnel necessary to provide appropriate nursing care for each patient in the hospital.

(ii) Specialty areas shall specify nursing requirements for their areas that also define any special nursing competency requirements, staffing patterns based on patient acuity, and the required ratio of nurses to technical staff.

(iii) A system of patient assignment shall be defined which reflects a consideration of patient needs and nursing staff qualifications and competencies.

(b) Delivery of Nursing Services. Nursing services must be delivered in accordance with patients' needs and generally accepted standards of practice.

A license registered nurse must be on duty at all times to provide or supervise the provision of care. Critical access hospitals are permitted some flexibility in meeting this requirement as set forth in Rule 111-8-40-.38 .
Within the first twelve (12) hours after admission, a basic nursing assessment shall be completed for each patient and a plan of care initiated.
The patient's condition shall be monitored by nursing staff on a schedule appropriate to the patient's needs.
Nursing staff shall be responsible for updating the patient's plan of care based on any changes in the patient's condition.
Nursing staff administering drugs and biologicals shall act in accordance with the orders from the medical staff responsible for the patient's care, generally accepted standards of practice, and any federal and state laws pertaining to medication administration.
Nursing staff shall report medication administration errors and adverse drug reactions in accordance with established hospital policies.
Blood transfusions and other blood products shall be administered by licensed nursing staff or other qualified practitioners as authorized by law in accordance with established hospital policies, which shall include, at a minimum, the following:

(i) Obtaining and documenting appropriate patient consent to treatment and procedures, as required;

(ii) Responding to and reporting of transfusion reactions;

(iii) Monitoring patients appropriately; and

(iv) Designating personnel qualified to perform these procedures.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Nursing Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.22 Pharmaceutical Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.22}

The hospital shall provide or have access to effective pharmaceutical services to meet the needs of its patients in accordance with generally accepted standards of practice and applicable laws and regulations.

(a) Pharmacy Director. All pharmaceutical services in the hospital shall be under the direction of a pharmacist licensed in Georgia. The responsibilities of the director of pharmaceutical services shall include:

Developing, supervising, and coordinating all activities of the pharmaceutical service to be in compliance with state rules and regulations for hospital pharmacies including the evaluation of the effectiveness of the services in coordination with the hospital's quality management program; and
Developing and implementing an effective system that does the following:

(i) Minimizes drug errors and identifies potential drug interactions and adverse drug reactions;

(ii) Controls the availability and storage of drugs throughout the hospital;

(iii) Distributes and administers the drugs in compliance with generally accepted standards of practice;

(iv) Tracks the receipt and disposition of all scheduled drugs;

(v) Staffs pharmaceutical services to provide sufficient qualified personnel to respond to the pharmaceutical needs of the patient population being served, including twenty-four (24) hours per day, seven (7) days per week emergency coverage;

(vi) Labels and dispenses drugs, including a requirement that only licensed pharmacists or properly supervised licensed pharmacy interns are permitted to compound, label, and dispense drugs or biologicals;

(vii) Manages drug recalls;

(viii) Addresses the removal of drugs when a pharmacist is not available;

(ix) Compiles and reports data related to drug ordering; dispensing and administration errors, and possible adverse drug reaction to the hospital's quality management program; and

(x) Reviews all activities and functions of the hospital's pharmaceutical services.

(b) Management of Drugs. The pharmacist shall be responsible for the management of drugs within the hospital.

The hospital's pharmaceutical services shall access, compile, and make available to medical and professional staff information relating to drug or food interactions, drug therapy, side effects, toxicology, dosage indicators, and routes of administration.
Loss and theft of controlled substances shall be reported to the pharmacy director, to the hospital administration, and to others as required by applicable laws and regulations.
All drugs and pharmaceuticals shall be stored in an area or on a cart which shall be locked when unattended to prevent access by unauthorized individuals.
Outdated, mislabeled, or otherwise unusable drugs and pharmaceuticals shall not be available for patient use.
Certain drugs and pharmaceuticals not specifically prescribed as to limitation of time or number of doses shall be automatically discontinued after a specified time pursuant to guidelines developed by the medical staff in conjunction with the pharmacy director.
Drug administration errors, adverse drug reactions, and drug incompatibilities shall be immediately reported in a timely manner to the attending physician and the pharmacist.
Drugs brought into the hospital by a patient may be administered to the patient only if the medications can be accurately identified, properly stored and secured, and ordered by the attending physician for the patient's hospitalization. If the drugs cannot be administered to the patient, the drugs shall be returned to an adult member of the patient's immediate family or returned to the patient upon discharge unless otherwise prohibited by law.

History

Authority: O.C.G.A. §§ 16-4-77, 16-13-20et seq. and 31-7-2.1
History. Original Rule entitled "Pharmaceutical Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.23 Food and Dietary Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.23}

The hospital shall have an organized food and dietary service that is directed and staffed by an adequate number of qualified personnel to meet the nutritional needs of hospital patients. All hospital food service areas and operations shall comply with current federal and state laws and rules concerning food service.

(a) Organization of Food and Dietary Services.

Food Service Manager. The hospital shall have a manager of food and dietary services who has training and experience in management of a food service system in a health care setting and receives on-going training. The responsibilities of the manager shall include:

(i) Overall coordination and integration of the therapeutic and administrative aspects of the service;

(ii) Development and implementation of policies and procedures concerning the scope and conduct of dietary services, including food preparation and delivery systems;

(iii) Orientation and training programs for dietary service personnel and other hospital personnel involved in food delivery on all applicable dietary services policies and procedures, including personal hygiene, safety, infection control requirements, and proper methods of waste disposal;

(iv) The implementation of a system to ensure that prescribed diets are delivered to the correct inpatients;

(v) Maintenance of a staff of sufficient numbers of administrative and technical personnel competent in their assigned duties to carry out the dietary service program;

(vi) Procurement of food, paper, chemical, and other supplies sufficient to meet the anticipated food service needs of the hospital; and

(vii) Implementation of procedures to rotate all food items to ensure use in a timely manner.

Dietitian. Clinical supervision of the hospital's dietary service shall be provided by a dietitian on a full-time, part-time, or consultant basis, as determined by the needs of the hospital. If supervision by the dietitian is provided by a contractual arrangement or on a consultation basis, such services shall occur at least once per month for not less than eight hours. The dietitian shall be responsible for:

(i) Evaluation of inpatients' nutritional status and needs. If the admission screening identifies that an inpatient may be nutritionally at risk, the follow-up evaluation by the dietitian must be performed within twenty-four (24) hours of determination of the need for evaluation of the patient;

(ii) Review and approval of all menus, including menus for therapeutic or prescribed diets;

(iii) Participation in the development, revision, and review of policies and procedures for dietary services;

(iv) Guidance to the manager of dietary services and to the staff of the service on methods for maintaining nutritionally balanced meals that meet the needs of each patient and in maintaining sanitary dietary practices; and

(v) Appropriate documentation in the inpatients' medical records of any evaluation of nutritional status or needs.

(b) Physical Environment Requirements for Food Service Areas. The hospital shall provide adequate space, equipment, and supplies for efficient, safe, and sanitary receiving, storage, refrigeration, preparation, and service of food. The physical environments for food service activities must meet the requirements of state regulations for food service.

(c) Delivery of Dietary Services. Dietary services shall be delivered in accordance with the nutritional needs of the hospital's patients.

There shall be a mechanism in place for the evaluation of nutritional needs for inpatients identified during admission as needing further assessment. The mechanism shall require that such evaluations be completed promptly, with modifications to patients' diets, if any, recorded in the patients' medical records within twenty-four (24) hours of notification of the need for the evaluation.
A current therapeutic diet manual, approved by the dietitian and medical staff, shall be readily available to all medical, nursing, and dietary service personnel.
Therapeutic diets shall be prescribed by the member of the medical staff responsible for the care of the inpatient.
A written order for the modified diet prescription as recorded in the inpatient's medical record shall be readily available to dietary service personnel throughout the duration of the order.
When clinically indicated, the dietary staff shall provide education for inpatients regarding their diets and nutritional needs. This training shall be documented in the inpatients' medical records.
Unless medically contraindicated, at least three (3) meals a day shall be provided for inpatients, with no more than fifteen (15) hours elapsing between dinner and breakfast.
There shall be a system for providing means for inpatients outside the normal meal service hours, when necessary.
A system for meal requisition shall be in place and shall require a notation regarding the inpatients' food allergies, if any.
Snacks shall be available between meals and at night, as appropriate to each patient's needs and medical condition.
The dietary service shall follow policies and procedures approved by the medical staff for the management of possible food and drug interactions.
Pertinent observations and information related to special diets, the inpatients' food habits, and response to dietetic treatment or diet modifications shall be recorded in the inpatients' medical records.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Food and Dietary Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.24 Imaging and Therapeutic Radiology Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.24 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.24}

(1) Imaging Services. The hospital shall maintain or arrange for effective imaging services to meet the needs of patients. The radiological imaging services shall be provided by the hospital in accordance with the rules under Chapter 111-8-90 Rules and Regulations for X-rays, where applicable.

(a) Organization and Staffing for Imaging Services. The hospital shall have an organizational plan for imaging services that identifies the scope of the services provided and the qualifications of the individuals necessary for the performance of various aspects of imaging services and delineates the lines of authority and accountability.

There shall be a qualified director of imaging services who is a member of the medical staff and a licensed doctor of medicine or osteopathy with knowledge and experience in imaging services to supervise the provision of imaging services on a full-time or part-time basis.
The director shall be responsible for all clinical aspects of the organization and delivery of imaging services, including the evaluation of the effectiveness of the services in coordination with the hospital's quality management program.
Basic radiological imaging services shall be available at all times, or there shall be an on-call procedure to provide access to qualified x-ray personnel within thirty (30) minutes.
The hospital shall have qualified staff performing imaging services.

(b) Orders of Imaging Procedures. No imaging procedures, except screening mammograms, shall be performed without an order or referral from a licensed doctor of medicine or osteopathy, chiropractor, dentist, podiatrist, physician assistant or nurse with advanced training where such order is in conformity with an approved job description or nurse protocol, and as authorized under state law for such licensed healthcare professionals.

(c) Verbal/telephone orders for imaging services shall be given only to health care professionals licensed or certified by state law or authorized by medical staff rules and regulations and other hospital policy to receive those orders, in accordance with these rules, and shall be entered into the patient's medical record by those licensed, certified, or authorized health care professionals.

(2) Reports of Imaging Interpretations. Interpretation of imaging test results or procedures shall be made only by those medical staff designated as qualified to interpret those tests or procedures. Interpretations must be signed and dated by the medical staff providing the interpretation.

(a) Reports of all imaging interpretations and consultations shall be included in the patient's medical record.

(b) The hospital shall have an effective procedure for notifying in a timely manner the patient's physician and responsible nursing staff of critical interpretations identified through imaging tests.

(c) Films, scans, and other images shall be retained by the hospital for at least five years after the date of the procedure unless the release of the original images is required for the care of the patient. When original images are released, documentation of the disposition of the original images shall be retained for the applicable five-year period. If the patient is a minor, the records shall be retained for at least five years past the age of majority.

(3) Therapeutic Radiology Services. Radiation oncology services, if provided, must be directed by a physician with training and experience in therapeutic radiology. The service must have a medical oncologist and hematologist available for consultation.

(a) Therapeutic radiology procedures shall be ordered by a licensed Doctor of Medicine or osteopathy and administered by persons trained and qualified for those procedures and as required under current state law and regulations.

(b) Reports of all imaging interpretations, consultations, and therapies shall be included in the patient's medical record.

(c) Radiation Safety. If the hospital is providing diagnostic or therapeutic radiological services, hospital policies and procedures shall be implemented to ensure that patients and hospital staff are not exposed to unnecessary or unsafe levels of radiation. All imaging staff and therapeutic radiology staff shall be trained in these policies and procedures.

(d) Medical Emergencies. The hospital shall have written protocols for managing medical emergencies in the imaging area and therapeutic radiology area.

(e) Infectious Disease. The hospital shall have written protocols for managing patients with infectious diseases and critical care patients in the imaging area, or wherever imaging services are provided, and in the therapeutic radiology area.

History

Authority: O.C.G.A. §§ 31-7-2.1, 31-13-1et seq
History. Original Rule entitled "Imaging and Therapeutic Radiology Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Feb. 18, 2025; eff. Mar. 10, 2025.

Ga. Comp. R. & Regs. r. 111-8-40-.25 Laboratory Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.25 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.25}

The hospital shall maintain or arrange for clinical laboratory services to meet the needs of hospital patients.

(a) Organization and Staffing for Clinical Laboratory Services. The administration, performance, and operation of all laboratories used by the hospital, as well as any laboratory functions performed by the hospital, shall conform to the Rules and Regulations for Licensure of Clinical Laboratories, Chapter 111-8-10.

The hospital shall have an organizational plan for laboratory services that identifies the scope of the services provided and the qualifications of the individuals necessary for the performance of various aspects of clinical laboratory services and delineates the lines of authority and accountability.
There shall be a qualified director of clinical laboratory services who is a member of the medical staff and meets the requirements for a director set forth in the Rules and Regulations for Clinical Laboratories, Chapter 111-8-10.
The director shall be responsible for the administration of clinical laboratory services, including the evaluation of the effectiveness of the services in coordination with the hospital's quality management program.

(b) The hospital shall have emergency laboratory services available at all times.

(d) Reports of laboratory procedures and results shall be included in the patient's medical record.

(e) The hospital shall have an effective procedure for notifying in a timely manner the patient's physician and responsible nursing staff of critical values from laboratory tests.

(f) The hospital shall require that the laboratory report any epidemiologically significant pathogens to the hospital's infection control program.

(g) Tissue Pathology. Hospitals which provide surgery services shall have or arrange for tissue pathology services through a licensed or certified clinical laboratory which has a system for:

Designation of those tissue specimens which require examination and for procedures for maintaining a tissue file; and
Directing pathology reports to the patient's medical record and for reporting unusual or abnormal results to the attending physician in a timely manner.

History

Authority: O.C.G.A. Ch. 31-22, Sec. 31-7-2.1
History. Original Rule entitled "Laboratory Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.26 Respiratory/Pulmonary Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.26 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.26}

The hospital shall provide or arrange for effective services to meet the respiratory/ pulmonary needs of patients and shall define in writing the scope and complexity of the respiratory/pulmonary services offered by the facility.

(a) Organization and Staffing of Respiratory/Pulmonary Services.

The hospital shall have an organizational plan for respiratory/ pulmonary services that clearly defines the necessary staff for the services and the lines of authority and accountability.
Director. There shall be a qualified director of respiratory/pulmonary services who is a member of the medical staff and a licensed doctor of medicine or osteopathy with knowledge, experience, and capability to supervise the services on a full-time or part-time basis including the evaluation of the effectiveness of the services in coordination with the hospital's quality management program.

(i) The director shall be responsible for all clinical aspects of the organization and delivery of clinical respiratory care services, including the evaluation of the effectiveness of the services in coordination with the hospital's quality management program.

(ii) The director shall be responsible for the development, implementation, and periodic review of policies, procedures, and protocols for respiratory/pulmonary care, which shall reflect the scope of services offered, including at least:

(I) Routine inspection, cleaning, and maintenance procedures for respiratory equipment, as well as protocols for their assembly and operation;

(II) Adverse reaction protocols;

(III) Safety practices and interventions;

(IV) Staff participation in emergency situations at the facility;

(V) Infection control procedures;

(VI) Procedures for handling, storage, and dispensing of therapeutic gases;

(VII) Procedures for obtaining blood samples and analysis of samples, as applicable;

(VIII) Procedures for testing of pulmonary function, as applicable;

(IX) Procedures for therapeutic percussion and vibration and for broncho-pulmonary drainage, as applicable;

(X) Procedures for mechanical ventilation and oxygenation support and for administration of aerosol, humidification, and therapeutic gases, as applicable;

(XI) Policies for administration of medications;

(XII) A system for the reissuing and discontinuing of respiratory therapy orders; and

(XIII) Procedures for verbal/telephone orders taken by state-certified respiratory care professionals.

There shall be a sufficient number of qualified competent professionals and support personnel to respond to and meet the respiratory/ pulmonary care needs of the patients.

(b) Delivery of Respiratory/Pulmonary Services. Respiratory/ Pulmonary services shall be delivered in accordance with the needs of the patients.

Respiratory services shall be provided only in response to medical orders. Medical orders for services shall include the modality to be used, the type, frequency, and duration of treatment, and the type and dose of medications, including dilution ratios. Verbal/telephone orders for respiratory service shall be dated, timed, and given only to appropriately licensed or otherwise qualified individuals as determined by the medical staff in accordance with state law and these rules and shall be entered into the patient's medical record by those appropriately licensed or otherwise qualified individuals.
The hospital shall provide equipment and supplies sufficient to support the scope of the respiratory services offered.
All respiratory care services provided shall be documented in the patient's medical record, including the type of therapy, date and time of administration, effects of therapy, and any adverse reactions.
If blood gases or other clinical laboratory tests are performed by respiratory care staff, those staff shall have demonstrated competency in the administration of the tests as point-of-care technicians.

History

Authority: O.C.G.A. Ch. 31-22, Sec. 31-7-2.1
History. Original Rule entitled "Respiratory/Pulmonary Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.27 Organ, Tissue, and Eye Procurement and Transplantation {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.27 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.27}

The hospital shall participate, as appropriate, in the procurement of anatomical gifts.

(a) Receipt of Donations. The hospital shall receive donations of organs or tissues for the purposes of medical and dental education, research, advancement of medical or dental science, therapy, or transplantation only in accordance with the provisions of the "Georgia Anatomical Gift Act," O.C.G.A. Section 44-5-140 , and the applicable rules of Chapter 111-8-5.

(b) Voluntary Expression of Intent to Donate. The hospital shall establish and implement policies and procedures for documenting requests by patients regarding their intentions for disposition of their bodies or organs and for seeing that these expressed intentions are honored upon death when possible.

(c) Hospital Requests for Anatomical Gifts. The hospital shall establish and implement policies and procedures for requesting anatomical gifts on or before the occurrence of death in the absence of a patient's expressed intentions.

Policies and procedures shall provide for a written agreement(s) with an organ bank or storage facility with the provisions specified in Rules for Anatomical Gifts, Chapter 111-8-5-.07 , and provisions for the training of staff authorized to request the gifts, when applicable.
Where the hospital does not have the Organ Procurement Organization handle requests for anatomical gifts, the hospital shall designate staff authorized to make requests for anatomical gifts, and such staff shall be appropriately trained in the following areas:

(i) Psychological and emotional considerations when dealing with bereaved families;

(ii) Social, cultural, ethical, and religious factors affecting attitudes toward donations;

(iii) General medical concepts and issues in organ, tissue, and eye donations;

(iv) Procedures for declaring death and collecting and preserving organs, tissues, and/or other body parts and for how these procedures are to be explained to decedents' families;

(v) Procedures for notifying and involving banks or storage facilities; and

(vi) procedures for recording the outcomes of requests.

If the hospital engages in harvesting tissue and/or transplanting organs and tissues from living donors, the hospital shall develop a living donor organ/transplants policy that addresses the issues related to such donations.

(d) Physicians Participating in the Removing or Transplanting of Organs or Tissues. Where the medical staff participates in organ recovery, the hospital shall designate which medical staff members may not participate in the procedures for removing and transplanting of organs and body parts in accordance with the Rules for Anatomical Gifts, Chapter 111-8-5-.08 .

History

Authority: O.C.G.A. §§ 31-7-2.1 and 44-5-140
History. Original Rule entitled "Organ, Tissue, and Eye Procurement and Transplantation" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.28 Surgical Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.28 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.28}

If the hospital provides surgical services, the services shall be provided in a manner which protects the health and safety of the patients and follows current accepted standards of medical and surgical practice. Personnel, equipment, policies and procedures, and the number of operating rooms shall be appropriate for the scope of services offered.

(a) Organization of Surgical Services. The hospital shall have an organizational plan which defines lines of authority, responsibility, and accountability within all operating room areas where surgical procedures are performed.

There shall be a current roster of surgical privileges granted each medical staff member available to nursing and scheduling staff in the surgical services area(s).
The hospital shall have bylaws, rules, or policies and procedures developed by the medical staff which require that within twenty-four (24) hours prior to surgery either a history and physical examination or an update of a previous history and physical is completed for every surgical patient. Where an update is used, the previous history and physical examination must not have occurred more than thirty (30) days prior to surgery.
Roles, responsibilities, and qualifications for any non-physician first and second assistants participating in surgery shall be defined by the hospital medical staff, including any limitations to their roles in patient care.
Chief(s) of Surgery. Physician member(s) of the medical staff, who have been appropriately trained in the provision of surgical services, shall be designated by the medical staff to direct the hospital's surgical services, and shall be responsible for all clinical aspects of organization and delivery of the particular surgical services including the evaluation of the effectiveness of the services in coordination with the hospital's quality management program.

(i) The chief(s) of surgery shall be responsible for implementation of hospital policy related to medical staff utilizing the surgical suite.

(ii) In conjunction with the hospital's medical staff, the chief(s) of surgery shall implement procedures requiring an operative report for each surgery performed.

(I) The operative report shall describe techniques, findings, complications, tissues removed or altered, and the general condition of the patient during and following surgery.

(II) The full operative report shall be written or dictated immediately after surgery and signed or authenticated by the surgeon. Where the full operative report is not available to be placed immediately in the record, an operative/progress note by the surgeon must be entered into the medical record immediately.

Nurse Manager. A licensed registered nurse, who has been appropriately trained in the provision of surgical nursing services, shall manage the surgical suite(s) and shall be responsible for:

(i) Ensuring that a sufficient number of nursing personnel are on duty in the surgical suite to meet the needs and safety of the patients;

(ii) Ensuring that surgical technicians perform scrub functions only under the supervision of a licensed registered nurse who is immediately available to respond to emergencies;

(iii) Delineating the duties of scrub personnel and circulating registered nurses in the surgical suite;

(iv) Providing for orientation and on-going education and training of surgical personnel providing services within the surgical suite, to include at least equipment usage and inspections, infection control and safety in the surgical area, cardiopulmonary resuscitation, patient rights, and informed consent;

(v) Ensuring that patients are monitored and provided with nursing care from the time they enter the surgical suite to the time they exit the area;

(vi) Developing criteria for the use of equipment and supplies brought into the surgical suite from other areas; and

(vii) Ensuring that the operating room register is current and complete.

(b) Infection Control in the Surgical Suite. The hospital shall develop and implement infection control procedures specific to the surgical services areas, which include at least requirements for:

Surgical attire;
Surgical scrub procedures;
Housekeeping functions;
Cleaning, disinfecting, and sanitizing the area;
Appropriate maintenance of the heating, ventilation, and air conditioning systems for the surgical suite;
Packaging, sterilizing, and storage of equipment and supplies;
Waste disposal;
Traffic control patterns, including who may enter the operating room areas and under what circumstances; and
A surgical site surveillance system appropriate to the population served.

(c) Minimum Equipment for the Surgical Suite. The following emergency equipment shall be available and functional for the operating room(s) and for the post-anesthesia area, as appropriate:

A call system;
Cardiac monitors;
Resuscitation equipment;
A defibrillator;
Aspiration/suction equipment;
A traecheostomy kit;
A pulse oximeter; and
A end-tidal carbon dioxide monitor.

(d) Post-Anesthesia Care Unit.

The post-anesthesia care unit shall be located in an area of the hospital in close proximity to but physically separated from the operating room.
Policies and procedures for the post-anesthesia care unit shall include at a minimum the criteria for admission to and discharge from the unit.
If patients are not transferred to the post-anesthesia care unit following surgery, provisions shall be made for monitoring the patient until it is determined that the patient is stable.

History

Authority: O.C.G.A. §§ 31-7-2.1 and 31-9-6.1
History. Original Rule entitled "Surgical Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.29 Anesthesia Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.29 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.29}

Any hospital offering surgical or obstetrical services shall have an organized anesthesia service which shall be responsible for all anesthesia delivered at the hospital. The anesthesia services will be provided in a manner which protects the health and safety of patients in accordance with generally accepted standards of practice.

(a) Organization of Anesthesia Services.

Anesthesia services shall be directed by a qualified physician member of the medical staff who is responsible for organizing the delivery of anesthesia services provided by the hospital in accordance with generally accepted standards of practice.
The anesthesia director shall be responsible for monitoring the quality and appropriateness of anesthesia services and for ensuring that identified problems are addressed through the quality management program.
The anesthesia director shall be responsible for establishing an orientation and continuing education program for anesthesia services staff that include, at a minimum, instruction in safety precautions, emergency patient management, equipment use and inspections, and infection control procedures in the surgical suite.

(b) Anesthesia Service Delivery.

Anesthesia shall be administered only by qualified members of the medical staff or qualified individuals who have been granted clinical privileges to administer anesthesia in accordance with these rules and as permitted by state laws and regulations. Persons qualified to administer anesthesia may include:

(i) Anesthesiologists;

(ii) Physicians;

(iii) Dentists or oral surgeons possessing an active permit for administration of general anesthesia as issued by the State of Georgia;

(iv) Certified registered nurse anesthetists administering such anesthesia under the direction and responsibility of duly licensed physicians who are members of the medical staff; and

(v) Physician's assistants licensed by the State of Georgia with approved job descriptions as anesthesia assistants functioning under the direct supervision of anesthesiologists who are members of the medical staff and as otherwise authorized by applicable laws and regulations.

A pre-anesthesia patient evaluation shall be completed for each patient by a person qualified and granted privileges to administer anesthesia within a reasonable period of time preceding the surgery. The patient evaluation shall be updated immediately prior to induction. The pre-anesthesia evaluation must include review of heart and lung function, diagnostic data (laboratory, x-ray, etc., as applicable), medical and anesthesia history, notation of anesthesia risk, any potential anesthesia problems identified, and notation of patient's condition immediately prior to induction.
Checks of all anesthesia equipment shall be performed and documented immediately prior to each anesthesia administration.
A person qualified and granted privileges to administer anesthesia shall be continuously present throughout the administration of all general anesthesia or major regional anesthesia and monitored anesthesia care.
During the administration of anesthesia, patients shall be monitored as appropriate for the nature of the anesthesia. Such monitoring shall include as appropriate:

(i) Heart and breath sounds, using a precordial or esophageal stethoscope;

(ii) Oxygenation levels;

(iii) Ventilation;

(iv) Circulatory function;

(v) The qualitative content of expired gases, if the patient has an endotracheal tube; and

(vi) The patient's temperature.

The intraoperative anesthesia record shall document all pertinent actions and events that occur during the induction, maintenance, and emergence from anesthesia.
The person qualified and granted privileges to administer anesthesia shall remain immediately available until the patient has been determined to be stable and is ready for discharge or transfer from the post-anesthesia care unit.
A person qualified and granted privileges to administer anesthesia shall complete the post-anesthesia evaluation for each patient receiving anesthesia, and it shall be included in the patient's medical record.

(i) The evaluation shall note at a minimum the presence or absence of anesthesia-related abnormalities or complications, the patient's level of consciousness and cardiopulmonary status, and any follow-up care needed.

(ii) For outpatients, the post-anesthesia evaluation shall be performed prior to hospital discharge to check for anesthesia recovery in accordance with procedures and timelines established by the hospital's medical staff.

(c) Anesthesia Safety Precautions. Safety precautions related to the administration of anesthesia shall be clearly identified in written policies and procedures which are enforced and shall include at a minimum:

Routine maintenance and inspection of anesthesia equipment, recorded in a service record for each machine;
Emergency preparedness plans;
Life safety measures, including alarm systems for ventilators capable of detecting disconnection of any components, monitoring for scavenger gases, and a system for internal reporting of equipment malfunctions and unavailability;
Infection control procedures sufficient to adequately sterilize or appropriately disinfect all equipment components; and
Procedures for ensuring patient safety.

(d) Conscious sedation. The hospital shall develop and implement, with the assistance of the anesthesia services director, policies and procedures for the administration of conscious sedation, which shall be applicable hospital-wide. These policies and procedures shall be approved by appropriate members of the medical staff and shall include at least the following:

Designation of the licensed personnel authorized to administer conscious sedation and/or monitor the patient during conscious sedation;
Drugs approved for use in administering conscious sedation;
Patient monitoring requirements; and
Criteria for discharge.

History

Authority: O.C.G.A. §§ 31-7-2.1, 43-22-21 and 43-26-11.1
History. Original Rule entitled "Anesthesia Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.30 Nuclear Medicine Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.30 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.30}

If the hospital provides nuclear medicine services, those services shall be organized and effective. The nuclear medicine services shall be provided in a manner consistent with applicable state laws and regulations and generally accepted standards of practice.

(a) Radioactive materials used in the provision of nuclear medicine services shall be prepared by personnel authorized as defined by state law to prepare radiopharmaceuticals and shall be labeled, used, transported, stored, and disposed of in a manner consistent with the "Georgia Radiation Control Act," O.C.G.A. Chapter 31-13 et seq. , and applicable rules.

(b) If a clinical laboratory is utilized in the provision of nuclear medicine services, the laboratory shall be licensed to perform these services as required by the Rules and Regulations for Clinical Laboratories, Chapter 111-8-10.

(c) Nuclear medicine services shall be directed by a doctor of medicine or osteopathy who is a member of the medical staff qualified to perform and supervise those services. The director shall be responsible for the administration of nuclear medical services, including the evaluation of the effectiveness of the services in coordination with the hospital's quality management program.

(d) Nuclear medicine procedures shall be administered and/or supervised by licensed doctors of medicine or osteopathy as authorized by state law.

History

Authority: O.C.G.A. §§ 31-7-2.1, 31-13-1et seq. and 31-22-1 et seq
History. Original Rule entitled "Nuclear Medicine Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.31 Emergency Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.31 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.31}

The hospital shall provide, within its capabilities, services to persons in need of emergency care.

(a) Full-time Emergency Services. If the hospital offers emergency care as an organized service and/or holds itself out to the public as offering emergency services, the service shall be included in the scope of services submitted with the application for the hospital permit and shall be offered twenty-four (24) hours per day.

Organization. Supervision and organization of emergency services shall be under the direction of a qualified member of the medical staff.

(i) The director shall be responsible for the development of policies and procedures related to emergency services and the review and update of policies as necessary. The policies and procedures shall be approved by appropriate members of the medical staff.

(ii) The director shall implement systems to assess the effectiveness of the emergency service and to address improvement issues through the hospital's quality management program.

(iii) Staffing assignments shall provide for sufficient nursing, medical, and technical staff to meet the anticipated needs of emergency patient care. There shall be available to emergency room staff procedures for accessing additional staff on an as-needed basis to meet unanticipated needs.

(iv) Patient care responsibilities for emergency services staff shall be specified by written policies and procedures, which shall include training and experience requirements appropriate to the assigned responsibilities and clearly defined lines of authority.

Delivery of Services. When the hospital provides emergency services, the services shall comply with the following:

(i) Policies and procedures for processing patients presenting for emergency care shall be in writing and shall include the procedures for initial patient assessment, prioritization for medical screening and treatment, and patient reassessment and monitoring.

(ii) There shall be a central log of all patients presenting for emergency care, with the presenting complaint and the level of acuity or triage documented. Entries in the log must be retrievable by the date and time the patient presents for treatment;

(iii) An emergency medical record shall be maintained for each patient which includes all assessment and treatment information about the patient from the time of presentation until the time of discharge or transfer;

(iv) Written protocols and standards of practice to guide emergency interventions by non-physician staff shall be available in the emergency services area;

(v) A licensed physician shall be available to cover basic emergency room services either on-site or by telephone. Where the licensed physician is providing such coverage by telephone, the physician must be able to arrive in the emergency room within thirty (30) minutes of the need for physician services having been determined;

(vi) The emergency services area shall have operable equipment and sufficient and appropriate supplies and medications to support emergency care for patients of all ages, including at least:

(I) An emergency call system;

(II) Oxygen;

(III) Manual breathing bags and masks;

(IV) Cardiac monitoring and defibrillator equipment;

(V) Laryngoscopes and endotracheal tubes;

(VI) Suction equipment; and

(VII) Emergency drugs and supplies as specified by the medical staff;

(vii) The hospital shall integrate functions of the emergency services with other services of the hospital to ensure appropriate patient care and treatment including those patients awaiting admission or transfer to another facility, placement in a hospital bed, or transfer to another facility;

(viii) Policies and procedures shall be developed and implemented for the appropriate transfer of emergency patients to other facilities or other areas of the hospital when appropriate;

(ix) The hospital shall have policies and procedures for the management of mass casualty situations which may require the coordination of the hospital's emergency services with other facilities, the local Emergency Management Agency (EMA), and local ambulance service providers;

(x) Emergency Services Where Maternity Services Are Customarily Offered. In addition to applicable federal laws regarding the treatment of persons requesting treatment for emergency medical conditions that are enforced by the federal government, state law requires any hospital which operates an emergency service to provide appropriate and necessary emergency services to any pregnant woman who is a resident of this state and who presents herself in active labor, to the hospital, if those services are usually and customarily provided in that facility. Such services shall be provided within the scope of generally accepted practice based upon the information furnished the hospital by the pregnant woman, including such information as the pregnant woman reveals concerning her prenatal care, diet, allergies, previous births, general health information, and other such information as the pregnant woman may furnish the hospital. If, in the medical judgment of the physician responsible for the emergency service, the hospital must transfer the patient because the hospital is unable to provide appropriate treatment, the hospital shall provide appropriate treatment as set forth in O.C.G.A. § 31-8-42 ; and

(xi) Diversion Status - Inability to Deliver Emergency Services. The hospital shall develop and implement a diversion policy in consultation with the medical staff which describes the process of handling those times when the hospital must temporarily divert ambulances from transporting patients requiring emergency services to the hospital. The policy must include the following: when diversion is authorized to be called, who is authorized to call and discontinue diversion, efforts the hospital will make to minimize the usage of diversion, and how diversion will be monitored and evaluated. In connection with going on diversion status, the hospital shall:

(I) Notify the ambulance zoning system when it is temporarily unable to deliver emergency services and is declaring itself on diversion;

(II) Notify the ambulance zoning system when diversion status is no longer determined to be necessary; and

(III) Monitor and evaluate its usage of diversion status and make changes within its control to minimize the use of diversion status.

(b) Hospitals Without Organized Emergency Services. Hospitals not providing an organized emergency service shall have current policies and procedures and sufficient qualified staff to provide for the appraisal and initial treatment of any patients or persons presenting with an emergency medical or psychiatric condition, within the capabilities of the hospital, and for referral of the patient for further treatment when appropriate.

History

Authority: O.C.G.A. §§ 31-7-2.1, 31-7-3.1, 31-8-42 and 31-11-82
History. Original Rule entitled "Emergency Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.32 Outpatient Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.32 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.32}

Outpatient services offered by the hospital, including but not limited to ambulatory care services and off-campus clinics, shall be integrated with other hospital services and systems and shall be provided in accordance with applicable rules in this Chapter for the specific service.

(a) Organization of Outpatient Services.

The hospital shall develop and implement policies and procedures to ensure that outpatient care provided meets the needs of patients in accordance with generally accepted standards of practice.
Each outpatient service shall be staffed with sufficient qualified personnel to promptly, safely, and effectively meet the care needs of patients. Staff providing care to outpatients shall meet the same qualification requirements as staff providing similar services to inpatients of the hospital.
The hospital shall assign responsibility for the periodic assessment of the quality and effectiveness of the outpatient services provided, and this assessment shall be a part of the hospital's quality management program.

(b) Outpatient Service Delivery.

Hospital services for outpatients shall be provided only on the order of a licensed physician, dentist, osteopath, physician's assistant, or advanced practice nurse as permitted by law in accordance with the system of accountability established by the medical staff.
Outpatient services shall be provided in a manner which ensures the privacy of each patient and the confidentiality of the patient's disclosures. Private rooms or cubicles shall be provided for the use of outpatients and staff for consultation purposes, as appropriate to the needs of the service.
Hospitals shall provide waiting areas for outpatients with sufficient seating for the expected volume of patients.
Each outpatient shall have an outpatient record, which shall be maintained and stored in a manner to be available for subsequent outpatient or inpatient hospital visits.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Outpatient Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.33 Rehabilitation Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.33 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.33}

The hospital shall define the scope of rehabilitation services provided to patients. The hospital may offer limited or comprehensive rehabilitation services including such services as physical therapy, occupational therapy, audiology, speech-language pathology, or other services.

(a) Organization of Limited Rehabilitation Services. Where a hospital chooses to offer limited rehabilitation services, which are typically single or stand-alone therapy discipline(s), the rehabilitation service(s) shall be coordinated by an appropriately qualified individual assigned responsibility for the clinical aspects of organization and delivery of the rehabilitation service(s) provided by the hospital. The coordinator shall be responsible for monitoring the quality and appropriateness of rehabilitation services and for ensuring that identified problems are addressed through the quality management program.

(b) Organization of Comprehensive Rehabilitation Services. Where a hospital chooses to offer a comprehensive rehabilitation service program which provides integrated and coordinated multidisciplinary therapy services as an organized inpatient service, the director must be a qualified member of the medical staff with appropriate training and experience.

(c) Professional and paraprofessional staff providing patient care shall meet licensing or registration requirements consistent with state law.

(d) Rehabilitation services shall be provided in accordance with orders from the licensed practitioner responsible for the patient's care. Orders for services shall be entered in the patient's medical record with the date of the order and shall be signed by the person giving the order. If rehabilitation services are provided by the hospital on an outpatient basis, the hospital shall specify how orders from outside sources will be managed.

(e) Following assessment, treatment services shall be provided according to a written treatment plan, which specifies the goals of treatment and the frequency and expected duration of services.

(f) There shall be a functional system for recording in the patient's medical record the patient's response to treatment and for communicating information regarding the patient's response or progress to the ordering licensed practitioner.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Rehabilitation Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.34 Maternal and Newborn Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.34 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.34}

(1) No later than 90 days after the effective date of these rules, if the hospital offers an organized service for the provision of care for expectant mothers and newborns, it shall clearly define the level of services provided according to the levels described in these rules (basic, intermediate, or intensive) and comply with the rules set forth in this section.

(a) The hospital shall establish and utilize admission criteria for the maternal and newborn services that reflect the level of services offered by the hospital.

(b) The hospital shall have established mechanisms, through written agreement and other arrangement, for transfers to or consultations with facilities providing services at the higher levels of care for those maternal and newborn patients who require such care. The agreements or arrangements shall ensure that there is collaboration between the sending and receiving hospital concerning the transfer of such patients prior to the actual need for transfer and shall include mechanisms for the communication of information regarding the outcome of each transfer and for periodic review of the agreements or arrangements.

(c) All hospitals offering obstetrical care shall have facilities, staff, and equipment necessary for delivery, management, and stabilization of expectant women who present at the hospital in active labor and for whom delivery is imminent, regardless of the level of care anticipated for the newborn. The hospital shall have in place a system for communication and consultation with a board certified obstetrician or maternal-fetal medicine specialist and a board certified neonatologist for situations where transport of high-risk patients prior to delivery is not feasible.

(d) The hospital shall establish a system for receipt of prenatal records for admissions to the maternal and newborn service other than emergency admissions to include the results of any routine laboratory tests as required by the hospital.

(e) The hospital shall have written plans and procedures for transfer of expectant mothers or newborns presenting at the hospital who exceed the criteria for admission, which shall include mechanisms for accessing transportation appropriate to the needs of the patient(s).

(f) The hospital shall include in the internal quality management program a systematic review of the admissions and transfers for maternal and newborn services, with comparison to the established admission criteria, which shall prompt corrective action when indicated.

(g) With the exception of hospitals permitted as specialized children's hospitals, hospitals shall offer a level of services for maternal care comparable to the level of services offered for neonatal care.

(2) The hospital shall have sufficient staff, space, facilities, equipment, and supplies to support the range of maternal and infant services offered, according to generally accepted standards of practice.

(3) Basic Maternal and Newborn Services. All hospitals offering maternal and newborn services shall offer at least a basic level of those services. The basic level of maternal and newborn services shall provide comprehensive care for women with low-risk pregnancies, anticipated uncomplicated deliveries, and apparently normal developing fetuses with estimated gestation of thirty-six (36) weeks or greater and for newborns with anticipated birth weights of 2500 grams or greater. The maternal and newborn services of these hospitals shall meet the following minimum requirements:

(a) Organization of Basic Maternal and Newborn Services.

The director of obstetrical services shall be a board eligible or board certified obstetrician, or a board eligible or board certified family practitioner with obstetrical privileges, or shall be a credentialed member of the medical staff with obstetrical privileges with access to such board eligible or board certified specialists by consultation.
The director of newborn services shall be a member of the medical staff who is a board eligible or board certified pediatrician, or a board eligible or board certified family practitioner, or shall be a credentialed member of the medical staff with access to such specialists by consultation. The director of newborn services shall be responsible for ensuring that medical care is provided for all newborns.
The perinatal nurse manager shall be a licensed registered nurse with education and demonstrated knowledge and experience in perinatal nursing;

(b) Delivery of Basic Maternal and Newborn Services.

Staffing Plan. The hospital shall follow a staffing plan that ensures the availability of appropriate numbers of qualified staff for the perinatal services offered, according to generally accepted standards of practice and state licensing regulations.

(i) Staffing for the Labor and Delivery Area. For the delivery of newborns, the hospital shall provide for at least the following:

(I) A birth attendant, who may be an obstetrician, a physician with obstetrical privileges, or a certified nurse midwife who has been granted clinical privileges in accordance with these rules, present at the hospital or immediately available by telephone and able to be on-site within thirty (30) minutes;

(II) A registered nurse present to assist with each delivery;

(III) An individual credentialed in neonatal resuscitation to be present in the delivery room for each delivery for the purpose of receiving the newborn;

(IV) For Cesarean deliveries, an additional physician or certified nurse midwife, a registered nurse, or a surgical assistant or technician, able and qualified to assist with a Cesarean section, on-site or able to arrive in sufficient time to accommodate the time limit for emergency Cesarean section of thirty (30) minutes from the physician's decision to operate to the initial incision; and

(V) Professional staff qualified to administer anesthesia, on-site or able to arrive in sufficient time to accommodate the time limit for emergency Cesarean section of thirty (30) minutes from the physician's decision to operate to initial incision.

(ii) Staffing for the Newborn Nursery. The hospital shall provide for at least:

(I) A qualified registered nurse with experience or training in the care of newborns to supervise and be responsible for the quality of nursing care given to newborns, for nursing in-service programs in nursery issues, for assisting the director of the newborn nursery in carrying out his or her duties, and for the maintenance of the nursery records;

(II) A licensed nurse on duty in the nursery at all times in hospitals with a daily newborn nursery census greater than ten (10) newborns; and

(III) A staff member trained in newborn service provision present in the newborn nursery when it is occupied by any newborn.

The directors of obstetrical and newborn services shall develop and implement written policies, procedures, and guidelines for the services that reflect current standards of practice and address at least:

(i) Admission criteria for the services based on the level of service provided;

(ii) Guidelines and mechanisms for specialty consultations and transfer for high-risk patients whose needs exceed the range of services offered at the hospital;

(iii) The orientation program for maternal and newborn services staff;

(iv) Patient care requirements for mothers and newborns, including but not limited to nursing assessments, gestational age assessment, newborn assessments including Apgar scoring immediately after delivery, assessment and management of nutritional needs including feedings for the newborn whether normal or gavage, umbilical and circumcision care, assessment of thermoregulation by the newborn, prevention of blindness, hypoglycemia, and hemorrhagic disease for the newborn, use of appropriate prophylaxes, patient monitoring needs, and assessment of educational needs of the mother;

(v) Procedures for a family-centered environment (rooming-in) as an option for each patient unless contraindicated by the medical condition of the mother or infant or unless the hospital does not have sufficient facilities to accommodate all such requests;

(vi) Room assignments and procedures for traffic control and security, including such security measures as are necessary to limit access to newborns by unauthorized persons and to prevent kidnapping of newborns;

(vii) Guidelines for the use of anesthetic agents for pain management and the requirements for the qualifications and responsibilities of persons who administer the agents and the required patient monitoring;

(viii) Guidelines for induction and augmentation of labor and for designation of qualified personnel who must be in attendance during these procedures;

(ix) Indicators and procedures for vaginal birth after Cesarean section (VBAC);

(x) Indicators and procedures for operative vaginal deliveries;

(xi) Staffing and procedural guidelines for management of obstetrical and newborn emergencies, including the availability of staff components to manage such emergencies twenty-four (24) hours per day;

(xii) Guidelines for the monitoring of newborns during the first twelve (12) hours after birth and until discharge;

(xiii) Procedures for infection control, including isolation procedures, visiting privileges, individualized infant hygiene care, and specific policies regarding the prevention and management of infectious diseases, including but not limited to Hepatitis B, Hepatitis C, Group B Streptococcal infections, tuberculosis, human immunodeficiency virus (HIV), and sexually transmitted diseases;

(xiv) Requirements for newborn screening tests for metabolic disorders and hemoglobinopathies and other screenings, as required by law.

(xv) Procedures for continuous and unquestionable identification of newborns;

(xvi) Procedures for completing birth and death certificates in accordance with Georgia's official vital records registration system; and

(xvii) Guidelines for discharge of mothers and newborns, including early discharge, and for assessment of education and other discharge needs.

Obstetrical and newborn service areas shall be located, arranged, and utilized so as to provide for every reasonable protection from infection and from cross-infection. The physical arrangements shall separate the obstetric patients from other patients with the exception of non-infectious gynecological patients.
Rooms used for patients in labor shall be located with convenient access to the delivery room(s). If labor rooms also serve as birthing rooms, the rooms shall be equipped to handle obstetric and neonatal emergencies.
Delivery suites shall be used for no purpose other than for the care of obstetrical patients. Each room shall have the necessary equipment and facilities for infection control and for the management of obstetric and neonatal emergencies. Delivery suites shall be designed to include an anesthesia supply and equipment storage room and a communication system to ensure that emergency backup personnel can be summoned when needed.
A newborn stabilization area shall be located within each delivery room or birthing room and shall be equipped with oxygen and suction outlets.
The newborn nursery shall have an air temperature maintained at 75-80 degrees Fahrenheit, with a relative humidity of thirty percent to sixty percent (30% - 60%).
Air from other areas of the hospital shall not be recirculated into the newborn nursery. Ventilation of the nursery suite(s) shall provide the equivalent admixture of a minimum of six (6) total air changes per hour.
Life-sustaining nursery equipment and lighting for the nursery areas shall be connected to outlets with an automatic transfer capability to emergency power.
Each labor room, delivery room, birthing room, and nursery station shall be equipped with sufficient power outlets to handle the equipment required for the provision of patient care without the use of extension cords,"cheater" plugs, or multiple outlet adapters, which are prohibited.

(d) Clinical Laboratory, X-Ray, and Ultrasound Services. Diagnostic support services such as laboratory, x-ray, and ultrasound, shall be available on an on-call basis, with the capability to perform studies as needed for maternal and newborn care; and

(e) Records Requirements.

The medical record for each maternity patient shall be maintained in accordance with Section 111-8-40-.18 of these rules, with the following additions:

(i) The medical record for each maternity patient shall contain a copy of the patient's prenatal records, submitted at or before the time of admission;

(ii) The admission data shall include the date and time of notification of the birth attendant, the condition on admission of the mother and fetus, labor and membrane status, presence of bleeding, if any, fetal activity level, and time and content of the most recent meal ingested; and

(iii) Labor and postpartum care notes shall be included.

The medical record for each newborn shall be cross-referenced with the mother's medical record and shall contain the following additional record information:

(i) Physical assessment of the newborn, including Apgar scores, presence or absence of three cord vessels, and vital signs;

(ii) Accommodation to extra uterine life including the ability to feed and description of maternal-newborn interaction;

(iii) Treatments and care provided to the newborn to include the specimens collected, newborn screening tests performed, and appropriate prophylaxes;

(iv) The infant's footprint and mother's fingerprint, or comparable positive newborn identification information; and

(v) Report of the physical examination of the newborn prior to discharge, performed by an appropriately credentialed physician, physician's assistant, nurse practitioner, or nurse midwife.

The hospital shall maintain a register of births, in which is recorded the name of each patient admitted for delivery, the date of admission, date and time of birth, type of delivery, names of physicians or other birth attendants, assisting staff and anesthetists, the sex, weight, and gestational age of the infant, the location of the delivery, and the fetal outcome of the delivery.
The hospital shall maintain annual statistics regarding the number of births and number of infant deaths. Death statistics for infants shall include birth weights, gestational ages, race, sex, age at death, and cause of death.

(4) Intermediate Maternal and Newborn Services. The hospital offering intermediate maternal and newborn services shall offer comprehensive care for women with the potential or likelihood for only certain pre-defined high-risk complications and with anticipated delivery of a newborn at greater than thirty-two (32) weeks' gestation and birth weight greater than 1500 grams who are anticipated to have only such medical conditions which can be expected to resolve rapidly. The maternal and newborn service shall meet all of the requirements for provision of the basic services as described above in these rules, with the following additions or exceptions:

(a) Organization of Intermediate Maternal and Newborn Services.

The director of obstetric services shall be a member of the medical staff who is a board eligible or board certified obstetrician or board eligible or board certified maternal-fetal medicine specialist; provided, however, within five (5) years from the effective date of these rules, the director of obstetric services shall be a board certified obstetrician or board certified maternal-fetal medicine specialist.
The director of newborn services shall be a member of the medical staff who is board eligible or board certified pediatrician or board eligible or board certified neonatologist; provided, however, within five (5) years from the effective date of these rules, the director of newborn services shall be a board certified pediatrician or board certified neonatologist.
A board eligible or board certified neonatologist shall be available to participate in care for the neonates.
The perinatal nurse manager shall be a licensed registered nurse with the training and demonstrated knowledge and experience in care of high-risk maternal care and moderately ill newborns.
When a neonate is on mechanical ventilation or when a high risk maternity patient is being managed, a respiratory therapist, certified lab technician/blood gas technician, and an x-ray technologist shall be on-site and available to the maternal and newborn services area on a twenty-four (24) hour basis.
If the facility offers care for newborns requiring parenteral support, a licensed dietitian and a licensed pharmacist with parenteral experience shall be on staff.

(b) Delivery of Intermediate Maternal and Newborn Services. Service delivery shall meet the requirements of the basic maternal and newborn services, with the following additions or exceptions:

The hospital shall provide care for expectant mothers and newborns requiring the basic level of maternal and newborn services, as well as for those requiring an intermediate level of care;
Portable x-ray and ultrasound equipment and services shall be available on a twenty-four (24) hour basis;
The intermediate level nursery shall provide care to neonates expected to require no more than short-term mechanical ventilation or parenteral support. Such support, if needed for more than forty-eight (48) hours, shall be authorized daily by the consulting neonatologist, or the neonate shall be transferred to a facility with a higher (intensive) level of care; and
Written policies, procedures, protocols, and guidelines shall reflect the pre-defined level of care provided. Criteria for admission to and discharge from the intermediate level nursery shall be defined in the written policies and procedures.

(c) Physical Environment for Intermediate Maternal and Newborn Services. The physical environment shall meet the requirements of the basic maternal and newborn services, with the following additional requirements:

There shall be provided in the intermediate level nursery sufficient space between each patient station to allow for easy access for staff and visitors on three (3) sides of the patient bed and to allow for easy access with portable diagnostic and support equipment as may be required;
Each patient station in the intermediate level nursery shall have at least two (2) oxygen outlets, two (2) compressed air outlets, and two (2) suction outlets;
There shall be adequate lighting provided for patient care while avoiding extra illumination of adjacent neonates; and
The patient bed areas shall be designed to minimize the impact of noise on the infants.

(5) Intensive Maternal and Newborn Services. The hospital offering an intensive level of maternal and newborn services shall provide services for normal and high-risk maternal, fetal, and newborn conditions. The hospital providing the intensive level of services shall meet all requirements for basic and intermediate maternal and newborn services, with the following additions and/or exceptions:

(a) The director of intensive obstetric services shall be a member of the medical staff who is a board certified obstetrician or board certified maternal-fetal medicine specialist;

(b) The director of intensive newborn services shall be a member of the medical staff who is a board certified pediatrician or board certified neonatologist;

(c) The hospital shall have on call, on a twenty-four (24) hour basis, a board certified obstetrician or maternal-fetal medicine specialist to provide on-site supervision and management of maternal patients;

(d) The hospital shall have available for consultation a maternal-fetal medicine specialist;

(e) The hospital shall have on call, on a twenty-four (24) hour basis, a board certified neonatologist to provide on-site supervision and management of neonates;

(f) The hospital shall provide pediatric subspecialties on staff or have a mechanism to provide consultation and care for pediatric subspecialties in a timely manner;

(g) The nursery manager of the intensive care nursery shall have demonstrated knowledge, training, and experience in neonatal intensive care nursing and shall have a dedicated assignment to the intensive care nursery;

(h) The hospital shall have on staff pharmacology personnel competent in perinatal pharmacology. Total parenteral nutrition shall be available; and

(i) The hospital shall have on staff a licensed physical therapist or occupational therapist and a licensed dietitian with training and experience in neonatal care.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Maternal and Newborn Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.35 Pediatric Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.35 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.35}

Any hospital providing care to infants and children shall have facilities, equipment, and policies and procedures specific to the provision of services for pediatric patients.

(a) Hospital policies shall define the ages of patients considered to be appropriate for pediatric services and the scope of services to be provided to them.

(b) Staff providing services to pediatric patients shall have experience and training in serving the pediatric population and shall have documented in-service training at least annually on age-specific care issues for the pediatric population served by the hospital.

(c) Protocols for screening and assessment of pediatric patients shall be approved by the medical staff and shall be individualized for the age and presenting signs and symptoms of the patient. In addition to the screening and assessment information required for all patients, the general screening and assessment protocol for pediatric patients shall include at a minimum:

Chronological age, weight, and length or height;
For infants and young children, a measurement of head circumference;
Immunization history;
A statement as to the developmental age and growth of the child as related to established norms; and
Family relationships, including expected family involvement during treatment.

(d) The hospital shall establish and implement policies and procedures to prohibit access to pediatric patients by unauthorized persons and to prevent kidnapping or elopement of pediatric patients.

(e) The hospital shall provide space and equipment to allow for visitation of family members in the patient rooms and to allow for overnight stay of a parent or guardian where the parent or guardian's presence does not interfere with the course of treatment. The pediatric patient's medical record shall clearly indicate persons who are not permitted to visit the pediatric patient.

(f) Medical supplies and equipment including emergency equipment appropriate to the size and age of the pediatric patient shall be available in all areas of the hospital providing services to pediatric patients.

(g) The phone number for the Poison Control Center shall be available in a conspicuous place in the pediatric service area(s).

(h) Where pediatrics is provided as an organized service, there must be a qualified physician member of the medical staff with experience or training in pediatrics assigned responsibility for directing the clinical aspects of organization and delivery of all pediatric services provided by the hospital. The pediatric medical director shall be responsible for monitoring the quality and appropriateness of pediatric services in coordination with the hospital's quality management program and for ensuring that identified opportunities for improvement are addressed.

(i) Hospitals providing services to pediatric patients as an organized service shall have space, facilities, and appropriately sized equipment for providing those services apart from adult patient rooms and newborn units and shall provide for regular and routine cleaning of play equipment in the pediatric area according to protocols established for that purpose by the hospital's infection control program.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Pediatric Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.36 Dialysis Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.36 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.36}

(1) If the hospital provides acute inpatient dialysis services or outpatient services either directly or through contract arrangements, the scope and organization of those services shall be defined.

(2) Organization and Administration of Renal Dialysis Services. The hospital shall have an organizational plan for dialysis services which clearly defines lines of authority, responsibility, and accountability and which includes provision for adequate staffing to provide dialysis care according to generally accepted standards of practice.

(a) Medical Director. The medical director for dialysis services shall be a physician member of the medical staff qualified to provide oversight to the specialized care required for dialysis patients and the medical director shall have at least one-year's experience in care for patients with end stage renal disease.

(b) Nursing Services. A registered nurse with demonstrated clinical competencies in providing dialysis services for patients shall be available during all dialysis treatments. Nursing staff and dialysis care technicians providing dialysis services shall have evidence of education, training, and demonstrated competencies in the provision of appropriate dialysis services and emergency care of patients receiving dialysis.

(c) Policies and Procedures for Dialysis Services. Where the hospital provides dialysis services directly to its patients, the hospital shall develop and implement policies and procedures that address the special needs of dialysis patients and shall include at least the following:

Maintenance of dialysis equipment;
Water treatment system safety;
Infection control;
Reuse of dialyzers and dialysis supplies, if applicable, and
Care of dialysis patients experiencing common complications of dialysis treatments.

(d) Contracted Services. Where the hospital provides dialysis services through a contract arrangement, the hospital must contract with a Georgia-licensed End Stage Renal Disease Facility. The contract must outline what specific services shall be provided and include who will be responsible for the maintenance of the dialysis equipment, the water treatment safety system, infection control, reuse of dialyzers and supplies, if applicable, the clinical qualification of staff to be provided, and the clinical supervision that will be provided to dialysis patients during the administration of dialysis treatments.

(3) Appropriate Treatment. The hospital shall provide dialysis services in accordance with accepted standards of care for the persons requiring dialysis services.

(4) Quality Improvement. The hospital shall ensure that problems identified during the on-going monitoring of the dialysis services are addressed in the hospital quality improvement program. Contracted services must participate in the hospital quality improvement program.

(5) Outpatient Chronic Dialysis Services. A hospital choosing to provide outpatient dialysis services directly as an integral part of the hospital to persons with end stage renal disease on a regularly recurring basis must meet the rules set forth in the Rules and Regulations for End Stage Renal Disease Facilities, Chapter 111-8-22, which are herein incorporated by reference, except for .03, .04, and .19.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Dialysis Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.37 Psychiatric and Substance Abuse Services {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.37 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.37}

(1) If the hospital provides psychiatric and/or substance abuse treatment services as an organized service, the scope of those services, including whether the services are provided for inpatients, outpatients, or both, shall be defined in the hospital's application for permit and meet the requirements set forth in this section and generally accepted standards of care.

(2) Organization and Administration of Psychiatric and Substance Abuse Services. The hospital shall have a plan for the service which clearly defines lines of authority, responsibility, and accountability and which includes provision for adequate staffing to provide patient care according to generally accepted standards of practice.

(a) Director of Psychiatric and Substance Abuse Services. The director of psychiatric and substance abuse services shall be a licensed physician member of the medical staff appropriately trained and qualified to supervise the provision of these services.

If the hospital offers substance abuse services only, the director shall be a licensed physician member of the medical staff certified or eligible for certification in addiction medicine by the American Society of Addiction Medicine or the American Osteopathic Academy of Addiction Medicine or a licensed physician member of the medical staff appropriately trained and qualified to supervise the service. If the director of the substance abuse services meets this certification requirement but is not board certified in psychiatry, the hospital must have a board eligible or board certified psychiatrist on staff to be utilized for psychiatric consultation as needed.
The director of the psychiatric and/or substance abuse services shall be responsible for all clinical aspects of the organization and delivery of services and for the evaluation of the effectiveness of the services in coordination with the hospital's quality management program.

(b) Staffing for Psychiatric and Substance Abuse Services. The hospital shall provide sufficient clinical and support staff to assess and address the needs of psychiatric and substance abuse patients and to ensure the maintenance of a safe therapeutic environment for patients and staff.

Nursing Manager/Director. The nursing care for the psychiatric and/or substance abuse services shall be supervised by a licensed registered nurse with at least three (3) years of clinical psychiatric and/or substance abuse experience. Authorization from the Georgia Board of Nursing to practice as a Clinical Nurse Specialist, Psychiatric/Mental Health may substitute for two (2) years of the required clinical experience.
Counseling Services. Counseling services for the psychiatric and substance abuse services shall be supervised by a master's level clinician licensed in social work, marriage and family therapy, professional counseling, or a clinical nurse specialist, psychiatric mental health.
Clinical Psychologist. A licensed clinical psychologist shall be available to provide testing and treatment consultation for patients as needed.
Child Psychiatrist. If psychiatric services are provided for children, a board eligible or board certified child psychiatrist shall be on staff.
Special Staffing Requirements for Inpatient Psychiatric or Substance Abuse Services. Hospitals providing inpatient psychiatric and/or substance abuse care shall provide:

(i) A physician, with training and qualifications appropriate to the services offered, present in the hospital or available on call on a twenty-four (24) hour basis;

(ii) At least one registered nurse on duty at all times; and

(iii) Rehabilitative and therapeutic activity staff, trained and qualified to meet the needs of the patients as specified in the patients' individualized service plans.

(c) Policies and Procedures for Psychiatric and Substance Abuse Services. In addition to hospital policies and procedures otherwise required by these rules, the hospital providing psychiatric and/or substance abuse services shall develop and implement policies and procedures that address the special needs of the population served, to include at least:

Admission and discharge criteria and procedures, which comply with Georgia laws concerning involuntary admissions or treatment;
Safety and security precautions for the prevention of suicide, assault, and patient injury;
The handling of medical emergencies, including but not limited to suicide attempts, cardiac arrest, aspiration, or seizures;
Special procedures, such as electro convulsive therapy (ECT) and medical detoxification, as applicable; and
Procedures for the use of seclusion and restraint in accordance with O.C.G.A. Chapters 3 and 7 of Title 37 and these rules.

(3) Patient's Rights in Psychiatric and Substance Abuse Services.

(a) In addition to the rights afforded all patients at the hospital, the hospital shall ensure that patients served by the psychiatric and substance abuse services shall have the right to:

Receive treatment in the hospital using the least restrictive methods possible; and
Participate to the extent possible in the development, implementation, and review of their individualized service plan.

(b) Any permissible restriction of patient rights by the hospital program shall be imposed only in order to protect the health and safety of the patient or others and shall be temporary. The nature, extent, and reason for the restriction shall be entered into the patient's medical record as a written order by a physician or licensed psychologist and reviewed for necessity as required by state law.

(4) Patient Assessment and Treatment.

(a) In addition to other assessment and treatment procedures otherwise required by these rules, psychiatric and substance abuse service programs at the hospital shall provide:

For inpatients:

(i) With the admission assessments performed within twenty-four (24) hours of admission, a psychiatric or substance abuse evaluation as indicated by the reason for admission; and

(ii) An individualized service plan, initiated within the first twelve (12) hours after admission and updated as needs are identified through assessments;

For outpatients:

(i) Within seven (7) days following the initiation of outpatient services, a complete assessment of patient needs, including an evaluation sufficient to identify significant medical conditions which may impact the course of treatment; and

(ii) Within ten (10) days following initiation of outpatient services, an individualized service plan developed and implemented to address needs identified;

Each patient's individualized service plan shall be developed from the patient's needs as identified through psychological, medical, and social assessment and shall be an organized statement of the proposed treatment process which serves to guide the providers and patient through the duration of the service provision. The service plan shall reflect the following:

(i) The patient's participation, to the extent possible, in the development of the individualized service plan;

(ii) Measurable goals and/or objectives to be met toward the established discharge criteria; and

(iii) Regular review of the patient's progress toward goals and/or objectives in the individualized service plan, with modifications to the plan made in response to progress or lack of progress as reflected in progress notes recorded at each visit which document the patient's status and response to treatment;

At the time of development of the patient's treatment plan and with the participation of the patient, a discharge plan shall be developed for each inpatient or an aftercare plan for each outpatient. The discharge/aftercare plan shall be re-evaluated periodically during treatment to identify any need for revision; and
All medications administered or prescribed for psychiatric or substance abuse patients shall be solely for the purpose of providing effective treatment or habilitation as described in the individualized service plan and/or for protecting the safety of the patient or others and shall not be used for punishment or for the convenience of staff.

(b) If the hospital is not able to meet the patient needs as identified, including any acute medical or surgical needs, the hospital shall assist the patient in locating and accessing services to meet those needs, which may include transfer to another facility.

(5) Physical Space and Design Requirements for Inpatient Psychiatric and Substance Abuse Services. Hospitals providing inpatient psychiatric and substance abuse services shall have:

(a) At least one seclusion area must be available to be used for the involuntary confinement of patients when necessary. The seclusion area shall be large enough to provide access to the patient from all sides of the bed or mattress and to accommodate emergency life-sustaining equipment, have a door that opens outward, and have provision for direct patient observations at all times by staff;

(b) A design conforming to the suicide prevention recommendations from the Guidelines for Design and Construction of Hospital and Healthcare Facilities , produced by the American Institute of Architects' Academy of Architecture for Health with the assistance of the U.S. Department of Health and Human Services, which is hereby adopted by reference;

(d) Space for storage of patient's personal belongings and for securing valuables;

(e) A system for summoning help from within the immediate service area or other areas of the hospital in the event of an emergency.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Psychiatric and Substance Abuse Services" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.38 Special Requirements for Critical Access Hospitals {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.38 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.38}

Critical access hospitals (CAHs) shall be required to comply with the entirety of this chapter, as applicable to the scope of services offered, with the following exceptions and/or additions:

(a) Prior to application for a hospital permit, the hospital shall be approved for critical access hospital status by the Georgia Department of Community Health.

(b) The CAH shall be a member of a rural health network having at least one (1) additional hospital that furnishes acute care hospital services, which will serve as an affiliate hospital for the CAH. The CAH shall have current written agreement(s) with affiliate hospital(s) which include provisions for:

Patient referral and transfer between the facilities, with the use of emergency and non-emergency transportation;
Credentialing of medical and professional staff; and
Participation in quality management activities.

(c) The CAH's organization, scope, and availability of patient care services shall be defined and approved by the governing body, medical staff, and affiliate hospital. The CAH shall have:

Operational policies for the CAH shall be developed with participation from one (1) or more licensed physicians, one (1) or more healthcare practitioners if on the staff of the critical access hospital, and at least one (1) member of the affiliated hospital's staff who is not on the staff of the CAH;
Operational policies for the CAH which describe the patient care services the CAH will provide directly and those that will be provided through contract or other arrangement;
No more than twenty-five (25) inpatient beds or as currently defined in federal regulations. Of these beds, at least two (2), but no more than fifteen (15), shall be used for acute inpatients. If the CAH has approved swing bed services, a maximum of twenty-three (23) beds may be utilized for swing bed patients;
An average length of stay for patients of no more than ninety-six (96) hours or as currently defined in federal regulations;
A mechanism in place to ensure that emergency care is available twenty-four (24) hours per day. The CAH shall not be required to remain open twenty-four (24) hours per day when it does not have inpatients.

(i) The CAH shall, in accordance with the local emergency response systems, establish procedures under which a physician is immediately available by telephone or radio contact, on a 24-hour per day basis, to receive emergency calls, provide information or treatment of emergency patients, and refer patients to the CAH or other appropriate location for treatment.

(ii) A physician or limited health care practitioner with training in emergency care shall be on-call and immediately available by telephone or radio contact and available to be on-site at the CAH within thirty (30) minutes.

(iii) The CAH shall have equipment, supplies, and medications available for treating emergencies, as are required of other organized hospital emergency services.

(iv) Staff assigned to provide emergency patient care shall have training in handling medical and non-medical emergencies; and

A registered nurse or licensed practical nurse shall be on duty whenever the critical access hospital has one (1) or more inpatients.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Special Requirements for Critical Access Hospitals" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-40-.39 Special Requirements for Rural Free Standing Emergency Departments {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.39 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.39}

Rural Free Standing Emergency Departments shall be required to comply with the entirety of this chapter, as applicable to the scope of services offered by the Rural Free Standing Emergency Department, with the following exceptions and/or additions:

(a) The Rural Free Standing Emergency Department shall make all reasonable efforts to secure written agreement(s) with hospital(s) within 35 miles which include provisions for patient referral and transfer between the facilities, with the use of emergency and non-emergency transportation.

(b) The Rural Free Standing Emergency Department's organization, scope, and availability of patient care services shall be defined and approved by the governing body.

(c) The Rural Free Standing Emergency Department shall have operational policies developed with participation from one (1) or more licensed physicians. The operational policies must describe the patient care services the Rural Free Standing Emergency Department will provide directly and those that will be provided through contract or other arrangement.

(d) A Rural Freestanding Emergency Department that is not otherwise subject to the federal Emergency Medical Treatment & Labor Act, 42 U.S.C. 1395 dd shall provide to each patient, without regard to the individual's ability to pay, an appropriate medical screening examination to determine whether an emergency medical condition exists, and if so, shall provide stabilizing treatment within its capability. If the Rural Freestanding Emergency Department is unable to stabilize the patient within its capability, or if the patient requests, it shall implement a transfer of the patient to another facility that has the capability of stabilizing the patient.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Physical Plant Design and Construction" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: Renumbered as 111-8-40-.40. New Rule entitled "Special Requirements for Rural Free Standing Emergency Departments" adopted. F. Apr. 29, 2014; eff. May 19, 2014.

Ga. Comp. R. & Regs. r. 111-8-40-.40 Physical Plant Design and Construction {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.40 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.40}

(1) General. The hospital shall be designed and constructed in accordance with the needs of the patients being served.

(a) The design and construction specifications for the hospital shall conform to those nationally accepted standards for hospital design and construction as set forth in the Guidelines for Design and Construction of Hospital and Healthcare Facilities , published by the American Institute of Architects' Press, which has been accepted for use by the Department and which are current, as determined by the Department to be applicable, at either:

The time of construction of the hospital when the initial permit was obtained; or
The time of request for approval for renovation(s) or addition(s) to areas of the hospital which impact patient care.

(b) Compliance with standards acceptable to the Department shall be determined by a state architect designated by the Department to review hospital design and construction specifications.

All parts of the facility shall be subject to the architect's review, including new and existing buildings, additions, alterations, or renovations to existing structures, any mobile, transportable, or relocatable units, and any off-site structures intended to house hospital services or functions.
The hospital shall notify the Department prior to initiating new construction, modifications, or additions and shall submit plans for such new construction for review and approval by the state architect designated by the Department.

(c) The hospital shall have evidence of a satisfactory inspection of all buildings and structures, including any mobile units, by the local representative of the state fire marshal, the local fire and building authorities (where required by local ordinance), and the state architect.

(d) Designated space for the laundry, power plant, mechanical equipment, ambulance entrance, autopsy or morgue, loading dock, incinerator, garbage can cleaning, and storage areas for garbage and trash shall be constructed or arranged to avoid unreasonable noise, steam, odors, hazards to patients, and unsightliness relative to patient bedrooms, dining rooms, and lounge areas.

(e) Electrical, mechanical, and plumbing work and equipment shall be designed and installed in accordance with local and state ordinances.

(2) Special Requirements for Mobile, Transportable, and Relocatable Units. If the hospital utilizes, by ownership or contract, mobile, relocatable, or transportable units for the provision of hospital services, the units shall meet the following requirements:

(a) If the unit is used to provide routine ancillary services for hospital inpatients or to provide services for the hospital emergency room, there shall be a covered or enclosed walkway from the hospital to the unit to ensure patient safety from the outside elements;

(b) The unit shall be located so as to prevent diesel or exhaust fumes from the tractor or unit generator from entering the fresh air intake of either the unit or the facility;

(d) The hospital shall provide waiting areas for the unit and, in close proximity to the unit, patient and staff toilet facilities for use by the staff providing services from the unit and for use by the patients accessing the services in the unit;

(e) Each unit shall be accessible to wheelchair and stretcher bound patients;

(f) The hospital shall provide access to hand washing facilities for staff in the unit, as appropriate to the services provided in the unit and sufficient to allow compliance with the hospital's infection control program;

(g) The hospital shall have a plan for the handling of emergencies that may occur in the unit. The unit shall be connected to the hospital communication system for access to emergency response services;

(h) Waste lines to the unit shall be designed and constructed to discharge into an approved sewage system. The hospital shall ensure that back-flow prevention is installed at the point of water connection on the unit;

(i) If stairs are used to access the unit, they shall have stable handrails; and

(j) The hospital shall ensure that approaches to the unit have adequate lighting for safe negotiation at all hours of operation.

(3) Emergency Lighting and Power. The hospital shall have access to emergency lighting and electrical power meeting the following requirements:

(a) Functioning automatic emergency lighting equipment in all corridors in nursing units and in each operating room, delivery room, emergency room, exit, elevator, and stairway; and

(b) A functioning emergency electrical system. 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 or more primary automatic transfer switches to all emergency lighting; all alarms; blood banks; nurses' call; equipment necessary for maintaining telephone service; pump for central suction system; and receptacles in operating rooms and delivery rooms, patient corridors, patient rooms, recovery rooms, intensive care nursing areas, and nurseries. All other lighting and equipment required to be connected to the emergency system shall either be connected through the above-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 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. Where fuel is normally piped underground to the site from a utility distribution system, storage facilities on the site will not be required.

History

Authority: O.C.G.A. § 31-7-2.1
History. Original Rule entitled "Requests for Waiver or Variance" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: Renumbered as 111-8-40-.41. New Rule entitled "Physical Plant Design and Construction" adopted. F. Apr. 29, 2014; eff. May 19, 2014.

Ga. Comp. R. & Regs. r. 111-8-40-.41 Requests for Waiver or Variance {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.41 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.41}

A hospital may request a waiver or variance of a specific rule by application on forms provided by the Department. A waiver or variance may be granted in accordance with the following considerations:

(a) The Department may grant or deny the request for waiver or variance at its discretion. If the waiver or variance is granted, the Department may establish conditions which must be met by the hospital in order to operate under the waiver or variance. Waivers or variances may be granted with consideration of the following:

Variance. A variance may be granted by the Department upon a showing by the applicant that the particular rule or regulation that is the subject of the variance request should not be applied as written because strict application would cause undue hardship. The applicant must also show that adequate standards exist for affording protection for the health, safety, and care of patients, and these existing standards would be met in lieu of the exact requirements of the rule or regulation.
Waiver. The Department may dispense altogether with the enforcement of a rule or regulation by granting a waiver upon a showing by the applicant that the purpose of the rule or regulation is met through equivalent standards affording equivalent protection for the health, safety, and care of the patients.
Experimental Waiver or Variance. The Department may grant a waiver or variance to allow experimentation and demonstration of new and innovative approaches to delivery of services upon a showing by the applicant that the intended protections afforded by the rule or regulation in question are met and the innovative approach has the potential to improve service delivery;

(b) Waivers and variances granted by the Department shall be for a time certain, as determined by the Department; and

(c) Waivers and variances granted to a facility shall be recorded and shall be available to interested parties upon request.

History

Authority: O.C.G.A. § 31-2-7
History. Original Rule entitled "Enforcement of Rules and Regulations" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: Renumbered as 111-8-40-.42. New Rule entitled "Requests for Waiver or Variance" adopted. F. Apr. 29, 2014; eff. May 19, 2014.

Ga. Comp. R. & Regs. r. 111-8-40-.42 Enforcement of Rules and Regulations {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.42 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.42}

A hospital that fails to comply with these rules and regulations shall be subject to sanctions and/or permit revocation as provided by law. The enforcement and administration of these rules and regulations shall be as prescribed in the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25, pursuant to O.C.G.A. § 31-2-8.

History

Authority: O.C.G.A. § 31-2-8
History. Original Rule entitled "Severability of These Rules" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: Renumbered as 111-8-40-.43. New Rule entitled "Enforcement of Rules and Regulations" adopted. F. Apr. 29, 2014; eff. May 19, 2014.

Ga. Comp. R. & Regs. r. 111-8-40-.43 Severability of These Rules {#sec-ga.-comp.-r.-regs.-r.-111-8-40-.43 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-40-.43}

In the event that any rule, sentence, clause or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof. The remaining rules or portions of rules shall remain in full force and effect, as if such rule or portions thereof so determined, declared or adjudged invalid or unconstitutional were not originally a part of these rules.

History

Authority: O.C.G.A. §§ 31-2-1et seq. and 31-7-1 et seq
History. Original Rule entitled "Severability of These Rules" adopted. F. Apr. 29, 2014; eff. May 19, 2014.

Subject 111-8-41 Rules and Regulations for Hospital Transparency

Ga. Comp. R. & Regs. r. 111-8-41-.01 Legal Authority {#sec-ga.-comp.-r.-regs.-r.-111-8-41-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-41-.01}

These rules are adopted and published pursuant to the Official Code of Georgia Annotated (O.C.G.A.) § 31-7-22 et seq. (effective Oct. 1, 2019).

History

Authority: O.C.G.A. § 31-7-22
History. Original Rule entitled "Legal Authority" adopted. F. Dec. 12, 2019; eff. Jan. 1, 2020.

Ga. Comp. R. & Regs. r. 111-8-41-.02 Applicability {#sec-ga.-comp.-r.-regs.-r.-111-8-41-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-41-.02}

These rules shall apply to all Hospitals, any Affiliate, and any Subsidiary as defined in these Rules. This information is provided with the intent to give healthcare consumers the tools to make an informed decision in selecting a hospital.

History

Authority: O.C.G.A. § 31-7-22
History. Original Rule entitled "Applicability" adopted. F. Dec. 12, 2019; eff. Jan. 1, 2020.

Ga. Comp. R. & Regs. r. 111-8-41-.03 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-41-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-41-.03}

As used in these Rules, the term

(1) "Administrative Position" shall mean a non-clinical hospital employee or contractor, which shall include, but is not limited to, a management company or similar entity, with a gross annual salary or payment of $100,000 or more.

(2) "Affiliate" shall mean any hospital that is united; being in close connection, allied, associated, or attached as a member or branch to another hospital.

(3) "Captive Insurance Company" shall include any agency captive insurance company, association captive insurance company, captive insurance company, dormant captive insurance company, industrial insured captive insurance company, or pure captive insurance company as defined in O.C.G.A. § 33-41-2 .

(4) "Hospital" shall mean a nonprofit hospital, a hospital owned or operated by a hospital authority, or a nonprofit corporation formed, created, or operated by or on behalf of a hospital authority.

(5) "Joint Venture" shall mean an enterprise shared between two or more entities. A joint venture is a business entity created by two or more business entities, which enter into an agreement to share funding, profits or losses, and control over the new entity.

(6) "Link" shall mean publicly-accessible single-click access from a prominent place on the webpage of either the Hospital or the department to the web location where the subject documents are posted.

(7) "Parent Corporation" shall mean a business entity that forms another business entity and retains ownership in the new entity. A parent corporation is a corporation that creates or acquires another business entity, retaining ownership or control in the new entity, which is the Subsidiary corporation.

(8) "Real Estate" shall mean the physical parcel of land, improvements to the land, improvements attached to the land, real fixtures, and appurtenances such as easements.

(9) "Real Property Holdings" shall mean the bundle of rights, interests, and benefits connected with the ownership of real estate. Real property does not include the intangible benefits associated with the ownership of real estate, such as the goodwill of a going business concern.

(10) "State Funds" shall mean state dollars, but shall not include funding necessary for the continued state participation in the federal Medicaid program.

(11) "Subsidiary" shall mean a company or companies organized by a parent corporation.

(12) "Subsidiary Holding Company" shall mean a company or companies organized by a parent corporation or a Subsidiary corporation to the parent corporation.

History

Authority: O.C.G.A. § 31-7-22
History. Original Rule entitled "Definitions" adopted. F. Dec. 12, 2019; eff. Jan. 1, 2020.

Ga. Comp. R. & Regs. r. 111-8-41-.04 Required Documentation {#sec-ga.-comp.-r.-regs.-r.-111-8-41-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-41-.04}

Beginning October 1, 2019, each Hospital in this state shall make public the most recent version of the following subject documents:

(1) Federal related disclosures:

(A) Copies of audited financial statements that are general purpose financial statements, which express the unqualified opinion of an independent certified public accounting firm for the most recently completed fiscal year for the Hospital; each of its Affiliates, except those Affiliates that were inactive or that had an immaterial amount of total assets; and the Hospital's parent corporation that include the following:

(i) A PDF version of all audited financial statements;

(ii) A note in the Hospital's audited financial statements that identifies individual amounts for such Hospital's gross patient revenue, allowances, charity care, and net patient revenue;

(iii) Audited consolidated financial statements for Hospitals with subsidiaries and consolidating financial statements that at a minimum contain a balance sheet and statement of operations and that provide a breakout of the Hospital's and each Subsidiary's numbers with a report from independent accountants on other financial information; and

(iv) Audited consolidated financial statements for the Hospital's parent corporation and consolidating financial statements that at a minimum contain a balance sheet and statement of operations and that provide a breakout of the Hospital's and each Affiliate's numbers with a report from independent accountants on other financial information; and

(B) Copy of audited Internal Revenue Service Form 990, including Schedule H for hospitals and other applicable attachments; provided, however, that for any Hospital not required to file IRS Form 990, the department shall establish and provide a form that collects the same information as is contained in Internal Revenue Service Form 990, including Schedule H for hospitals, as applicable; and

(2) Georgia supplemental disclosures:

(A) Copy of the Hospital's completed annual hospital questionnaire, as required by the department;

(B) The community benefit report prepared pursuant to O.G.C.A. § 31-7-90.1 , if applicable;

(D) Listing of all Real Property Holdings of the Hospital, including the location and size, parcel ID number, purchase price, current use, and any improvements made to such property;

(E) Listing of any ownership or interest the nonprofit Hospital has in any Joint Venture, partnership, Subsidiary Holding Company, or Captive Insurance Company; where any such entity is domiciled; and the value of any such ownership or interest;

(F) Listing of any bonded indebtedness, outstanding loans, and bond defaults, whether or not in forbearance; and any bond disclosure sites of the Hospital;

(G) A report that identifies by purpose, the ending fund balances of the net assets of the Hospital and each Affiliate as of the close of the most recently completed fiscal year, distinguishing between donor permanently restricted, donor temporarily restricted, board restricted and unrestricted fund balances. The Hospital's interest in its foundation shall be deducted from the foundation's total fund balance;

(H) Copy of all going concern statements regarding the Hospital;

(I) The most recent legal chart of corporate structure, including the Hospital, each of its Affiliates and Subsidiaries, and its Parent Corporation, duly dated;

(J) Report listing the salaries and fringe benefits for the ten highest paid Administrative Positions in the Hospital. Each position shall be identified by its complete, unabbreviated title. Fringe benefits shall include all forms of compensation, whether actual or deferred, made to or on behalf of the employee, whether full or part-time;

(K) Evidence of accreditation by accrediting bodies, including, but not limited to, the Joint Commission and DNV; and

(L) Copy of the Hospital's policies regarding the provision of charity care and reduced cost services to the indigent, excluding medical assistance recipients, and its debt collection practices.

History

Authority: O.C.G.A. § 31-7-22
History. Original Rule entitled "Required Documentation" adopted. F. Dec. 12, 2019; eff. Jan. 1, 2020.

Ga. Comp. R. & Regs. r. 111-8-41-.05 Posting Requirements {#sec-ga.-comp.-r.-regs.-r.-111-8-41-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-41-.05}

(1) Each Hospital shall post a Link entitled "Hospital Transparency Information" in a prominent location on the main page of its website to the documents listed in Rule 111-8-41-.04 on July 1 of each year or more frequently at its discretion. Documents from prior years shall remain posted and accessible on the Hospital's website indefinitely.

(2) All documents listed in Rule 111-8-41-.03 shall be prepared in accordance with generally accepted accounting principles, as applicable.

(3) Each Hospital shall provide the Link to the department annually and in the manner requested.

(4) The department shall post the Link in a prominent location on its website for each Hospital in this state.

History

Authority: O.C.G.A. § 31-7-22
History. Original Rule entitled "Posting Requirements" adopted. F. Dec. 12, 2019; eff. Jan. 1, 2020.

Ga. Comp. R. & Regs. r. 111-8-41-.06 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-41-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-41-.06}

(1) Any Hospital that fails to post the documents required by these Rules within 30 days of the dates required in this Rule section shall be suspended from receiving any State Funds or any donations pursuant to O.C.G.A. § 48-7-29.20 ; provided, however, that the department shall provide a hospital notice of any deficiency and opportunity to correct such deficiency prior to any suspension of funds pursuant to this subsection.

(2) Any hearing under these Rules shall be held in accordance with the Georgia Administrative Procedure Act.

(3) Any person who knowingly and willfully includes false, fictitious, or fraudulent information in any documents required to be posted pursuant to O.C.G.A. § 31-7-22 and these Rules shall be subject to a violation of O.C.G.A. § 16-10-20 and be referred by the department to the Office of the Attorney General for investigation.

History

Authority: O.C.G.A. § 31-7-22
History. Original Rule entitled "Enforcement" adopted. F. Dec. 12, 2019; eff. Jan. 1, 2020.

Subject 111-8-47 Intermediate Care Homes

Ga. Comp. R. & Regs. r. 111-8-47-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.01}

Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning hereinafter respectively ascribed to them; except, however, same do not apply to facilities owned or operated by the federal government:

(a) An "Intermediate Care Home" is a facility which admits residents on medical referral; it maintains the services and facilities for institutional care and has a satisfactory agreement with a physician and dentist who will provide continuing supervision including emergencies; it otherwise complies with these rules and regulations;

(b) The term "Intermediate Care" means the provision of food, including special diets when required, shelter, laundry and personal care services, such as help with dressing, getting in and out of bed, bathing, feeding, medications and similar assistance, such services being under the supervision of a registered, licensed undergraduate, or licensed practical nurse.1. Intermediate care does not normally include providing care for bed patients except on an emergency or temporary basis, the insertion or changing of catheters, handfeeding of patients, and the care of patients who cannot go to the medication area without assistance.

(c) The term "Distinct Part" means a physically identifiable unit of a medical facility such as an entire ward or contiguous wards, wing, floor, or building. It consists of all beds and related facilities in the unit;

(d) The term "Intermediate Care Unit" means a clearly defined administrative unit within which is located a specified number of resident beds and supportive services;

(e) The term "Medication Area" means a circumscribed space within the Intermediate Care Unit containing equipment for proper storage, preparation and administration of medicines prescribed by the residents' physician or dentist;

(f) The term "Resident" means any person residing in and receiving care in an Intermediate Care Home. Residents are individuals who because of their physical or mental condition (or both) require living accommodations and care which, as a practical matter, can be made available to them only through institutional facilities; and who do not have such an illness, disease, injury or other condition as to require the degree of care and treatment which a hospital or nursing home is designed to provide;

(g) The term "Resident Activities Program" means a schedule of events which are regularly planned for all residents, including social and recreational activities involving active participation by the residents, entertainment of appropriate frequency and character and opportunities for participation in community activities as possible and appropriate;

(h) The term "Transfer Agreement" means a written contract with other facilities providing for transfer of residents between the facilities and for interchange of medical and other information, when the facility cannot provide the level of care needed by the resident;

(i) "Physician" shall mean a doctor of medicine and/or a doctor of osteopathy duly licensed to practice in this State by the Georgia Composite Medical Board, under the provisions of the Georgia Medical Practice Act (O.C.G.A. § 43-34-1 et seq.);

(j) "Dentist" means any person who is licensed to practice in this State under the provisions of the Dentists and Dental Hygienists Act;

(k) "Pharmacist" shall mean an individual licensed to practice pharmacy in accordance with the provisions of the Pharmacy Practice Act, O.C.G.A. § 26-4-1 et seq.;

(l) "Physical Therapist" shall mean an individual who practices physical therapy and who is registered with the Board of Physical Therapy of the State of Georgia (O.C.G.A. § 43-33-1 et seq.);

(m) A "Registered Nurse" is a person who holds a current and valid license as a registered nurse issued by the State of Georgia;

(n) A "Licensed Undergraduate Nurse" is a person who holds a current and valid license as a licensed undergraduate nurse issued by the State of Georgia;

(o) A "Licensed Practical Nurse" is a person who holds a current and valid license as a licensed practical nurse issued by the State of Georgia;

(p) The term "Full-time Employee" means any person employed who normally works at least forty (40) hours per week in the home;

(q) The term "Governing Body" means the Board of Trustees, the partnership, the corporation, the association, the person or group of persons who maintain and control the home and who is legally responsible for the operation;

(r) The term "Administrator" means an individual who is licensed by the Georgia State Board of Nursing Home Administrators and who has the necessary authority and responsibility for management of the home;

(s) "Permit" means authorization by the Department to the Governing Body to operate a home and signifies satisfactory compliance with these rules and regulations.

(t) "Provisional Permit" means authorization by the Department to the Governing Body to operate a home on a conditional basis for a period not to exceed six months to allow a newly established home a reasonable but limited period of time to demonstrate operational procedures in satisfactory compliance with these rules and regulations; or to allow an existing home a reasonable length of time to comply with these rules and regulations, provided said home shall first present a plan of improvement acceptable to the Department. Successive Provisional Permits may be granted to any home having deficiencies only in exceptional cases, in which cases the governing body must present a plan of improvement acceptable to the Department;

(u) The term "Plan of Improvement" means a written plan submitted by the Governing Body and acceptable to the Department. The plan shall identify the existing noncompliances of the institution, the proposed procedures, methods, means and period of time to correct the noncompliances;

(v) The term "Board" means the Board of Community Health;

(w) The term "Department" means the Department of Community Health;

(x) The term "Commissioner" means the chief executive of the Department.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Definitions" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.02 Governing Body {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.02}

(1) There shall be a governing body which assumes full legal responsibility for the overall conduct of the facility.

(2) The ownership of the facility shall be fully disclosed to the Department. In the case of corporations, partnerships and other bodies created by statute, the corporate officers and all others owning ten percent or more of the corporate stock or ownership shall be made known to the Department.

(3) The governing body shall be responsible for compliance with all applicable laws and regulations pertaining to the facility.

(4) The governing body shall certify to the Commissioner, the name of the person to whom is delegated the responsibility for the management of the facility, including the carrying out of rules and policies adopted by the governing body. This person shall be known as the administrator.

(5) The word hospital, sanitorium or sanitarium shall not be used in the official title of any home permitted under the provisions of these rules and regulations.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Governing Body" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.03 Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.03}

(1) Each intermediate care home shall be under the supervision of a licensed nursing home administrator. An administrator may serve as the administrator of not more than one facility, except that two facilities having common ownership or management located on the same premises may be served by a single administrator. Distinct part facilities sharing a common roof shall be considered one facility. In exceptional circumstances, a waiver may be granted by the Department for a period of six months.

(2) Each home shall be operated in accordance with policies approved by the Department. These policies shall include but not be limited to those governing admissions, transfers, discharges, physicians' and dental services, social services, intermediate resident care services, housekeeping, environmental sanitation, recreational services and health records.

(3) Each facility shall have a written transfer agreement in effect with one or more hospitals and nursing homes. Intermediate care homes that are a Distinct Part of a hospital or skilled nursing home will be considered to meet this requirement if acceptable provisions for the transfer of residents are included in the home's policies.

(5) The facility and its premises shall be used only for those purposes for which the facility is operated and permitted.

(6) In response to a reasonable request by a resident or visitor, privacy shall be afforded for private conversation and/or consultations.

(7) Criminal History Background Checks for Owners Required. Prior to the issuance of any new license, the owner of the business or agency applying for the license must comply with the requirements of the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(8) Criminal History Background Checks for Administrators Required. The home must obtain a satisfactory fingerprint records check determination for the person being considered for employment as an administrator. The records check determination must be done in compliance with the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(9) Criminal History Background Checks for Direct Access Employees Required. Prior to serving as a direct access employee, the home must obtain a satisfactory fingerprint records check determination for the person to be hired in compliance with the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

History

Authority: O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Administration" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.
Amended: F. June 11, 2026; eff. July 1, 2026.

Ga. Comp. R. & Regs. r. 111-8-47-.04 Personal Care Services {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.04}

(1) A registered nurse, licensed undergraduate nurse, or a licensed practical nurse, shall be employed full time as supervisor of care.

(2) In addition to the supervisor of care, there shall be sufficient staff members on duty at all times to assure each resident proper care according to his needs. This includes staff members awake and on duty all night. Proper care includes, but is not limited to: assistance with activities of daily living, clean and proper clothing, good grooming, free of body odor, clean hair and scalp, clean and trimmed finger and toe nails, daily mouth care and barber services, including shaves.

(3) All resident care and related services shall be carried out in accordance with written resident care policies which are assembled, available and understood by all staff and including but not limited to:

(a) Clearly established lines of administrative and supervisory responsibility;

(b) Clearly defined duties which are assigned to staff members and consistent with their training and experience.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Personal Care Services" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.05 Professional Service {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.05}

(1) Residents shall be admitted only on medical evaluation and referral.

(2) Each resident's health care is under the continuing supervision of a physician who sees the resident as needed and in no case less often than sixty (60) days, unless justified otherwise and documented by the attending physician.

(3) There shall be a physician and dentist on call who will provide for the resident's medical and/or dental needs when his attending physician or dentist is not available.

(4) A home shall admit only those residents for whom it can provide the care needed and for which it holds a permit.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Professional Service" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.06 Dietary Service {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.06}

(1) If an intermediate care home accepts or retains residents in need of medically prescribed special diets, the menus for such diets shall be planned by a qualified dietitian (American Dietetic Association or equivalent qualifications), or shall be reviewed and approved in writing by the attending physician.

(2) Meals, adequate as to quantity and quality, shall be served in sufficient numbers with a maximum of five (5) hours apart with no longer than fourteen (14) hours between the evening meal and breakfast. Between meal and bedtime snacks shall be offered to each resident.

(3) A nutritionally adequate diet shall be provided all residents and adjusted to resident's age, sex, activity, and physical condition. Nutrient concentrates and supplements shall be given only on written order of a physician.

(4) Menus shall be planned and dated. Used menus shall be kept on file for a period of thirty days for reference by the resident's physician and personnel of the home.

(5) Modified diets shall be provided in accordance with written orders of a physician or dentist. An approved diet manual shall be readily available to food service personnel.

(6) Sufficient perishable foods for a twenty-four hour period and nonperishable foods for a three-day period shall be on the premises for use in an emergency.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Dietary Service" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

(1) Each home shall provide services to assist all residents in dealing with social and related problems through one or more caseworkers on the staff of the facility or through arrangements with an appropriate outside agency.

(2) Social service information concerning each resident shall be obtained and kept. This information shall cover social and emotional factors related to the resident's condition and information concerning his home situation, financial resources and relationships with other people.

(3) All employees having contact with residents shall receive social service orientation and inservice training toward understanding emotional problems and social needs of residents.

(4) One person in each home shall be designated as being responsible for the social services aspects of care in the home.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Social Service" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.08 Medications {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.08}

Each facility shall insure that the handling of patient medication is in full compliance with state and federal laws and regulations.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Medications" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.09 Physical Therapy Service {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.09}

(1) When a home has a physical therapy program, the services must be provided or directly supervised by a physical therapist.

(2) A therapy record will be kept as part of the health folder on each resident receiving physical therapy. Information in the health folder shall include referral, diagnosis, precautions, initial physical therapy evaluation, treatment plans and objectives, frequency and dates of medical reevaluation.

(3) The physical therapist shall keep progress notes on each resident including progress or lack of progress, symptoms noted, and changes in treatment plans.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Physical Therapy Service" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.10 Resident Care {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.10}

(1) Each resident shall have a physician's written statement of his or her condition at time of admission or within forty-eight (48) hours thereafter and it shall be kept on file in the resident's health folder.

(a) Physicians' prescriptions for medications for residents needing medication shall accompany the resident upon admission to the facility;

(b) The physician's statement of the resident's condition should state any special care required including special diets.

(2) Each home shall have a written agreement with a physician and a dentist who will be available to the home for emergencies, and who will provide the home with consultation concerning medical and dental problems.

(3) Each home shall maintain a plan of care for each resident. This plan shall be kept current and will show, as a minimum, the name and frequency of medications, kind of diet, social problems, special care required, and ability to provide self-care. The plan of care shall be available to all personnel.

(4) Reports of all resident evaluations and examinations shall be kept in the individual health folder.

(5) The home shall have a microbial and infection control program. Policies and procedures for infection control shall be written, assembled and available to all staff members. Procedures shall be specific for practice in the home and shall be included in the training of every staff member. As a minimum, procedures shall include the following control measures:

(a) Prevention of spread of infection from personnel to resident: Any person whose duties include direct resident care, handling food, or handling clean linen, and who has an acute illness such as "strep" throat, or an open sore or boil, shall not be allowed to work until he is fully recovered;

(b) Prevention of spread of infection from visitors to residents;

(c) Prevention of spread of infection from resident to personnel or other residents. Isolation techniques to be observed according to the source of infection and the method of spread; and

(d) Reporting of communicable diseases as required by the rules and regulations for notification of diseases which have been promulgated by the Department of Public Health.

(6) Restraint and/or forcible seclusion of a resident will be permitted only on a signed order of a physician, except in an emergency and then only until the advice of a physician can be obtained.

(7) Provisions shall be made for proper sterilization of supplies, utensils, instruments and other materials as needed for the residents.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Resident Care" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.11 Records {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.11}

(1) There shall be an individual health folder for each resident including:

(a) The name, address and telephone number of his physician and dentist;

(b) A record of the physician's findings and recommendations including the preadmission evaluation of the resident's condition and subsequent reevaluations and all orders and recommendations of the physician for care; and

(c) All symptoms and other indications of illness or injury brought to the attention of the staff by the residents, or from other sources, including the date, time and action taken regarding each.

(2) Each facility shall keep resident statistics, including admissions, discharges, deaths, resident days, and percent of occupancy. Statistical records shall be open for inspection, and upon request, data shall be submitted to the Department.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Records" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.12 Equipment {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.12}

(1) Resident beds shall be single, at least thirty-six (36) inches wide, with firm even springs covered by a mattress not less than four inches thick.

(2) The home shall provide all linens and blankets essential to the treatment and comfort of residents.

(3) Wheelchairs and walkers shall be provided by the home when needed.

(4) Each resident shall have necessary furniture which shall include a bedside table, a reading lamp, a chair, drawer space for clothes, enclosed space for hanging clothing, individual towel rack, soap dish, drinking glass, and access to a mirror. Each resident shall have a suitable signaling device.

(5) Individual equipment shall be cleaned after each use and disinfected at least once each week. Equipment such as bedpans, urinals and wash basins, if not individual, should be disinfected after each use.

(6) Each resident shall be provided adequate supplies and equipment for proper oral hygiene including a toothbrush or a denture brush and denture receptacle when needed.

(7) Bedrails shall be available for use as required by the resident's condition.

(8) There shall be an electric clock with a bold face that can be read from a distance of twenty (20) feet installed in the lobby of each home.

(9) Disposable equipment and supplies shall be used only once and disposed of in an approved manner.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Equipment" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.13 Safety {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.13}

(1) All buildings and equipment shall be maintained in such condition that no hazards to the life and safety of the patients exist.

(2) Adequate parking shall be available nearby. Parking areas and service entrances shall be so designated that fire fighting equipment will have unobstructed access to all parts of the building.

(3) Handrails shall be provided on all stairways and ramps. Stairtreads shall be made of or covered with safe nonslip material. Doors opening onto stairways shall not open directly onto risers, but shall open onto a landing not less than the width of the door.

(4) Safety barriers at the head of stairways, and handrails in hallways shall be provided. There shall be no low windows, open porches, changes in floor levels or similar hazards.

(5) Doors to rooms used by residents shall be equipped with locks or other devices which will not allow the room to be locked from the inside.

(6) Floor surfaces shall be smooth and level; scatter rugs and highly polished floors in resident areas are prohibited.

(7) Showers, tubs, and toilets shall have grab bars firmly installed convenient to resident use; the floor in bathing areas shall be provided with a nonslip surface. No resident shall be permitted to bathe without an attendant available to regulate water temperature and to provide generally for the safety of the resident, unless the resident's physician has provided a written statement to the effect that the resident is sufficiently responsible to bathe himself. Shower heads shall not be installed above bathtubs.

(8) Warning signs shall be posted prohibiting smoking or open flames of any kind in areas where oxygen is in use or stored.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Safety" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.14 Environmental Sanitation and Housekeeping {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.14}

(1) Equipment and supplies for proper sanitation will be maintained on the premises.

(2) Laundry shall be handled, stored and processed so that spread of infection will be minimized. A sufficient clean linen supply shall be insured at all times. Soiled linen shall not be permitted to accumulate.

(3) The premises and all areas within the home shall be kept clean and free from debris. Ventilation openings, such as ports for exhaust fans, shall be equipped with covers that close automatically when the fan is not in operation. Doors and other openings shall be equipped and maintained to minimize the ingress of flies, insects and rodents.

(4) Provision shall be made to maintain clean containers and store garbage in areas that are separate from food handling, food preparation and food storage area.

(5) Sanitary containers, sputum cups, and other satisfactory individual containers must be provided when needed.

(6) Each home shall have an infection control program which provides for policies, procedures and training programs. Great care should be exercised to prevent spread of infection by fomites or by infected person to person.

History

Authority: Ga. L. 1964, pp. 507. 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Environmental Sanitation and Housekeeping" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.15 Health of Employees {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.15}

(1) Health Screenings. Each home shall have in place a health screening program designed to identify conditions that may place residents at risk for infection, injury, or improper care. The program shall include requirements and processes for initial, routine, and targeted health screenings for employees and contractors who interact with residents or conduct other activities with environmental impact.

(2) Screening for Tuberculosis (TB). Prior to starting work, all employees must be screened for TB in accordance with Centers for Disease Control and Prevention (CDC) guidelines for baseline screening and testing for health care personnel.

(3) Records. Copies or certificates of the health screenings shall be kept in the employee's personnel folder.

History

Authority: O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Health of Employees" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.
Amended: F. June 11, 2026; eff. July 1, 2026.

Ga. Comp. R. & Regs. r. 111-8-47-.16 Recreation {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.16}

(1) An individual shall be designated as being in charge of resident activities. This individual shall have experience and/or training in group activities, or shall have consultation made available from a qualified recreational therapist or group activity leader.

(2) Provisions shall be made for suitable recreational and entertainment activities for residents according to their needs and interests. These activities are an important adjunct to daily living and are to encourage restoration to self-care and resumption of normal activities. Variety in planning shall include some outing activities in suitable weather.

(3) Residents shall be encouraged but not forced to participate in patient activities.

(4) The facility shall make available a variety of supplies and equipment adequate to satisfy the individual interests of residents. Examples are: books, magazines, daily newspapers, games, stationery, radio, television, and the like.

(5) An active resident activities program shall be carried out that will meet the needs of all residents.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Recreation" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.17 Resident Capacity {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.17}

(1) The number of beds provided shall be indicated on each permit and provisional permit.

(2) The number of residents receiving care within the home shall not exceed the number of beds shown on the permit. In exceptional cases, temporary waivers, not to exceed thirty (30) days, may be granted by the Department.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq, Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Resident Capacity" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.18 Physical Plant Standards {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.18}

(1) Requirements under this rule "Physical Plant Standards" will be enforced with the effective date of these regulations. In exceptional cases and upon application to the Department by the governing body of the home, variances may be granted at the discretion of the Department if it is determined that these requirements will place an undue burden or extreme hardship on the home or its occupants, provided that the health or safety of the residents is not jeopardized.

(2) At least two rooms per fifty (50) beds shall be designed for single occupancy (one bed). At least one room designed for single occupancy shall have an adjoining private bathroom, containing a lavatory, water closet and a bathtub or shower equipped with grab bars. Intermediate care homes which are a Distinct Part of a nursing home may utilize the single occupancy rooms of the nursing home, provided that there are at least two single occupancy rooms per each fifty (50) beds for the combined patient and resident capacities.

(3) All resident rooms shall open into corridors leading to the exterior of the building. No resident room will be so located as to make it necessary for a resident to pass through another room to gain entrance to a corridor leading to the exterior.

(4) Each resident room shall be an outside room with window space equal to at least one-eighth of the floor area with opening in area large enough to remove resident by mattress.

(5) Resident bedrooms shall contain not less than one hundred (100) square feet of usable floor space in private or single rooms and no less than eighty (80) square feet per bed of usable floor space in multibed rooms. Usable floor space is in addition to area provided for closets, toilet rooms and entry ways.

(6) Not less than three (3) feet or space shall be provided between beds and between the foot of the bed and wall or other obstruction. There shall be sufficient space so beds may be made accessible from both sides for nursing care when needed.

(7) An individual clothes closet or wardrobe with door shall be provided per bed in every resident room. Clothes closets or wardrobes shall be at least twenty-two (22) inches deep and twenty (20) inches wide with at least one shelf above a hanging space equipped with a device for clothes hangers.

(8) There shall be sufficient bedside screens available to provide privacy for residents when needed or requested. Bedside screens shall be rendered and maintained flame resistant.

(9) Employees, staff, and visitors shall not use water closets provided for residents. Toilets, including a water closet, lavatory, soap, paper towels and dispensers shall be provided near or adjacent to the following locations:

(a) Medication area;

(b) Kitchen;

(10) Resident bathing and toilet facilities:

(a) Unless there is a bathroom adjoining each resident's room containing a lavatory, water closet and a bathtub or shower there shall be a general bathing area in each Intermediate Care Unit. This area shall contain at least one bathtub accessible from three sides, one stall shower with adjacent drying space, one lavatory, with soap, paper towels and dispenser, and one water closet. This unit shall be of sufficient size to provide space for dressing, a wheelchair, and an attendant. Unless the bathing fixtures are located in separate rooms, compartments must be provided to permit independent use to afford privacy for each sex. Special institutional tubs or showers may be approved for use if the program of service indicates;

(b) At least one enclosed water closet and one lavatory shall be provided for each eight beds or major fraction thereof;

(c) At least one bathing facility (bathtub or shower) shall be provided for each fifteen (15) beds, or major fraction thereof, located in patient bedrooms that do not adjoin a toilet room in which a bathing facility is located;

(d) Unless bathtubs in bathrooms adjoining resident rooms are located so as to be accessible from three sides, handrails or grab bars on the tub or on the wall by the tub shall be provided;

(e) All shower stalls shall be at least four feet by four feet square and must have handrails on three sides, be equipped with curtains and be designed for wheelchair use. Thresholds to showers must be flush with the floor. The floor of the shower stall shall drain properly;

(f) Grab bars, securely attached to walls and conveniently located, adjacent to all bathtubs, showers, and water closets intended for resident use shall be provided.

(11) A medication area shall be provided in each Intermediate Care Unit. It shall contain a call system, charting desk and supplies, medicine storage, lavatory with soap, towels and towel dispenser, preparation area and a refrigerator.

(12) There shall be a floor pantry in each Intermediate Care Unit located near or adjacent to the medication area. The floor pantry shall contain a hot plate, sink, counter, cabinets and a refrigerator that shall not be used to store drugs, biologicals, or laboratory specimens.

(13) There shall be separate clean and soiled utility rooms in each Intermediate Care Unit located near the medication area. The clean utility room shall contain wall and base cabinets and stain resistant counter top, a small sink set into the counter or with drain boards. The soiled utility room shall contain a counter with a stain resistant top and storage cabinets underneath. In addition, it shall contain a deep service sink with stopper for chemical sterilization of bedpans, urinals and commode pails. The deep service sink with stopper may be omitted if a steam autoclave for sterilizing is available to the home.

(14) At least one bedpan cleansing device shall be provided in each Intermediate Care Unit. It may be located in the soiled utility room or in a special bedpan closet conveniently located. The bedpan cleansing device may be omitted if water closets in residents' toilets are equipped with bedpan lugs, spray hose and elevated vacuum breaker.

(15) Sufficient space shall be provided in each Intermediate Care Unit for stretcher and wheelchair parking. Such space shall be out of corridor traffic.

(16) A drinking fountain which shall not impair any passageway shall be provided in each Intermediate Care Unit.

(17) There shall be a treatment room convenient to resident rooms containing a treatment table, lavatory equipped with soap, paper towels and dispenser, instrument table and storage cabinet, and providing adequate room for transfer of residents. A treatment room may be used for consultation if appropriately enlarged. Intermediate care homes that are a Distinct Part of a hospital or nursing home may utilize the treatment room in the other facility.

(18) There shall be a resident dining and recreation area provided in each facility. The minimum total area shall be twenty (20) square feet of floor space per bed. One-half the required space shall be for dining. Intermediate care facilities that are a Distinct Part of a nursing home may utilize the dining facilities of the other facility if the dining facilities are of sufficient size to accommodate the total patient and resident capacity.

(19) A room with sufficient space for residents' active exercise regimens including such equipment as a full-length mirror, parallel bars, steps, a wall-mounted wheel, and an exercise table shall be provided. The room shall also contain a lavatory with gooseneck spout and wrist controls. Soap, paper towels and towel dispenser shall also be provided.

(20) There shall be a lobby and/or waiting room in each facility. The size of this area shall be determined according to the size of the facility and the program of service. Intermediate care homes that are a Distinct Part of a nursing home may utilize the lobby or waiting room of the other facility.

(21) There shall be at least one building exit at ground level and at least one building exit shall be provided with a suitable ramp designed for a stretcher or a wheelchair. There shall be one such exit leading to the outdoor recreation area.

(22) A public telephone shall be located near the lobby. At least one telephone shall be arranged to be convenient for a wheelchair user.

(23) The central kitchen area shall be located to permit efficient service to the dining rooms and the Intermediate Care Units. It must be arranged and equipped for adequate food storage; preparation and serving of food in proper sequence; dish and utensil cleaning and storage; and refuse storage and removal. Homes that are a Distinct Part of another facility may utilize the service of a central kitchen provided it is of adequate size and adequately equipped to serve the total patient/resident population. Storage space shall be sufficient to store a 24-hour supply of perishable foods and a 3-day supply of nonperishable foods.

(24) Each facility shall have a laundry room with adequate washing and drying equipment for the use of residents to launder their personal clothing.

(25) Separate and adequate clean laundry storage and separate and adequate soiled laundry storage rooms shall be provided appropriate to the frequency of deliveries and linen needs.

(26) Janitor's closets shall be provided on the basis of at least one closet for the dietary area and one for the remainder of the home. This room shall be of sufficient size to include racks for equipment, storage space, and a service sink.

(27) General storage space for the storage of supplies, furniture, equipment and residents' possessions shall be provided. Such space may be provided in one or more rooms and shall be commensurate with the needs of the home, but not less than five (5) square feet per bed.

(28) Maintenance area or areas commensurate with the needs of the home, including storage space for building and grounds maintenance equipment, tools, supplies and materials and shop space for mechanical, painting and carpentry work shall be provided.

(29) Floor, wall and ceiling finishes shall be smooth, easily cleaned and be wear-resistant appropriate to location. In addition, the floors of the following spaces shall be waterproof: toilets, baths, bedpan rooms, floor of pantries, kitchens, utility rooms, janitors' closets and treatment rooms. Areas subject to wetting shall have nonslip flooring. Carpeting, wall and ceiling finishes shall be approved by the State Fire Marshal.

(30) Stairways, door and corridors:

(a) Stairways serving resident areas shall not be less than forty-four (44) inches in clean width;

(b) Stairs shall be individually enclosed and be separated from any public hall;

(c) A landing shall be provided at the top and bottom of every stair run. Doors shall swing with exit travel to provide safe exit;

(d) The minimum dimension of landing shall be as wide as the required width of the stairway it serves. A door swinging into a landing, when open, shall not overlap the required width of the landing;

(e) The width of stair to risers shall not be less than ten (10) inches plus a one inch nosing;

(f) Winders and single risers are not acceptable;

(g) Stairs and landings shall have a nonslippery finish;

(h) Residents' room corridor entrances and all required exits shall be not less than forty-four (44) inches in clean width. All other doors through which residents must pass shall be not less than thirty-six (36) inches in clean width except that doors to toilets in resident bedrooms may be not less than thirty-two (32) inches wide. Doors through which residents or equipment do not pass shall be not less than thirty (30) inches wide, except that doors to resident closets may not be less than twenty (20) inches wide;

(i) When a door swings out on any platform, balcony, or porch or terrace, the minimum width of the platform, balcony, porch or terrace shall be thirty (30) inches plus the width of the door, measured at right angles to the wall containing the door. Exit doors, other than for living units shall swing in the direction of exit from the structure;

(j) Corridors in areas used by residents shall be not less than eight (8) feet in clean width. Handrails may project into corridors, but drinking fountains, desk or other projections or obstructions may not reduce the eight (8) foot minimum dimension;

(k) Ramps shall be not less than forty-four (44) inches wide. Where ramps provide a change of corridor level, the minimum width shall be not less than that of the corridor;

(l) The maximum slope of ramps shall be not greater than ten (10) percent. Changes in direction, if any, shall be on level landings with a minimum width the same as the ramp width;

(m) Ramps shall have a nonslip finish. Ramps serving as a required means of egress shall be enclosed or protected as indicated for required stairways;

(n) Handrails shall be provided on each side of all resident corridors and on each side of stairways and ramps.

(31) Light and Ventilation:

(a) The total glass area in resident bedrooms shall be not less than one-eighth of the floor area of the room. The ventilating area shall be not less than four (4) percent of the floor area;

(b) Openings providing required natural light, which open on a covered porch whose depth exceeds four (4) feet, shall be increased in area ten (10) percent per foot of depth over four (4) feet;

(c) The heads of windows (sash opening) shall not be more than one foot below the finished ceiling unless they are at least six (6) feet, eight (8) inches above the finished floor. The lower level of the window glass shall be not more than forty-eight (48) inches above the floor level;

(d) Ceiling heights shall be not less than eight (8) feet except that seven (7) feet six (6) inches may be used in corridors, halls, toilet rooms and bathrooms;

(e) The lower edge of resident bedroom windows shall in every instance be above grade.

(32) Mechanical:

(a) All bathrooms and toilet rooms shall be provided with mechanical ventilation capable of producing a minimum of ten (10) air changes per hour. Utility rooms, community rooms and corridors shall be provided with not less than four (4) changes per hour with at least two (2) of the air changes being outside air. Ducts ventilating bathrooms or toilet rooms shall not be interconnected with other duct systems but shall be discharged to the outside. Resident rooms shall be provided with at least two (2) air changes per hour of outside air. Corridors and exit halls shall not be used as a plenum for supply or return air to heating or air-conditioning systems;

(b) Kitchens, laundries, non-refrigerated garbage storage rooms, and rooms used to store combustible materials, shall be provided with an independent system of mechanical ventilation discharging above the roof and remote from any window. A minimum of ten (10) air changes per hour shall be provided. Exhaust hoods shall be installed over cooking ranges;

(c) All buildings shall be provided with a heating system designed to maintain a temperature of 75 degrees Fahrenheit in all habitable rooms and corridors when the outside temperature is at design level. The heating system should provide warm floors;

(d) All steam-operated equipment such as sterilizers, laundry and kitchen units, shall be provided with steam at temperatures and pressures as recommended by the equipment manufacturers;

(e) The quality and quantity of the water supply and the method of sewage disposal shall have the approval of the Department;

(f) A safe method shall be employed to heat water to provide an adequate supply of hot water at necessary temperatures for all purposes;

(g) Temperature controls shall be provided so that hot water for personal uses shall not exceed 110 degrees Fahrenheit;

(h) Hot water temperatures for other uses shall be as required by the equipment served;

(i) The quantity of hot water for kitchens and laundries shall be adequate to serve the equipment installed;

(j) Wrist control handles shall be provided for sinks or lavatories in floor pantries, medicine preparation rooms, clean utility rooms, soiled utility rooms, treatment or examination rooms, rehabilitation or physical therapy rooms and at handwashing fixtures in the kitchen area;

(k) Gooseneck spouts shall be provided for sinks or lavatories in treatment or examination rooms, physical therapy or rehabilitation rooms and at handwashing fixtures in the kitchen area;

(l) Vacuum breakers shall be provided for any plumbing fixture having a hose or hoses attached or to any plumbing fixture having trim to which a hose may be attached, including shampoo sinks, service sinks, combination hot and cold water outlets at can wash areas and hose bibs for clean-up purposes in the dishwashing area of kitchens;

(m) Aerators shall not be included as part of trim for plumbing fixtures;

(n) With relationship to adjacent areas, a positive air pressure shall be provided for clean utility rooms, floor pantries and medicine preparation rooms;

(o) With relationship to adjacent areas, a negative air pressure shall be provided for soiled utility rooms, physical therapy or rehabilitation rooms, janitor's closets, soiled laundry rooms and bathrooms or toilets. Air from these rooms shall not be recirculated; air shall be exhausted;

(p) Floor grilles shall not be used for supply or return air openings in heating, air-conditioning or ventilating systems;

(q) Ventilation openings, such as ports for exhaust fans, etc., shall be equipped with covers that close automatically when the fan is not in operation;

(r) Intake air ducts shall be designed and maintained so as to prevent the entrance of dust and insects;

(s) Hot air ducts from the heating system shall not emit temperatures in excess of 150 degrees Fahrenheit.

(33) Electrical:

(a) All areas shall be adequately lighted as required by duties performed in each space. Bedrooms and combination living-bedrooms shall have a night light, a light for general illumination and a reading light at the head of each bed. The outlets for general illumination and night lights shall be switched at the door. The reading light shall be controlled at the bedside. Each stairway, hall, corridor, or general passage shall have five (5) foot candles of illumination, doubled at building and stair entrance, or change of floor level, or at ramps;

(b) Receptacles appropriate for the designed space use shall be located where plug-in service is required. There shall be not less than one duplex receptacle at the head or near the head of each bed. All other spaces shall have general and special purpose outlets suited to the need of the space; including an outlet in the lobby for an electric clock and receptacles for cleaning and maintenance equipment spaced not more than fifty (50) feet apart in corridors;

(c) Emergency lighting shall be provided for exits, stairs, and corridors which shall be supplied by an emergency generator or a battery with automatic switch;

(d) Each toilet room and bathroom and each bed location shall be furnished with an electrical or mechanical call signal audible or visible at the medication area. A duplex unit may be used for two beds.

(34) Elevators and Dumbwaiters:

(a) Where residents' rooms are located on more than one floor at least one elevator shall be provided. Other elevators shall be provided, depending upon the needs and size of the home;

(b) At least one elevator in multistory buildings shall be arranged of sufficient size to admit a stretcher and an attendant;

(c) Elevator doors shall be automatic slide type with safety interlock. Elevators shall be equipped with grab bars and an automatic self-leveling control which will automatically bring car platforms level with the landing;

(d) Dumbwaiter cabs shall be not less than twenty-four (24) by twenty-four (24) by thirty-six (36) inches of steel with one shelf.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Physical Plant Standards" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.19 Application for Permit {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.19}

(1) The governing body shall submit to the Department an application for a permit.

(2) The application for a permit shall be made on forms provided by the Department and shall be filed at least thirty (30) days prior to the anticipated date of opening and commencement of operation of a new home.

(3) A letter from the physician and dentist who have agreed to provide emergency service and the names of the administrator and supervisor of care shall accompany the application.

(4) A plan for progressive employment of personnel to match increasing occupancy and to assure compliance with these rules and regulations shall be submitted at the time established for the preopening inspection.

(5) Proof of ownership shall accompany the application.

(a) Corporations shall submit a copy of their charter and the name and address of all owners with ten (10) percent or more of the stock and shall identify each corporate officer;

(b) Nonprofit associations and hospital authorities shall submit legal proof of the organization, the name and address of each trustee and the office held, if any;

(6) Proof of an active liability insurance policy or a self-insurance trust for the home's benefit for a nursing home claim.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Application for Permit" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.20 Permits {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.20}

(1) To be eligible for a permit the home must be in satisfactory compliance with these rules and regulations and the provisions at law which apply to the locations, construction, and maintenance of homes and the safety of the patients therein.

(2) Prior to the issuance of a permit and at the request of the Commissioner, the governing body shall furnish to the Department evidence of satisfactory compliance with any laws or regulations thereunder applicable to homes but the enforcement of which is the responsibility of a department or agency of government other than the Department.

(3) Each home shall, as a condition precedent to obtaining or maintaining a permit to operate an intermediate care home, carry or be covered by liability insurance coverages or establish or have established for its benefit a self-insurance trust for a nursing home claim. If a home fails to carry or be covered by liability insurance coverages or establish or have established for its benefit a self-insurance trust for a nursing home claim, the Department shall provide notice to such home of its noncompliance and allow such home 60 days in which to comply. A home's failure to maintain such coverage or establish such trust shall result in the Department:

(a) Revoking such home's permit issued to operate the intermediate care home;

(b) Denying any application to renew such permit; and

(4) The permit shall be framed and publicly displayed at all times.

(5) Permits are not transferable from one governing body to another, nor valid when the home is moved from one location to another.

(6) The permit shall be returned to the Department when the home ceases to operate, or is moved to another location or the ownership changes or the governing body is significantly changed or the permit is suspended or revoked.

(7) A permit shall be required for each home located on different premises where more than one home is operated under the same governing body. When a home operates as distinct parts, then a permit shall be required for each distinct part.

(8) Each home shall be in compliance with O.C.G.A. § 26-2-370 et seq. entitled "Food Service Establishments" and the Rules and Regulations as adopted and promulgated thereunder, entitled "Rules and Regulations for Food Service" and with any amendment to the law or rules promulgated thereunder.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A.§§ 26-2-370 et seq., 31-2-4 et seq., 31-7-1 et seq., 31-2A-2 et seq
History. Original Rule entitled "Permits" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.21 Provisional Permits {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.21}

(1) Provisional permits may be granted to the governing body of a newly established home to demonstrate operational procedures in satisfactory compliance.

(2) A provisional permit may be granted to the governing body of an existing home to demonstrate operational procedures in satisfactory compliance.

(3) Provisional permits granted to allow a reasonable time to demonstrate satisfactory compliance of operational procedures shall be limited to a period of not more than six (6) months.

(4) A provisional permit may be granted to the governing body of an existing home to give reasonable time to comply with regulations and standards which relate to the structural or physical condition of the home.

(5) No provisional permits shall be granted to the governing body of a newly established home which is in substantial noncompliance with rules, regulations and standards relating to the structural or physical condition of the home. Provisional permits granted to allow time for correction of structural or physical conditions shall not exceed twelve (12) months.

(6) A provisional permit shall not be issued when there are noncompliances of any type which present an immediate hazard to the life, health or safety of the patients.

(7) No provisional permit shall be granted to an existing home unless the governing body shall first present to the Commissioner a plan of improvement which shall list each noncompliance to be corrected, the time required to demonstrate acceptable operational procedures or to correct noncompliances which relate to the structural or physical condition of the home and the means, methods and procedures to be used in the correction of the noncompliances.

(8) The governing body of a home operating under a provisional permit may petition the Department for an extension of time if needed to correct noncompliances where the failure to make such corrections within the time allotted is an extenuating circumstance beyond the control of the governing body. Such petitions shall be submitted to the Department at least thirty (30) days prior to expiration date of the provisional permit.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Provisional Permits" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.22 Inspections {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.22}

(1) The home shall be available at reasonable hours for observation and examination by properly identified representatives of the Department.

(2) The administrator or authorized representative shall notify the Department of the anticipated opening date of a newly constructed home in order that a preopening licensure survey of the home may be conducted to determine compliance with these rules and regulations.

(3) The administrator or his representative shall accompany the Department representative on tours of inspection.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Inspections" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.23 New Construction {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.23}

(1) General Requirements:

(a) A program narrative and all plans and specifications for construction, including additions, alterations, and renovations, shall be approved by the Department prior to commencing work on the building;

(b) The program narrative shall be submitted prior to or along with the schematic or initial plans for construction. The program narrative should include the following:

The names and addresses of each owner. If the owner is a public stock corporation, the names and addresses of each officer shall be included;
The geographical area to be served;
Admission policies;
Cooperative programs of service with local agencies, including hospitals and nursing homes;
Arrangements for medical and dental care, e.g., physicians on contract and agreements with hospitals, nursing homes and home health agencies for resident referral;
List of personnel by types of employees and proposed salaries;
Plans for securing the services of professional personnel including registered nurses, licensed practical nurses, social workers, dietitians, pharmacists, physicians and therapists;
A description of the service to be provided the community, i.e., the level of care to be provided and the economic segments of the population to be served;
Source and amount of financing;
Anticipated first two-year cost of operation, income and source of operating funds;
Exact location of proposed site;
Utilities available, i.e., electricity, gas, water, sewage and waste disposal, and transportation;
The name, address and telephone number of the person selected to represent the owner during the period of planning and construction.

(c) Any individual or group planning construction shall submit complete architectural, structural, mechanical and electrical plans and specifications to the Department for review and approval prior to any new construction, addition, alteration or renovation. Final plans submitted shall be in sufficient detail to show the building site, driveways and parking areas, type of construction, mechanical and electrical systems, the type and location of major items of equipment, the intended use of each room, the proposed location of beds, the type and source of utilities, food service system, and the proposed system of garbage and refuse disposal;

(d) Plans for addition and/or remodeling of an existing building will be submitted in sufficient detail to include type of construction and layout of the existing building to show overall relationship. Any changes in the approved final plans shall also be submitted to the Department for approval.

(2) Location and site:

(a) The site shall be approved by the Department;

(b) The site shall have proper drainage. Sewage disposal, water, electrical telephone, and other necessary facilities shall be available to the site.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "New Construction" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-47-.24 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-47-.24 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-47-.24}

The administration and enforcement of these rules and regulations shall be as prescribed in O.C.G.A. § 31-2-8 and the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25.

History

Authority: Ga. L. 1964, pp. 507, 612, as amended by Ga. L. 1969, p. 715 et seq., Ga. L. 1972, p. 1015 et seq., O.C.G.A. §§ 31-2-4, 31-2-8, 31-7-1 et seq
History. Original Rule entitled "Enforcement" adopted. F. Jan. 27, 2017; eff. Feb. 16, 2017.

Subject 111-8-50 Long-Term Care Facilities: Residents' Bill of Rights

Ga. Comp. R. & Regs. r. 111-8-50-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.01}

Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning hereafter respectively ascribed to them:

(a) "Administrator" means an individual who is licensed by the Georgia State Board of Nursing Home Administrators and who has the necessary authority and responsibility for management of the facility;

(b) "Department" means the Department of Community Health of the State of Georgia;

(c) "Long-term Care Facility" or "Facility" means any intermediate care home, skilled nursing home or intermingled home now or hereafter subject to regulation and licensure by the Department;

(d) "Resident" means any person residing in and receiving treatment in a long-term care facility;

(e) "Guardian" means a resident's legal guardian or conservator, or the parent of a minor resident who does not have a duly appointed guardian;

(f) "Representative" means a person authorized by a resident or his guardian to act for the resident as an official delegate or agent;

(g) "Long-term Care Ombudsman" or "Ombudsman" means a person certified as a community ombudsman or the state ombudsman pursuant to O.C.G.A. § 31-8-52 et seq. ;

(h) "Complainant" means resident, applicant for residency, guardian or representative, who presents a grievance or complaint;

(i) "Physician" shall mean a person duly licensed to practice in this State by the Composite State Board of Medical Examiners, under the provisions of O.C.G.A. § 43-34-1 et seq. ;

(j) "Person in Charge" means either the administrator of a facility or the person authorized by the administrator to be in charge when the administrator is not present;

(k) "Medical Necessity Review" means a review of the social and medical needs of a resident, whose stay is being paid by Medicaid or Medicare or other third party payor, to determine the appropriate level of care of such resident;

(l) "Referee" means a volunteer jointly chosen by the complainant and the administrator;

(m) "Grievance" means a complaint presented pursuant to Rule .14 of these regulations.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-102, 31-8-124 and 31-8-127
History. Original Rule entitled "Definitions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.02 Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.02}

(1) Each facility shall establish written policies and procedures to provide that it complies with these rules and regulations and provides for implementation of these rules and regulations at the facility. Such written policies and procedures shall not conflict with the intent of the Act nor these rules and regulations and shall not be more restrictive than these rules and regulations except where specifically provided.

(2) Each facility must conduct training or make provision for the training of all staff on a quarterly basis, and for new staff, as employed. The content of the training may vary from quarter to quarter as long as it provides that all staff are familiar with the Long-term Care Facilities: Residents' Bill of Rights. O.C.G.A. § 31-8-100 et seq. and these rules and regulations. Such training may be combined with any other quarterly training required to be done for staff of long-term care facilities. The facility shall document the dates, topics, and staff attending such training.

(3) Each facility must provide a written explanation of the rights, grievance procedures, and enforcement procedures to each resident and guardian, or representative if the resident does not have a guardian.

(4) A facility must bill for all charges at least once each month, unless otherwise agreed to in writing by the facility and the resident or guardian. Each bill must itemize charges for daily or monthly rates and for all extra charges.

(5) Each facility must post in the most frequented and conspicuous places, accessible to all residents, notices of residents' rights prepared by the Department.

(6) Copies of these rules and regulations shall be kept by the facility and shall be available for examination by any resident, guardian or representative.

(7) Upon the request of the resident, guardian or representative, the facility shall provide such person making the request with the name, address and telephone number of the resident's physician.

(8) Each resident or guardian shall he entitled to have reported promptly to persons of the resident's choice significant changes in the resident's health status. A resident or guardian who desires that family members or other persons of their choice be notified in the case of significant changes in the resident's health status shall either:

(a) Notify the administrator in advance that he desires that certain persons be notified in the event of any significant change in the resident's health status, with such notification being made part of the resident's personal file; or

(b) If such advance notification has not been given, a resident or guardian may inform the physician or administrator at any time that he desires that certain persons be notified of significant current changes. In the case of a resident unable to communicate who does not have a legally appointed guardian, the physician or administrator shall immediately contact family members or other interested persons concerning any significant change in the resident's health status.

(9) Upon a resident's request or a request of his or her guardian or representative, the facility must provide him or her with a current list of all services and charges. Current charges must be posted in the most frequented places, conspicuous, and accessible to all residents.

(10) The facility must inform each resident in writing, at least 30 days in advance of the effective date of any changes in the rates or the services that these rates cover.

(11) Each resident or his guardian or authorized representative shall be entitled to inspect and receive a copy of the resident' s non-medical records kept by the facility. The facility may charge a reasonable fee for duplication, not to exceed actual cost.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-104, 31-8-106, 31-8-108, 31-8-122 and 31-8-127
History. Original Rule entitled "Administration" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.03 Notification of Rights {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.03}

(1) At or before being admitted to a facility, each resident and guardian, or representative if there is no guardian, must be given a copy of the written explanation of the resident's rights, grievance procedure and enforcement procedures. A staff member must also orally explain to such persons the resident's rights, grievance procedures and enforcement procedures. Written acknowledgement of this written and oral explanation must be given by the resident, or in the case of a resident unable to give a written acknowledgement, by the resident's guardian or representative if there is no guardian. Such written acknowledgement shall be kept in the resident's file.

(2) At the time of admission to a facility, each resident, guardian, or representative must be provided with the following information in writing:

(a) The basic daily or monthly rate of the facility for the level of care to be received by the resident;

(b) A list of the services of the facility. Such list must show which services are offered as a part of the daily rate and which services are offered on an as-needed basis along with the related charges for such services. Such list must also show which services are not covered under Medicare or Medicaid programs and for which there are extra charges;

(c) A statement disclosing the facility's name and business address and the administrator's name and business address. The statement should also disclose that upon request at any time during normal business hours, a resident or a person applying to be a resident must be given a current copy of the annual disclosure statement filed with the Department of Medical Assistance.

(d) Notice of right of access to the written policies and procedures of the facility adopted pursuant to .02(1) of these rules and regulations during normal business hours;

(e) The right to select at admission, or to change at any time, the pharmacy or pharmacist of the resident's choice for those pharmaceutical supplies and services not provided as a part of the facility's basic rate. If the facility uses a specific type of unit dose drug system, any pharmacy or pharmacist chosen by the resident must be able to provide pharmaceuticals under such a system. Such notice at the time of admission shall also include a list of which pharmaceutical supplies and services are not provided by the facility.

(3) Provisions of these rules and regulations shall apply to current as well as future residents.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-104, 31-8-106, 31-8-110, 31-8-118 and 31-8-127
History. Original Rule entitled "Notification of Rights" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.04 Citizenship and Personal Choice {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.04}

Residents shall be free from any duty to perform services for the facility and must be permitted to exercise all rights of citizenship and of personal choice in accordance with the following:

(a) All residents legally eligible to vote must be permitted to vote in all primary, special and general elections and in referenda. If requested by the resident, the facility must assist in obtaining voter registration forms, applications for absentee ballots and in obtaining such ballots and assist the resident in meeting all other legal requirements in order to be able to vote. The facility shall not interfere with nor attempt to influence the actual casting of the resident's vote.

(b) All residents must be free to practice their religion and religious beliefs as they choose. All residents must also be free from the imposition, by the facility or any of its employees, of any religious beliefs and practices if they so choose.

(c) All residents must be free to associate, meet and communicate in private with persons of the resident's choice. Residents must be permitted to participate in social, familial, religious, and community group activities of their choice either on or off of the facility grounds, provided that if such event occurs off the facility grounds, the right to leave the facility shall be subject to .10 of these rules and regulations.

(d) All residents shall be permitted (subject to .10 of these rules and regulations) to rise and retire at any time of their choice, provided the resident does not interfere with the rights of others.

(e) Subject to applicable state law and the written policies of the facility given and explained to the resident, guardian and/or representative at the time of admission, all residents must be permitted to use tobacco and to consume alcoholic beverages, as long as the resident does not interfere with the rights of others. This right is subject to .10 of these rules and regulations. Residents shall be notified 30 days in advance of any change in the facility's policies affecting the use of tobacco or consumption of alcoholic beverages;

(f) Subject to .10 of these rules and regulations, all residents must be free to enter and leave the facility grounds as the resident chooses. If the facility desires, as stated in its written policies, it may require a resident to inform the facility at the times he is leaving and re-entering the facility grounds.

(g) The facility must have visiting hours of at least 12 continuous hours in any 24-hour period, seven days a week.

(h) Visitors must be granted access to residents during normal visiting hours provided that each visitor entering a facility promptly discloses his presence and identifies himself to the person in charge and enters the immediate living quarters of a resident only after identifying himself and receiving permission to enter. Place of visitation shall be any place of the resident's choice so long as it does not disrupt the normal operation of the facility or disturb the other residents. Residents may terminate visits at any time. The person in charge may refuse a visitor access or require such a visitor to leave only if:

The person in charge has reason to believe that the presence of such visitor would result in severe harm to a resident's health, safety or property; or
Access is sought for financial solicitation or commercial purposes; or
A resident does not wish such visitor to stay. If access by a visitor is denied, the person in charge shall document such denial, along with the reasons therefore. This section does not limit the power of any public agency, ombudsman, persons from federally mandated advocacy programs, or other persons permitted or required by state or federal law to enter or inspect a facility.

(i) Residents must be permitted to form resident councils to address any issues they may feel are appropriate or for other purposes and to meet without staff, if residents so desire. The facility must provide sufficient space for meetings of such resident councils and shall assist in attending such meetings those residents who request such assistance. The facility shall not compel the attendance of any residents at such meetings.

(j) Each resident must be permitted to voice complaints and recommend changes in policies, procedures, and services to the administrator, his or her designee, or the residents' counsel.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-111, 31-8-112, 31-8-114, 31-8-117 and 31-8-127
History. Original Rule entitled "Citizenship and Personal Choice" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.05 Privacy {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.05}

All residents shall enjoy privacy in their rooms and in their portions of any room which they share.

(a) Staff shall not enter a resident's room without first making their presence known before entering unless such staff member has reason to believe that the resident is asleep or it is an emergency which threatens the health or safety of the resident or unless it is required by the resident's care plan and documented in said plan.

(b) A resident shall be entitled to an available private room and a personal sitter if the resident pays the difference between the facility's charge for such a room and/or sitter and the amount reimbursed through Medicaid or Medicare provided that this provision is not prohibited by overriding Federal law or regulations.

(c) A resident shall have the right to visit privately with the resident's spouse. A resident and spouse shall be permitted to share a room if both are residents of the facility and space permits.

(d) Residents shall enjoy the right of freedom from eavesdropping, and the right to unimpeded, private and uncensored communication with anyone of the resident's choice by mail, telephone and visit. The administrator shall provide that mail is received and mailed on regular postal days. Public telephones must be available and accessible to residents, including those in wheelchairs, and must permit and be conducive to private conversation. Residents shall have the right to refuse any telephone call or correspondence. Such refusal shall be documented in the resident's file.

(e) The facility must provide at least one place for private visitation during normal visiting hours. This place must be provided in addition to the residents' rooms.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-114 and 31-8-127
History. Original Rule entitled "Privacy" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.06 Management of Personal Property and Financial Affairs {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.06}

(1) Each resident must be permitted to retain and use his/her personal property in his/her immediate living quarters subject to space limitations and state and federal safety laws and regulations.

(2) Upon request, the facility shall provide a means of securing the resident's property in his/her room or another convenient location in the facility, subject to the following:

(a) The resident must have access to the secured items at least during all normal business hours and where facility policy allows, on weekends and holidays;

(b) The facility shall keep an updated written record of all personal belongings which a resident has requested that the facility keep in a secure place.

(3) The facility shall have procedures for investigating complaints and allegations of thefts of residents' property. Such procedures must provide that the facility promptly investigate complaints of theft, and the facility report the results of its investigation to the complainant within two weeks.

(4) All payments made to or on behalf of a resident, regardless of the source, shall be used only for the benefit of that resident, unless state or federal law provides otherwise.

(5) Every resident or guardian shall be permitted to manage his own financial affairs. The facility may establish a personal account, consistent with federal regulations, for each resident at the facility. The resident or guardian may authorize the administrator or designated employee of the facility to help in managing the resident's financial affairs subject to the following:

(a) The resident or guardian must authorize the facility in writing to help in the management of all or the part specified of the resident's finances. Such written authorization must be kept in the resident's file;

(b) The facility may expend funds for the resident only at the specific written or oral request of the resident or guardian and only for the purpose designated by the resident or guardian.

(c) The resident or his guardian shall be given any portion or all of the resident's funds upon request of the resident or guardian. The resident or guardian may authorize in writing a representative to withdraw funds from the resident's account. Such authorization must contain a specific amount permitted to be withdrawn and the date such authorization expires.

(d) A current written record of all financial arrangements and transactions made to or on behalf of the resident must be maintained by the facility either individually in each resident's file or individually in a separate file for all transactions made to or in behalf of each resident. A resident or guardian shall be permitted to inspect and duplicate at cost such current record for that resident.

(e) The facility shall issue to each resident or guardian a written quarterly statement, and prior to any change in ownership of the facility, showing the current balance and an itemized listing of all transactions made to or on behalf of the resident.

(6) Funds received from a resident on his behalf may be deposited in an interest bearing account. All funds not needed for the ordinary use by a resident on a daily basis above $150.00 per resident must be kept in an account insured by agencies of or corporations chartered by the state or federal government. Such account must clearly show that the facility has only a fiduciary interest in the funds in such account. All interest earned upon such account must accrue to the resident, with each resident being credited with the portion of the interest attributable to his portion of the account.

(7) To guarantee the security of residents' funds, each facility shall obtain an irrevocable letter of credit from a bank or savings and loan association, as defined in O.C.G.A. § 7-1-4 , or purchase a surety bond at least equal to the amount of all funds in the residents' accounts maintained by the facility.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-113, 31-8-115 and 31-8-127
History. Original Rule entitled "Management of Personal Property and Financial Affairs" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.07 Residential Care and Treatment {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.07}

Each resident must receive care, treatment and services which are adequate and appropriate for the condition of the resident, as determined by periodic review of each resident's treatment plan. Such care, treatment, and services must be provided with reasonable care and skill and in compliance with all applicable laws and regulations and with the goal of the resident's return home or to a less restrictive environment.

(a) The quality of a particular service or treatment must be the same to all residents without regard to the source of payment for such service or treatment. In particular, the quality of care provided to a resident whose care is being paid for from Medicaid or Medicare funds must be that same quality of care provided to those residents whose care is being paid for from other sources.

(b) Care, treatment and services must be provided with respect for the resident's personal dignity and privacy subject to the following:

All aspects of a resident's medical, personal and bodily care program shall be conducted in private and kept confidential. Any persons not directly involved in the particular aspect of care being provided to a resident must have the resident's permission to be present at the time that component of the resident's care is being provided;
A resident's personal and medical records must be kept confidential. Only the resident or guardian may approve the release or disclosure of such records to persons or agencies outside the facility which must be in writing, unless it is a case of the resident's transfer to another health care facility or during Medicare, Medicaid, licensure, medical care foundation, or peer review surveys, or as otherwise provided by law or third-party payment contract;
Each resident or guardian shall have the right of access to all information in the medical and personal records of that resident and to have given to him by the physician a complete and current explanation of his medical diagnosis, treatment and prognosis in language the resident can understand. Each resident or guardian shall have the right to inspect and receive a copy of such records unless said right is suspended in accordance with .10 of these rules and regulations. The facility may charge a reasonable fee for duplication of the medical records, not to exceed actual cost.

(c) Each resident or guardian shall be entitled to choose or change at any time the resident's physician(s). A physician so chosen shall inform the resident in advance whether or not the physician's fees can be paid for by Medicaid, Medicare, or from any other public or private benefits and agree to and provide documentation to any third party payor as required by law, regulations or contract.

(d) The resident or guardian shall be entitled to participate in the development of the resident's care plan and in the provision of treatment under the plan. The resident or guardian shall be informed of the right to participate in the planning of care and treatment each time a substantial change in the treatment is needed.

(e) A resident shall not take part in any experimental research or be the recipient of any experimental treatment unless informed written consent (consistent with O.C.G.A. § 31-9-1 et seq. ) is given by the resident or guardian. Such written consent shall be made a part of the resident's medical record.

(f) Subject to the resident's choice of pharmacy or pharmacist, pursuant to .03(2)(e) of these rules and regulations, each resident shall receive pharmaceutical supplies and services at reasonable prices not exceeding applicable and normally accepted prices for comparably packaged pharmaceutical supplies and services within the community.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-108, 31-8-114 and 31-8-127
History. Original Rule entitled "Resident Care and Treatment" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.08 Refusal of Medical Treatment, Dietary Restrictions and Medications {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.08}

Each resident or guardian shall have the right to refuse any aspect of medical treatment, dietary restriction or any medication, subject to the following:

(a) When a resident or guardian makes such refusal such person shall be notified by the appropriate facility staff person or physician of the immediate and possible long-term consequences of the refusal. The refusal shall be documented in the resident's record as shall the possible consequences of the refusal, and the resident's physician shall be notified as soon as practical.

(b) If such refusal would result in serious injury, illness or death, the facility shall:

Promptly notify the resident's physician and if serious injury, illness or death is imminent, transport the resident to a hospital; and
Notify the resident's guardian, representative or responsible family member in that order of priority as specified in O.C.G.A. § 31-9-2 or if no such persons are immediately available, notify the director of the County Department of Family and Children Services or his designee. The director or designee shall document such notification and take appropriate protective measures.

(c) If such refusal would result in injury, illness or death to any other person, such resident or guardian shall not enjoy this right of refusal. The likelihood of injury, illness, or death to any other person must be documented in the resident's records by the resident's physician.

(d) Any facility or employee of a facility acting in accordance with this section shall be immune from all liability resulting from such refusal in accord with Ga. Code Ann; 88-1914B.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-108 and 31-8-127
History. Original Rule entitled "Refusal of Medical Treatment, Dietary Restrictions and Medications" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.09 Use of Restraints, Isolation and Restrictions {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.09}

Each resident must be free from actual or threatened physical restraints, isolation or restrictions on mobility within or outside the facility grounds, including the use of drugs to limit mobility, activity and functional capacity or the use of any other restrictions, except to the minimum extent necessary to protect the resident from immediate injury to the resident or to any other person. Restraints are defined to include, but not limited to, any contrivance, situation, safety device, or medication that has the purposeful or incidental effect of restricting a resident's mobility within or outside of the facility grounds. All authorization and use of restraints, restrictions, or isolation must be documented in the resident's medical file.

(a) Restraints, restrictions, or isolation may not be used for punishment, incentive, behavior conditioning or modification, convenience of the facility or any purpose other than to protect the resident from immediate injury to himself or to any other person.

(b) Except in an emergency situation described in subsection (c) of this rule, below, restraints, restrictions, or isolation must be authorized as follows:

Prior to authorizing restraints, restrictions, or isolation, the attending physician shall make a personal examination and individualized determination that such restraint, restriction, or isolation is necessary to protect the resident or other persons from immediate injury; and
The physician shall specify the length of time for which such restraint, restriction, or isolation is authorized. Such authorization may not exceed 65 days for intermediate care home residents or 35 days for skilled nursing home residents, but in no event shall such restraint, restriction, or isolation be used beyond the period of actual need to protect the resident or other persons from immediate injury. Any period beyond that specified shall be regarded as a new period and all requirements for the use of such restraints, restriction or isolation must be met.

(c) In an emergency situation severely threatening the health or safety of the resident or others, restraints, restrictions, or isolation may be authorized only by the person in charge. In an emergency situation, restraints, restrictions or isolation may be used only for 12 hours from the time of onset of the emergency situation. Beyond the 12-hour period, restraints, restrictions, or isolation may not be used unless it is in accordance with subsection (b) of this rule.

(d) The resident and guardian or persons designated by the resident, if any, shall be immediately informed of the need for such restraints, restrictions or isolation, the reasons for such use, and the time specified for such use.

(e) A restrained or isolated resident shall be monitored by staff at least every hour. A restrained or isolated resident must be released and exercised every two hours except during normal sleeping hours. Such activities shall be documented in the resident's record.

(f) A resident who is restrained, restricted or isolated pursuant to this section shall retain all other rights and responsibilities provided by these rules and regulations.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-109 and 31-8-127
History. Original Rule entitled "Use of Restraints, Isolation or Restrictions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.10 Temporary Suspension of Rights {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.10}

Convenience to the facility shall not justify the suspension of any rights to individual residents.

(a) Only the following rights may be temporarily suspended:

The right to rise and retire as the resident chooses, pursuant to .04(d) of these rules and regulations;
The right to use tobacco and consume alcoholic beverages, pursuant to .04(e) of these rules and regulations;
The right of access to his own medical records and explanation of condition, treatment and diagnosis, pursuant to .07(b)3 of these rules and regulations; and
The right to enter and leave as desired, pursuant to .04(f) of these rules and regulations.

(b) The above rights may be temporarily suspended only after the following:

The physician must personally examine the resident and document in the resident's file that the exercise of such right or rights endangers the health or safety of other residents or imposes an immediate and substantial danger to the resident;
Prior to or at the time of such suspension, the resident and guardian or representative if there be no guardian, shall be notified of such suspension, its duration and of the resident's right to meet with legal counsel, ombudsman, family members, his guardian, or any other person of the resident's choice;
If the threatened danger is only to the resident and not to the health or safety to other residents, and the resident has had the reasons for the proposed suspension fully explained to him along with the danger if that right is exercised, the resident's rights shall not be suspended pursuant to this regulation if the resident or guardian understands the danger and insists on the exercise of the right. This fact must be documented in the resident's file.

(c) A temporary suspension of rights may be authorized for a maximum of 65 days for residents of intermediate care homes and for 35 days for residents of nursing homes. In no event shall the suspension of such right or rights be authorized for a period longer than actual need. Any additional period shall be considered a new suspension, for which all provisions and requirements of this section shall be met.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-117 and 31-8-127
History. Original Rule entitled "Temporary Suspension of Rights" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.11 Transfer and Discharge {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.11}

(1) In an emergency situation where the resident or other residents are subject to an imminent and substantial danger that only immediate transfer or discharge will relieve, the facility may involuntarily transfer the resident to another health facility. The person in charge shall document in the resident's file the reasons for such emergency transfer and shall immediately inform the resident, guardian and other persons of the resident's choice regarding such transfer and the place where the resident is to be transferred.

(2) In all other situations an involuntary transfer or discharge must be in accordance with any of the following reasons and procedures and only after all other reasonable alternatives to transfer have been exhausted:

(a) The resident's physician or, if unavailable, another physician determines that failure to transfer the resident will result in injury or illness to the resident or others. The resident's physician shall be kept informed of actions taken. The attending physician must document that determination in the resident's record. If the basis for the transfer or discharge is the threat of injury or illness to the resident only, the resident cannot be transferred or discharged unless the physician documents in the resident's medical record that such transfer or discharge is not expected to endanger the resident to a greater extent than remaining in the facility; or

(b) The facility does not participate in, or voluntarily or involuntarily ceases to operate or participate in the program which reimburses for the resident's care. In the event that a facility voluntarily or involuntarily ceases to operate or participate in the program which reimburses for the resident's care and proposes to transfer or discharge a resident because of that fact, the facility must cooperate fully with and take all reasonable directives from the State Medicaid Agency and the Health Care Financing Administration Regional Office in the implementation of any transfer planning and transfer counseling conducted by these agencies; or

(c) Nonpayment of allowable fees has occurred. When a resident has been converted from full or private pay status to Medicaid eligibility due to exhaustion of personal financial resources, nonpayment of allowable fees has not occurred so long as the facility participates in the Medicaid program. Similarly, conversion from Medicare/Medicaid eligibility status does not constitute nonpayment of allowable fees; or

(d) The findings of a Medicare or Medicaid medical necessity review determine that the resident no longer requires the level of care presently being provided, subject to the right of the resident to any appeal procedure available to challenge the determination of medical necessity review. Where space permits, the resident must be given the option of staying at the facility, if the facility is certified to provide the new level of care.

(3) The facility must give written notice to the resident, guardian or representative, if there is no guardian, and the resident's physician at least 30 days before any proposed transfer or discharge is made in accordance with subsections (2)(a), (2)(b), or (2)(c) of this rule. The written notice must contain the following information: the reasons for the proposed transfer or discharge; the effective date of the proposed transfer or discharge; the location or other facility to which the facility proposes to transfer or discharge the resident; and notice of the right to a hearing pursuant to the Georgia Administrative Procedure Act and Section .15 of these rules and regulations, and of the right to representation by legal counsel. If the resident so desires, the facility shall also send a copy of such notice to the community ombudsman, or state ombudsman if there is no community ombudsman.

(4) If two residents are married and the facility proposes to transfer one spouse to another facility at a similar level of care, notice must be given to the other spouse of the right to be transferred to the same facility if the other spouse makes a request to that facility in writing. Married residents must be transferred on the same day, pending availability of accommodations. If also available, that facility shall place both residents in the same room if the residents so desire.

(5) In the event of an involuntary transfer pursuant to subsections (2)(a), (2)(b), or (2)(c) of this rule, the facility must assist the resident and guardian in finding a reasonably appropriate alternative placement prior to the proposed transfer or discharge by developing a plan designed to minimize any transfer stress to the resident. Such plan shall include counseling the resident, guardian, or representative, regarding available community resources and informing the appropriate state or social service organizations, including, but not limited to, the community or state long-term care ombudsman and assisting in arranging for the transfer.

(6) In the event that the facility proposes an involuntary transfer of the resident to another bed in the same facility, the resident and guardian shall receive 15 days written notice prior to such change.

(7) A resident shall be voluntarily discharged from a facility when the resident or guardian gives the person in charge notice of the resident's intention to be discharged and the expected date of departure. In the case of a resident without a guardian, the facility may not require that the resident be "signed out" or authorized to be discharged by any person or agency other than the resident. Notice of the resident's or guardian's intention to be discharged, and the expected and actual dates of departure shall be documented in the resident's record. If the resident appears to be capable of living independently of the facility, upon such discharge, the facility is relieved of any further responsibility for the resident's care, safety, or well-being.

(8) If a resident being voluntarily discharged into the community, appears to be incapable of living independently of the facility, in addition to the requirements under section (7) of this rule, the facility shall also do the following:

(a) Notify the Department of Human Services in order to obtain social or protective services for the resident immediately after the facility receives notice of the resident's intention to be discharged;

(b) Document such notice to the Department of Human Services in the resident's record along with the resident's notice of intention to be discharged and the expected and actual dates of departure;

(c) Upon notice to the Department of Human Services and upon actual discharge of the resident, the facility shall be relieved of any further responsibility for the resident's care, safety, or well-being.

(9) Each resident transferred from a facility to a hospital, other health care facility, or trial alternative living placement shall have the right to return to the facility immediately upon discharge from the hospital, other health care facility or upon termination of the trial living placement, provided that the resident has continued to pay the facility or payment on behalf of the resident by another person or agency has been provided for the period of the resident's absence. If payment is provided for the period of absence, the facility shall continue the same room assignment for such resident. In cases of nonpayment to the facility during such absence, a resident who requests to return to a facility from a hospital shall be admitted to the facility to the first bed available, with priority over any existing waiting list.

(10) Whenever allowed by the resident's health condition, a resident shall be provided treatment and care, rehabilitative services, and assistance by the facility to prepare the resident to return to the resident's home or other living situation less restrictive than the facility. Upon the request of the resident, guardian, or representative, the facility shall provide him with information regarding available resources and inform him of the appropriate state or social service organizations.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-101, 31-8-116 and 31-8-127
History. Original Rule entitled "Transfer and Discharge" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.12 Contributions to the Facility {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.12}

No resident, resident's family, guardian or representative shall be coerced directly or indirectly into contributing to a resident, facility, staff person, or corporation or agency with any financial interest in the facility.

(a) Free will contributions may be made for general or restricted purposes. When free will contributions are made by a person for a restricted purpose, such contribution must be used only for the purpose so designated.

(b) When a free will contribution is made, a signed receipt shall be issued to the person making the contribution and shall contain the following information:

The name of the person making the contribution;
The date the contribution is made;
The amount and type of the contribution;
The restricted purpose, if any, for which the contribution is intended.

(c) The facility shall keep in a central file, copies of all receipts issued in accordance with section (b) of this rule.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-119 and 31-8-127
History. Original Rule entitled "Contributions to the Facility" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.13 Nondiscrimination {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.13}

(1) Each resident or person requesting admission to a facility shall be free from discrimination by the facility through its refusing admission or continued residency on the basis of the resident's or applicant's history or condition of mental or physical disease or disability unless either:

(a) Such admission would cause the facility or any resident or applicant to lose eligibility for any state or federal program of financial assistance; or

(b) The facility cannot provide adequate and appropriate care, treatment, and services to the resident or applicant due to such disease or disability, provided such exclusion is not contrary to federal or state law and regulation prohibiting such discrimination nor contrary to federal or state law or regulation requiring that care must be provided if the facility participates in a financial program requiring such admittance or continued residency.

(2) A facility shall not discriminate in the provision of a service to a resident based upon the source of payment for the service.

(3) No person shall be discriminated against as to admission or continued residency on the basis of the person's choice of pharmacy, pharmacist and/or physician.

(4) No person shall be discriminated against as to admission or continued residency and as to care, treatment and services on the basis of failure or refusal by the resident, guardian or representative to make contributions to a resident, facility, staff person, or corporation or agency with a financial interest in a facility.

(5) No person shall be discriminated against in any manner whatsoever for exercising any of the rights described in these rules and regulations, nor shall any form of restraint, interference, or coercion be used against any person for exercising any of the rights described in these rules and regulations.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-108, 31-8-110, 31-8-118 and 31-8-127
History. Original Rule entitled "Nondiscrimination" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.14 Grievance Procedure {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.14}

Any resident, guardian or representative who believes his rights or, in the case of a guardian or representative, the rights of the resident, have been violated, may present a grievance. The grievance procedure shall be in accordance with the following:

(a) The facility shall maintain a confidential central file of documents and materials pertaining to grievances. Any resident, guardian or representative shall be free to review any document or materials pertaining to that resident. All documents and materials pertaining to grievances shall be available to the Department.

(b) To initiate a grievance, the resident, guardian, or representative must submit an oral or written complaint to the administrator or his designee, who, in the event of an oral complaint, shall promptly reduce the substance of the complaint to writing. The administrator shall also promptly act to resolve the complaint. If the complaint is not resolved within three business days, the administrator or designee shall give a written response to the complainant. The content of such response shall include:

The names of the complainant and of the person making the written response;
The date the grievance was commenced and the date of the written response;
A complete description of the complaint;
The facility's position in regard to the complaint; and
A description of the review and appeal rights including the name and telephone number of the community ombudsman or state ombudsman, if there is no community ombudsman.

(c) If the complainant is not satisfied with the resolution or written response of the administrator or designee, he shall submit an oral or written complaint to the community or state ombudsman, pursuant to O.C.G.A. § 31-8-124 and 31-8-150 et. seq.

(d) If the ombudsman is unable to resolve the grievance to the complainant's satisfaction within 10 calendar days of submission to such ombudsman, the complainant may submit the grievance to an impartial referee, jointly chosen by the administrator or his designee and the complainant. The referee may be any person who is mutually acceptable to the complainant and the administrator or designee.

(e) Within 14 calendar days after the complainant has requested a hearing before an impartial referee, such hearing shall be held at a time convenient to the administrator, complainant and referee and such hearing shall be held at the facility. The complainant and the administrator may review relevant records and documents, present evidence, call witnesses, cross-examine witnesses, make oral arguments, and be represented by any persons of their choice. The referee may ask questions of any person, review relevant records and documents, call witnesses, and receive other evidence as appropriate. The referee shall keep a record of the proceedings, which may be a sound recording. In the event that the complainant and the administrator/designee cannot agree upon an imparital referee within seven calendar days after the complainant has requested a referee's hearing, the complainant shall have the right to an administrative hearing pursuant to .15 of these rules and regulations.

(f) Within 72 hours after the hearing before the referee, the referee shall render a written decision, on forms to be provided by the Department. Copies of the decision shall be given to the complainant, to the administrator for filing in the central file for that purpose, and a copy shall be sent to the Department. The decision shall be divided as follows:

Contentions of the parties;
Findings of the relevant and significant facts;
Decisions of the referee as to whether a violation of resident's rights has occurred, along with a recommendation to the Department for corrective action and the date by which the correction should be made; and
A complete description of the right and manner in which to appeal the referee's decision in accordance with .15 of these rules and regulations

(g) The decision of the impartial referee shall be binding upon all the parties unless reversed upon appeal.

(h) If a resident or complainant is unable for any reason to understand any writing or communication pertinent to this section, such information shall be communicated to him in a manner that takes into account any communication impairment he may have.

(i) A resident, guardian or representative who elects not to proceed under this section shall not be prohibited from proceeding under .15 or .16 of these rules and regulations. Nothing in these rules and regulations is meant to modify or diminish any complaint procedure set up or in operation pursuant to O.C.G.A. § 31-8-80 et seq.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-50et seq., 31-8-80et seq., 31-8-101, 31-8-124 and 31-8-127
History. Original Rule entitled "Grievance Procedure" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.15 Administrative Hearing {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.15}

Any resident, guardian or representative or administrator who is dissatisfied with the decision of the impartial referee or any resident, guardian or representative who is unable to agree upon an impartial referee, or who be believes that any of his rights under these rules and regulations have been violated, shall have the right to request a hearing from the Department pursuant to the Georgia Administrative Procedure Act O.C.G.A. § 50-13-1et seq. in conjunction with the statute, Long-term Care Facilities: Residents' Bill of Rights O.C.G.A. § 31-8-125.

(a) The Department is authorized to hold such hearings and in the cases of an appeal from the decision of a referee, the Department may hold such hearings by review of the record of the hearing provided by the referee.

(b) A person desiring a hearing under this section may request such a hearing in writing to the Department. The request shall include the person's name, the name of the facility and the reason the hearing is requested. The request shall be mailed or delivered to the Department of Community Health.

(c) The hearing shall be conducted within 45 calendar days of the receipt by the Department of the request for the hearing. The Department shall send written notice to the administrator and complainant confirming the date, time and location (which shall be the facility unless the resident's medical condition requires a different location) of the hearing. Except where the ombudsman has been unable to resolve the matter at issue, the Department shall refer the complaint to the state or community ombudsman for informal resolution pending the hearing.

(d) Except in the event of an emergency situation in which the resident or other residents are subject to imminent and substantial danger that only immediate transfer will reduce, o except in case of nonpayment under subsection .11(2)(c), of these rules and regulations, no transfer shall take place until all appeal rights are exhausted. However, if a resident is transferred before exhaustion of all appeal rights, such resident in no way relinquishes any appeal rights under these rules and regulations.

(e) Where two or more residents in a facility allege a common complaint, the Department may, at the resident's request, schedule a common hearing.

(f) The decision of the hearing officer shall be made within 30 calendar days from the date of the hearing and shall be based upon whether or not a violation has been found. The decision shall be divided as follows:

The issues to be decided;
A summary of any actions already taken;
The contentions of the parties;
The findings of the hearing officer including whether a violation has occurred;
If a violation has occurred, the corrective action to be taken, and the date by which such corrective action shall be taken; and
The right to appeal the decision to the Superior Court of the county in which the facility is located or as provided otherwise by law.

(g) Upon the failure to correct any violations found within the time specified, the Department may impose appropriate civil penalties as provided in .16 of these rules and regulations.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-125 and 31-8-127
History. Original Rule entitled "Administrative Hearing" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-50-.16 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-50-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-50-.16}

Any person or persons aggrieved because a long-term care facility has violated or failed to provide any rights granted under O.C.G.A. § 31-8-100et seq. or these rules and regulations shall have a cause of action against such facility for damages and such other relief as the court having jurisdiction of the action deems proper. No person shall be prohibited from maintaining such an action for failure to exhaust any rights to administrative or other relief granted under O.C.G.A. § 31-8-100et seq. or these rules and regulations. In addition to all other penalties or remedies that may be imposed by these rules and regulations, or any state or federal law, the Department is authorized to impose civil penalties as follows:

(a) If a violation has occurred, the Department shall order the facility to correct such violation by a specified date. It shall be presumed for the purposes of this section that a violation has occurred when any of the following findings are made:

An impartial referee has rendered a decision pursuant to subsection .14(f)3 that a violation has occurred and such finding is not reversed upon appeal; or
A hearing officer determines pursuant to subsection .15(f) that a violation has occurred and such finding is not reversed upon appeal; or
A superior court judge, pursuant to an action under O.C.G.A. § 31-8-126 , finds that a facility has violated or failed to provide any rights under O.C.G.A. § 31-8-100 et seq. , and such finding is not reversed upon appeal; or
The Department determines in any inspection, required or permitted by law or regulation, that a violation has occurred.

(b) If an impartial referee, hearing officer, superior court judge, or the Department finds a violation pursuant to section (a) of this rule, the facility shall correct such violation within the time specified by the Department. If the facility does not correct the violation within the time specified or within a reasonable time, as established by the Department, the Department shall have the power to order the facility to discontinue admitting residents to such facility until such violation has been corrected. The Department shall have the authority to visit and inspect the facility to determine if a known or alleged violation has been corrected.

(c) In cases of violation repeated by a facility under the same license within a 12-month period, the Department may assess a civil penalty not to exceed $75.00 per violation for each day in which the violation continues, except that the maximum civil penalty for each violation within a 12-month period shall not exceed $2,500.00. If a facility commits a violation against an individual or group of individuals and commits the same violation within a 12-month period against another individual or group of individuals, such violation shall be considered a repeat violation for the purpose of imposing civil penalties under this section. In imposing such civil penalties, the Department shall consider all relevant factors including, but not limited to:

The amount of assessment necessary to insure immediate and continued compliance;
The character and degree of impact of the violation on the health, safety, and welfare of any resident in the facility;
The conduct of the person or facility against whom the citation is issued in taking all feasible steps or procedures necessary or appropriate to comply or to correct the violations;
Any prior violations by the facility of statutes, regulations, or orders administered, adopted, or issued by the Department.

(d) No civil penalty shall be collected by the Department until notice and opportunity for hearing are afforded pursuant to O.C.G.A. § 31-2-8 . Any person or facility subject to a civil penalty is entitled to review pursuant to O.C.G.A. § 50-13-19 . Nothing in these regulations shall be construed to preempt any other law or regulations or to deny any rights or remedies which are provided under any other law or regulations.

(e) All civil penalties recovered by the Department shall be paid into the State Treasury.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-8-126, 31-8-127 and 50-13-1et seq
History. Original Rule entitled "Enforcement" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Subject 111-8-53 Rules and Regulations for Narcotic Treatment Programs

Ga. Comp. R. & Regs. r. 111-8-53-.01 Legal Authority {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.01}

These rules are adopted and published pursuant to the Official Code of Georgia Annotated § 26-5-2et seq.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5 and 31-2-7
History. Original Rule entitled "Legal Authority" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-53-.02 Title and Purpose {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.02}

These rules shall be known as the Rules and Regulations for Narcotic Treatment Programs. The purpose of these rules is to provide for the licensing and inspection of narcotic treatment programs.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5 and 31-2-7
History. Original Rule entitled "Title and Purpose" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013

Ga. Comp. R. & Regs. r. 111-8-53-.03 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.03}

Unless the context otherwise requires, as used in these rules the term:

(a) "Administrator" means the individual designated by the program's governing body who is responsible for the on-going and day-to-day operations of the program, for overall compliance with federal, state, and local laws and regulations regarding the operation of narcotic treatment programs, and for all program employees including practitioners, agents, or other persons providing services at the program;

(b) "Applicant" means any individual affiliated with a partnership, corporation, association or individuals or groups of individuals submitting an application to operate a narcotic treatment program under this article.

(c) "Clinical director" means the individual designated by the program's governing body who is responsible for the on-going and day-to-day clinical aspects of treatment for those patients admitted to the program;

(d) "Clinical staff" means registered nurses, licensed practical nurses, and registered pharmacists, all operating within their respective scope of practice as authorized by law and regulation, as well as those members of the medical staff as such term is defined by these rules;

(e) "Counselor" means an individual who is qualified by education, training, and experience to provide substance abuse counseling and who is licensed or certified if required by state practice acts or these rules;

(f) "Crime" means the commission of any of the following offenses:

A violation of Code Section 30-5-8 , relating to abuse, neglect, or exploitation of a disabled adult or elder person;
A violation of Code Section 16-5-1 , relating to murder;
A violation of Code Section 16-5-2 , relating to voluntary manslaughter;
A violation of Code Section 16-5-21 , relating to aggravated assault;
A violation of Code Section 16-8-41 , relating to armed robbery with a firearm;
A violation of Code Section 16-6-21 , relating to aggravated sexual battery;
A violation of Code Section 16-6-5 , relating to enticing a child for indecent purposes;
A violation of Code Section 16-5-70 , relating to cruelty to children;
A violation of Code Section 16-5-101 , relating to cruelty to a person 65 years of age or older or a disabled adult;
A violation of Code Section 16-6-1 , relating to rape;
A violation of Code Section 16-6-4 , relating to child molestation;
A felony violation of Code Section 16-8-2 , relating to theft by taking;
A felony violation of Code Section 16-8-3 , relating to theft by deception;
A felony violation of Code Section 16-8-4 , relating to theft by conversion;
A felony violation of Code Section 16-9-1 , relating to forgery;
A violation of Code Section 16-8-40 , relating to robbery;
A felony violation of Chapter 13 of Title 16, relating to controlled substances;
A felony violation of Code Section 16-5-23.1 , relating to battery; or
Any other offense committed in another jurisdiction which, if committed in this state, would be deemed to be such a crime without regard to its designation elsewhere. Any other criminal offense as determined by the Department and established by rule adopted pursuant to Chapter 13 of Title 50, the "Georgia Administrative Procedure Act," that would indicate the unfitness of an individual to be involved in the operations or activities of a narcotic treatment program.

(g) "Criminal history background check" means a search as required by law of the criminal records maintained by law enforcement authorities to determine whether the individual has a criminal record as defined in these rules.

(h) "Criminal record" means:

Conviction of a crime; or
Arrest, charge, and sentencing for a crime where:

(i) A plea of nolo contendere was entered to the charge; or

(ii) First offender treatment without adjudication of guilt pursuant to the charge was granted; or

(iii) Adjudication or sentence was otherwise withheld or not entered on the charge; or

Arrest and being charged for a crime if the charge is pending, unless the time for prosecuting such crime has expired pursuant to Chapter 3 of Title 17 O.C.G.A.

(i) "Department" means the Department of Community Health, operating through the Division of Healthcare Facility Regulation, or its successor;

(j) "Director of Pharmacy Services" means a pharmacist licensed by the Georgia Board of Pharmacy who has been designated by the governing body of the narcotic treatment program to direct, oversee, establish protocols and be responsible for all pharmacy related transactions of the narcotic treatment program;

(k) "Final administrative decision" means the issuance of a ruling by the Commissioner of the Department of Community Health or his or her designee or any appeal from a decision of an administrative law judge pursuant to a contested case involving the imposition of a sanction; a decision of an administrative law judge finalized by operation of law where no appeal is made to the Commissioner of the Department of Community Health; the disposition of a contested case through settlement by the parties; or a sanction imposed by the Department that is uncontested by a facility within the allotted time period;

(l) "Governing body" means the county board of health, the partnership, the corporation, the association, or the person or group of persons who maintains and controls a narcotic treatment program, who is legally responsible for its operation, and who holds the license to operate that program;

(m) "Individual treatment plan" means a comprehensive plan that outlines for each patient attainable short-term and long-term treatment goals that are mutually acceptable to the patient and the narcotic treatment program and that specify the services to be provided and the frequency and schedule for such provision;

(n) "Inspection" means any examination by the Department or its representatives of a provider, including, but not limited to, the premises, staff, persons in care, and documents pertinent to initial and continued licensing so that the Department may determine whether a provider is operating in compliance with licensing requirements or has violated any licensing requirements. The term inspection includes any survey, monitoring visit, complaint investigation, or other inquiry conducted for the purposes of making a compliance determination with respect to licensing requirements;

(o) "License" means the official permit issued by the Department that authorizes the holder to operate a narcotic treatment program for the term provided therein;

(p) "Medical director" means a physician licensed by the Georgia Composite Medical Board who has been designated by the governing body of the narcotic treatment program to be responsible for the administration of all medical services performed by the narcotic treatment program, including compliance with all federal, state, and local laws and rules regarding medical treatment of narcotic addiction;

(q) "Medical staff" means the physicians licensed in the State of Georgia who are responsible for the medical treatment being provided to patients through a licensed narcotic treatment program. In limited circumstances, as defined in these rules, medical staff may also include a nurse practitioner, operating under an approved written protocol, and a physician's assistant, operating under an approved job description, supervised by either the program physician or medical director;

(r) "Methadone" means an opioid agonist treatment medication as approved by the Food and Drug Administration under Section 505 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355 , for use in the treatment of opiate addiction;

(s) "Narcotic treatment program" means any system of treatment provided for chronic heroin or opiate-like drug-dependent individuals that administers narcotic drugs under physicians' orders either for detoxification purposes or for maintenance treatment in a rehabilitative context offered by any county board of health, partnership, corporation, association, or person or groups of persons engaged in such administration;

(t) "Owner" means any individual or any person affiliated with the corporation, partnership, or association with 10 percent or greater ownership interest in a business or agency licensed as a narcotic treatment program and who:

Purports to or exercises authority of an owner in the business or agency;
Applies to operate or operates the business or agency; or
Enters into a contract to acquire ownership of such a business or agency.

(u) "Patient" means any individual who undergoes treatment in a narcotic treatment program;

(v) "Program physician" means any physician licensed in the State of Georgia, including the medical director, who is employed by a narcotic treatment program to provide medical services to patients;

(w) "Registered Nurse" means a person who holds a current and valid license as a registered nurse issued by the State of Georgia;

(x) "Records check application" means two sets of classifiable fingerprints, a records search fee to be established by the Department by rule and regulation, payable in such form as the Department may direct to cover the cost of a fingerprint records check, and an affidavit by the applicant disclosing the nature and date of any arrest, charge, or conviction of the applicant for the violation of any law, except for motor vehicle parking violations, whether or not the violation occurred in this state, and such additional information as the Department may require;

(y) "Region" means one of the 49 geographical areas specified in O.C.G.A. § 26-5-48(h) ;

(z) "Satisfactory criminal history background check determination" means a written determination that a person for whom a records check was performed was found to have no criminal record which includes one of the covered crimes outlined in paragraph (f) of this section, if applicable;

(aa) "State Board of Pharmacy" means the board created to regulate the practice of pharmacy pursuant to Article 2 of Chapter 4 of Title 26 of the Official Code of Georgia Annotated and the Rules and Regulations of the Georgia State Board of Pharmacy, Chapter 480-18; and

(bb) "Unsatisfactory criminal history background check determination" means a written determination that a person for whom a records check was performed has a criminal record which includes one of the covered crimes outlined in paragraph (f) of this section, if applicable.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Definitions" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.04 Governing Body {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.04}

Each licensed program shall have a clearly identified governing body that accepts responsibility for operating the narcotic treatment program in accordance with applicable laws, rules, and regulations.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5 and 31-2-7
History. Original Rule entitled "Governing Body" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-53-.05 Licenses {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.05}

No governing body may operate a narcotic treatment program in the state without first obtaining a license from the Department.

(a) License. A license will be issued, upon presentation of evidence satisfactory to the Department, that the program is in compliance with these rules and all applicable federal and state laws for the handling and dispensing of drugs and all state and local health, safety, sanitation, building, and zoning requirements. Unless suspended or revoked by the Department, a license shall remain in force and effect for a period determined by the Department based upon outcomes and a program's compliance history with these rules. Effective July 1, 2017, the Department shall limit licenses to four (4) per Region unless a waiver is approved pursuant to Rule 111-8-53-.07(12) .

(b) Compliance with Requirements of Other State and Federal Agencies. To obtain a license, a program must submit evidence satisfactory to the Department that it will operate in compliance with the requirements of the Substance Abuse and Mental Health Services Administration (SAMHSA), the Drug Enforcement Administration (DEA), the Georgia State Board of Pharmacy, and any other applicable federal or state agency.

(c) License is Nontransferable. A license to operate a narcotic treatment program is nontransferable for a change of location or governing body. Each license shall be returned to the Department in cases of changes in location or governing body or if suspended or revoked. When a licensee intends to relocate or there is change in governing body, it must notify the Department and submit an application in accordance with these rules. The program may be subjected to an on-site visit by the Department prior to the issuance of a license at the discretion of the Department.

(d) Exceptions for programs licensed prior to May 4, 2017. Programs licensed prior to May 4, 2017 must submit an application only in the event of a change of governing body or location. If such program is in good standing with the Department and the change of location is within the program's Region, the requirements of Rule 111-8-53-.07 shall not apply except for 111-8-53-.07(4)(b) and (4)(n) . Upon application for an additional program by a current licensee, each location operated by such licensee shall be inspected, except that any such location inspected within the preceding 36 months shall be exempt from the requirement of an on-site inspection.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Licenses" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.06 Provisional Licenses {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.06}

(1) Provisional licenses may be issued for a period not to exceed 90 days to the governing body of a new narcotic treatment program that is in substantial compliance with these rules or of an existing program that is in substantial compliance with these rules as a result of having submitted an acceptable plan of correction to the Department.

(2) A provisional license shall not be issued to a narcotic treatment program in which there are conditions that present an immediate hazard to the life, health, or safety of patients or staff.

(3) Provisional licenses shall be renewed at the discretion of the Department only in cases of extreme hardship and in no case for longer than 90 days.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5 and 31-2-7
History. Original Rule entitled "Provisional Licenses" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-53-.07 Applications {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.07}

(1) Mandatory Information Forum. Potential applicants must send at least one representative to attend the Information Forum which shall be held at least fourteen (14) days prior to the start of the Open Enrollment Period. Failure to attend the Information Forum shall disqualify any applicant from consideration during open enrollment.

(2) Letter of Intent. Applicants for licensure must submit a letter of intent stating such applicant's intention to apply for a narcotic treatment program license. Such letter of intent shall include the intended address and Region location. The letter shall be delivered to the Department at least seven (7) days prior to the beginning of the Open Enrollment Period.

(3) The first Open Enrollment Period shall be held December 1, 2017 through December 31, 2017. Thereafter, the Open Enrollment Period shall be held in the month of December of each following year unless the Department issues a Public Notice prior to December 1 specifying an alternate time frame for enrollment.

(4) No later than the last day of the Open Enrollment Period, an application for a license to operate a narcotic treatment program must be submitted by the governing body to the Department on forms provided by the Department and must contain all information and documents designated by the Department, including, at a minimum:

(a) Data and details regarding treatment and counseling plans;

(b) Written operating standards that demonstrate an organizational capability to meet these rules;

(d) A listing of all currently licensed narcotic treatment programs within the Region of proposed location and within a 75 mile radius, whether or not such other programs are outside of the Region.

(e) Patient levels of currently licensed programs in the proposed Region of care and within 75 miles, including

The number of patients admitted to current narcotic treatment programs in the most recent month; and
The number of patients served by current narcotic treatment programs in the most recent month,

(f) Data on demographic, social, health, economic, alcohol and drug related crimes, alcohol and drug overdoses, and hospital and emergency department admission of individuals addicted to opioids for the program location;

(g) Applicant experience operating a narcotic treatment program or working at such program, including complete history of such experience both within this state and in any other state;

(h) Program ownership in other locations, if any, including a complete and accurate description of narcotic treatment program experience, including whether the applicant currently holds, has held, or had revoked any licenses, registrations, enrollments, accreditations, contracts, and network memberships. The applicant shall disclose any adverse actions against the applicant while employed by or as a result of ownership of a narcotic treatment program;

(i) Evidence the applicant sought community input for the proposed location from substance abuse advocacy organizations, civic organizations, neighborhood associations, locally elected officials, and other groups;

(j) Proof of notification of intent to file an application with all law enforcement offices within a 25 mile radius of the proposed program location;

(k) Proof of notification of intent to file an application with all drug courts within a 75 mile radius of the proposed program location;

(l) A narrative description of and information about adjoining businesses and occupancies within 200 feet of the facility, including a description of transportation access, traffic patterns, security features, local area police and crime reports, and neighborhood safety;

(m) A complete description of the facility's parking arrangements for staff and patients; and

(n) Assurances satisfactory to the Department that the program is in compliance with all applicable federal and state laws for the handling and dispensing of drugs and all state and local health, safety, sanitation, building, and zoning requirements.

(5) Approval by SAMHSA, the DEA, and the Georgia State Board of Pharmacy. An application must include assurances satisfactory to the Department that the program will meet the requirements for approval by SAMHSA or other applicable federal agency, the DEA, and the Georgia State Board of Pharmacy.

(6) False or Misleading Information. An application for a license must be truthfully and fully completed. In the event that the Department has reason to believe that an application has not been completed truthfully, the Department may require additional verification of the facts alleged. The Department may revoke a license or refuse to issue a license where material false statements have been made on or in connection with an application.

(7) History of Compliance. When an existing licensee applies to operate another program, the Department will consider the licensee's history of compliance in Georgia and may consider the licensee's compliance in any other state when determining the applicant's eligibility for another license. When an applicant that has previously operated a program applies to operate a new program, the Department will consider the compliance history of the applicant in Georgia and may consider the compliance history of the applicant in any other state.

(8) No license shall be issued to any governing body that has been denied a license by the Department during the previous 12 months. No license shall be issued to any governing body that has had a license revoked by the Department during the previous 12 months.

(9) Criminal Background Checks for Applicant/Owner. Prior to the issuance of any new license, the applicant of the business or agency applying for the license shall be required to submit a records check application so as to permit the Department to obtain a criminal history background check. After initial licensure, the owner shall be required to submit evidence of a satisfactory background check to the Department every three (3) years.

(a) At the time of initial licensure, in lieu of a records check application, the applicant may submit evidence, satisfactory to the Department, that within the immediately preceding 12 months the owner has received a satisfactory narcotic treatment program criminal records check determination.

(b) A narcotic treatment program license shall not be issued, and any issued license shall be revoked, where it has been determined that the applicant/owner has received an unsatisfactory criminal records check determination involving any of the covered crimes, as defined in paragraph (f) of Rule 111-8-53-.03 .

(c) An owner with a valid narcotic treatment program license who acquires a criminal record for any of the crimes listed in paragraph (f) of Rule 111-8-53-.03 subsequent to the effective date of the license shall disclose the criminal record to the Department.

(d) If at any time the Department has reason to believe an owner holding a valid license has been arrested, charged, or convicted of any of the covered crimes listed in paragraph (f) of Rule 111-8-53-.03 , the Department shall require the owner to submit a records check application immediately for determination of whether a revocation action is necessary.

(e) An owner holding a valid narcotic treatment program license issued prior to May 4, 2017 shall not be subject to any of the background check requirements stated in this Rule 111-8-53-.07(9) . However, if there is a change in the governing body of a program licensed prior to May 4, 2017, any new individuals with an ownership interest in the program shall be subject to the requirements of this Rule 111-8-53-.07(9) .

(10) Application Review Committee. Where more applications are received for a particular Region during the Open Enrollment Period than are permissible under these rules, the Department shall first review the applications to determine that all information required under subsections (1) - (9) above has been submitted. All complete applications will then be sent to the Application Review Committee to be scored based on the following criteria:

(a) Compliance with all state and federal laws and regulations;

(b) Compliance with all applicable standards of practice;

(d) Impact on the delivery of opioid treatment services of the applicant in the applicable population.

(11) Notice of Intent to Issue License/Notice of Appeal Rights. Programs selected for licensure by the Application Review Committee shall receive a notice of the Department's intent to issue a license. Programs not selected shall receive notice of the right to an administrative hearing. Upon waiver of or exhaustion of administrative appeal rights, the Department shall issue license(s) to the selected program(s).

(12) Waiver Applications under O.C.G.A. § 26-5-48(f) . The Department, in its discretion, may grant a waiver to an applicant to allow an application to be submitted for review in a Region that has four or more licensed narcotic treatment programs. The Application Review Committee shall consider such waiver applications based on criteria developed jointly by the Department and the Department of Behavioral Health and Developmental Disabilities with emphasis on the needs assessment and/or justification for the establishment of a new program (including identification of treatment gaps), as well as community stakeholder support.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Applications" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.08 Inspections and Plans of Correction {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.08}

(1) The Department is authorized to conduct on-site inspections of any program to verify compliance with these rules and all relevant laws or regulations at any time. A program shall permit any authorized representative of the Department to enter upon and inspect any and all program premises which, for the purpose of these rules, shall include access to all parts of the facility, staff, persons in care, and all records pertinent to initial and continued licensure. For the purpose of conducting any investigation, inspection, or survey, the Department shall have the authority to require the production of any books, records, papers, including all patient records or other information related to the initial or continued licensing of any program. The Department may require at reasonable intervals that each licensee shall furnish copies of complete records of each person treated or advised by the program, provided, however, that patient identifying information shall be redacted from such records prior to submission to the Department. Failure to permit entry and inspection is a violation of these rules and may result in the denial of any license applied for or in the suspension or revocation of a license.

(2) If, as a result of an inspection, violations of these rules requiring corrective action are identified, the Department shall issue a written inspection report that identifies the rules violated and requires the program to submit a written plan of correction that states what the program will do to correct each of the violations identified. The program may offer an explanation or dispute the findings of violations in the written plan of correction so long as an acceptable plan of correction is submitted within 10 days of the receipt of the inspection report. Failure to submit an acceptable plan of correction may constitute cause for the Department to deny a license or suspend or revoke a license. Upon the discovery of any violation of these rules, the Department may proceed to suspend or revoke a program's license in accordance with these rules. In determining whether to suspend or revoke a license, the Department may consider whether the violations can be corrected, the program's history of compliance, the nature and seriousness of the violations, the impact of the violations on the safety and welfare or the program's patients and the surrounding community and any other relevant circumstances.

(3) Programs shall also cooperate with interested parties seeking to apply for licensure by providing the information detailed in Rule 111-8-53-.07(4)(e) within a reasonable period of time.

(4) After initial licensure, the Department shall conduct on-site inspections of each program on an annual basis. The Department may authorize third party audits or inspections of programs for the purpose of determining whether or not a program is in compliance with these rules.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Inspections and Plans of Correction" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.09 Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.09}

(1) Program Purpose. A licensed program shall operate, in accordance with these rules, under written policies and procedures that define its philosophy, purpose, program orientation, and procedures. Such policies and procedures must identify the types of drug-dependent individuals and the ages of the patients that the program serves, including referral sources.

(2) Program Description. A licensed program shall develop and fully implement written policies and procedures that describe the range of treatment and services provided by the program. These policies and procedures must describe how identified treatment and services will be provided and how such treatment and services will be assessed and evaluated. A program description must show what services are provided directly by the program and what treatment and services are provided in cooperation with available community or contract resources.

(3) Finances. The governing body shall provide for the preparation of an annual budget and approve such budget. Copies of the current year's budget and expenditure records must be made available to the Department for examination and review by the Department upon request.

(4) Fees. The program shall develop and implement a written schedule of patient fees. The schedule must identify all fees that are chargeable to patients and a copy of the current schedule shall be posted in a conspicuous place so as to inform patients and their parents, guardians, or responsible parties of such schedule of fees.

(5) Patient Records. The patient record must accurately reflect the course of appropriate treatment provided to the patients. Programs must organize and coordinate patient records in a manner that demonstrates that all pertinent patient information is accessible to all appropriate staff and to the Department. The patient's Central Registry I.D. number must be maintained in each patient record and some form of a patient identification must appear on each page of the record. Each patient record must contain, at a minimum, the following:

(a) Basic identifying information including name, current address, current telephone number, date of birth, sex, and race;

(b) If applicable, the names, addresses, and telephone number of parents, or guardians, or responsible parties;

(d) Appropriate evidence of a history of opiate addiction prior to entry into the program;

(e) Records of screening and assessment, including information about expected charges for services;

(f) If applicable, documentation of why the patient was not admitted for treatment and suggested referrals given to patient;

(g) Written consents, signed by the patient and dated and witnessed, as required in Rule 111-8-53-.12(1)(c)1. ;

(h) Documentation of Central Registry clearance as required in Rule 111-8-53-.19 ;

(i) Documentation of orientation as required in Rule 111-8-53-.12(1)(c)3. ;

(j) The individual treatment plan and documentation of patient involvement in the development of the individual treatment plan;

(k) Medical reports, nursing notes, laboratory results including reports of drug screens, progress notes, and documentation of current dose and other dosage data, with all entries signed and dated by the appropriate professional staff;

(l) Dated and signed case entries of all significant contacts with or concerning patients, including a record of each counseling session in chronological order, as well as dated and signed forms and assessments;

(m) Correspondence with the patient, his or her family members, and other individuals and record of each referral for service and the results thereof;

(n) Documentation by appropriate professional staff that supports the course of treatment being provided; and

(o) Discharge summary, including reasons for discharge and any referral.

(6) Confidentiality of Patient Records. Written policies and procedures shall be established and implemented for the maintenance and security of patient records specifying who shall supervise the maintenance of such records, who shall have custody of such records, and to whom records may be released. Confidentiality of patient records and release of such records must comply with 42 CFR, Part 2, Confidentiality of Alcohol and Drug Abuse Patient Records and any applicable state laws, including but not limited to O.C.G.A. § 26-5-56 . Patients shall be informed that all clinical records are subject to inspection by the Department in connection with the initial and on-going licensure of the program.

(7) Drug Records. Medication orders and dosage changes must be written or printed on a physician's order sheet or a form that clearly displays the physician's signature and tracks orders over time. Dosage dispensed, prepared, or received must be recorded and accounted for by written or printed notation in a manner that reflects an accurate inventory at all times. Every dose shall be recorded in the patient's individual medication record at the time the dose is dispensed or administered and shall be properly authenticated by the licensed person administering such dose. Where computerized systems are used, authentication procedures will be strictly enforced. If initials are used, the full signature and credentials of the qualified person administering or dispensing must appear at the end of each page of the medication sheet. The perpetual inventory must be totaled and recorded in milligrams daily. Methadone and related drugs shall be counted and reconciled with the written inventory at the beginning and end of each dosing day with all discrepancies satisfactorily resolved.

(8) Personnel Records. A program shall maintain written and verified records for each employee. Each employee file shall include:

(a) Identifying information including name, current address, current telephone number, and emergency contact persons;

(b) A five-year employment history or a complete employment history if the person has not worked five years;

(c) Evidence of a criminal record check obtained from a state or local law enforcement agency that reflects the individual does not have any convictions of a crime, as defined in paragraph (f) of Rule 111-8-53-.03 , within the previous five years; for employees working in an administrative capacity who are not providing care to patients and for employees working as peer counselors, the program may accept a criminal record check which includes conviction of a nonviolent crime such as those listed in 111-8-53-.03(f)(12) - (17) ;

(d) Records of educational qualifications if applicable;

(e) Date of employment;

(f) The person's job description or statements of the person's duties and responsibilities;

(g) Documentation of training and orientation required by these rules;

(h) Any records relevant to the employee's performance, including an appropriate health status of the employee; and

(i) Evidence that any professional license required as a condition of employment is current and in good standing.

(9) Referral to Other Programs. Each program shall have arrangements for referral of patients to other programs that offer different treatment modalities.

(10) Closing of a Program. A program that intends to close the program voluntarily shall notify the Department no later than sixty (60) days prior to closure. Any program that closes, either voluntarily or involuntarily, shall submit satisfactory evidence to the Department that the program has developed a transition plan for the continuity of care for its patients. Such transition plan shall include, at a minimum:

(a) Written notice to all current patients of record that the program is closing. Such notice shall be provided to patients at least thirty (30) days prior to closure and shall include information on other programs in close proximity which have availability to treat new patients;

(b) Coordination with other programs to ensure continuity of care for patients that need assistance in locating a new treatment program;

(d) A plan for the transfer of appropriate clinical/treatment records to the receiving program in a manner that complies with state and federal privacy laws;

(e) A timeline for management of closure-related activities; and

(f) A protocol for securing all medications to ensure that there is no diversion and to transfer any excess medications to the U.S. Drug Enforcement Administration.

(11) Hours of Operation. Program hours of operation shall accommodate persons involved in activities such as school, homemaking, childcare, and variable-shift work. Programs shall offer comprehensive services, including, but not limited to, individual and group counseling, medical services, and referral services, at least five days per week. A program may close on Sundays and state and federal holidays provided appropriate treatment arrangements are made for patients. In order to accommodate patients for whom take-home medication has not been authorized, the program shall dispense medication at least seven days per week when necessary. Programs shall further develop a plan for contingencies, emergencies, etc., including 24 hour emergency services during non-operating hours to assist patients in crisis situations.

(12) Community Liaison and Concerns. A program shall schedule and provide services to its patients in such a manner as to minimize the impact on local community services.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Administration" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.10 Staffing {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.10}

(1) Staff Ratios and Responsibilities. The program shall have sufficient and appropriate types and numbers of staff to provide the treatment and services as required by applicable state law and regulation and as outlined in its program description. When the program is open to provide treatment, there shall be a minimum of one clinical staff member and at least one additional staff member on site at all times. Patient-staff ratios shall be adjusted to ensure reasonable and prompt access to medical staff and counselors by patients and to provide the frequency and intensity of medical and counseling services required by the patients.

(a) Administrator. The governing body of each program shall designate in writing an administrator. The administrator shall be responsible for the on-going and day-to-day operations of the program, for overall compliance with federal, state, and local laws and regulations regarding the operation of narcotic treatment programs, and for all program employees including practitioners, agents, or other persons providing services at the program. The administrator must be at least 21 years of age, must have at least one year of supervisory and administrative experience in the field of substance abuse treatment, and must have at least one year of experience working in a narcotic treatment program. Programs must notify the Department in writing within 10 calendar days whenever there is a change in administrator.

(i) Criminal History Background Check - Administrators. The program must obtain a satisfactory criminal history background check for the person being considered for employment as an administrator and must obtain a new background check for the employed administrator every three (3) years thereafter. The records check must be performed as prescribed in these rules. Programs licensed prior to May 4, 2017 shall only be subject to the requirements of Rule 111-8-53-.10(a)(i) - (iv) if there is a change in the administrator.

(ii) At the time of initial employment, in lieu of a records check application, the program may submit evidence, satisfactory to the Department, that within the immediately preceding 12 months the administrator has received a satisfactory narcotic treatment program criminal records check determination.

(iii) A person with an unsatisfactory criminal history background check determination must not serve as an administrator of a licensed narcotic treatment program. Failure to satisfy this requirement may result in enforcement action against the facility as prescribed in Chapter 111-8-25.

(iv) The administrator must immediately submit to an additional criminal history background check when the Department provides the administrator with written notice of any one of the following:

There is reason to believe that the administrator has acquired a criminal record as defined by these rules; or
The criminal history background check is required in connection with a complaint investigation being conducted by the Department.

(b) Clinical Director. The governing body of each program shall designate in writing a clinical director. The clinical director shall be responsible for the day-to-day and on-going clinical aspects of the program and of the treatment for those patients admitted to the program. Programs must notify the Department in writing within 10 calendar days whenever there is a change in clinical director.

(c) Medical Director. The governing body of each program shall designate in writing a medical director to be responsible for the administration of all medical services, including compliance with all federal, state, and local laws and regulations regarding the medical treatment of narcotic addiction. A physician may serve as medical director of no more than two narcotic treatment programs provided that all such programs are in substantial compliance with these rules and are within 50 miles of the physician's primary residence or primary office location. Programs must notify the Department in writing within 10 calendar days whenever there is a change in medical director.

(d) Program Physician. Programs are required to provide sufficient physician coverage to provide the medical treatment and oversight necessary to serve patient needs. A program physician's responsibilities for each patient include, but are not limited to, performing medical history and physical exams, determination of diagnosis under current DSM criteria, determination of narcotic dependence, reviewing treatment plans determining dosage and all changes in doses, ordering take-home privileges, discussing cases with the treatment team, and issuing any emergency or verbal orders relating to patient care. At all times a program is open and a physician is not present on site, a program physician must be available on call for consultation and emergency orders. Programs must be able to document a referral agreement with a local hospital or health care facility. Any program physician who is not a medical director must work under the supervision of the program's medical director.

(e) Physician's Assistants and Nurse Practitioners. Licensed physician's assistants and certified nurse practitioners may be employed by programs and perform any functions permitted under Georgia law.

(f) Nurses. Programs shall ensure that appropriate nursing care is provided at all times the program is in operation and that an appropriately licensed and qualified health care professional is present at all times medication is administered at the program.

(g) Counselors. There must be at least one full-time counselor for every 50 patients. To be considered "full-time," a counselor must work a minimum of 35 hours per week. The program shall assign no more than 40 patients to counselors in training who are not yet certified.

(2) Staff Qualifications.

(a) Medical Director. All medical directors shall be licensed to practice medicine in Georgia, shall maintain their licenses in good standing and shall have had, at a minimum, 12 hours of training in narcotic-addiction treatment within the 12 months preceding the date of hire when hired after the effective date of these rules.

(b) Program Physician. All program physicians must be licensed to practice medicine in the State of Georgia, must maintain their licenses in good standing, and must have had, at a minimum, 12 hours of training in narcotic-addiction treatment within the 12 months preceding the date of hire when hired after the effective date of these rules. If the program physician has not had such training, he or she must be working under the direction of a qualified medical director with an acceptable training plan, completed within 12 months of the date of hire, that consists of a combination of continuing education in addiction medicine and in-service training by the program's medical director.

(c) Medical staff. All medical staff must be licensed and in good standing to practice their respective professions in the State of Georgia, have 12 hours of training in narcotic-addiction treatment within the 12 months preceding the date of hire when hired after the effective date of these rules, and practicing within the scope authorized by law. If any member of the medical staff has not had such training, he or she must be working under the direction of a qualified medical director with an acceptable training plan, completed within 12 months of the date of hire, that consists of a combination of continuing education in addiction medicine and in-service training by the program's medical director.

(d) Nurses. All registered nurses and licensed practical nurses must be licensed to practice in Georgia in compliance with Chapter 26 of Title 43 of the Official Code of Georgia Annotated, the "Georgia Registered Professional Nurse Practice Act," and must maintain their licenses in good standing.

(e) Counselors. All counselors must be certified in addiction counseling pursuant to Section 7(b)(15) of Chapter 10A of Title 43 of the Official Code of Georgia Annotated within three (3) years of employment by the program. Programs licensed prior to May 4, 2017 shall have three (3) years to comply with this requirement.

(f) Clinical Directors. All clinical directors must be licensed to practice medicine in the State of Georgia, licensed as a practitioner to provide treatment, therapeutic advice, or counseling for the rehabilitation of drug-dependent persons in compliance with state practice acts, or certified as an addiction counselor, must be at least 21 years of age, and must have at least one year of supervisory and administrative experience in the field of substance abuse treatment.

(g) Professional Practice. All professional staff members, including, but not limited to, physicians, pharmacists, physicians' assistants, nurse practitioners, registered nurses, licensed practical nurses, and counselors, may perform only those duties that are within the scope of their applicable professional practice acts and Georgia licenses.

(3) Medical Staff Supervision. Programs that do not employ a registered nurse to supervise the nursing staff must ensure that licensed practical nurses adhere to written protocols and are supervised by the Medical Director to ensure that nursing services are being appropriately delivered.

(a) Supervision by Medical Director must occur at least one time per month, be documented in writing, reviewed with the Administrator and Clinical Director, and include the following areas:

the written policies and procedures required in Rule 111-8-53-.15 ;
changes made to policies and procedures required in Rule 111-8-53-.15 ; and
areas identified by Administrator, Clinical Director, Director of Pharmacy Services, Medical Director or Program Physician as requiring training for all licensed practical nurses;

(4) Staff Training and Orientation. Prior to working with patients, all staff members who provide treatment and services must be oriented in accordance with these rules and must thereafter receive additional training in accordance with these rules.

(a) Orientation must include instruction in:

The program's written policies and procedures that are relevant to the employee's range of duties and responsibilities;
The employee's assigned duties and responsibilities;
Reporting patient progress and problems to supervisory personnel and procedures for handling medical emergencies or other incidents that affect the delivery of treatment or services; and
Customer service.

(b) Additional training consisting of a minimum of 16 hours of training or instruction must be provided annually for each staff member who provides treatment services to patients. Such training must be in subjects that relate to the employee's assigned duties and responsibilities and in subjects about current clinical practice guidelines for narcotic treatment, such as dosage based on a physician's clinical decision making and an individual patient's needs; drug screens; take-home medication practices; phases of treatment; treating abusers of multiple substances; narcotic treatment during pregnancy; HIV and other infectious diseases; co-morbid psychiatric conditions; and referring patients for primary care or other specialized services. Programs shall maintain records documenting that each staff member has received the required annual training.

(5) Employee Drug Testing. Programs shall establish and implement written policies and procedures for pre-employment and ongoing random drug testing of all program employees. Each sample must be collected and handled in accordance with accepted standards of clinical laboratory practice and tested for opiates, methadone and related drugs, amphetamines, cocaine, benzodiazephines, THC, and other drugs with satisfactory documentation of the results retained by the program.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Staffing" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.11 Physical Plant and Safety {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.11}

(1) A program shall be in compliance with all applicable local health, safety, sanitation, building, and zoning requirements.

(2) A program shall be in compliance with all applicable laws and rules issued by the state fire marshal and the proper local fire marshal or state inspector and shall have a certificate of occupancy, if required.

(3) All buildings and grounds must be accessible by the disabled and constructed and maintained in a safe manner in accordance with these rules.

(4) A program shall have appropriate and sufficient space to meet the programmatic needs of its patients, and carry out the program's array of services. Such space must include areas conducive to privacy for dosing, counseling and group activities, reception/waiting areas, and bathrooms that ensure privacy for collection of urine specimens.

(5) Medications shall be separately and appropriately stored. Medical specimens and food will be stored separately and appropriately to prevent cross-contamination.

(6) Facilities shall have NARCAN, or other medically appropriate emergency narcotic antagonists, available on site when care is being provided to patients; and

(7) Any laboratory functions performed by the program shall conform to the Rules and Regulations for Licensure of Clinical Laboratories, Chapter 111-8-10.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Physical Plant and Safety" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.12 Patient Screening, Assessment, and Admission {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.12}

(1) A program may only admit and retain patients whose known needs can be met by the program in accordance with its program purpose and description and applicable federal and state laws and regulations. Written policies and procedures for patient referral, intake, screening, assessment, and admission must be established and implemented and must include the following provisions or requirements.

(a) Screening. All applicants for admission must be initially screened by program staff to determine eligibility for admission. No applicant may be admitted until it has been verified that he or she meets all applicable criteria and that the sources and methods of verification have been recorded in the applicant's case folder. The screening process must include:

Verification, to the extent possible, of an applicant's identity, including name, address, date of birth, and other identifying data;
Drug history and current status, including determination and substantiation, to the extent possible, of the duration of substance dependence;
If an applicant has been previously discharged from treatment at another narcotic treatment program, the admitting program must initiate an investigation into the applicant's prior treatment history, inquiring of the last program attended the reasons for discharge from treatment;
If an applicant is 18 years of age or older, verification of dependence on opium, morphine, heroin or any derivative or synthetic drug of that group for a period of one year; and
If an applicant is under 18 years of age, verification that the applicant has had two documented unsuccessful attempts at short-term detoxification or drug-free treatment within a 12 month period to be eligible for maintenance treatment. No person under 18 years of age may be admitted to maintenance treatment unless a parent, legal guardian, or responsible party consents in writing to such treatment.

(b) Assessment. Each patient admitted to the program must be assessed by the medical director, the program physician, or an appropriately licensed and qualified member of the medical staff who has been determined to be qualified by law, education, training, and experience to perform or coordinate the provision of such assessments. A program shall not admit a patient for a maintenance program unless it is the most appropriate treatment modality. Before any medication is prescribed or administered, a patient who is admitted to a program shall be assessed by the medical director, the program physician, or an appropriately licensed and qualified member of the medical staff who has been determined to be qualified by law, education, training, and experience to perform or coordinate the provision of such assessments. The assessment must include:

Medical history, including HIV status, pregnancy, current medications (prescription and non-prescription), and active medical complications;
Psychiatric history and current medical status examination;
Determination if the applicant needs special services, such as treatment for alcoholism, or psychiatric services, and determination that the program is capable of addressing these needs either directly or through referral;
Explanation of treatment options, detoxification rights, and program charges, including fee agreement, signed by the applicant; and
An in-person physical examination in accordance with current and accepted standards of medical practice, complete with laboratory tests, including drug screens, HIV status (if the applicant consents to be tested), CBC and chemistry profile, and pregnancy, STD, and Mantoux TB tests, to determine dependence on opium, morphine, heroin, or any derivative or synthetic drug of that group and to determine current DSM diagnosis. The purpose of such assessments shall be to determine whether narcotic substitution, short-term detoxification, long-term detoxification, or drug-free treatment will be the most appropriate treatment modality for the patient and to establish additional educational, vocational, and treatment needs of the patient. In lieu of a complete physical examination being performed by the program physician, the individual may present a complete physical examination, dated within 90 days of admission, performed by a physician licensed in good standing in the State of Georgia. Such examination shall be updated as necessary to reflect the individual's current condition at the time of admission, including updated laboratory tests.

Consent. Except as otherwise authorized by law, no person may be admitted for treatment without written authorization from the patient and parent, guardian, or responsible party, if applicable. The following information must be explained by a trained staff person to the patient and other consenters, signed by the patient and such other consenters, and documented in the patient file:

(i) The program's services and treatment;

(ii) The specific condition that will be treated;

(iii) The expected charges for service including any charges that might be billed separately to the patient or other parties; and

(iv) The program's rules regarding patient conduct and responsibilities.

Admission Clearance. No person may receive medications unless the program first conducts an inquiry with the Central Registry in accordance with Rule 111-8-53-.19 and receives clearance from the Central Registry that the person is not simultaneously enrolled in another program.
Orientation. The program shall provide orientation to patients who are admitted for treatment within 24 hours of admission. Orientation must be done by a staff person who has been determined to be qualified by education, training, and experience to perform the task. Patients must be reoriented as needed to ensure an understanding of the program. Programs shall ensure that each patient signs a statement confirming that the following has been explained to the patient:

(i) The expected benefits of the treatment that the patient is expected to receive;

(ii) The patient's responsibilities for adhering to the treatment regimen and the consequences of non-adherence;

(iii) An explanation of individual treatment planning;

(iv) The identification of the staff person who is expected to provide treatment or coordinate the treatment;

(v) Program rules including requirements for conduct and the consequences of infractions, including involuntary discharge;

(vi) Patient's rights and responsibilities;

(vii) Procedures for complaining to the program and to the Department of Community Health;

(viii) Drug screening policies and procedures;

(ix) HIV education; and

(x) Community awareness.

Programs shall ensure that patients receive a written copy of the orientation information.

(2) Any program licensed or funded by the Department shall implement a priority admissions policy for the treatment of drug dependent pregnant females which provides for immediate access to services for any such female applying for admission, which access shall be contingent only upon the availability of space. The program must coordinate the treatment of the pregnant female with appropriate health care providers monitoring the progress of the pregnancy. Pregnancy tests for females must be conducted at admission, unless otherwise indicated.

(3) No program may provide a bounty, free services, medication, or other reward for referral of potential patients to the program.

(4) No program may provide temporary discounted financial incentives to a potential patient that does not conform to the schedule of fees established by such program as required by these rules. No program shall provide discounted fees for services during the first ninety (90) days of treatment. This paragraph (4) shall not apply to drug dependent pregnant females.

(5) Non-Admissions. The program shall maintain written logs that identify persons who were considered for admission or initially screened for admission but were not admitted. Such logs must identify the reasons why the persons were not admitted and what referrals were made for them by the program.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Patient Screening, Assessment, and Admission" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.13 Individual Treatment Plan {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.13}

A program must develop a preliminary individual treatment plan for each patient within 10 days of admission, which includes an initial treatment recommendation. A complete individual treatment plan for each patient must be developed within 30 days of admission. Patients must be involved in the development of their treatment plans. Treatment plans must document a consistent pattern of substance abuse treatment services and medical care appropriate to individual patient needs and must meet the requirements of 42 C.F.R. § 8.12(f)(4).

(a) Medical care, including referral for necessary medical service, and evaluation and follow-up of patient complaints must be compatible with current and accepted standards of medical practice. All patients must receive a physical examination by the medical director, the program physician, or an appropriately licensed and qualified member of the medical staff at least annually. All other medical procedures performed at the time of admission must be reviewed by the medical staff on an annual basis, and all clinically indicated tests must be repeated. The medical director or program physician shall evaluate the results of this annual medical examination and review of patient medical records and document such evaluation in each patient's record.

(b) In recognition of the varied medical needs of patients, the case history and individual treatment plans must be reviewed at least every 90 days for patients in treatment less than one year and at least annually for patients in treatment more that one year. This review will be conducted by the medical director or program physician along with the primary counselor and other appropriate members of the treatment team for general quality controls and evaluation of the appropriateness of continuing the form of treatment on an ongoing basis. This review must also include an assessment of the current dosage and schedule and the rehabilitative progress of the patient, as part of determination of whether additional medical services are indicated. If such review results in a determination that additional or different medical services are indicated, the program must ensure that such services are made available to the patient and appropriate referrals for additional care are made.

(c) When the program physician prescribes other controlled substances to patients in the program, the program physician shall ensure that such prescriptions are in accordance with all applicable statutes and regulation and with current and accepted standards of medical practice. Such prescriptions shall not be issued to any patient unless the medical director, the program physician, or a member of the medical staff first sees the patient and assesses the patient's potential for abuse of such medications.

(d) As part of the rehabilitative services provided by the program, each patient must be provided with individual or group counseling appropriate to his or her needs. The frequency and duration of counseling provided to patients must be determined by appropriate program staff and be consistent with the individual treatment plan. Individual treatment plans must indicate a specific level of counseling services needed by the patient as part of the rehabilitative process.

(e) All patients shall receive HIV risk reduction education appropriate to their needs.

(f) When appropriate, each patient must be enrolled in an education program, or be engaged in a vocational activity (vocational evaluation, education, or skill training), or make documented efforts to seek gainful employment. Deviations from compliance with these requirements must be explained in the patient's record. Each program shall take steps to ensure that a comprehensive range of rehabilitative services, including vocational, educational, legal, mental health, alcoholism, and social services are made available to patients who demonstrate a need for such services. The program can fulfill such responsibility by providing support services directly or by appropriate referral. Support services recommended and utilized must be documented in the patient record.

(g) All programs will develop and implement policies for matching patient needs to treatment and providing treatment in accordance with current and accepted standards of medical practice. These policies shall include treatment phasing, in which the intensity of medical, counseling, and rehabilitative services provided to a patient varies depending upon the patient's phase of treatment. Phases of treatment may include intensive stabilization for new patients and those in need of acute care, graduated rehabilitation phases, and medical maintenance or appropriate treatment-tapering phases for long-term stable patients.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Individual Treatment Plan" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.14 Discharge and Aftercare Plans {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.14}

(1) A program must complete, in accordance with accepted standards of practice, an individual discharge and aftercare plan prior to discharge for patients who leave the program with notice. The patient and, as applicable, his or her parents, guardian, or responsible persons must participate in discharge and aftercare planning.

(2) A discharge summary must be completed within seven days of discharge of a patient and must include a final assessment of the patient's status at the time of discharge and a description of aftercare plans for patients; and

(3) The program must establish and maintain a formal plan of cooperation with other programs in the State to allow for continuity of care for drug dependent persons.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Discharge and Aftercare Plans" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.15 Narcotic Drugs {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.15}

Programs shall develop and implement written policies and procedures for prescription and administration of narcotic drugs and their security. These policies and procedures must include the following:

(a) Administration.

The program physician shall determine the patient's initial and subsequent dose and schedule. If the program physician did not perform the medical assessment required in Rule 111-8-53-.12 , the program physician must consult with the person who performed the assessment before determining the patient's initial dose and schedule. The program physician shall communicate the initial and subsequent doses and schedule to the pharmacy or the person supervising medication. The program physician may assign such dose and schedule by verbal order; however, the program physician must confirm all such orders in writing within 72 hours.
Individual doses shall be based on the clinical judgment of the program physician who has personally reviewed the patient's record and who has considered all available relevant information, including, but not limited to, drug screens, quantitative levels of methadone and related drugs, patient interview, and specific circumstances pertaining to the individual patient.
A program shall maintain current procedures that are adequate to ensure that the following dosage form and initial dosage requirements are met:

(i) Methadone shall be administered or dispensed only in oral form and shall be formulated in such a way as to reduce its potential for parenteral abuse;

(ii) For each new patient enrolled in a program, the initial dose of methadone shall not exceed 30 milligrams and the total dose for the first day shall not exceed 40 milligrams, unless the program physician documents in the patient's record that 40 milligrams did not suppress opiate abstinence symptoms; and

(iii) For the use of any other approved opioid agonist treatment medication, the program shall ensure that the dosage form and initial dosage requirements are in accordance with currently accepted standards of treatment.

Patients are stabilized on methadone or a related drug when they are receiving a therapeutic dose that is sufficient to stop opioid use and sufficient to keep the patient comfortable for at least 24 hours with no need to resort to illicit opiates to satisfy opiate cravings.
The dose must either be administered by a licensed medical professional authorized by law to do so or be self-administered by the patient while under the supervision of a licensed medical professional. No methadone or any other drug may be administered unless the applicant has undergone all of the screening and admission procedures required, unless there is an emergency situation that is fully documented in the records. In that case, intake procedures must be completed on the next working day. No take-home medication may be given in such an emergency.
The program shall be responsible for ensuring that all dosages are within therapeutically acceptable limits;

(b) Any narcotic drug prescribed and administered shall be documented on an individual medication administration record that is maintained on site and stored when complete in the patient's clinical record. The record must include:

Name of medication;
Date prescribed;
Dosage;
Frequency;
Route of administration;
Date and time administered; and
Signed documentation of staff administering medication or supervising self-administration;

(c) Take-home doses of methadone shall be handled in accordance with applicable rules of SAMHSA or other applicable federal agency. A narcotic treatment program shall permit take-home doses of methadone according to these rules and the following restrictions:

During the first 90 days of treatment for a patient, the take-home supply shall be limited to a single dose per week, not to include any single take-home supply given to the patient for a day that the clinic is legitimately closed for business, including Sundays and state and federal holidays;
During the second 90 days of treatment for a patient, the take-home supply shall be limited to two doses per week, not to include any single take-home supply given to the patient for a day that the clinic is legitimately closed for business, including Sundays and state and federal holidays;
During the third 90 days of treatment for a patient, the take-home supply shall be limited to three doses per week, not to include any single take-home supply given to the patient for a day that the clinic is legitimately closed for business, including Sundays and state and federal holidays;
During the remaining months of the first year of treatment for a patient, the take-home supply shall be limited to no more than a six-day supply;
After one year of continuous treatment for a patient, the take-home supply shall be limited to no more than a two-week supply; and
After two years of continuous treatment for a patient, the take-home supply shall be limited to no more than a one-month supply, provided that the patient makes at least one visit per month;

(d) Adverse drug reaction and medication administration errors must be documented and reported to a program physician immediately and corrective action initiated. The adverse reaction or error also must be recorded in the drug administration record and the nurse progress notes and the Medical Director must be alerted;

(e) No drug shall be dispensed or administered except upon receipt of a medication drug order written by a licensed medical practitioner granted rights to prescribe such medication under the Rules and Regulations of the Georgia State Board of Pharmacy, Chapter 480-18-.07 ;

(f) All medications must be appropriately stored in a locked safe when not being administered or self-administered; and

(g) Emergency medications, such as NARCAN or other medically appropriate emergency narcotic antagonists, must be kept available for appropriate use.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Narcotic Drugs" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.16 Drug-Screen Tests {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.16}

The program shall develop and implement written policies and procedures for random drug-screen tests. These policies and procedures will be for the purposes of assessing the patient abuse of drugs and making decisions about the patient's treatment. These policies and procedures must include the following provisions:

(a) Clinically appropriate drug-screen tests done in accordance with current and accepted standards of medical practice must be conducted initially upon admission and on a random basis bi-weekly for new patients during the first 30 days of treatment and at least monthly thereafter. However, patients on a monthly schedule who fail the drug-screen tests will be returned to a bi-weekly schedule for at least two weeks or longer if clinically indicated;

(b) Each sample collected must be screened for opiates, oxycodone, methadone, methadone metabolite; amphetamines, cocaine, benzodiazepines, THC, and other drugs as indicated by individual patient use patterns or that are heavily used in the locale of the patient; and

(c) Programs shall develop and enforce policies for the proper collection and handling of drug-screen test samples to ensure that samples collected from patients are properly handled, are actually collected from the patient being tested, and are unadulterated. Such policies may include random direct observation, which shall be conducted professionally, ethically, and in a manner that respects patients' privacy.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Drug-Screen Tests" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.17 Quality Improvement {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.17}

(1) Programs shall develop and implement a written quality improvement plan that provides for the delivery of care in accordance with accepted standards of practice. At a minimum, the plan must include the following areas:

(a) A service delivery assessment that evaluates appropriateness of treatment plans and services delivered, completeness of documentation in patient records, quality of and participation in staff training programs, linkage to and utilization of primary care and other out-of-program services, patient grievance procedures, availability of services and medications for other conditions, and at least one indicator to evaluate the effectiveness of services at the program; and

(b) A documented assessment of medication-related issues including take-home procedures, security, inventory, and dosage issues completed with the Director of Pharmacy Services or an appropriate delegate.

(2) Such plan shall serve to continuously monitor the program's compliance with the requirements set forth in these rules. Responsibility for administering and coordinating the quality improvement plan must be delegated to a staff person who has been determined to be qualified by education, training, and experience to perform such tasks. The medical director shall be actively involved in the development, full implementation, and continuous monitoring of the plan.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Quality Improvement" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.18 Patient Rights, Responsibilities, and Complaints {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.18}

(1) Programs shall develop and implement written policies and procedures regarding the rights and responsibilities of patients and the handling and resolution of complaints. These policies and procedures must include a written notice of rights and responsibilities provided to each patient at orientation. The required notice must contain the following items:

(a) Right to humane treatment that affords reasonable protection from harm, exploitation, and coercion;

(b) Right to be free from physical and verbal abuse;

(d) Right to be promptly and fully informed of any changes in the plan of treatment;

(e) Right to accept or refuse treatment;

(f) Right to confidentiality of patient records;

(g) Right to be informed of the program's complaint policy and procedures and the right to submit complaints without fear of discrimination or retaliation and to have them investigated by the program within a reasonable period of time;

(h) Right to receive a written notice of the address and telephone number of the state licensing authority, i.e. the Department, and the right to file a complaint with the Department;

(i) Right to obtain a copy of the program's most recent completed report of licensing inspection from the program upon written request. The program is not required to release a report until the program has had the opportunity to file a written plan of correction for the violations as provided for in these rules; and

(j) Right to an informal review and appeal of any involuntary discharge.

(2) These policies and procedures shall also include provisions for patients and others to present complaints to the program, either orally or in writing, and to have their complaints addressed and resolved as appropriate in a timely manner.

(3) The program shall provide services in a manner that respects the rights and responsibilities of patients.

(4) The program shall post the name and phone number of the Complaint Intake Line for the Department of Community Health and the most recent inspection report issued by the Department in an area visible to the patients.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5 and 31-2-7
History. Original Rule entitled "Patient Rights, Responsibilities, and Complaints" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-53-.19 Central Registry {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.19}

(1) To prevent simultaneous enrollment of a patient in more than one program, all programs shall participate in the Central Registry approved by the Department and operated by the Department of Behavioral Health and Developmental Disabilities and shall comply with any policies, procedures or rules of the Department of Behavioral Health and Developmental Disabilities which are associated with the Central Registry. The Central Registry shall require each program to provide the social security number and other identifying information of each patient. Patients must be informed of the program's participation in the Central Registry, and prior to initiating a Central Registry inquiry, the program must obtain the patient's signed consent. Within 24 hours of accepting patient for treatment, and prior to the administration of any medication, the program shall initiate a clearance inquiry by submitting to the approved Central Registry the patient's name, date of birth, social security number, anticipated date of admission, and any other relevant information required for the clearance procedure. All such information shall be considered confidential. No individual shall receive medication from a program if that individual is reported by the Central Registry to be participating in another such program. In the event a dual enrollment is discovered, the patient must be discharged from one program in order to continue enrollment at another program. Reports received by the Central Registry shall be treated as confidential and shall not be released except to a licensed program or as required by law. Information made available by the Central Registry to programs shall also be treated as confidential.

(2) To prevent simultaneous enrollment of persons in different programs located in different states, if a program operates within 125 miles of any adjoining state and that state also has a Central Registry, the program shall participate in the Central Registry of the adjoining state, if available.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Central Registry" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.20 Reporting to the Department {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.20}

(1) A narcotic treatment program shall report to the Department within 24 hours and also follow the Department of Behavioral Health and Developmental Disabilities reporting protocol whenever any of the following incidents involving patients occurs or the program has reasonable cause to believe that such an incident involving a patient has occurred:

(a) Any death of a patient;

(b) Any rape that occurs in the program;

(d) Any assault on a patient, any battery on a patient, or any abuse, neglect, or exploitation of a patient by program staff; and

(e) An external disaster or other emergency situation that affects the continued safe operation of the program.

(2) The report shall be received by the Department in confidence and shall include at least:

(a) The name of the program and the name of the administrator or clinical director;

(b) The date of the incident and the date the program became aware of the incident;

(d) Any immediate corrective or preventative action taken by the program to ensure against the replication of the incident.

(3) Where the Department determines that a rule violation related to the incident has occurred, the Department will initiate a separate complaint investigation of the incident. The complaint investigation report and the report of any rule violation compiled by the Department arising either from the initial report received from the program or an independent source shall be subject to disclosure in accordance with applicable laws.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Reporting to the Department" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Amended: F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.21 Enforcement and Penalties {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.21}

(1) When the Department finds that an applicant for a license fails to fulfill the requirements of these rules, the Department may, subject to notice and opportunity for a hearing, refuse to grant the license. The Department is not required to hold a hearing prior to taking such action.

(2) When the Department finds that any licensed program violates any requirements of these rules, the Department may, subject to notice and opportunity for a hearing, suspend or revoke the license.

(a) License Suspension.

The Department may suspend any license for a definite period calculated by the period necessary for the facility to implement long-term corrective measures and for the facility to be deterred from lapsing into noncompliance in the future. As an alternative to suspending a license for a definite period, the Department may suspend the license for an indefinite period in connection with the imposition of any condition or conditions reasonably calculated to elicit long-term compliance with licensing requirements that the program must meet and demonstrate before it may regain its license.
In lieu of a full suspension, the Department, in its discretion, may suspend the authority of the narcotic treatment program to operate a portion of the program, e.g. granting take-home medication privileges or admitting new patients.
If the sanction of license suspension is finally imposed, as defined by a final administrative decision, the program must return its license to the Department. Upon the expiration of any period of suspension, and upon a showing by the program that it is capable of achieving compliance with licensing requirements, the Department shall reissue the program license. Where the license was suspended for an indefinite period in connection with conditions for the re-issuance of a license, once the program can show that any and all conditions imposed by the Department have been met, the Department shall reissue the program license.

(b) License Revocation. If the sanction of license revocation is finally imposed, as defined by a final administrative decision, the program must return its license to the Department.

(c) Notice. The Department shall provide notice of its actions to revoke the license or seek an emergency suspension of the program's license to operate to patients and to their legal guardians, if any, as follows:

The notice, together with the Department's complaint intake phone number and website, shall be provided to patients and to their legal guardians, if any, through the following methods:

(i) The posting of the official notice of the revocation or emergency suspension action and any final resolution at the program by Departmental staff in an area that is visible to the patients and to their legal guardians, if any;

(ii) The posting of the official notice of the revocation or emergency suspension action and any final resolution on the Department's website; and

(iii) The distribution by Departmental staff of a brief notice of the initial filing of actions to revoke or suspend the program's license to the patients and to their legal guardians, if any, who are receiving services at the program location at the time that the notice of revocation or emergency suspension is posted by the Department;

The Department may share any notice of the revocation or emergency suspension action and any information pertaining thereto with any other agencies that may have an interest in the welfare of the patients in care at the program;
When the Department has posted a notice of the revocation and/or emergency suspension actions in the program, the program shall ensure that the notice at the program continues to be visible to the patients and to their legal guardians, if any, throughout the pendency of the revocation and emergency suspension actions including any appeals;
The program shall have posted at the program in an area that is readily visible to the patients and to their legal guardians, if any, any inspection reports that are prepared by the Department during the pendency of any revocation or emergency suspension action; and
It shall be a violation of these rules for the program to permit the removal or obliteration of any notices of revocation, emergency suspension action, resolution, or inspection survey reports posted by the Department on the premises of the program during the pendency of any revocation or emergency suspension action.

(3) The Department is authorized to take emergency actions against any program when it determines that the public health, safety, or welfare requires such action.

(4) All enforcement actions shall be administered in accordance with Chapter 13 of Title 50 of the Official Code of Georgia Annotated, the "Georgia Administrative Procedure Act" and the Rules and Regulations for Enforcement of General Licensing and Enforcement Requirements, Chapter 111-8-25. Any requests for hearings in response to enforcement actions must be in writing and must be submitted to the Department no later than 10 calendar days from the date of receipt of any notice of intent by the Department to impose an enforcement action.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7, 50-13-1et seq
History. Original Rule entitled "Enforcement and Penalties" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.

Ga. Comp. R. & Regs. r. 111-8-53-.22 Variance and Waiver {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.22}

(1) The Department may, in its discretion, grant variances and waivers of specific rules upon application or petition filed on forms provided by the Department. The Department may establish conditions which must be met by the program in order to operate under the variance or waiver granted.

(a) Variance. A variance may be granted by the Department upon a showing by the applicant or petitioner that the particular rule or regulation that is the subject of the variance request should not be applied as written because strict application of the rule would cause undue hardship. The applicant or petitioner must also show that adequate standards affording protection for the health, safety, and care of patients exist and will be met in lieu of the exact requirements of the rule or regulations in question. The Department may require additional documentation by the program to support its application for a variance or waiver.

(b) Waiver. The Department, in its discretion, may dispense entirely with the enforcement of a rule or regulation by granting a waiver upon a showing by the applicant or petitioner that the purpose of the rule or regulation is met through equivalent standards affording equivalent protection for the health, safety, and care of patients.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Severability" adopted. F. Sep. 9, 2013; eff. Sept. 29, 2013.
Repealed: New Rule entitled "Variance and Waiver" adopted. F. Feb. 15, 2018; eff. Mar. 7, 2018.

Ga. Comp. R. & Regs. r. 111-8-53-.23 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-53-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-53-.23}

In the event that any rule, sentence, clause, or phrase of any of these rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof. The remaining rules or portions of rules shall remain in full force and effect, as if such rule or portions thereof so determined, declared, or adjudged invalid or unconstitutional were not originally a part of these rules.

History

Authority: O.C.G.A. §§ 26-5-2et seq., 31-2-5, 31-2-7
History. Original Rule entitled "Severability" adopted. F. Feb. 15, 2018; eff. Mar. 7, 2018.

Subject 111-8-56 Nursing Homes

Ga. Comp. R. & Regs. r. 111-8-56-.01 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.01}

Unless a different meaning is required by the context, the following terms as used in these rules and regulations shall have the meaning hereafter respectively ascribed to them; except, however, same do not apply to nursing homes owned or operated by the Federal Government:

(a) "Nursing Home" is a facility which admits patients on medical referral only and for whom arrangements have been made for continuous medical supervision; it maintains the services and facilities for skilled nursing care, rehabilitative nursing care, and has a satisfactory agreement with a physician and dentist who will be available for any medical and/or dental emergency and who will be responsible for the general medical and dental supervision of the home; it otherwise complies with these rules and regulations;

(b) "Skilled Nursing Care" means the application of recognized nursing methods, procedures, and actions directed toward implementation of the physician's prescribed therapeutic and diagnostic plan, detection of changes in the human body's regulatory system, preservation of such body defenses, prevention of complications, and promotion of emotional well-being, including but not limited to the following:

The administration of oral or injectable medications which cannot be self-administered. Other examples include the administration of oxygen, the use of suction, the insertion or changing of catheters, the application of medicated dressings, the use of aseptic technique and preparation of the patient for special procedures;
Observation in the care of the patient for symptoms and/or physical and mental signs that may develop and which will require attention of the physician and a revision in the patient's treatment regimen.

(c) "Rehabilitative Nursing" means the use of nursing skills and techniques to combat deformities and helplessness, to maintain or restore body functions, and to promote independence in self-care. Such techniques will include but not be limited to the following:

Positioning patients in or out of bed to maintain good body alignment (unless contraindicated by physician's orders), the use of range of motion exercises to maintain joint mobility;
Arranging a progression of self-care activities such as transfer and walking, and attention to bowel and bladder schedules together with retraining when indicated.

(d) The term "Distinct Part" means a physically identifiable unit of a medical facility such as an entire ward or contiguous wards, wing, floor, or building. It consists of all beds and related facilities in the unit;

(e) The term "Nursing Unit" means the number of patient beds assigned to a nurses' station;

(f) The term "Nurses' Station" means a circumscribed location containing communication and recording tools and equipment essential for the operation of nursing services;

(g) The terms "Patient" and "Resident" mean any person residing in and receiving care or treatment in a nursing home;

(h) The terms "Patient Care Plan" or "Plan of Care" mean a personalized daily plan of care indicating what care is needed, how it can be best accomplished for each patient, how each patient likes things done, what methods and approaches are most successful, and what modifications are necessary to ensure best results;

(i) The term "Patient Activities Program" means a schedule of events which are regularly planned and available for all patients, including social and recreational activities involving active participation by the patient, entertainment of appropriate frequency and character, and opportunities for participation in community activities as possible and appropriate;

(j) The term "Transfer Agreement" means a written contract with other facilities providing for transfer of patients between the facilities and for interchange of medical and other information when the facility cannot provide the level of care needed by the patient;

(k) "Physician" shall mean a doctor of medicine and/or a doctor of osteopathy duly licensed to practice in this State by the Composite State Board of Medical Examiners, under the provision of the Georgia Medical Practice Act, O.C.G.A. § 43-34-20 et seq. ;

(l) "Dentist" means any person who is licensed to practice in this State under the provisions of the Dentists and Dental Hygienists Act;

(m) "Pharmacist" shall mean an individual licensed to practice pharmacy in accordance with the provisions of O.C.G.A. § 26-4-1 et seq. ;

(n) "Physical Therapist" shall mean an individual who practices physical therapy, and who is registered with the Board of Physical Therapy of the State of Georgia, O.C.G.A. § 43-33-1 et seq. ;

(o) A "Registered Nurse" is a person who holds a current and valid license as a registered nurse issued by the State of Georgia;

(p) A "Licensed Undergraduate Nurse" is a person who holds a current and valid license as a licensed undergraduate nurse issued by the State of Georgia;

(q) A "Licensed Practical Nurse" is a person who holds a current and valid license as a licensed practical nurse by the State of Georgia;

(r) The term "Full-time Employee" means any person employed who normally works forty (40) hours per week in the home;

(s) The term "Governing Body" means the Board of Trustees, the partnership, the corporation, the association, the person or group of persons who maintain and control the home and who is legally responsible for the operation;

(t) The term "Administrator" means an individual who is licensed by the Georgia State Board of Nursing Home Administrators and who has the necessary authority and responsibility for management of the home;

(u) "Permit" means authorization by the Department to the Governing Body to operate a home and signifies satisfactory compliance with these rules and regulations;

(v) "Provisional Permit" means authorization by the Department to the Governing Body to operate a home on a conditional basis for a period not to exceed six months to allow a newly established home a reasonable but limited period of time to demonstrate operational procedures in satisfactory compliance with these rules and regulations; or to allow an existing home a reasonable length of time to comply with these rules and regulations, provided said home shall first present a plan of improvement acceptable to the Department. Successive Provisional Permits may be granted to any home having deficiencies only in exceptional cases, in which cases the Governing Body must present a plan of improvement acceptable to the Department;

(w) The term "Plan of Improvement" means a written plan submitted by the Governing Body and acceptable to the Department. The plan shall identify the existing noncompliance of the institution, the proposed procedures, methods, means and period of time to correct the noncompliance;

(x) The term "Board" means the Board of Community Health of the State of Georgia;

(y) The term "Department" means the Department of Community Health of the State of Georgia;

(z) The term "Commissioner" means the chief executive of the Department.

(aa) The term "Dining Assistant" means an individual employed or compensated by the nursing home, or who is used under an arrangement with another agency or organization, to provide assistance with feeding and hydration to residents in need of such assistance. Such individual shall not provide other personal care or nursing services unless certified as a nurse aide or licensed as a registered nurse or practical nurse.

(bb) "Certified Medication Aide" is a person who is a Georgia certified nurse aide and in good standing with the Department who has successfully completed a state-approved medication aide training program, successfully passed a written competency examination and has demonstrated the requisite clinical skills to serve as a medication aide and who is registered on the Georgia Certified Medication Aide Registry.

History

Authority: O.C.G.A. § 31-7-1et seq
History. Original Rule entitled "Definitions" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Dec. 29, 2021; eff. Jan. 18, 2022.

Ga. Comp. R. & Regs. r. 111-8-56-.02 Governing Body {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.02}

(1) There shall be a governing body which assumes full legal responsibility for the overall conduct of the home.

(2) The ownership of the home shall be fully disclosed to the Department. In the case of corporations, partnerships and other bodies created by statute the corporate officers and all others owning ten percent or more of the corporate stock or ownership shall be made known to the Department.

(3) The governing body shall be responsible for compliance with all applicable laws and regulations pertaining to the home.

(4) The governing body shall certify to the Commissioner, the name of the person to whom is delegated the responsibility for the management of the home, including the carrying out of rules and policies adopted by the governing body. This person shall be known as the administrator.

(5) The word hospital, sanitorium or sanitarium shall not be used in the official title of any home permitted under the provisions of these rules and regulations.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Governing Body" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.03 Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.03}

(1) Each nursing home shall be under the supervision of a licensed nursing home administrator. An administrator may serve as the administrator of not more than one facility, except that two facilities having common ownership or management located on the same premises may be served by a single administrator. Distinct part facilities sharing a common roof shall be considered one facility. In exceptional circumstances, a waiver may be granted by the Department for a period of six months. Existing facilities not currently meeting this requirement would be exempt for a period of two years from the effective date of this regulation. If an existing facility should undergo a change of administrators during this two-year period, such facility would be required to comply with the regulations.

(2) Each home shall be operated in accordance with policies approved by the Department. These policies shall include but not be limited to those governing admissions, transfers, discharges, physicians' services, nursing services, dietary services, restorative services, pharmaceutical services, diagnostic services, social services, environmental sanitation services, recreational services and clinical records.

(3) Each home shall have a written transfer agreement in effect with one or more hospitals. Nursing homes that are a Distinct Part of a hospital will be considered to meet this requirement if acceptable provisions for the transfer of patients are included in the facility's policies.

(4) There shall be a separate personnel folder maintained for each employee. This folder shall contain all personal information concerning the employee, including the application and qualifications for employment, physical examination and job title assigned. A current job description shall be available for each classification of employee, but may be maintained separately from the personnel folder. The nursing home shall also maintain all documentation of successful completion of the entire certified medication aide training program for each certified medication aide it employs. In addition to all other documents required by state or federal regulations, the nursing home shall maintain documentation of successful completion of the dining assistant training program for each dining assistant.

(5) The home and its premises shall be used only for the purposes for which the home is operated and permitted.

(6) Each home shall, as a condition precedent to obtaining or maintaining a permit to operate a nursing home, carry or be covered by liability insurance coverages or establish or have established for its benefit a self-insurance trust for a nursing home claim. If a home fails to carry or be covered by liability insurance coverages or establish or have established for its benefit a self-insurance trust for a nursing home claim, the Department shall provide notice to such home of its noncompliance and allow such home 60 days in which to comply. A home's failure to maintain such coverage or establish such trust shall result in the Department:

(a) Revoking such home's permit issued to operate the nursing home;

(b) Denying any application to renew such permit; and

(7) In response to a reasonable request by a patient or visitor, privacy shall be afforded for conversation and/or consultations.

History

Authority: O.C.G.A. § 31-7-1 et seq
History. Original Rule entitled "Administration" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Jan. 27, 2017; eff. Feb. 16, 2017.
Amended: F. Dec. 29, 2021; eff. Jan. 18, 2022.

Ga. Comp. R. & Regs. r. 111-8-56-.04 Nursing Services {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.04}

(1) A registered nurse shall be employed full time as director of nursing services. She shall not also be the administrator.

(2) The director of nursing services shall normally be employed on the daytime shift and shall devote full time to the administration of the nursing service which includes a reasonable amount of time with all nursing shifts.

(3) The director of nursing services may also serve as the director of nursing services in another facility in close proximity to the home provided she has a registered nurse assistant who is assigned to each facility full time as supervisor of nursing care. The director's assistant shall devote full time to the supervision of nursing care.

(4) There shall be at least one nurse, registered, licensed undergraduate, licensed on duty and in charge of all nursing activities during each eight-hour shift.

(5) A nursing home may employ certified medication aides for the purpose of performing the technical aspects of the administration of certain medications in accordance with O.C.G.A. § 31-7-12.7 . A nursing home shall not employ an individual as a certified medication aide unless such individual is listed in the medication aide registry established and maintained by the Department pursuant to paragraph (2) of subsection (g) of O.C.G.A § 31-7-12.2 , and is in good standing with the Department, and has met all of the qualifications in paragraph (3) of subsection (g) of O.C.G.A § 31-7-12.2 .

(a) A certified medication aide who meets the criteria established in O.C.G.A. § 31-7-12.7 shall be permitted to perform the following tasks in a nursing home in accordance with the written instructions of a physician:

i. Administer physician ordered oral, ophthalmic, topical, otic, nasal, vaginal, and rectal medications;

ii. Administer insulin, epinephrine, and B12 pursuant to physician direction and protocol;

iii. Administer medications via a metered dose inhaler;

iv. Conduct finger stick blood glucose testing following established protocol;

v. Administer a commercially prepared disposable enema as ordered by a physician; and

vi. Assist residents in the supervision of self-administration of medications.

(b) A certified medication aide shall record in the medication administration record all medications that such certified medication aide has personally administered to a resident of a nursing home and any refusal of a resident to take a medication. A certified medication aide shall observe a resident to whom a medication has been administered and shall report any changes in the condition of such resident to a charge nurse.

(c) All medications administered by a certified medication aide in accordance with O.C.G.A. § 31-7-12.7 shall be in unit or multidose packaging.

(d) Nothing in this rule or O.C.G.A. § 31-7-12.7 shall authorize certified medication aides employed by a nursing home to administer any Schedule II controlled substance that is a narcotic.

(e) A nursing home that employs one or more certified medication aides to administer medications in accordance with O.C.G.A. § 31-7-12.7 shall secure the services of a licensed pharmacist to perform the following duties as part of the nursing home's peer review, medical review, and quality assurance functions:

(i) Perform a quarterly review of the drug regimen of each resident of the nursing home and report any irregularities to the nursing home administrator;

(ii) Remove for proper disposal any drugs that are expired, discontinued, in a deteriorated condition, or when the resident for whom such drugs were ordered is no longer a resident;

(iii) Establish or review policies and procedures for safe and effective drug therapy, distribution, use, and control; and

(iv) Monitor compliance with established policies and procedures for medication handling and storage.

(f) A nursing home that employs one or more certified medication aides to administer medications in accordance with this Code section shall ensure that each certified medication aide receives ongoing medication training as prescribed by the Department. A registered professional nurse or pharmacist shall conduct quarterly unannounced medication administration observations and report any issues to the nursing home administrator.

(g) A nursing home that employs certified medication aides the nursing home shall annually conduct a comprehensive clinical skills competency review of each certified medication aide employed by such nursing home.

(6) There shall be sufficient nursing staff on duty at all times to provide care for each patient according to his needs. A minimum of 2.0 hours of direct nursing care per patient in a 24-hour period must be provided. For every seven (7) total nursing personnel required, there shall be not less than one registered nurse or licensed practical nurse employed. Dining assistants are to be used to supplement, not replace, existing nursing staff requirements and as such are not considered nursing staff and are not to be included in computing the required minimum hours of direct nursing care.

(7) The nursing staff shall be employed for nursing duties only.

(8) There shall be sufficient qualified personnel in attendance at all times to ensure properly supervised nursing services to the patients, including direct supervision of dining assistants in accordance with these rules. This includes staff members dressed, awake and on duty all night.

(9) All nursing care and related services shall be carried out in accordance with the facility's patient care policies. The lines of administrative authority and supervisory responsibility shall be clearly stated. Duties assigned to staff members shall be clearly defined and consistent with their training and experience. Policies and procedures governing nursing care shall be assembled, available and understood by the staff members and shall be the basis for staff education and practice.

(10) An active in-service nursing education program shall be in effect for all nursing personnel. This program shall be developed and conducted by a registered nurse who may be employed part-time and under the direction of the director of nursing services.

(11) The in-service nursing educational program shall be in writing and shall show the frequency of training. Attendance and progress records shall be kept for each person receiving instruction.

History

Authority: O.C.G.A. § 31-7-1et seq
History. Original Rule entitled "Nursing Service" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Dec. 29, 2021; eff. Jan. 18, 2022.

Ga. Comp. R. & Regs. r. 111-8-56-.05 Professional Service {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.05}

(1) There shall be an organized professional staff, with one physician designated as chief of staff. The professional staff shall consist of at least one physician, one dentist and one registered nurse. Other professional personnel such as the dietitian, social worker, physical therapist, pharmacist, etc. may be included on the professional staff. This organization shall function under appropriate bylaws and shall meet at regularly scheduled intervals not less than semiannually. It shall be the responsibility of this staff to develop and review care policies and to advise administration on matters pertaining to patient care. The minutes of the meetings of this staff shall be available for inspection by the Department.

(2) Patients shall be admitted only on referral of a physician.

(3) Each patient shall be under the continuing care of a physician who sees the patient at least once every thirty (30) days following admission. The patient's total program of care (including medications and treatment) is reviewed during a visit by the attending physician at least once every thirty (30) days for the first ninety (90) days, and revised as necessary. A progress note is written and signed by the physician at the time of each visit and he signs all his orders. Subsequent to the ninetieth day following admission, an alternate schedule for physician visits may be adopted where the attending physician determines and so justifies in the patient's medical record that the patient's condition does not necessitate visits at thirty-day intervals.

(4) A home shall admit only those patients for which it can provide needed care and only if the home has a permit covering that type of care. When a patient develops a condition requiring care of a level or type not provided at that home, the administration shall arrange for transfer of the patient to another home, hospital or home health agency which has a permit or is certified to provide such care or shall make satisfactory arrangements for the needed care if the condition is to be of short duration.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Professional Service" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.06 Dietary Service {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.06}

(1) Each home shall employ the services of a qualified dietitian (American Dietetic Association or equivalent qualifications). The services of the dietitian shall not be less than eight (8) hours per month.

(3) A nutritionally adequate diet shall be provided all patients and adjusted to patient's age, sex, activity, and physical condition. Nutrient concentrates and supplements shall be given only on written order of a physician.

(4) Menus shall be planned or approved by a qualified dietitian and dated. Used menus shall be kept on file for a period of thirty days for reference by the patient's physician and personnel of the home.

(5) Modified diets shall be provided in accordance with written orders of a physician or dentist. An approved diet manual shall be readily available to food service personnel.

(6) Sufficient perishable foods for a twenty-four hour period and nonperishable foods for a three-day period shall be on the premises for use in an emergency.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Dietary Service" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

(1) Each home shall provide services to assist all patients in dealing with social and related problems through one or more case-workers on the staff of the facility or through arrangements with an appropriate outside agency.

(2) Social service information concerning each patient shall be obtained and kept. This information shall cover social and emotional factors related to the patient's condition and information concerning his home situation, financial resources and relationships with other people.

(3) All nursing personnel and employees having contact with patients shall receive social service orientation and in-service training toward understanding emotional problems and social needs of patients.

(4) One person in each home shall be designated as being responsible for the social services aspects of care in the home.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Social Service" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.08 Pharmacy Management and Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.08}

Each home shall provide pharmaceutical services in full compliance with State and Federal laws and regulations.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Pharmacy Management and Administration" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.09 Physical Therapy Service {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.09}

(1) When a home has a physical therapy program, the services must be provided or directly supervised by a physical therapist.

(2) A therapy record will be kept as a part of the medical record on each patient receiving physical therapy. Information in the medical record shall include referral, diagnosis, precautions, initial physical therapy evaluation treatment plan and objectives, frequency and dates of medical reevaluations.

(3) The physical therapist shall keep progress notes on each patient including progress or lack of progress, symptoms noted, and changes in treatment plans.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Physical Therapy Service" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.10 Medical, Dental and Nursing Care {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.10}

(1) Each patient shall have a physician's written statement of his or her condition at time of admission or within forty-eight (48) hours thereafter and it shall be kept on file with the patient's medical record.

(2) Each patient shall have a physician's orders for treatment and/or care upon admission to the facility.

(3) Each home shall have an adequate arrangement for medical and dental emergencies.

(4) Reports of all evaluations and examinations shall be kept with the patient's medical records.

(a) Prevention of spread of infection from personnel to patient: Any person whose duties include direct patient care, handling food, or handling clean linen, and who has an acute illness such as "strep" throat, or an open sore or boil, shall not be allowed to work until he is fully recovered;

(b) Prevention of spread of infection from visitors to patients;

(c) Prevention of spread of infection from patient to personnel or other patients: Isolation techniques to be observed according to the source of infection and the method of spread;

(d) Reporting of communicable diseases as required by the rules and regulations for notification of diseases which have been promulgated by the Department.

(6) All medications, administered to patients must be ordered in writing by the patient's physician or oral orders may be given to a licensed nurse, immediately reduced to writing, signed by the nurse and countersigned by the physician as soon as practical.

(a) Medications not specifically limited as to time or number of doses, when ordered, must be automatically stopped in accordance with written policy approved by the organized professional staff.

(b) The patient's attending physician shall be notified of stop order policies and contacted promptly for renewal of such orders so that continuity of the patient's therapeutic regimen is not interrupted.

(7) All medications must be administered by medical or nursing personnel in accordance with the Medical and Nurse Practice Acts of the State of Georgia. Each dose administered shall be properly recorded in the clinical records:

(a) The nurses' station shall have readily available items necessary for the proper administration of medication;

(b) In administering medications, medication cards or other State approved systems must be used and checked against the physician's orders;

(c) Legend drugs prescribed for one patient shall not be administered to any other patient unless ordered by a physician;

(d) Self-administration of medications by patients should be discouraged except for emergency drugs on special order of the patient's physician or in a predischarge program under the supervision of a licensed nurse;

(e) Medication errors and drug reactions shall be immediately reported to the patient's physician and an entry thereof made in the patient's clinical records as well as on an incident report;

(f) Up-to-date medication reference texts and sources of information shall be available.

(8) Nursing care shall be provided each patient according to his needs and in accordance with his patient care plan.

(9) Restraint and/or forcible seclusion of a patient will be used only on a signed order of a physician, except in emergency and then only until the advice of a physician can be obtained.

(10) Provisions shall be made for proper sterilization of supplies, utensils, instruments, and other materials as needed for the patients.

(11) When a patient dies in the facility, a physician assistant, a nurse practitioner, or a registered professional nurse licensed in this state and employed by the facility at the time of the patient's apparent death, may make the determination and pronouncement of death in the absence of a physician. When it appears that a patient died from other than natural causes, only a physician may make the determination or pronouncement of death. The determination or pronouncement shall be made in writing on a form approved by the department.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-7-1et seq
History. Original Rule entitled "Medical, Dental and Nursing Care" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Mar. 19, 2018; eff. Apr. 8, 2018.

Ga. Comp. R. & Regs. r. 111-8-56-.11 Records {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.11}

(1) Each home shall maintain a complete medical record on each patient containing sufficient information to validate the diagnosis and to establish the basis upon which treatment is given. All active medical records shall be maintained at the nurses' station. The completed record shall normally contain the following:

(a) Name, address, birth date, sex, marital status of the patient and religion; the name, address and telephone number of physician; the name, address and telephone number of the responsible party to contact in emergency;

(b) Date and time of admission;

(d) Admitting diagnosis;

(e) Final diagnosis;

(f) Condition on discharge;

(g) History and physical examination;

(h) Treatment and medication orders;

(i) Physicians' progress notes (at least monthly);

(j) Nurses' notes;

(k) Special examination and reports.

(2) Each home shall keep patient statistics, including admissions, discharges, deaths, patient days, and percent of occupancy. Statistical records shall be open for inspection and upon request, data shall be submitted to the Department.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Records" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.12 Equipment {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.12}

(1) Patient beds shall be single, at least thirty-six inches wide, with firm even springs covered by a mattress not less than four inches thick.

(2) The home shall provide all linens and blankets essential to the treatment and comfort of patients.

(3) Wheelchairs, walkers, and mechanical lifters shall be provided by the home when needed.

(4) Each patient shall have necessary furniture which shall include a bedside table, a reading lamp, a chair, drawer space for clothes, enclosed space for hanging clothing, and individual towel rack, soap dish, drinking glass, and access to a mirror. Each patient shall have a suitable signaling device.

(6) Each patient shall be provided adequate supplies and equipment for proper oral hygiene including a toothbrush or a denture brush and denture receptacle when needed.

(7) Bedrails shall be available for use as required by the patient's condition.

(8) There shall be an electric clock with a bold face that can be read from a distance of twenty (20) feet installed in the lobby of each home.

(9) Disposable equipment and supplies shall be used only once and disposed of in an approved manner.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Equipment" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.13 Safety {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.13}

(1) All buildings and equipment shall be maintained in such condition that no hazards to the life and safety of the patients exist.

(2) Adequate parking shall be available nearby. Parking areas and service entrances shall be so designated that fire fighting equipment will have unobstructed access to all parts of the building.

(3) Handrails shall be provided on all stairways and ramps. Stairways shall be made of or covered with safe nonslip material. Doors opening onto stairways shall not open directly onto risers, but shall open onto a landing not less than the width of the door.

(4) Safety barriers at the head of stairways, and handrails in hallways shall be provided. There shall be no low windows, open porches, changes in floor levels or similar hazards.

(5) Doors to rooms used by patients shall be equipped with locks or other devices which will not allow the room to be locked from the inside.

(6) Floor surfaces shall be smooth and level; scatter rugs and highly polished floors in patient areas are prohibited.

(7) Showers, tubs and toilets shall have grab bars firmly installed convenient to patient use; the floor in bathing areas shall be provided with a nonslip surface. No patient shall be permitted to bathe without an available attendant to regulate water temperature and to provide generally for the safety of the patient, unless the patient's physician has provided a written statement to the effect that the patient is sufficiently responsible to bathe himself. Shower heads shall not be installed above bathtubs.

(8) Warning signs shall be posted prohibiting smoking or open flames of any kind in areas where oxygen is in use or stored.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Safety" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.14 Environmental Sanitation and Housekeeping {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.14}

(1) Equipment and supplies for proper sanitation will be maintained on the premises.

(2) Laundry shall be handled, stored, and processed so that spread of infection will be minimized. A sufficient clean linen supply shall be insured at all times. Soiled linen shall not be permitted to accumulate.

(4) Sanitary containers, sputum cups, and other satisfactory individual containers must be provided when needed.

(5) Each home shall have an infection control program which provides for policies, procedures and training programs. Great care should be exercised to prevent spread of infection by fomites or by infected person to person.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Environmental Sanitation and Housekeeping" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.15 Health of Employees {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.15}

(1) Health Screenings. Each home shall have in place a health screening program designed to identify conditions that may place patients at risk for infection, injury, or improper care. The program shall include requirements and processes for initial, routine, and targeted health screenings of employees and contractors who interact with patients or conduct other activities with environmental impact.

(2) Screening for Tuberculosis (TB). Prior to starting work, all employees must be screened for TB in accordance with Centers for Disease Control and Prevention (CDC) guidance for baseline screening and testing for health care personnel.

(3) Records. Copies or certificates of health screenings shall be kept in the employee's personnel file.

History

Authority: O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq
History. Original Rule entitled "Health of Employees" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. June 30, 2026; eff. July 20, 2026.

Ga. Comp. R. & Regs. r. 111-8-56-.16 Recreation {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.16}

(1) An individual shall be designated as being in charge of patient activities. This individual shall have experience and/or training in group activities, or shall have consultation made available from a qualified recreational therapist or group activity leader.

(2) Provisions shall be made for suitable recreational and entertainment activities for patients according to their needs and interests. These activities are an important adjunct to daily living and are to encourage restoration to self-care and resumption of normal activities. Variety in planning shall include some outdoor activities in suitable weather.

(3) Patients shall be encouraged but not forced to participate in patient activities.

(5) An active patient activities program shall be carried out that will meet the needs of all patients.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Recreation" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.17 Patient Capacity {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.17}

(1) The number of beds provided shall be indicated on each permit and provisional permit.

(2) The number of patients receiving care within the home shall not exceed the number of beds shown on the permit. In exceptional cases, temporary waivers, not to exceed thirty (30) days, may be granted by the Department.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Patient Capacity" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.18 Physical Plant Standards {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.18}

(1) Requirements under this rule "Physical Plant Standards" will be enforced with the effective date of these regulations EXCEPT that homes holding a valid permit prior to the effective date of these regulations, shall comply with the regulations in effect at the time the home was issued a permit or the plans were approved. Provided however, that any such homes which hold a valid permit prior to the effective date of these regulations must comply with these regulations when improvements or modifications are made within any twelve (12) month period and the cost of such improvements or modifications exceeds a total of twenty percent (20%) of the fair market value of the home. If no such improvements are made, the homes holding a valid permit prior to the effective date of these regulations must then comply with these regulations within fifteen (15) years of the effective date of these regulations. In exceptional cases and upon application to the Department by the governing body of the home, variances may be granted at the discretion of the Department (if it determines that these requirements will place an undue burden or extreme hardship on the home or its occupants), provided that the health and safety of the patients is not jeopardized.

(3) All patient rooms shall open into corridors leading to the exterior of the building. No patient room will be so located as to make it necessary for a patient to pass through another room to gain entrance to a corridor leading to the exterior.

(4) Each patient room shall be an outside room with window space equal to at least one-eighth of the floor area with opening in area large enough to remove patient by mattress.

(5) Patient bedrooms shall contain not less than one hundred (100) square feet of usable floor space in private or single rooms and no less than eighty (80) square feet per bed of usable floor space in multibed rooms. Usable floor space is in addition to area provided for closets, toilet rooms and entry ways.

(6) Not less than three (3) feet of space shall be provided between beds and between the foot of the bed and wall or other obstruction. There shall be sufficient space so beds may be made accessible from both sides for nursing care when needed.

(7) An individual clothes closet or wardrobe with door shall be provided per bed in every patient room. Clothes closets or wardrobes shall be at least twenty-two (22) inches deep and twenty (20) inches wide with at least one shelf above a hanging space equipped with a device for clothes hangers.

(8) Each patient room having more than one bed shall have permanently installed curtain tracks to permit closing each bed with curtains to allow for the privacy of each patient without obstructing the passage of other patients either to the corridor or to the toilet or lavatory adjacent to the patient room. Curtains used for enclosing patient beds shall be rendered and maintained flame resistant.

(9) Employees, staff and visitors shall not use water closets provided for patients. Toilets, including a water closet, lavatory, soap, paper towels and dispensers shall be provided near or adjacent to the following locations:

(a) Nurses' station or medication area;

(b) Kitchen;

(10) Patient bathing and toilet facilities:

(a) There shall be a general bathing area in each nursing unit. This area shall contain at least one bathtub accessible from three sides, one stall shower equipped with grab bars with adjacent drying space, one lavatory and one water closet. This unit shall be of sufficient size to provide space for dressing, a wheelchair, and an attendant. Unless the bathing fixtures are located in separate rooms, compartments must be provided to permit independent use to afford privacy for each sex. Special institutional tubs or showers may be approved for use if the program of service indicates;

(b) At least one enclosed water closet and one lavatory shall be provided for each eight beds or major fraction thereof;

(d) Unless bathtubs in bathrooms adjoining patient rooms are located so as to be accessible from three sides, handrails or grab bars on the tub or on the wall by the tub shall be provided;

(f) Grab bars, securely attached to walls and conveniently located, adjacent to all bathtubs, showers and water closets intended for patient use shall be provided.

(11) A nurses' station shall be provided in each nursing unit. It shall contain a nurses' call system, charting desk and supplies, medicine storage, lavatory with soap, towels and towel dispenser, preparation area and a refrigerator. The nurses' station shall not be more than 120 feet from the entrance of the most remote room served.

(12) There shall be separate clean and soiled utility rooms in each nursing unit located near the nurses' station. The clean utility room shall contain wall and base cabinets and stain resistant counter top, a small sink set into the counter or with drain boards. The soiled utility room shall contain a counter with a stain resistant top and storage cabinets underneath. In addition, it shall contain a deep service sink with stopper for chemical sterilization of bedpans, urinals and commode pails. The deep service sink with stopper may be omitted if a steam autoclave for sterilizing is available to the home.

(13) At least one bedpan cleansing device shall be provided in each nursing unit. It may be located in the soiled utility room or in a special bedpan closet conveniently located in each nursing unit. The bedpan cleansing device may be omitted if water closets in patient toilets are equipped with bedpan lugs, spray hose and elevated vacuum breaker.

(14) Sufficient space shall be provided in each nursing unit for stretcher and wheelchair parking. Such space shall be out of corridor traffic.

(15) There shall be a floor pantry in each nursing unit located near or adjacent to the nurses' station. The floor pantry shall contain a hot plate, sink, counter, cabinets and a refrigerator that shall not be used to store drugs, biologicals or laboratory specimens.

(16) A drinking fountain which shall not impair any passageway shall be provided in each nursing unit.

(17) There shall be a treatment room convenient to patient rooms containing a treatment table, lavatory equipped with soap, paper towels and dispenser, instrument table and storage cabinet and providing adequate room for transfer of patients. A treatment room may be used for consultation if appropriately enlarged.

(18) There shall be a patient dining and recreation area provided in each home. The minimum total area shall be twenty (20) square feet of floor space per bed. One-half the required space shall be for dining.

(19) A room with sufficient space for patients' active exercise regimens including such equipment as a full-length mirror, parallel bars, a wall-mounted wheel, and an exercise table shall be provided. The room shall also contain a lavatory with gooseneck spout and wrist controls. Soap, paper towels and towel dispenser shall also be provided.

(20) There shall be a lobby and/or waiting room in each home. The size of this area shall be determined in relation to the size of the home and the program of service.

(21) There shall be at least one building exit at ground level and at least one building exit shall be provided with a suitable ramp designed for a stretcher and a wheelchair. There shall be one such exit leading to the outdoor recreation area.

(22) A public telephone shall be located near the lobby. At least one telephone shall be arranged to be convenient for a wheelchair user.

(23) The central kitchen area shall be located to permit efficient service to the dining rooms and the nursing units. It must be arranged and equipped for adequate food storage; preparation and serving of foods in proper sequence; dish and utensil cleaning and storage, and refuse storage and removal. Homes that are a distinct part of another home may utilize the service of a central kitchen provided it is of adequate size and adequately equipped to serve the total patient population. Storage space shall be sufficient to store a 24-hour supply of perishable foods and a 3-day supply of nonperishable foods.

(24) Separate and adequate clean laundry storage and separate and adequate soiled laundry storage rooms shall be provided appropriate to the frequency of deliveries and linen needs.

(25) Janitor's closets shall be provided on the basis of at least one closet for the dietary area and one for the remainder of the home. This room shall be of sufficient size to include racks for equipment, storage space and a service sink.

(26) General storage space for the storage of supplies, furniture, equipment and patients' possessions shall be provided. Such space may be provided in one or more rooms and shall be commensurate with the needs of the home, but not less than five (5) square feet per bed.

(27) Maintenance area or areas commensurate with the needs of the home, including storage space for building and grounds maintenance equipment, tools, supplies and materials and shop space for mechanical, painting and carpentry work shall be provided.

(28) Floor, wall and ceiling finishes shall be smooth, easily cleaned and be wear-resistant appropriate to location. In addition, the floors of the following spaces shall be waterproof: toilets, baths, bedpan rooms, floor of pantries, kitchens, utility rooms, janitors' closets and treatment rooms. Areas subject to wetting shall have nonslip flooring. Carpeting, wall and ceiling finishes shall be approved by the State Fire Marshal.

(29) Stairways, doors and corridors:

(a) Stairways serving patient areas shall not be less than forty-four (44) inches in clean width;

(b) Stairs shall be individually enclosed and be separated from any public hall;

(c) A landing shall be provided at the top and bottom of every stair run. Doors shall swing with exit travel to provide safe exit;

(d) The minimum dimension of landing shall be as wide as the required width of the stairway it serves. A door swinging into a landing, when open, shall not overlap the required width of the landing;

(e) The width of stair to risers shall not be less than ten (10) inches plus a one (1) inch nosing;

(f) Winders and single risers are not acceptable;

(g) Stairs and landings shall have a non slippery finish;

(h) Patients' room corridor entrances and all required exits shall be not less than forty-four (44) inches in clean width. All other doors through which patients must pass shall be not less than thirty-six (36) inches in clean width except that doors to toilets in patient bedrooms may not be less than thirty-two (32) inches wide. Doors through which patients or equipment do not pass shall be not less than thirty (30) inches wide, except that doors to patient closets may not be less than twenty (20) inches wide;

(j) Corridors in areas used by patients shall not be less than eight (8) feet in clean width. Handrails may project into corridors, but drinking fountains, desk or other projections or obstructions may not reduce the eight (8) foot minimum dimension;

(k) Ramps shall be not less than forty-four (44) inches wide. Where ramps provide a change of corridor level, the minimum width shall be not less than that of the corridor;

(l) The maximum slope of ramps shall be not greater than ten (10) percent. Changes in direction, if any, shall be on level landings with a minimum width the same as the ramp width;

(m) Ramps shall have a nonslip finish. Ramps serving as a required means of egress shall be enclosed or protected as indicated for required stairways;

(n) Handrails shall be provided on each side of all patient corridors and on each side of stairways and ramps.

(30) Light and Ventilation:

(a) The total glass area in patient bedrooms shall be not less than one-eighth of the floor area of the room. The ventilating area shall be not less than four (4) percent of the floor area;

(b) Openings providing required natural light, which open on a covered porch whose depth exceeds four (4) feet, shall be increased in area ten (10) percent per foot of depth over four (4) feet;

(c) The heads of windows (sash opening) shall not be more than one foot below the finished ceiling unless they are at least six (6) feet eight (8) inches above the finished floor. The lower level of the window glass shall be not more than forty-eight (48) inches above the floor level;

(d) Ceiling lights shall be not less than eight (8) feet except that seven (7) feet six (6) inches may be used in corridors, halls, toilet rooms and bathrooms;

(e) The lower edge of patient bedroom windows shall in every instance be above grade.

(31) Mechanical:

(a) All bathrooms and toilet rooms shall be provided with mechanical ventilation capable of producing a minimum of ten (10) air changes per hour. Utility rooms, community rooms and corridors shall be provided with not less than four (4) changes per hour with at least two (2) of the air changes being outside air. Ducts ventilating bathrooms or toilet rooms shall not be interconnected with other duct systems but shall be discharged to the outside. Patient rooms shall be provided with at least two (2) air changes per hour of outside air. Corridors and exit halls shall not be used as a plenum for supply or return air to heating or air-conditioning system;

(d) All steam-operated equipment such as sterilizers, laundry and kitchen units, shall be provided with steam at temperatures and pressures as recommended by the equipment manufacturers;

(e) The quality and quantity of the water supply and the method of sewage disposal shall have the approval of the Department;

(f) The method employed to heat water shall provide an adequate supply of hot water at necessary temperatures for all purposes, in a safe manner;

(g) Temperature controls shall be provided so that hot water for personal uses shall not exceed 110 degrees Fahrenheit;

(h) Hot water temperatures for other uses shall be as required by the equipment served;

(i) The quantity of hot water for kitchens and laundries shall be adequate to serve the equipment installed;

(k) Gooseneck spouts shall be provided for sinks or lavatories in treatment or examination rooms, physical therapy or rehabilitation rooms and at handwashing fixtures in the kitchen area;

(l) Vacuum breakers shall be provided for any plumbing fixture having a hose or hoses attached or to any plumbing fixture having trim to which a hose may be attached, including shampoo sinks, service sinks, combination hot and cold water outlets at can wash areas. Hose bibs shall be provided for clean-up purposes in the dishwash area of kitchens;

(m) Aerators shall not be included as part of trim for plumbing fixtures;

(n) With relationship to adjacent areas, a positive air pressure shall be provided for clean utility rooms, floor pantries and medicine preparation rooms;

(p) Floor grilles shall not be used for supply or return air openings in heating, air-conditioning or ventilating systems;

(q) Ventilation openings, such as ports for exhaust fans, etc., shall be equipped with covers that close automatically when the fan is not in operation;

(r) Intake air ducts shall be designed and maintained so as to prevent the entrance of dust and insects;

(s) Hot air ducts from the heating system shall not emit temperatures in excess of 150 degrees Fahrenheit.

(32) Electrical:

(a) All areas shall be adequately lighted as required for duties performed in each space. Bedrooms and combination living-bedrooms shall have a night light, a light for general illumination and a reading light at the head of each bed. The outlets for general illumination and night lights shall be switched at the door. The reading light shall be controlled at the bedside. Each stairway, hall, corridor or general passage shall have five (5) foot candles of illumination, doubled at building and stair entrance, or change of floor level, or at ramps;

(c) Emergency lighting supplied by an emergency generator or a battery with automatic switch, shall be provided for exits, stairs and corridors;

(d) Each toilet room and bathroom and each bed location shall be furnished with an electrical or mechanical nurses' call audible or visible at the nurses' station. A duplex unit may be used for two beds.

(33) Elevators and Dumbwaiters:

(a) Where patients' rooms are located on more than one floor at least one elevator shall be provided. Other elevators shall be provided, depending upon the needs and size of the home;

(b) At least one elevator in multistory buildings shall be arranged of sufficient size to admit a stretcher and an attendant;

(c) Elevator doors shall be automatic slide type with safety interlock. Elevators shall be equipped with hand rails and automatic self-leveling control which will automatically bring car platforms level with the landing;

(d) Dumbwaiter cabs shall be not less than twenty-four (24) by thirty-six (36) inches of steel with one shelf.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Physical Plant Standards" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.19 Application for Permit {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.19}

(1) The governing body shall submit to the Department an application for a permit.

(3) Each application shall be accompanied by a copy of the bylaws of the professional staff, a copy of the policies for operating the home and a certification from each member appointed to the professional staff that he has accepted the appointment including the name and license number of the administrator and the name and license number of the director of nursing. In homes with a professional staff of ten (10) or more physician members, only the physician members elected as officers need submit a certification as to their appointment.

(4) A plan for progressive employment of personnel to match increase bed occupancy and to assure compliance with these rules and regulations shall be submitted at the time established for the preopening inspection.

(5) Proof of ownership shall accompany the application.

(a) Corporations shall submit a copy of their charter and the name and address of all owners with ten (10) percent or more of the stock and shall identify each corporate officer;

(b) Nonprofit associations and hospital authorities shall submit legal proof of the organization, the name and address of each trustee and the office held, if any;

(6) Proof of an active liability insurance policy or a self-insurance trust for the home's benefit for a nursing home claim.

History

Authority: O.C.G.A. §§ 31-2-4 et seq. and 31-7-1 et seq
History. Original Rule entitled "Application for Permit" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. Jan. 27, 2017; eff. Feb. 16, 2017.

Ga. Comp. R. & Regs. r. 111-8-56-.20 Nursing Home Permit Requirements {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.20}

(1) To be eligible for a permit the nursing home must be in satisfactory compliance with these rules and regulations and the provisions at law which apply to the locations, construction and maintenance of homes and the safety of the patients therein.

(2) Prior to the issuance of a permit and at the request of the Commissioner, the governing body or operator shall furnish to the Department evidence of satisfactory compliance with any laws or regulations thereunder applicable to homes but the enforcement of which is the responsibility of a department or agency of government other than the Department.

(3) The permit shall be framed and publicly displayed at all times.

(4) Permits are not transferable from one governing body or operator to another, nor valid when the home is moved from one location to another.

(5) Nursing homes shall provide the Department at least ninety (90) days prior written notice of the following events via electronic mail at HFRD.NH@dch.ga.gov (or such other updated address posted on the Department's website), and, for applicable events, shall take the following required actions:

(a) Date of a proposed transfer of ownership and/or change of the operator of the nursing home. The transferring nursing home owner and/or the owner of the real estate upon which the nursing home is located shall provide to the Department a copy of the acquisition agreement, operator or management agreement, lease agreement, and any other documents regarding the transfer as requested by the Department.

(b) Date of closure of the nursing home or anticipated interruption of nursing home operations. Prior to ceasing operations, a nursing home shall timely notify the Department of the planned storage location for residents' medical records, medical staff information, and other critical information. The nursing home shall publish on its webpage in a prominent location and in a widely circulated newspaper(s) in the nursing home service area a notice indicating where medical records and other critical information can be retrieved. The nursing home shall also provide this information to its residents or their designated representatives in writing. Following its closure, the nursing home shall promptly notify the Department in writing of any change in location of the residents' medical records, medical staff information, and other critical information;

(c) The effective date of a transaction involving a nursing home's acquisition, sale, divestment, transfer of operations, or merger with another nursing home or other business entity; or

(d) Effective date of material changes affecting nursing home operations, including but not limited to the addition of any services, reduction or elimination of bed capacity, or other material change(s) regarding the nursing home's delivery of services. Such notification shall include a detailed description of the material changes. A nursing home may be fined by the Department in an amount of $1000.00 per day that any notification required by Ga. Comp. R. & Regs. r. 111-8-56-.20 is late, subject to waiver or reduction of such notice requirement by the Department for good cause, as it determines in its sole discretion. A nursing home may also be fined $1000.00 per day that it fails to take any other action required by Ga. Comp. R. & Regs. r. 111-8-56-.20, after receipt of written notice by the Department. The Department shall review all proposed events and actions in accordance with its regulatory authority. A nursing home must also promptly respond to information requests issued by the Department.

(6) The permit shall be surrendered to the Department upon occurrence of any of the following events:

(a) The final onsite inspection by the Department on the last day of operation for the nursing home;

(b) The nursing home's cessation of operations;

(d) A change of more than fifty percent (50%) of the nursing home's ownership or governing body, or any change of operator of the nursing home; or

(e) The Department's suspension or revocation of the nursing home's permit.

(7) A permit shall be required for each nursing home located on different premises where more than one home is operated under the same governing body. When a nursing home operates as distinct parts, then a permit shall be required for each distinct part.

(8) Each nursing home shall be in compliance with O.C.G.A. § 26-2-370 et seq., entitled "Food Service Establishments" and the Rules and Regulations as adopted and promulgated thereunder entitled "Rules and Regulations for Food Service" and with any amendment to the law or rules promulgated thereunder.

History

Authority: O.C.G.A. §§ 26-2-370et seq., 31-2-1, et seq., 31-7-1 et seq
History. Original Rule entitled "Permits" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: New title, "Nursing Home Permit Requirements." F. Mar. 10, 2023; eff. Mar. 30, 2023.

Ga. Comp. R. & Regs. r. 111-8-56-.21 Provisional Permits {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.21}

(1) Provisional permits may be granted to the governing body of a newly established home to demonstrate operational procedures in satisfactory compliance.

(2) A provisional permit may be granted to the governing body of an existing home to demonstrate operational procedures in satisfactory compliance.

(3) Provisional permits granted to allow a reasonable time to demonstrate satisfactory compliance of operational procedure shall be limited to a period of not more than six (6) months.

(4) A provisional permit may be granted to the governing body of an existing home to give reasonable time to comply with violations of regulations and standards which relate to the structural or physical condition of the home. Provisional permits granted to allow time for correction of structural or physical conditions shall not exceed twelve (12) months.

(6) A provisional permit shall not be issued when there are noncompliances of any type which present an immediate hazard to the life, health or safety of the patients.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Provisional Permits" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.22 Inspections {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.22}

(1) The home shall be available at reasonable hours for observation and examination by properly identified representatives of the Department.

(2) The administrator or authorized representative shall notify the Department of the anticipated opening date of a newly constructed home in order that a pre-opening licensure survey of the home may be conducted to determine compliance with these rules and regulations.

(3) The administrator or his representative shall accompany the Department representative on tours of inspection.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "Inspections" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.23 New Construction {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.23}

(1) General Requirements:

(a) A program narrative and all plans and specifications for construction, including additions, alterations and renovations, shall be approved by the Department prior to commencing work on the building;

(b) The program narrative shall be submitted prior to or along with the schematic or initial plans for construction. The program narrative should include the following:

The names and addresses of each owner. If the owner is a public stock corporation, the names and addresses of each officer shall be included;
The geographical area to be served;
Admission policies;
Cooperative programs of service with local agencies, including hospitals;
Arrangements for medical and dental care, e.g., physicians on contract and agreements with hospital for patient referral;
List of personnel by types of employees and proposed salaries;
Plans for securing the services of professional personnel including registered nurses, licensed practical nurses, social workers, dietitians, pharmacists, physicians and therapists;
A description of the service to be provided the community, i.e., the level of care to be provided and the economic segments of the population to be served;
Source and amount of financing;
Anticipated first two-year cost of operation, income and source of operating funds;
Exact location of proposed site;
Utilities available, i.e., electricity, gas, water, sewage and waste disposal and transportation;
The name, address and telephone number of the person selected to represent the owner during the period of planning construction.

(2) Location and Site:

(a) The site shall be approved by the Department;

(b) The site shall have proper drainage. Sewage disposal, water, electrical, telephone and other necessary facilities shall be available to the site.

History

Authority: O.C.G.A. §§ 31-2-4et seq. and 31-7-1 et seq
History. Original Rule entitled "New Construction" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.24 Enforcement {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.24 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.24}

The administration and enforcement of these rules and regulations shall be as prescribed in O.C.G.A. §§ 31-2-8 and 50-13-13et seq.

History

Authority: O.C.G.A. §§ 31-2-4et seq., 31-7-1et seq. and 50-13-13 et seq
History. Original Rule entitled "Enforcement" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.25 Dining Assistants {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.25 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.25}

(1) Dining assistants shall work under the direct supervision of a registered nurse or a licensed practical nurse. Direct supervision means that the registered nurse or licensed practical nurse is present in the same room and available to respond to the need for assistance.

(2) Dining assistants are to be used to supplement, not replace, existing nursing staff requirements and as such are not considered nursing staff and are not to be included in computing the required minimum hours of direct nursing care.

(3) Dining assistants shall:

(a) Be at least 16 years of age; and

(b) Have successfully completed the dining assistant training program in accordance with these rules.

(4) Dining assistants shall provide feeding and hydration assistance only to those residents who have been determined to meet the following criteria:

(a) A nursing home's registered professional nursing staff shall determine which residents a dining assistant may safely assist with feeding and hydration. The determination shall be based on the resident's latest nursing assessment and plan of care, which is performed in accordance with generally accepted standards of practice and applicable laws and regulations;

(b) The resident's plan of care shall clearly reflect the nurse's determination that the resident may be safely assisted with feeding and hydration by a dining assistant; and

(c) Dining assistants shall not provide feeding and hydration assistance to residents who have complicated feeding problems, including, but not limited to, difficulty swallowing, recurrent lung aspirations, and tube or parenteral/IV feedings.

(5) The nursing home's dining assistant training program shall be conducted under the direction of a registered nurse and shall require participants to perform return demonstrations, as applicable, to demonstrate competencies on program components.

(6) The minimum requirements of the dining assistant training program shall include a minimum of 16 hours of training. The training shall include practical application of feeding and hydration skills and shall include at least the following components:

(a) Feeding techniques;

(b) Assistance with feeding and hydration;

(d) Appropriate responses to resident behavior;

(e) Safety and emergency procedures, including the Heimlich Maneuver;

(f) Infection control;

(g) Recognizing changes in residents that are inconsistent with their normal behavior and the importance of reporting such changes to the supervisory nurse;

(h) Reporting requirements as specified by Article 4 of Chapter 8 of Title 31 of the Official Code of Georgia Annotated, the "Long-term Care Facility Resident Abuse Reporting Act"; and

(i) Resident rights, including abuse and neglect prevention.

(7) The nursing home shall maintain a written record of all individuals who have successfully completed the dining assistant training program. At a minimum, such written record maintained by the nursing home must include the dining assistant's complete name and address, the name and address of the nursing home, the name and signature of the registered nurse directing the training program, and the date the training program was successfully completed. The nursing home shall provide a copy of such written record in a timely manner to any dining assistant who has successfully completed the training program upon the dining assistant's written request.

(8) A copy of the written record of the satisfactory completion of the dining assistant training program may be used by a subsequent nursing home hiring the dining assistant in lieu of repeating the training, provided that the dining assistant satisfactorily performs return demonstrations of the minimum skills required of dining assistants as specified in these rules for the hiring nursing home. Such satisfactory demonstrations of skills shall be documented by a registered nurse and retained by the nursing home in the dining assistant's record along with a copy of the initial documentation of successful completion of the training program as specified in these rules.

(9) In addition to all other documents required by state or federal regulations, the nursing home shall maintain the following records:

(a) A copy of the nursing home's dining assistant training program; and

(b) Documentation of successful completion of the training program for each dining assistant.

History

Authority: O.C.G.A. § 31-7-1et seq
History. Original Rule entitled "Dining Assistants" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Ga. Comp. R. & Regs. r. 111-8-56-.26 Background Screening and Employees {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.26 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.26}

(1) Criminal History Background Checks for Owners Required. Prior to the issuance of any new license, the owner of the business or agency applying for the license must comply with the requirements of the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(2) Criminal History Background Checks for Administrators Required. The home must obtain a satisfactory fingerprint records check determination for the person being considered for employment as an administrator. The records check determination must be done in compliance with the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(3) Criminal History Background Checks for Direct Access Employees Required. Prior to serving as a direct access employee, the home must obtain a satisfactory fingerprint records check determination for the person to be hired in compliance with the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(4) Documentation of the nursing home's background screening shall be maintained for each employee.

History

Authority: O.C.G.A. §§ 31-2-4 et seq., 31-7-1 et seq., 31-7-350 et seq
History. Original Rule entitled "Background Screening of Employees" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.
Amended: F. June 30, 2026; eff. July 20, 2026.

Ga. Comp. R. & Regs. r. 111-8-56-.27 Vaccines {#sec-ga.-comp.-r.-regs.-r.-111-8-56-.27 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-56-.27}

(1) Unless contraindicated, all nursing homes shall annually offer an influenza virus vaccine, contingent on availability, to all Medicare and Medicaid eligible residents and private pay residents in their facilities and a pneumococcal bacteria vaccine, contingent on availability, to all Medicare eligible residents and all private pay residents, 65 years of age or older, in their facilities.

(2) Vaccines and other medications shall only be administered by the nursing home's licensed personnel in accordance with applicable state laws and regulations.

(3) Vaccines and other medications shall be stored safely and appropriately monitored to prevent unauthorized use or access.

(4) Vaccines and other medications shall be properly labeled and handled in accordance with current accepted standards of practice and applicable laws and regulations. Outdated, mislabeled, or otherwise unusable vaccines and other medications shall not be available for resident use.

(5) Vaccines and other medications shall be kept in original containers with original labels intact.

History

Authority: O.C.G.A. § 31-7-1et seq
History. Original Rule entitled "Vaccines" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.

Subject 111-8-62 Personal Care Homes

Ga. Comp. R. & Regs. r. 111-8-62-.01 Authority {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.01}

The legal authority for this Chapter is the Official Code of Georgia Annotated, Chapters 2 and 7 of Title 31.

History

Authority: O.C.G.A. §§ 31-2-4, 31-2-7, 31-2-8, and 31-7-1et seq
O.C.G.A. Secs. 31-2-4, 31-2-7, 31-2-8, 31-2-9, 31-2-11, 31-7-1et seq.
History. . Original Rule entitled "Authority" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.02 Purposes {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.02}

The purposes of these rules and regulations are to establish the minimum standards for the operation of personal care homes which provide residential and personal services to adults who require varying degrees of supervision and care and to assure safe, humane and comfortable, supportive residential settings.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-2-8, 31-2-9, 31-2-11, 31-7-1, 31-7-2.1, 31-7-12
History. . Original Rule entitled "Purposes" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.03 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.03}

In these rules, unless the context otherwise requires, the words, phrases and symbols shall mean the following:

(a) "Abuse" means any intentional or grossly negligent act or series of acts or intentional or grossly negligent omission to act which causes injury to a resident, including but not limited to, assault or battery, failure to provide treatment or care, or sexual harassment of the resident.

(b) "Activities of daily living" means bathing, shaving, brushing teeth, combing hair, toileting, dressing, eating, laundering, cleaning private living space, managing money, writing letters, shopping, using public transportation, making telephone calls, grooming, obtaining appointments, engaging in leisure and recreational activities, or other similar activities.

(c) "Administrator" means the manager designated by the governing body as responsible for the day-to-day management, administration and supervision of the personal care home, who may also serve as the on-site manager and responsible staff person except during periods of his or her own absence.

(d) "Ambulatory Resident" means a resident who has the ability to move from place to place by walking, either unaided or aided by prosthesis, brace, cane, crutches, walker or hand rails, or by propelling a wheelchair or scooter; who can respond to an emergency condition, whether caused by fire or otherwise, and escape with minimal human assistance such as guiding a resident to an exit, using the normal means of egress.

(e) "Applicant" means any of the following:

When the personal care home is owned by a sole proprietorship, the individual proprietor shall be the applicant for the license, complete the statement of responsibility and serve as the licensee.
When the personal care home is owned by a partnership, the general partners shall be the applicant for the license, complete the statement of responsibility and serve as the licensee.
When the personal care home is owned by an association or limited liability company (LLC), the governing body of the association or LLC shall authorize the application for the license and complete the statement of responsibility and the association shall serve as the licensee.
When the personal care home is owned by a corporation, the governing body of the corporation shall authorize the application for the license and complete the statement of responsibility and the corporation shall serve as the licensee.

(f) "Assisted living care" means the specialized care and services provided by an assisted living community which includes the provision of personal services, the administration of medications by a certified medication aide, the provision of assisted self-preservation, and the provision of limited nursing services.

(g) "Certificate" means a certificate issued by the Department to operate a memory care center in a licensed assisted living community or personal care home.

(h) "Chemical Restraint" means a psychopharmacologic drug that is used for discipline or convenience and is not required to treat medical symptoms.

(i) "Department" means the Georgia Department of Community Health operating through the Division of Healthcare Facility Regulation.

(j) "Direct care staff person" means any employee, facility volunteer or contract staff who provides to residents any personal services, including but not limited to, medication administration or assistance, assistance with ambulation and transfer, and essential activities of daily living such as eating, bathing, grooming, dressing, and toileting.

(k) "Disabled individual" means an individual that has a physical or mental impairment that substantially limits one or more major life activities and who meets the criteria for a disability under state or federal law.

(l) "Employee" means any person, other than a director, utilized by a personal care home to provide personal services to any resident on behalf of the personal care home or to perform at any facilities of the personal care home any duties which involve personal contact between that person and any paying resident of the personal care home.

(m) "Exploitation" means an unjust or improper use of another person or the person's property through undue influence, coercion, harassment, duress, deception, false representation, false pretense, or other similar means for one's own personal advantage.

(n) "Governing Body" means the person or group of persons as defined in Georgia law who maintain and control the home and who are legally responsible for the operation of the home.

(o) "Health services" means the specialized assistance that may be provided by or at the direction of either licensed healthcare professionals, such as doctors, nurses, physical therapists or through licensed healthcare programs, such as home health agencies, hospices and private home care providers to address health needs that the home is not authorized by law or regulations to provide.

(p) "Injury" as used in the definition of abuse means a wrong or harm caused by an individual to a resident which is manifested by a physical or behavioral reaction or change in the appearance or actions of the resident, such as, but not limited to, reddened or bruised skin not related to routine care, crying, startling or cowering reaction by the resident and malnutrition or pressure ulcers, such as skin breakdowns, for which the home has not provided proper care.

(q) "Legal Surrogate" means a duly appointed person who is authorized to act, within the scope of the authority granted under the legal surrogate's appointment, on behalf of a resident who is adjudicated or certified incapacitated. The legal surrogate may act on a resident's behalf where a resident has not been adjudicated as incapacitated provided that the action is consistent with the resident's wishes and intent and is within the scope of the authority granted. Where such authority is exercised pursuant to a Power of Attorney executed by a resident, the facility must maintain a copy of this document in the resident's files. The residents duly appointed legal surrogate(s) shall have the authority to act on the resident's behalf as established by written applicable federal and state of Georgia law and shall be entitled to receive information relevant to the exercise of his or her authority. No member of the governing body, administration, or staff of the personal care home or affiliated personal care homes or their family members may serve as the legal surrogate for a resident.

(r) "Limited nursing services" means the assessment of the physical, mental, and emotional status to determine the appropriate level of care for an individual; the performance of health maintenance activities, as defined in division (a)(9)(C)(ii) of Code Section 43-26-12 ; and the provision of any nursing care within the direct care staff person's scope of practice that can be completed within seven days or intermittently.

(s) "Medical alert system" means any device or combination of devices used to detect and immediately communicate that an individual is experiencing a medical emergency. Such device or combination of devices must be approved for their effectiveness by the department in its sole discretion.

(t) "Medical services" means services which may be provided by a person licensed pursuant to Article II of Chapter 34 of Title 43 of the Official Code of Georgia Annotated. or appropriately licensed and supervised nurse practitioners and physicians' assistants.

(u) "Memory care services" means the additional watchful oversight systems, program, activities and devices that are required for residents who have cognitive deficits which may impact memory, language, thinking, reasoning, or impulse control, and which place the residents at risk of eloping, i.e., engaging in unsafe wandering activities outside the home.

(v) "Memory care center" means the freestanding or incorporated specialized unit within a personal care home or assisted living community that either:

(i) holds itself out as providing additional or specialized care to persons with diagnoses of probably Alzheimer's or other dementias or with cognitive deficits that may place the resident at risk; or

(ii) charges higher rates for care for residents with Alzheimer's or other dementias than for care to other residents.

(w) "Non-Family Adult" means a resident 18 years of age or older who is not related by blood within the third degree of consanguinity or by marriage to the person responsible for the management of the personal care home or to a member of the governing body.

(x) "Nursing services" means those services which may be rendered by a person licensed pursuant to Articles I and 2 of Chapter 26 of Title 43 of the Official Code of Georgia Annotated.

(y) "On-site manager" means the administrator or person designated by the administrator as responsible for carrying on the day-to-day management, supervision, and operation of the personal care home, who may also serve as the responsible staff person except during periods of his or her own absence.

(z) "Owner" means any individual or any person affiliated with a corporation, partnership, or association with 10 percent or greater ownership interest in the facility providing care to persons under the license of the facility in this state and who:

purports to or exercises authority of the owner in a facility;
applies to operate or operates a facility;
maintains an office on the premises of a facility;
resides at a facility;
has direct access to persons receiving care at a facility;
provides direct personal supervision of facility personnel by being immediately available to provide assistance and direction during the time such facility services are being provided; or
enters into a contract to acquire ownership of a facility.

(aa) "Permit" or "Regular Permit" means the authorization granted by the Department to the governing body to operate a Personal Care Home.

(bb) "Personal Care Home", "home" or "facility" means any dwelling, whether operated for profit or not, which undertakes through its ownership or management to provide or arrange for the provision of housing, food service, and one or more personal services for two or more adults who are not related to the owner or administrator by blood or marriage.

(cc) "Personal Services" includes, but is not limited to, individual assistance with or supervision of self-administered medication, assistance with ambulation and transfer, and essential activities of daily living such as eating, bathing, grooming, dressing, and toileting.

(dd) "Physician" means an individual who is currently licensed to practice medicine in the State of Georgia. For purposes of these rules, it shall be acceptable for any services required to be performed by a physician to be performed by any other licensed medical professional (i.e., Nurse Practitioner, Physician Assistant, etc.) who is permitted to provide such services under applicable state scope of practice rules and regulations.

(ee) "Proxy caregiver" means an unlicensed person or a licensed health care facility that has been selected by a disabled individual or a person legally authorized to act on behalf of such individual to serve as such individual's proxy caregiver and meets the requirements contained in the Rules and Regulations for Proxy Caregivers Used in Licensed Healthcare Facilities, Chapter 111-8-100.

(ff) "Physical Restraints" are any manual or physical device, material, or equipment attached or adjacent to the resident's body that the individual cannot remove easily which restricts freedom 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, and wheelchair safety bars. Also included as restraints are practices employed by the home which function as a restraint, such as tucking in a sheet so tightly that a bedbound resident cannot move, bedrails, or chairs that prevent rising, or placing a wheelchair-bound resident so close to a wall that the wall prevents the resident from rising. Wrist bands or devices on clothing that trigger electronic alarms to warn staff that a resident is leaving a room do not, in and of themselves, restrict freedom of movement and should not be considered as restraints.

(gg) "Plan of Correction" means the written plan prepared in response to cited rule violations which identify by date certain the specific actions that will be taken by the personal care home to come into compliance with applicable rules.

(hh) "Representative" means a person who voluntarily, with the resident's written authorization, may act upon resident's direction with regard to matters concerning the health and welfare of the resident, including being able to access personal records contained in the resident's file and receive information and notices pertaining to the resident's overall care and condition. This written authorization may take the form of an advance directive.

(ii) "Resident" means any non-family adult receiving or requiring personal assistance and residing in a personal care home.

(jj) "Responsible Staff Person" means the employee designated by the administrator or on-site manager as responsible for supervising the operation of the home during periods of temporary absence of the administrator or on-site manager.

(kk) "Self-administration of medications" or "self-administered medications" means those prescription or over-the-counter drugs that the resident personally chooses to ingest or apply where the resident has been assessed and determined to have the cognitive skills necessary to articulate the need for the medications and generally knows the times the medications are to be taken, and physical characteristics of medications to be taken.

(ll) "Self-preservation" means the ability to respond to an emergency condition, whether caused by fire or otherwise, and escape the emergency without physical, hands-on assistance from staff. The resident may move from place to place by walking, either unaided or aided by prosthesis, brace, cane, crutches, walker or hand rails, or by propelling a wheelchair or scooter.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-8, 31-2-9, 31-7-2.1, 31-7-1 et seq., 31-8-80 et seq
History. Original Rule entitled "Definitions" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Apr. 16, 2018; eff. May 6, 2018.
Amended: F. Feb. 28, 2020; eff. Mar. 19, 2020.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.
Amended: F. May 1, 2025; eff. May 21, 2025.

Ga. Comp. R. & Regs. r. 111-8-62-.04 Applicability of Rules and Exemptions {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.04}

(1) These rules apply to all personal care homes unless the facility is specifically exempted as provided in paragraph (2) of this rule.

(2) These regulations do not apply to the following facilities:

(a) Boarding homes or rooming houses which provide no personal services other than lodging and meals.

(b) Facilities offering temporary emergency shelter, such as those for the homeless and victims of family violence.

(c) Other facilities, homes or residences licensed by the Department which have not been classified as personal care homes, e.g. assisted living communities, hospices, traumatic brain injury facilities, drug abuse treatment facilities.

(d) Facilities providing residential services for federal, state or local correctional institutions under the jurisdiction of the criminal justice system.

(e) Facilities regulated by the Department of Behavioral Health and Developmental Disabilities.

(f) Host homes as defined in O.C.G.A. § 37-1-20(18) .

(g) Group residences organized by or for persons who choose to live independently or who manage their own care and share the cost of services including but not limited to attendant care, transportation, rent, utilities and food preparation.

(h) Charitable organizations providing shelter and other services without charging any fee to the resident.

(i) Any separate and distinct dwelling which is classified by the Department as a community living arrangement subject to the Rules and Regulations for Community Living Arrangements, Chapter 290-9-37. A facility classified as a Community Living Arrangement cannot be operated on the same premises as a personal care home.

(j) Medical foster homes regulated by the U.S. Department of Veterans Affairs.

History

Authority: O.C.G.A. §§ 26-5-1, 31-2-4, 31-2-7, 31-7-1 et seq., 37-1-20(18)
History. Original Rule entitled "Exemptions" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New title of "Applicability of Rules and Exemptions". F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.
Amended: F. May 1, 2025; eff. May 21, 2025.

Ga. Comp. R. & Regs. r. 111-8-62-.05 Application for Permit {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.05}

(1) The governing body of each home must submit to the Department an application for a permit in the required format in order to be eligible to operate if the application is approved.

(2) No application for licensure will be acted upon by the Department unless it has been determined to be complete and include all required attachments and fees due the Department as specified in the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25.

(3) The application must truthfully and accurately disclose required information.

(4) Each application for a permit must be accompanied by a sketch, plat, photos or simple drawing of the home, and grounds with identification of all structures on the premises by the applicant. The visual depiction must show the property, windows, doors, room measurements, and bed placement for residents, family and/or staff and be accompanied by documentation of ownership or lease agreement for the property on which the home will be operated.

(5) The name of the administrator or on-site manager, who will be working in the home, if known, must be included with the application for a permit. If such information is not known at the time of application, it must be provided to the Department before a permit will be issued.

(6) The ownership of the home shall be fully disclosed in its application for a permit. In the case of corporations, partnerships, and other bodies created by statute, the corporate officers and all other individuals or family groups owning ten percent or more of the corporate stock or ownership must be disclosed in the application for a permit as well as the registered agent for service of process.

(7) Local zoning and other local requirements regarding the proper location and establishment of homes must be addressed by the applicant with the responsible local officials.

(8) The filing of an application for licensure constitutes a representation that the applicant is or will be in complete control of the home as of a specified date.

(9) For initial application for licensure of a home with twenty-five (25) beds or more, the applicant shall include a financial stability affidavit from a certified public accountant affirming the applicant's ability to operate as a going concern for the next two years.

(10) No personal care home shall be operated and no residents admitted without such a permit which is current under these rules and regulations.

(11) No memory care center shall be operated and no residents admitted without a certificate which is current under these rules and regulations.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-9, 31-2-14, 31-7-1 et. seq
History. Original Rule entitled "Application for Permit" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-62-.06 Permits {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.06}

(1) The governing body of each personal care home must obtain a valid permit from the Department prior to operating as a personal care home.

(2) The permit must be displayed in a conspicuous place on the premises that is visible to residents and visitors.

(3) A licensed personal care home must not serve more residents than its approved licensed capacity

(4) A permit is no longer valid and must be returned to the Department when the home ceases to operate, is moved to another location, the ownership changes, the governing body is significantly changed, or the permit is suspended or revoked.

(5) A permit is required for each home located on different premises where more than one home is operated under the same governing body.

(6) No personal care home is permitted to provide personal services to individuals living in spaces which are not located within the authorized space assigned to the licensed personal care home.

(7) A home licensed as a personal care home, but not specifically licensed as an assisted living community, must not provide assisted living care.

(8) A personal care home must not operate or allow another business to operate on the premises of the licensed home where the business intrudes on the residents' quiet enjoyment and use of the licensed home.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-2-9, 31-2-11, 31-7-1, 31-7-2.1, 31-7-12
History. Original Rule entitled "Permits" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.07 Governing Body {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.07}

(1) The governing body is responsible for providing the oversight necessary to ensure that the home operates in compliance with applicable requirements: Chapter 7 of Title 31 of the Official Code of Georgia Annotated, administrative rules and regulations of the Department of Community Health, Chapters 111-8-25, 111-8-62 and 111-8-100, and all other statutes, rules and regulations.

(2) The governing body must ensure that the Department has current contact information consisting of name, e-mail address for departmental notifications to the home, physical addresses, and phone numbers for the governing body and the administrator or on-site manager of the home. The governing body must ensure that staff is held accountable for delivering any notices provided to the governing body at the listed addresses to the governing body.

(3) The governing body is responsible for implementing policies, procedures and practices in the home that support the core values of dignity, respect, choice, independence and privacy of the residents in a safe environment and in accordance with these rules. At a minimum, the policies and procedures that are developed must provide direction for the staff and residents on the following:

(a) The services available in the home, including, personal services, memory care services/centers and any other specialized services such as designated proxy caregivers.

(b) Admissions, discharges and immediate transfers which ensure that the home does not admit or retain residents who need more care than the home is authorized or capable of providing.

(d) Training and ongoing evaluation of staff, including specialized training if designated proxy caregivers are provided or memory care is offered.

(e) House rules and their enforcement.

(f) Protecting the rights of the residents as set forth in these rules;

(g) Medication management, procurement and the professional oversight provided for such services.

(h) Health and hygiene issues for residents and staff relating to infection control, work policies and return to work policies, food borne illnesses and reportable diseases.

(i) The investigation and reporting of abuse, neglect, exploitation of residents, residents' wandering away from the community, accidents, injuries and changes in residents' conditions to required parties.

(j) Discipline procedures for handling conduct which is inconsistent with the policies of the home committed by staff.

(k) Emergency preparedness, drills and evacuation requirements.

(l) Quality assurance and peer review mechanisms to determine opportunities for improving care utilizing information acquired from reports and investigations of serious incidents, including resident and family feedback.

(m) The use of volunteers, who have unsupervised access to the residents and their orientation regarding resident's rights and basic safety precautions.

(n) The specific use of proxy caregivers allowed within the home and the oversight of proxy caregivers the home requires or provides in accordance with Georgia law, these rules and the rules for proxy caregivers, Chapter 111-8-100.

(o) The safety and security precautions that will be employed by the home to protect residents from harm by other residents, designated proxy caregivers and other individuals, not employed by the home who routinely come into the home.

(p) The staffing plan which takes into account the specific needs of the residents and also includes arrangements for staffing in the absence of regularly scheduled staff.

(4) The governing body must not permit any person who is a member of the governing body, administration or staff to serve as the representative of a resident of the home.

(5) Where a member of the governing body, administration or staff serves as the representative payee of the resident, the home must use the funds received for the exclusive use and benefit and in the best interest of the resident and maintain necessary records to support such use.

(6) The governing body must ensure that staff accepts certified mail from the Department when sent to the licensed home.

History

Authority: O.C.G.A. §§ 31-2-7, 31-7-1, 31-7-2.1, 31-7-3, 31-7-12
History. Original Rule entitled "Provisional Permits" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New title "Governing Body." F. Dec. 19, 2012; eff. Jan. 8, 2013.
Note: Correction of non-substantive typographical error in Rule History, "Amended: Dec. 19, 2012; eff. Jan. 8, 2013." corrected to "Amended: New title "Governing Body." F. Dec. 19, 2012; eff. Jan. 8, 2013." to cite title change omitted in 2012. Effective Sep. 13, 2021.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-62-.08 Administration {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.08}

(1) The home must have an administrator, who is at least 21 years of age and meets the following requirements, as applicable:

(a) Administrators of homes licensed for fewer than twenty-five (25) beds must have either (i) an Associate's Degree or, (ii) a G.E.D. or a high school diploma and 2 years of experience working in a licensed personal care home or other healthcare-related setting.

(b) Administrators of homes licensed for twenty-five (25) or more beds must hold a valid license from the State Board of Long-Term Care Facility Administrators with an effective date no greater than sixty (60) days from the date of hire or July 1, 2021, whichever is later.

(2) The administrator or on-site manager of each personal care home must do the following:

(a) Ensure that the policies and procedures are effective and enforced to support the health and safety of the residents.

(b) Designate qualified staff as responsible staff to act on his or her behalf and to carry out his or her duties in the administrator or on-site manager's absence. No resident shall be designated as staff.

(c) Investigate serious incidents involving residents which result in injuries or death in order to identify and implement opportunities for improvement in care.

(d) Monitor and document staff performance to ensure that care and services are being delivered safely and in accordance with these rules.

(3) Personnel must be assigned duties consistent with their positions, training, experience, and the requirements of Rule 111-8-62-.09 .

(4) The facility must comply with the requirements of Chapter 111-8-16, Rules and Regulations for Disaster Preparedness Plans.

(5) Each home must have a telephone which is maintained in working order at all times and is accessible to the residents.

(6) Notification of Emergency Relocation . The home must provide timely notification of the relocation address to the residents, their family contacts and representatives, if any, and the Department whenever the home must relocate the residents as a result of an emergency situation which disrupts the provision of room and board for the residents at the licensed location.

(7) Notification of Bankruptcy, Eviction or Change of Ownership . The home must provide:

(a) a minimum of sixty (60) days written notice to the department and all residents of any impending bankruptcy or property eviction that may force discharge or relocation of residents or otherwise adversely impact the provision of safe care and oversight; and

(b) a minimum of thirty (30) days written notice to the department and all residents of any impending change of ownership. The notice to the department shall be in the form of an application which must be approved before the permit is issued to the new owner(s).

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-9, 31-7-1 et seq., 43-27-1 et seq
History. Original Rule entitled "Governing Body" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Administration." F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Apr. 16, 2018; eff. May 6, 2018.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-62-.09 Workforce Qualifications and Training {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.09}

(1) Age Requirements. The on-site manager and all other direct-care supervisory staff working in a personal care home must be at least 21 years of age. Non-supervisory staff providing hands-on care to the residents must be at least 18 years of age.

(2) The administrator or on-site manager must be responsible for ensuring that any person working in the home as an employee, under contract or otherwise, receives work-related training within the first sixty days of employment. Such training must include, at a minimum, the following:

(a) Evidence of current certification in emergency first aid except where the staff person is a currently licensed health care professional;

(b) Evidence of current certification in cardiopulmonary resuscitation where the training course required return demonstration of competency;

(d) Medical and social needs and characteristics of the resident population;

(e) Residents' rights;

(f) Identification of conduct constituting abuse, neglect or exploitation of a resident and reporting requirements to include the employee's receipt of a copy of the Long-Term Care Facility Resident Abuse Reporting Act as outlined in O.C.G.A. § 31-8-81 et seq.; and

(g) General infection control principles including the importance of hand hygiene in all settings and attendance policies when ill.

(3) At least one staff person having completed the minimum training requirements of Rule 111-8-62-.09(2)(a) through (g) above must be present in the home at all times resident(s) are present in the home.

(4) All direct care staff, including the administrator or on-site manager, must satisfactorily complete continuing education each year, in courses, relevant to their job duties, including, but not limited to, appropriate medication assistance, working with the elderly, working with residents with Alzheimer's or other cognitive impairments, working with the mentally ill and developmentally disabled, social and recreational activities, legal issues, physical maintenance and fire safety, housekeeping, or other topics as needed or as determined by the Department.

(5) All direct care staff, including the administrator or on-site manager, must have at least sixteen (16) hours of training per year.

(6) The administrator, on-site manager, and each employee must have received a tuberculosis screening and a physical examination by a licensed physician, nurse practitioner or physician assistant within twelve months prior to their employment with the home which examination was sufficiently comprehensive to assure that the employee is free of diseases communicable within the scope of employment and physically qualified to work. Follow-up examinations must be conducted by a licensed physician, nurse practitioner or physician assistant of each administrator or staff person to determine readiness to return to work following a significant illness or injury. Copies of information regarding staff member health must be kept in the staff person's file accessible at the licensed home or within one hour of the request.

(7) Criminal History Background Checks for Owners Required . Prior to the issuance of any new license, the owner of the business or agency applying for the license must comply with the requirements of the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(8) Criminal History Background Checks for Directors, Administrators and Onsite Managers Required . The home must obtain a satisfactory fingerprint records check determination for the person being considered for employment as a director, administrator or onsite manager. The records check determination must be done in compliance with the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(9) Criminal History Background Checks for Direct Access Employees Required . Prior to serving as a direct access employee, the home must obtain a satisfactory fingerprint records check determination for the person to be hired in compliance with the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(10) The administrator or on-site manager must obtain and verify a five year employment history when possible for each employee and maintain documentation in the employee's file. If the potential employee has no prior employment history, then the home must retain documentation of a satisfactory personal reference check.

(11) Personnel file(s) for each employee must be maintained either in the home or available for inspection by departmental staff within one hour of request or prior to the end of the on-site survey and for three years following the employee's departure or discharge. These files must include all of the following:

(a) Evidence of a satisfactory fingerprint record check determination, if applicable.

(b) Report of a physical examination completed by a licensed physician, nurse practitioner or physician assistant.

(c) Evidence of trainings, skills competency determinations and recertifications as required by these rules and, if applicable, the Rules for Proxy Caregivers, Chapter 111-8-100.

(d) Employment history, if previously employed, including places of work, employers and telephone contacts with previous employers.

(e) Supporting documentation reflecting that the employee has the basic qualifications as represented, e.g. personal references, documentation of good standing by nursing board, no findings of abuse, neglect or exploitation entered against the individual in the nurse aide registry, satisfactory report of motor vehicle driving record where the employee may be transporting residents.

(f) Written evidence of satisfactory initial and annual work performance reviews, which can take the form of skills competency checklists, for unlicensed staff providing hands-on personal care. Where the unlicensed staff performs specialized tasks, such as health maintenance activities, such performance reviews must include the satisfactory completion of skills competency checklists as specified in applicable rules. Such reviews must be conducted by staff or contractors qualified by education, training and experience to assess that the assigned duties are being performed in accordance with applicable rules and accepted health and safety standards.

(12) Where the home permits a resident to hire his or her own companion-sitter, proxy caregiver to perform health maintenance activities or aide of any sort, the home must require assurance that the companion-sitter, proxy caregiver or aide so hired is familiar with emergency evacuation routes and has documentation reflecting compliance with the provisions of the Rules for Proxy Caregivers, Chapter 111-8-100, as applicable.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-9, 31-7-2.1, 31-7-12, 31-7-350
History. Original Rule entitled "Administration" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Workforce Qualifications and Training". F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Feb. 28, 2020; eff. Mar. 19, 2020.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-62-.10 Staffing {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.10 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.10}

(1) Homes licensed for less than 25 beds must maintain a minimum on-site staff to resident ratio of one awake direct care staff person per 15 residents during waking hours and one awake direct care staff person per 25 residents during non-waking hours where the residents have minimal care needs. Homes licensed for 25 or more beds must maintain an average monthly minimum on-site staff to resident ratio of one awake direct care staff person per 15 residents during waking hours and one awake direct care staff person per 20 residents during non-waking hours. Average monthly minimum staffing levels shall be calculated and documented by the home using methods and forms specified by the department. Notwithstanding the above requirements, all homes must staff above these minimum on-site staff ratios to meet the specific residents' ongoing health, safety and care needs.

(a) Staff, such as cooks and maintenance staff, who do not receive on-going direct care training and whose job duties do not routinely involve the oversight or delivery of direct personal care to the residents, must not be counted towards these minimum staffing ratios. Personnel who work for another entity, such as a private home care provider, hospice, or private sitters cannot be counted in the staff ratios for the home.

(b) At least one administrator, on-site manager, or a responsible staff person must be on the premises 24 hours per day and available to respond to resident needs, with a minimum of one staff person per occupied floor. Homes licensed for 25 beds or more must ensure that at least two on-site administrators or on-site direct care staff persons are present on the premises at all times with at least one staff person on each occupied floor and that person shall be required to remain posted on their designated floor at all times; provided, however, that the staff person posted on the designated floor may move about the premises as necessary if the personal care home has implemented a medical alert system and each resident has been offered a wearable device that connects to such system when activated to alert an administrator or direct care staff person of a medical emergency.

(2) All staff, including the administrator or on-site manager, who offer direct care to the residents on behalf of the home, must maintain an awareness of each resident's normal appearance and must intervene, as appropriate, if a resident's state of health appears to be in jeopardy.

(3) For purposes of these regulations, a resident must not be considered a staff person.

(4) All homes must develop and maintain accurate staffing plans that take into account the specific needs of the residents and monthly work schedules for all employees, including relief workers, showing planned and actual coverage for each day and night.

(5) The home must retain the completed staff schedules for a minimum of one year.

(6) Sufficient staff time must be provided by the home such that each resident:

(a) Receives treatments, medications and diet as prescribed.

(b) Receives proper care to prevent pressure ulcers and contractures.

(d) Is treated with dignity, kindness, and consideration and respect.

(e) Is protected from avoidable injury and infection.

(f) Is given prompt, unhurried assistance if she or he requires help with eating.

(g) Is given assistance, if needed, with daily hygiene, including baths, oral care.

(h) Is given assistance with transferring when needed.

(7) The administrator, on-site manager, or staff person must not be under the influence of alcohol or other controlled substances while engaged in any work-related activity on behalf of the home.

(8) A home licensed to serve more than 24 residents must ensure that staff wear employee identification badges which are readily visible.

(9) Medical Alert Systems. Homes utilizing medical alert systems to allow on-site staff to move about as specified in Rule 111-8-62-.10(1)(b) must meet the following requirements:

(a) The medical alert system must include a wearable sensor device that enables the resident to request help when needed.

(b) The home may encourage, but not require, residents to wear the sensor device and must ensure that residents who do not consistently wear the sensor device receive appropriate monitoring from staff.

(c) The wearable sensor device must be programmed to immediately notify appropriate staff, and to identify the specific resident or location from which the alert signal has been made, by:

(i) activating a portable electronic device worn by the administrator and/or a direct care staff person with an audible tone or vibration; or

(ii) sending a signal to a stationary electronic device located in a designated area monitored by staff.

(d) The home must establish policies and procedures which address the following requirements and must maintain documentation to demonstrate compliance with such policies and procedures:

(i) routine testing and maintenance of the medical alert system;

(ii) initial training for residents and staff on use of the system and additional training as needed;

(iii) procedures for electrical outages or severe weather events that include making more frequent rounds to check on residents if the system is not working, as well as testing the system following such events to ensure operability; and

(iv) a process for reviewing any documentation produced by the system for opportunities to enhance individualized care and service.

(e) The department may prohibit a home from using or relying on a medical alert system if the above requirements are not met.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-9, 31-7-1 et seq., 31-7-250 et seq
History. Original Rule entitled "Personnel" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Staffing". F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.
Amended: F. May 1, 2025; eff. May 21, 2025.

Ga. Comp. R. & Regs. r. 111-8-62-.11 Home Accountability and Inspections {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.11 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.11}

(1) The home and its records must be available for review and examination by properly identified representatives of the Department. Inspections may be conducted both on an announced and unannounced basis. Unannounced inspections shall be conducted as needed.

(2) Where the Department identifies rule violations, the home will receive a written report of inspection. Within 10 days of receipt of the written report of inspection, the home must develop a written plan for correcting any rule violations identified. The plan of correction must identify the specific actions the home will take promptly to come into compliance with each rule for which a deficient practice was identified and file the plan with the Department as directed.

(3) If the home disagrees with the facts and conclusions stated in the inspection report, the home may include with its plan of correction a written statement explaining its disagreement and any evidence supporting the disagreement to the Department. Where the Department concurs with the written statement of disagreement, the Department will issue a revised inspection report to the home.

(4) A copy of the most recent inspection report and plan of correction must be displayed in the home in a location that is routinely used by the home to communicate information to residents and visitors. Additionally, if the home maintains a website, it shall post a web link in a prominent location on the main page of the website that provides access to copies of all inspection reports and plans of correction from the previous 18 months. When the Department develops a web site for receiving plans of correction electronically and notifies the home of the appropriate internet address, the home also must file its plan of correction electronically on the Department's web site within 10 days of receipt of the report of inspection.

(5) The home must assess the effectiveness of its plan of correction in correcting the deficient practice and modify the plan of correction as necessary to ensure compliance with the rules.

(6) The home must complete and maintain an accurate and current licensed residential care profile on file with the Department when the Department makes available a system for the submission and collection of such information electronically.

(7) The home must provide services that are consistent with the information reported on its licensed residential care profile, its license and these rules.

(8) A personal care home which is not licensed as an assisted living community must not use the term "assisted living" in its name or marketing materials.

History

Authority: O.C.G.A. §§ 31-2-7, 31-7-1, 31-7-3, 31-7-2.1, 31-7-12, 31-7-12.2, 31-7-12.3
History. Original Rule entitled "Staffing" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Home Accountability and Inspections". F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Feb. 28, 2020; eff. Mar. 19, 2020.

Ga. Comp. R. & Regs. r. 111-8-62-.12 Home Design Requirements {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.12 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.12}

(1) A home must be constructed, arranged, and maintained to provide adequately for all of the following:

(a) Health, safety, and well-being of the residents.

(b) Independence, privacy and dignity of the residents.

(c) Safe access of all residents with varying degrees of functional impairments to living, dining and activity areas within the home.

(2) A currently licensed home which undergoes major structural renovation or one that is first licensed after the effective date of these rules must be designed and constructed in compliance with applicable state and local building and fire codes.

(3) Where the home intends to make changes to the home which would result in a change to the floor sketch from the one that was submitted at the time of initial licensing or certificate of need review, the home must have such proposed changes approved by the Department.

(4) Any renovations to the home which put the home out of compliance with these rules may subject the home to revocation of its license.

(5) Common Areas. The home must provide common living areas for the use of the residents.

(a) Separate and distinct sleeping and living areas must be provided which allow for necessary supervision and assistance by staff and are conveniently located within easy walking distance of each resident's private living space (room), available for the residents' informal use at any time and do not require any resident to leave the building to use.

(b) Living rooms must be provided which are large enough to accommodate the residents without crowding. The rooms must be comfortably and attractively furnished, well heated, well lighted, ventilated and clean.

(c) The home must have handrails, grab bars, doorways and corridors which accommodate permitted mobility devices, such as walkers, motorized scooters, wheel chairs and crutches or canes as the residents require for their safety and allow the residents to move about the home freely.

(d) The home must provide an area for use by residents and visitors which affords privacy.

(e) The home must place at least one current calendar and working clock in the common living area.

(f) The home must provide a comfortable dining area which is properly equipped and adequate in size for the number of residents being served.

(g) The home must provide a means of locked storage for any resident's valuables or personal belongings, upon request.

(h) No living room, dining room, hallway, and any other room not ordinarily used for sleeping is permitted to be used for sleeping by residents, family, staff or renters.

(i) A home must provide laundering facilities on the premises for the residents' personal laundry that prevents the cross-contamination of clean and dirty laundry.

(6) Bedrooms or Private Living Spaces. The following minimum standards for resident bedrooms or private living spaces must be met:

(a) Bedrooms or private living spaces must have at least 80 square feet of usable floor space per resident. Usable floor space is defined as that floor space under a ceiling at least seven feet in height. However, licensed personal care homes approved prior to or on February 6, 1981 to operate with bedrooms or private living spaces with a minimum of 70 square feet of usable floor space per resident which have continuously operated since that date may continue to use the minimum 70 square feet standard. Where a home operating under this exception has its permit revoked, changes ownership, changes location, or undergoes extensive renovations, or for any other reason surrenders its permit, this exception regarding the minimum square footage is no longer available.

(b) There shall be no more than four residents per bedroom or private living space unless the home is presently permitted to serve more than four residents per bedroom or private living space and no change in the ownership, location or licensure status of the home occurs.

(c) Each bedroom or private living space must have at least one window opening through an exterior wall of the home. Bedrooms or private living spaces must be well ventilated and maintained at a comfortable temperature.

(d) If the residents specifically choose in writing to share a private bedroom or living space with another resident of the home, then the residents must be permitted to share the room, subject to the usable square feet requirement and the limitation that no more than four residents may share any bedroom or private living space.

(e) Bedrooms or private living spaces for residents must be separated from halls, corridors and other rooms by floor to ceiling walls.

(f) The floor plan of the home must be such that no person other than the residents assigned to a bedroom or private living space should pass through that residents' bedroom or private living space in order to reach another room.

(g) Doorways of bedrooms or private living spaces occupied by residents must be equipped with side-hinged permanently mounted doors equipped with positively latching hardware which will insure opening of the door by a single motion, such as turning a knob or by pressing with normal strength on a latch. For bedrooms or private living spaces which have locks on doors, both the occupant and administrator or on-site manager must be provided with keys to assure easy entry and exit.

(h) A room must not be used as a bedroom or private living space where more than one-half the room height is below ground level. Bedrooms or private living spaces which are partially below ground level must have adequate natural light and ventilation and be provided with two useful means of egress. Control of dampness must be assured.

(i) When a resident is discharged, the room and its contents must be thoroughly cleaned.

(7) Bathroom Facilities . The following minimum standards apply to bathroom facilities:

(a) At least one functional toilet and lavatory must be provided for each four residents and at least one bathing or showering facility must be provided for each eight residents living in a home.

(b) At least one toilet and lavatory must be provided on each floor having residents' bedrooms.

(d) Bathrooms and toilet facilities without windows must have forced ventilation to the outside. Bathroom windows used for ventilation must open easily.

(e) Toilets, bathtubs and showers must provide for individual privacy.

(f) All plumbing and bathroom fixtures must be maintained in good working order at all times and must present a clean and sanitary appearance.

(g) A home serving a person dependent upon a wheelchair or scooter for mobility mus t have at least one bathroom that permits the resident to use all bathroom fixtures easily and independently where able.

(8) Interior Design and Construction. The home must be designed and built to provide for the following:

(a) All stairways and ramps must have sturdy and securely fastened handrails, not less than 30 inches nor more than 34 inches above the center of the tread. Exterior stairways, decks and porches must have handrails on the open sides.

(b) Floor covering must be intact and securely fastened to the floor. Any hazard that may cause tripping must be removed.

(c) All areas of the home, including hallways and stairs must provide sufficient ambient lighting such that the residents may move about safely and objects may be easily observed by the residents. In addition, appropriate task lighting necessary for more visually demanding activities such as reading, knitting or preparing food must also be provided for resident use.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-2-9, 31-7-1, 31-7-2.1, 31-7-3, 31-7-12
History. Original Rule entitled "Inspections" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Home Design Requirements". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.13 Physical Plant Health and Safety Standards {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.13 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.13}

(1) Each home must be in compliance with fire and safety rules promulgated by the Office of the Safety Fire Commissioner for the personal care homes it regulates.

(2) Each home must be in compliance with applicable local ordinances that specifically address fire safety in homes of that size and function. Private quarters must be maintained in such a manner as to comply with fire safety codes and not threaten the health or safety of residents. In the absence of or in addition to any such local ordinances, the following requirements must be met:

(a) Wall type electric outlets and lamps or light fixtures must be maintained in a safe and operating condition. The home must provide functioning light bulbs for light fixtures.

(b) Cooking appliances must be suitably installed in accordance with approved safety practices. Where metal hoods or canopies are provided, they must be equipped with filters which must be maintained in an efficient condition and kept clean at all times.

(c) Space heaters must not be used, except during an emergency situation after obtaining specific written approval of the fire safety authority having jurisdiction over the home.

(d) Fire screens and protective devices must be used with fireplaces, stoves and heaters, including space heaters.

(e) Each home must be protected with sufficient smoke detectors, powered by house electrical service with battery back-up which, when activated, must initiate an alarm which is audible in the sleeping rooms.

(f) Each home must have at least one charged 5 lb. multipurpose ABC fire extinguisher on each occupied floor and in the basement. These extinguishers must be checked annually to assure they remain in operable condition.

(g) Each home must have a working doorbell or doorknocker which is audible to staff inside at all times.

(h) Exterior doors must be equipped with locks which do not require keys to open them from the inside.

(3) The electrical service of the home must be inspected by a licensed electrician or local code enforcement official and declared free of hazards within no more than six months prior to the date of filing the application for a permit. A signed copy of this inspection report must be submitted to the Department as a part of the application. Electrical service must be maintained in a safe condition at all times. The Department may require a re-inspection of the electrical service at any time renovation or repair work is done in the home or there is a request for a change in capacity or there is reason to believe that a risk to residents exists.

(4) Where the Department has reason to believe, based on the number of residents requiring assistance with ambulation and staffing patterns that the home may not be able to evacuate all of the residents to a designated point of safety within an established period of time as determined by the fire safety officials, the Department may either require the home to conduct an immediate fire safety drill or make a referral for a new compliance determination to responsible fire safety officials. The Department may also require a repeat fire safety inspection where substantial renovations or repairs have been made to the home.

(5) Water and sewage systems must meet applicable federal, state, and local standards and/or regulations.

(6) Floors, walls, and ceilings must be kept clean and in good repair.

(7) Kitchen and bathroom areas must be kept clean and sanitized, at least once daily with disinfectant and more often as needed to insure cleanliness and sanitation.

(8) The storage and disposal of bio-medical and hazardous wastes must comply with applicable federal, state, and local rules and/or standards.

(9) Solid waste which is not disposed of by mechanical means must be stored in vermin-proof, leak-proof, nonabsorbent containers with closefitting covers until removed. Waste must be removed from the kitchen at least daily and from the premises at least weekly.

(10) An insect, rodent or pest control program must be maintained and conducted in a manner which continually protects the health of residents.

(11) Poisons, caustics, and other dangerous materials must be stored and safeguarded in areas away from residents, food preparation and food storage areas, and medication storage areas.

(12) The home must have an adequate hot water system that supplies heated water, comfortable to the touch but not exceeding 120 degrees Fahrenheit (F.) to the residents for their usage.

(13) Entrances and exits, sidewalks, yards and escape routes must be maintained free of any hazards such as refuse, equipment, unsafe furniture, debris or any other impediments. Ice and snow must be cleared from the home's entrances, exits and walkways.

(14) The home must have its house number and name displayed so as to be easily visible from the street.

(15) The exterior of the home must be properly maintained to remain safe and in good repair.

(16) The following evacuation requirements must be met:

(a) Residents who need assistance with ambulation must be assigned bedrooms which have a ground-level exit to the outside or to rooms above ground level which have exits with easily negotiable ramps or easily accessible elevators.

(b) There must be an established procedure and mechanism for alerting and caring for residents in case of emergencies and evacuating them to safety. This procedure must include instructions and evacuation plans posted on each floor of a home. Each sleeping room must have a secondary exit. This secondary exit may be a door or a window usable for escape. A plan showing these routes of escape must be posted in the home on each floor.

(c) A home serving person(s) dependent upon wheelchairs or scooters for mobility must provide at least two exits from the home, remote from each other, that are accessible to these persons.

History

Authority: O.C.G.A. §§ 31-2-9, 31-7-1, 31-7-2.1, 31-7-12
History. Original Rule entitled "Minimum Floor Plan Requirements" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Physical Plant Health and Safety Standards". F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-62-.14 Furnishings and Fixtures {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.14 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.14}

(1) Furnishings of the home in the living room, bedrooms and dining room must be maintained in good condition, intact, and functional.

(2) Furnishings and housekeeping standards must be such that a home presents a clean and orderly appearance.

(3) Resident bedroom furnishings must include all of the following:

(a) An adequate closet or wardrobe.

(b) Working lighting fixtures sufficient for reading and other resident activities.

(c) A bureau or dresser or the equivalent and at least one chair with arms per resident in each bedroom or private living space.

(d) A mirror appropriate for grooming unless the resident or resident's representative specifically requests to have it removed;

(e) An individual bed at least 36-inches wide and 72-inches long with comfortable springs and mattress, clean and in good condition. Where a particular resident is very tall, the home must provide an extra long mattress upon request. The mattress shall be not less than five-inches thick, or four-inches, if of a synthetic construction. Couples may request a double bed when available. Roll-a-ways, cots, double-decks, stacked bunks, hide-a-beds and studio couches are not to be used in lieu of standard beds.

(f) Bedding for each resident which includes two sheets, a pillow, a pillow case, a minimum of one blanket and bedspread. A home must maintain a linen supply for not less than twice the bed capacity where the residents do not choose to provide their own linens. Where the residents choose to provide their own linens, the home must maintain an adequate supply of spare linens on hand to accommodate the needs of the residents. A home must change and launder bed linens for each resident at least weekly or more often if soiled.

(4) Provision must be made for assisting a resident to personalize the bedroom by allowing the use of his or her own furniture if so desired and mounting or hanging pictures on bedroom walls.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-2-9, 31-7-1, 31-7-2.1, 31-7-12
History. Original Rule entitled "Physical Plant Health and Safety Standards" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Furnishings and Fixtures". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.15 Admission {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.15 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.15}

(1) Criteria for admission and retention of residents in a home are as follows:

(a) Persons admitted to a personal care home must be at least 18 years of age.

(b) Except for aging in place exceptions, the home is permitted to admit and retain only ambulatory residents who are capable of self-preservation with minimal assistance, i.e. staff may assist the resident in transferring from a sitting or reclining position and provide verbal directions to residents who are able to self-propel to the nearest exit.

(c) Aging in Place Exceptions. The home may allow up to three (3) non-ambulatory residents to remain in the home to support an aging in place strategy that is in the best interests of the resident, subject to the requirements herein. These aging in place exceptions may be revoked by the Department at any time, as part of the survey process, if the facility fails to meet any of the following criteria:

(i) The resident has not experienced any significant change in a physical or medical condition which would make continued placement in the facility inappropriate;

(ii) The facility maintains responsibility for meeting resident needs for continuing care provided within the scope of services the personal care home is licensed to deliver;

(iii) The resident remains under hospice services (if the resident was under such services at the time of the aging in place decision);

(iv) The facility monitors its performance of fire drills to ensure that it can safely evacuate all of the residents at any time in 13 minutes or less;

(v) The facility increases the number of documented fire drills to a minimum of one fire drill per month, covering all shifts, as long as one or more residents in the facility are non-ambulatory;

(vi) The facility notifies the local fire department in writing within two (2) weeks of the change in the resident's status to aging in place so that there is local awareness of the presence of a non-ambulatory resident at the home;

(vii) The facility ensures sufficient staff on all shifts to support the safe and timely evacuation of all residents in the event of an emergency; and

(viii) The facility is in substantial compliance with the department's rules and is not subject to any pending enforcement action by the department.

(d) The home must not admit, or retain persons who require the use of physical or chemical restraints, isolation, or confinement for behavioral control.

(e) No home is permitted to admit residents who either require continuous medical services or continuous nursing care and treatment.

(f) Medical, nursing, health or therapeutic services required on a periodic basis, or for short-term illness, must not be provided as services of the home. When such services are required, they must be purchased by the resident or the resident's representative or legal surrogate, if any, from appropriately licensed providers managed independently from the home. The home may assist in arrangement for such services, but not provision of those services.

(2) No home is permitted to admit or retain a resident who needs care beyond which the home is permitted to provide.

(3) The administrator or on-site manager of a home must conduct an interview with the applicant and/or representative or legal surrogate, if any, of the applicant to ascertain that the home can meet the applicant's needs. The administrator or on-site manager must obtain a report of physical examination conducted by a by a licensed physician, nurse practitioner or physician's assistant dated within 30 days prior to the date of admission using the specific report of physical examination form made available by the Department on its website to assess whether the home can meet the applicant's needs. Where a home admits a resident without the required physical examination pursuant to a specific request for an emergency placement made by a governmental agency responsible for adult protective service, local law enforcement or a case manager, the home must retain documentation of the need for the emergency placement and obtain a copy of a physical examination within 14 days following the emergency admission. The required report of physical examination form must be completed in its entirety.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-9, 31-7-1 et seq
History. Original Rule entitled "Furnishings and Fixtures" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Admission". F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-62-.16 Admission Agreement {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.16 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.16}

(1) A written admission agreement must be entered into between the governing body and the resident. Such agreement must contain the following:

(a) A current statement of all fees and daily, weekly or monthly charges; any other services which are available on an additional fee basis, for which the resident must sign; a request acknowledging the additional cost; and the services provided in the home for that charge.

(b) A statement that residents and their representatives or legal surrogates must be informed, in writing, at least 30 days prior to any increase in established charges related to the provision of personal services and at least 60 days prior to any increase in charges for room and board.

(d) Provisions for the administrator or on-site manager's continuous assessment of the resident's needs, referral for appropriate services as may be required if the resident's condition changes and referral for transfer or discharge if required due to a change in the resident's condition.

(e) Provision for transportation of residents for shopping, recreation, rehabilitation and medical services, which must be available either as a basic service or on a reimbursement basis. Provision must also be made for access to emergency transportation at all times.

(f) A statement of the home's refund policy including but not limited to when a resident decides not to move into the home, dies, is transferred or discharged.

(g) A statement that a resident may not perform services for the home.

(h) A copy of the house rules, which must be in writing and also posted in the home. House rules must be consistent with residents' rights. House rules must include, but not be limited to, policies regarding the use of tobacco and alcohol, the times and frequency of use of the telephone, visitors, hours and volume for viewing and listening to television, radio and other audiovisual equipment, whether residents' personal pets or household pets are permitted and the use of personal property.

(i) For residents first admitted after the effective date of these rules, a statement disclosing whether the home permits the resident to hire independent proxy caregivers, sitters, or requires the purchase of such services from the home or approved providers.

(j) For residents first admitted after the effective date of these rules, the admission agreement must disclose how and by what level of staff medications are handled in the home. The agreement must also specify who is responsible for initial acquisition, refilling of prescribed medications and whether unit or multi-dose packaging of medications is required.

(k) An explanation of how and when residents must be discharged or transferred from the home.

(l) For residents first admitted after the effective date of these rules, an explanation of how social media, photos of residents and other media involving residents are handled.

(m) For residents first admitted after July 1, 2025, information on the medical alert system, if applicable, including a statement explaining that use of the system is optional for residents.

(2) Each resident, and representative, where applicable, prior to the execution of the admissions agreement, must have an opportunity to read the agreement. In the event that a resident is unable to read the agreement, the administrator or on-site manager must take special steps to assure communication of its contents to the resident.

(3) The resident and representative or legal surrogate, if any, must each be given a signed copy of the agreement and a copy signed by both parties (resident and administrator or on-site manager) must be retained in the resident's file and maintained by the administrator or on-site manager of the home.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-9, 31-7-1, 31-7-2.1, 31-7-12
History. Original Rule entitled "Admission" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Admission Agreement." F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Apr. 16, 2018; eff. May 6, 2018.
Amended: F. May 1, 2025; eff. May 21, 2025.

Ga. Comp. R. & Regs. r. 111-8-62-.17 Services {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.17 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.17}

(1) Personal assistance must be given to those residents who are unable to keep themselves neat and clean.

(2) Each home must provide sufficient activities to promote the physical, mental and social well-being of each resident.

(3) Each home must provide books, newspapers, and games for leisure time activities. Each home must encourage and offer assistance to residents who wish to participate in hobbies, music, arts and crafts, religion, games, sports, social, recreational and cultural activities available in the home and in the community.

(4) Each home must have at least one operable, non-pay telephone which is accessible at all times for emergency use by staff. Residents must have access to an operable, non-pay telephone in a private location, both to make and receive personal calls. The same telephone may meet all the requirements of this section.

(5) The daily living routine of the home must be such that a resident may spend the majority of his or her non-sleeping hours out of the resident's bedroom, if he or she so chooses.

(6) A home must not restrict a resident's free access to the common areas of the home unless the resident is living in a specialized memory care center. If the resident is residing in a specialized memory care center, unrestricted access to the common areas contained within the memory care center must be provided to the resident.

(7) A home must not lock the resident into or out of the resident's bedroom or private living space.

(8) Resident Needs Assessment . The home must complete an assessment of the resident at the time of admission and update as changes occur that addresses the resident's care needs taking into account the resident's family supports, the resident's functional capacity relative to the activities of daily living, physical care needs, medical information provided, cognitive and behavioral impairments, if any, and personal preferences relative to care needs.

(9) Written Care Plan . Utilizing the information acquired during the admission process and the move-in adjustment period, a home which provides proxy caregivers or memory care must develop the resident's individual written care plan within 14 days of admission and require staff to use the care plan as a guide for the delivery of care and services to the resident. The care plan must include the following:

(a) A description of the resident's care and social needs and the services to be provided, including frequency to address care and social needs.

(b) Resident's particular preferences regarding care, activities and interests.

(d) Any physician order or order of a nurse practitioner or physician assistant working under protocol or job description, respectively for assistive devices.

(e) Staff primarily responsible for implementing the care plan.

(f) Evidence of resident and family involvement in the development of the plan when appropriate.

(g) Evidence of the care plan being updated at least annually and more frequently where the needs of the resident change substantially.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-9 and 31-7-1 et seq
History. Original Rule entitled "Admission Agreement" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Services". F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-62-.18 Precautions for Residents at Risk of Elopement {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.18 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.18}

(1) A home which serves residents with cognitive deficits which place the residents at risk of eloping, i.e. engaging in unsafe wandering activities outside the home must do the following:

(a) Develop, train and enforce policies and procedures for staff to deal with residents who may elope from the home including what actions, as specified in rule 111-8-62-.30 are to be taken if a resident wanders away (elopes) from the home.

(b) Utilize appropriate effective safety devices, which do not impede the residents' rights to mobility and activity choice or violate fire safety standards, to protect the residents who are at risk of eloping from the premises.

If the safety devices include locks used on exit doors, as approved by the fire marshal having jurisdiction over the home, then the locking device shall be electronic and release whenever the following occurs: activation of the fire alarm or sprinkler system, power failure to the home or by-pass for routine use by the public and staff for service using a key button/key pad located at the exit or continuous pressure for thirty (30) seconds or less.
If the safety devices include the use of keypads to lock and unlock exits, then directions for operation must be posted on the outside of the door to allow individuals' access to the memory care center. However, if the center is a whole home, then directions for the operation of the locks need not be posted on the outside of the door. The center must not have entrance and exit doors that are closed with non-electronic keyed locks nor shall a door with a keyed lock be placed between a resident and the exit.

(2) A home serving residents who are at risk of eloping from the premises must retain on file at the home current pictures of residents who are at risk of eloping.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-9, 31-7-1 et seq
History. Original Rule entitled "Services" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Requirements for Memory Care Services". F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: New Title "Precautions for Residents at Risk of Elopement." F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-62-.19 Additional Requirements for Certified Memory Care Centers {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.19 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.19}

(1) A home must meet the additional requirements contained in rule 111-8-62-.19 where the home serves persons with probable diagnoses of Alzheimer's Disease or other dementia and does any of the following:

(a) Holds itself out as providing additional or specialized care to such residents; or

(b) Charges rates in excess of that charged other residents for the provision of additional or specialized care.

(2) Written Description. The home must develop an accurate written description of the memory care center that includes the following:

(a) A statement of philosophy and mission.

(b) How the services of the memory care center are different from services provided in the rest of the personal care home.

(c) Staffing, including job titles of staff who work in the center, staff training and continuing education requirements.

(d) Admission procedures, including screening criteria.

(e) Assessment and service planning protocol, including criteria to be used that would trigger a reassessment of the resident's status before the customary quarterly review.

(f) Staffing patterns, maintained within the center, including the ratio of direct care staff to resident for a 24-hour cycle.

(g) A description of the physical environment including safety and security features.

(h) A description of activities, including frequency and type, how the activities meet the needs of residents with dementia.

(i) The program's fee or fee structure for all services provided by the center.

(j) Discharge criteria and procedures;

(k) The procedures that will be utilized for handling emergency situations.

(l) The involvement of the center with families and family support programs.

(3) Disclosure of Description. A personal care home with a memory care center must disclose the written description of the center to:

(a) Any person upon request.

(b) The family or resident's representative before admission of the resident to the center.

(4) Physical Design, Environment, and Safety. The memory care center must be designed to accommodate residents with severe dementia or Alzheimer's Disease in a home-like environment which includes the following:

(a) Multipurpose room(s) for dining, group and individual activities which are appropriately furnished to accommodate the activities taking place.

(b) Secured outdoor spaces and walkways which are wheel chair accessible and allow residents to ambulate safely but prevent undetected egress.

(c) High visual contrasts between floors and walls and doorways and walls in resident use areas except for fire exits, door and access ways which may be designed to minimize contrast to conceal areas where the residents should not enter.

(d) Adequate and even lighting which minimizes glare and shadows.

(e) The free movement of the resident, as the resident chooses, between the common space and the resident's own personal space in a bedroom that accommodates no more than four residents.

(f) Individually identified entrances to residents' rooms to assist residents in readily identifying their own personal spaces.

(g) An effective automated device or system to alert staff to individuals entering or leaving the building in an unauthorized manner. A home need not use an automated alert for an exit door when the particular exit is always staffed by a receptionist or other staff member who views and maintains a log of individuals entering and leaving the home. If the exit door is not always staffed, then the home must have a system that activates an automated alert when the door is not attended;

(h) A communication system(s) which permit staff in the center to communicate with other staff outside the center and with emergency services personnel as needed; and

(i) A center or home which undergoes major renovation or is first constructed after December 9, 2009 must be designed and constructed in compliance with applicable state and local building and fire codes relevant to the center and the home.

(5) Staffing Requirements. The home must ensure that the center is staffed at all times with sufficient specially trained staff to meet the unique needs of the residents in the center. At a minimum, the home must provide the following staffing:

(a) One dementia trained direct care staff person for every 12 residents on-site during all waking hours and for every 15 residents on-site during all nonwaking hours based on a monthly average; provided, however, that such ratio is adequate to meet the needs of the residents;

(b) One registered professional nurse, licensed practical nurse, or certified medication aide on-site or available in the building at all times;

(c) Two direct care staff persons on-site at all times, which may include one licensed registered professional nurse, licensed practical nurse, or certified medication aide, if they remain on-site in the memory care center; and

(d) One registered professional nurse or licensed practical nurse on-site or available in the building at all times as follows:

(i) For memory care centers with one to 12 residents, a minimum of eight hours per week;

(ii) For memory care centers with 13 to 30 residents, a minimum of 16 hours per week;

(iii) For memory care centers with 31 to 40 residents, a minimum of 24 hours per week; or

(iv) For memory care centers with more than 40 residents, a minimum of 40 hours per week.

(6) Staff Training Requirements. The home shall ensure that all staff are properly trained initially and on an annual basis to provide safe, quality care to residents in the memory care center. Effective July 1, 2021, the memory care center shall meet the following training requirements:

(a) General Orientation. All staff, regardless of role, shall receive at least four (4) hours of dementia-specific orientation within the first thirty (30) days of working in the center. Such orientation shall include:

(i) Basic information about the nature, progression, and management of Alzheimer's and other dementias;

(ii) Techniques for creating an environment that minimizes challenging behavior from residents with Alzheimer's and other dementias;

(iii) Methods of identifying and minimizing safety risks to residents with Alzheimer's and other dementias; and

(iv) Techniques for successful communication with individuals with Alzheimer's and other dementias.

(b) Direct Care Orientation. All direct care staff shall receive initial orientation training within the first thirty (30) days of caring for residents independently that, at a minimum, includes:

(i) General training, to include:

(A) Development, updating, and implementation of comprehensive and individual service plans;

(B) Skills for recognizing physical or cognitive changes in the resident that warrant seeking medical attention;

(D) General infection control principles;

(E) Emergency preparedness training;

(F) Emergency first aid; and

(G) Cardiopulmonary resuscitation.

(ii) A minimum of sixteen (16) hours of specialized, competency-based training using forms specified by the department, to include, at a minimum:

(A) The nature of Alzheimer's and other dementias;

(B) The center's philosophy related to the care of residents with Alzheimer's and other dementias;

(D) Common behavior problems characteristic of residents with Alzheimer's and other dementias;

(E) Positive therapeutic interventions and activities;

(F) Skills for maintaining the safety of the resident; and

(G) The role of the family in caring for residents with Alzheimer's and other dementias.

(iii) Staff members who have passed a memory care specialist competency exam established by the department, as documented by the home, may satisfy the training requirements of Rule 111-8-62-.19(6)(b)(ii) by completing a minimum of four (4) hours of training on the topics specified in Rule 111-8-62-.19(6)(b)(ii)(B) and (C) .

(c) Ongoing Training. Direct care staff shall complete a minimum of eight (8) hours of specialized competency-based training in dementia care on an annual basis using forms specified by the department.

(d) Hospice Training for Certified Medication Aides Administering Morphine. The memory care center shall ensure that any medication aide(s) who will be administering liquid morphine to any hospice patient(s) residing in the center receive adequate training from a licensed hospice on the safe and proper administration of liquid morphine prior to such administration and on an annual basis thereafter. The memory care center shall maintain documentation of all training provided.

(e) Training Documentation. The memory care center shall maintain documentation reflecting course content, instructor qualifications, agenda, and attendance rosters for all training sessions provided.

(7) Special Admission Requirements for Memory Care Center Placement. Residents must have a Report of Physical Examination completed by a licensed physician, nurse practitioner or physician's assistant within 30 days prior to admission to the center on forms provided by Department. The physical examination must clearly reflect that the resident has a diagnosis of probable Alzheimer's Disease or other dementia and has symptoms which demonstrate a need for placement in the center. However, the center may also care for a resident who does not have a probable diagnosis of Alzheimer's Disease or other dementia, but desires to live in the center as a companion to a resident with a probable diagnosis of Alzheimer's Disease or other dementia with which the resident has a close personal relationship. In addition, the physical examination report must establish that each potential resident of the center does not require 24-hour skilled nursing care.

(8) Post-Admission Assessment. The home must assess each resident's care needs to include the following components: resident's family supports, level of activities of daily living functioning, physical care needs and level of behavior impairment.

(9) Individual Service Plans. The post-admission assessment must be used to develop the resident's individual service plan within 14 days of admission. The service plan must be developed by a team with at least one member of the direct care staff participating and input from each shift of direct care staff that provides care to the resident. All team members participating must sign the service plan and the service plan must be shared with the direct care staff providing care to the resident and serve as a guide for the delivery of services to the resident. The service plan must include the following:

(a) A description of the resident's care and social needs and the services to be provided, including frequency to address care and social needs.

(b) Resident's expressed preferences regarding care, activities and interests.

(d) Names of staff primarily responsible for implementing the service plan.

(e) Evidence of family involvement in the development of the plan, if possible, with incorporation of family and personal history to support a person-centered approach to care.

(f) Evidence of the service plan being updated at least quarterly or more frequently if the needs of resident change substantially.

(10) Therapeutic Activities. The center must provide therapeutic activities appropriate to the needs of the individual residents and adapt the activities, as necessary, to encourage the participation of the residents. The following kinds of therapeutic activities must be provided at least weekly with at least some therapeutic activities occurring daily:

(a) Gross motor activities; e.g. exercise, dancing, gardening, cooking, other outdoor activities.

(b) Self-care activities; e.g. dressing, personal hygiene/grooming;

(d) Sensory enhancement activities, e.g. distinguishing pictures and picture books, reminiscing and scent and tactile stimulation.

(11) No licensed personal care home may provide or hold itself out as providing specialized care for residents with probable Alzheimer's disease or other dementia or charge a differential rate for care of residents with cognitive deficits that place the residents at risk of engaging in unsafe wandering activities (eloping) unless it meets the additional requirements specified in Rule 111-8-62-.19 .

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-9, 31-7-1 et seq., 43-26-32
History. Original Rule entitled "Requirements for Memory Care Services" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Additional Requirements for Specialized Memory Care Units or Homes". F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: New Title "Additional Requirements for Certified Memory Care Centers." F. Aug. 24, 2021; eff. Sept. 13, 2021.
Amended: F. May 1, 2025; eff. May 21, 2025.

Ga. Comp. R. & Regs. r. 111-8-62-.20 Medications {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.20 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.20}

(1) Self-Administration of Medications . Residents who have the capacity to self-administer medications safely and independently without staff assistance or supervision must be allowed to store their own medications securely and self-administer medications if they so desire.

(2) Assistance with Self-Administration . A resident who is not capable of independent self-administration of medication may be assisted and supervised in self-administration by staff to the following extent;

(a) Staff providing such assistance or supervision may perform the following:

Take the medication, in its previously dispensed, properly labeled container, from where it is stored, and bring the medication to the resident.
Read the label, open the container, remove a prescribed amount of medication from the container, and close the container, in the presence of the resident.
Place an oral dosage in the resident's hand or in another container where the resident requests assistance.
Apply topical medications.
Assist with self-administration of drops, inhalers, nasal sprays and patches.
Return the medication container to proper secured storage.
Assist the resident's use of an EPI pen where the resident has known severe allergies for which an EPI pen has been prescribed on condition that there is an established written protocol detailing how it is to be used and when. The protocol must include immediately calling Emergency Services, 911, after any use of the EPI pen.

(b) Staff assisting with or supervising self-administration of medications must be proficient in English and able to read, write and follow written instructions in English.

(3) Basic Medication Training for Staff Assisting with Self-Administration . The home must provide and document medication training for the unlicensed staff that are providing assistance with or supervision of self-administration of medications to capable residents. The medication training must be conducted with an appropriate curriculum for providing medication assistance and include at least the following topics:

(a) The home's medication policy and procedures, including actions to take if concerns regarding resident's capacity to self-administer medications are identified.

(b) How to read prescription labels including common abbreviations.

(c) Providing the right medication to the right resident at the right time in the right amount and the right way including how to measure various medications.

(d) Actions to take when concerns regarding medications are identified.

(e) Infection control procedures relative to providing assistance with medications.

(f) Proper medication storage and disposal.

(g) Recognition of side effects and adverse reactions for the specific medications.

(h) Understanding the common classifications of medications, typical side effects and adverse reactions and medications for which unlicensed staff may never provide assistance with or supervision of self-administration.

(i) Proper documentation and record keeping using the Medication Assistance Record.

(4) Medication Skills Competency Determinations . Unlicensed staff in homes providing assistance with or supervision of self-administered medications must demonstrate to a qualified supervisor when hired and at least, annually thereafter, the necessary skills to perform the medication tasks assigned competently.

(5) Memory Care Medication Administration. Medications for residents living in the memory care center must be provided to the residents by a proxy caregiver trained in accordance with the requirements of Chapter 111-8-100; a licensed registered nurse; a licensed practical nurse working under the supervision of a physician or registered nurse; or a certified medication aide subject to the requirements set forth below.

(6) Certified Medication Aide Requirements. A home using certified medication aides must meet the requirements below. CMAs working in the memory care center may also assist non-memory care residents in the same building.

(a) Check the Registry. The home must check to ensure that the medication aides employed in the home are listed in good standing on the Georgia Certified Medication Aide Registry and have no record of being terminated for cause relating to the performance of medication aide tasks before permitting the aides to administer medications.

(b) Administer Skills Competency Checks. The home must administer skills competency checks to determine and document that the medication aides who have been certified for more than one year upon hiring continue to have the knowledge and skills necessary to administer medications properly for the residents in care. The home must use a skills competency checklist which meets the requirements contained in the standardized clinical skills competency checklist used to certify medication aides.

(c) Quarterly Observations. The home must use a licensed registered professional nurse or a pharmacist to conduct quarterly random medication administration observations to determine that the aides are administering medications correctly and in compliance with these rules and report any issues to the home's administration for resolution.

(d) Quarterly Drug Regimen Reviews. The home must secure the services of a licensed pharmacist to perform all of the following duties:

(i) conduct quarterly reviews of the drug regimen for each resident of the assisted living community and report any irregularities to the assisted living community administration;

(ii) remove for proper disposal any drugs that are expired, discontinued or in a deteriorated condition or where the resident for whom such drugs were ordered is no longer a resident;

(iii) establish or review policies and procedures for safe and effective drug therapy, distribution, use and control; and

(iv) monitor compliance with established policies and procedures for medication handling and storage.

(e) Authorized Tasks for Certified Medication Aides. A home may allow a certified medication aide to do only the following tasks related the administration of medications utilizing only unit or multidose packaging of medications:

(i) Administer physician ordered oral, via a feeding tube, ophthalmic, topical, otic, nasal, vaginal and rectal medications;

(ii) Administer insulin, epinephrine, and B12 pursuant to physician direction and protocol;

(iii) Administer medications via a metered dose inhaler;

(iv) Conduct finger stick blood glucose testing following established protocol;

(v) Administer a commercially prepared disposable enema ordered by a physician;

(vi) Assist residents in the supervision of self-administration of medications; and

(vii) Administer liquid morphine to a resident of the community who is the patient of a licensed hospice, pursuant to a hospice physician's written order that contains specific instructions for indication, dosage, frequency and route of administration.

(f) Annual Competency Reviews. Complete comprehensive clinical skills competency reviews for each certified medication aide utilizing the skills competency checklist at least, annually after hiring to determine that the aides continue to have the necessary skills to perform the medication tasks assigned competently. Such skills competency checklists must be administered by Georgia-licensed registered nurses, pharmacists or physicians, who indicate in writing that the tasks observed are being performed competently.

(g) Proper Notice of Separation for Cause. Ensure that where a medication aide is terminated for cause relating to the performance of medication aide tasks, the aide is provided with the following:

(i) a separation notice that clearly describes the facts that support the termination for cause;

(ii) written notice that being terminated for cause related to the administration of medications, if not successfully appealed through a hearing on right to unemployment benefits will result in the loss of good standing on the Georgia Certified Medication Aide Registry; and

(iii) the loss of good standing on the Certified Medication Aide Registry will make the aide ineligible for hiring as a certified medication aide by another assisted living community.

(h) Registry Notification. Submit to the Georgia Certified Medication Aide Registry a copy of the Separation Notice for the certified medication aide only if the separation related specifically to the performance of medication aide tasks and the termination for cause has either been finally upheld by the Department of Labor or the time for appealing the Separation Notice has expired.

(7) Homes Conducting Certified Medication Aide Training. A home choosing to provide a certified medication aide training program must do all of the following:

(a) Utilize the state-approved medication aide training program ensuring that the training is administered by a Georgia licensed registered nurse, pharmacist, or physician;

(b) Require the aide to demonstrate the requisite clinical skills to serve as a medication aide before a Georgia-licensed registered nurse, pharmacist or physician utilizing the standardized medication administration checklist developed by the Department;

(d) Verify that the aide is in good standing on the Georgia certified nurse aide registry;

(e) Provide information to the aide on the registration and locations for taking the written competency examination;

(f) Provide the documentation to the Georgia Certified Medication Aide Registry that is necessary to complete the application for placement of the aide's name on the Georgia Certified Medication Aide Registry; and

(g) Not permit the aide to administer medications independently unless the aide is listed on the Georgia certified medication aide registry in good standing.

(8) Maintaining Records on Medication Assistance and Administration . Where the home either provides assistance with, or supervision of self-administered medications, or administers medications to residents, the home must maintain a daily Medication Assistance Record (MAR) for each resident receiving such service.

(a) The MAR must include the name of the specific resident, any known allergies, the name and telephone number of the resident's health care provider, the name, strength and specific directions including a summary of severe side effects and adverse reactions for use of each medication and a chart for staff who provide assistance or administration to record initials, time and date when medications are taken, refused or a medication error is identified (e.g. missed dosage).

(b) The staff providing the assistance or administration of medications must update the MAR each time the medication is offered or taken.

(c) The home must make medication information concerning the descriptions of medication, dosing, side effects, adverse reactions and contraindications for each medication being administered to the residents immediately available for reference by staff providing medication assistance or administration.

(d) Staff providing assistance with or administration of medications must document in the resident's record any unusual reactions to the medications and provide such information to the resident, the resident's representative and the health care provider as appropriate.

(e) Refills of prescribed medications must be obtained timely so that there is no interruption in the routine dosing. Where the home is provided with a new medication for the resident, the MAR must be modified to reflect the addition of the new medication within 48 hours or sooner if the prescribing physician, advance practice registered nurse or physician assistant indicates that the medication change must be made immediately. In homes, where unit or multi-dose packaging is not available for immediate changes in medications, unit or multi-dose packaging of the medication must be obtained when the prescription is refilled.

(f) For any administration of liquid morphine by a certified medication aide, staff shall observe and document the following in the resident's record:

(i) the resident's need for PRN liquid morphine, including but not limited to verbalizations of pain, groaning, grimacing or restlessness;

(ii) the date, time and location of the initial dose administered by a licensed hospice health care professional;

(iii) the dosage, time and route of administration for the morphine administered in the community;

(iv) the training provided by the licensed hospice; and

(v) information regarding the special circumstances under which the hospice was unavailable to administer the medication.

(9) Orders Required for All Medications . A home must not allow its staff to assist with, provide supervision of self-administered medications, including over-the-counter medications, unless there is a physician, advance practice registered nurse or physician assistant's order or individualized prescription bottle, specifying clear instructions for its use on file for the resident.

(10) Timely Management of Medication Procurement . The home must obtain new prescriptions within 48 hours of receipt of notice of the prescription or sooner if the prescribing physician indicates that a medication change must be made immediately. If the pharmacy does not have the medication needed for the immediate change, available and has not obtained further directions from the physician, the home must notify the physician of the unavailability of the prescription and request direction.

(11) Storage of Medications .

(a) The home is accountable for having an effective system to manage the medications it receives including storing medications under lock and key, or other secure system to prevent unauthorized access, at all times, whether kept by a resident or kept by the home for the resident, except when required to be kept by a resident on his or her person due to need for frequent or emergency use, as determined by the resident's physician, advance practice registered nurse or physician assistant, or when closely attended by a staff member. Additionally, for controlled substances, the secure storage must be a locked cabinet or box of substantial construction and a log must be maintained and updated daily by the home to account for all inventory.

(b) Medication kept by a resident may be stored in the resident's bedroom, in a locked cabinet or other locked storage container. Single occupancy bedrooms which are kept locked at all times are acceptable. Duplicate keys for the resident's locked storage container and room must be available to the resident and the administrator, on-site manager or designated staff.

(d) A home may stock over-the-counter medications such as aspirin or acetaminophen for the convenience of residents who have PRN (as needed) orders for the specific medication and dosage. However, where the resident takes an over-the-counter medication daily as prescribed in a written order by a licensed physician, nurse practitioner or physicians assistant, such as vitamins or low-dose aspirins, the resident must have an individual bottle of the prescribed medication that is kept for the resident's individual usage.

(e) Unused or expired medications must be properly disposed of using the current U.S. Food and Drug Administration or U.S. Environmental Protection Agency guidelines for the specific medications.

(f) The supply of liquid morphine on site shall be limited to 50 ml for each hospice patient in the home for which there is a physician's order for such medication.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-9, 31-7-1, 31-7-2, 31-7-2.1, 31-7-12, 31-8-180 et seq., 43-26-32
History. Original Rule entitled "Additional Requirements for Specialized Memory Care Units or Homes" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Medications". F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-62-.21 Nutrition {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.21 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.21}

(1) A minimum of three regularly scheduled, well-balanced, meals must be provided seven days a week. There must be no more than 14 hours elapsing between the scheduled evening and morning meals. Meals must meet the general requirements for nutrition currently found in the Recommended Daily Diet Allowances, Food and Nutrition Board, National Academy of Sciences Meals must be of sufficient quantity, proper form, consistency and temperature. Food for at least one nutritious snack shall be available and offered each mid-afternoon and evening.

(2) Food received or used in a personal care home must be from satisfactory sources and must be clean, wholesome, free from spoilage, adulteration, and misbranding, and safe for human consumption.

(3) Properly Furnished Food Areas. A home must have a properly equipped kitchen with appropriate cabinets, drawers, holders and shelves or racks for storage of necessary equipment and utensils to prepare meals safely unless the home has arranged for meals to be obtained from a permitted food service establishment. The kitchen must be kept clean and disinfected at least daily unless more frequent sanitization is required to prevent the spread of infection or food borne illnesses.

(4) Handling of Food. All foods while being stored, prepared and served must be protected from spoilage and contamination and be safe for human consumption. The home must ensure that staff does the following:

(a) Store perishable foods properly, such as but not limited to meat, fish, eggs, dairy products, juices at temperatures that will minimize spoilage, i.e. at or below 41 degrees F.

(b) Thaw frozen foods properly, i.e. in the refrigerator or under cold running water with an unplugged sink.

(c) Provide hot and cold running water and sanitizing agents and ensure that they are used appropriately in the kitchen to clean and sanitize food, hands and utensils as required for safe food preparation.

(d) Prevent cross-contamination of foods via hands, cutting boards or utensils during preparation.

(e) Ensure that hot foods leave the kitchen (e.g. pot, steam table) for serving at or above 140 degrees F. and that cold foods leave the kitchen for serving at or below 41 degrees F.

(5) A home serving 25 or more residents must possess a valid food service permit issued through the authority of the Department of Public Health or a copy of the valid food service permit of the caterer who provides meals to the residents.

(6) Catered Food Service. When the a home uses a catered food service (food service establishment), the home must ensure that the service is properly licensed, provides meals in accordance with these rules, has a satisfactory record of compliance with food safety requirements and properly transports and stores food at time of delivery to maintain food safety.

(7) A home must maintain a three day supply of non-perishable food and water for emergency needs. The quantity of food required to be stored must be based on the usual resident census. The food must be kept in sealed containers which are labeled and dated. The food must be rotated in accordance with shelf life to ensure safety and palatability. Water sufficient for drinking and food preparation must also be stored.

(8) Menus must be written and posted 24 hours prior to serving the meal. Any change or substitution must be noted and considered as a part of the original menu. Alternatives to the food offered on the menu must be available to accommodate individual resident preferences.

(9) Homes must maintain records of all menus as served for 30 days after use.

(10) The person designated by the home as being responsible for managing the preparation of meals for the residents must enforce safe food handling practices which address basic food safety, hygiene, cross contamination, time and temperature requirements and sanitation with staff and residents.

(11) A home must arrange for special therapeutic diets as prescribed by the resident's physician, advance practice registered nurse of physicians assistant.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-2-9, 31-7-1, 31-7-2.1, 31-7-12, 31-12-3
History. Original Rule entitled "Medications" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Nutrition". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.22 Temperature Conditions {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.22 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.22}

(1) The temperature throughout the home must be maintained by an adequate heating and cooling systems or its equivalent at ranges which are consistent with individual health needs of residents and provides a comfortable environment for the residents.

(2) Temperatures in the home must not fall below 68 degrees during waking hours and 62 degrees F during sleeping hours. Mechanical cooling devices must be made available for use in those areas of the building used by residents when inside temperatures exceed 80 degrees F. No resident must be in any residence area that exceeds 85 degrees F.

(3) Where a power outage or mechanical failure impacting the ability of the home to maintain appropriate temperature ranges occurs, the home must take immediate action to provide for the health and safety of the residents, including but not limited to, arranging immediately for a service call, providing additional blankets or fans or utilizing an emergency power generator in accordance with the home's emergency preparedness plan.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-2-9, 31-7-2.1
History. Original Rule entitled "Nutrition" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Temperature Conditions". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.23 Infection Control, Sanitation and Supplies {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.23 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.23}

(1) The home must have a supply of first-aid materials available for use. This supply must include, at a minimum, gloves, band aids, thermometer, tape, gauze, and an antiseptic.

(2) A home must provide hand-sanitizing agents or soap and water at the sinks, clean towels and toilet tissue at each commode.

(3) Hand washing facilities provided in both kitchen and bathroom areas must include hot and cold running water, soap, and clean towels.

(4) The home must have an effective infection control program which includes, at least the following:

(a) Training provided to staff on effective measures for minimizing the spread of infections and food borne illnesses.

(b) Responding to disease outbreaks appropriately and participating in infection control investigations.

(c) Staff demonstrating their understanding and use of proper infection control practices in their delivery of care to the residents.

(d) Enforcing work and return to work policies to minimize the spread of infection and illnesses.

(f) Providing notices as recommended by public health regarding outbreaks and infestation issues to residents, staff and any visitors. Homes licensed for twenty-five (25) or more beds must meet the notification requirements of the Rules and Regulations for Disaster Preparedness Plans, Chapter 111-8-16.

(5) The home must have an adequate supply of sanitizing and cleaning agents, e.g. effective hand hygiene products, hand soap, laundry soap, household disinfectants and other cleaning materials, properly stored to prevent accidental ingestion but available for and properly used in the home to minimize the spread of infections.

(6) Residents' private living spaces or bedrooms must be thoroughly cleaned and sanitized after residents move out of the rooms.

(7) The home must clean the residents' private living spaces periodically and as needed to ensure that the space does not pose a health hazard.

(8) Homes licensed for twenty-five (25) or more beds must follow the additional infection control requirements set forth in the Rules and Regulations for Disaster Preparedness Plans, Chapter 111-8-16, regarding pandemic plans, supplies and policies and procedures.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-9, 31-7-2.1, 31-7-12.3, 31-7-12.5
History. Original Rule entitled "Temperature Conditions" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Infection Control, Sanitation and Supplies". F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-62-.24 Resident Files {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.24 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.24}

(1) An individual resident file must be maintained by the administrator or on-site manager for each resident in the home. Personal information must be treated as confidential and must not be disclosed except to the resident and his or her representative or legal surrogate, if any, an authorized agent of the Department, and others to whom written authorization is given by the resident or his representative or legal surrogate, if any. The resident file must be made available for inspection and/or copy to the Department, the resident or the resident's representative or legal surrogate, if any, upon request.

(2) Each resident file must include the following information:

(a) Identifying information including name, social security number, veteran status and number, age, sex, and previous address.

(b) Name, address and telephone number of next of kin, legal guardian and/ or representative or legal surrogate, if any, or representative payee and any court order or written document designating the resident's representative or legal surrogate, if any.

(c) Name, address and telephone number of any person or agency providing additional services to the resident. This information must include the name of the agency personnel primarily responsible, (i.e. the caseworker, case manager, or therapist).

(d) An admission and discharge log to include the date of admission, prior residence of resident, referral source, agency-contact and telephone number of referral source.

(e) Date of discharge, facility or residence discharged to and telephone number.

(f) The name, address and telephone number of a physician, hospital and pharmacy of the resident's choice.

(g) A record of all monetary transactions conducted on behalf of the resident with itemized receipts of all disbursements and deposits.

(h) A record of all monies and other valuables entrusted to the home for safekeeping; a receipt for same shall be provided to the resident or representative or legal surrogate, if any, at the time of admission and at anytime thereafter when the resident acquires additional property and wishes to entrust such property to the home for safekeeping.

(i) Health information including all health appraisals, diagnoses, prescribed diets, medications, and physician's instructions.

(j) An inventory of all personal items brought to the home by the resident to be updated at anytime after admission if a resident or representative or legal surrogate, if any, submits to the home a new inventory of the resident's personal items.

(k) A signed copy of the Resident's Rights form.

(l) A signed copy of the admission agreement.

(m) Any power of attorney or document issued by a court or by the Social Security Administration or any other governmental authority which designates another person as responsible for management of the resident's finances.

(n) A copy of a living will and/or durable power of attorney for health care if executed prior to 2007 or a copy of the Georgia advance directive for health care and a physician's order for life-sustaining treatment, if any. At least the advance directive for health care form must be made available at the time of admission and shall remain available to the resident.

(o) A copy of the resident's written waiver of the personal needs allowance charge pursuant to the provisions of Rule 111-8-62-.26(p)1.

(p) Any signed medical orders impacting end of life care, e.g. do not resuscitate, physician's orders for life sustaining treatment.

(q) All individual written care plans required by these rules and the rules for proxy caregivers, Chapter 111-8-100 if applicable.

(r) Any informed written consents signed by the resident or resident's representative, designating and delegating to any trained proxy caregiver, whether employed by the home or not, the performance of identified health maintenance activities.

(s) A copy of the search results obtained from the National Sex Offender Registry website maintained through the Department of Justice and any resulting safety plan for residents, staff and visitors.

(3) The following information may be requested to be given voluntarily by the resident, guardian, or representative or legal surrogate, if any, but may not be required of the resident:

(a) Spiritual preference e.g., church membership, name and telephone number of minister, priest, rabbi, or imam.

(b) Information about insurance policies and prearranged funeral and burial provisions, if any.

(4) Resident files must be maintained by the home for a period of three years after a resident's discharge.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-2-9, 31-7-2.1, 31-7-12.3, 31-8-131, 32-32-1
History. Original Rule entitled "Supplies" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Resident Files". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.25 Supporting Residents' Rights {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.25 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.25}

(1) The home must operate in a manner that respects the personal dignity of the residents and the human rights of the residents, which rights cannot be waived, except as provided in these rules by the resident or the resident's representative or legal surrogate.

(a) Each resident must receive care, and services which must be adequate, appropriate, and in compliance with applicable federal and state law and regulations.

(b) The home, its agents or employees, must not punish or harass the resident, because of the resident's efforts to enforce his or her rights.

Exercise the constitutional rights guaranteed to citizens of this state and this country including, but not limited to, the right to vote.
Choose activities and schedules consistent with the resident's interests and assessments.
Interact with members of the community both inside and outside the home and to participate fully in the life of the community.
Make choices about aspects of his or her life in the home that are significant to the resident.

(d) Each resident must have the right to enjoy privacy in his or her room; home personnel and others must respect this right by knocking on the door before entering the resident's room.

(e) Each resident must have the right to associate and communicate freely and privately with persons and groups of the resident's choice without being censored by staff.

(f) Each resident must be treated with dignity, kindness, consideration and respect and be given privacy in the provision of personal care. Each resident must be accorded privacy and freedom for the use of bathrooms at all hours.

(g) No religious or spiritual belief or practice may be imposed upon any resident. Residents must be free to practice their religious beliefs as they choose. Each resident must have the right to participate in social, religious, and community activities that do not interfere with the rights of other residents.

(h) Each resident has the right to be free from mental, verbal, sexual and physical abuse, neglect and exploitation. Each resident has the right to be free from actual or threatened physical or chemical restraints and the right to be free from isolation, corporal or unusual punishment and interference with the daily functions of living, such as eating or sleeping.

(i) Each resident has the right to use, keep and control his or her own personal property and possessions in the immediate living quarters, except to the extent a resident's use of his or her property would interfere with the safety or health of other residents. Each resident has the right to reasonable safeguards for the protection and security of his or her personal property and possessions brought into the home.

(j) Each resident's mail must be delivered unopened to the resident on the day it is delivered to the home. Each resident's outgoing correspondence may not be opened or tampered with prior to being mailed or otherwise delivered.

(k) Each resident must have access to a telephone and the right to have a private telephone, at the resident's own expense. Telephones must be placed in areas to insure privacy without denying accessibility.

(l) Each home must permit immediate access to residents by others who are visiting with the consent of the resident. Residents have the right to have visitors at mutually agreed upon hours. Once the hours are agreed upon, no prior notice is necessary. Each resident has the right to refuse to see visitors or terminate any visit.

(m) Each resident has the right to manage his or her own financial affairs, including the right to keep and spend his or her own money unless that resident has been adjudicated incompetent by a court of competent jurisdiction. Each resident has the right to be free from coercion to assign or transfer to the home money, valuables, benefits, property or anything of value other than payment for services rendered by the home.

(n) Each resident has the right to a personal needs allowance for the free use of the resident in the amount of twenty dollars per week to be distributed by the administrator, on-site manager, or a responsible staff person in the home unless waived by the resident. The following conditions must be met regarding the personal needs allowance:

The personal needs allowance must be included as a charge for services to each resident's account which a resident or a resident's representative or legal surrogate, if any, may waive by signing a written waiver upon admission or anytime thereafter. No allowance charge may be assessed where a resident or a resident's representative or legal surrogate, if any, has signed a written waiver of the personal needs allowance. Such a waiver must be kept in a resident's file.
Where no waiver has been signed, the personal needs allowance must be tendered to each resident, in cash, on the same day each week.
The personal needs allowance must not be intended or needed for purchasing necessary goods such as toilet paper and light bulbs which the home ordinarily supplies, and must in no way relieve the home of the obligation to insure that such necessary goods are available to the resident.

(o) Each resident has the right to receive or reject medical care, dental care, or other services except as required by law or regulations.

(p) Each resident has the right to choose and retain the services of a personal physician and any other health care professional or service. No home is permitted to interfere with the resident's right to receive from the resident's attending physician complete and current information concerning the resident's diagnosis, treatment and prognosis. Each resident and his or her representative or legal surrogate, if any, has the right to be fully informed about care and of any changes in that care and the right of access to all information in medical records retained in the home.

(q) Each resident has the right to fully participate in the planning of his or her care. Case discussion, consultation and examination shall be confidential and conducted discreetly. A person who is not directly involved in the resident's care may be present when care is being rendered only if he or she has the resident's permission.

(r) Each resident has the right to inspect his or her records on request. Each resident has the right to make a copy of all records pertaining to the resident. Each resident has the right to confidential treatment of personal information in the resident file.

(s) Each resident who has not been committed to the home by court order or who does not have a representative or legal surrogate with specific written authority to admit, transfer or discharge, may discharge or transfer himself or herself upon notification to the home in conformance with the home's policies and procedures.

(t) Each resident has the right to access to the State Long-Term Care Ombudsman Program O.C.G.A. § 31-8-50 et seq. and the name, address, and telephone number of the ombudsman must be posted in a common area of the home.

(u) Residents have the right to form a Resident Council and have meetings in the home outside the presence of owners, management or staff members of the home.

(v) Each resident has the right to file a complaint with the Department concerning care being provided in the home that violates these rules. The home must post the name of the Department and the address and telephone number where licensing complaints are received in the common area of the home.

(2) Each resident must be provided, at the time of admission to the home, with a copy of the Resident's Bill of Rights, as provided in Rule 111-8-62-.25 which must include provisions for protecting the personal and civil rights of each resident. In the event that a resident is unable to read the Resident's Bill of Rights the manager must take special steps to assure communication of its contents to the resident.

(3) A personal care home must comply with the provisions of the "Remedies for Residents of Personal Care Homes Act" as outlined in O.C.G.A. § 31-8-131 et seq.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-2-9, 31-7-2.1, 31-8-131et seq., 31-32-1et seq
History. Original Rule entitled "Resident Files" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Supporting Residents' Rights". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.26 Procedures for Change in Resident Condition {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.26 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.26}

(1) In case of an accident or sudden adverse change in a resident's physical condition or emotional adjustment, a home must take the actions appropriate to the specific circumstances to address the needs of the resident, including notifying the representative or legal surrogate, if any. The home must retain a record of all such accidents or sudden adverse changes and the home's response in the resident's files.

(2) Where the sudden change in the resident's condition causes the resident to experience cardiac or respiratory arrest, the home must immediately take one of the following actions:

(a) If the resident is enrolled in a licensed hospice and has a specific hospice plan of care, the home must contact the hospice for directions regarding the care to be provided. If the hospice staff is not available to provide direction, then home must immediately contact the duly-appointed health care agent for direction. If no health care agent has been appointed or is not available and if no Do Not Resuscitate (DNR) order has been written, then the home must initiate cardiopulmonary resuscitation immediately and must contact emergency medical services immediately to arrange for emergency transport.

(b) If the resident has a valid DNR order, the caregiver may effectuate the DNR order if done in good faith.

(c) If the resident has appointed a health care agent in a living will, durable power of attorney for health care or an advance directive for health care which complies with the requirements of O.C.G.A. § 31-32-1 et seq. then the home must immediately contact the health care agent for directions regarding the care to be provided. Where the health care agent is not immediately available and there is no valid DNR order for the resident, the home must initiate cardiopulmonary resuscitation immediately and contact emergency medical services to arrange for emergency transport.

(d) If the resident is not enrolled in hospice, and does not have either a DNR or an advance directive, then the staff of the home must immediately initiate cardiopulmonary resuscitation where it is not obvious from physical observation of the resident's body (e.g. body is stiff, cool to the touch, blue or grayish in color) that such efforts would be futile and there is not a physician, or authorized registered nurse or physician assistant on site to assess and provide other direction and contact emergency medical services immediately to arrange for emergency transport.

(3) The staff must have ready access to phone numbers for emergency medical personnel and the resident's file or appropriate emergency medical and contact information for each resident, both at the home and when residents are being transported by the home for any reason.

(4) An immediate investigation of the circumstances associated with an accident or injury involving a resident must be initiated by the administrator or on-site manager of the home. Additionally, a report of the occurrence of the accident or injury must be made to the representative or legal surrogate, if any, with a copy of the notification report maintained in the resident's file. The complete investigative review concerning the circumstances, cause of the incident and opportunities identified to improve care, must be retained in a central file for quality assurance/peer review.

(5) In the event a resident develops a significant change in physical or mental condition, the governing body must provide to the Department, upon request, a current physical examination report from a physician, nurse practitioner or physician assistant, indicating the resident's continued ability to meet the resident retention requirements in these rules.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-2-9, 31-7-2.1, 31-7-12.3, 31-8-50et seq., 31-8-131et seq
History. Original Rule entitled "Residents' Rights" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Procedures for Change in Resident Condition". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.27 Death of a Resident {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.27 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.27}

(1) Should a resident die while in the home, the administrator, on-site manager or responsible staff person must immediately notify the resident's physician, the next of kin, and the representative or legal surrogate, as applicable. Statutes applicable to the reporting of sudden or unexpected death and reports which must accompany the deceased must be followed.

(2) Upon death of the resident, the home must refund to the representative or legal surrogate, as applicable, any security deposit made to the home by or on behalf of the resident in compliance with O.C.G.A. § 44-7-30 et seq.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-7-2.1, 31-2-9, 31-7-2.1, 44-7-30
History. Original Rule entitled "Procedures for Change in Resident Condition" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Death of a Resident". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.28 Immediate Transfer of Residents {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.28 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.28}

(1) The administrator or on-site manager of the home must initiate immediate transfer if the resident develops a physical or mental condition requiring continuous medical care or nursing care or if a resident's continuing behavior or condition directly and substantially threatens the health, safety and welfare of the resident or any other resident.

(2) In the event such immediate transfer is required, the administrator or on-site manager of the home must advise both the resident and the resident's representative or legal surrogate and case manager, if any, and immediate arrangements must be made based on the written admission agreement to transfer such resident to an appropriate facility. The administrator or on-site manager must document in the resident's file the reasons for the transfer.

(3) Where immediate transfer is to be made pursuant to paragraphs (1) and (2), the administrator or on-site manager must make arrangements for transfer in accordance with the admission agreement and shall transfer the resident to an appropriate facility where the resident's needs can be met. Prior to making such transfer, the administrator or on-site manager must:

(a) Inform the resident and representative or legal surrogate and case manager, if any, of the reason for the immediate transfer.

(b) Inquire as to any preference of the resident and representative or legal surrogate, if any, regarding the facility to which the resident is to be transferred.

(d) Inform the resident and the representative or legal surrogate, if any, of the place to which the resident is to be transferred.

(e) Provide a copy of the resident file to the receiving facility within 24 hours of transfer.

(f) Document in the resident's file the following:

The reason for the immediate transfer.
The manner in which the resident and the representative or legal surrogate, if any, were informed pursuant to this paragraph.
The name, address, and telephone number of the place to which the resident is to be transferred or discharged.

(4) Upon immediate transfer of the resident, the home must refund to the resident or representative or legal surrogate, if applicable, any security deposit made to the home by or on behalf of the resident in compliance with O.C.G.A. § 44-7-30 et seq.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-2-9, 31-7-2.1, 44-7-30et seq
History. Original Rule entitled "Death of a Resident" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Immediate Transfer of Residents". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.29 Discharge or Transfer of Residents {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.29 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.29}

(1) The administrator or on-site manager must contact the representative or legal surrogate, if any, when there is need for discharge or transfer of a resident. The home must provide 30 days' written notice of its intent to discharge or transfer the resident unless an immediate transfer is required. The written notice must be issued to both the resident and the representative or legal surrogate, if any.

(2) In all cases, except those requiring immediate transfer pursuant to Rule 111-8-62-.28 , residents whose needs cannot be met by the home or who no longer choose to live in the home must be discharged or transferred to an appropriate facility based on discharge and transfer procedures entered into at the time of admission. Where the resident is incapable of making informed decisions and there is no representative or legal surrogate or the representative or legal surrogate is unwilling to act, the administrator or on-site manager must petition the probate court in the county where the home is located for an order authorizing the discharge or transfer. The transferring home must provide a copy of the resident's file to the receiving facility prior to or at the time of transfer.

(3) Where the Department has reason to believe that a resident is receiving or requires continuous medical or nursing care, the Department may require the home to discharge the resident. However, the provision of medical, nursing or health services required by the resident on a periodic basis or for a short-term illness, where such services are not provided by the home is permissible.

(4) Upon discharge or transfer of the resident, the home must refund to the resident or representative or legal surrogate, if any, any security deposit made to the home by or on behalf of the resident in compliance with O.C.G.A. § 44-7-30 et seq.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-2-9, 31-7-2.1, 44-7-30et seq
History. Original Rule entitled "Immediate Transfer of Residents" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Discharge or Transfer of Residents". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.30 Reporting {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.30 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.30}

(1) The staff of the personal care home must call the local police department to report the elopement of any resident from the home within 30 minutes of the staff receiving actual knowledge that such person is missing from the home in accordance with the Mattie's Call Act and the requirements set forth in O.C.G.A. § 35-3-170 et seq. The home must also report the initiation and discontinuation of a Mattie's call to the Department utilizing the complaint intake system within 30 minutes of communications with local law enforcement authorities having occurred.

(2) The personal care home must report a serious incident using the complaint intake system and location designated by the Department within 24 hours following the occurrence of a serious incident or the home's learning that a serious incident involving a resident may have occurred. The serious incidents that must be reported to the Department include the following:

(a) Any accidental or unanticipated death of a resident not directly related to the natural course of the resident's underlying medical condition.

(b) Any serious injury to a resident that requires medical treatment.

(c) Any rape, assault, any battery on a resident, or any abuse, neglect, or exploitation of a resident in accordance with the Long Term Care Resident Abuse Reporting Act O.C.G.A. § 31-8-80 et seq.

(d) An external disaster or other emergency situation that affects the continued safe operation of the residence.

(e) Any circumstances where a member of the governing body, administration, staff associated with or affiliated with the personal care home, or family member of staff becomes associated with an account at a financial institution, will, trust, benefit of substantial value or life insurance policy of a resident or former resident to verify that such gift is knowingly and voluntarily made and not the result of any coercion.

(f) When an owner, director or employee acquires a criminal record as defined in these rules.

(3) The incident report, submitted through the home's peer review process will be received by the Department in confidence and must include at least:

(a) The name of the personal care home and the name of the administrator or site manager.

(b) The date of the incident and the date the personal care home became aware of the incident.

(d) Any subsequent remedial and quality measures determined through peer review to be taken by the personal care home to make such injury or harm arising from the particular incident less likely to recur.

(4) Where the Department determines that a rule violation related to the reported incident has occurred, the Department will initiate a separate complaint investigation of the incident. The complaint investigation report and the report of any rule violation compiled by the Department arising either from the initial report received from the personal care home or an independent source is subject to disclosure in accordance with applicable laws.

History

Authority: O.C.G.A. §§ 31-2-7, 31-7-2.1, 31-7-12, 31-8-80et seq. and 35-3-170 et seq
O.C.G.A. Secs. 31-2-7, 31-2-9, 31-7-2.1, 31-7-12, 31-8-80et seq., 35-3-170et seq., 44-7-30et seq.
History. Original Rule entitled "Discharge or Transfer of Residents" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Reporting". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.31 Deemed Status {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.31 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.31}

The Department may accept the certification or accreditation of a home by an accreditation body or certifying authority recognized and approved by the Department provided that certification or accreditation constitutes compliance with standards that are substantially equivalent to these rules. Nothing herein shall prohibit any departmental inspection to determine compliance with licensure rules.

History

Authority: O.C.G.A. Secs. 31-7-1, 31-2-9, 31-7-2.1, 31-7-3, 31-7-12, 31-8-80et seq., 35-3-170et seq
History. Original Rule entitled "Reporting" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Deemed Status". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.32 Variance and Waiver {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.32 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.32}

(1) The Department may, in its discretion, grant variances and waivers of specific rules upon application or petition filed on forms provided by the Department. The Department may establish conditions which must be met by the home in order to operate under the variance or waiver granted.

(a) Variance . A variance may be granted by the Department upon a showing by the applicant or petitioner that the particular rule or regulation that is the subject of the variance request should not be applied as written because strict application of the rule would cause undue hardship. The applicant or petitioner must also show that adequate standards affording protection for the health, safety, and care of the residents exist and will be met in lieu of the exact requirements of the rule or regulations in question. The Department may require additional documentation by the home to support its application for a variance or waiver.

(c) Experimental Variance or Waiver . The Department may grant variances and waivers to allow experimentation and demonstration of new and innovative approaches to delivery of services upon a showing by the applicant or petitioner that the intended protections afforded by the rule or regulation which is the subject of the request are met and that the innovative approach has the potential to improve service delivery without compromising health, safety, residents' rights, or other relevant standards.

(2) The home may request a final review of the initial waiver or variance decision made by program staff to the chief of the division by filing a written request for review of the initial decision and providing any additional written information which supports the request for review. The chief of the division will issue a final decision on behalf of the Department. Where the governing body believes that the Department has abused its discretion in acting upon the waiver or variance request, it may seek appropriate relief.

(3) Where the Department has denied the application for a waiver or variance in writing, the Department will not consider a subsequent application for the same waiver or variance as a new application unless the applicant includes new evidence of a substantial change in the circumstances which formed the basis for the initial request.

History

Authority: O.C.G.A. §§ 31-2-7, 31-7-2.1 and 31-7-12
O.C.G.A. Secs. 31-2-7, 31-7-1, 31-7-2.1, 31-7-3, 31-7-12.
History. Original Rule entitled "Deemed Status" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Variance and Waiver". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.33 Enforcement and Penalties {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.33 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.33}

A home that fails to comply with licensing requirements contained in these rules, the Rules and Regulations for the Use of Proxy Caregivers, Chapter 111-8-100 as applicable and the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25, is subject to civil and administrative actions brought by the Department to enforce licensing requirements as provided by law and rules. Such actions will be initiated in compliance with the Georgia Administrative Procedures Act, O.C.G.A. § 50-13-1et seq., O.C.G.A. § 31-2-11 and the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-8, 31-7-1et seq., 43-26-12 and 50-13-1et seq
O.C.G.A. Secs. 31-2-7, 31-2-8, 31-2-9, 31-7-1, 31-7-2.1, 31-7-12, 43-26-12 and 50-13-1et seq.
History. Original Rule entitled "Variance and Waivers" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Enforcement and Penalties". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Ga. Comp. R. & Regs. r. 111-8-62-.34 Severability {#sec-ga.-comp.-r.-regs.-r.-111-8-62-.34 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-62-.34}

In the event that any rule, sentence, clause or phrase of any of the rules and regulations may be construed by any court of competent jurisdiction to be invalid, illegal, unconstitutional, or otherwise unenforceable, such determination or adjudication shall in no manner affect the remaining rules or portions thereof. The remaining rules or portions thereof shall remain in full force and effect as if such rule or portions thereof so determined, declared or adjudicated invalid or unconstitutional were not originally part of these rules.

History

Authority: O.C.G.A. Secs. 31-2-7, 31-2-8, 31-2-11, 31-7-2.1, 31-7-1et seq., 31-7-4
History. Original Rule entitled "Enforcement and Penalties" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: New Title "Severability". F. Dec. 19, 2012; eff. Jan. 8, 2013.

Subject 111-8-63 Rules and Regulations for Assisted Living Communities

Ga. Comp. R. & Regs. r. 111-8-63-.01 Authority {#sec-ga.-comp.-r.-regs.-r.-111-8-63-.01 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-63-.01}

The legal authority for this Chapter is found in O.C.G.A. §§ 31-2-7 and Chapter 7 of Title 31.

History

Authority: O.C.G.A. §§ 31-2-4, 31-2-7, 31-2-8, 31-2-9 and 31-7-1, et seq
History. Original Rule entitled "Authority" adopted. F. Dec. 13, 2012; eff. Jan. 2, 2012.

Ga. Comp. R. & Regs. r. 111-8-63-.02 Purpose {#sec-ga.-comp.-r.-regs.-r.-111-8-63-.02 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-63-.02}

The purpose of these rules and regulations is to establish the minimum standards for the operation of personal care homes to be licensed as assisted living communities. Such communities provide assisted living care to adults who require varying degrees of assistance with the activities of daily living but who do not require continuous medical or nursing care.

History

Authority: O.C.G.A. §§ 31-2-7 and 31-7-1et seq
History. Original Rule entitled "Purpose" adopted. F. Dec. 13, 2012; eff. Jan. 2, 2012.

Ga. Comp. R. & Regs. r. 111-8-63-.03 Definitions {#sec-ga.-comp.-r.-regs.-r.-111-8-63-.03 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-63-.03}

In these rules, unless the context otherwise requires, the words, phrases and symbols set forth herein shall mean the following:

(c) "Administrator" means the manager designated by the Governing Body as responsible for the day-to-day management, administration and supervision of the assisted living community, who may also serve as the on-site manager and responsible staff person except during periods of his or her own absence.

(d) "Applicant" means an individual or entity that submits an application for licensure pursuant to these rules as described below:

When the assisted living community is owned by a sole proprietorship, the individual proprietor must be the applicant for the license, complete the statement of responsibility and serve as the licensee;
When the assisted living community is owned by a partnership, the general partners must be the applicant for the license, complete the statement of responsibility and serve as the licensee;
When the assisted living community is owned by an association, limited liability company (LLC) the governing body of the association or LLC must authorize the application for the license, complete the statement of responsibility and serve as the licensee; and
When the assisted living community is owned by a corporation, the governing body of the corporation must authorize the application for the license, complete the statement of responsibility and serve as the licensee.

(e) "Assistive device" means a device that may restrain movement which has been determined to be required by a licensed physician, nurse practitioner or physician's assistant working under a protocol or job description respectively and is applied for protection from injury or to support or correct the body alignment of the person, for the treatment of a person's physical condition, and may only be used as a treatment intervention where a specific written plan of care has been developed and the resident consents to such use.

(g) "Assisted living community" or "community" means a personal care home serving 25 residents or more that is licensed by the department to provide assisted living care.

(h) "Assisted self-preservation" means the capacity of a resident to be evacuated from an assisted living community to a designated point of safety and within an established period of time as determined by the Office of Fire Safety Commissioner. Assisted self-preservation is a function of all of the following:

the condition of the individual,
the assistance that is available to be provided to the individual by the staff of the assisted living community; and
the construction of the building in which the assisted living community is housed, including whether such building meets the state fire safety requirements applicable to an existing health care occupancy.

(i) "Certificate" means a certificate issued by the department to operate a memory care center in a licensed assisted living community or personal care home.

(j) "Chemical Restraint" means a psychopharmacologic drug that is used for discipline or convenience and not required to treat medical symptoms.

(k) "Department" means the Department of Community Health of the State of Georgia operating through the Division of Healthcare Facility Regulation.

(l) "Direct care staff person" means any employee, facility volunteer, or contract staff who provides to residents:

(i) any personal services, including but not limited to, medication administration or assistance, assistance with ambulation and transfer, and essential activities of daily living such as eating, bathing, grooming, dressing, and toileting; or

(ii) any other limited nursing services.

(m) "Director" means the chief administrator, executive officer or manager.

(n) "Disabled individual" means an individual that has a physical or mental impairment that substantially limits one or more major life activities and who meets the criteria for a disability under state or federal law.

(o) "Employee" means any person, other than a director, utilized by an assisted living community to provide personal services to any resident on behalf of the assisted living community or to perform at any facilities of the assisted living community any duties which involve personal contact between that person and any paying resident of the assisted living community.

(q) "Governing Body" means the owner, the board of trustees or directors, the partnership, the corporation, the association, the sole proprietorship or the person or group of persons who maintains and controls the assisted living community and who is legally responsible for the operation of the community.

(r) "Health maintenance activities" means those limited activities that, but for a disability, a person could reasonably be expected to do for himself or herself. Such activities are typically taught by a registered professional nurse, but may be taught by an attending physician, advanced practice registered nurse, physician assistant, or directly to a patient and are part of ongoing care. Health maintenance activities are those activities that do not include complex care such as administration of intravenous medications, central line maintenance, and complex wound care; do not require complex observations or critical decisions; can be safely performed and have reasonably precise, unchanging directions; and have outcomes or results that are reasonably predictable. Health maintenance activities conducted pursuant to this paragraph shall not be considered the practice of nursing.

(s) "Health services" means the specialized assistance that may be provided by or at the direction of either licensed healthcare professionals, such as doctors, nurses, physical therapists or through licensed healthcare programs, such as home health agencies, hospices and private home care providers to address health needs that the assisted living community is not staffed to provide or is not authorized by law or regulations to provide.

(t) "Injury" as used in the definition of "abuse" means a wrong or harm caused by an individual to a resident which is manifested by a physical or behavioral reaction or change in the appearance or actions of the resident, such as, but not limited to, reddened or bruised skin not related to routine care, crying, startling or cowering reaction by the resident and malnutrition or pressure ulcers for which the facility has not provided proper care.

(u) "Legal Surrogate" means a duly appointed person who is authorized to act, within the scope of the authority granted under the legal surrogate's appointment, on behalf of a resident who is adjudicated incapacitated.

(v) "Limited nursing services" means the assessment of the physical, mental, and emotional status to determine the appropriate level of care for an individual; the performance of health maintenance activities, as defined in division (a)(9)(C)(ii) of Code Section 43-26-12 ; and the provision of any nursing care within the direct care staff person's scope of practice that can be completed within seven days or intermittently.

(w) "Medical alert system" means any device or combination of devices used to detect and immediately communicate that an individual is experiencing a medical emergency. Such device or combination of devices must be approved for their effectiveness by the department in its sole discretion.

(x) "Medical services" means services which may be provided by a person licensed pursuant to Article II of Chapter 34 of Title 43 of the Official Code of Georgia Annotated.

(y) "Memory care services" means the additional watchful oversight systems and devices that are required for residents who have cognitive deficits which may impact memory, language, thinking, reasoning, or impulse control, and which place the residents at risk of eloping, i.e. engaging in unsafe wandering activities outside the assisted living community.

(z) "Memory care center" means the freestanding or incorporated specialized unit that either:

(i) holds itself out as providing additional or specialized care to persons with diagnoses of probable Alzheimer's or other dementias or with cognitive deficits that may place the resident at risk; or

(ii) charges higher rates for care for residents with Alzheimer's or other dementias than for care to other residents.

(aa) "Non-Family Adult" means a resident 18 years of age or older who is not related by blood within the third degree of consanguinity or by marriage to the person responsible for the management of the assisted living community or to a member of the governing body.

(bb) "Nursing services" means those services which may be rendered by a person licensed pursuant to Articles I and 2 of Chapter 26 of Title 43 of the Official Code of Georgia Annotated.

(cc) "On-site manager" means the administrator or person designated by the administrator as responsible for carrying out the day-to-day management, supervision, and operation of the assisted living community, who may also serve as responsible staff person except during periods of his or her own absence.

(dd) "Owner" means any individual or any person affiliated with a corporation, partnership, or association with 10 percent or greater ownership interest in the business or agency licensed as an assisted living community and who:

purports to or exercises authority of the owner in a facility;
applies to operate or operates the business or agency;
maintains an office on the premises of the assisted living community;
resides at the assisted living community;
has direct access to persons receiving care at the assisted living community;
provides direct personal supervision of assisted living community personnel by being immediately available to provide assistance and direction during the time such assisted living community services are being provided; or enters into a contract to acquire ownership of such a business or agency.

(ee) "Permit" or "license" means the authorization granted by the Department to the governing body to operate an assisted living community.

(ff) "Personal care home" means any dwelling, whether operated for profit or not, which undertakes through its ownership or management to provide or arrange for the provision of housing, food service, and one or more personal services for two or more adults who are not related to the owner or administrator by blood or marriage.

(gg) "Personal Services" includes, but is not limited to, individual assistance with or supervision of self-administered medication, assistance, essential activities of daily living such as eating, bathing, grooming, dressing, toileting, ambulation and transfer.

(hh) "Physical Restraints" are any manual or physical device, material, or equipment attached or adjacent to the resident's body that the individual cannot remove easily which restricts freedom 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, and wheelchair safety bars. Also included as restraints are assisted living community practices which function as a restraint, such as tucking in a sheet so tightly that a bedbound resident cannot move, bedrails, or chairs that prevent rising, or placing a wheelchair bound resident so close to a wall that the wall prevents the resident from rising. Wrist bands or devices on clothing that trigger electronic alarms to warn staff that a resident is leaving a room do not, in and of themselves, restrict freedom of movement and should not be considered as restraints.

(ii) "Physician" means an individual who is currently licensed to practice medicine in the State of Georgia. For purposes of these rules, it shall be acceptable for any activities required to be performed by a physician to be performed by any other licensed medical professional (i.e., Nurse Practitioner, Physician Assistant, etc.) who is permitted to perform such activities under applicable state scope of practice rules and regulations.

(jj) "Plan of Correction" means the written plan prepared in response to cited rule violations that identifies by date certain the specific actions that will be taken by the assisted living community to come into compliance with these rules.

(kk) "Proxy caregiver" means an unlicensed person or a licensed health care facility that has been selected by a disabled individual or a person legally authorized to act on behalf of such individual to serve as such individual's proxy caregiver and meets the requirements contained in the Rules and Regulations for Proxy Caregivers Used in Licensed Healthcare Facilities, Chapter 111-8-100.

(ll) "Representative" means a person who voluntarily, with the resident's written authorization, acts upon resident's direction with regard to matters concerning the health and welfare of the resident, including being able to access personal and medical records contained in the resident's file and receive information and notices pertaining to the resident's overall care and condition. This written authorization may take the form of an advance directive.

(mm) "Resident" means any non-family adult who receives or requires assisted living care and resides in the assisted living community.

(nn) "Responsible Staff Person" means the employee designated by the administrator or on-site manager as responsible for supervising the operation of the assisted living community during periods of temporary absence of the administrator or on-site manager.

(oo) "Self-administration of medications" or "self-administered medications" means those prescription or over-the-counter drugs that the resident personally chooses to ingest or apply where the resident has been assessed and determined to have the cognitive skills necessary to articulate the need for the medication and generally knows the times, and physical characteristics of medications to be taken.

(pp) "Self-preservation" means the ability to respond to an emergency condition, whether caused by fire or otherwise, and escape the emergency without physical, hands-on assistance from staff. The resident may move from place to place by walking, either unaided or aided by prosthesis, brace, cane, crutches, walker or hand rails, or by propelling a wheelchair.

(qq) "Staff" means any person who performs duties in the assisted living community on behalf of the assisted living community.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-8, 31-2-9, 31-7-1, 31-7-12.2, 43-26-12
History. Original Rule entitled "Definitions" adopted. F. Nov. 19, 2009; eff. Dec. 9, 2009.
Amended: F. Dec. 19, 2012; eff. Jan. 8, 2013.
Amended: F. Apr. 16, 2018; eff. May 6, 2018.
Amended: F. Feb. 28, 2020; eff. Mar. 19, 2020.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.
Amended: F. May 1, 2025; eff. May 21, 2025.

Ga. Comp. R. & Regs. r. 111-8-63-.04 Exemptions {#sec-ga.-comp.-r.-regs.-r.-111-8-63-.04 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-63-.04}

These regulations do not apply to the following facilities:

(a) boarding homes or rooming houses which provide no services other than lodging and meals;

(b) facilities offering temporary emergency shelter, such as those for the homeless and victims of family violence;

(c) other facilities, homes or residences licensed by the department which have not been classified as assisted living communities, e.g. community living arrangements, personal care homes, hospices, traumatic brain injury facilities;

(d) facilities providing residential services for federal, state or local correctional institutions under the jurisdiction of the criminal justice system;

(e) charitable organizations providing shelter and other services without charging any fee to the resident or billing any fee on behalf of the residents;

(f) group residences organized by or for persons who choose to live independently or who manage their own care and share the cost of services including but not limited to attendant care, transportation, rent, utilities and food preparation;

(g) facilities licensed by the Department of Behavioral Health, Developmental Disabilities and Addictive Diseases; or

(h) host homes as defined in O.C.G.A. § 37-1-20(18) .

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-8, 31-7-1et seq., 37-1-20 and 37-1-29
History. Original Rule entitled "Exemptions" adopted. F. Dec. 13, 2012; eff. Jan. 2, 2012.

Ga. Comp. R. & Regs. r. 111-8-63-.05 Application for Permit {#sec-ga.-comp.-r.-regs.-r.-111-8-63-.05 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-63-.05}

(1) The governing body of each assisted living community must submit to the Department an application for a permit in order to operate.

(2) The application for a permit must be made on forms made available by the Department or in a format acceptable to the Department.

(3) No application for licensure will be acted upon by the Department unless it has been determined to be complete and include all required attachments and fees due the Department as specified in the Rules and Regulations for General Licensing and Enforcement Requirements, Chapter 111-8-25.

(4) Each application for a permit must be accompanied by an accurate floor plan showing windows, doors, common areas, and resident room measurements and digital copies in .jpg format of pictures of the assisted living community's exterior, common areas and typical resident room.

(5) The name of the administrator or on-site manager, who will be working in the assisted living community, if known, must be included with the application for a permit. If such information is not known at the time of application, it must be provided to the Department before a permit will be issued.

(6) The ownership of the assisted living community must be fully disclosed in the application for a permit. In the case of corporations, partnerships, and other entities recognized by statute, the corporate officers and all other individuals or family groups owning ten percent or more of the corporate stock or ownership must be disclosed in the application, as well as the registered agent for service of process.

(7) Each application must include documentation of ownership or lease agreement for the property on which the assisted living community will be operated.

(8) The filing of an application for licensure constitutes a representation that the applicant is or will be in complete control of the community as of a specified date.

(9) Local zoning and other local requirements regarding the proper location and establishment of the assisted living community must be addressed by the applicant with the responsible local officials.

(10) The initial application for licensure shall include a financial stability affidavit from a certified public accountant affirming the applicant's ability to operate as a going concern for the next two years.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-8, 31-2-9, 31-7-1 et seq
History. Original Rule entitled "Application for Permit" adopted. F. Dec. 13, 2012; eff. Jan. 2, 2012.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-63-.06 Permits {#sec-ga.-comp.-r.-regs.-r.-111-8-63-.06 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-63-.06}

(1) The governing body of each assisted living community must obtain a valid permit from the Department to provide assisted living care prior to admitting any residents.

(2) The permit must be displayed on the premises in a conspicuous place that is visible to residents and visitors.

(3) Permits are not transferable from one assisted living community or location to another.

(4) A permit must be returned to the Department and is no longer valid when any of the following events occurs:

(a) The assisted living community is moved to another location which has not been licensed.

(b) The ownership of the community changes.

(5) A separate permit is required for each assisted living community located on different premises.

(6) An assisted living community must not serve more residents than its approved licensed capacity, which is listed on the face of the permit issued by the Department.

(7) An assisted living community must provide assisted living care as authorized by law and these rules.

(8) An assisted living community must disclose its licensure classification as an assisted living community in its marketing materials.

(9) An assisted living community must not operate or allow another business to operate on the premises of the assisted living community where the business intrudes on the residents' quiet enjoyment and exclusive use of the premises, in any way.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-8, 31-2-9 and 31-7-1et seq
History. Original Rule entitled "Permits" adopted. F. Dec. 13, 2012; eff. Jan. 2, 2012.

Ga. Comp. R. & Regs. r. 111-8-63-.07 Owner Governance {#sec-ga.-comp.-r.-regs.-r.-111-8-63-.07 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-63-.07}

(1) The assisted living community must have a functioning governing body which is responsible for providing the oversight necessary to ensure that the community operates in compliance with these rules, the Rules for General Licensing and Enforcement, Chapter 111-8-25, the Rules for Proxy Caregivers, Chapter 111-8-100, as applicable and other applicable state laws and regulations.

(2) The governing body is responsible for implementing policies, procedures and practices in the community that support the core values of dignity, respect, choice, independence and privacy of the residents in a safe environment and in accordance with these rules. At a minimum, the policies and procedures that are developed must provide direction for the staff and residents on the following:

(a) the services available in the assisted living community, including, personal services, assisted living care, memory care services and any other specialized services such as memory care centers and designated proxy caregivers;

(b) the staffing plan that the community utilizes to ensure that staffing ratios increase proportionally as the number of residents who require assisted self-preservation increases;

(c) admissions, discharges and immediate transfers which ensure that the community does not admit or retain residents who need more care that the assisted living community is authorized or capable of providing;

(d) refunds when a resident is transferred or discharged;

(e) training and ongoing evaluation of staff, including specialized training if designated proxy caregivers are provided or memory care is offered;

(f) house rules and their enforcement;

(g) protecting the rights of the residents as set forth in these rules;

(h) medication management, procurement, the use of certified medication aides and professional oversight provided for such services;

(i) health and hygiene issues for residents and staff relating to infection control, work policies and return to work policies, food borne illnesses and reportable diseases;

(j) the investigation and reporting of abuse, neglect, exploitation of residents, residents' wandering away from the community, accidents, injuries and changes in residents' conditions to required parties;

(k) discipline procedures for handling acts committed by staff which are inconsistent with the policies of the assisted living community;

(l) emergency preparedness, drills and evacuation requirements;

(m) quality assurance review mechanisms, including resident and family feedback to determine opportunities for improving care;

(n) the use of volunteers and their orientation regarding resident's rights and basic safety precautions;

(o) the specific use of proxy caregivers allowed within the community and the oversight of proxy caregivers the community requires or provides in accordance with Georgia law, these rules and the rules for proxy caregivers, Chapter 111-8-100; and

(p) the safety and security precautions that will be employed by the assisted living community to protect residents from harm by other residents, designated proxy caregivers, and other individuals, not employed by the community who routinely come into the community.

(3) The governing body must designate an administrator or on-site manager as responsible for the overall management of the assisted living community and for carrying out the rules and policies adopted by the governing body.

(4) The governing body must ensure that the Department has current emergency contact information consisting of name, e-mail contact for notifications to the licensed community, physical addresses, and phone numbers for the governing body and the administrator or on-site manager of the assisted living community.

(5) The governing body must take appropriate measures within its control, to protect the residents from criminal activity occurring in the assisted living community.

(6) The governing body must not allow persons who are not residents of the assisted living community to live on the premises if they are listed on the National Sex Offender Registry.

(7) No member of the governing body, administration, or staff of the assisted living community or an affiliated assisted living community or family members of the governing body or any staff may serve as the legal surrogate or representative of a resident.

(8) Where the governing body, a member of the governing body's family or a staff member of the assisted living community or an affiliated assisted living community serves as the representative payee of a resident, the individual or entity must be covered by a surety bond.

(9) Notification of Emergency Relocation . The community must provide timely notification of the relocation address to the residents, their family contacts and representatives, if any, and the department whenever the community must relocate the residents as a result of an emergency situation which disrupts the provision of room and board for the residents at the licensed location.

(10) Notification of Bankruptcy, Eviction or Change of Ownership. The community must provide:

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-8, 31-7-1 et seq
History. Original Rule entitled "Owner Governance" adopted. F. Dec. 13, 2012; eff. Jan. 2, 2012.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-63-.08 Community Leadership {#sec-ga.-comp.-r.-regs.-r.-111-8-63-.08 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-63-.08}

(1) Each community must have a full-time administrator to provide day-to-day leadership to the community. The administrator must be 21 years of age or older and hold a valid license from the State Board of Long-Term Care Facility Administrators with an effective date no greater than sixty (60) days from the date of hire or July 1, 2021, whichever is later.

(2) The administrator is responsible for ensuring that the policies and procedures are effective and enforced to ensure compliance with these rules and community policies and procedures.

(3) Each assisted living community must have a separate administrator or on-site manager who works under the supervision of the administrator.

(4) The administrator or on-site manager must designate qualified staff as responsible staff to act on his or her behalf and to carry out his or her duties in the absence of the administrator or on-site manager.

(5) Residents must not be allowed to function or be counted as staff.

(6) Staff must be assigned duties consistent with their positions, training, experiences, and the requirements of Rule 111-8-63-.09 .

(7) The administrator is responsible for ensuring that the assisted living community has an effective quality assurance program which includes at least the following:

(a) investigating resident incidents which result in injuries or death in order to identify and implement opportunities for improvement in care;

(b) implementing changes made to support improved care, such as those necessary to minimize illness outbreaks and eliminate identified rule violations;

(c) monitoring staff performance to ensure that care and services are being delivered safely and in accordance with these rules and community policies; and

(d) obtaining and using feedback from the residents and representatives, at least annually, on the quality of services provided by the community and opportunities for improvement of services.

History

Authority: O.C.G.A. §§ 31-2-7, 31-2-8, 31-7-1 et seq., 43-27-1 et seq
History. Original Rule entitled "Community Leadership" adopted. F. Dec. 13, 2012; eff. Jan. 2, 2012.
Amended: F. Aug. 24, 2021; eff. Sept. 13, 2021.

Ga. Comp. R. & Regs. r. 111-8-63-.09 Workforce Qualifications, Training and Staffing {#sec-ga.-comp.-r.-regs.-r.-111-8-63-.09 omnilex-key=us-ga-regs-official--department-111--Ga. Comp. R. & Regs. r. 111-8-63-.09}

(1) The on-site manager and responsible staff persons must be at least 21 years of age and responsible for supervising the provision of care by all other staff. No staff person under the age of 18 is permitted to work in the assisted living community unless there is direct line-of-sight supervision being provided by the administrator, on-site manager or a responsible staff person or the staff member is at least 17 years of age and has successfully completed a vocational technical training track as a nursing assistant through a Georgia high school.

(2) Initial Training for All Staff. The administrator or on-site manager must ensure that any person working in the assisted living community as staff, receives training within the first 60 days of employment on the following:

(a) residents' rights and identification of conduct constituting abuse, neglect or exploitation of a resident and reporting requirements to include the employee's receipt of a copy of the Long-Term Care Facility Resident Abuse Reporting Act as outlined in O.C.G.A. § 31-8-81 et seq.;

(b) general infection control principles including importance of hand hygiene in all settings and attendance policies when ill;

(d) emergency preparedness.

(3) Initial Training for Staff Providing Hands-On Personal Services. In addition to the initial training required of all staff in paragraph (2) above, the administrator must ensure that staff hired to provide hands-on personal services to residents receive training within the first 60 days of employment which includes the following:

(a) current certification in emergency first aid except where the staff person is a currently licensed health care professional;

(b) current certification in cardiopulmonary resuscitation where the training course required return demonstration of competency;

(c) medical and social needs and characteristics of the resident population, including special needs of residents with dementia;

(d) residents' rights and the provision of care to residents that is individualized and helpful; and

(e) training specific to assigned job duties, such as, but not limited to, permissible assistance with medications, contraindications for medications that must be brought to the attention of appropriate individuals, assisting residents in transferring, ambulation, proper food preparation, proper performance of health maintenance activities if serving as a designated proxy caregiver and responding appropriately to dementia-related behaviors.

(4) Trained Staff Present. At least two staff who have completed the minimum training requirements of Rule 111-8-63-.09(2)(a) through (d) and (3)(a) through (e) above must be present in the assisted living community at all times any residents are present, with at least one staff person on each occupied floor, to provide necessary oversight and assistance to staff providing hands-on personal services who have not completed the training, to ensure that care and services are delivered safely and in accordance with these rules. The staff person posted on the designated floor may move about the premises as necessary if the community has implemented a medical alert system and each resident has been offered a wearable device that connects to such system when activated to alert an administrator or direct care staff person of a medical emergency.

(5) Training Hours Required During First Year of Employment. All staff offering hands-on personal services to the residents, including the administrator or on-site manager, must satisfactorily complete a total of at least twenty-four (24) hours of continuing education within the first year of employment as a direct care worker. The courses offered must be relevant to assigned job duties and include such topics as cardiopulmonary resuscitation and first aid certifications, utilizing standard precautions in working with aging residents, working with residents with Alzheimer's or other cognitive impairments, working with persons who have developmental disabilities or persons who have mental illness, providing social and recreational activities, understanding legal issues, performing necessary physical maintenance, fire safety, housekeeping activities, recognizing and reporting abuse, neglect and exploitation, preparing and serving food safely, preserving the dignity and rights of residents receiving care to make meaningful choices, providing and documenting medication assistance, or other topics as determined necessary by the Department to support compliance.

(6) Ongoing Staff Training. Beginning with the second year of employment, staff providing hands-on personal services must have a minimum of sixteen (16) hours of job-related continuing education as referenced in paragraph 111-8-63-.09(5) above annually.

(7) Training Records. The community must maintain documentation reflecting course content, instructor qualifications, agenda and attendance rosters for all trainings provided.

(8) Proxy Caregiver Training. An assisted living community employing proxy caregivers must provide training to the proxy caregivers in accordance with the Rules and Regulations for Use of Proxy Caregivers, Chapter 111-8-100 subject to the limitation that only certified medication aides may administer medications on behalf of the community.

(9) Hospice Training. The assisted living community shall ensure that any medication aide(s) who will be administering liquid morphine to any hospice patient(s) residing in the community receive adequate training from a licensed hospice on the safe and proper administration of liquid morphine prior to such administration and on an annual basis thereafter. The community shall maintain documentation of all training provided.

(10) Staff Health Examinations and Screenings. The administrator, on-site manager, and each employee must have received a tuberculosis screening and a physical examination by a licensed physician, nurse practitioner or physician's assistant within twelve months prior to providing care to the residents. The physical examination must be sufficiently comprehensive to assure that the employee is physically qualified to work and free of diseases communicable within the scope of employment. Follow-up examinations must be conducted by a licensed physician, nurse practitioner or physician's assistant for each administrator or staff person to determine readiness to return to work following a significant illness or injury. Health information, screenings, assessments and medical releases regarding each staff member must be retained in a readily retrievable format by the assisted living community and made available for review and/or copying by Department representatives upon request.

(11) Criminal History Background Checks for Owners Required. The owner of the business or agency applying for the license must comply with the requirements of the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(12) Criminal History Background Checks for Director, Administrator and Onsite Manager Required. Prior to serving as a director, administrator or onsite manager of an assisted living community, the community must obtain a satisfactory fingerprint records check determination for the person to be hired in compliance with the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(13) Criminal History Background Checks for Direct Access Employees Required. Prior to serving as a direct access employee, the community must obtain a satisfactory fingerprint records check determination for the person to be hired in compliance with the Rules and Regulations for Criminal Background Checks, Chapter 111-8-12.

(14) The administrator or on-site manager must obtain an employment history for each employee and maintain documentation in the employee's file. If the potential employee has no prior employment history, then the assisted living community must retain documentation of a satisfactory personal reference check.

(15) Personnel files must be maintained in the assisted living community for each employee and for three years following the employee's departure or discharge. These files must be available for inspection by departmental staff but must be maintained to protect the confidentiality of the information contained in them from improper disclosure. The files must include the following:

(a) evidence of a satisfactory fingerprint record check determination, if applicable;

(b) report of physical examination completed by a licensed physician, nurse practitioner or physician's assistant, and a TB screening completed within the 12 months preceding the date of hire;

(c) evidence of trainings, skills competency determinations and recertifications as required by these rules and, if applicable, the Rules for Proxy Caregivers, Chapter 111-8-100;

(d) employment history, including previous places of work, employers and telephone contacts with previous employers;

(e) supporting documentation reflecting that the employee has the basic qualifications as represented, e.g. documentation of good standing by nursing board, no findings of abuse, neglect or exploitation entered against the individual in the nurse aide registry, satisfactory report of motor vehicle driving record where the employee may be transporting residents; and

(f) written evidence of satisfactory initial and annual work performance reviews for unlicensed staff providing hands-on personal care. Where the unlicensed staff perform specialized tasks, such as health maintenance activities, assistance with medications or medication administration, such performance reviews must include the satisfactory completion of skills competency checklists as specified in applicable rules. Such reviews must be conducted by staff or contractors qualified by education, training and experience to assess that the assigned duties are being performed in accordance with these rules and accepted health and safety standards.

(16) Where the assisted living community permits a resident to hire his or her own companion-sitter, proxy caregiver to perform health maintenance activities or aide of any sort, the assisted living community must require assurance that the companion-sitter, proxy caregiver or aide so hired is familiar with emergency evacuation routes and has documentation reflecting compliance with the provisions of the Rules for Proxy Caregivers, Chapter 111-8-100, as applicable.

(17) The administrator, on-site manager, and staff persons must not be under the influence of alcohol or other controlled substances while engaged in any work-related activity on behalf of the assisted living community.

(18) The community must maintain an average monthly minimum on-site staff to resident ratio of one awake direct care staff person per 15 residents during waking hours and one awake direct care staff person per 20 residents during non-waking hours where the residents have minimal care needs. Average monthly minimum staffing levels shall be calculated and documented by the community using methods and forms specified by the department. However, the assisted living community must staff above these minimum on-site staff ratios to meet the specific residents' ongoing health, safety and care needs.

(a) Staff, such as cooks and maintenance staff, who do not receive on-going direct care training and whose job duties do not routinely involve the oversight or delivery of direct personal care to the residents, must not be counted towards these minimum staffing ratios. Personnel who work for another entity, such as a private home care provider, hospice, etc. or private sitters cannot be counted in the staff ratios for the assisted living community.

(b) At least two on-site direct care staff persons must be on the premises 24 hours per day providing supervision whenever residents are present, with at least one staff person on each occupied floor.

(c) A registered professional nurse or licensed practical nurse must be on-site to support care and oversight of the residents, as follows:

(i) For communities with one to 30 residents, a minimum of 8 hours per week;

(ii) For communities with 31 to 60 residents, a minimum of 16 hours per week;

(iii) For communities with 61 to 90 residents, a minimum of 24 hours per week;

(iv) For communities with more than 90 residents, a minimum of 40 hours per week;

(d) Residents must be supervised consistent with their needs.

(19) Sufficient staff time must be provided by the assisted living community such that each resident:

(a) receives services, treatments, medications and diet as prescribed;

(b) receives proper care to prevent decubitus ulcers and contractures;

(d) is treated with dignity, kindness, and consideration and respect;

(e) is protected from avoidable injury and infection;

(f) is given prompt, unhurried assistance if she or he requires help with eating;

(g) is given assistance, if needed, with daily hygiene, including baths and oral care; and

(h) is given assistance in transferring and assisted self-preservation when needed.

(20) All persons, including the administrator or on-site manager, who offer direct care to the residents on behalf of the assisted living community, must maintain an awareness of each resident's normal appearance and must intervene, as appropriate, if a resident's state of health appears to be in jeopardy.

(21) All assisted living communities must develop and maintain accurate staffing plans that take into account the specific needs of the residents and monthly work schedules for all employees, including relief workers, showing planned and actual coverage for each day and night. The assisted living community must retain the completed staff schedules for a minimum of one year.

(22) Staff must wear employee identification badges which are readily visible with abbreviations for professional/special credentials displayed on the badges, if any.

(23) Medical Alert Systems. Homes utilizing medical alert systems to allow on-site staff to move about as specified in Rule 111-8-63-.09(4) must meet the following requirements: